ORTHOWORLD » Other Articles of Interest
Articles of Interest
August 31, 2015
| ConforMIS Initiates Voluntary Recall of Certain PSI for iUni, iDuo and iTotal Knee Systems
ConforMIS (CFMS) initiated a voluntary recall of certain patient-specific instrumentation for iUni, iDuo, iTotal CR and iTotal PS knee systems following three complaints of moisture on the instrumentation. Approximately 950 patient-specific instrumentation sets are affected, of which ~650 sets were used in knee procedures and ~300 sets shipped but not yet used. CFMS does not believe that customized knee implants included with the sets were affected, and has not received reports of related adverse events, to date.
The recalled instrumentation appears to have held excess water before undergoing ethylene oxide sterilization and, as a result, may contain small amounts of ethylene glycol residue. ConforMIS has temporarily suspended use of the ethylene oxide sterilization process, and CFMS will use a validated, alternative sterilization process (hydrogen peroxide-based, per Canaccord Genuity analysts).
~ 950 patient-specific instrumentation sets affected
~650 sets used in knee implant procedures, ~300 sets shipped but not yet used
Affected sets manufactured and distributed from the company’s new manufacturing facility between July 18, 2015 and August 28, 2015
Manufacturing is likely to be substantially reduced in September (possibly into October) in light of investigation and resolution activities. Wells Fargo analysts cite CFMS’ expectation to secure a solution within this timeframe, with a potential resolution by year-end.
Combined, the effect of recalled products that were shipped but not used, lower production capacity and potential commercial disruption will impact sales; CFMS is revising 2015 revenue to a range of $64 million to $66 million (up 39% to 43% in constant currency)—a reduction of $8 million from previous guidance.
In early 3Q15, ConforMIS closed its IPO of 10,350,000 shares of common stock at $15/share (before underwriting discounts), and in mid-3Q, the company announced that interim analysis of 295 total knee replacement patients at seven U.S. centers indicated that patients with iTotal CR (cruciate-retaining) devices were more likely to have an excellent or good objective Knee Society Score and walked statistically significantly faster than patients with standard, off-the-shelf total knees.
Sources: ConforMIS, analyst notes
August 19, 2015
| FDA Extends UDI Deadlines Following Database Security Issues
FDA has extended the upcoming deadline for compliance with labeling and data submission to the Global Unique Device Identification Database (GUDID) due to the Agency pulling the database offline after an undisclosed security vulnerability was detected.
Manufacturers of implantable, life sustaining and life supporting devices, as well as Class III devices that received extensions expiring between August 7 and the original September 24 deadline, now have until October 24 to submit data.
In May, FDA launched the database
that will house submitted data from medical device companies. The database allows the public to track medical devices from manufacturing through the supply chain to patient use.
August 11, 2015
| Senate Legislation Exempts ASC Procedures from Meaningful Use
The Electronic Health Fairness Act of 2015 (S. 1347, H.R. 887) is approved by the U.S. Senate and now proceeds to the president’s desk.
Presently, Medicare provides incentive payments to hospitals and eligible professionals who become “meaningful users” of certified electronic health record technology (EHR). As of 2015, eligible professionals who are not meaningful users may be subject to a penalty.
The Health Information Technology for Economic and Clinical Health (HITECH) authorized Medicare and Medicaid incentive payments to promote EHR use; however, HITECH didn’t include ambulatory surgical centers (ASCs) in the incentive program. Therefore, development of EHR products tailored to ASCs was not a vendor priority, nor was it included in the certification process. As such, states the bill language, providers in ASC facilities should not be disadvantaged in the program.
The bill would exclude ASC services from being counted toward the 50 percent meaningful use eligibility threshold until certified EHR technology applicable to the ASC setting is available. This exclusion would end three years after the Secretary, by rulemaking, determines that CEHRT applicable to the ASC setting is available.
Senate Report 114-106 is available here.
August 07, 2015
| FDA Announces FY16 User Fee Rates
FDA announced FY16 fee rates and payment procedures for medical device user fees, which apply from 10/1/15 through 9/30/16. Under the user fee system, device companies pay FDA when they register their establishments and list devices with the agency, when they submit an application or a notification to market a new medical device in the U.S. and for certain other submissions. The collected fees are intended to support FDA’s endeavors to conduct efficient, timely and transparent reviews.
For FY16, the fee for establishment registration is $3,845, up from $3,646 for FY15. There is no fee reduction for small businesses, but they do qualify for lower user fees on certain application types. (Per FDA, if your business has gross receipts or sales of no more than $100MM for the most recent tax year, you may qualify. If your business has gross sales or receipts of no more than $30MM, you may also qualify for a waiver of the fee for your first premarket approval application, product development protocol, biologics license application or premarket report.)
The table below summarizes FY16 rates for all medical device fees, compared to rates for FY15. Fees for 510(k) submissions increased by $210 standard and $105 for a small business; PMA fees increased by $10,493 and $2,623, respectively.
Application Fee Type
FY 2016 Standard Fee
FY 2015 Standard Fee
FY 2016 Small Business Fee
FY 2015 Small Business Fee
(PMA, PDP or BLA)
(to an approved BLA)
513(g) request for classification information
August 03, 2015
| Wright Medical Updates Augment's FDA Approval Status
In 1Q15, Wright Medical announced that an Augment® Bone Graft vendor received a Form 483 with 13 observations following an FDA pre-approval facility inspection. Later that quarter, the vendor was notified by FDA that its facility would be reinspected and must be in substantial compliance with the current Good Manufacturing Practice (cGMP) regulation as a condition for approval of the Augment Bone Graft Premarket Approval Application.
Following reinspection in late 2Q15, the vendor received a Form 483 including seven observations—none specifically related to Augment Bone Graft.
The vendor has submitted its response to the FDA, and FDA has not informed Wright Medical if a vendor reinspection will be required. Assuming no additional reinspection, Wright anticipates final approval of Augment Bone Graft in 2H15.
In the 2Q15 earnings call
, Wright Medical President & CEO Bob Palmisano stated, “Let me be clear, that based upon the approval letter that we received from the FDA, we continue to believe that Augment will be approved and the product, as well as the PDGF [Platelet-Derived Growth Factor] technology platform, will be important drivers of long-term growth for our business for years to come.” Also, “we’re not changing our previously provided  revenue guidance, given the strength of our first half sales results, our current sales trajectory and currency rate as of today.” He later noted that the timing of the approval will impact where Wright falls within that guidance range.
The PDGF pipeline includes an Augment Injectable format and potential applications for rotator cuff and tennis elbow repair. Augment Injectable presently sells in Australia, with a reportedly strong positive response to its ease of use.
July 20, 2015
| Why Orthopaedics Will Grow in Asia
Orthopaedics remains an attractive and growing market, especially in Asia. Multiple factors contribute to the growth of the orthopaedic market in this region.
First, the quickly-growing elderly population increases the prevalence of orthopaedic disorders and thus, has driven the demand for products and procedures. Second, per capita income and national wealth is rising in Asian countries. For example, the per capita income in Singapore is $15,000 higher than in the U.S. This has improved the capability for the general population to afford more orthopaedic procedures and has boosted government investments in healthcare infrastructure. Third, common health conditions such as diabetes and obesity are rising, further heightening the risks of disorders like osteoarthritis. Finally, increased vehicle sales have led to a rise in the number of car accidents and injuries that require orthopaedic treatment.
Market Opportunity: Japan, China and India
The global orthopaedic device market is anticipated to reach about $50 billion by 2017, according to ORTHOWORLD®’s ORTHOPAEDIC INDUSTRY ANNUAL REPORT®
. Asia accounts for 60 percent of the world’s population, but the region currently holds about 15 percent of the global orthopaedic device market. Thus, there is significant room for growth in the region, specifically in Japan, Korea, Taiwan and China, which all have rapidly-aging populations.
Japan has the largest share of the Asian orthopaedic market. In 2014, 45 percent of the Asian orthopaedic products market was claimed by Japan. Moderate growth is estimated in the large joint reconstruction device market (which includes hip and knee implants), but in the spine area, growth is still strong. The Japanese orthopaedic market faces some challenges, however, such as a cultural aversion to invasive surgical procedures and the reluctance of doctors to adopt some new Western technologies.
China’s orthopaedic market is also experiencing high growth, at about 15 to 20 percent per year. More than 200 million Chinese citizens are over the age of 60, and about 10 million people are added to this group every year. With this growing elderly population, urbanization of the country and other factors discussed above, orthopaedic growth is expected to continue in China. Analysts have estimated different values of the Chinese market. Frost and Sullivan estimates that the Chinese orthopaedic implant market will surpass Japan in 2015. According to an estimate by the Boston Consulting Group, the Chinese orthopaedic implant market will grow from $1.3 billion in 2013 to $4.1 billion in 2020.
India’s orthopaedic market also sees strong growth at about 15 percent per year. The Indian orthopaedic market will continue to grow in coming years due to the country’s demographics, increased health awareness and growing public and private insurance market. India’s population is expected to surpass China by 2040. With a fast-growing population, the incidence of spinal, joint and general bone-related conditions is increasing dramatically. Furthermore, as India’s middle class continues to expand, demand for better healthcare services and orthopaedic devices will also rise. Finally, India has the highest number of diabetic patients in the world; this further heightens the risks of disorders like osteoarthritis.
ORTHOWORLD’s latest market intelligence report focuses on the Japanese market and is available for complimentary download.
According to the report:
Japan’s large joint segment is expected to reach $1.5 billion, with small joints reaching $0.75 million in 2015.
A shrinking yet aging population will support the need for hip and knee replacements; Japanese tend to gravitate toward devices that support high range of flexion and small anatomies.
Revisions to the Pharmaceutical Affairs Law (renamed the Pharmaceutical and Medical Device Law), enacted in 2014, should ease long regulatory review times for orthopaedic medical devices.
June 30, 2015
| Integra Expands Focus on Wound Care with TEI Acquisition
Intergra LifeSciences entered into a definitive agreement to acquire TEI Biosciences and TEI Medical, furthering its Orthopedics and Tissue Technologies division’s focus on regenerative wound care and tissue repair. The acquisition is valued at $312 million cash and expected to close in 3Q15.
TEI manufactures one orthopaedic-related product, TissueMend, which is indicated for tendon repair surgery. In 4Q14, Integra announced it would increase its focus on wound care and extremities and spin off its spine business into the publicly-traded company SeaSpine, which is expected to begin trading on Nasdaq as SPNE July 1.
At the time, ORTHOWORLD interviewed Mark Augusti, Integra’s Corporate Vice President and President, Orthopedics and Tissue Technologies about the company’s three-point growth strategy:
Focus on new product introductions in shoulder and foot.
Conduct clinical studies that emphasize the diabetic foot segment
Grow its distributor and direct rep model
The full BONEZONE® interview with Augusti can be found here.
June 25, 2015
| Zimmer Closes Biomet Acquisition
On Wednesday, June 24, Zimmer completed its acquisition of Biomet in a cash equity transaction valued at ~$14 billion.
Zimmer announced its plans to acquire its cross-town rival in Warsaw, Indiana in April 2014. The newly-named Zimmer Biomet Holdings Inc. now becomes the world’s second-largest orthopaedic device company, with estimated market share of 17 percent. Combined, the companies’ orthopaedic revenues reached nearly $7.5 billion in 2014.
Zimmer Biomet leaders affirmed that the acquisition enhances the company’s ability to diversify its revenue mix, create cross-selling opportunities and improve global distribution channels.
An estimated 72 percent of the company’s revenue will derive from joint reconstruction, where the combined company will hold 35 percent of segment share, according to ORTHOWORLD’s Orthopaedic Device Company Profiles: Top Performers. (See Exhibit 1.) Specifically, the acquisition gives Zimmer Biomet an edge in the knee and hip markets and accelerates its growth—and market position—in arthroscopy/soft tissue, trauma and spine.
Exhibit 1: Zimmer Biomet Worldwide 2014 Revenue by Market Segment
Updated net annual synergies were provided during the acquisition closing announcement. Zimmer Biomet expects synergies of approximately $350 million by the end of its third year, with approximately $135 million synergies anticipated in the first 12 months. The company’s planned research and development budget is $360 million, nearly double Zimmer’s previous spend.
To satisfy regulators, Zimmer agreed to divest U.S. rights and assets for the ZUK unicondylar knee to Smith & Nephew, and U.S. rights and assets for Biomet’s Discovery® Total Elbow, Cobalt™ Bone Cement and Optivac® Cement Mixing Accessories to DJO Global. Lima Corporate acquired the ZUK and Discovery Elbow within the European Economic Area and Switzerland, as well as the Biomet Vanguard™ Complete Knee for Denmark and Sweden.
Wells Fargo suggested that the divestiture of Biomet’s bone cement may indicate FTC’s treatment of future M&A in the hip and knee arena. With four major players in the bone cement segment representing 98% market share (Stryker 40%, Zimmer 30%, Johnson & Johnson/DePuy Synthes 18% and Biomet 10%, per FTC), FTC viewed the Zimmer Biomet rollup as anti-competitive. In hips/knees, 90% of the market* is led again by four entities (Zimmer Biomet 37%, Stryker 23%, Johnson & Johnson/DePuy Synthes 21%, Smith & Nephew 10%). In light of these numbers, it’s possible that FTC could treat future transactions in that segment in the same way as with bone cement.
For more M&A coverage, read BONEZONE’s articles on Globus Medical and supplier consolidation and leverage ORTHOWORLD’s M&A Activity Tool.
*FTC's 90% is slightly higher than ORTHOWORLD's estimate of 87% hip/knee market share held by these four companies. See our lineup in the ANNUAL REPORT.
June 24, 2015
| OMTEC 2015 Highlights: The Paradigm Shift in R&D Spend
Orthopaedic professionals in attendance at OMTEC® 2015 received less of a warning and more of a mandate from surgeon and hospital executive, Wael Barsoum, M.D.
: device companies that want to get paid must spend resources to produce transformational devices, or to produce today’s clinically-proven devices at a lower cost. Hospitals will no longer purchase devices with incremental changes at a slight surcharge, due to the reimbursement pressures they face from public and private payors.
“This is a paradigm shift in how we think about spending our R&D dollars,” said Barsoum, President of Cleveland Clinic Florida and Vice Chairman of the hospital system’s Orthopaedic Department. “It requires a completely different thought process than how we’ve done it in the last 30 years.”
Barsoum’s comments offered context to the perspective provided by device company executives in Wednesday’s OMTEC keynote
. That panel included:
Moderator Doug Kohrs, Managing Director of startup Responsive Orthopedics and Past President and CEO of Tornier
B. Sonny Bal, M.D., J.D., Chairman, President and CEO of Amedica and a joint replacement surgeon at the University of Missouri
Ken Gall, Ph.D., Founder and Chief Technology Officer of MedShape and Chair of the Mechanical Engineering and Materials Science Department at Duke University
Rod Mayer, President of Nextremity Solutions
The panelists agreed that one of today’s major obstacles to commercialization is getting products through value analysis committees—a challenge that will remain for the foreseeable future.
Mayer, too, noted that Nextremity has experienced value analysis committee decision-making terms from 30-60 days up to 18 months. Kohrs shed light on the Mayo Clinic’s process, adding that the hospital system’s new product committee has 14 people: one orthopaedic surgeon, one cardiologist and 12 accountants.
As a joint replacement surgeon at the University of Missouri’s orthopaedic hospital, Dr. Bal said that he and his colleagues face procedure-specific price parameters. If he wants to use a knee system that costs more than the set price, he must justify his decision to a committee. He described the uphill climb that is getting new materials and differentiated products through the committees.
What, then, will hospitals pay for? And what is needed to get through committees?
Barsoum, who sits on the new products committee at the Cleveland Clinic, said that if the device is not cheaper or if it’s new, companies must present one or more of the following: existing human data, level 1 studies, reproducible published studies in peer-reviewed literature and cost-benefit studies.
Herein lies the gap: development of differentiated products takes time and money. Collection of data takes time and money.
“A lot of devices don’t have clinical data,” Bal said. “You introduce a new knee system, and by the time you get clinical data that compares it to its predicate, it’s been a decade. Most of us are dead by that time.
“What the industry needs—and this is a challenge—is good, validated, short-term proxies for how something will perform over the long run. It’s very important so that we can go to value analysis committees and say, ‘Some clinical data is impossible to obtain because of ethical reasons; some are decades out, but here’s the valid testing we’ve done that shows an advantage.’ ”
Business changes, whether they center upon manufacturing, marketing or organization, take time and money, too. The price squeeze has driven consolidation at the device company and supplier level in order to increase breadth of product and capacity and achieve operational synergies. The price squeeze is expected to continue to drive device company and supplier consolidation
, just as it has at the hospital level.
Amidst these market changes, all five keynote participants maintained that orthopaedic innovation is not dead. However, innovation will need to focus on differentiated products, efficient processes and surgeon education. The ability to navigate these pathways will stand as the greatest challenge throughout the next five years.
June 11, 2015
| Globus Medical Completes Acquisition of Branch Medical
Globus Medical closed its acquisition of Branch Medical Group (BMG), a transaction added to a short list of recent OEM purchases of partners. The initial price of $52.9 million was finalized at $57 million in cash, $5.3 million in deferred consideration and an estimated $0.9 million payable upon finalization of closing adjustments. An amount payable to BMG on the date of acquisition of $5.2 million was also settled in connection with the acquisition. The final purchase price was $68.4 million.
Globus and Branch, neighbors in southeast Pennsylvania, have worked together for a decade.
• Branch became a Globus supplier in 2005.
• Globus management and insiders owned 49 percent of Branch prior to the acquisition.
• Globus uses Branch to manufacture about 25 percent of its products—a number that management
expects to double over the next three to four years.
• Branch, which achieved $23.3 million in revenue and $9.1 million in adjusted EBITDA in 2014,
booked 94 percent of its sales from Globus.
Analysts at Canaccord Genuity noted that the acquisition favorably positions Globus to realize gross profit leverage, and the transaction offered insight on the operating and manufacturing profile between the two.
“Bearish investors have historically pointed to the BMG related-party relationship as one of the main reasons for Globus’s best-in-class margin profile, i.e. investors speculated that Globus used its relationship with BMG to secure very attractive manufacturing terms (low inventory costs),” Canaccord Genuity wrote in its analysis of the merger. “That said, $9.1M in EBITDA for 2014 equates to a margin profile of 39 percent, which is very high in the contract manufacturing industry, and therefore should put an end to investor speculation.”
The BMG acquisition comes on the heels of Globus’ purchases of Transplant Technologies of Texas and Excelsius Surgical in 2014. Globus achieved 2014 revenue of $474.4 million, an increase of 9 percent over 2013, and has released 2015 guidance of $510 million in revenue.
Overall orthopaedic industry consolidation has kept pace with the first half of 2014, as OEMs buy OEMs, suppliers buy suppliers and partners buy partners. In the first two quarters of 2015, Smith & Nephew acquired EuroCiencia Colombia, its sole Colombian distributor of reconstruction, trauma and sports medicine products since 2006; Exactech acquired BlueOrtho SAS, the company that helped develop the ExactechGPS® Guided Personalized Surgery system and McGinley Orthopaedic Innovation purchased its supplier partner, DS Manufacturing.
Read more about industry consolidation in ORTHOKNOW®:
Suppliers Consolidate in Response to OEM M&A Activity
The Seven Phases of M&A
Business Development Execs Speak on M&A and Innovation
May 27, 2015
| NuVasive Names Lucier as CEO
NuVasive appointed Gregory T. Lucier as CEO. Mr. Lucier had served as Interim CEO since April 1, when it was announced that Alex Lukianov resigned
after results from an independent investigation found a failure to comply with expense reimbursement and personnel policies.
Mr. Lucier has served as a member of NuVasive’s Board of Directors since December 2013 and will continue his role as its Chairman.
Mr. Lucier previously led the small startup, Invitrogen, through its merger with Applied Biosystems and transformation of that entity, renamed Life Technologies, into a global biotechnology firm with 50,000 products, 12,000 employees and ~$4 billion in sales in more than 180 countries.
NuVasive reported first quarter sales of $192.4 million, up 10 percent vs. 2014. The company’s spinal surgery division achieved sales of $159 million and its biologics division, $13 million. In early May, the company launched the Integrated Global Alignment Platform (iGA™) plus, a suite of alignment-focused products.
May 07, 2015
| Build a Supply Base that Supports the Corporate Vision
Achieving strategic alignment throughout the entire organization isn’t easy, and can be especially difficult for purchasing departments. Jeoff Burris addresses this in a recent article
about the benefits of building a supply chain that supports the corporate vision.
The difficulty lies in the fact that:
Corporate visions can provide conflicting messages—a company may strive to be a technology leader while experiencing pressures from low-cost producers.
Economics and competitive pressures change—visions should be static, but plans to achieve them need to be flexible.
Suppliers’ visions for their businesses may not align with your company’s vision.
Mr. Burris continues:
“A strategically aligned supply base efficiently leverages the resources of suppliers that can best help your company achieve its vision, and provides extended benefits to those suppliers. A strategically aligned supply base can also help lower the cost of products and reduce investments required to develop new products or expand into geographic regions.”
How can this be achieved?
Step 1: Purchasing Must Understand Company Strategy
Step 2: Purchasing Must Assess and Identify Commodities with the Highest Impact on the Strategy
April 01, 2015
| NuVasive, Self-claimed #3 Spine Company, Under New Interim Leadership
On Wednesday, April 1, NuVasive (NUVA) announced the appointment of Gregory Lucier as Chairman and Interim CEO following the resignation of Alex Lukianov. Mr. Lukianov stepped down after results from an independent investigation found that he failed to comply with expense reimbursement and personnel policies. Mr. Lukianov will reportedly remain as a consultant to NUVA for 18 months.
NUVA achieved 2014 sales over $760 million, growing 12% over 2013 on its path to the $1 billion mark. The company has proposed 2015 revenue guidance of $810 million, and just announced 1Q15 anticipated revenue of over $190 million. It claims the No. 3 position in the global spine market, though ORTHOWORLD estimates place it at No. 4, excluding NUVA’s biologic and neuromonitoring revenue. Matters related to the aforementioned investigation are said to be immaterial to financial results.
Analysts weighing in on the announcement suggest that this change at the helm may pave the way for NUVA’s acquisition, or at the very least, a re-evaluation of all strategic options, noting also the upcoming (and unrelated) departure of Keith Valentine as Chief Operating Officer and recent appointments of Pat Miles as President/COO and Matt Link as President, U.S. Sales and Services.
Mr. Lucier’s experience includes leadership of the small startup, Invitrogen, through its merger with Applied Biosystems and transformation of that entity, renamed Life Technologies, into a global biotechnology firm with 50,000 products, 12,000 employees and ~$4 billion in sales in more than 180 countries.
More can be learned about players in the spine segment in the newly-released ORTHOPAEDIC INDUSTRY ANNUAL REPORT®. Details on this yearly overview are available online.
