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ORTHOWORLD » Other Articles of Interest

Articles of Interest

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
and you want to receive strategic announcements coming out of AAOS
start your 30-day trial!​

 

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
start your 30-day trial!​



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.

February 28, 2017 | New Appointments at AAOS, Active Implants

The American Academy of Orthopaedic Surgeons/AAOS selected Thomas E. Arend, Jr., CAE as Chief Executive Officer, effective April 1, 2017. The appointment follows the retirement of Karen L. Hackett, FACHE, CAE after 14 years as AAOS' CEO.

Arend is leaving a position as Executive Vice President, Chief Operating Officer and General Counsel at the American College of Cardiology where, since 2004, he managed the entity's financial health, operations and strategic direction. Further, he was responsible for all aspects of the College’s legal, risk management and compliance activities.

Like his predecessor, Mr. Arend will oversee a staff of 250 and manage an annual budget of $60 million.


From BONEZONE: AAOS President, Gerald R. Williams Jr., M.D., answers the question,
"Where will the greatest change come in orthopaedics in the next five years?"

 

Active Implants, developer of the NUsurface® Meniscus Implant, named Ted Davis as President and CEO, succeeding Henry Klyce who has moved to Chairman of Active Implants' board.

Mr. Davis' previous appointments include CEO of MicroPort Orthopedics and President of Wright Medical Technology’s global OrthoRecon division following ten years in life sciences venture capital, employed at MB Venture Partners and Vector Fund Management.

In 2Q16, Active Implants announced the first meniscus replacement in the SUN (Safety Using NUsurface) clinical trial, investigating the treatment for patients with persistent knee pain following medial meniscus surgery.

January 26, 2017 | DePuy Synthes' President Set to Lead AdvaMed's Orthopaedic Priorities of Registries, Payments

AdvaMed announced its orthopaedic priorities and the leader of its initiatives.

The organization has named Juan-José Gonzalez, President, U.S. DePuy Synthes, to head its orthopaedic sector by assisting with coordination of the regulatory and reimbursement advocacy priorities that impact AdvaMed’s orthopaedic member companies.

AdvaMed identified its orthopaedic priorities as:
1. Working with stakeholders to design, develop and maintain an effective device registry in the U.S.
2. Ensuring that new payment methodologies capture the value of orthopaedic implants

Both priorities speak to the U.S.’s shift to value-based medicine and its connection of quality and cost measures. The importance of data for benchmarking has increased as hospitals face the demands of public and private payors to meet set outcome metrics. The pressure has trickled down from the hospital to device companies, which are expected to prove product quality and cost through data. Hip and knee replacement, $8 billion and $6.5 billion markets respectively, arguably face the greatest scrutiny in orthopaedics.

In 2016, the Centers for Medicare & Medicaid Services (CMS) required hospitals in 67 regions to participate in its Comprehensive Care for Joint Replacement (CJR) Model, a five-year program that compensates providers by episode of care, from the time of the hip or knee replacement through 90 days after discharge, rather than just for the surgery itself.

CJR is just one model in the emergence of bundled payments. The impact that bundled payments will have on implant pricing remains unknown. The pricing models have, however, driven device companies to launch services to help hospitals address the components of an episode of care. DePuy Synthes, Zimmer Biomet, Stryker, Smith & Nephew and Medtronic—the five largest orthopaedic companies by revenue—have introduced solution platforms for joint replacement customers. 

DePuy Synthes, Smith & Nephew, Stryker and Zimmer Biomet also support the American Joint Replacement Registry (AJRR). AdvaMed has representation on AJRR’s board.

The top five companies account for 61% of worldwide orthopaedic revenue and ~80% of joint replacement revenue, according to the ORTHOPAEDIC INDUSTRY ANNUAL REPORT. Gonzalez takes the lead of AdvaMed’s orthopaedic sector following representation most recently from Smith & Nephew, Biomet and Zimmer.

January 04, 2017 | 2017's Industry Opportunity: Diversification of Portfolios

We know that, like us, many of you rely on our financial forecasts and industry insight to assist in budget and business development.

As we all look to the new year, we thought it timely to offer our estimates for end of year performance for the top five companies, as well as share an observation on one theme that shaped the industry in 2016 and is expected to remain top of mind in 2017: that is, diversification. Read on.

October 06, 2016 | Headcount Reductions, New Appointments at Biologics and Spine Companies

Alphatec Spine announced a workforce reduction of ~20%, part of its plan to reduce operating expenses by $20 million following sale of its international business to Globus Medical. At the end of 2015, Alphatec employed approximately 430 people worldwide.

Moving forward, Alphatec is focused on U.S. expansion of Arsenal™ Degenerative and Deformity systems, the Battalion™ Universal Interbody System and launches of Battalion Lateral and XYcor® Expandable Spinal Spacer systems (the latter of which received FDA 510(k) market clearance in August 2016).

Amedica has reduced its workforce by ~38% in a move to realize savings of ~$2.0 million in cash operating expenses, on an annualized basis. The company will continue its focus on adding new surgeons, territories and distributors. In March 2016, the company employed 56 people.

