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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).

Stats:

  • ~ 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.
 
UDI compliance best practices and the remaining deadlines can be found in the article, “UDI Implementation: Your Next Steps.”
 
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

Premarket application
(PMA, PDP or BLA)
 
$261,388 $250,895 $65,347 $62,724

Premarket report 
 
$261,388 $250,895 $65,347 $62,724

Efficacy supplement
(to an approved BLA)
 
$261,388 $250,895 $65,347 $62,724

Panel-track supplement
 
$196,041 $188,171 $49,010 $47,043

180-day supplement
 
$39,208 $37,634 $9,802 $9,409

Real-time supplement
 
$18,297 $17,563 $4,574 $4,391

510(k) premarket
notification submission

 
$5,228 $5,018 $2,614 $2,509

30-day notice
 
$4,182 $4,014 $2,091 $2,007

513(g) request for classification information
 
$3,529 $3,387 $1,765 $1,694

 

August 03, 2015 | Wright Medical Updates Augment's FDA Approval Status
Background:
 
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. 
 
Update:
 
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 [2015] 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.
 
This complete article "International and Domestic Manufacturers Compete to Serve Growing Asian Population" by Ames Gross of Pacific Bridge Medical can be found in the August issue of ORTHOKNOW®.
 

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. 

Dr. Gall, who has pushed new biomaterials like NiTiNOL and additively-manufactured devices through regulatory bodies, said FDA has a bad rap for its slow and convoluted processes, but the value analysis committees have been five times worse than FDA. 
 
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.
 
The challenges and opportunities discussed by these executives was recapped in an article in the latest issue of ORTHOKNOW®, Success in Orthopaedics Lies in Products that Improve Quality, Decrease Costs

Stay tuned for more OMTEC highlights here and at BONEZONE® and ORTHOPRENEUR®.
 
 
 
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.
 
DePuy Synthes also recently named new leadership during a reorganization at Johnson & Johnson.
 
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
 
Learn how to execute these steps. Read the full article and attend Mr. Burris’s OMTEC session.
 
April 13, 2015 | OMTEC 2015 Preview: Meet 25 Longtime Exhibitors

Of the ~130 companies set to exhibit at OMTEC® 2015, 25 have attended since OMTEC’s early days. Many are full-service providers, while some maintain a specialized focus in areas such as surgical instrumentation, sterilization, raw materials, etc. How can they assist with your initiatives? Read on.

 

Meet the newcomers! Here are 25 first-time OMTEC exhibitors.

Returning OMTEC speaker, John Gagliardi, is sharing even more solutions than ever at a pre-OMTEC CAPA workshop.

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:

  • Joint Reconstruction
  • Trauma
  • Arthroscopy/Soft Tissue Repair
  • Spine
  • Orthobiologics
     

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.

A-list
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
     Requirements

     Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation and Testing
     (Biocompatibility)

Draft Guidance Topics

     UDI FAQs
        • 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.