March 25, 2015
| Worldwide Orthopaedic Market 2014-2020
In a time of heightened M&A activity, ORTHOWORLD announces the availability of its annually produced ORTHOPAEDIC INDUSTRY ANNUAL REPORT®. The 200-page, comprehensive overview of the industry, complete with 2014 sales estimates and projections to 2020, is presented in 5 major market segments:
Arthroscopy/Soft Tissue Repair
ORTHOWORLD estimates 2014 worldwide sales of $45.5 billion, an estimated 3% YOY growth, with consistent, steady growth projected through 2020. “The various market segments have their unique challenges and opportunities,” commented Carolyn LaWell, Content Manager for ORTHOWORLD and co-author of the report. “For example, non-fusion technologies in spine are gaining traction, but reimbursement and regulatory headwinds will continue to provide resistance for the near term, whereas certain extremities products are posting double digit growth and experiencing little to no pricing pressure. The ANNUAL REPORT is a valuable read for anyone seeking a firmer grasp on the present (and future) landscape of orthopaedics.”
ORTHOWORLD Members receive an annual installment of the report as part of their Benefits Package. Others (veterans and newcomers alike) are encouraged to consider purchasing a Membership to gain access to the report, though a standalone purchase is available.
March 11, 2015
| Compliance Isn't Accidental: A Case for Management's Commitment to Quality
John Gagliardi, BONEZONE® author, writes:
During my global travels, I’ve met a wide variety of people, including an assortment of executives who strategically drive their medical device companies toward success. Are they all successful? No. I say that tongue-in-cheek, because some managers with executive responsibilities make a decent profit for their companies every year, but fail miserably in directing and enabling the quality and regulatory requirements mandated by FDA and ISO Registrars. It’s true. They don’t know how to handle these requirements.
In this ongoing, quiet recession with which the world is struggling (and getting used to), there is a not-so-fine line drawn in the sand that separates business acuity and regulatory compliance. Purists say there is no line, and “the architecture of the Quality System Regulation and ISO 13485:2012” thrives on a seamless relationship between regulatory requirements and business systems excellence. Realists say there is no contest; business initiatives and monetary success are clear winners, while quality and regulatory are just a means to a predetermined end.
FDA investigators and ISO auditors like me also have a lot to say about the approach that should be taken. Mainly, it must document demands for management commitment and establish a policy for quality that is understood by all employees at all levels of the company. Business and quality must be equal under one roof.
Read on at BONEZONEpub.com.
Specifically, management's lack of CAPA knowledge and commitment to resources impacts a manufacturer's Quality Management System. Join John Gagliardi at his OMTEC® 2015 workshop, CAPA: Why is My Process Not Working?
February 12, 2015
| In Memory of Biomet Founder, Dane Miller
Orthopaedics lost an industry stalwart this week with the passing of Dane A. Miller, Ph.D., one of four Biomet founders and CEO of the company from 1977 to 2006. He was 69.
Biomet was founded to compete in a market dominated by pharmaceutical companies with orthopaedic device divisions. Under Miller’s leadership, Biomet grew from $17,000 in revenue in 1978, its first fiscal year in operation, to more than $2 billion in 2006. Biomet has long been known for its family-like culture that was fostered by Miller even as the company grew to become of the largest in the industry.
“It is impossible in one short statement to give justice to his impact on our company, on our industry, and on the communities where we operate – especially Warsaw and Winona Lake, Indiana,” Biomet President and CEO, Jeff Binder, said in a statement. “It is also impossible to describe adequately Dane’s impact on the lives of our Team Members and on the members of the orthopaedic community with whom he worked and developed friendships over many years.
“Dane Miller was a true pioneer both in regard to the development of new technologies and in the management and development of Biomet’s unique work environment and culture.”
His dedication to technological advancement and the Biomet team is evidenced in a 2004 Executive Interview Miller gave to ORTHOKNOW®.
Grace College will hold a memorial service on February 20. Click here for more information.
February 04, 2015
| CMS Announces Goals to Increase Value-Based Purchasing
The Department of Health and Human Services (HHS) seeks to move 90 percent of Medicare fee-for-service payments to value-based purchasing models by 2018, according to goals released last week.
Alternative payment models include Accountable Care Organizations, advanced primary care medical home models, new models of bundling payments for episodes of care and integrated care demonstrations for beneficiaries enrolled in Medicare/Medicaid.
HHS has placed CMS payments into four categories:
Category 1: fee-for-service with no link of payment to quality
Category 2: fee-for-service with a link of payment to quality
Category 3: alternative payment models built on fee-for-service architecture
Category 4: population-based payment
Value-based purchasing applies to payments made in categories 2-4. In 2014, an estimated 20 percent of Medicare reimbursements shifted to these payment models, linking physician reimbursement to patient outcomes.
HHS has set the goal of 30 percent of Medicare payments in categories 3 and 4 by the end of 2016 and 50 percent by the end of 2018. HHS seeks to have 85 percent of Medicare fee-for-service payments in value-based purchasing categories 2 through 4 by 2016 and 90 percent by 2018.
For more information on CMS’s latest announcement, click here.
Learn more about bundled payments in the ORTHOKNOW® article, Pricing Strategy Shifts from Operating Room to Episode of Care.
January 13, 2015
| CDRH 2015 Priorities to be Addressed at OMTEC
FDA’s Center for Device and Radiological Health (CDRH) issued a list of guidance documents it intends to publish in 2015, as well as other changes to its priorities, such as a retrospective review of previously-issued final guidance documents and a new guidance document database.
Pertinent topics for orthopaedic device companies, based on CDRH’s 2015 priorities, will be addressed by industry experts and CDRH directors at OMTEC 2015, such as FDA Update: What's New in Orthopaedic Devices. Others include the following.
Final Guidance Topics
Applying Human Factors & Usability Engineering to Optimize Medical Device Design
• OMTEC Session
Submission and Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile
• OMTEC Session: Improve Your Device Submission Process
Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval
Intent to Exempt Certain Class II and Class I Reserved Medical Devices From Premarket Notification
Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation and Testing
Draft Guidance Topics
• OMTEC Sessions: UDI: Lessons in Implementation
• UDI: How Do I Make This Data Work for Me?
Medical Device Accessories
Medical Device Decision Support Software
Benefit/Risk Factors to Consider When Reviewing IDE Submissions
UDI Direct Marking
Informed Consent: Policy for Observational Data Used to Fulfill Device Requirements
Adaptive Design for Medical Device Clinical Studies
Stay informed on these and other relevant topics through OMTEC’s education sessions. For all OMTEC 2015 Education, click here.
January 08, 2015
| Webinar: FDA's Medical Device Clinical Trials Program, January 22, 2015
In an effort to ensure that patients in the U.S. have access to high-quality, safe and effective medical devices, the medical device clinical trials program at FDA has undergone many changes. Some of these changes include issuing guidance documents and revising organizational structure and policies. This webinar will address the present and future of FDA's medical device clinical trials program. Topics to be covered include:
Clinical Trial Strategic Priority
IDE SOP Implementation
FY14 Performance and FY15 Performance Goals
Early Feasibility Studies
Future Program Plans
Target Audience: Medical Device Industry, Medical Device Developers, Medical Device Industry Associations, Researchers, Academia
Find all pertinent details online at FDA.gov.
December 17, 2014
| EU Proposes Significant Changes for Importers and Distributors
The EU’s proposed Medical Device Regulation will subject companies within the supply chain to the same rules, differing from the current fragmented national regulation.
An important change in the new supply chain checks system is that each downstream economic operator has to verify that the previous economic operator complies with the MDR requirements. Thus, importers and distributors have to make sure that, prior to placing a device on the market, the manufacturer, the importer and the device itself meet the MDR requirements.
Authors Erik Vollebregt and Arber Gjunkshi of Axon Lawyers outline obligations for importers and distributors in the BONEZONE® article, EU Proposes Significant Changes for Importers and Distributors.
December 01, 2014
| Surgeons and CEOs to Deliver Industry Forecasts at ORTHOWORLD Symposium
What does the future hold for the orthopaedic industry? Surgeons
and industry will unite for The State and Future of the Orthopaedic Industry™ Symposium to provide perspective on critical dynamics shaping the market.
ORTHOWORLD® was founded on the principle that discussing challenges and providing a place for our industry’s voice would lead to idea sharing and, ultimately, success. We realize the importance of sharing a greater understanding of the future—to preview what success will look like in five years. With that, it is our pleasure to revive the Symposium, which will be held January 19-20, 2015 in Nashville, Tennessee.
The event will equip you with knowledge and networking opportunities in order to secure more wins and break through more barriers.
We’ll kick off the morning with a 2020 forecast, asking CEOs to answer market-specific questions, including, "How much growth do you project in the market segments in which you play? What challenges and opportunities do you expect will play a role in that growth?"
Hutton Hotel | Nashville, TN
Monday, January 19, 2015
6:00 p.m. - 7:30 p.m.
Tuesday, January 20, 2015
8:00 a.m. - 1:30 p.m.
Breakfast, refreshment breaks and
lunch will be provided.
Download the Agenda
Read Press Release
Our participants include:
Moderator: Doug Kohrs, Past President and CEO, Tornier
Panelists: B. Sonny Bal, M.D., JD, Chairman, President and CEO, Amedica
Rod. K. Mayer, President and CEO, Nextremity Solutions
Once projections are laid out, our panel will dive into a Q&A about major regulatory and economic factors shaping the global orthopaedic industry and the opportunities that can be uncovered. The impact of the Affordable Care Act, medical device tax, M&A activity and changes to product delivery models will be amongst the broader topics discussed. Ample time will be left for audience Q&A.
Surgeon entrepreneur Selene Parekh, M.D., Partner at North Carolina Orthopaedic Clinic, Associate Professor at Duke University and Clinical Advisor at Excelerate Health Ventures, will present during lunch.
Dr. Parekh will cover the factors that have driven us to the current intersection of innovation and regulation and how to approach the undue burdens on the surgeon/device company relationship. The medical device tax has forced cuts to R&D spend; Open Payments has created excessive documentation and a restrictive FDA has led to the overseas-first launch of new technologies, many of which arose from U.S. surgeon ideas. "What will be the long-term impact on orthopaedic innovation? How can surgeons and device companies maintain strong relationships to move the industry forward?" Dr. Parekh aims to answer these questions.
Do you have a question? Emily McCandless is happy to assist and can be reached by email or phone at 440.543.2101.
More information on the Symposium speakers:
Doug Kohrs, Past President and Chief Executive Officer, Tornier N.V.
Mr. Kohrs has more than 30 years of experience in the medical device industry, primarily as a founder or executive of innovative companies. He served as the Chief Executive Officer and President of Tornier from 2006 to 2012, and Chief Executive Officer and President of American Medical Systems Holdings from 1999 to 2005.
He currently serves as President of Foundation for Essential Needs and serves on boards at Proto Labs, Inova Spine, Boi2 Technologies, OmniGuide and Tenex Health.
He has previously served on boards at InHealth, Tornier, ev3, Kyphon, Disc Dynamics, American Medical Systems, Pioneer Surgical and SpineCore.
Mr. Kohrs holds a B.S. in Bioengineering from Texas A&M University, a B.A. in Engineering Sciences from Austin College and an MBA from Northeastern University.
B. Sonny Bal, M.D., J.D., Chairman of the Board, President and CEO, Amedica Corporation
Dr. Bal has served on Amedica’s Board of Directors since February 2012, as Chairman of the board since August 2014 and as President and Chief Executive Officer since October 2014. He is Professor and Chief of Adult Reconstruction at the University of Missouri - Columbia and Adjunct Professor of Material Sciences at the University of Missouri at Rolla. Dr. Bal is a member of the American Academy of Orthopaedic Surgeons, the American Association of Hip and Knee Surgeons and the International Society of Technology in Arthroplasty. He also serves on the editorial board of several peer-refereed orthopaedic journals and has published extensively on the biomedical applications of silicon nitride ceramics. He continues that work with presentations at scientific forums worldwide.
Dr. Bal received his M.D. from Cornell University, an MBA from Northwestern University and a J.D. from the University of Missouri.
Rod K. Mayer, President and CEO, Nextremity Solutions, Inc.
Mr. Mayer has served in the orthopaedic industry since 1977, most recently as President and CEO of Nextremity Solutions as of February 2013.
Mr. Mayer started his orthopaedic career with DePuy, spending 18 years in various roles. His overall history in the industry includes extensive experience in sales, distribution and business development.
In the fall of 2002, Mr. Mayer founded DVO Extremity Solutions LLC, a company focused upon development and commercialization of innovative products for the upper extremity market. Mr. Mayer co-led the development, growth and eventual sale of DVO to Tornier in March 2007. He then served as Vice President of Sales Execution and was a member of Tornier’s executive management team. Mayer also co-founded Del Palma Orthopedics, a product development company, for which he was named President and CEO in April 2009 and currently serves as a Director. Mr. Mayer also serves on the Boards of Conventus Orthopedics and SDG Holdings.
Selene G. Parekh, M.D.
Dr. Selene G. Parekh, M.D., MBA, has been a partner at the North Carolina Orthopaedic Clinic and Associate Professor of Orthopaedic Surgery at Duke University since 2009. Before arriving at Duke, he was a foot and ankle surgeon at the University of North Carolina, where he served as the foot and ankle consultant to the athletic department and taught medical students and residents.
Dr. Parekh graduated from the Boston University School of Medicine, completed his residency at the Hospital of the University of Pennsylvania and his fellowship in foot and ankle surgery. He obtained his MBA from Boston University and completed a one-year Healthcare Entrepreneurship Fellowship at the Wharton School of Business at the University of Pennsylvania. He developed the Business of Orthopaedics conference, which taught practice management, product development, entrepreneurship, personal financial management, leadership and negotiations.
Dr. Parekh is dedicated to teaching medical students the importance of business in healthcare and diving into new technologies to improve patient outcomes.
November 11, 2014
| Wright Medical and Tornier Merge to Expand Extremities Portfolio
Wright Medical and Tornier’s $3.3 billion merger agreement is expected to secure the combined company as the biggest player in the global extremities segment with nearly 30 percent market share, followed by Zimmer Biomet and Johnson & Johnson/DePuy.
The new Wright Medical pure-play extremities/biologics business will strive to:
Offer surgeons and hospitals a comprehensive collection of upper and lower extremity products, with a global presence
Capitalize on opportunities in rapid-growth segments of upper extremities, lower extremities and biologics, including sales of biologics across the entire product portfolio, and increase global growth via complementary international footprints
Gain needed scale for both businesses, without diluting focus
The deal is expected to finalize in 1H15.
Get a strategic overview of the agreement and gain insight into Wright’s future product and sales plans, including ways that the merger impacts the global extremities market.
Read the full article online in BONEZONE® at www.bonezonepub.com.
October 22, 2014
| CMS Announces New Efforts to Strengthen ACOs
Despite the model’s mixed results in cost containment, the Centers for Medicare & Medicaid Services (CMS) announced a new initiative to bolster Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program (MSSP).
The ACO Investment Model is designed to provide assistance to rural and underserved areas through loans up to $114 million allocated for up to 75 ACOs across the U.S. Both current and new ACOs applying for the second round of contracts in 2016 in the MSSP are eligible. CMS will recover the loans through an offset of an ACO’s earned shared savings.
The MSSP program has over 240 participants, while the ACO Pioneer program is down to 19 participants from the original total of 32. ACOs continue to receive criticism for not significantly decreasing spending, as the model was intended.
Opponents say that ACOs create financial disincentives to hospitalize patients or refer for advanced care, leading to higher costs and poor outcomes for sick patients.
October 15, 2014
| Surgeon Leadership Essential to Influence Implant Purchasing Committees
Changes in hospital purchasing decisions directly impact the surgeon’s ability to freely select surgical implants. Yet, a reduction in the hospital’s absolute number of “surgeon preference items,” such as implants handled by the facility, drives efficiencies on a variety of levels. Dr. John Pracyk explores that ways that flexibility, collaboration and transparency can allow surgeons to work with their hospitals and manufacturers, successfully responding to changes in purchasing and procurement.
Read about it in ORTHOPRENEUR®.
September 30, 2014
| Federal Appeals Court Finds FDA Exceeded its Authority in Reclassifying ReGen's 510(k)
The U.S. Court of Appeals for the District of Columbia Circuit ruled that FDA has no “inherent reconsideration authority” to reclassify 510(k) cleared devices without proper notice and comment procedures.
The ruling found in favor of Ivy Sports Medicine, formerly ReGen Biologics, which had a storied history with FDA that involved several findings that ReGen’s scaffold wasn’t substantially equivalent, political pressure from ReGen’s congressional delegation and direct involvement from CDRH’s director at the time. An expert advisory panel was later convened and determined the scaffold to be substantially equivalent.
After the clearance, the press alleged that the approval was granted as a result of outside influence and FDA’s newly appointed Acting Commissioner ordered an internal investigation of the Collagen Scaffold’s review process. FDA stated the clearance process had procedural irregularities, so it revoked its substantial equivalence determination, reclassifying the device from a Class II to a Class III and withdrawing the product from the market.
Ivy Sports challenged FDA’s reclassification decision in June 2011 as procedurally flawed and argued that FDA did not follow the procedure laid out in statute to reclassify their device. The recent ruling determined that FDA did in fact act outside of its authority.
September 24, 2014
| U.S. Announces Regulations to Deter Inversions
The U.S. Treasury Department announced actions that will reduce tax benefits of corporate inversions, making inversions more difficult and less appealing for U.S. companies.
Prevent inverted companies from accessing a foreign subsidiary’s earnings while avoiding U.S. taxes through the use of strategic loans, known as “hopscotch” loans
Prevent inverted companies from restructuring a foreign subsidiary to access the subsidiary’s earnings tax-free
Close loopholes to prevent inverted companies from transferring assets from a controlled foreign company to the new parent to avoid U.S. taxes
Increase difficulty of inversions by enforcing the requirement that the former owners of the U.S. entity own less than 80 percent of the new combined entity (this does not apply to deals closed before September 22, 2014)
The Treasury is expected to further reduce tax benefits of inversions through additional regulatory guidance and by reviewing U.S. tax treaties and international commitments.
These actions could affect Medtronic’s acquisition of Covidien. Analysts predict Medtronic may have to borrow to finance the Covidien purchase. The company may also face negative tax consequences and restricted access to Covidien’s overseas earnings due to the action of closing the “hopscotch” loan. Also, Medtronic may have to readjust the agreement terms in order to avoid decreasing company value.
For more on M&A in the orthopaedic industry:
Best Practices for Successful M&As
September 22, 2014
| House Votes to Repeal Medical Device Tax
The House of Representatives voted to repeal the 2.3 percent medical device tax by a vote of 253 to 163 last week. The tax was a component of the Jobs for America Act (H.R. 4).
National organizations said a full repeal will remove a financial burden from device companies that has decreased investment in R&D for new technologies.
The Medical Imaging & Technology Alliance (MITA), Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA) voiced their collective support for the bipartisan efforts to repeal the 2.3 percent medical device excise tax.
“MDMA thanks the House of Representatives for working to strengthen medical technology innovation by removing a major roadblock towards developing the cures of tomorrow,” said Mark Leahey, President and CEO of MDMA. “Repealing the medical device tax not only empowers patients and providers, but will allow America’s innovators to create more high-tech manufacturing jobs that our communities desperately need.”
September 10, 2014
| FDA Publishes Q&A on UDIs
The deadline for Unique Device Identifier (UDI) implementation for medical devices is September 24, 2014. This deadline applies to Class III (including class III I/LS/LS) devices licensed under the Public Health Service (PHS) Act, and Humanitarian Use Devices.
In a recently-published 14-page document, FDA answered FAQs regarding UDIs and provided information on critical dates, label formatting and technology requirements, direct marking criteria and the Global Unique Device Identifier Database (GUDID), as well as exceptions, alternatives and exemptions to UDI requirements.
Source: Unique Device Identifier System: Frequently Asked Questions, Vol. 1
August 20, 2014
| OpenFDA Releases Decades of Device Company Data
FDA’s new initiative, openFDA
, has enabled easier access to medical device company reports dating back to the early 1990s.
OpenFDA uses an Application Programming Interface (API) to allow web developers, researchers and the general public to access thousands of reports. The Office of Informatics and Technology Innovation is leading the program and plans to first focus on devices, drugs and food and the adverse events, recalls and labeling issues that take place within those industries. The first data released on medical devices
comes from the Manufacturer and User Facility Device Experience (MAUDE) database.
This data has always been publicly available. However, by making the data more easily accessible and digestible, FDA believes that it will help consumers, companies and government identify potential safety signals and pinpoint which classes of devices may be associated with certain adverse events. The agency does caution users that this dataset is not a definitive account of every event with every device and may contain incomplete, inaccurate, unverified or biased data.
OpenFDA also plans to implement a platform to voice challenges issued by FDA, in which the community can interact with one another and FDA domain experts in hopes of furthering innovation around FDA data.
Some in the medical device industry have voiced
that openFDA might serve as a viable tool for startups seeking to avoid the mistakes of more mature companies, as well as a valuable tool for competitor analysis.
What do you think?
Is the release of this data good for the industry?
How might you or your company use it?
August 18, 2014
| Notable U.S. Companies in Fracture Repair
The fracture repair market is expected to expand by single-digits through 2018, with growth supported by its reach across all age groups and the increasing number of osteoporosis-related fractures. Notable orthopaedic companies in the fracture repair segment are meeting the healthcare market’s demand for technological innovations that improve patient outcomes, while decreasing invasiveness and costs.
The newest ORTHOWORLD® market intelligence report, NOTABLE U.S. COMPANIES IN FRACTURE REPAIR, profiles 16 of these companies, detailing their product descriptions, company principles, regulatory status, funding and value proposition. Select profiles include information regarding capital sought, paths to commercialization, future indications, exit plans and five-year visions.
View the complete list of companies and download the report here.
July 22, 2014
| Greater Memphis Medical Device Council Forms to Support Industry Health
Seventeen medical device manufacturers from Shelby County in Tennessee have formed the Greater Memphis Medical Device Council (GMMDC), an incorporated not-for-profit association, to address issues critical to the local medical device industry. GMMDC will seek to assist in matters of workforce training and education on available career paths to ensure a robust pool of talent for local manufacturers.
Companies represented by the council's charter members include Ariste Medical, Big River Engineering, Bioventus, Enteroptyx, InnoVision, MB Innovations, Medtronic, MicroPort Orthopedics, Gyrus ACMI, Onyx Medical, Restore Medical, Smith & Nephew, Surface Dynamics, Titan Medical, Wright Medical, Y&W Technologies and Zimmer Spine.
Source: Bartlett Area Chamber of Commerce
July 07, 2014
| How Far is Possible for Risk Management
ISO 14971 is the risk management standard for medical devices. FDA and Health Canada have recognized the 2007 version of this international standard, but the European Commission has identified 7 deviations from the Essential Requirements of the European Medical Device Directives. These deviations are identified in Annex ZA of EN ISO 14971:2012.
