Welcome. How can we help?
30 Day Trial

ORTHOWORLD » Other Articles of Interest

Articles of Interest

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.

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

 
Welcome/Cocktail Reception
Monday, January 19, 2015
6:00 p.m. - 7:30 p.m.

Symposium
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.

Regulations will:

  • 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
M&A Tracking 

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 | Web Technology Seeks to Improve Total Joint Label Reading in OR

Standardized implant labels have long been discussed as a way to decrease wrong usage and wasted product in the OR and ultimately, to cut costs and improve patient care. In the absence of mandated standardization, one surgeon entrepreneur developed OrthoSecure, a system that reads and uniformly formats labels for total knee and hip replacement implants.

What is OrthoSecure? Learn about it in ORTHOPRENEUR®.

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.