Carmell Therapeutics has added members to its senior management team in support of U.S. FDA clearance for REPAIR™ Putty, a plasma-based bioactive product designed to accelerate bone healing. New hires there include Donna Godward, Chief Quality Officer; Stephanie Kladakis, Ph.D., Vice President of R&D and Janet Vargo, Ph.D., Vice President of Clinical Sciences.

Xtant Medical has selected Carl O’Connell as its President, bringing perspective from a range of responsibilities within a variety of medical device segments including spine, extremities and orthobiologics.

Sources: Company press releases, filings with the U.S. Securities and Exchange Commission

September 15, 2016 | 2016 M&A Activity Edges Past Full-year 2015

By Julie Vetalice

With the recent bump in merger and acquisition announcements, I got curious. Checking ORTHOWORLD's M&A Activities database affirmed my hunch; I see that it's logged 39 transactions year-to-date for 2016, already ahead of 2015's whole-year total of 36. 

This is a good time to revisit some of the M&A recaps that ORTHOWORLD has assembled. (Don't forget that the database itself spans back to 1993, contains transaction detail where available—including sales multiples—and also has a downloadable Excel version for ORTHOWORLD Members.)


1H16 M&A Recap: Big Players Make Moves

36 Acquisitions Completed in 2015

NASS PREVIEW: A Guide to the Recently-merged in Spine

Suppliers Consolidate in Response to OEM M&A Activity

 

August 03, 2016 | Amendia Adds Manufacturing Expansion to List of Major Strategic Moves

Amendia, a vertically-integrated U.S. spinal implant company, has expanded its manufacturing facility in Marietta, Georgia to support growth in multiple capabilities, such as manufacturing, surgeon training and R&D efforts.   

The expansion comes on the heels of several major announcements from Amendia. In early 2015, Amendia acquired Custom Spine, SpineSelect, Baxano Surgical’s iO-Flex and iO-Tome, and announced a strategic venture to develop Promimic’s HAnano surface technology. In April 2016, private equity firm Kohlberg & Company acquired majority ownership in Amendia, and in June 2016, the company named Chris Fair, a spine industry veteran and investment manager, as its President and CEO. 

Amendia is one of multiple spine companies focused on internal manufacturing expansion. Most notably, NuVasive and Globus have shifted their percent of in-house vs. outsourced manufacturing. In its 2Q16 earnings calls, NuVasive leadership said that its initiative to achieve 100% in-house manufacturing remains on track, with initial production slated to commence in August at a new Ohio facility, while Globus leadership said the company remains on schedule to grow in-house manufacturing capacity to 50% by 2018.

These in-house manufacturing strategies are largely attributed to companies’ beliefs that they’ll be better positioned to control operating margins.
 

July 18, 2016 | Recent Activities Further Progress for 2-level Cervical Disc Replacement in the U.S.

Recent announcements have brought new players to the 2-level cervical disc replacement market in the U.S. Zimmer Biomet finalized its $1 billion acquisition of LDR, which added Mobi-C to its spine portfolio, while Medtronic received FDA Premarket Approval for a 2-level application for Prestige LP.

Mobi-C had been the only 2-level disc on the U.S. market. Expanded reimbursement coverage, updated labeling claims and published peer-reviewed papers resulted in U.S. Mobi-C sales increasing 80% in 2015 vs. 2014.  

Further, in April 2016, LDR reported that Mobi-C surpassed >$100MM in cumulative U.S. revenue since its 2013 launch. Half of the Mobi-C units sold are for 1-level indications and half are for 2-level indications. 

The acquisition of LDR allows Zimmer Biomet to capture about 1% of the worldwide spine market, increasing its share of the market to about 5%, according to ORTHOWORLD estimates. While the purchase of LDR also expands Zimmer Biomet’s traditional cervical and lumbar offerings, Mobi-C is presumably the technology that attracted Zimmer Biomet in seeking to enhance its portfolio.

Medtronic’s entry into the 2-level market is expected to put competitive pressure on Zimmer Biomet and Mobi-C. The 2-level discs will be sold in a small market that faces a lack of reimbursement. To dive into specifics, >50 million lives are covered for Mobi-C’s 2-level procedure, and ORTHOWOLD estimates place the total artificial disc market at ~$275 million in 2016. 

Medtronic’s clout as the largest player in the global spine market, with nearly 30% market share, could drive increased reimbursement coverage and spur market expansion, analysts have said, but the volume and pace of that growth is hard to predict.

Still, Medtronic clearly sees promise in the disc market. In 2Q16, it released data showing that the Prestige LP 2-level disc demonstrated favorable clinical outcomes and patient satisfaction vs. 2-level anterior cervical discectomy and fusion. Though the company has yet to launch the Prestige LP 2-level disc, leadership has said that it is one of a handful of new products among its strategies to invigorate growth in its spine business.

Overall, Medtronic’s worldwide spine sales decreased 4.3% from $2.5 billion in 2014 to $2.4 billion in 2015. (Please note that ORTHOWORLD estimates exclude biologics.) Medtronic also recently restructured its Restorative Therapies Group, which includes spine, orthobiologics, neuro and surgical technologies, to turn the business around. 

The upside for the two companies is that the barrier for approval for a 2-level disc in the U.S. is quite high, e.g. Medtronic’s study took seven years to complete, which is not uncommon. Therefore, Medtronic and Zimmer Biomet are only competing against each other in the 2-level cervical disc market for the foreseeable future.