In this article, authors Rob Packard and Erik Vollebregt examine Deviation No. 3, Risk reduction "as far as possible" vs. "as low as reasonably practicable." How should manufacturers comply?
Read their recommendations in BONEZONE®, June 2014.
June 24, 2014
| Coatings: Trends and Technologies in the Orthopaedic Industry
As the orthopaedic industry has evolved, so too have coatings for implants and instruments. BONEZONE® queried five companies to better understand trends in coatings, as well as ways that device companies can work with suppliers to adapt new technologies and overcome regulatory and cost barriers.
Coatings with certain surface properties, such as high roughness, interconnected porosity and the growing interest in 3-D printed implants
Combining novel implant designs with coatings to support high-performing implants
The benefits of Type 2 titanium anodizing
Introducing products and adapting to regulations in new geographic regions
Read the full article online in BONEZONE at www.bonezonepub.com.
June 18, 2014
| Orthopaedic Industry Must Respond to Payor Denial of Implant Coverage
Orthopaedic device manufacturers have long battled the regulatory landscape to product approval. But, “FDA [regulatory] approval doesn’t equal insurance [payor] approval,” surgeon entrepreneur and inventor Robert S. Bray, Jr., M.D., reminded industry during his keynote address at OMTEC®, the 10th Annual Orthopaedic Manufacturing & Technology Exposition and Conference.
Payor denial of procedures and products lacking long-term data are expected to escalate as both industry and government-sponsored payor systems scrutinize spend to support and comply with the Affordable Care Act. Bray’s keynote remarks echo observations offered in 2011 by veteran OMTEC speaker Kelli Hallas, when she urged attendees to integrate reimbursement strategy at the development phase and offered a ten-step checklist to aid in the process. “Even some of the most promising technologies have failed because of lack of reimbursement,” cautioned Ms. Hallas.
Founded in 2005, OMTEC is recognized as an international conference that provides orthopaedic industry professionals the tools and partnerships needed to improve performance. OMTEC 2014 speaker presentations and 2015 event updates are available at www.OMTECexpo.com. Industry is encouraged to save the dates of June 17-18 for the 2015 event in Chicago, Illinois.
June 16, 2014
| Medtronic Acquiring Covidien
The transaction, which is subject to regulatory clearances in the U.S., E.U., China and certain other countries, is expected to close by early 2015 and is valued at ~$42.9 billion. Following completion, the combined businesses will be called Medtronic plc with principal executive offices in Ireland. Operational headquarters will remain in Minneapolis, MN.
Medtronic will commit $10 billion in technology investments over the next 10 years to support early-stage venture capital investments, acquisitions and R&D in the U.S.
Michael Matson of Needham & Company notes that "The acquisition broadens MDT's current portfolio of cardiovascular, spine, neuromodulation, and diabetes products to include COV's surgical, vascular, respiratory, and patient monitoring products." Further, Matson thinks that "cash-rich balance sheets, slow market growth, pricing pressure, and consolidation among the med tech companies' customers are all driving deals in addition to tax considerations" such as those that might be in play given the difference between the Ireland vs. U.S. corporate tax rate (12.5% vs. 35%, respectively, per Wells Fargo).
COV includes Sports Surgery among its product categories online, listing just one product that is part of the Stratis Femoral Fixation Device. Other products for ACL and meniscus repair, such as TriTis and Herculon, remain visible via site search but are not named otherwise in COV's web site.
Medtronic's press release
DealBook/New York Times coverage
June 05, 2014
| Element Orthopedics Adds Three Board Members, Launches New Web Site
Source: Element Orthopedics
Element Orthopedics announced that its board of directors has appointed three new members. Joining the Board are Douglas E. King, Mr. Patrick J. McCullagh, PhD. and William E. Tidmore, all veterans of the orthopedic med-tech community.
“We are committed to augmenting our already outstanding board with the most talented industry leaders,“ said Dan Nemes, board chairman. “These gentlemen bring tremendous industry expertise and experience to the table. They see the potential for our company technology and are ready to roll up their sleeves and help.”
The company’s new web site, www.elementorthopedics.com, introduces the technology, products and clinical applications. “Our hard work and dedication are paying off,” said Paul Zwirkoski, the technology inventor. “We are poised to introduce the first ever, minimally invasive composite implant (solid beads and a fluent agent) that can be injected without using pressure. This new web site, which features a concise 3D animation, is a great platform for helping people quickly learn about our exciting innovations.”
Element Orthopedics is dedicated to making surgery in compromised bone consistent, reproducible and reliable.
For more information, visit the web site at www.elementorthopedics.com or contact Don Kennedy, President, at 952- 500-3990.
May 29, 2014
| Worldwide Orthopaedic Product Sales to Exceed $54 Billion by 2018, Cites ORTHOWORLD's Market Intelligence Report
Fracture Repair, Extremities and Arthroscopy/Soft Tissue Segments are expected to post 7% to 12% YOY Growth with Joint Replacement, Orthobiologics, Spine and Others Remaining in the Low- to Mid-single-digits
ORTHOWORLD®’s report cites that orthopaedic product sales exceeded $44.6 billion in 2013, an increase of 3% or $1.4 billion over 2012, with DePuy Synthes, Stryker, Zimmer, Medtronic, Smith & Nephew, Biomet, Arthrex, Aesculap, DJO and NuVasive dominating with a combined 75% of total market share.
THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT® reaffirms that industry has gained traction in the new post-healthcare reform, regulatory-intensive environment as evidenced by growth across all segments, including spine.
Order the report here (ORTHOWORLD Members can download immediately)
Download the Table of Contents/List of Exhibits
Download sample pages
May 19, 2014
| The Future Opportunity for Free Market Medicine
A huge opportunity may be on the way for free market medicine courtesy of the Affordable Care Act. The ACA has forced countless people on to the Medicaid rolls. As these Medicaid rolls expand, more and more doctors will opt out. This will leave more and more Americans without access to medical treatment. Health insurance does not mean healthcare.
To compete in the healthcare arena, hospitals, surgery centers and caregivers must unite to provide a transparent price that the consumer patient can actually digest: for example, an “all in” price.
Read about it in ORTHOPRENEUR® online at www.ORTHOPRENEURpub.com.
April 25, 2014
| Osiris Therapeutics Appoints Dwayne Montgomery as GM of Orthopedics and SportsMed
Most recently, Mr. Montgomery served as the Senior Vice President of Sales and Marketing for IlluminOss Medical, overseeing worldwide commercialization of the Photodynamic Bone Stabilization System within the orthopedic trauma market. Earlier positions include Vice President of Commercial Operations at TranS1 and progressing executive roles at Smith & Nephew, such as Vice President of Sales & Marketing for the Clinical Therapies Global Business and Vice President/General Manager for the Orthopedics Global Trauma Business.
"Osiris continues its transformation from being primarily R&D oriented to one also capable of commercializing and supporting newly launched products in our targeted therapeutic areas - wound care, orthopedics and sports medicine,” said Lode Debrabandere, Ph.D., President and CEO. “We are building a strong executive team with the commercial, reimbursement and R&D expertise needed to accomplish our ambitious goals. With more than 20 years of experience in orthopedics, Dwayne brings a depth of general management experience and leadership that will be instrumental to our overall growth strategy."
Read the full release from Osiris Therapeutics online.
April 08, 2014
| Integra LifeSciences Appoints Mark Augusti as CVP, President, Orthopedics & Tissue Technologies
Mr. Augusti will be responsible for the management of the Spine and Extremities divisions, including strategic direction, portfolio management and evaluation of corporate development opportunities.
Prior to joining Integra, Mr. Augusti served as CEO at Bioventus and spent nine years with Smith & Nephew in a series of leadership roles, most recently as President of Smith & Nephew's Biologic Division. He served as Smith & Nephew's President of the Orthopaedic Trauma & Clinical Therapies Global Business and Senior Vice President and General Manager of the Trauma business. Prior to that, he spent 13 years at GE Medical Systems in various sales, marketing and strategic management roles, both in the U.S. and internationally.
Read the full release online.
April 01, 2014
| Gainesville Sun: New biotechs have plenty of ideas, no lab space
Anthony Clark of The Gainesville Sun notes that start-up companies in his region face a challenge to locate lab space to support their efforts, once they outgrow university labs and incubators. Specifically,
"Grants and venture capital that finance many biotech companies are often restricted to product development and cannot be spent on real estate, while developers and lenders are reluctant to take a chance on building and financing high-cost space for companies that have not established a track record of profitability and cannot guarantee a long-term lease."
One developer, however, noted that banks appear to be interested in assembling deals to support new lab facilities in the region. Companies that have inhabited lab space in the area include Nanotherapeutics, RTI Surgical and Exactech.
Read Mr. Clark's full article in The Gainesville Sun online.
March 25, 2014
| Round2Funding Investment Portal Launches to Connect Investors with Early Stage Healthcare Companies
From BONEZONE news: MEDTOWN Ventures launched Round2Funding, an invitation-only investment portal directly connecting accredited investors and vetted healthcare companies, to focus on healthcare startups seeking $1 to $5 million in investments and to allow investors to anonymously evaluate these healthcare companies.
Round2Funding is hosting a pitch competition, The Main Event, in Atlanta on May 17. Learn more at www.round2funding.com/main-event. Companies will be showcased to accredited Investors and receive feedback from experienced entrepreneurs, industry professionals and accomplished investors.
Read more at BONEZONEpub.com.
Learn even MORE! From Tech Flash in the Atlanta Business Chronicle:
“Early stage inventors are creators, and building a business that is going to commercialize that product brings a great deal of “conflict” decision-making,” Medtown Managing Director and Co-founder Chris Fair said. “That transition is hard and the inventor normally does not have that DNA in them.”
“If you think of company development like child development, we get involved after elementary school, work with them through the high school years and when they are stable and ready to head off to college, we transition out,” Fair said. “It is not our goal to be operating these companies long term, but to provide them the tools to succeed so they can do it on their own.”
MEDTOWN's operating team brings extensive experience from companies like DePuy, Genzyme, OrthoPediatrics, RTI Biologics and Zimmer. Read deeper coverage by Urvaksh Karkaria from the Atlanta Business Chronicle.
March 17, 2014
| The Journal Gazette: Biomet growth plan to add 150 jobs
Biomet's $40.5 million Warsaw expansion would create 150 jobs by 2018, though job types to be created have not been revealed. The project calls for capital improvements such as building renovations, 3-D printing and optical scanning technology and upgrades to Biomet’s Global Center of Excellence surgeon education program.
Biomet officials said the project will go forward only if county and state tax breaks and other incentives are approved. The Indiana Economic Development Corp. in August 2010 approved almost $3 million in tax credits and training grants for Biomet, which announced plans to create 278 jobs at that time. Kosciusko County approved additional incentives on the $26 million investment.
Read the full article in The Journal Gazette online.
March 03, 2014
| Stryker Enters Marketing Relationship with the PGA Tour
The centerpiece of Stryker's on-site PGA tournament presence will be The Stryker Mobility Zone, a joint health destination designed to educate tournament attendees about hip and knee treatment options, featuring:
• Orthopaedic surgeons who will interact with fans and provide education and joint health assessments.
• A fan engagement area featuring a Putting Challenge and the chance to meet Champions Tour members
Fred Funk and Hal Sutton.
• Information about the Fisher House Foundation, a network of homes built on the grounds of major
military and Veterans Affairs medical centers where military and veterans' families can stay for free
while a family member receives medical treatment.
Read more about this marketing initiative online.
February 11, 2014
| Pre-Flight Checklist: What it Takes to Get an Idea Off the Ground
For most innovators, the first phase of development is the most invigorating. You may feel that the hard work has been done; all that remains is to hammer out a few details. At this point, the work has just begun.
A strong start will set the stage for a smooth flight through subsequent phases of development leading to a successful market launch. What three elements will keep an innovator grounded and allow ideas to take flight?
Find out at ORTHOPRENEURpub.com.
February 05, 2014
| Five Steps to Regulatory Strategy Development
Regulatory requirements continue to evolve and grow in complexity. A solid regulatory plan and execution can maximize opportunities to achieve regulatory goals and provide a competitive advantage. Mark D. Kramer, RAC, draws a 5-point guide for BONEZONE:
Identify Product Attributes
Conduct Regulatory Intelligence
“Triangulate” and Document
Verify the Strategy’s Viability
Make the Strategy a Living Process
Follow each step in the process at BONEZONEpub.com.
January 29, 2014
| Dr. Richard Steadman to Retire From Surgical Practice at Steadman Clinic
Dr. J. Richard Steadman, founder of The Steadman Clinic and the Steadman Philippon Research Institute, has announced that he is retiring from his active surgical practice.
Dr. Steadman will continue to consult with his physician colleagues at The Steadman Clinic, focusing on the practice of evidence-based medicine to return patients to their active lifestyles. He will also continue as co-chairman of the institute, the charitable entity known throughout the world for its research into the causes, prevention and treatment of orthopaedic disorders.
Read the full announcement online.
January 24, 2014
| Selene G. Parekh, M.D. uses Google Glass during foot/ankle procedure
Dr. Parekh conducted the procedure while wearing the Google Glass technology and broadcast live streaming video via the Internet. The technology allowed for hands-free recording video without the OR disruption of a video crew and related risk of infection. Additionally, it provided viewers the surgeon's unique vantage point during the surgery.
Nextremity Solutions, an orthopaedic device company which specializes in forefoot surgery implants, recently obtained Google Glass and will evaluate its applications in its surgeon training initiatives. The company will work with Dr. Parekh to ensure that the technology is used in a manner most beneficial to surgeons.
Read the full release from Nextremity Solutions online.
January 15, 2014
| Transcript Published for FDA Orthopaedic and Rehabilitation Devices Panel on Spinal Spheres
FDA's Orthopaedic and Rehabilitation Devices Panel has published its transcript from the meeting regarding the classification of spinal sphere devices. The meeting occurred on December 12, 2013. Based on the information collected and materials presented, FDA recommends that spinal sphere devices for use in arthrodesis procedures be regulated as Class III devices requiring a PMA.
The devices are manufactured from metallic or polymeric materials and designed for insertion between vertebral bodies from L3-S1 to promote fusion and stabilization, and are presently regulated under Product Code NVR.
View the full transcript here.
January 14, 2014
| How Surgeons can Prepare for the Changing U.S. Orthopaedic Landscape in 2014
In 2014, a number of Federal regulatory changes are expected to increase patient volume, decrease practice revenue and lead to more administrative burdens. Orthopaedic practices need to prepare now in order to maintain profitability. Thomas C. Barber, M.D., orthopaedic surgeon and Chair of AAOS’s Council on Advocacy, outlines these coinciding changes and provides insight on plans for:
More patients, less revenue
Additional administrative burdens
How to get ready
Read the full article on ORTHOPRENEURpub.com.
January 09, 2014
| ISTO Technologies names George W. Dunbar, Jr. President and CEO
George W. Dunbar, Jr., was appointed President and Chief Executive Officer, effective immediately. Mitchell Seyedin, Ph.D., will continue to serve as Executive Chairman and will remain on the Board. Mr. Dunbar's former experience includes serving as president, chief executive officer and later chairman of Aastrom Biosciences.
ISTO develops proprietary products for spinal therapies and sport medicine applications, intended for the repair and regeneration of damaged or injured cartilage and bone.
Read the full release from ISTO Technologies online.
January 07, 2014
| Changes at the helms of SkelRegen, ETEX
SkelRegen, a leader in small molecule musculoskeletal tissue regeneration and the first to identify multiple small molecules that are osteoinductive and target different aspects of the skeletal tissue formation pathway, has appointed Todd F. La Neve, J.D. as CEO.
Stephen R. La Neve, former SkelRegen CEO, will continue to serve as co-founder and director and recently accepted the position of President and Chief Executive Officer at ETEX.
Read the full releases from SkelRegen and ETEX online.
December 16, 2013
| M&A Activity Updates: MAKO/Stryker, Wright Medical/MicroPort
MAKO Surgical stockholders voted at a special meeting to approve the adoption of the Agreement and Plan of Merger providing for the merger of MAKO with Stryker. The parties expect that the transaction will close on December 17, 2013, whereupon MAKO will be delisted from NASDAQ.
Full release available online.
Wright Medical has been advised by MicroPort Scientific that the Hong Kong Stock Exchange granted clearance of the disclosure circular required for its shareholder meeting to approve the acquisition of Wright’s OrthoRecon business. MicroPort has scheduled a shareholder meeting for January 3, 2014 to approve the transaction. Wright now expects the closing of the transaction to occur on or about January 9, 2014.
Full release available online.
December 10, 2013
| ORTHOWORLD Position Paper on Healthcare Reform
As the healthcare reform initiative moves through the halls of Washington, we will undoubtedly be
debating what treatments do and do not work and what options should be made available to the
American people. When we enter these heated discussions, it is imperative that the facts be examined that
allow evaluation of medical procedures and their effectiveness in returning the health and productivity of
the citizenry. Orthopaedic care has clearly demonstrated its efficacy. Without question. It has changed
tens of millions of lives for the better, forever.
Orthopaedic problems and interventions affect us all at one time or another in our lives. The National
Center for Health Statistics estimates that nearly 108 million American adults reported bone and joint
medical conditions in 2005.1 That’s nearly half of all Americans over the age of 18. Musculoskeletal
disorders and conditions are the leading cause of disability in the U.S. and the most frequently cited
reasons for limitations in daily activities of life, with 15 million Americans aged 18+ limited by arthritis,
back or neck problems, fractures, connective tissue conditions, etc. More Americans report
musculoskeletal conditions than either circulatory (heart disease, stroke, etc.) and respiratory
(emphysema, asthma, hay fever, bronchitis, etc.) problems and musculoskeletal conditions remain the
greatest cause of lost work days and medical bed days in the U.S.(ibid)
Continue reading this position statement here in PDF format.
Read the press release.
Prepared by ORTHOWORLD Inc.
Published August 5, 2009
December 10, 2013
| Summary of the Patient Protection and Affordable Care Act
Expand Coverage/Improve Access
Mandate that employers with more than 200 employees automatically enroll employees in health insurance plans offered by the employer (employees may opt out). (2014) Companies with 50 or fewer employees are exempt from fees.
Those with fewer than 200 employees do not have to offer coverage; however, those with more than 50 employees must pay a fee.
Continue reading this summary in PDF format.
Published by ORTHOWORLD
December 06, 2013
| Generic, Value-Priced Implants: What's the Difference?
The number of generic, low-cost manufacturers continues to grow, as does the pressure from hospitals for orthopaedic departments to lower expenses. Still, the industry has been slow to adopt this model. ORTHOPRENEUR queried two of these manufacturers, Emerge Medical and Empower Spine, to better understand how they define themselves, how they handle industry challenges and how they drive price and innovation.
Question #1: Generic, low-cost manufacturing, low-cost sales: What’s the difference among these names? Is there a preference? Read on.
November 20, 2013
| How to Build a Better Supplier Scorecard
Supplier scorecards are intended to be a simple tool to help you evaluate suppliers. These steps provide for an easier and more efficient process. What’s better about this scorecard?
This scorecard is simple.
This scorecard requires fewer resources.
This scorecard does not require an expensive software solution.
This scorecard will help you continuously improve supplier quality.
Read on at www.BONEZONEpub.com.
November 06, 2013
| Summary of OIG Overview on PODs
The U.S. Office of Inspector General of the Dept. of Health and Human Services' overview of prevalence and use of physician owned distributors (PODs) of spinal devices does not make specific recommendations for action, but notes that in FY11, PODs supplied devices used in ~1 in 5 spinal fusions billed to Medicare. In FY12, surgeons performed more spinal surgeries at sampled hospitals that purchased from PODs than at those that did not purchase from PODs.
Read on for a deeper summary and links to source documents.
October 22, 2013
| Stryker submits plans for new 22MM Euro R&D hub in Cork, Ireland
The plans, announced in 2012 and valued at ~US $30MM, call for an approximately 45,000 sq. ft. R&D and product innovation center to support testing, manufacturing process development, training, etc. Staff at the facility will cooperate with other divisions including Kalamazoo, MI to develop next-generation surgical devices.
The new facility is expected to house 20 employees upon completion.
Read the full story online in The Independent.
October 14, 2013
| Exactech names new VP of U.S. large joint sales as Bob Purcell retires
Effective today, Bill Shopoff, a 30-year veteran of the orthopaedic industry, is appointed at Exactech. Mr. Shopoff has provided global sales and business leadership for Smith & Nephew since 1984, most recently serving as president of Trauma and Extremities.
He replaces Bob Purcell, who retires after 40+ years in orthopaedics and healthcare capital equipment sales. During Purcell’s six years as Exactech’s vice president of U.S. Sales, he strengthened the domestic sales team and led the organization to a CAGR of 10%.
Read the full release online.
October 08, 2013
| NovaBone Products Announces Major Expansion
NovaBone Products, developer of orthopaedic biomaterials, is relocating to a 30,000 sq. ft. building in Alachua, Florida, more than doubling its existing facilities. Increased manufacturing space will support the greater than 40% sales growth the company has experienced for each of the past four years.
The relocation, expected to be done by year-end 2013, combines NovaBone's manufacturing and R&D under one roof.
Further, though the company is conducting a vigorous new product development program for bone graft products that meet desired performance and handling characteristics, it notes a greater emphasis on collagen products and collagen composite products.
Read the full release from NovaBone online.
October 03, 2013
| Ace Your Next Test: partner with testing labs
Manufacturers should view testing and inspection companies as strong allies, involving these partners early and often in the product development process. BONEZONE queried testing laboratories on the latest challenges and trends to help OEMs uncover opportunities and capitalize on efficiencies, safety and speed to market.
Learn the one question these experts wish you would ask them, right here.
September 27, 2013
| Change to management of Mathys Group
(Source: Mathys Ltd Bettlach) After more than three years as CEO, Dr Arne Faisst is leaving the family-owned company Mathys by mutual consent due to different views on the future of Mathys. Hugo Mathys is taking over management.
Dr Arne Faisst has worked for Mathys in several roles since 1997 before being appointed as CEO in 2010. During this time he has made a valuable contribution to the overall development of the company. The Board of Directors and Arne Faisst have agreed to go separate ways due to different views on the future of Mathys; by mutual consent, Arne Faisst will leave the company.
Hugo Mathys, Chairman of the Board of Directors, who has headed up the company since 2010, will assume management again. ‘The double role of CEO and Chairman of the Board of Directors worked well in the past; it is not a problem in a family-owned business, and it even results in certain benefits,’ explains Hugo Mathys. He refers to the more direct interface between strategic and operative management as the key advantage.
The company posted stable growth of 7.6%, 6.8% adjusted for currency effects, as at the end of August 2013 compared to the same period in the previous year despite a difficult market environment.
