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ORTHOWORLD » Other Articles of Interest

Articles of Interest

January 10, 2018 | Survey: In 2018 and Beyond, Where do Opportunities Lie for You and Your Company?

Each year, ORTHOWORLD publishes THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT®.

This year, we endeavor to collect your voice beforehand.

ORTHOWORLD is conducting an Orthopaedic Industry Survey, an 8-question survey that we estimate takes just 3 minutes to complete.

We will use survey answers and data in the 2018 ORTHOPAEDIC INDUSTRY ANNUAL REPORT, where helpful. This will be done anonymously, of course. (We will not include or publish names without express written permission.)

Not only does this survey give us a clearer picture of the state of the orthopaedic industry, based on the answers you provide, but is also gives us a better understanding of the challenges you are working to overcome and the opportunities you are working to seize.

Thank you in advance for your candor, cooperation and participation in our research.

Please click here to begin the survey.

January 01, 2018 | FDA CDRH Proposed 2018 Draft Guidance to Include Alternative 510(k) Pathway

By Robert Meyer

As 2017 came to a close, FDA released its annual priority list for the new year, as well as previously-issued final guidance documents for which the Center for Devices and Radiological Health (CDRH) is accepting feedback as part of its retrospective review.

Prioritized medical device guidance documents that FDA intends to publish in FY18 include an alternative pathway for manufacturers seeking 510(k) clearance.

Read more at BONEZONE.

December 14, 2017 | FDA Finalizes Additive Manufacturing Guidance

By Carolyn LaWell

FDA recently published its guidance on additive manufacturing technical considerations, outlining the Agency’s long-awaited position on use of the technology for medical devices.

Like you, we’ve eagerly awaited the finalization of this guidance. Few topics have dominated our conversations with device companies, suppliers and surgeons like additive has in recent years. FDA points out that the 31-page document is considered “leapfrog” guidance, a term reserved for FDA’s anticipation that its initial thoughts on an emerging technology will change over time. In short, more questions and answers will continue to arise as the technology is adopted.

What we do know is that FDA outlines its thoughts on the phases of design development, production process, process validation, semi-finished and final finished device testing.

While the full guidance, “Technical Considerations for Additive Manufactured Medical Devices,” can be read online, we’ve chosen to highlight three points related to questions with which readers have often approached us: device design, materials and cleaning/testing.

Read more at BONEZONE.

December 07, 2017 | CMS Finalizes Joint Bundled Payment, Outpatient Changes

The Centers for Medicare & Medicaid Services (CMS) finalized cancellation of the mandatory hip fracture and cardiac bundled payment models that were to be operated by the CMS Innovation Center and implemented changes to the Comprehensive Care for Joint Replacement (CJR) bundled payment model.

These changes will offer greater flexibility and choice for hospitals in providing care to Medicare patients, according to CMS.

“While CMS continues to believe that bundled payment models offer opportunities to improve quality and care coordination while lowering spending, we believe that focusing on developing different bundled payment models and engaging more providers is the best way to drive health system change while minimizing burden and maintaining access to care,” CMS Administrator Seema Verma said, in a release.

Ms. Verma expects to announce new voluntary bundles at a later, unspecified date. In the final rule, CMS reduced the number of mandatory geographic areas participating in CJR from 67 areas to 34. CMS is also making participation voluntary for all low-volume and rural hospitals in all 67 areas.

Read on for more details abut these CMS changes, cancellations and finalizations. 

November 29, 2017 | The Joint Surgeon's Wish List

By Julie Vetalice

Matthew Dietz, M.D. is an Assistant Professor for the orthopaedics department at West Virginia University School of Medicine. In his surgical practice he performs primary hip and knee arthroplasties, including complex revisions—fueling his research focus on biophysical disruption of biofilms in total joint arthroplasty and the care of patients affected by prosthetic joint infection.

