Extremely Simple and Efficient

Tony Finau has learned quite a lot about himself over the past 12 months. Besides gaining new insights into his fortitude, humility,  and confidence, the 29-year-old professional golfer discovered a keen sense of humor he perhaps never before realized (or cared to admit).
 
The latter trait was a particular surprise to Finau’s fans, considering the clever manner in which it was divulged.
 
Shortly before the 2019 Master’s Tournament, Nike and Finau teamed up to create a signature shoe he could wear at the year’s first major should the 6-foot, 4-inch Samoan decide to partake in another disastrous hole-in-one victory run (Finau injured his left ankle during last year’s Master’s celebrating an ace at the seventh hole). Debuting on April Fool’s Day, the fairway-colored, incredibly high-topped Finau1 boot came with a three-and-a-half minute “mockumentary” that poked fun at Finau and his injury.
 
“Not a lot of people come back from that—not the injury but the embarrassment,” Carl Madore, a Nike “footwear designer,” quips in the video. Finau adds further comic relief with lines such as, “Like any elite athlete, I had to get back in the lab and rebuild my body from ground up,” and “I thought to myself, ‘What if we designed a golf shoe for stability in my ankle? Why not?’”
 
“I felt like if you can’t laugh at yourself in something like that, then I think you’re doing it all wrong,” Finau told Star Tribune (Minneapolis) sports columnist Jim Souhan at the start of the Master’s. “I thought it was quite funny after the fact, celebrating a hole-in-one and ruining my ankle for a few months.”
 
Few in Finau’s inner circle were laughing after the mishap last spring, though. Thankfully, however, Finau sustained only soft tissue damage and some torn ligaments; he rebounded the following day to shoot a four-under-par 68 in the opening round and briefly led the tournament before slipping behind three-time major winner Jordan Spieth to tie for second place with Matthew Kuchar. He finished the contest at T10, winning $286,000.
 
Although Finau now makes light of his injury, ankle sprains are no laughing matter: Studies have shown such traumas can have lasting consequences, leading to joint damage, chronic instability, and ACL troubles. Sprains have become one of the most common sports injuries and demand for non-invasive, simple solutions is expected to drive the global foot and ankle treatment market over the next half decade. Other factors like rising osteoporosis rates and an aging world population also will contribute to the growth.
 
ODT’s May/June feature “A Little Extreme” examines the innovation being developed in this burgeoning sector (and the overall worldwide extremities market) that eventually will contribute to its solid growth over the next half decade.
 
Julie Dewey, senior vice president and chief communications officer at Wright Medical Group N.V., shared her insights on the market for the story. Her full input is provided in the following Q&A.
 
Michael Barbella: What trends/factors are currently impacting the global extremities market?
Julie Dewey: Patients are increasingly become more engaged in decisions that affect their health and well-being and are more informed and proactive than ever before. Growth is being driven by innovations that make procedures easier, more predictable to perform and more efficient for the healthcare system.
 
Barbella: What factors are driving growth in this market? What segment is the growth most prolific—upper extremity, lower extremity, small joint (fingers, toes), etc., or is it fairly even across the board?
Dewey: The overall extremities market (upper and lower extremities) is one of the fastest growing market segments within orthopaedics, with annual growth rates of 7 percent to 10 percent.

• The major factors driving the market are an aging global population, a higher incidence of osteoarthritis and musculoskeletal disorders, and an increased prevalence of obesity and diabetes. 
• Aging baby boomers also want to stay active and mobile, and with more physically active life styles, there is a higher incidence of sports injuries and fracture. 
• Growth in the market is also being driven by product and technological advances. Our total ankle replacement business has seen above market growth driven by the launch of easier to use implants such as our INFINITY total ankle, the availability of our PROPHECY planning system and patient-specific guides and the recent launch of our INVISION ankle revision system. Advanced technologies such as the Cartiva SCI Synthetic Cartilage Implant and the PROstep MIS Minimally Invasive Surgery System are also growing at above market rates. 
• In shoulder arthroplasty, the aging population is increasing both the incidence of arthritis, driving the total shoulder market, and the incidence of massive irreparable cuff tears, driving the reversed shoulder market. Within the shoulder market, reversed shoulder arthroplasty is the largest and fastest growing shoulder arthroplasty segment. Positive outcomes associated with the procedure over time, as well as the ability to address more complex cases, fractures, and the fast growing revision market, are expanding the use of the reversed shoulder. 

Barbella: What types of extremity solutions are popular with surgeons? Why?
Dewey: Lower extremities growth is being driven by end-stage ankle arthritis, specifically total ankle replacement, as well as innovative implants that keep patients moving like the Cartiva SCI Synthetic Cartilage Implant. There is also growing interest around minimally invasive solutions, like our PROstep MIS System, that get patients back on their feet quicker, with less pain and an improved cosmetic result.
In shoulder, surgeons are looking for advanced technologies that simplify more complex procedures through both implant and digital solutions. New augmented glenoid implants, such as PERFORM Reversed, are driving a lot of attention by simplifying more complex cases. For the anatomic shoulder market, stemless humeral implants, like SIMPLICITI, are gaining adoption due to the efficiency of their use and the ability to preserve bone. Digital planning technologies like BLUEPRINT continue to grow in adoption as it provides improved pre-operative planning and intra-operative guidance in both standard and more complex cases.
 