About Mathys Ltd Bettlach
Swiss orthopaedics company Mathys was founded in 1946 and looks back at 54 years of experience in the field of medical technology. Since 1 November 2003 the company has focused exclusively on the development, production and marketing of joint replacement products. Although some products are manufactured in Germany, most are made in Switzerland. At this point in time Mathys supplies hip, knee and shoulder implants and synthetic bone replacement material, and the company plans to enter the sports orthopaedics market in 2013.
Mathys operates 11 subsidiaries, in China, Germany, France, Belgium, England, Holland, Japan, Austria, Australia, New Zealand and Switzerland, and is owned by the Mathys and Marzo families.
For more information please contact:
Head of Corporate Communication & Services
Mathys Ltd Bettlach
Robert Mathys Strasse 5
2544 Bettlach, Switzerland
Phone (direct): 032 644 1 497
Mobile: 079 593 89 35
Fax (direct): 032 644 1 186
Switchboard: 032 644 1 644
September 25, 2013
| ulrich medical USA Expands U.S. Corporate Headquarters
ulrich medical's new U.S. HQ facility at 18221 Edison Avenue in Chesterfield, Missouri is more than three times larger than its former location.
The company claims to have experienced 60% case growth for the past 2 years and expects 2013 revenue growth of 25% over 2012. The 101-year-old private company has 14 FDA-cleared spinal implant products available in the market.
Read the full release online.
September 20, 2013
| GHX urges OEMs to think holistically, strategically about UDI implementation
Bruce Johnson, CEO of GHX, noted that "UDI is not about just ticking a regulatory box; it is about all parties having a 360-view of the healthcare supply chain - from regulators seeking a better approach to post market surveillance, to manufacturers having control of their regulatory master data, to hospitals being able to do the kind of analytics necessary to achieve more value for our healthcare dollar."
Read GHX's response to FDA's UDI final rule online.
Karen Conway, Director of Industry Relations at GHX, authors blog posts on UDI guidance at The Healthcare Hub. Her frequent BONEZONE® articles offer additional guidance for industry.
September 19, 2013
| A Supplier's View on the Indian Market
With a population of 1.2 billion and a 1.3% growth rate, India’s already $3BB medical device market is set for growth based upon demographics alone. But before orthopaedic device manufacturers and suppliers choose a path to enter or expand in the Indian market, they need to consider the regulatory environment, economic conditions and competitive landscape.
See the bigger picture in BONEZONE.
September 10, 2013
| Advanced Biologics Opens New, Expanded Headquarters in Carlsbad, California
To better support its growing sales/distribution network and prepare for new and upcoming product launches, Advanced Biologics is expanding and relocating its company headquarters to Carlsbad, CA. The 15,000 sq. ft. facility adds additional office space, warehousing capabilities and enhanced R&D areas.
Advanced Biologics markets the OsteoAMP® family of osteoinductive/conductive products, its first line of orthobiologic offerings.
Read the full release online.
September 04, 2013
| Nextremity Solutions moving to the Orthopaedic Capital of the World
Nextremity Solutions is relocating to Warsaw, Indiana. The company obtained $10 million in private equity funding in July, per the Kosciusko Economic Devopment Corp. The new HQ will support 15 employees, initially, serving as a base for management, marketing, financial and sales functions for the company. The company contracts out manufacturing, and its research and development operation will remain in New Jersey.
Nextremity specializes in small joint products such as its Nextra medical device to correct hammer toe. The company also has a line of Precision Ready Systems that includes precision screws and staples.
Read the full article online in the Fort Wayne Business Weekly.
August 28, 2013
| Tyber Medical Elects Arthur Alfaro As Board Member
Mr. Arthur Alfaro founded Nextremity Solutions and ORTHOCON, serving as President, CEO and Director for both. He also served as President and COO of Osteotech; President, Sofamor Danek Thoracolumbar and in various positions at Sulzer Carbomedics and Boston Scientific.
Tyber Medical is focused on addressing an industry-wide need for rapid access to regulatory approved orthopaedic implants. The company markets devices for trauma/extremities and spinal interbody spacers in configuations for ACIF, ALIF, PLIF, OLIF, TLIF and DLIF.
Read the full release from Tyber Medical online.
August 26, 2013
| Vilex Receives ISO 13485:2003 Certification
Vilex received ISO 13485:2003 certification. The ISO standard specifies the requirements for comprehensive quality management systems in the design and manufacture of medical devices.
Vilex manufactures cannulated bone screws, small joint resurfacing implants, memory staples, plates, IM nailing systems, subtalar implants, external ring fixators, monorails and power equipment for orthopaedic and podiatric surgery in the small bones of the foot, ankle and hand.
Read the full release online.
August 19, 2013
| Free event: FDA Small Business Regulatory Education for Industry Conference
September 25-26; Bethesda, Maryland
This free conference joins regulatory educators from FDA’s Center for Drug Evaluation and Research and Center for Devices and Radiological Health with small manufacturers of drug and medical device products who want to learn about how FDA approaches drug/device regulation.
The conference features a cross-cutting plenary addressing FDASIA updates as they impact both drugs and devices, as well as individual break-out sessions. Common themes include:
Meetings with FDA
Clinical Studies and Review
August 09, 2013
| Summary of Conference Call: Wright Medical Announces Receipt of FDA Not Approvable Letter for Augment Bone Graft
FDA concerned that patient population enrolled was predominantly low risk, may not have warranted use of either autograft or Augment Bone Graft
FDA believes that a new clinical study would be required to evaluate use of Augment as a substitute for autograft in hindfoot and ankle fusion procedures in a well-defined high-risk target population, where use of autograft would be clinically warranted
WMGI believed that all FDA concerns as outlined in their previous Non Approvable Letter from December 2011 were fully addressed in the PMA amendment that BioMimetic submitted in June 2012
Company must determine next steps in ex-U.S. markets with opportunity for CE Mark
Product selling robustly in Australia, also has business in Canada which is “pretty much business as usual”
Doesn't expect announcement to impact stated 2013 guidance
Other ongoing clinical projects in earlier stages unaffected (e.g., Augment Injectable)
Sources: Company press release; Corporate conference call/Thomson Reuters
July 29, 2013
| NuVasive Takes Position as 10th Largest Orthopaedic Device Company After DePuy Synthes Merger
NuVasive entered the list of top 10 largest orthopaedic device companies by revenue upon Johnson & Johnson/DePuy’s 2012 acquisition of Synthes. Today, the top 10 comprises DePuy Synthes, Stryker, Zimmer, Smith & Nephew, Medtronic, Biomet, Arthrex, DJO, Aesculap and NuVasive.
Observations in ORTHOPAEDIC DEVICE COMPANY PROFILES: THE TOP TEN show that in the slowing orthopaedic market, NUVA was one of only 3 top 10 companies to achieve double-digit growth in 2012, alongside Arthrex and DePuy Synthes.
Read the press release to learn more about this new publication and secure your copy here.
July 18, 2013
| BONEZONE: China Becomes Vastly Improved Player
The People’s Republic of China, by some estimates, has already surpassed Japan to become the second largest medical device market in the world after the U.S. Experts estimate that the medical device market in China will grow between 15 to 20 percent annually over the next five years. Despite a recent drop in economic growth, China’s economy is still on the upswing, and so is its medical device market. One could say that it is out of control. On the contrary, it’s not.
China's medical device market is growing fast, and the competition is fierce. Companies seeking to enter the market or expand their business need to understand the following changes in the industry.
July 09, 2013
| Personnel changes at SpineVision: Ken Yamada and Danny Severens
Ken Yamada has joined SpineVision's U.S. subsidiary as Chief Operating Officer, and Danny Severens is promoted to Sales Manager, Northern Europe.
Most recently, Mr. Yamada spent more than two years with Wright Medical Technology as Vice President of International Operations. Previously, he held several executive positions within the medical industry for more than 17 years.
Mr. Severens will be responsible for the development of SpineVision’s sales network in Germany, as well as his current responsibilities as Country Manager for Benelux.
Read the full release online.
June 26, 2013
| The Race to the Patent Office Is On
Now that the U.S. is operating under the “first-inventor-to-file” (FITF) system, timely patent filing action must sit at the forefront of an inventor’s mind--AND bcome a part of new filing procedures for companies. Gone are the days of not filing on a product until it is completely developed. BONEZONE author John Boger shares quick tips to consider in dealing with the new FITF system.
#1: File a provisional application early in the development process of an invention. This will protect your date and eliminate possible intervening filings or inadvertent disclosures.
For tips #2 to #5, read the full article online now.
June 20, 2013
| Leadership changes at Orthofix
In connection with the realignment, Orthofix announced the following leadership changes:
*Brad Niemann, currently Senior Vice President, Commercial Operations has been promoted to President of the BioStim business, effective immediately. Mr. Niemann has more than 15 years of experience in the medical device industry, with a particularly strong focus on bone growth stimulation technology.
*Brad Mason, President and Chief Executive Officer of Orthofix, will assume all senior management duties for the Spine Fixation business on an interim basis.
*Brian McCollum, currently President of Global Spine, will be leaving the Company on July 15, 2013.
*Mark Atkinson is named Chief People Officer, effective immediately, overseeing all human resources management, executive and employee development and corporate culture.
*Michael Finegan is appointed Chief Strategy Officer
*Jeff Schumm is appointed Chief Administrative Officer to supervise all regulatory affairs, legal matters, and government affairs.
Read the full release online.
June 19, 2013
| JBJS: 3rd Annual Role of the Orthopaedic Surgeon Study reveals Top 10 predictions about the future
Surgeon respondents indicate that they expect:
#10: More insurance hassles
#9: Will hire more healthcare "extenders" (PAs, NPs)
#8: Will work harder for less
#7: Lower reimbursement
#6: Nothing will change (regarding role as an orthopaedic surgeon)
#5: More government regulation
#4: Will become hospital employees
#3: Will have less autonomy
#2: Will retire/stop performing surgery
#1: Will have more admin work
Of note, >90% of survey respondents reported that they have an influence in orthopaedic device purchasing decisions, a finding confirmed by hospital purchasing professionals.
Read the press release here and view the presentation slides from The Journal of Bone and Joint Surgery study.
Methodology: Email survey sent to 2,868 JBJS U.S. subscribers; 469 orthopaedic surgeons responded, representing 16% response rate
June 10, 2013
| Is Private Practice Dying?
The number of surgeons closing private practices and becoming hospital employees continues to grow as business expenses and malpractice insurance increase while reimbursements decrease. The percentage of orthopaedic private practices acquired by hospitals is expected to grow to 10% of the total acquisitions in 2013, up from 6% in 2012.
To reiterate, that's 10% of this year's private practice acquisitions that are expected to be orthopaedic. Are we nearing the end of private practice? Read on and add your thoughts.
June 04, 2013
| Providence Medical Technology expands management team to launch full U.S. product portfolio
Kevin Shaw has joined Providence Medical Technology as Vice President, Sales. He most recently served as Vice President, Sales for S-I BONE. Previously, Mr. Shaw was one of the four original Area Sales Directors responsible for the launch of the X-STOP IPD for St. Francis Medical Technologies.
Edward Liou has been promoted to Vice President, Engineering and Operations. Mr. Liou joined Providence as Director, Engineering in 2010 from Speck Design, where he led development of the DTRAX Facet System, which is currently sold outside of the U.S. Prior to Speck, he co-founded Alter-G, a venture-backed leader in the rehabilitation space.
View the full release online.
June 03, 2013
| MAKO Surgical appoints Ian Dawson as Senior Vice President of Marketing
MAKO's commercial marketing activities were formerly overseen by Ivan Delevic, who will transition to President of Corporate Development.
Mr. Dawson has >25 years of experience in marketing. From June 2008 through May 2013, he served as Vice President of North America Marketing for Smith & Nephew Advanced Wound Management. From May 2004 to June 2008, Mr. Dawson held various marketing leadership positions with Zimmer, including Senior Director of U.S. Knee Marketing. From July 2001 to April 2004, he served as the Vice President - Product Group Knee, for Centerpulse Orthopedics.
Read the full release online from MAKO Surgical.
May 31, 2013
| Worldwide Orthopaedic Product Sales Reached $43.1 Billion in 2012
ORTHOWORLD® has published the latest ORTHOPAEDIC INDUSTRY ANNUAL REPORT®.
Orthopaedic product sales >$43 billion in 2012,+3% vs. 2011; Segments contributing greatest growth included trauma ($6.1 billion), sports medicine ($4.2 billion); 9 of the top 10 orthopaedic device companies posted year over year growth; top 10 now includes NuVasive following Johnson & Johnson/DePuy’s acquisition of Synthes; Industry gaining traction in a new environment: evidenced by increased use of resources outside the U.S., investments in data collection, exploration of new sales/distribution models, nurturing of supplier partnerships all along the supply chain, continued emergence of generic and lower-cost offerings
Read the press release online
View Table of Contents and Sample Pages (PDFs)
Order a copy
May 30, 2013
| Sonoma Orthopedic Products appoints Eric Swanstrom as Vice President of U.S. Sales
Swanstrom's 17 years of experience in the orthopaedic device and healthcare industry include sales management and executive positions at Advanced Surgical, ArthroCare, Emerging Medical, Knee Creations, Opus Medical and Pegasus Biologics.
Eric replaces Joe Sinkovich as Vice President of Sales.
Swanstrom's efforts will support continued growth of the CRx clavicle fracture nail and the VELOX less-invasive clavicle technique, as well as new programs focused on the WRx wrist facture device and continued distribution channel development. Swanstrom will also spearhead commercialization of future products incorporating the proprietary Sonoma flexible-to-rigid intramedullary technologies.
Read the full release online.
May 23, 2013
| Life Spine highlights offshore and international growth
Life Spine reports that new customers in Hawaii, Puerto Rico, New Zealand, Brazil, India and New Zealand have begun to purchase products from the company's product portfolio. Life Spine primarily focused its marketing and distribution efforts within the continental U.S. when the company formed in 2004, and has actively built distribution outside the U.S. since late 2010.
Read the full release online.
May 09, 2013
| What if Your ISO Auditor is Wrong?
Auditors are human, sure. But what should you do when they're wrong?
Rob Packard wants you to know three things:
Audit findings are not a jail sentence.
There is an appeal process.
You can and should push back.
But what does this look like? See the scene through Rob's eyes. Begin reading here.
(Consider attending some of Rob's OMTEC sessions, too: June 12-13 in Chicago, Illinois.)
May 08, 2013
| K2M promotes Gianluca Iasci to EVP, Global Sales
Mr. Iasci's promotion to Executive Vice President, Global Sales is effective immediately. He previously served as K2M’s Senior Vice President, International Sales.
Prior to joining K2M, Mr. Iasci served as Senior Vice President of International at AGA Medical and served for 12 years with Johnson & Johnson in various European Sales and Marketing positions. He also was the Managing Director of Italy while at Guidant (now Boston Scientific) and spent four years at St. Jude Medical where he was stationed in Hong Kong and gained experience in the Asia Pacific Market.
Read the full release online.
May 03, 2013
| The Change Management Project: One Surgeon's Attempt to Fix a Hospital Orthopaedic Service
This is the first entry into a series of articles about implementing and managing changes by a small group of participants in orthopaedic services at a community hospital. We will see if the efficiencies perfected in a single specialty surgery center can be applied to a small hospital.
As we embark upon a pilot project to reform a hospital’s orthopaedic department from the bottom up, we have enacted a few basic tenets:
Every change must move in the direction of improved quality and value.
A small core orthopaedic team will begin a dialogue about changes.
Hospital protocols will be respected, but will also be reviewed to determine if they are bringing value to the process or merely exist to place a check in a box.
Change management will begin with a bottom-up approach.
Follow Blair Rhode, M.D.'s steps in ORTHOPRENEUR®. Start reading here.
April 30, 2013
| Medscape's Orthopaedists Compensation Report 2013: How has surgeon behavior changed in 2012?
Results from a 2012 survey of ~22,000 U.S. surgeons indicate that orthopaedic surgeons earn a mean income of $405,000/year, +27% from 2011, an increase due in part to an aging population. More highlights from the results:
The highest earners were partners ($480,000); then single-specialty group practices ($469,000), followed by doctors in healthcare organizations ($422,000) and multispecialty groups ($422,000). Outpatient clinics were at the lower end in 2012, with a mean compensation of $200,000, as were academic settings ($304,000).
Only 39% of orthopaedists feel fairly compensated. A significant majority: 61%--feels underpaid.
In last year's Compensation Report, only 8% of orthopaedists either participated in an ACO or planned to join one in the coming year. This year saw a large jump, to 22%.
Of orthopaedic surgeon respondents, 37% indicated a plan to drop insurers who pay poorly.
Of orthopaedic surgeon respondents, 37% indicated that they would choose medicine as a career path again.
Read the press release, Medscape Physician Compensation Report: 2013 Results
View the Slideshow
To view the orthopaedic-specific slideshow, please register at Medscape and click here.
April 24, 2013
| MedWatcher: FDA's mobile app for voluntary reporting of device problems
From FDA today:
MedWatcher Mobile App
MedWatcher is a mobile application that allows individuals to submit voluntary reports of serious medical device problems to the FDA using a smart phone or tablet. The app makes it easier and faster for healthcare professionals, patients and caregivers to send voluntary reports of medical device problems to FDA, compared to the traditional reporting methods - mail, phone or online.
The MedWatcher app allows users to upload photographs of medical devices, which can help identify visible problems with the device, such as breakage or corrosion. App users can also choose to automatically receive MedWatch Safety alerts, FDA safety communications, recall information, relevant articles and other information on specific medical products of interest.
Read FDA's full coverage online.
April 24, 2013
| Three new execs at Sonoma Orthopedic Products
Victoria Good, Ph.D.: Director of Clinical Affairs
>16 years in orthopedics and clinical studies
Authored >50 medical device publications
Past companies: Smith and Nephew, Covidien, Carl Zeiss Meditec
Alex Winber: Vice President of Marketing
16 years at Wright Medical, leading commercialization of products from computer-derived surgical navigation to micro-invasive hip replacement technique
Kyle Lappin: Director of Research and Development
10 years in orthopedic design engineering
>20 patents and patent applications at Wright Medical Technology, Biomet, DePuy
Past 5 1/2 years at DePuy's shoulder division
Read the full release from Sonoma Orthopedic Products online.
April 23, 2013
| SkelRegen appoints John M. Wozney, Ph.D. as Director of Scientific Affairs
In this role, Wozney will set experimental design and direction; lead collaboration with development partners; build alternative R&D pathways; and optimize project quality, cost and time variables.
Wozney is an internationally recognized expert in the key-signaling molecules involved in the growth and maintenance of bone and soft tissues called bone morphogenetic proteins (BMPs), and musculoskeletal biology. SkelRegen is focused upon small molecule musculoskeletal tissue regeneration. Read the full release online.
April 23, 2013
| NLT SPINE among the Red Herring Top 100 Europe
Red Herring's list of winners represents Europe’s leading private companies and startups, with innovative technologies across their respective industries.
NLT SPINE has developed the “non-linear” technology platform enabling implantation of large spinal implants and instruments through small incisions for the treatment of degenerative conditions of the spine. With the “non-linear” technology platform, which is applicable to a wide variety of surgical spine procedures, implant and instrument size is not limited by the incision size. Read the full release online.
April 15, 2013
| Carmell Therapeutics' biologically-active bone putty: development update, newly-published article
In a recent MedCity article with brief video, President and CEO Alan West gives a quick update on Carmell's biologic bone putty under development as an inexpensive approach to accelerate healing and reduce complications for bone fractures. A 30-patient study is ongoing in South Africa, and the company is pursuing a Series B to support product launch in Europe by year-end 2014. The product may enter a U.S. clinical trial in 2014, as well.
Read Deanna Pogorelc's article in MedCity News, "Biologically active putty” under development could help bone fractures heal quicker
Further, in the journal Disruptive Science and Technology, West and co-authors describe how a solid form of bioactive pooled plasma-based biomaterials (PBMs) can accelerate tissue healing in products that are easy to work with, inexpensive to produce, safe and available off-the-shelf.
The comprehensive article provides deep detail on the material, manufacturing, testing, disruptive potential, challenges, etc.
Read the article online, Biologically Active Blood Plasma-Based Biomaterials as a New Paradigm for Tissue Repair Therapies, from Disruptive Science and Technology (doi:10.1089/dst.2012.0024.)
April 15, 2013
| KHN: Doctor-Owned Hospitals Prosper Under Health Law
Jordan Rau of KHN writes that "physician-owned hospitals have emerged as among the biggest winners under two programs in the health law. One rewards or penalizes hospitals based on how well they score on quality measures. The other penalizes hospitals where too many patients are readmitted after they leave."
Of 161 physician-owned hospitals (POHs) eligible to participate in the health law's quality programs, 122 are getting extra money and 39 are losing funds, Kaiser Health News analysis shows, vs. 74% of other hospitals, which are being penalized.
The hospitals seem to be thriving due to high scores in clinical quality and the ability to please patients, as well as reaping the benefits of a narrow surgical focus. Detractors suggest that patterns of cherry-picking the wealthiest patients should have disqualified POHs from the Federal programs.
Read Jordan Rau's complete article online at Kaiser Health News.
April 11, 2013
| NuVasive participation at AANS 2013: Booth, labs and papers
NuVasive (NUVA) is participating in the American Association of Neurological Surgeons (AANS) Scientific Meeting from April 27 to May 1 in booth #1845 at the Ernest N. Morial Convention Center in New Orleans, LA. NUVA's booth will showcase minimally disruptive products and procedures, including XLIF®, MAS® TLIF, MAS PLIF, ALIF, ILIF®, Precept™, PCM® Cervical Disc, Biologics and the NVM5® neuromonitoring system.
Practical courses will be held on April 27 and Sunday, April 28, including extensive hands-on offerings. More details are available at http://budurl.com/AANSPracticalCourses.
Further, NUVA notes that numerous invited podium presentations and sections of the AANS scientific program will be dedicated to lateral approach surgery with an emphasis on XLIF for basic and advanced applications.
For full details on NuVasive's participation at AANS, please visit the company web site.
April 05, 2013
| Blue Belt Technologies resolves lawsuit filed by MAKO Surgical
Following yesterday's announcement regarding the permanent injunction, Blue Belt President and CEO, Eric Timko, stated, “We believe that this lawsuit was without merit and MAKO failed to prove that Blue Belt engaged in any wrongdoing. In fact, MAKO failed to substantiate many of the allegations it made in its complaint and we are confident that Blue Belt would have prevailed had the litigation continued."
Read the full release from Blue Belt online.
March 21, 2013
| Zimmer Highlights Vivacit-E Vitamin E Advanced Bearing Technology at 2013 AAOS Annual Meeting
Vivacit-E® Advanced Bearing Technology with Vitamin E material is antioxidant infused to deliver the longest lasting bearing material for orthopaedic implants. A proprietary manufacturing process results in an advanced highly cross-linked polyethylene material that delivers oxidative stability, ultra-low wear rates and strength. First launched for use in hip replacements, the material is now also available in unicompartmental knee replacements and Persona, The Personalized Knee System.