As is well-known, the Baby Boomer joint surgery candidate is a different kind of patient from her grandparents. She is a healthy patient with functional limitations, and as Dr. Dietz described, surgeons “want to provide efficient, safe, surgical care; we want to improve patient outcomes and limit complications. When we do have to deal with complications, we want to address them in a safe, effective manner.”

In the Knowledge Pod at OMTEC 2017, Dr. Dietz shared his take on challenges with patient care using present systems and devices, and offered thoughts on what he’d like to see in the future. Here are three points from Dr. Dietz’s Wish List:

Prevent Burnout
We need to collect data that lets us know how we’re doing. However, with studies showing that 28% of our time is spent on patient care, while 43% of time is spent on data entry to feed electronic medical records, increasing numbers of surgeons are opting to leave the practice altogether. Data entry and data analysis need to be made easier. We need implants and technology that can help to collect information and report it to our healthcare providers.

Read on for more items on Dr. Dietz's Wish List.

November 21, 2017 | Quebec: A Growing Orthopaedic Innovation Hub

By Robert Poggie

North of the U.S. border, about a six-hour drive from New York City, lies the Canadian province of Quebec. Known for the French language, the iconic hotel Chateau Frontenac, maple syrup, hockey, snow, vast woodlands and countless lakes, it’s also home to a robust orthopaedic industry characterized by innovation, research, a history of achievement, manufacturing prowess and investment. Since the 1960s, private companies, government, education and healthcare institutions and pre-clinical research organizations have coalesced into an engine for commercializing innovative products. This article spotlights the people, companies and products — many of whom I’ve worked with — that have placed Quebec firmly on the world map as an orthopaedic center of excellence.

Leaders in Education and Orthopaedic Research

Significant contributions to orthopaedic innovation can in part be traced back to 1967 and the founding of the Jo Miller Laboratory at the Montreal General Hospital/McGill University. Originally planned for biological and surgical research, the lab, led by Jo Miller, M.D., quickly evolved into a center for biomechanical and materials testing.

From the 1970s to mid-1980s, original pioneering research was performed on porous coated implants, bone ingrowth, fixation and stress-related peri-implant bone remodeling, development of improved bone cements and cementing techniques and commercial implant designs such as the MultiRadius and Miller-Galante knee systems.

Read more about how Quebec is becoming home to a a robust orthopaedic industry characterized by innovation, research, a history of achievement, manufacturing prowess and investment.

November 15, 2017 | Examining Critical Trends in Trauma Surgery

By Carolyn LaWell

Two of the greater challenges that trauma surgeons face today are an increased number of complex fractures and complications from fractures. The Orthopaedic Trauma Association (OTA) convened for its annual meeting in October, and many of the themes that resonated in surgeon voices and research—areas ripe for device company product development—fell in line with those two issues.

For greater context, we spoke with Michael D. McKee, M.D., Chairman of the Department of Orthopaedic Surgery at the University of Arizona College of Medicine and Program Chair of the Annual Meeting. Dr. McKee outlined four areas of opportunity identified at the meeting: periprosthetic fractures, infection prevention, early weight-bearing recommendations and percutaneous pelvic fractures.

Periprosthetic Fractures

Dr. McKee: A number of papers and talks centered on the use of various implants to treat periprosthetic fractures, especially in the lower but also the upper extremities, because these fractures are becoming much more common. The number of patients who have multiple periprosthetic fractures is increasing, so now we’re seeing interprosthetic fractures—meaning a fracture not only below the total hip, for example, but below a total hip and above a total knee in the same leg.

One of the teaching points made by several authors was that if you have a total hip or bipolar hip and you break below it, rather than simply fixing the fracture, perhaps it’s time for orthopaedic surgeons to consider protection of the entire femur. Even if you have success with a fracture union, there is a much-increased rate of another fracture below your implant.

BONEZONE: What is your recommendation for femur protection?

Dr. McKee: In the previous example, you would need an implant that would go all the way down to the condyles, with screws across it, to help protect the entire femur at risk. Companies are designing and manufacturing such implants, or a surgeon may choose to maneuver a regular implant to do the job in that fashion.