Barbella: What makes the extremity market an attractive alternative to the large joint and spine sectors? Why is this one of the fastest-growing areas of orthopedics?
Dewey: The overall extremities market is one of the fastest growing market segments within orthopedics, growing at more than twice the rate of the large joint and spine sectors. In addition, there is still plenty of room for innovation because the market is still early and underpenetrated. 
 
Barbella: What new innovations/technologies are in the works? What technologies hold the most promise for patients? For market growth?
Dewey: We believe major trends in the overall extremities market include procedure-specific and anatomy-specific devices and an increase in replacement or arthroplasty procedures.

• Major trends in the upper extremities market include next-generation joint arthroplasty systems, bone preserving solutions, virtual planning systems, and revision of failed previous shoulder replacements in older patients.
• Major trends in the lower extremities market include the use of external fixation devices in diabetic patients, total ankle arthroplasty, advanced tissue fixation devices, virtual planning systems, and biologics. 
• In lower extremities, we are very excited about our innovations that get patients moving. We are focused on procedures and implants that get patients back on their feet faster and with less pain. Two products that do this are the CARTIVA Synthetic Cartilage Implant for great toe osteoarthritis and the PROstep Minimally Invasive Surgery System to treat bunions. 
• In upper extremities, we have several shoulder arthroplasty implant solutions in the pipeline focused in areas of high market growth and unmet clinical needs. Our REVIVE revision shoulder implant is a dedicated revision humeral platform designed to simplify the challenges of the fast growing revision shoulder market. We are also heavily focused on the expansion of our BLUEPRINT digital ecosystem. We already offer a powerful 3D planning platform that helps the surgeon make pre-operative decisions about the optimal surgical plan for their patients, and we look forward to further developing this platform to include elements of artificial intelligence, machine learning and mixed reality.  

Barbella: How does your company stay innovative in this increasingly crowded market? How do you differentiate yourself from other players in the sector?
Dewey: We are built on a foundation of clinical research, market leading innovation and a focus in the extremities space. These core elements fuel our ability to aggressively attack fast growing markets ahead of the competition. Since we solely focus on extremities, every person in our organization is supporting our ability to maintain our leadership in this space without competing priorities.
Our approach is twofold. First, we invest in franchises where we want to extend our leadership position. Second, we are willing to acquire breakthrough products with differentiated innovation platforms that we can develop. Examples of these platform technologies that we have acquired include AUGMENT bone graft, an alternative to autograft in ankle and/or hindfoot fusion procedures and the first clinically proven protein therapeutic to come to the U.S. orthopedics market in over a decade and the CARTIVA SCI Synthetic Cartilage, the only PMA-approved product for treatment of great toe osteoarthritis.
 
Barbella: How is product development in extremities different than that in large joint or spine?
Dewey: Extremities procedures are done in various settings of care, including hospital inpatient, hospital outpatient and ambulatory surgical centers. This has a direct impact on the design criteria of the implants, instruments, packaging, and delivery methods. In addition, the extremities market is still underpenetrated and earlier in the market and product development lifecycle curve. Outcomes data is a big focus, as well as work in implant designs, biomechanics and bearing surface materials.
 
Barbella: How is value-based healthcare and market forces like robotics, 3D printing, and computer-aided surgery impacting extremities technologies and product development?
Dewey: 3D printing has unlocked new capabilities to manufacture implant solutions otherwise limited by traditional manufacturing methods. Many of Wright’s existing and pipeline products leverage this technology to maximize our implant features and function.  For example, Wright’s investment in this technology has enabled our market-leading PERFORM REVERSED shoulder solutions, as well as our BLUEPRINT patient-specific surgical guides and PROPHECY patient specific alignment guides for total ankle replacement. 
Surgical planning is here to stay, and we have committed ourselves to the development of our BLUEPRINT software platform that will deliver not only surgical planning but the creation of a complete digital ecosystem that has value elements for all of the stakeholders involved in patient care. We believe this is the future of orthopedic healthcare, and we believe we are well positioned to be a market leader with software platforms now and in the future. 
While robotics may eventually make its way into extremities from other markets, the clinical utility and ease of use for extremities applications is unknown. Additionally, robotics requires a significant upfront capital investment and comes with a sizable footprint that takes up valuable operating room space. We believe that software-enabled solutions, like BLUEPRINT, are the future. We also believe the future of orthopedic implant surgery will include advanced elements of artificial intelligence and augmented reality.  When fully developed, we believe such software-enabled surgery will leapfrog the current mechanical approaches some orthopedic companies have developed primarily for hip and knee replacement surgery.
 
Barbella: How do you expect the extremities market to evolve over the next half decade?
Dewey: We believe the extremities market will continue to be an attractive growth market. Innovative, enabling technologies that drive efficiency, simplification and improved outcomes will continue to drive development efforts in the extremities space. We will also see digital technologies continue to expand and add to the value of implant solutions in the market.