Read the full release online.
March 15, 2013
| Jeffrey Paulsen, Group President Global Businesses, to leave Zimmer
From Form 8-K:
On March 11, 2013, Zimmer Holdings, Inc. announced the separation of Jeffrey B. Paulsen, Group President, Global Businesses, effective March 20, 2013. The separation is not the result of any misconduct. The Company anticipates that it will enter into a separation agreement with Mr. Paulsen, the terms of which, once finalized, will be described in a subsequent Current Report on Form 8-K.
Review the filing online.
March 14, 2013
| IBJ: Nexxt Spine consolidating ops, relocating HQ to Noblesville, IN
From the Indianapolis Business Journal: Nexxt Spine, manufacturer of spinal implants, is consolidating operations and moving its headquarters and manufacturing facility to Noblesville, Indiana. A 3-year tax abatement expected to support the addition of 44 jobs by 2018. The company has 11 employees at its current Fishers HQ and a manufacturing facility in Indianapolis.
Nexxt Spine was founded in 2009 by Andrew Elsbury, who previously had served as a contract manufacturer for several large medical device companies.
Read the full story in the Indiana Business Journal online.
March 14, 2013
| Orthofix Appoints Brad Mason as President and Chief Executive Officer
Mr. Mason succeeds Robert Vaters, who resigned to pursue other interests.
Mason had previously served Orthofix from 2003 to 2010 in roles of increasing responsibility, including an instrumental contribution in driving the acquired Spinal Implants business to profitability. He joined Orthofix upon the acquisition of Breg, which he founded in 1989. Further, he was dj Orthopedics’ first head of Manufacturing Operations and Product Design. Mr. Mason is also the named inventor on 38 issued patents in the orthopedic product arena.
Read the full release online.
March 13, 2013
| Steven Ek Named President and CEO of Arthrosurface
Steven Ek was named President and Chief Executive Officer of Arthrosurface, effective November 20, 2012. Mr. Ek is one of the original founders and directors of the company. Prior to Arthrosurface, Mr. Ek served as Vice President of Engineering at STD Med, an OEM manufacturer of medical devices, and he spent 9 years as Director of R&D at Smith & Nephew Endoscopy.
Read the full story online.
March 12, 2013
| Cerapedics Adds New Board Member, Antony Koblish
Antony Koblish, President and CEO of Tela Bio and former CEO of Orthovita, is appointed to Cerapedics' Board of Directors. He most recently served as President of Stryker Orthobiologics, and as President and CEO of Orthovita prior to the company's acquisition by Stryker.
Cerapedics is developing and commercializing novel osteobiologic products based upon its proprietary synthetic small peptide (P-15™) technology platform, including i-FACTOR bone graft.
Read the full release online.
March 04, 2013
| Trade group identifies medical device makers passing on Federal tax
From the Reuters release by Debra Sherman:
The Healthcare Supply Chain Association, which represents the biggest group purchasing organizations used by hospitals, said the new site, www.devicetaxwatch.com would help raise awareness of efforts by some manufacturers "to shift costs of the tax directly to hospitals, healthcare providers, patients and taxpayers."
Beverly Slate, director of supply chain operations at Memorial Health Care System in Chattanooga, Tennessee, and past president of American Hospital Association, said she has seen some manufacturers include the device tax as a line item on their invoice. The practice does not seem widespread, but it is happening.
Read the full release online.
February 26, 2013
| SANUWAVE Health Appoints New CEO, Joseph Chiarelli
SANUWAVE Health has appointed Wall Street and healthcare industry veteran Joseph Chiarelli as Chief Executive Officer and a Director.
Since 2011, Chiarelli has been responsible for financial advisory, business development and a healthcare hedge fund at Auriga Capital Management. He was the Chairman of Clarent Hospital Management Corp and spent time with Wall Street Access and Oppenheimer & Company as the head of the healthcare research teams. Mr. Chiarelli has also held prior positions at JPMorgan Chase & Co. where he was responsible for three healthcare sectors of the equity markets.
Read the full release online.
February 05, 2013
| Blue Belt Technologies Announces U.S. Commercial Leadership Team
Blue Belt Technologies, developer of the NavioPFS™ orthopaedic surgical system for unicondylar knee replacement, announces the following U.S. leadership team:
Jim Bruty, U.S. Vice President of Sales and Marketing: Past nine years at Stryker in Sales and Marketing leadership roles; 15-year veteran of the medical device industry, including Brainlab, Laser Diagnostic Technologies and Johnson and Johnson
Mike Lobinsky, Area Vice President of Sales for East Region: Over 16 years of experience in the medical device industry; most recently Vice President of Sales and Marketing with BioMedix
Jeff Gellman, Area Vice President of Sales for West Region: Past 20 years in sports medicine, total joints, navigation and most recently robotics at MAKO Surgical; earlier experience at GE Healthcare and Johnson & Johnson
Read the detailed release online.
February 05, 2013
| Nextremity Solutions Names Rod K. Mayer as President and CEO
Mr. Mayer has a 34-year history in the orthopaedic industry, including extensive entrepreneurial experience in sales, distribution and business development. Since starting his orthopaedic sales career with Depuy in 1977, he has founded and/or co-founded Lake City Medical, contract manufacturer of orthopaedic instruments and implants; DVO, an extremity orthopaedic company acquired by Tornier and, most recently, Del Palma Orthopedics, a product development company. Mr. Mayer serves on the boards of Articulinx and Conventus Orthopaedics.
Read the full story online.
January 29, 2013
| Amedica expands executive team to support promotion of proprietary Silicon Nitride technology
To support expanded use of Silicon Nitride in orthopaedic applications, Amedica has appointed the following executive team:
Vytas Rupinskas joins as VP of Marketing (previous senior positions at St Jude Medical, DePuy Orthopedics, DePuy International and DePuy Spine)
Paul Sendro, formerly Amedica SVP of Sales, is now appointed SVP of Market Development (has held leadership positions at US Spine, Vertebron, Blackstone Medical, Stryker and Synthes)
Jim Abraham joins as SVP of Sales (previous positions at Stryker Orthopedics, IsoTis Orthobiologics, Regeneration Technologies, Encore Orthopedics and Sulzermedica)
Kevin Ontiveros joins as Chief Legal and Compliance Officer (>20 years of experience as in-house and outside corporate counsel for publicly traded and privately held medical device and biotechnology/pharmaceutical companies)
Read Amedica's full release online.
January 28, 2013
| Crain's Detroit: UM spinoff aims to use mesh to create bone
Tissue Regeneration Systems (TRS) is developing biodegradable polymer mesh to support the growth of new bone and replace the use of titanium implants. As noted by Tom Henderson of Crain's,
"TRS uses a biodegradable polyester polymer called polycaprolactone to serve as spinal implants, to mend cracks or fill in voids in broken bones, to repair broken orbital sockets and for facial reconstruction.
"The polymer is formed as a mesh and coated with growth factors that encourage a patient's own bone to grow over and through the mesh. As the bone grows, the polymer eventually dissolves."
Polycaprolactone is FDA-cleared for applications in coating drugs and sutures, but is not yet cleared for use in the bone repair and replacement market.
TRS has received $2.25 million in a 2nd round of VC funding, including $500,000 from state-sponsored funds. The company seeks to bring a product to market by 2015.
Read the full article in Crain's Detroit online.
January 24, 2013
| Medical Device Tax Belongs to Medical Device Industry, States Novation
In its press release, Novation notes that Congress' intent with the Affordable Care Act was to "evenly distribute the costs associated with providing health care services to millions of additional Americans throughout the health care industry."
While the pharma industry committed to taking on $80 billion of those costs, and health care providers $155 billion over ten years ("Despite their slim operating margins"), Novation comments that medical device manufacturers refused to voluntarily contribute and thus, the government imposed the Medical Device Tax to cover their portion.
Jody Hatch, Novation President and CEO, is quoted as saying, "While most device manufacturers are taking responsibility for this Tax, there are some manufacturers attempting to pass their obligation on to hospitals. This Tax should be the responsibility of the manufacturers, and Novation is dedicated to ensuring that member hospitals are impacted by it as little as possible."
January 16, 2013
| Washington Post: Shining a light on Medicare payments
Charles Lane, editorial writer for the Post, notes that Medicare cost $37.4 billion in 1980. It now costs >$500 billion annually and sits "central to the United States' fiscal predicament."
Dow Jones is seeking reversal of a 1979 Florida district court order that exempted all provider-specific data on Medicare payments–nationwide–from the Freedom of Information Act. (A ruling is reportedly imminent.)
Because of the court order, the public is unable to see which treatments individual physicians billed to Medicare, nor how much Medicare paid for them. According to the GAO, Medicare made $28.8 billion in improper payments in 2011.
Doctors warn that lifting the ban could harm the physician/patient relationship, with one noting that public disclosure of Medicare billing could increase patient misconceptions that physicians prescribe a therapy "for the money rather than for their well-being."
Read Charles Lane's full article at The Washington Post online.
January 14, 2013
| NYT: New York City Ties Doctors' Income to Quality of Care
New York City’s Health and Hospitals Corporation is developing a plan to base doctors’ raises upon performance to 13 indicators/quality measures.
Could quality of care erode as patients are encouraged to see the available doctor vs. the one who knows them already, if speed is among the measurements?
Would doctors consider the idea to be demeaning? An anonymous union official noted, “To say we’ll stick a carrot in front of you and therefore you’re going to be a better doctor is a little disingenuous."
The union, Doctors Council S.E.I.U., supports the move if the efforts “will improve patient care,” but suggested that the union would demand more doctors and support staff. Additionally, the union proposed expanding the indicators to 20, including bonuses for going to community meetings, giving lectures, screening patients for obesity and counseling them to stop smoking, etc. It also proposed excluding some patients (e.g. developmentally disabled, homeless) from incentives aimed at reducing the time patients spend in the hospital.
Read the full article online in The New York Times.
January 08, 2013
| RTI Biologics investing $14MM in new Logistics and Technology Center
RTI Biologics broke ground on a new 41,000-square-foot Logistics and Technology center in Alachua, Florida. The $14 million dollar facility will accommodate research and development labs, clean rooms, warehouse, shipping and finished implants, as well as production of RTI’s forthcoming map3 cellular allogeneic bone grafts.
RTI expects to occupy the center in early 2014.
Read the full release online.
January 08, 2013
| Stryker appoints Scott Bruder, MD, PhD as Vice President, Chief Medical and Scientific Officer
In this newly-created position, Scott P. Bruder, MD, PhD will oversee Stryker's clinical and scientific efforts and represent the company to trade associations, regulatory bodies and other entities.
Dr. Bruder's past positions included Chief Science and Technology Officer for Becton, Dickinson and Company, eight years at Johnson & Johnson in a series of senior executive and scientific roles and leadership roles at Anika Therapeutics and Osiris Therapeutics.
Read the full release at Stryker's web site.
January 03, 2013
| Raising an angel round of investment in 10 steps or less
From David S. Rose, CEO of Gust, provider of services for entrepreneurs and angel investors:
How would you break down the process of raising an angel round of investment in 5-10 steps?
Understand everything about your business, product, customer and competition so well that you can answer any question asked
Understand what investors seek to invest in, and why
Reach deep into your own pockets first (investors want to know that YOU believe in your startup), and consider friends/family, too
Prepare components to support your pitch: emails, funding applications, presentations, due diligence
Start fundraising! Tell everyone about your startup, and learn which investors are most productive for you to approach
Apply with your local business angel investment group
Apply to accelerators
Find your lead investor/primary champion/mentor
Get a lawyer with experience in early stage financing
Communicate with your investors every month
Read every supporting detail online at Gust.com.
January 02, 2013
| CORDIS: Could wood replace damaged bones?
Findings from studies at the National Research Council of Italy suggest, perhaps:
"what has been discovered is that the structure of some woods at the microscopic level is very close to that of natural bone. Furthermore, the structure shares biomechanical properties such as high strength and lightness, due to its hierarchical organisation."
The research team believes that "the technology could exploit the hierarchical physical structure of rattan wood to render it useful as a scaffold, thus creating a synthetic material to replace damaged and lost bone. An additional benefit is that such a material could be load-bearing, a factor that has precluded the use of earlier biomimetic materials."
Though processing could be long and complex, the patented material is claimed to be:
has good biomechanics
Read the full release from CORDIS News online.
January 02, 2013
| Graftys recognized for outstanding growth in the Deloitte Technology Fast 500 for the EMEA
Graftys is pleased to announce that it has won a prestigious award for outstanding growth: in the Deloitte Technology Fast 500™ for the EMEA (Europe, Middle East, Africa) region, Graftys was selected as the fastest growing company in Biotech/Pharma/Medical Equipment sector. (Source: Graftys)
Graftys has posted stunning 5-year revenue growth of 3,400%. The company is engineering synthetic bone tissue to support treatment of diseases such as osteoporosis, and seeks to enter emerging markets to further the success it has already enjoyed in Brazil. Alain Valet, CEO, states that a focus on research and development is “the main reason we have already patented four products and developed our portfolio to 2018.”
Read a brief profile of Graftys in the Deloitte Technology Fast 500 EMEA Winners Profiles area of the Deloitte web site.
December 27, 2012
| Board changes at Corin Group
Board changes at Corin Group, following the offer by 2IL Orthopaedics being declared wholly unconditional, include:
Peter Huntley, Linda Wilding and David Young have resigned
Stefano Alfonsi is appointed as CEO and acting chairman
Marco Fumagalli, Enrico Amo and Pierluca Antolini, directors of 2IL Orthopaedics, are appointed to the board of Corin as non-executive directors
Alfonsi has served in senior management at Johnson and Johnson, DePuy, Covidien and Lima Corporate. He is currently employed at Inion.
Read the full release online.
December 20, 2012
| Lanx Launches Patient Education Site on Minimally Invasive Spinal Fusion
Lanx launched a new educational website for patients with chronic back and leg pain, www.MinimallyInvasiveSpineFusion.com. The site highlights Lanx's minimally invasive offerings, such as the ASPEN MIS Fusion System for posterior spinous process fixation, TELLURIDE MIS Spinal Fixation System for less invasive pedicle screw fixation and TIMBERLINE Lateral Fusion System for the lateral approach to interbody fusion, and includes:
information on common causes of pain
available treatment options, including new minimally invasive approaches to fusion
a spine specialist locator
Review the full release online.
December 18, 2012
| Is Uncle Sam swiping your medical 'privacy'?
There is no more medical privacy. Since 2009, according to the Office for Civil Rights, nearly 21 million patients have had their medical data lost or stolen from electronic records.
Privacy forms the foundation of the ethical doctor/patient relationship. Dr. Lee Hieb shares the one way to protect your medical privacy: read the full opinion online.
December 13, 2012
| Max Reinhardt Named WW President of DePuy Synthes Spine
Mr. Reinhardt has been with the company since 2002, most recently as Vice President of Worldwide Marketing.
Mr. Reinhardt began his career with DePuy Spine in 2002 as Director of Sales and Marketing in the U.K. Four years later he became Vice President of Sales in the U.S., and in early 2011, was named Vice President of Worldwide Marketing. In 2012, when Johnson & Johnson completed its acquisition of Synthes, Inc., Mr. Reinhardt was charged with helping to integrate the global spine divisions of both companies into DePuy Synthes Spine.
Source: DePuy Synthes Spine
December 12, 2012
| St. Louis BizTalk: Spectrum, SpineSource brace for medical device tax
Reporter Samantha Liss spoke with Jeff Toedtmann, President of Spectrum Medical, a distributor of primarily orthopaedic implants, and Tom Mitchell, President and CEO of SpineSource, a distributor of spinal implants. In response to the impending medical device tax, they noted:
Toedtmann, Spectrum Medical:
16-person team expects less in commission in 2013, ~$300,000 to $400,000 due to the tax
Group earns 20% in commission for each sale; expects manufacturers to cut commission percentage by at least 2%
Doesn’t anticipate layoffs due to the tax, but won’t be hiring. 2012 revenue could reach $14MM; 2013 is less predictable because of the tax
Tax is causing company to forgo importing a new spinal implant from Europe that could have contributed at least $5MM in added 2014 revenue
Won’t cut jobs from 3-person staff, but holding off on new devices hurts company’s growth
Finally, from Dave Dillon, media relations for the Missouri Hospital Association: “Until we know how the device industry will respond, it is hard to know how hospitals need to plan.”
Read the full article at St. Louis Business Journal.
December 11, 2012
| Naples News: Arthrex response to medical device excise tax
In the face of rules finalized by the IRS last week regarding the medical device tax, Arthrex notes that the company:
doesn't expect to reduce its workforce or scale back expansion plans as a result of the medical device excise tax
doesn't anticipate a significant change to near-term hiring and expansion plans in Southwest Florida
does not expect to raise prices to try to offset the tax
With annual sales of about $1.5 billion, Arthrex stands to pay as much as $34 million in new taxes under the ACA.
Read the full article at Naples News online.
December 04, 2012
| Medical Device Veteran Peter Wehrly Joins NLT SPINE's Board of Directors
NLT SPINE, a developer of products for Minimally Invasive Spine Surgery and percutaneous procedures, announced today that Peter Wehrly has joined the company’s Board of Directors.
Mr. Wehrly brings over 25 years of experience and expertise in the medical device field, and formerly served as President of Medtronic's $3 billion Spinal, Biologics and Navigation Division. He has served as Group President of Covidien since July 2011. In this position, he is responsible for the Respiratory & Monitoring Solutions and Vascular Therapy businesses, as well as the Japan, Australia-New Zealand and Canada businesses.
Read the full release from NLT SPINE online.
December 04, 2012
| WND: America on Lenin's path to 'health care' - Dr. Lee Hieb tracks history of socialism via 'medicine'
Vladimir Lenin said, "Medical care is the keystone in the arch of socialism." Dr. Hieb writes, "If the election results are to be believed, the majority of Americans do not trust themselves and their highly trained physicians to make decisions about their health. Rather, they have relinquished total control of their medical care..."
Dr. Hieb continues with a historical review of the 1st government-run healthcare system, introduced in the late 19th century by Kaiser Wilhelm in Germany.
In future columns, Dr. Hieb promises to
explore the truth of government healthcare around the world to clarify what the U.S. should expect in the coming years
address steps individuals can take to protect themselves medically when the system fails to help
discuss latest scientific breakthroughs in longevity and wellness
discuss how medicine can be saved
Read the full installment at WND online.
December 03, 2012
| Active Implants appoints President/COO, establishes ex-U.S. HQ
Active Implants appointed Lex R. Giltaij, MD MBA as President and Chief Operating Officer and established its subsidiary’s international headquarters in The Netherlands.
Dr. Giltaij has held senior executive positions in Stryker Benelux and Stryker Biotech, and was responsible for creating the international market for the X-STOP® Interspinous Implant for St. Francis Medical Technologies. Further, he established a direct sales effort and a distribution presence in Europe, China, the Middle-East, South-Africa and Russia for Pioneer Surgical Technology.
Read the full release online.
December 03, 2012
| G. Keith Smith, M.D. asks, Will There Be Any Physicians Left To Implement ObamaCare?
Dr. Smith suggests that with ObamaCare, there is little evidence that the government officials and bureaucrats who created the current disaster have learned anything. What will happen when physicians simply stop practicing medicine, in the interests of better use of their time?
"The consideration of the next best alternative use of an individual’s time and resources is innate, something that each and every one of us does without even thinking. The belief that American physicians won’t do this is naive and arrogant. It may represent one of the greatest miscalculations in the bloody history of central planning. And what will “medicine” look like if the “providers” work begrudgingly, under terms that they see as detrimental to their own interests and their patients?
"Physicians in this country will always be physicians. However, they might not be practicing medicine. The tyrants who would point a gun at a doctor to extract some “right” to health care assume that the doctors will show up for this work camp the next day, again and again, instead of seeking work conditions that are more advantageous. The current shortage of physicians will look like a surplus in a short time, if price controls and bureaucratic risk outweigh the benefit of medical practice."
Read Dr. Smith's full commentary at AAPS online.
December 03, 2012
| AAPS: The Patient Protection and Affordable Care Act and the Fiscal Cliff
Marilyn M. Singleton, M.D., J.D. notes that the PPACA contains ~100 new programs that have not been evaluated for effectiveness prior to their funding. Congress has the power to back off from the PPACA contribution to the fiscal cliff, if it has the will to do so.
Dr. Singleton notes that PPACA is "a financial disaster":
"The Congressional Budget Office (CBO) has projected a cost of $1.4 trillion over 10 years, but if we look at history, such projections are meaningless. In 1967, the House Ways and Means Committee said Medicare would only cost $12 billion in 1990. The actual cost was $110 billion. In 2010, total Medicare expenditures were $523 billion. Medicare spending has been forecasted by the CBO to increase to $922 billion in 2020.
"Just the IRS and HHS costs to implement the PPACA, $20 billion over 10 years, exceed the House’s initial estimate for all Medicare spending."
Read Dr. Singleton's full commentary online at AAPSonline.org.
December 03, 2012
| OrthoSensor's Knee Balancer: sensor technology designed to make knee surgery much more precise
In a profile of OrthoSensor, Miami Herald writer Joseph A. Mann Jr. notes that the company:
Developed Knee Balancer to aid in implant placement: single-use disposable device being used in U.S. trials by 30 hospitals and orthopaedic teaching centers, costs ~$500
Has raised $42 million in venture capital
Is advancing development of implants that assess bone density by emission of sound waves; units that electronically transmit data on internal temperature, blood acidity levels and other indicators used to detect infections following orthopedic surgeries, etc.
Is planning late 2014 launch of implants that can monitor load, range of motion and loosening
Read the full profile at The Miami Herald online.
December 03, 2012
| Star Ledger: Three questions with James Pastena of Precision Spine
Among the questions, Mr. Pastena was asked about the effect of the affordable healthcare law on medical technology. He responded,
"Right now, the things that we’re starting to see is surgeons retiring early. They’re tired of fighting with insurance companies. At the same time, I can constantly hear from surgeons that Obamacare is coming between the patient and the doctor, so they’re starting to leave. We’re getting ready for some major impacts. They put a 2.3 percent medical device tax on our business gross sales. We don’t even know how it’s going to be paid. This is going to take money out of the business."
Read the Q&A online at the Star Ledger.
November 28, 2012
| GHX Predicts Accelerated Healthcare Change to Avert Industry Fiscal Cliff
GHX CEO Bruce Johnson predicts that our unsustainable fiscal path and mounting political pressures are accelerating the change required to transform healthcare into a sustainable system. Johnson suggests the upcoming year will bring:
Acceleration of industry consolidation to create an economy of scale for hospital providers to remain solvent (e.g., insurance companies acquiring hospitals)
Shift toward centralization for increased operational efficiency (hospitals and suppliers embracing business process changes)
Improved dependence on supply chain for meaningful use reporting and fiscal visibility (e.g. aid in data capture and sharing)
Greater global commonality for worldwide alignment around unique device identification
Read Johnson's comments in the full release online.