Similarly, implants that are amendable to fix a fracture between a total knee and total hip will become more popular as time moves on, and I think a number of other authors thought the same thing.

For periprosthetic fractures, which often occur in older women, making them non-touch or weight-bearing afterward is counterproductive and impractical. We need to make our construct strong enough so that we can allow full weight-bearing after [surgery].

Read Dr. McKee's insight on infection prevention, weight-bearing loads and pelvic devices.  

November 08, 2017 | 5 Steps to a Highly Collaborative Supplier Agreement

By Kate Vitasek

If your recent experiences with contract negotiations are something like visiting the dentist for a root canal, there is a much better—and pain-free!—way to go about wrangling that strategic agreement.

It’s called Getting to We—a five-step process for crafting business relationships with the intent to drive collaborative partnerships. (The process is described in the book, Getting to We: Negotiating Agreements for Highly Collaborative Relationships.)

There are plenty of negotiation ”how-to” books out there. So, what is different about the Getting to We methodology? Simply put, Getting to We puts the focus on negotiating the foundation of the relationship, not just on getting to a deal. You still get to a contract, but how you get there is vastly different.

Getting to We starts by changing the way you approach your negotiation to embrace a “what’s-in-it-for-we” (WIIFWe) philosophical mantra, forming the structure of a collaborative and trusting relationship.

Negotiating the true nature of the relationship under a WIIFWe mindset means that the negotiating parties move away from the usual tit-for-tat cycle of tradeoffs and concessions; instead, they create a negotiation atmosphere that encourages cooperation.

So, how do you do it?

Five Simple Steps

  1. Getting ready for WIIFWe

The first step is to candidly discuss three foundational elements for a successful collaborative relationship: trust, transparency and compatibility. Completing this step helps the parties to understand to what extent they can build the foundation for their relationship. The more trust, transparency and cultural fit between a buyer and supplier, the more the parties will be comfortable making investments in the relationship, innovations and continuous improvement opportunities that can benefit both parties. 

For example, let’s say that you traditionally negotiate an annual contract renewal with an incumbent that has been a trusted “strategic” supplier for the last five years. You have a good cultural fit and work well together, but have operated under a conventional transaction-based business model with limited transparency. This year, you decide to host a two-day offsite meeting to discuss the art of the possible with the relationship; the agenda starts with a discussion about ways to improve trust, transparency and compatibility. The conclusion? You can make a good relationship great by being more transparent, which will enable the parties to work collaboratively to reduce total ownership cost and not just the “price.”

Read the next four steps. 

October 25, 2017 | 3D Printing, Expandable Cages Popular Among Pre-NASS Product Launches

Companies got a jump on their spine product announcements well ahead of day one of the NASS Annual Meeting, this year. From September 1 to October 23 alone, we covered 45 spine-centric announcements, from funding to patents to reimbursements, etc. Here we recap just the product updates to acquaint you with what you'll see and hear on the exhibit floor. 

  • 4WEB Medical launched its next-generation 3D-printed Anterior Spine Truss interbody fusion system.
  • ChoiceSpine received FDA 510(k) clearance to market the HAWKEYE Ti vertebral body replacement, its first 3D-printed device.
  • Expanding Orthopedics received FDA 510(k) clearance for the FLXfit™15 expandable interbody cage.
  • Mazor Robotics received CE Mark approval for the Mazor X Surgical Assurance Platform. 
  • Nexxt Spine received FDA 510(k) clearance to market 3D-printed NEXXT MATRIXX™ interbody and vertebral body replacement devices. 
  • NuVasive launched LessRay®, hardware and software designed to minimize overexposure to radiation in the O.R., and Modulus® XLIF®, 3D-printed titanium implants for use in lateral lumbar interbody fusion.
  • Spineology commenced full market release of the Elite™ Expandable Interbody Fusion system. More than 300 cases have been completed since limited launch in 2Q16. 
  • Stryker Spine received FDA 510(k) clearance to market its 3D-printed Tritanium® C Anterior Cervical Cage. 


