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Articles of Interest

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

May 30, 2017 | Tools to Achieve Your 2017 Priorities

“Become a more diverse provider.” This 2017 market opportunity was a resounding response from device and supplier company leaders whom we surveyed in 2016. Companies are exploring myriad approaches to diversification, from launching new brands to entering new markets to engaging in acquisitions. These paths are often directed by company size and focus.


Top 15 Device Companies
 by Revenue*

1. DePuy Synthes
2. Zimmer Biomet
3. Stryker
4. Smith & Nephew
5. Medtronic
6. Arthrex
7. DJO
8. NuVasive
9. Aesculap
10. Wright Medical
11. Globus Medical
12. Orthofix
13. ConMed
14. Exactech
15. Acumed

*based on ORTHOWORLD® estimates

In thinking of diversification, three of orthopaedics’ top 15 device companies come to mind based solely on 2Q17 activity: Orthofix’s launch of the JuniOrtho pediatric brand; Globus Medical’s pursuit of regulatory clearance to enter the robotics market and DePuy Synthes’ acquisition of 3D printing technology.                                                             

I mention the top 15 because 74% of the $48.1 billion in 2016 worldwide orthopaedic product revenue was derived from these 15 device companies, which are listed to the right. The companies on this list, and especially the top five, often lead the adoption of new business models, technologies, industry norms, etc. The remaining 26% of industry is made up of hundreds of companies and thousands of professionals who also seek to drive innovation by responding with a level of agility that can’t be matched by the bigs.

Now, almost halfway through 2017, it’s important to identify the tools and expertise needed for the next seven months to satisfy your company’s diversification commitments. In considering those needs, I challenge you to tap into the diverse mindset of your peers—at companies large and small—to learn and collaborate.

Nearly 1,000 orthopaedic industry professionals from around the world will gather at OMTEC, the Orthopaedic Manufacturing & Technology Exposition and Conference, on June 13 to 15 in Chicago. Attendees include surgeons, representatives from the largest contract manufacturers, to testing labs and material providers, as well as the previously-mentioned top 15 device companies and representatives from startups. This is an opportunity for you to meet and gain knowledge from their experiences.

    Your Industry Toolbox:


THE ORTHOPAEDIC INDUSTRY
ANNUAL REPORT®

ORTHOPAEDIC DEVICE COMPANY PROFILES: THE TOP 5

OMTEC 2017 Final Program

OMTEC Attendees

OMTEC Exhibitors 

 

Alongside those conversations, you can glean insight from industry executives on ways that your diversification priorities fit within the industry outlook beyond 2020.  Further, their voices will be positioned alongside data published in THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT®, which provides a comprehensive overview of the market and a snapshot of industry trends and growth through 2021.

A benefit of conducting business today is the vast number of resources available to aid in making strategic decisions to diversify—or conversely, to specialize. The value of OMTEC is that there are a thousand resources in one place to upgrade your toolbox.

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

May 03, 2017 | OMTEC 2017 to Highlight Latest in Orthopaedic Innovations

Orthopaedic companies of all sizes stand to benefit from dozens of new technologies waiting to be embraced. Staying abreast of technology advancements can be difficult to do among our daily demands, though. OMTEC 2017 will pack reviews of multiple orthopaedic innovations into three days, educating you on the latest in research and adoption rates. Four innovations that will be covered in the Tech Center include:

1. Additive Manufacturing: Design, Materials and RA/QA Standards
How to use additive manufacturing or 3D printing remains a complex question for surgeons, device companies and suppliers alike. OMTEC has dedicated four sessions to additive in order to dive deeper into the subject. You can expect the surgeon perspective on printing-on-demand, the engineer’s perspective on how to design for additive, the supplier perspective on how to choose materials and the society perspective on ways that industry muscle is driving important regulatory and quality standards.

2. Implant Infection Prevention
Post-surgical infection control is a top priority in the reduction of complications, revisions and costs. It’s a topic of importance all along the product development spectrum, from the surgeon, to the research level, to the start-up, through the industry’s largest companies. A joint reconstruction surgeon, Stryker’s R&D director of trauma and a university department head will come together to share their research and discuss current and future technologies being developed to address surgical infections.

3. Stem Cells: Engineering New Regenerative Therapies
The repair of cartilage following joint injury or degeneration remains a challenge for the orthopaedic community. Techniques have been developed to treat cartilage defects, but there have been few attempts at tissue-engineered therapies for end-stage osteoarthritis. Bradley T. Estes, Ph.D., who has over 25 years in orthopaedic device design, research and development, will demonstrate that by combining techniques in functional tissue engineering and synthetic biology, researchers are able to reproduce native cartilage, providing the potential for complete resurfacing of the entire joint surface.