November 27, 2012
| Spinal Elements launches "Pledge to be a Hero" program in the U.S.
Following its introduction in October at the North American Spine Society meeting, Spinal Elements has launched the “Pledge to be a Hero” program in support of Hero allograft. The name honors those who made the tissue donation possible. Spinal Elements will donate all profits from the sale of Hero Allograft products to charities benefiting children with life-threatening medical conditions.
The “Pledge to Be a Hero” program offers surgeons and hospitals the opportunity to pledge to use only allograft tissue from companies that do not profit from the transfer of that tissue whenever clinically feasible. Working with local media, Spinal Elements will inform each participant’s community about their involvement in the program.
Read the full release from Spinal Elements online.
November 19, 2012
| Journal Gazette: Zimmer suing Greatbatch over production move, claims potentially millions in lost sales
Zimmer (ZMH) claims that Greatbatch's plan to move production out of Switzerland could cost ZMH millions in lost sales. The suit is filed in the South Bend division of the U.S. Bankruptcy Court for the Northern District of Indiana.
Greatbatch makes specialized surgical instruments for ZMH to implant orthopaedic devices, including hips and knees. ZMH's standard contract with suppliers includes provisions that keep a supplier from moving production without approval. ZMH claims that Greatbatch's plans to move production by the end of 2013 from its plant in Switzerland to existing factories in Fort Wayne and Tijuana, Mexico is too short to allow ZMH to get required approval from various geographies to sell products there, including items made by suppliers. In addition, Greatbatch has fallen behind on filling orders, ZMH claims.
Sherry Slater writes that "Greatbatch plans to sell its Swiss facility to an unnamed buyer. That would prevent the possibility of the company moving some work while continuing in Switzerland to build a stockpile of products for ZMH, the lawsuit argues. ZMH says it could lose millions if it’s unable to sell orthopaedic devices and instruments in the meantime."
Read Sherry Slater's full article online in the Ft. Wayne Journal Gazette.
November 14, 2012
| Ortho Kinematics appoints Paul Gunnoe CEO, Chip Wade Chief Scientist
Mr. Gunnoe brings over 15 years of healthcare experience and a strong track record of success as an entrepreneur and CEO of multiple successful healthcare businesses. His experience as a healthcare CEO ranges from successfully-exited startups to public companies. Mr. Gunnoe also brings a strong track record in raising capital and driving revenue growth for early-stage companies.
Adam Deitz, the company’s founder, has transitioned from CEO to the role of Chief Technology Officer.
Lloyd (Chip) Wade, Ph.D., will support all research and clinical initiatives as well as industry collaborations across the healthcare sector and insurance industry.
Read the full release from Ortho Kinematics online.
November 13, 2012
| MedCity News: NovoSource, Orthopedic implant startup, hopes to find market share with lower-cost proven technology
Deanna Pogorelc writes, "NovoSource Inc. doesn’t claim to have the next cutting-edge advancement in orthopedic devices. Instead, it’s one of a number of small orthopedic device firms looking to cut costs from the process of developing and selling existing orthopedic implants."
NovoSource was co-founded by Harold Linville, former Chief Business Development Officer at Leis Medical/Innovative Medical Device Solutions. NovoSource's total knee is under FDA 510(k) review, with potential launch occurring in 1Q13. A hip implant is expected to launch following that.
NovoSource joins other companies in the low-cost manufacturing movement, such as White Box Orthopedics and Emerge Medical.
Read Deanna Pogorelc's full article on MedCity News, online.
November 13, 2012
| IMDS Names Bryan McMillan to Serve as President, Co-Innovation Division
IMDS (Innovative Medical Device Solutions) has appointed Bryan McMillan to serve in the newly-created position of President of the company’s Co-Innovation Division, effective November 12, 2012.
Mr. McMillan's prior positions include roles at Orthofix as the Vice President of Global Development, Executive Vice President-General Manager for the Spinal Implants Global Business and President for the Global Spine Business Unit.
Prior to Orthofix, Mr. McMillan served a 9-year tenure at Stryker in strategic sales and marketing, corporate accounts and business development, ultimately being promoted to the position of Vice President, Stryker Finance.
Read the full story from IMDS online.
November 12, 2012
| Tornier Appoints David H. Mowry as Interim President and Chief Executive Officer
Tornier has appointed David H. Mowry as Interim President and Chief Executive Officer, effective immediately. Mr. Mowry succeeds Douglas W. Kohrs, who has retired as President, Chief Executive Officer and Executive Director.
Mr. Mowry joined Tornier N.V. in July 2011 as Chief Operating Officer. He brings to Tornier 23 years of medical device industry experience in various engineering and management assignments. Prior to Tornier, Mr. Mowry served as Senior Vice President and President of the Neurovascular Division of Covidien plc, and in the same position with ev3 Inc., prior to its acquisition by Covidien. Mr. Mowry is a graduate of the United States Military Academy in West Point, New York with a degree in Engineering.
Read Tornier's full release online.
November 12, 2012
| ConforMIS Appoints Peter Traynor as New Chief Financial Officer
Prior to joining ConforMIS, Mr. Traynor spent 10 years at Genzyme Corporation where he served as the Chief Accounting Officer and most recently as the Senior Vice President of Business Unit Finance.
Mr. Traynor earned an M.S. in Finance from Bentley College Graduate School and a B.A. in Accounting from the University of Massachusetts. He is currently completing a G.M.A in International Relations from the Fletcher School of Law and Diplomacy at Tufts University.
Read the full release from ConforMIS online.
November 08, 2012
| David Floyd appointed Group President, Orthopaedics at Stryker
Mr. Floyd joins Stryker after 25 years in the medical technology and orthopaedics industry where he held a number of senior level leadership roles at DePuy, Abbott Spine, AxioMed Spine, Centerpulse Orthopaedics and most recently as Chief Executive Officer for OrthoWorx.
Effective January 1, 2013. Mr. Floyd will also take on responsibility for Stryker's Spine division, and Timothy J. Scannell will assume responsibility for Stryker's Neurotechnology businesses, including the Neurovascular division and Craniomaxillofacial business. As Group President of MedSurg and Neurotechnology, Mr. Scannell will maintain responsibilities for the Instruments, Medical, Endoscopy, and Sustainability Solutions divisions.
Mr. Scannell began his career with Stryker in 1990 and held various leadership positions within the Endoscopy, Biotech, and Spine divisions before being named Group President in 2008. He currently serves as Group President of MedSurg and Spine.
Read the full release from Stryker online.
November 07, 2012
| From the blog of Bruce Krasting: JNJ Gets Nailed Again
Bruce Krasting, an independent banking professional, maintains a personal blog of his take on financial events. Recently, Mr. Krasting wrote about a reported recall of Synthes trochanteric femoral nails due to a packaging issue.
"Apparently, questions have been raised as to the possibility of a package getting a tear at some point. In an abundance of caution, Synthes is going to replace the existing inventory of nails (most trauma hospitals have these nails in inventory)."
Read Mr. Krasting's blog post online at brucekrasting.com.
November 07, 2012
| Wright Medical appoints new EVP/COO, new Presidents of OrthoRecon and Extremities divisions
Pascal E.R. Girin is appointed Wright Medical's Executive Vice President and Chief Operating Officer. In this newly created position, Mr. Girin will have global operating responsibility for Wright's Extremities, OrthoRecon and International businesses and Clinical, Regulatory and Quality. Mr. Girin served in several executive roles at Keystone Dental and ev3, and served on the board of directors of Tornier from November 2010 to November 2012.
In the U.S., Wright will now have an Extremities division and an OrthoRecon division. Eric Stookey is promoted to President of the Extremities division and Ted Davis to President of the OrthoRecon division.
Read the full release online.
November 07, 2012
| Titan Spine appoints Marcus Klarl as Vice President of Sales, Europe
Mr. Klarl joins the company following 22 years in the medical device industry in Europe, including the last 12 in various strategic sales, sales management, marketing, education and clinical affairs positions in the spinal implant industry. He will be responsible for sales efforts of Endoskeleton interbody fusion devices.
Mr. Klarl was most recently responsible for significant sales increases of the M6™ Cervical and Lumbar Artificial Discs for Spinal Kinetics in the German market. Prior to that, Mr. Klarl led the European sales, marketing and clinical efforts for Impliant, the developer of the TOPS™ facet arthroplasty device. Mr. Klarl has also held various sales management, business development and marketing positions with Depuy Spine/Johnson & Johnson and Steris Corporation.
Read the full release from Titan Spine online.
November 05, 2012
| Crain's CLE Business: OrthoHelix could generate $30 million in sales for 2012
"The volume of business that officials at OrthoHelix Surgical Designs in Medina oversee is about to double, thanks to its new Dutch parent," writes Chuck Soder In Crain's Cleveland Business.
OrthoHelix is expected to generate $30 million in sales in 2012
In 2012 to date, OrthoHelix has increased the size of its staff from 65 to 82; plans to hire 20 to 30 people over the next 6-8 months
Tornier agreed to keep OrthoHelix in Ohio for at least 2 years
OrthoHelix plans to commence ex-U.S. sales in 2013; Tornier gives OrthoHelix access to Europe, Australia and Japan
Read the full article in Crain's online.
November 01, 2012
| From KHN: How The Health Law Might Be Changed By The Next President
Kaiser Health News staff writer Mary Agnes Carey reports: "On the presidential campaign trail, Republican Mitt Romney has repeatedly called for repeal of the 2010 health law and President Barack Obama has vowed to implement it. Yet both men could face obstacles: Romney may be stymied by the lack of a majority in Congress to do his will and Obama could be forced by fiscal concerns or public opinion to revamp parts of the law. Here is a look at how Obama and Romney might change the health law in the years ahead based on interviews with health policy experts" (Carey, 10/31).
Read the story provided by Kaiser Health News.
November 01, 2012
| ConforMIS Announces New Corporate HQ: Accommodating Substantial Growth, Job Creation and Scaled Manufacturing
ConforMIS relocated its headquarters to 28 Crosby Drive in Bedford, MA. The new space, combined with the manufacturing facility in Burlington, quadruples the total square footage to >120,000 square feet available for its operations. The expansion will facilitate the development of advanced manufacturing capabilities, new product development initiatives and a broader commercialization strategy, resulting in more than 100 new jobs over the next 12 to 18 months.
ConforMIS is retaining its existing facility at 11 North Avenue in Burlington as a manufacturing plant, allowing for scaled production to meet broad commercial demand for its cutting edge knee replacement systems.
Read the full release from ConforMIS online.
November 01, 2012
| Parker Hannifin and Vanderbilt sign licensing agreement for exoskeleton technology
Parker Hannifin signed an exclusive licensing agreement with Vanderbilt University for its exoskeleton technology, which allows individuals with severe spinal cord injury to walk and enhances rehabilitation for people who have suffered a stroke. Parker will hold exclusive rights to develop, manufacture and sell the device, and intends to invest in further development of the technology and establish a business unit targeting commercial launch of the exoskeleton device in 2014.
The Parker exoskeleton:
is 40-50% lighter than competing devices
provides a modular design that can be assembled and disassembled for ease of use and transportation.
is small, with a slim profile and no bulky backpack components or footplates
features a proprietary control interface for smooth operation that works in harmony with natural human movement and body position
is the only wearable device that incorporates a proven rehabilitation technology called functional electrical stimulation
November 01, 2012
| OrthoCyte Appoints Francois Binette as Vice President of Research and Business Development
BioTime subsidiary, OrthoCyte, announced the appointment of Francois Binette, PhD, as Vice President of Research and Business Development. Dr. Binette’s primary focus will be to develop and partner near- and long-term product opportunities in regenerative medicine with an emphasis on orthopedic diseases and injuries. OrthoCyte is a wholly owned subsidiary of BioTime, Inc. that develops cellular therapeutics for orthopedic repair, diseases, and injuries.
Previously, Dr. Binette has served as Director of Biologics R&D for Medtronic Spinal & Biologics and he held a variety of positions with Johnson & Johnson, focusing on regenerative medicine therapies for various orthopedic indications, including cartilage injuries and back pain. Dr. Binette began his corporate career at Genzyme Tissue Repair, where he helped pioneer Carticel, the first FDA Biologic License Application-approved cell therapy product.
Read the full release from BioTime online.
October 24, 2012
| Imaging in Clinical Trials - Unique Compliance Challenges: A complimentary webinar Nov. 7
IMARC and ImageIQ host a Complimentary Webinar on Wednesday, November 7th at 11am EST
Imaging in Clinical Trials – Unique Compliance Challenges
For all clinical trials, operating in compliance with the federal regulations, the agreements, the investigational plan, and the requirements of the IRB are critical to protect human subjects and to demonstrate quality and integrity of the resulting data. When imaging is introduced into the trial, a new layer of complexity is added, and additional considerations with regard to helping sites maintain compliance with the imaging requirements should be implemented.
CLICK HERE to see what you'll learn.
REGISTER HERE for this webinar.
October 23, 2012
| AMEDICA Announces Poster Presentation Highlighting Benefits of Silicon Nitride Biomaterial at 2012 North American Spine Society Annual Meeting
At NASS 2012, Alpesh Patel, M.D., Associate Professor in the Division of Spine Surgery at the Loyola University Chicago Stritch School of Medicine, will present ePoster (#P82), "Decreased Bacterial Count and BioFilm Formation Associated with Silicon Nitride (Si3N4) Materials Used in Interbody Fusion Cages (IBF) Compared to Titanium and Polyetheretherketone (PEEK)." Reports on recently published peer-reviewed studies conducted at Brown University that demonstrated Silicon Nitride's decreased vulnerability to bacterial colonization and biofilm formation in comparison with PEEK and titanium. These attributes may contribute significantly to achieving optimal patient outcomes in clinical applications.
AMEDICA is also hosting a Surgeon Educational Symposium at the conference, with Bryan McEntire, AMEDICA's Chief Technology Officer, providing an overview of the published results of the studies conducted at Brown University, and the company's expansion of biomaterial claims for its FDA 510(k)-cleared Valeo® Interbody Fusion Devices. Two spine surgeons, Grant Skidmore, M.D. and Mark Crawford, M.D. will also present patient case studies illustrating the use and efficacy of AMEDICA's Silicon Nitride Interbody Fusion Devices to treat patients suffering from back pain requiring spinal fusion surgery.
The symposium will be held on Wednesday, October 24th at 5:30 p.m. CDT at the Adolphus Hotel Century Room, 1321 Commerce Street, Dallas. The Symposium is open to all NASS attendees.
For additional information or to arrange interviews, please visit AMEDICA at NASS (Booth #1638) or visit www.Amedica.com.
October 18, 2012
| OMNIlife science Announces Changes to the Board of Directors and Management Team
OMNIlife science, a subsidiary of Orthopaedic Synergy, announced the following changes to its Board of Directors and Management Team.
Richard “Nik” Nikolaev announced his retirement following six years as a member of the Board of Directors. He was the driving force behind many major milestones, including the Enztec and Praxim acquisitions. His 40 years of prior experience in the orthopaedic industry proved instrumental in the success OSI has enjoyed to date.
Dr. Florian Reinaud, a former Praxim Board member, recently joined the OSI Board of Directors. Dr. Reinaud is a Partner at Paris, France based Innovation Capital, which was the largest shareholder in Praxim before it was acquired by OSI.
Thomas Prokop, Vice President of Sales, also announced his retirement. Mr. Prokop has been with OMNI since 2007 and has been a key contributor to the dramatic sales growth the company has achieved during his tenure.
Jack Turner will join the Executive Team as Vice President of Sales. Before joining OMNI, Mr. Turner was the National Director of Sales for MAKO Surgical where he identified strategic and tactical opportunities for improvement that resulted in significant revenue increases over a two-year period.
Albert “Skip” Farinha has also joined the Management Team as Vice President of Quality Assurance. Mr. Farinha comes to OMNI with over 25 years of quality and regulatory experience.
Read the full release online.
October 17, 2012
| Nexxt Spine Launches Website Supporting DIRECT and Traditional Sales Channels
Nexxt Spine's redesigned website features all of the capabilities and much of the content of its predecessor, while incorporating a number of significant improvements to meet the needs of surgeons, healthcare facilities, distributors and patients accessing by mobile phone, tablet or desktop.
Upgrades include an enhanced information platform featuring optimized navigation menus, new landing pages and a more intuitive design, as well as a cleaner, more streamlined interactive customer information portal.
Read the full release online.
October 16, 2012
| Brian McCollum to Lead Orthofix Spine Global Business Unit
Orthofix has promoted Brian McCollum to President of its Spine Global Business Unit. Mr. McCollum will continue to serve as Chief Financial Officer through November 10, 2012. He has served Orthofix for 11 years in various operational and financial executive roles.
Orthofix appointed Emily Buxton to Interim Chief Financial Officer, effective November 11, 2012. Ms. Buxton has been with Orthofix for nine years, most recently as the Chief Financial Officer of the Global Orthopedics Business Unit.
Bryan McMillan, the current President of the Spine Global Business Unit, has resigned due to family reasons.
Read the full release online.
October 10, 2012
| Zimmer Celebrates 15 Years of Advanced Orthopaedic Implant Technology
Zimmer today celebrated 15 years of clinical history of its Trabecular Metal™ Technology. Trabecular Metal Technology is a core platform technology for Zimmer, helping to restore mobility and alleviate pain for millions of people around the world.
Since its introduction in 1997, Trabecular Metal Technology has been used in more than 800,000 surgeries worldwide. The technology has been featured in more than 240 clinical publications and countless surgeons have adopted it for use with their patients. Over the past 15 years, applications of Trabecular Metal Technology have grown steadily. Trabecular Metal Technology is now used in knee, hip and shoulder replacements, trauma applications, spine implants, dental implants and bone void fillers and augments used in oncology.
Read the full release online.
October 04, 2012
| Alphatec Spine Appoints Thomas McLeer New Senior Vice President of U.S. Commercial Operations
Alphatec Spine has named Thomas McLeer as Senior Vice President of U.S. Commercial Operations. Mr. McLeer will have responsibility for U.S. Sales and Marketing, Alphatec Spine's Biologics Division and Research and Development.
Most recently, he served as Chief Marketing Officer and General Manager of Spinal Operations for Pioneer Surgical. Prior to that, Mr. McLeer was Vice President of Sales and Marketing for Archus Orthopedics. Mr. McLeer has also held several other executive-level positions at Spinal Concepts, Interpore Cross and Zimmer.
Read the full release online.
October 03, 2012
| An orthopaedic surgeon asks: Do Medicare and Medicaid Payment Rates Really Threaten Physicians with Bankruptcy?
In a HealthAffairs.com blog post, James Rickert, M.D., private practice orthopedic surgeon, asks:
"Is there any truth to the claim that specialty physicians, such as orthopedists, lose money treating Medicare patients or make just $8 an hour to do so?"
Dr. Rickert suggests that such statements are gross hyperbole, and that family practictioners will be harder hit than specialty physicians. Read the full post, including supportive references, at HealthAffairs.com.
October 02, 2012
| Gary Henley Named CEO of United Orthopedic Group
Gary Henley, former Chief Operating Officer of United Orthopedic Group, has assumed the position of Chief Executive Officer. Mr. Henley has served as UOG’s COO for the last year. Stepping aside from his role as CEO for the past five years, Greg Nelson will continue as the Executive Chairman of the Board of Directors for UOG.
UOG services the orthopaedic brace and supports market by designing, manufacturing and selling a broad portfolio of medical products through Bledsoe Brace Systems and Hope Orthopedic.
Read the full release online.
October 01, 2012
| Stryker names Kevin Lobo as President/CEO
Kevin A. Lobo is named Stryker's President and Chief Executive Officer, effective immediately. He has also been named to the Company's Board of Directors.
Curt R. Hartman, who served as Stryker's Interim CEO since February 2012, has decided to pursue opportunities outside of Stryker but has agreed to stay on as an Advisor to the CEO to assure a smooth transition as the Company conducts a search for a permanent CFO.
Mr. Lobo joined Stryker in April 2011 and was most recently Group President of Stryker Orthopaedics. Orthopaedics includes the Company's Reconstructive, Osteosynthesis, Joint Preservation, Orthobiologics and Performance Solutions businesses.
Read the full release at Stryker's web site.
September 25, 2012
| Iconacy Orthopedic Invests $2.63MM in Warsaw, Indiana Manufacturing Complex
Iconacy Orthopedic Implants, developer and manufacturer of orthopaedic implants such as the i-Hip, will invest $2.63 million on a Warsaw, Indiana manufacturing complex, with plans to hire manufacturing, engineering, finance, marketing and administrative positions beginning in 2013.
The Indiana Economic Development Corporation offered Iconacy up to $575,000 in conditional tax credits based on the company’s job creation plans. These credits are performance-based, meaning until Hoosiers are hired, the company is not eligible to claim incentives. The firm plans to initially hire up to 50 additional employees. In addition, the city of Warsaw approved additional property tax abatement at the request of the Kosciusko Economic Development Corporation.
Read the full story from Area Development Online.
September 18, 2012
| LDR launches new corporate web site
LDR, manufacturer of fusion and non-fusion spinal implants, launched a new global corporate website at www.ldrmedical.com. The site's clean look features user-friendly navigation to the company’s region-specific product content, as well as interactive multimedia elements including video vignettes highlighting LDR’s culture of innovation and focus on spine.
Country-specific product pages ensure that visitors have access to information for the products cleared for use and available in their respective markets. Further, the site is optimized for viewing in a variety of browsers and mobile devices. (Source: LDR)
September 17, 2012
| TranS1 Appoints Stephanie M. Fitts, Ph.D. as VP Regulatory, Quality and Compliance
Stephanie M. Fitts, Ph.D. is appointed Vice President of Regulatory, Quality and Compliance for TranS1.
Dr. Fitts has nearly 20 years of medical device experience in the areas of clinical research, regulatory, quality and compliance. For the past nine years, Dr. Fitts worked at Stryker Orthopaedics, including most recently as Senior Director, Regulatory Affairs and Compliance and, from 2008 until 2011, as Director, Regulatory Affairs and Compliance. Prior to that, she served as Senior Clinical Program Manager at Medtronic from 2000 until 2003.
Read the full release online. (Source: TranS1, Inc.)
September 12, 2012
| Paradigm Spine Welcomes Hallett Mathews, MD, MBA As Its Executive Vice President & Chief Medical Officer
Paradigm Spine, a provider of non-fusion spinal implant and medical device technologies, welcomes Hallett Mathews, MD, MBA as Executive Vice President and Chief Medical Officer. Dr. Mathews will hold global responsibility for medical education initiatives, surgeon/faculty training functionalities and strategic management of the company's clinical, compliance and regulatory policies.