We’ll continue to cover strategic announcements from the Annual Meeting. If you’d like to receive notices via email, and you’re not an ORTHOWORLD® Member, consider a complimentary 30-day Membership trial.

October 18, 2017 | Your EU Medical Device Regulation Guide

Big changes are underway for the regulation of medical devices on the European market, with the unveiling of the Medical Device Regulation 2017/745 (MDR). This regulation replaces the long-standing Medical Devices Directive 93/42/EEC (MDD), specifically MedDev 2.7/1 for medical devices, which was created in 1992 and most recently updated to Revision 4 in July 2016. The MDR is a significant deviation from the MDD and MedDev 2.7/1, especially when it comes to clinical evaluations, and it is important to implement necessary changes to your literature searches, postmarket surveillance and postmarket clinical follow-up in the 2017-2018 timeframe to be prepared for MDR by 2020. BONEZONE author Debra Munro offered a set of guidelines for making a smooth transition.

Read more on MDR guidelines.

October 12, 2017 | Coatings Support Early Integration, Infection Prevention

After combing through company product launches, university research findings and surgeon-led discussions at meetings, and receiving requests for supplier partner referrals, it’s clear that implant coatings are of great interest to orthopaedic professionals all along the supply chain.
 
Naturally, these interests align with the way that coatings are developed, the problems they solve and the outcomes they produce. Further, these findings uncover current trends, like spine companies coating PEEK with titanium, the search for the holy grail to end postsurgical infection and the focus on ease of manufacturing and cost. (To the latter point, Jason Mansell, Ph.D., whom you’ll hear more from, ended our conversation with, “Suffice to say, you could make this new coating in your kitchen using water as the solvent in a matter of hours!”)
 
Coating technology is exciting and provides a means for innovation and even just incremental improvements. We spoke with three individuals, all professors and one a surgeon, all at different stages of coating research. 
 
We asked about the basics behind the technology they seek to advance, what role coatings play in the implant, what level they perceive their colleagues’ understanding of coatings science to be, what they would share with device companies commercializing new technologies. And, what will be the dialogue around coatings five years from now. In this BONEZONE article, we learn what they're excited about.

Read more on BONEZONE.

October 06, 2017 | Surgical Assistance: Milestones and Funding

Tools that improve ease of use and support a personalized implant fit for patients have experienced a recent bump in our reporting. These assistance technologies for use in joint reconstruction and spine include computer assisted robotics, surgical simulation/training, navigation and visualization tools, etc., for which companies tout benefits such as procedure reproducibility and precision, yielding better post-op function and greater patient satisfaction. Here’s what’s made headlines in the past two months.

  • Augmedics secured US $8.3MM in Series A funding. Proceeds will support research and development, pre-clinical and clinical trials, distribution and FDA 510(k) clearance for The ViZOR Augmented Reality surgical visualization system, with its first application in minimally invasive spine procedures.
     
  • Intellijoint Surgical received CE Mark approval for intellijoint HIP®, a 3D mini-optical navigation system. EU market launch is slated for 2018, and Australian Therapeutic Goods Administration approval is expected to occur in November 2017.
     
  • Mazor Robotics received CE Mark approval for the Mazor X Surgical Assurance Platform. Medtronic will proceed to market and sell the system in appropriate regions. 
     
  • OMNIlife science announced completion of >17,000 total knee replacements worldwide assisted with the OMNIBotics® robotic platform since its introduction in 2010.
     
  • OrthAlign received CE Mark approval to market the DAA HipAlign® Direct Anterior Approach Total Hip and UniAlign® Unicompartmental Knee Arthroplasty, building on previous availability in Japan and the U.S.
     
  • OrthAlign raised US $10MM in a Series D financing round. Proceeds will support product development as OrthAlign expands its computer-assisted navigation platform from total knee into partial knee and total hip applications. Funds will also support hiring and commercial expansion in the U.S. and ex-U.S.
     
  • THINK Surgical entered the South Korean market and completed >10 total knee arthroplasty cases using the TSolution One robotic surgical system.
     