4. Material Advancements
Innovation in orthopaedics is linked to the adoption of new materials and new manufacturing processes for established materials. A rapid-fire session will profile the properties, indications and manufacturing processes that advance the use of different materials like bioabsorbable metals, PEEK and titanium.

With the gain of this new knowledge, how will you decide which innovations to pursue for new product development? You can also learn best practices to on ways to assess new technology. What suppliers can you turn to for support? The OMTEC exhibit hall will host 147 suppliers and service providers, who will be waiting for your questions.

Carolyn LaWell is ORTHOWORLD's Chief Content Officer. She can be reached by email.

April 06, 2017 | Growth in Joint Recon Returns to the Leading Orthopaedic Companies

The joint reconstruction segment is a priority for the five leading orthopaedic companies: DePuy Synthes, Zimmer Biomet, Stryker, Smith & Nephew…and yes, even Medtronic. (In 2016, Medtronic announced its entry into the knee and hip market with the acquisition of Responsive Orthopedics – though revenue won’t post until later this year.) A stable U.S. and strengthened ex-U.S. market, along with new product launches and acquisitions, returned this segment to growth in 2016 for all but newcomer Medtronic.

Declining/flat hip and knee sales were the primary factor underlying 2015’s underperformance. And frankly, we did not expect the turnaround to occur by close of 2016. We’re pleased to report that the top five outperformed our projections by 3%. Combined, they grew by $671.7 million, +2.4% from 2015. Of that growth, joint recon revenue accounts for $371.1MM…that’s 55% of that $671.7MM, underscoring the fact that if joint recon isn’t growing, these companies face significant obstacles.

Here’s how that $371.1MM shook out.

 Zimmer Biomet #1  2016  2015  $ Change  % Change 
   Knee  $2,751.9  $2,735.1  $16.8  0.2% 
   Hip  $1,867.9  $1,839.4  $28.5  0.8% 
   Extremities  $392.7  $371.0  $21.7  4.8% 
 Total Zimmer Biomet  $5,012.5  $4,945.5  $67.0  1.4% 
 
 Stryker #2 2016  2015  $ Change  % Change 
   Knee  $1,870.9  $1,765.8  $105.1  5.6% 
   Hip  $1,432.9  $1,380.0  $52.9  3.4% 
   Extremities  $104.3  $99.4  $4.9  4.9% 
 Total Stryker  $3,408.1  $3,245.2  $162.9  5.0% 
 
 DePuy Synthes #3 2016  2015  $ Change  % Change 
   Knee  $1,557.6  $1,531.5  $26.1  1.7% 
   Hip  $1,394.6  $1,367.8  $26.8  2.0% 
   Extremities  $406.9  $390.9  $16.0  4.1% 
 Total DePuy Synthes  $3,359.0  $3,290.1  $68.9  2.1% 
 
 Smith & Nephew #4 2016  2015  $ Change  % Change 
   Knee $960.5  $883.0  $77.5  8.8% 
   Hip $597.0  $604.0  -$7.0  -1.2% 
   Extremities  $52.3  $50.6  $1.7  3.4% 
 Total Smith & Nephew  $1,609.8  $1,537.6  $72.2  4.7% 
 
 Top Joint Recon Companies  2016  2015  $ Change  % Change 
   Knee  $7,140.9  $6,915.4  $225.6  3.3% 
   Hip  $5,292.3  $5,191.1  $101.2  1.9% 
   Extremities  $956.1  $911.8  $44.4  4.9% 
 Total Top 4 Companies  $13,389.4  $13,018.3  $371.1  2.9% 

 

Stryker posted the largest revenue increase, $162.9MM, which pushed the company above DePuy Synthes to the #2 market position by a mere $49MM lead. It will be interesting to see how the rankings play out this year. Stryker’s consistent, steady growth is renowned. DePuy Synthes has voiced its mandate to be #1. All of the leading companies are engaged…asserting their unique and powerful strategies to maintain and grow market share whilst meeting head-on the demands of a changed marketplace and empowered patient. It’s an exciting time in joint recon and in orthopaedics overall.

Acknowledgement:

Data was culled from ORTHOWORLD’s newest report, The Top 5. The report is available through Membership or direct purchase. Learn more here.

March 15, 2017 | More Highlights from the Floor: AAOS 2017

The exhibit floor is open at the American Academy of Orthopaedic Surgeons meeting, and the news is pouring in. Since Monday, we've seen Corin's U.S. launch of the Optimized Positioning System for hip replacement, Stryker's official launch of Mako for total knee and the rebranding of Soft Tissue Regeneration (now Biorez). 
 

If you're not an ORTHOWORLD Member
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Here's more from the floor.