Dr. Mathews' previous positions include Vice President of Medical Affiars, Vice President of Clinical Affairs and Chief Medical Officer of Medtronic Spinal and Biologics; President of MidAtlantic Spine Specialists in Richmond and Williamsburg, VA and Associate Clinical Professor of Orthopedic and Neurologic Surgery at Virginia Commonwealth University in Richmond, VA. He has also served as President of Musculoskeletal, Clinical and Regulatory Advisors, LLC. Dr. Mathews is a society fellow of the American Academy of Orthopedic Surgery; former member of the Board of Directors of the North American Spine Society; former member of the Board of Directors of the Spine Arthroplasty Society and member and past President for the International Society for Minimally Invasive Spine Surgery.
Read the complete press release from Paradigm Spine.
September 07, 2012
| Orthofix International Comments on Judge's Ruling
Orthofix International commented on the Federal court rejection of the previously signed plea agreement between the Department of Justice and Orthofix Inc., a subsidiary of the Company, to resolve the bone growth stimulation criminal investigation:
“The Company and the government stand behind their agreements and continue to discuss a resolution of the matter following the court’s rejection of the plea,” said President and Chief Executive Officer Robert Vaters. “We remain confident that this matter will be resolved amicably and in a manner that is in the best interests of our shareholders.”
Read the full release online.
September 04, 2012
| Integra LifeSciences Announces Two Key Executive Appointments
Appoints John Mooradian as Senior Vice President, Global Operations and Supply Chain; Joseph Vinhais as Senior Vice President, Global Quality Assurance, to report to Peter Arduini, President and CEO
Prior to joining Integra, Mr. Mooradian spent 24 years at Abbott Laboratories where he significantly improved critical manufacturing processes and systems and implemented key compliance enhancements.
Mr. Vinhais has over 20 years of global experience in quality assurance, regulatory affairs, compliance and operations, most recently as Head of Quality Assurance, Regulatory Affairs and Sustainability at Philips Healthcare Imaging Systems.
Read the full release online.
August 29, 2012
| Osseon Therapeutics Names Ron Clough as New Chief Operating Officer
Osseon Therapeutics named Mr. Ron Clough as Chief Operating Officer. Most recently, he served as VP of Operations at Theken Spine and was a key executive in the acquisition and integration of Theken Spine into Integra LifeSciences, which acquired Theken for $200 million dollars in a two-year earn out in July 2008.
Osseon Therapeutics, Inc. focuses on bringing to market alternative minimally invasive treatments for degenerative bone and joint disease. (Source: Osseon Therapeutics, Inc.)
August 28, 2012
| Cleveland Clinic's 2012 Medical Innovation Summit Highlights Orthopaedic Technologies
Cleveland Clinic's 10th Annual Medical Innovation Summit – Innovative to the Bone! will host >1,000 executives, investors, entrepreneurs and clinicians from Oct. 29 to 31 to assess the state of healthcare innovation and share insights on the hottest orthopaedic technologies. The meeting will be capped by a presentation of the "Top 10 Innovations" that will have a breakthrough impact on healthcare next year.
The three-day gathering will feature detailed discussions with healthcare leaders, presentations by top medical innovators, and demonstrations of new orthopaedic therapies. Speakers will explore:
What is the outlook on medical innovation in light of the affirmation of the Affordable Care Act?
Is this a bull or bear market for orthopaedic innovations?
What outlook do top CEOs have for the industry?
What devices are on the horizon to detect and protect athletes from traumatic brain injuries?
How will healthcare IT fully utilize "Big Data" to improve care, decrease cost and enhance safety?
Read the full press release online and visit the event web site.
August 28, 2012
| Former Zimmer Exec Sheryl Conley Named New OrthoWorx CEO
Sheryl Conley has been named Chief Executive Officer at OrthoWorx, replacing David Floyd, who is returning to industry. Ms. Conley, a native of Warsaw, Indiana, served for 25 years until 2008 in various management capacities at Zimmer where her last position was Group President, Americas and Global Marketing, and Chief Marketing Officer. (Source: OrthoWorx)
August 27, 2012
| WSJ: Cheesecake Factory Medicine, Obamacare's real vision for healthcare
"While ripping Mr. Ryan, ObamaCare's intellectual architects have been laying out in more detail their own vision for the future of American health care.
"The immediate danger of the Orszag-Gawande-Obama vision is that layer on layer of new regulation will lock in less-than-best practices. This makes the status quo worse, because too-big-to-fail oligopolists have less incentive to innovate to reduce costs and improve quality.
"The longer-run danger is that Mr. Orszag's cost board starts to decide what types of care "work" for society at large and thus what individual patients are allowed to receive. One way or another, health costs must come down. And if Mr. Ryan's market proposal is rejected, then government a la Orszag will do it by brute political force."
Read the full article online at the Wall Street Journal.
August 13, 2012
| Patient Protection and Affordable Care Act: Estimates of the Effect on the Prevalence of Employer-Sponsored Health Coverage
Highlights of GAO-12-768, Estimates of the Effect on the Prevalence of Employer-Sponsored Health Coverage, a report to the U.S. Senate Committee on Health, Education, Labor and Pensions
Full report (41 pages, PDF)
Five microsimulation study estimates ranged from a net decrease of -2.5% to net increase of +2.7% in total number of individuals with employer-sponsored coverage within 1st 2 years of implementation of key PPACA provisions (~4MM individuals)
Of 19 employer surveys, 16 reported estimates of employers dropping coverage for all employee types.
Four employer surveys found that smaller employers were more likely to stop offering health coverage altogether
Nine employer surveys indicated that employers are considering key changes to benefit design, some of which may result in greater employee cost for health coverage
See also: Wall Street Journal, Deloitte: One in 10 U.S. Employers to Drop Health Coverage, 7/24/12
August 02, 2012
| NASS Meeting Preview: U.S. Registry Pilot Seeks to Collect Spine Outcomes Data
An October 25 symposium will spotlight NASS' plan to build a registry to collect de-identified data to enhance understanding of spine care treatments, patient outcomes and the natural history of spine disorders. The pilot will test the data collection process, platform and measures, and determine the administrative and cost burden to participants before expanding the registry to the NASS membership.
Speakers at "NASS Registry Pilot Update: Collecting Data to Inform Spine" will discuss registries and present details of a 15-month pilot that will collect data from 15 U.S. sites. The pilot will examine common lumbar spinal disorders and document conditions and treatment of surgical and nonsurgical patients. The immediate goal is to have data ready for peer review by the 2014 NASS Annual Meeting.
Read the full preview online.
July 30, 2012
| Fox News: Indiana company scraps plans for expansion over ObamaCare device tax (Cook Medical)
Cook Medical, an Indiana-based medical equipment manufacturer, is scrapping plans to open five new plants in the coming years because of a looming tax tied to President Obama's health care overhaul law.
Cook Medical claims the tax on medical devices, set to take effect next year, will cost the company roughly $20 million a year, cutting into money that would otherwise go toward expanding into new facilities over the next five years.
"This is the equivalent of about a plant a year that we're not going to be able to build," a company spokesman told FoxNews.com. The spokesman said the impact is greater than just a 2.3 percent uptick in taxes. He said the impact on actual earnings is another 15 percent, and he projected the company's total tax burden next year will rise to over 50 percent. Read the full story online.
July 25, 2012
| Providers and Surgeons Partner to Define Knee and Hip Care Best Practices
TriZetto Group and BlueCross BlueShield of Tennessee will collaborate with four orthopaedic practices to define and standardize best practices in medical care that health plan members should receive before, during and after total knee and hip replacement. Beginning 10/12, BlueCross will make single, bundled payments to partnering providers for agreed-upon medical services. BlueCross anticipates that 12+ practices will participate in the payment-bundling program by 1H13.
Read the full release online.
July 23, 2012
| AAPS: ObamaCare is the Wrong Answer. Doctors explain real solutions for putting patients first.
Highlights from Video of Capitol Hill Briefing on July 18, 2012: The OPTION Act. A Healthy Patient-Physician Relationship Requires Options, Not Mandates.
Congress has inserted the U.S. government in the exam room alongside the patient and physician to enforce one-size-fits-all "solutions." This degradation of the patient-physician relationship leads to undesirable consequences: poorer health outcomes, increased costs and less availability of care.
Doctor Broun's OPTION Act, HR 4224, frees patients and physicians to provide even higher quality care, increased access to care, at lower prices. Innovative medical practices are already implementing and proving that these ideas work for patients from all walks of life and levels of health.
The OPTION Act fosters patient-centered solutions developed by the people who know patients' needs best: their doctors. Watch the briefing video here.
July 20, 2012
| Doc says physicians have reached a tipping point [VIDEO]
From The Daily Caller: (Surgeon interview at the link)
Dr. Louis McIntyre, representing AAOS before the House Small Business Committee, told The Daily Caller that "physicians have reached a tipping point” under current health care laws, as they cannot both care for their patients and comply with mandated regulations.
Testimony of Dr. Louis McIntyre to the U. S. House of Representatives Select Committee on Small Business, July 19, 2012 (PDF)
Decreased reimbursement, increased reporting requirements, the need for huge outlays for technology improvements and uncertainty about future earning potential are driving private practice physicians to seek employed positions.
Employment, however, significantly decreases physician autonomy in affecting the environment in which patient care takes place.
As more physicians seek employed positions, there will be a generation who will have never experienced private practice and the business aspect of medicine. They will be unaware of the costs and management issues of providing health care. They may see less of a need to join and maintain membership in medical societies and specialty organizations that in the past have been oriented toward the private practice of medicine.
The loss of tax revenue resulting from private practice physicians migrating to hospital employment may be significant and worthy of further study.
Source: Transcript at House Committee on Small Business
July 19, 2012
| From AIS Health: In New Angle on Stark Cases, Government Hits Hospitals for Lack of Physician Profit
Hospitals that employ physicians may run afoul of the Stark law in the eyes of the government if they don’t make a profit on the physicians’ professional services. According to recent cases being pursued by some government attorneys, most employment arrangements would not be commercially reasonable — a criterion of Stark exceptions — unless they generate a profit, one lawyer says.
Further, another attorney states that CMS’s own words may undercut the Department of Justice’s ability to base Stark cases on the premise that employment arrangements are not commercially reasonable if the hospital doesn’t turn a profit on the physician’s professional services. CMS essentially says that as long as hospitals make a profit without considering Medicare DHS referrals from their employed physicians, they will have satisfied the commercial reasonableness standard. Read more online at AIS Health.
July 18, 2012
| MAKO Surgical Announces Management Changes
MAKO Surgical, a medical device company that markets its RIO® Robotic Arm Interactive Orthopedic surgical platform, MAKOplasty® joint specific applications, and proprietary RESTORIS® implants that together enable orthopedic surgeons to consistently, reproducibly and precisely treat patient specific osteoarthritic disease, today announced that Steven J. Nunes tendered his resignation as MAKO's Senior Vice President of Sales & Marketing effective July 17, 2012.
Maurice R. Ferré, M.D., MAKO's President and Chief Executive Officer, will assume sales responsibilities on an interim basis while MAKO conducts a search for a Senior Vice President of Sales. Ivan Delevic, MAKO's Senior Vice President of Strategic Marketing and Business Development, will transition to the new role of Senior Vice President of Marketing and assume commercial marketing responsibilities, in addition to his existing strategic marketing responsibilities. (Source: MAKO Surgical Corp.)
July 11, 2012
| U.S. House Again Votes to Repeal Obama's Health Care Law
The Republican-led U.S. House voted to repeal President Barack Obama’s health care law, an action party leaders said was intended to demonstrate their resolve to undo the president’s main domestic-policy achievement.
The bill, H.R. 6079, was passed on a vote of 244-185 today. It represents the 33rd time that House Republicans have voted to revoke all or parts of the 2010 health care law, known as the Patient Protection and Affordable Care Act. The measure won’t advance in the U.S. Senate, where Democrats hold the majority. (Source: Bloomberg)
July 11, 2012
| Voice of America: US Congress to Vote on Health Care Law
The Republican-controlled U.S. House of Representatives will hold a vote Wednesday to repeal the Affordable Care Act, the new national health care reform law.
Wednesday's vote will be the 31st vote to undermine the Affordable Care Act, either through repeal or blocking funding for various provisions, since Republicans took control of the House in 2010. The current repeal effort is sure to be defeated in the Democratic-led Senate. And Obama has pledged to veto such a measure, if it reaches his desk. Read the full story online.
July 10, 2012
| American Commitment: States can stop Obama's health care law cold
From Phil Kerpen: "On Friday, 73 House and Senate conservatives sent a very important letter to the National Governors Association, urging the states not to adopt state health care exchanges. These exchanges (which are completely optional for the states) are the centerpiece of Obama’s new entitlement that provies vast taxpayer-funded subsidies up to 400 percent of the poverty level. They are also the mechanism for imposing a $3000 per employee tax on employers who cannot afford to offer health coverage.
As I wrote last year, the text of the law is crystal clear that the subsidies and penalties only apply in states that adopt exchange laws. However, as I predicted, the IRS has asserted — contrary to law — that the subsidies and penalties apply in states that refuse to set up exchanges. The U.S. Senate, however, will likely vote soon on overturning that lawless IRS rule (talk about taxation without representation!), under a procedure called the Congressional Review Act that gives the minority the power to force a vote on overturning new regulations that cannot be filibustered. This will be a very telling vote for senators from states like Florida that have made clear they will not set up exchanges."
Read Phil's entire article and view the 6/29/12 letter online.
June 28, 2012
| Discgenics Establishes Development Phase Operations in Salt Lake City, Utah
Discgenics completed its Memphis, TN research-feasibility activities and established its development phase operations and activities in Salt Lake City, UT.
Founded in 2007, Discgenics is developing technology that uses human nucleus pulposus (NP) tissue as a source for adult disc stem cells that can be expanded into therapeutic cell populations known as Discospheres™. These cells have different properties compared to traditional mesencyhmal stem cells, and early research suggests that they may have a better capacity to regenerate NP tissue due to their direct origin within the disc and genetic footprint. Discgenics is developing an investigational product that provides the disc with new cells that can help restore the original properties of the disc.
Read the complete announcement online.
June 27, 2012
| Star Tribune: Insurance makes or breaks devices (OrthoCor Medical's Active Knee)
OrthoCor's launch of a new knee brace that uses electromagnetic pulse therapy to alleviate pain and speed healing could serve as a medical technology tutorial.
Safety and effectiveness? Check.
U.S. Food and Drug Administration approval? Check.
Ample angel investment and a growing roster of impressed orthopedic doctors and happy patients? Check, check and check.
But there remains a speed bump along the way to OrthoCor Medical Inc. raking in oodles of cash for its Active Knee System: Medicare and widespread insurance company reimbursement. Until that comes, OrthoCor lingers on the verge of becoming big.
"We are right on the cusp," said OrthoCor President and CEO John Dinusson, who added that "some" insurers are paying for the $695 device. "We are basically educating them on why they should be covering. If we get reimbursement, the patient population is huge."
Read James Walsh's article at the Star Tribune site.
June 27, 2012
| Advanced BioMedical Technologies Completes GMP Certified Renovation in China
Advanced BioMedical Technologies, developer and manufacturer of orthopaedic internal fixation devices, has completed renovations at its GMP certified facilities in Shenzhen, China. The facilities were renovated to meet the newly adopted "SFDA Sterilized Medical Devices and Medical Implants Regulation." The completed renovation has been approved by the SFDA Guangzhou Medical Device Inspection Center. The Company's facilities now meet the new SFDA standard and exceed the GMP requirements in certain areas.
The completed renovation includes:
1. Upgraded existing laboratory to higher level sterilized laboratory to meet the requirement of GMP standard -- 100 - 10,000 of < 5uM micro-dust per cube meter. Additional 16% capacity has been added to the central air control system.
2. Upgraded water supply system which will provide the entire modification area with purified water for production, fully compliant with the new SFDA's guideline.
3. Re-arranged part of the facilities to increase the production capacity.
Read the full release online.
June 25, 2012
| Motley Fool's takes on what happens after the ACA decision
"This Sector Will Be Crushed If Obamacare Passes" - If Obamacare is approved, medical device companies are expected to trim costs to account for the 2.3% medical device excise tax. Actions are expected to include passing along costs to end users, reducing R&D spend, outsourcing overseas and laying off workers. Sean Williams, Motley Fool contributor, proposes that "If Obamacare is upheld, the medical-device sector could see an unprecedented number of layoffs in 2013." Read the full take online.
"3 Sectors That'll Break Out the Champagne If Obamacare Is Upheld" - Williams proposes that Big Pharma, Hospitals and Medicaid providers stand to gain the most, should the ACA bill be approved in its entirety. Find out why he thinks so.
June 21, 2012
| Wright Medical launches MiToe Hammertoe Patient Outreach Program
Wright Medical announced the launch of its MiToe™ patient outreach program to increase awareness of treatment options for hammertoes. MiToe™ is the patient-facing brand for Wright’s hammertoe solutions, which include the PRO-TOE™ VO Hammertoe Fixation System.
Beginning at this week’s American Orthopaedic Foot & Ankle Society meeting, foot and ankle doctors will be introduced to this new initiative from Wright Medical. As part of this initiative, Wright’s MiToe™ hammertoe program website is now live and can be accessed at www.mitoe.com.
Read the full release online.
June 21, 2012
| Presentations on Augment Bone Graft from Regenerative Strategies & Emerging Technologies Forum at AOFAS Meeting
Numerous presentations were made during the Regenerative Strategies Forum at the 2012 American Orthopaedic Foot and Ankle Society annual meeting which supported the safety, effectiveness, clinical need, biologic rationale and cost effectiveness of Augment™ Bone Graft from BioMimetic Therapeutics.
Presentations included Augment Bone Graft: Worldwide Clinical Evidence; Analysis of Cost for Autologous Bone Graft for Foot and Ankle Surgery; Pain after Bone Graft Harvest: Are All Sites the Same?, etc.
Posters to be presented include Outcomes of Hindfoot Surgery Augmented with Injectable Bone Graft: Results of a Multi-centered Randomized Control Trial and Clinical Decision Making on the Need for Autologous Bone Graft: Results of a Nationwide Survey among Orthopaedic Foot and Ankle Surgeons.
Read the full release online.
June 19, 2012
| FOR Foundation Offers Help and Hope to Victims of Severe Orthopedic Trauma
On 01 April, 2012 The Foundation for Orthopedic Reconstruction, www.FORinternational.org, officially opened.
The Foundation, an exciting undertaking for the orthopedic and additive manufacturing communities, was developed to provide patient-specific medical implants at no cost to those in need and to encourage and fund innovative research within the orthopedic and additive manufacturing industries as a means to understand and advance orthopedic solutions.
Initial funding was received from the founders of Oxford Performance Materials (OPM).
The great strength of FOR is that it can provide needed trauma surgery around the world on a patient specific implant basis, and sponsor necessary research in the new arena of utilizing additive manufacturing to build polymer/PEKK implant solutions, thereby increasing our knowledge within this field. FOR seeks to provide the finest medical patient specific implant technology to trauma victims worldwide and develop better patient outcomes at a lower cost investment.
Please visit the FOR website to learn more and donate. Also, see the full press release online.
June 12, 2012
| Internal Fixation Systems Clarifies $7.5 Million Financing
Internal Fixation Systems' President and CEO, Stephen J. Dresnick, MD, clarified the $7.5 Million financing through Hyde Park Advisors, an affiliate of Central Park Financial, a N.Y.-based institutional investor.
According to Stephen Dresnick, MD, IFS' President and CEO, "The Company will be able to draw on the facility as needed. We will use the initial draw to build additional surgery sets of existing products. This will be the quickest way to grow our revenue. If each set is used 10-12 times each month, our revenues will quickly grow. Our small fragment bone sets costs $4-5,000 to build and should produce revenue of $700-800 per surgery. We would like to deploy an additional 100 sets by the end of this calendar year of both our mini-cannulated screw sets as well as our small fragment fracture plating system. "We have other sets in development and subsequent draws will enable us to put those products into the field. Costs and revenues per set are similar to our small fragment system." Read more online. http://www.globenewswire.com/newsroom/news.html?d=258978
June 12, 2012
| VG Innovations Announces John Kippenberger will Lead VGI's Sales and Marketing Efforts as VP of Sales
VG Innovations, an innovative company focused on spinal fixation device design and development, and the makers of the VerteLoc® Minimally Invasive Spine Stabilization System, today announced that John Kippenberger will join executive team as Vice President of Sales. With over 18 years’ experience in executive sales, marketing and management in the medical device industry, Kippenberger will assume responsibility of sales and marketing strategy.
Before coming to VGI, Kippenberger served in sales management positions for SulzerMedica, Smith&Nephew, TranS1, and most recently for Spineview, Inc. In these roles he implemented effective strategic sales initiatives for both direct and distribution model sales teams. Read the full release.
May 31, 2012
| The Hill: Awaiting the Court's decision on healthcare
Of the court's possible decisions, four are the most likely:
1. Court could uphold the law. Based on the "train wreck" of oral arguments, it seems unlikely that the law will escape unscathed. It is more likely that the law will be damaged. (But to what extent?)
2. Court could rule that the mandate is unconstitutional and such a central piece of the law that it is not severable from the rest, thus striking down the entire law. This is possible, but precedent on severability seems to make it fairly unlikely.
3. Court could rule that the mandate is unconstitutional and also grant the government’s request that if the mandate is overturned, two key provisions should go as well: guaranteed issue and community rating. THe likelihood of this is slim.
4. Court could strike down the individual mandate by itself. This seems to be the most likely decision.
Like this summary? Read David Merritt's entire article at The Hill's Congress Blog.
May 31, 2012
| Amedica Corporation Appoints Distinguished Ceramist As Chief Technology Officer
Amedica appointed Bryan J. McEntire to Chief Technology Officer, in charge of directing the company's technology strategies as it expands the use of the company's proprietary medical grade silicon nitride for spine, total joint, dental devices and potentially anti-infective coating applications.
Mr. McEntire holds B.S. and M.B.A. degrees in Materials Science and Engineering, and Operations Management, respectively, both from the University of Utah. He is an author or co-author of over 30 technical papers on ceramic materials, processing and characterization; and served as an invited short-course lecturer on Forming of Ceramics at the Annual Meeting of the American Ceramic Society from 1986 to 1995.
Mr. McEntire was elevated to the level of "Fellow" with the American Ceramic Society last month. Fewer than 1,000 individuals have been nominated to receive this award during the Society's 114-year history. (Source: Amedica Corporation)
May 30, 2012
| WSJ: Improvised Explosive Device Tax - Support is growing to repeal this levy on medical innovation
'Taxmageddon' isn't only about the half-trillion-dollar blow to the economy that arrives in 2013 on the end of the Bush-Obama tax rates. Several of the Affordable Care Act's worst tax increases kick in too, such as the new excise tax on medical devices.