  • VirtaMed introduced ArthroS™ Ankle, reportedly the world’s first high-fidelity simulator for ankle arthroscopy. The system will launch fully in late 4Q17.
     
  • Viseon Spine closed a US $5.0MM Series A financing. Funds will support product development, worldwide regulatory approvals, clinical evaluations, manufacturing and commercialization as the company develops single-use, disposable visualization and illumination technologies for minimally invasive spine surgery.
September 27, 2017 | AdvaMed and CAMDI Sign Innovation Cooperation Agreement

AdvaMed (the Advanced Medical Technology Association) and the China Association for the Medical Devices Industry (CAMDI) entered into a long-term cooperation framework partnership.

The agreement, which was was announced at The MedTech Conference Powered by AdvaMed in San Jose, California, will explore ways to enhance China/U.S. efforts to spur medical device innovation.

The collaboration seeks to build up the competitiveness of the China and U.S. medical device industry, promote its sustainable and healthy development, strengthen R&D capacity and drive further integration into the global innovation ecosystem to ultimately provide value to patients, ensuring access to advanced medical devices, diagnostics and therapies.

CAMDI's 4,000+ members include suppliers and OEMs that serve a variety of segments in the medical device industry. Numerous specialized committees address orthopaedics, biological materials and equipment; 3D printing of medical devices; packaging; infection control and more. 

As more orthopaedic companies eye the Chinese market, it's important to understand the available resources and the government's medtech initiatives. The Made in China 2025 directive includes share of domestic components in medical devices used in China (60% in 2020 and 80% in 2025), and number of internationally famous brands (5+ in each product area by 2025).

Source: AdvaMed

September 21, 2017 | Innovation in Spine: Suppliers & Service Providers Weigh In

Moving a product from idea to market calls on the expertise of many players. In preparation for attending the NASS Annual Meeting in October, we took time to speak to supplier and service provider companies to get a read on current trends and future advancements in spine.

The leaders we spoke with mentioned 3D printing, biologics, coatings, single-use instruments and exerting their expertise to help customers speed time to market, navigate regulatory obstacles and provide additional value that can be passed on to the surgeons and patients. While their answers were diverse, two distinct themes emerged: new technology and improved patient outcomes. Of course, these themes go hand in hand and are, in part, what makes the spine market exciting. Here we share these leaders’ answers, in their own words.

Today’s Trends

What excites you about the spine market right now?

Read answers from the experts on BONEZONE.

September 14, 2017 | NuVasive Restructures Commercialization Leadership Team

When announcing recent new commercialization roles for three members of its executive team, NuVasive reiterated its intent to transform global operations and drive efficiencies through the combination of manufacturing, supply chain, information technology, regulatory affairs and quality assurance. 

The words “combination of” stand out to me at a time when so much of our writing and expressed opinions of seasoned leaders have repeated the importance of breaking down silos—making yourself familiar with the decisions taking place next to, above and below you. A collaborative environment is essential when the work is complex. Too often, a seemingly inconsequential change at the manufacturing level can create major regulatory hurdles, or a miscommunication with a supplier results in costly quality issues. The examples are endless—I’m certain you have your own. 

NuVasive committed to bring its manufacturing in-house and to surpass $1 billion in revenue in 2017; therefore, the company needs a level of alignment within these divisions. Still, exactly how this “global operations transformation” unfolds will be interesting to watch. How will supply chain, regulatory and quality teams deliver on their own objectives while assisting each other achieve cross-functional goals? We’ll be looking for lessons that can be learned and adopted, especially from a supply chain and operations standpoint.

On BONEZONE, find the new titles and responsibilities of three NuVasive executives who will lead the commercialization channel.

September 06, 2017 | Critical Steps to Performance Improvement

What's your single most significant professional challenge right now...today? We posed that question in an OMTEC attendee survey conducted in June and July. Participants represented varying professional titles and company sizes. Interestingly, just over a quarter of 51 respondents answered with people- or skills-related hurdles. Here are some of their responses. Do they sound familiar?

