- Posted in Business Critical | January 07, 2019 | Comments (0)
- Tags: Editor's Choice, fda, supply chain, regulatory, omtec, spine, design control, surgeon, knee, thr, tkr, m&a, materials, additive manufacturing, peek, sterilization, orthopedic industry, titanium, orthopedic supplier, hip, arthroplasty, NASS, AAOS, robotics, arthroscopy
- By: Rob Meyer
Insights on robotics, major acquisitions in the contract manufacturing space, companies to watch, product recaps and surgeons’ implant material preferences were among the themes of the most-read articles published in BONEZONE during 2018.
Other content that proved popular with you and your peers included a recap of an OEM/supplier panel that convened at OMTEC® to discuss supply chain quality, a refresher on market entry into Brazil, how robust design controls can prevent labelling mistakes on devices and sterilization considerations recommended by an expert.
|Zimmer Biomet's ROSA robot|
Robotics was a major industry theme in 2018. The most-read article on our site this year was our look at the players and technologies in the robotic space and the ways that they fit into the greater industry context of data, outcomes and adoption.
We posited that robotics has the potential to be game-changing technology in orthopaedic surgery, as certain companies and surgeons extol benefits that include efficiency, predictability and consumer appeal that could increase procedure volume for users. Still, we believe that companies have yet to prove a sizeable market and the necessity for robotic technologies, and our conversations with surgeons in 2018 indicated that the topic remains polarizing. (Note that several of the companies mentioned in this article have strategically changed their approach to the robotic space since May, when the article was originally published.)
Our report on Zimmer Biomet’s first total knee replacement surgeries using ROSA was a popular read in 2018. These first five ROSA knee cases were performed in a single surgery day at an Australian hospital, which, as we pointed out, hints at the company’s positioning of ROSA as efficient and minimally disruptive to procedure flow. ROSA is expected to receive FDA 510(k) approval in 1H19. Full launch is expected in 2H19.
Contract Manufacturer M&A
NN shook up the industry’s supplier space with its acquisition of Paragon Medical for US $375MM in cash. Our report on this acquisition, as well as our coverage of Tecomet’s purchase of HD Surgical, were widely read, demonstrating the importance and wide-reaching impact that consolidation among top suppliers has on you and your company.
To summarize, Paragon Medical was an attractive purchase because it allowed NN to expand its orthopaedic device and instrument portfolio, and it provided entry into the delivery systems space. Post-acquisition, NN is positioned as one of the 10 largest contract manufacturers in orthopaedics (ranked by revenue), according to ORTHOWORLD® estimates.
Our revenue estimates place Tecomet first among contract manufacturers serving the orthopaedic industry. The purchase of HD Surgical allowed Tecomet to greatly expand its ability to support the complex instrument needs of its mid-size customers, according to company leadership.
M&A activity will continue to shape the broader orthopaedic supply chain base, with contract manufacturers like NN and Tecomet transforming in the last several years to keep pace with their scaling OEM customers.
Products, Companies to Watch
|Okani Medical's ORGKnee|
As has been the case in years past, articles leading up to and following major industry events—the American Academy of Orthopedic Surgeons (AAOS) Annual Meeting and the North American Spine Society Annual Meeting (NASS)—finished near the top of our most-read list.
What we took away from our conversations at AAOS: OEMs’ ability to gain market share in the total knee and hip reconstruction spaces will be dependent upon their response to the shift of procedures to ambulatory surgery centers, an uptick in bundled payments and any or all measures focused on cost.
The messaging around launched products, whether backed by data or not, was that the new products must correlate to better patient outcomes and more efficient (quicker, less expensive) procedures.
To give a partial glimpse into the larger knee and hip story, we interviewed personnel from two large players (DePuy Synthes and Stryker) and two smaller companies (Okani and UOC).
Use of additive manufacturing/3D printing, expandable interbodies, robotics, navigation, imaging, surface coatings and SI joint fusion technologies were reflected in the 14 products we previewed prior to NASS. Some of the companies highlighted were Emerging Implant Technologies (purchased by Johnson and Johnson Medical Devices), K2M (purchased by Stryker—our report on the transaction) and Paradigm Spine (purchased by RTI Surgical).
In a third market segment dive, we drew your attention to 11 small arthroscopy/soft tissue repair companies, with a focus on funding, patent and trial/study announcements from January 2017 to June 2018 to see whose initiatives are making waves. Products in this widely-read article included meniscus implants, a tissue-engineered device for ACL reconstruction, a synthetic cartilage implant, a handheld single-use visualization tool and more.
Surgeon input, of course, is critical in assessing trends in the industry. The most popular of our surgeon interviews was published prior to NASS, when three prominent surgeons confirmed that the inclination in newly-launched spinal cages has become a focus on expandables and additively manufactured devices, with a shift away from manufacturing cages with all-PEEK to those that incorporate titanium, whether in the coating or the body.
In a second surgeon interview, Kornelis Poelstra, M.D., Ph.D., explained that he believes new materials will bring the next wave of innovation in spine. This view spurred a partnership with an entrepreneurial cardiologist who has introduced molybdenum-rhenium (MoRe) to orthopaedics through his spine company, MiRus. Dr. Polestra has presented research on the use of MoRe in spinal applications and will speak on the topic at OMTEC 2019. Dr. Poelstra said that compared to what’s commonly used in spine—cobalt-chrome, titanium and stainless steel—MoRe has characteristics “that are a lot stronger.”
Four additional articles found at the top of the most-read list that we feel are certainly worth a read, if you missed them when originally published, include:
- Mistakes involving mislabeled and misbranded devices—one of the top three causes for recalls in the U.S.—can be minimized by device companies undertaking a series of steps. Where to start? Have robust design controls in place early in the process.
- Brazil is the largest market for medical devices in South America and home to about 6,500 hospitals. As we explained, Brazilian surgeons prefer imported orthopaedic products and, adding to the country's attractiveness, a new regulation may make it easier for companies to enter this market.
- Device companies are advised to take a deeper look at biocompatibility, endotoxins and their overall sterilization protocol. Though recent updates to standards and regulatory guidance have made these processes more complex, they remain critical for robust sterilization.
- A diverse panel of experts from Autocam Medical, MicroPort Orthopedics, Orchid Orthopedic Solutions and Zimmer Biomet convened at OMTEC 2018 to discuss OEM/supplier relationships, quality agreements, regulatory oversight and continuous improvement efforts.
*Images courtesy of manufacturers, Shutterstock