The 2.3% levy applies to the sale of everything from cardiac defibrillators to artificial joints to MRI scanners. The device tax is supposed to raise $28.5 billion from 2013 to 2022, and it is especially harmful because it applies to gross sales, not profits. Companies at make-or-break margins could be taxed out of existence, especially in an intensely competitive industry where four of five businesses are start-ups or midsized." Read the full article online.
May 29, 2012
| TransCorp Spine Names Christopher Welch President and Chief Executive Officer
Christopher Welch brings a wealth of executive and industry experience to TransCorp Spine, with over 25 years in the healthcare and medical device industries. Most notably, Mr. Welch was General Manager and Vice President of Sales at I-Flow, where he architected a sales transformation that resulted in the I-Flow acquisition made by Kimberly Clark.
TransCorp Spine is an early-stage medical device company dedicated to developing minimally-invasive, tissue-saving products and procedures for the treatment of cervical spine pathologies. TransCorp Spine products are designed to enable the surgeon to rapidly, safely and effectively decompress the cervical spine without the need to perform a discectomy, fusion or arthroplasty offering patients an early return to life activities. Read the full release online.
May 22, 2012
| WSJ: New DNA Test, Surgical Techniques Could Aid Scoliosis Patients
New genetic tests and advances in surgical techniques could change the way adolescents are treated for scoliosis, a curvature of the spine that can lead to serious health problems.
For instance, Axial Biotech's saliva-based ScoliScore DNA test relies on 53 genetic markers to predict the likelihood that a curve will progress to a severe level by the time of skeletal maturity. Over 5,000 patients have been tested since 2009. The test has a list price of close to $3,000, but discounts and patient-assistance plans mean most families get it for free or pay a nominal amount. Read the full article at Wall Street Journal's Health Blog.
May 21, 2012
| Las Vegas Is Becoming a Medical Tourism Destination for Spine Surgery
The Southern Nevada Medical Industry Coalition is drafting an asset analysis and a quality algorithm before writing a feasibility study on growing Southern Nevada’s $50 billion medical tourism industry and $106 billion medical wellness industry. Yevgeniy Khavkin, M.D. is a neurosurgeon at the Nevada Spine Institute, which markets in Russia, China and Middle East. Khavkin said Russian patients are convinced that the best medical care in the world is offered in the U.S. Read more at OrthoStreams online.
May 16, 2012
| Forecreu Introduces Pocket Reference for Orthopaedic Materials and Processes
Orthomaterials, a brand name of Forecreu, introduced "Materials and Processes for Orthopaedics," a pocket reference comprising contributions from an array of partners addressing metallic materials, synthetic polymers, ceramics and manufacturing processes such as forging, foundry, machining, coating, controlling, testing, etc.
The "Pocket Book" is of interest to designers, engineers, production executives, sales, orthopaedic surgeons and contract manufacturers. The book will be on display in Forecreu's booth #606 at OMTEC, June 13-14 in Chicago, Illinois. (Source: Forecreu)
May 07, 2012
| IFS Announces Management Addition of Scott Barczewski as VP of Operations
Internal Fixation Systems appointed Scott Barczewski as the Vice President of Operations.
Mr. Barczewski has been with the company since 2010 and was previously the Director of Customer Relations. He will lead all internal operations including but not limited to, production, inventory and personnel management, and working closely with all medical facilities that use IFS products.
Internal Fixation Systems is a manufacturer and marketer of high quality, responsibly-priced orthopedic, spinal and podiatric implants. (Source: Internal Fixation Systems, Inc.)
May 02, 2012
| Castlight Health Secures $100 Million in Series D Funding
With its healthcare management suite, Castlight Health enables employers to make reliable cost and quality data for medical services available to employees via the Web or mobile devices.
This latest funding round brings Castlight’s total funding to $181MM. The company plans to aggressively capitalize on growing customer demand for health care transparency solutions that improve the quality of health care and deliver savings to customers and users. Read more online.
April 23, 2012
| The Business Post, HPSU Startup of the day: X-Bolt Orthopaedics
Profiles of companies from Ireland's high potential startup (HPSU) program:
Company: X-Bolt Orthopaedics
Funding: Enterprise Ireland HPSU €250,000
What it does: developing an expanding bolt device to treat hip fracture
X-Bolt is patented in Europe and is weeks away from FDA clearance in the US. The product is manufactured in Caragh Precision, Galway. Read profile of X-Bolt in The Business Post.
April 23, 2012
| OMTEC Chicago 2012: Companies to seize US market thanks to pioneering joint LEP project
Organizations in Sheffield and Leeds (U.K.) are set to benefit from healthcare investments and trade opportunities in the U.S. Through a pioneering new project, Sheffield and Leeds City Region’s Local Enterprise Partnerships are combining forces to attract healthcare investments and trade opportunities across their regional boundaries.
Private sector professionals from the two city regions will team up to pitch for business at OMTEC in Chicago - the 8th Annual Orthopaedic Manufacturing and Technology Exposition & Conference. The visit is being supported by UKTI and Medilink with a visit package available for any Yorkshire companies wanting to take part. Read more online
. (Source: Sheffield City Region LEP)
April 18, 2012
| OrthoHelix Surgical Designs Named 2012 Leading EDGE Award Honoree
OrthoHelix Surgical Designs has been named a 2012 Leading Edge Award Honoree. On May 16 at The University of Akron, OrthoHelix will be honored, along with other Northeast Ohio companies, at the Leading EDGE annual dinner and program. Honorees are chosen based on percentage sales growth and other financial figures. This program annually recognizes around 100 companies generating significant value for themselves and the Northeast Ohio region.
OrthoHelix is a medical device company developing a comprehensive line of implants and instruments for use in small bone reconstructive surgery. Read more online
. (Source: OrthoHelix Surgical Designs, Inc.)
April 18, 2012
| Exactech Selects Medical Metrics as Imaging Core Lab for Cartilage Repair Study
Exactech selected Medical Metrics (MMI), provider of medical imaging core lab services for global clinical trials, to conduct an independent evaluation of medical images from the BiPhasic Cartilage Repair Implant (BiCRI) IDE Clinical Trial approved by the Taiwan FDA.
This prospective, randomized study will be conducted in Taiwan to evaluate a novel cartilage repair treatment. The biphasic implant is a 2-phase scaffold that is intended to promote integration with subchondral bone and regeneration of hyaline-like cartilage. During the study, MMI will provide comprehensive analysis and management of MR images. (Source: Medical Metrics, Inc.)
April 17, 2012
| University of Akron entrepreneurs win LaunchTown award for spinal implant
At the 6th annual LaunchTown Entrepeneurship Awards at the University of Akron, four finalists vied for a $10,000 first prize from the Burton D. Morgan Foundation and an advisory services package valued at $20,000. The prize was won by UA's "Telkesis" team of Jason King, Laura Vondeak, Esra Cipa and Margaret Brass, who created unique spinal implants for enhanced patient care.
The team developed a minimal shock set screw as an implant that promises to be safer, more flexible and more effective for surgical use in patients with back problems needing spinal stabilization.
"When a doctor today does a spinal fusion, the torque on the screw in your back has to be exact," said King, 28, of North Canton, who is getting a master's degree in biomedical education. "Too much or too little torque is bad. Our idea is dynamic stabilization which does not harm the back as much and reduces physical shock to both the patient and the surgeon."
The implant is made from a titanium alloy. King said his team has already applied for a patent.
The "Telkesis" team bested an original field of 20 applicants from Case Western Reserve, Cleveland State, Kent State and Youngstown State. That field was narrowed to eight semifinalists and then four finalists. The competition focuses on the best business ideas in science, engineering and biomedical fields. Read the entire article at Cleveland.com.
April 16, 2012
| NYT: Why Medical Bills Are a Mystery
Rising health care costs are busting the Federal budget as well as those of states, counties and municipalities. Policy makers and health care leaders have spent decades trying to figure out what to do about this.
Yet their solutions are failing because of a fundamental and largely unrecognized problem: We don’t know what it costs to deliver health care to individual patients, much less how those costs compare to the outcomes achieved.
Most health care providers have hundreds of opportunities to use time, equipment and facilities more intelligently. These opportunities have been obscured by existing costing systems that have little connection to the processes actually performed. Read the full article here.
April 13, 2012
| Tornier Announces 2012 Facility Consolidations
Tornier plans to consolidate its facilities to drive operational productivity and reduce annual operating expenses by $2.3 to $2.8 million, beginning in 2013.
Tornier’s facility consolidations will include relocation of its distribution operations in Stafford, Texas to Minnesota. The company plans to consolidate these operations with its U.S.-based marketing, training, regulatory, clinical, supply chain and corporate functions into a single leased site in Minneapolis. European facilities to be consolidated into nearby Tornier sites include those in St. Ismier, France and Dunmanway, Ireland. (Source: Tornier N.V.)
April 10, 2012
| Ivy Tech Rolls Out Orthopedic Quality Standards and Technical Skills Certificate Program
Ivy Tech Corporate College opened enrollment for the new Orthopedic Quality Standards and Technical Skills Certificate Program, developed in collaboration with OrthoWorx, through the organization’s Advanced Manufacturing Committee, and other industry experts.
The certificate’s curriculum was designed to train the workforce serving the orthopaedic industry. The program focuses on developing technical skills related to orthopaedic quality standards and introduces students to production processes in a world-class, lean manufacturing environment. Instructors are professionals from the orthopaedic device industry, providing students the benefit of real world experience and orthopedic industry insight.
The hands-on program includes a student orientation to the industry, FDA quality standards, preparation for the National Institute for Metalworking Skills certification in CNC and an introduction to lean manufacturing processes. (Source: Ivy Tech Community College)
April 10, 2012
| CarboFix Orthopedics Lands in Champaign, Illinois
CarboFix Orthopedics plans to base its U.S. subsidiary, CarboFix Inc., in north Champaign. CarboFix Orthopedics, based in Herzeliya, Israel, makes orthopaedic trauma implants such as rods, plates and screws, from carbon fiber and polymer rather than the conventional materials of stainless steel, titanium and titanium alloys. (Source: The News Gazette)
April 10, 2012
| ZipLine Medical announces appointment of John R. Tighe as CEO
ZipLine Medical appointed John R. Tighe as President and CEO in the third quarter of 2011. The company is developing PRELOC™ (Pre-placementRE-aligning Low-tensionClosure) for noninvasive surgical skin closure designed to provide a suture-like outcome with the speed of staples.
ZipLine’s initial target applications include C-section, laparotomy, pacemaker/ICD implant, laparoscopic port, orthopedic and excisional skin biopsy closure. (Source: ZipLine Medical, Inc.)
April 04, 2012
| BONESUPPORT'S New CEO Announces 100-Day Plan
BONESUPPORT revealed details of a One Hundred Day Plan presented by CEO Lloyd Diamond, addressing key initiatives to support global commercialization of the company's CERAMENT™ synthetic bone substitute.
Focusing resources on key market segments where CERAMENT offers a unique and significant clinical advantage over traditional bone grafting or other bone substitutes
Strengthening direct sales channels in Germany while expanding distribution in the U.S. and other key markets.
Building brand awareness of CERAMENT through clinical substantiation, relationship building among key opinion leaders and centers of excellence, and through patient and physician education efforts.
Continuing to develop a robust product pipeline to further extend the benefits and applications of CERAMENT. (Source: BONESUPPORT)
April 03, 2012
| Simpirica Spine Names Milena Ridl Vice President of International Sales and Marketing
Simpirica Spine, developer of minimally invasive, flexion-restricting stabilization devices, has appointed Milena Ridl as Vice President of International Sales and Marketing. In the new role, Ridl will be responsible for expanding commercialization of the company’s LimiFlex™ Spinal Stabilization System internationally. The CE marked LimiFlex is a novel dynamic stabilization system designed to address flexion (forward bending) pain and instability without the need for spinal fusion.
Ridl brings to Simpirica Spine more than 12 years of experience in medical technology sales and marketing, with significant focus in spine. She spent nearly five years of her career at Kyphon, where she held senior business development and European sales positions both before and after the company’s acquisition by Medtronic. She also served as director of European sales for SpineAlign Medical. Ridl joins Simpirica from biomaterials company MiMedx, where she was the vice president of sales for Europe, the Middle East and Africa. (Source: Simpirica Spine, Inc.)
April 03, 2012
| Blue Belt Technologies Announces New Pittsburgh Facility
Blue Belt Technologies is holding a ribbon-cutting ceremony and open house event on April 3, 2012 to celebrate its a new facility in Pittsburgh, PA. The company is commercializing the next generation of "smart" surgical instruments to provide precise robotic control, for initial use in orthopedic procedures.
In addition to continued internal product development, the facility will allow for manufacturing and support of initial European clinical sites, and represents another phase in Blue Belt Technologies' evolution. The space is configured to optimize cross-functional interaction during development and commercialization efforts. (Source: Blue Belt Technologies, Inc.)
March 27, 2012
| NYT: Hard Questions From Justices Over Insurance Mandate
With the fate of President Obama’s health care law hanging in the balance at the Supreme Court on Tuesday, a lawyer for the administration faced a barrage of skeptical questions from four of the court’s more conservative justices.
Everything about the argument was outsized. It was, at two hours, twice the usual length. The questioning was, even by the standards of the garrulous current court, unusually intense and pointed. And the atmosphere in the courtroom, which is generally subdued, was electric.
The legal question for the justices was whether Congress had exceeded its constitutional authority in requiring most Americans to obtain insurance or pay a penalty. The practical question was whether Mr. Obama’s signature domestic achievement would survive. Read the full article at New York Times online.
March 27, 2012
| BONESUPPORT Launches New Web Site
BONESUPPORT launched a new corporate web site at www.BONESUPPORT.com. The new site aims to update the BONESUPPORT brand while providing increased educational and clinical CERAMENT™ content to an expanding audience.
CERAMENT is an injectable, synthetic bone substitute that mimics the properties of cancellous bone, allows for controlled resorption to support future bone ingrowth and is injectable under local anesthesia for minimally invasive surgery. CERAMENT's unique biologic properties deliver a consistent, pre-packed and ready-to-use formulation to facilitate optimal delivery.
Mr. Diamond added, "With orthopedic trauma and bone infection rates dramatically increasing, it is very important to broadly and effectively educate patients and surgeons that there is a technology available that can deliver a less painful, minimally invasive and more effective treatment. This site truly reflects our strong commitment to innovation, education and improved clinical outcomes." (Source: BONESUPPORT)
March 23, 2012
| Hip Device Phaseout Followed FDA Data Request
Johnson & Johnson executives reportedly decided in 2009 to phase out the ASR hip implant and sell off its inventories for use in patients just weeks after the FDA asked for added safety data about the implant.
At the same time, the agency told the company that blood tests of some patients who got the all-metal hip showed a “high concentration of metal ions” that it found “concerning,” according to the FFDA letter, obtained by The New York Times under the Freedom of Information Act. (Source: The New York Times)
March 23, 2012
| OrthoHelix Donates Foot and Ankle Implants to United Hands for Health's Mission to Colombia
OrthoHelix has donated large quantities of plates, screws and instrumentation to United Hands for Health, Inc. for
their Annual Mission to Colombia. “The mission has been very successful and in addition to teaching of the regional
orthopedic surgeons, we are doing approximately 12 to 15 significant foot and ankle surgeries daily,” reported Dr. Mark Myerson of Mercy Medical in Baltimore, MD.
United Hands for Health, Inc. was established in 2005 by Armando Sardi, M.D. with 28 medical and non-medical volunteers to provide the underprivileged community with medical services. Today, they have helped over 30,000 patients in the past seven years and the numbers continue to grow. Their vision is not only to change the lives of these individuals, but to impact the whole community in which they live. (Source: OrthoHelix)
March 23, 2012
| Ascendx Spine appoints Eric W. Gilbert as Vice President of Sales & Marketing for its U.S. operations
“Eric will play a lead role in rolling out the U.S. launch of our initial FDA-cleared product, the Ascendx Acu-Cut VCF Augmentation System,” said Julian M. Mackenzie, CEO of Ascendx Spine.
Mr. Gilbert's previous positions include Director of Corporate Business Development at Stryker Corp., where he was responsible for creating and launching the entire Stryker Interventional Spine platform. Following Stryker, Gilbert was Director of Marketing for the Fracture business of Spine Wave. Most recently, he was Executive Vice President, Sales & Marketing, for Universal Medical, a regional distributor of spinal and orthopedic implants and pharmaceuticals and a worldwide distributor of bracing equipment. (Source: Ascendx Spine)
March 22, 2012
| Elizabeth L. Vliet, M.D.: Two Years of ObamaCare False Promises, Worse Harm to Come
Two years have given us time to see what’s in the healthcare bill. It is an ugly picture indeed. The promises all turned out to be empty rhetoric. Worse than just false promises, however, are the actual harms already done, and worse harms on the way.
The “Affordable Care Act” is not affordable at all: it is now estimated to cost $1.76 trillion over the next decade, adding markedly to the U.S. debt.
Doctors will be driven out of business by costly new rules. Insurance companies will close because they can’t cover the new mandates. Private options for medical care and health insurance won’t exist. New drugs and treatments will not be developed because of more taxes and regulations. Rationing of care will begin as costs rise, budgets are depleted, and fewer doctors are there to see patients. Read the full article at AAPSonline.org.
March 21, 2012
| OrthoWorx Launches Community Enhancement Initiatives Based on Comprehensive Attributes Survey
OrthoWorx announces several initiatives designed to support recruitment and retention of talented employees in the orthopaedic industry in the Warsaw, Indiana region.
ctions include a dedicated community web portal to increase awareness and visibility of the area's assets; financial support for existing bike paths and greenways; support for local educational and youth programs, etc.
OrthoWorx committed to provide funding of ~$350,000 for projects during 2012. (Source: OrthoWorx)
March 21, 2012
| Alphatec Spine Appoints New Vice President of Operations
Alphatec Spine announced that Michael Plunkett is named the company's Vice President of Operations.
Mr. Plunkett will have responsibility for direction and leadership of Alphatec Spine's U.S. Operations, including Supply Chain, Production, Manufacturing Engineering and Facilities. He has held various positions in Operations, Information Technology, and Program Management, and was most recently a Managing Director with the First Marblehead Corporation in Boston, MA. Prior to that, Mr. Plunkett served more than 24 years in the U.S. Navy, and retired with the rank of Captain in July 2003. (Source: Alphatec Spine)
March 19, 2012
| Arthrex ready to build $25 million Ave Maria plant, create hundreds of jobs
Arthrex plans to break ground in April for a manufacturing plant in Ave Maria, Florida, paving the way for hundreds of new jobs and kick-starting other economic development ventures in eastern Collier County.
Arthrex specializes in minimally invasive orthopedic surgery products and physician education. The construction cost for the plant is $25 million; another $8 million or more will be spent on equipment.
The building will have 190,000 square feet of usable space because of 30,000 square feet of office space on a second floor. Between 400 and 500 jobs will be established at the Ave Maria location by June 2016. The project will create a similar number of jobs during construction. (Source: Naples Daily News)
March 15, 2012
| Zimmer President and CEO David C. Dvorak Named Chairman of AdvaMed's Board of Directors
Zimmer President and CEO David C. Dvorak has been named Chairman of the AdvaMed Board of Directors for a 2-year term. During his tenure, Dvorak will focus on strategic initiatives that will:
Achieve the Association’s highest priority advocacy issues, such as working with FDA to ensure successful implementation of the new user fee agreement and repealing the medical device excise tax;
Enhance AdvaMed’s advocacy efforts in emerging markets such as China, India and Brazil;
Further build on the Association’s already strong relationships with patient and physician groups and other key stakeholders; and
Strengthen AdvaMed’s in-house research capacity in order to better inform policymakers, the news media and the general public.
March 14, 2012
| Paradigm Spine Announces Strategic Promotions and Hiring of Key Personnel
Paradigm Spine announces the promotion and addition of key strategic personnel to strengthen operations and further position the Company for long-term growth.
Guntmar Eisen has been promoted to the position of President and Chief Operating Officer. Prior to founding Paradigm, Eisen held positions of increasing responsibility in product development and commercial operations with Aesculap and Spine Solutions. He led several successful new product introductions, including the worldwide launch of PRODISC®.
Steven Amelio joined as the Company's new Chief Financial Officer. Steven will lead all financial administration, business planning and budgeting functions, and will partner with the Executive Management Team on all operating and strategic initiatives.
Mark J. Suseck has joined as the Company's new Vice President of Marketing. Mark will be responsible for providing executive leadership and management of all U.S. marketing activities, including product management, communications, market research, new product launch initiatives and sales force and surgeon training activities. (Source: Paradigm Spine, LLC)
March 12, 2012
| Interventional Spine to Present PerX360 System at ISASS Annual Meeting in Barcelona, Spain
Dr. Rudolf Morgenstern, Director and Chief Surgeon of the Morgenstern Institute for Endoscopic Spine Surgery at Centro Medico Teknon in Barcelona, and Dr. David Greenwald from Flagler Brain and Spine Institute of St. Augustine, Florida will present the PerX360™ System at the International Society for the Advancement of Spine Surgery Annual Meeting in Barcelona, Spain.
The PerX360 System is reportedly the 1st and only system to enable a percutaneous interbody fusion via 2 incisions that are <15mm each for the treatment of lumbar discogenic pain. To date, 17 patients have benefitted from the PerX360 technology with excellent clinical results and significant drops in pain scores. (Source: Interventional Spine, Inc.)
November 30, 2011
| Study: Surgeons with Financial Interest in MRIs Order More Exams
Studies indicate that orthopaedic surgeons with a financial interest in MRI equipment had a much higher rate of negative lumbar spine MRIs and were much more likely to order MRI exams on younger patients.
From Radiological Society of North America.
October 24, 2011
| Financial Payments to Surgeons Drops
Studies suggest that the number of financial payments to orthopaedic surgeons has dropped since 2007, though the average amount of payments has increased. The payments represent consulting fees, royalties, research support, etc.
From: Archives of Internal Medicine; Science Codex.
September 22, 2011
| Available Now--Worldwide Spine Surgery: Products, ...
Available Now--Worldwide Spine Surgery: Products, Technologies, Markets & Opportunities, 2010-2020. Published by MedMarket Diligence.
ORTHOWORLD readers can save 10% by using discount code 1316628965
Global coverage of spinal markets and products: Current and forecasted products and technologies; trends in clinical management; current and 10-year forecasts by region/country for procedures, unit sales, ASP and manufacturer revenues for Americas, European Union, Asia-Pacific and Rest of World. Forecasts address product- and country-specific impact of new technologies through 2020. Profiles of 46 key spinal companies: current and developing products, market position.
Full summary, Table of Contents, List of Exhibits and link to order
September 19, 2011
| Providers and Academia Look for Trends in Pricing Changes
AETNA, HUMANA, KAISER PERMANENTE and UNITEDHEALTH agreed to provide claims data to academic researchers to help identify changes in healthcare prices and the use of medical services.
From: The New York Times; Health Care Cost Institute.