  • Time to manage suppliers instead of fire-fighting
  • I’m in the process of transitioning into a new role. My biggest challenge is learning the new processes
    and filling gaps left by another colleague’s departure from the group.
  • Attracting and retaining talented employees
  • Doing more with less—huge opportunity, with limited manpower
  • Handling all of the project manager duties with a team that is not trained in project management
  • Developing the next generation of leadership
  • Keeping up on technology offerings across many suppliers
     

There will always be forces that lie out of our control. How we respond to factors that we can control is what can ultimately lead to career advancement. The latter point called to mind a BONEZONE article by Brian Moore from 2012. Moore, previously President and CEO of Symmetry Medical and now a business and leadership consultant, noted:


The most important job we all face is to manage ourselves. The better job we do of it, the more effective and valuable we are. I am sure that most of you have heard the expression, ”The only constant is change.” Issues of job security, constant regulation pressure, more expected for less, time pressures, etc., remind us every day how true this is, and it’s only likely to become more intense. The only real constant in your life is you.
 

Moore outlined critical aspects for us as individuals to improve our performance, including how to remain engaged in our work, how to react to other’s behavior and how to inspire colleagues and direct reports. While Moore was mainly writing about leadership, his insight is universal for those seeking to advance their knowledge, responsibilities and influence.

On BONEZONE, we republished a portion of that article as a reminder that we control our actions, and we can help others guide theirs as we all pursue professional development goals.

Read the rest of this article on BONEZONE.

August 31, 2017 | CMS Proposes Total Joint Bundled Payment, Outpatient Payment Changes

The Centers for Medicare & Medicaid Services (CMS) recently released two proposals related to total joint reconstruction that could impact procedure payments.

First, CMS is proposing to change its Comprehensive Care for Joint Replacement bundled payment model (CJR) and cancel mandatory Episode Payment Models (EPMs) that affect hip and femur fracture procedures. These initiatives were set to begin in January 2018.

CMS’ rule proposes to reduce the number of mandatory U.S. geographic areas participating in CJR from 67 to 34. Participants from the 33 remaining geographic areas would be made voluntary as of February 2018. Further, CMS proposes to make participation in the CJR model voluntary for all low-volume and rural hospitals in all of the CJR geographic areas.

The agency hopes that eliminating and modifying current models will allow greater flexibility to design and test other approaches to improve quality and care coordination across inpatient and post-acute-care. For example, originally only hospitals could own, or manage, CJR bundles. CMS is making CJR an Advanced Alternative Payment Model, giving surgeons and physician groups greater control over decision making within the 90-day episode of care.

Our conversations with surgeons prior to the announcement indicated that bundles, mandatory or not, are here to stay. Still, these reversals could certainly affect OEMs that have taken steps to help hospital customers in their handling of bundled payments.

CMS is accepting comments on this proposed rule until October 16.

Read the rest of the proposed changes on BONEZONE.

August 25, 2017 | U.S. Spine and Trauma Markets Gain New Entrants

By Julie A. Vetalice

Spine, trauma, spine, trauma—these two segments are leading FDA 510(k)s this year. In looking at recent clearances, I’m compelled to highlight these segments in part due to Globus Medical's activity. Globus (a ~$565MM company) has received clearance for its first two non-spinal trauma products. Seeking to diversify outside of spine, the company plans to derive 15% of its revenue from trauma and robotics by 2020. In Globus’ 2Q17 earnings call, leadership affirmed that several trauma products planned for 2017 had received FDA clearance and were in full production mode. Later in the call, it was mentioned that they are about halfway through their core bag in terms of FDA clearances, so perhaps this is an indication of four trauma products initially, from Globus. I will keep you apprised.