  • Exactech | Booth #1433, showcasing numerous products including revision systems, ExactechGPS and its latest clinical data
  • Hospital for Special Surgery | Booth #2934, launched the Center for the Advancement of Value in Musculoskeletal Care. Five core functions all focus on delivery and analysis of value, including development of new CME courses, research, analytic capabilities and so forth. (Read more here.) HSS also confirmed that a significantly shortened 7-question patient survey is a valid tool for assessing outcomes following total knee revision. (It's called KOOS Jr.)
  • Smith & Nephew | Booth #5133, hosting demonstrations of the NAVIO hand-held robotics-assisted total knee arthroplasty system ahead of its slated 2Q17 launch.
  • Zimmer Biomet | Booth #4333, touting 50 new products and guided tours for the official launch of Signature Solutions 

 

Don't forget to stop by Booth #1508, and spend some time with Carolyn, Fran and Mike.

March 13, 2017 | Education, Study Results and Product Showcases at AAOS 2017

Orthopaedic device companies have already started to announce the products they're launching at this year's American Academy of Orthopaedic Surgeons meeting.

Consensus Orthopedics launched TracPatch™, DJO Global launched the AltiVate™ Anatomic Shoulder and we're expecting Stryker's limited launch of Mako for total knee and the broad release of Zimmer Biomet's Signature Solutions.
 

If you're not an ORTHOWORLD Member
and you want to receive strategic announcements coming out of AAOS
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Here's what you can expect from others in the exhibit hall.
 

  • Bioventus | Booth #5223, showing the CELLXTRACT™ cell and bone marrow extraction tool, GELSYN-3™ next-generation 3-injection hyaluronic acid, OSTEOAMP® allograft bone and SIGNAFUSE bi-phasic mineral composite (bioactive glass + resorbable polymer)
     
  • EOS Imaging | Booth #4933, ten oral podium presentations featuring the EOS imaging technology and software solutions, particularly hipEOS
     
  • K2M | Booth #425, debut of the Balance ACS™ (BACS™) spine surgical platform of tools
     
  • Konica Minolta, Booth #1341, imaging solutions for orthopaedic procedures
     
  • OrthoGrid Systems | Booth #649, education on the HipGrid™ image-enhancement device for improved acetabular cup angle, leg length and hip offset in hip replacement procedures
     
  • OrthoSensor | Booth #5823, studies for VERASENSE intraoperative sensor product for use in total knee arthroplasty
     
  • Stryker Spine | Booth #3133, Tritanium Posterior Lumbar Cage (including new sizes and preclinical animal study results) and demonstrations of the Aero-C Cervical Stability System and Xia 4.5 Cortical Trajectory implants and instruments

 

There are numerous suppliers also on hand at the meeting.

We're at AAOS, too! We appreciate the opportunity to interview executives and surgeons, learn about new products and meet with customers....all with the purpose of discovering new ways to help you...the builder of orthopaedic products! Track us down in Booth 1508.

 

March 01, 2017 | Eric Timko Appointed OrthAlign CEO; Michael Orsinger Joins Lima Corporate's Board

OrthAlign appointed Eric B. Timko as its new Chief Executive Officer and Chairman of the Board. Mr. Timko's 25+ years of experience in the healthcare industry includes five years as President and Chief Executive Officer of Blue Belt Technologies, which under his leadership was sold to Smith & Nephew. Prior to joining Blue Belt Technologies, Mr. Timko served as President and Chief Executive Officer of NeuroVasx, President of Carl Zeiss Surgical and Vice President of Siemens Medical Systems.

Mr. Timko takes the helm ahead of full U.S. launch of the OrthAlign Plus® system for cup placement in direct anterior total hip arthroplasty, as well as global release of UniAlign® for use in partial knee replacement. OrthAlign's surgical navigation products supported 2016 sales growth of over 30% vs. 2015, with ex-U.S. sales growing 43%.

 

Michel Orsinger, former Chairman of Global Orthopedics Johnson & Johnson, has joined the Advisory Board of Lima Corporate. Mr. Orsinger joined J&J in 2012 following its purchase of Synthes, and subsequently established DePuy Synthes as the largest global orthopaedic company. Mr. Orsinger held the position of Worldwide Chairman DePuy Synthes Companies at J&J from 2012 to 2015, and also served on J&J's global management team.  

Prior to this, Mr. Orsinger served as COO and CEO of Synthes for eight years, and spent 11 years with Novartis.

In early 2016, EQT acquired the majority of shares of Lima Corporate with Hansjörg Wyss as co-investor. Other Advisory Board members for Lima include Chairman Valentin Chapero, former CEO of Sonova Holding; Doug Kohrs, former CEO and President of Tornier and Eric Lohrer, representative of Mr. Wyss who was the past majority shareholder of Synthes.

Mr. Lohrer is a participant in the OMTEC 2017 Keynote, 2025's Orthopaedic Leaders, to discuss current and future market forces pertinent to the industry.