Meanwhile, the continual entry of new companies into the U.S. spine and trauma markets does not come as a surprise, and frankly is expected to continue. Spine and trauma, the second and third largest orthopaedic market segments respectively, have not faced the same level of hospital scrutiny as the hip and knee segments. In the link below, I present new spine products from EIT Emerging Implant Technologies, HD LifeSciences and Osseus Fusion Systems, and new trauma products from Globus Medical and HNM Total Recon/HNM Medical. I chose these from the list of recent 510(k) clearances primarily because, except for Globus and Osseus, they’re new entrants to the U.S.

Continue reading this article on BONEZONE.

July 28, 2017 | Zimmer Biomet's Next CEO

By Julie A. Vetalice

None of us expects that the CEO hunt at Zimmer Biomet (ZBH) will close swiftly. “We have initiated a thorough search to identify the best candidate to serve as Zimmer Biomet’s next CEO. We are seeking a strong leader, whose strategic and operational track record aligns with Zimmer Biomet’s commitment to growth and enhancing stockholder value,” said board chairman Larry Glasscock, in the 2Q17 revenue commentary, because…of course they are. There’s much work to be done.

My ORTHOWORLD colleagues and I expect to see a candidate with experience in certain specific challenges: M&A integration, timely reconciliation of revenue-hindering disruptions, portfolio diversification.

We’re mindful of the potential names that are out there; the ones we’ve heard are all linked to medtech and healthcare. ZBH is the second-largest company in orthopaedics, by our estimates, and over 90% of the company’s overall annual revenue derives from orthopaedics, but we wonder about availability of a candidate with sufficient experience in ortho, in a company running at that size—in other words, we maintain that the board will likely cast its nets in waters other than just medical technology. The new CEO may not come from medtech at all.

Here’s some background on five of the possible candidates we’ve heard about.

Those with direct orthopaedic experience:

Jeff Binder, President & CEO of Immucor, formerly President & CEO of Biomet

Immucor is owned by TPG Capital, the same company that had partially owned Biomet. Mr. Binder was moved to his present position in June 2015, after the Zimmer/Biomet transaction closed. He had been President and CEO of Biomet since 2007.

Binder’s 20+ years of executive experience has primarily been in ortho and spine, including leadership posts at Howmedica Orthopedics, DePuy Orthopaedics, Spinal Concepts and Abbott Spine. (The latter was eventually acquired by Zimmer in 2008).

During his term at the helm of Biomet, the company reached 35 years of clinical results with the Oxford Partial Knee, purchased spinal company Lanx and also bought DePuy’s trauma business, so that JNJ could proceed with its purchase of Synthes. Also of note, in 2011, rumors floated that Biomet wanted to buy Smith & Nephew—a switch from early 2007, when a regulatory filing revealed that SNN offered to buy BMET. Instead, Biomet was purchased by a private equity consortium later that year.

Of those names mentioned in the public domain, Mr. Binder makes sense for his familiarity and insights on plant issues that have led to supply shortages of key products in the last year.

Stephen MacMillan, CEO of Hologic, formerly President & CEO of Stryker

Hologic offers clinical diagnostics, imaging and interventional/treatment services that focus on women’s health and well-being—including skeletal health. Mr. MacMillan joined the company in December 2013 after 2005 to 2012 with Stryker. Previous time was spent at Pharmacia and at Johnson & Johnson—the latter on the pharma side.

MacMillan’s orthopaedic experience at Stryker included acquisitions like Memometal, Orthovita and OtisMed, divestitures like the OP-1 product line, the very first Tritanium product launch and the move of overall revenue from $4.2 billion in 2004 up to $8.3 billion by 2011.

It seems unlikely that this is a time for Mr. MacMillan to make a switch; Hologic appears to be in a stable position.

Doug Kohrs, Managing Director of Responsive Arthroscopy

Mr. Kohrs’ current firm, which he describes as an Innovative Sports Medicine Company focused on Value Based Healthcare, was established in mid-2016 after his former start-up, Responsive Orthopedics, was bought by Medtronic for its low-cost total hip and knee replacements.

It’s probably easier to list the connections to companies with which he hasn’t been affiliated. Kohrs’ 35+ years of experience includes time employed at American Medical Systems, Sulzer Spine-Tech, Tornier, Zimmer Spine; he sits on numerous boards, including Lima Corporate and MedShape, and past seats have included AxioMed Spine, Axya Medical, Bio2 Technologies, Disc Dynamics, ev3, Innova Spine, Kyphon, Pioneer Surgical, SpineCore, Tenex, Vergent Biosciences, etc.

Mr. Kohrs’ background includes management of companies with revenue in the low hundreds of millions—that’s a different leadership experience than one in the billions. Plus, from what we know of Mr. Kohrs, we just don’t see him leaving the start-up life. He looks like he is having too much fun.

Those without:

Gail K. Boudreaux, CEO and Founder of GKB Global Health

Ms. Boudreaux has been a Director on the Zimmer Biomet Board since 2012, serving on its Audit and Corporate Governance committees. Boudreaux formed her own healthcare strategy and business advisory firm in 2015, after serving as CEO of insurance provider UnitedHealthcare from 2011 through 2014, and Executive Vice President to its parent, UnitedHealth Group, from 2008 to early 2015. Prior to that, she held leadership positions at Health Care Services Corporation, Blue Cross Blue Shield of Illinois and Aetna. In 2009, she was named among Forbes’ list of the 100 Most Powerful Women.

Honestly we can’t say that she has no orthopaedic exposure; of course she does, sitting on the ZBH board. This would be an interesting choice! Ms. Boudreaux would lend greater payor insight to the company’s strategy at a time when reimbursement remains a top priority for industry and customers. Also, of the candidates on this list, she has led the largest company: UnitedHealthcare achieved revenues of nearly $120 billion in 2014.

Michael Rousseau, former President of Abbott Laboratories Cardiovascular and Neuromodulation business and former CEO of St. Jude Medical Devices

Mr. Rousseau just left Abbott earlier this month, per an SEC filing. A Morningstar analyst added his hat to the ring, reportedly suggesting that he may be looking for something new now. All of his experience has been in cardio.

It’s absolutely possible that the final candidate will be an outsider to ortho.

What’s your take? Leave a comment below.

July 05, 2017 | Orthopaedic Product Launches from Top 4 Device Companies at Close of 2Q17

The top four orthopaedic device manufacturers—DePuy Synthes, Zimmer Biomet, Stryker and Smith & Nephew—ended the last week of the quarter with product launches. 

DePuy Synthes announced the acquisition and launch of new technologies expected to deepen its spine portfolio. Leadership has recently cited gaps in the company’s product portfolio as a reason for two years of spine revenue decreases. DePuy Synthes acquired Sentio and its smart sensor nerve localization technology used in minimally invasive spine surgery. The platform addresses two demands often stated by hospital customers today: create operating room efficiencies and make procedures adaptable to the outpatient setting. Additionally, DePuy Synthes launched two fenestrated screw systems to provide spinal column integrity for patients with advanced stage spinal tumors.

Smith & Nephew launched a total knee application (TKA) for its NAVIO handheld robotic-assisted technology. The announcement was imminent, as Smith & Nephew had received FDA 510(k) clearance for the application in 2Q16 and said that the technology’s first surgical use occurred in 1Q17. The TKA launch broadens Smith & Nephew’s NAVIO portfolio and creates competition for Stryker’s Mako total knee application.

Stryker and Zimmer Biomet both launched solutions that utilize X-ray imaging for preoperative planning. Stryker’s Hoffmann LFX Hexapod was introduced by its foot and ankle division for pre-and post-operative planning for deformity correction and limb reconstruction. Zimmer Biomet further introduced its X-PSI Knee System to generate three-dimensional anatomical models in preparation for TKA procedures. Zimmer Biomet leadership noted that preoperative planning tools have been limited to MRI or CT imaging, through X-ray is a more common use of imaging. 

ORTHOWORLD covered 19 product launches in June. A full list can be found here.

Carolyn LaWell is ORTHOWORLD’s Chief Content Officer. She welcomes your thoughts by email