Industry veterans united Wednesday to discuss the key trends that orthopedic companies can’t ignore over the next decade. 3D printing, minimally invasive surgery, robotics, regenerative medicine, the regulatory environment and today’s pressing concern, the coronavirus, were discussed.
You would probably expect these topics to make the list, and you’re likely well-versed in one or more of them. Still, we thought that perspective from the individual experts was worth sharing, knowing their longevity and clout in the industry.
The panel included:
Robin R. Young, Orthopedics This Week
Glenn Stiegman, MCRA
John Viscogliosi, Viscogliosi Bros. and Centinel Spine
Scott Bruder, Bruder Consulting and Venture Group
Earl Fender, Vertiflex
MedTech Momentum, Commenda and Orthopedics This Week organized the conversation.
COVID-19 is not a welcomed development. The pandemic is creating a great deal of uncertainty as device companies and suppliers seek to understand the impact that the virus will have on their business in the months to come. The recent announcements of elective procedure deferrals in the U.S. have added to that uncertainty.
Early forecasts from analysts predict that elective surgeries will decline by -23% to -28% for 2020, said Robin R. Young, Founder and CEO of Orthopedics This Week. He noted that the real story is the way that procedure postponement will play out by quarter. Analysts expect procedures in 1Q20 will be 90% normal, 2Q20 will be 30% normal, 3Q20 will be at 60% and 4Q20 could be at +120%.
Companies have a lot to consider right now—keep employees healthy, maintain manufacturing, understand revenue loss from procedure deferrals, handle supply chain disruptions. Young advised that companies should use this time before surgeries ramp up to increase communication with your surgeon customers and heighten internal communications for training sessions and product discussions.
“When the surge of surgeries happens—and it will come—those physicians hopefully will have your company, your products, top of mind because you invested the time now to be in touch with them,” he said.
2. Regulatory Environment
FDA’s priority remains its response to COVID-19, but the pandemic has not halted the submission process, said Glenn Stiegman, Senior Vice President, Clinical & Regulatory Affairs, MCRA. FDA’s Center for Devices and Radiological Health sounded the same message.
“We’ve told all of our clients to actually be more aggressive on submissions, meaning send them in as soon as you can, because you don’t know when the situation is going to change,” Stiegman said. “I believe as soon as someone does test positive in and around FDA, things will probably shut down.”
COVID-19’s most significant impact on the regulatory environment has been on clinical studies, Stiegman said. Companies involved in Investigational Device Exemptions aren’t able to get devices implanted and monitors aren’t allowed in hospitals.
“When you talk about make or break orthopedics or maybe any therapeutic area over the next decade, I’m looking at this particular scenario—the next three months to one-year time frame—to understand the impact it’s going to have on these studies,” he said. “On the flip side, the good part of this, we’re all resorting to creative ways to work from home and have meetings. I believe FDA and industry, in general, are going to start creating clinical studies that are virtual.”
The top orthopedic companies are highly invested in robotics. CEOs of these companies continue to be outspoken about moving resources to robotic product development. Christopher Prentice, CEO of Harmonic Bionics and former CEO of Mazor, said he expects the technology to accelerate even faster in the next decade. Knowing this, he advises all companies interested in the space to think about process and location.
From a process standpoint, he predicts that we’ll see an integration of capabilities. A robot that assists in knee and hip replacement today could be utilized in spine in the future. He also expects that we’ll see more information processing before and after the procedure, and use of robotics will increase for hospital logistics and transportation.
“I want you to open up your mind and think about where you will see robots,” Prentice said. “If you’re not aware of that in your strategy and your planning, you can lose out.”
From a location standpoint, Prentice said that companies need to think outside of the physical box, which is routinely the operating room. He expects robots will be used in physician offices, rehab centers, fitness centers and even people’s homes.
“Think upstream and downstream in the process; that’s where you’re going to see robotics,” he said.
4. 3D Printing
3D printing or additive manufacturing has become one of the faster growing technologies in orthopedics, with companies of all sizes and across all segments utilizing it in new product offerings.
John Viscogliosi, Principal of Viscogliosi Bros. and CEO of Centinel Spine, described 3D printing as the Wild Wild West of orthopedics. “Everyone is rushing to create something,” he said.
Whether 3D printing a metal, a polymer or a biologic, he cautioned that it’s incumbent on companies to make sure that they understand what they’re making due to the changes that occur with the material and differences in the design and validation processes versus traditional subtractive manufacturing
“When you’re creating the structure, you’re looking for chemically inert products, you’re looking for a bioactive action to be taking place, you’re looking for something that is strong, has a high fatigue resilience, a low elastomeric modulus so that it interconnects well,” he said. “You don’t want things to be corrosive.”
Viscogliosi focused a portion of his presentation on materials, noting that orthopedic companies seek to improve the characteristics of traditional materials. “I think that 3D printing will allow us to do that,” he said.
5. Regenerative Medicine
Orthobiologic market conditions demand that companies secure clinical evidence, said Scott Bruder, M.D., Ph.D., Founder of Bruder Consulting and Venture Group.
The new orthobiologic development paradigm, recommendations from societies, reimbursement securement and new FDA regulations are all in response to the need for more data. In December 2019, Dr. Burder wrote in BONEZONE, “Companies seeking commercial success would be well-served to abide by FDA guidance and invest in developing high-quality indication-specific evidence, and possess the patience to do both.”
What does all of this mean for new products? Dr. Bruder stressed the following:
- New entrants into the mature bone graft substitute market will need significant differentiation based on evidence, efficacy and value.
- Articular cartilage repair is often seen as the Holy Grail of orthobiologics, but current products have not been broadly adopted or substantially profitable for companies.
- Meniscal repair devices have had varied success, but an effective arthroscopically delivered implant would be a “blockbuster.”
- ACL repair remains an untapped market and could benefit from a new biomaterial with proper mechanics and remodeling.
- Intervertebral disc regeneration is a multi-billion dollar opportunity, but one that would take years and require an HCT/P or drug or combo product.
“There are ways to get products cleared into the 510(k) highway and get you market presence,” he said. “But in the absence of clinical data, the challenge is going to be reimbursement.”
6. Minimally Invasive Surgery
Minimally invasive surgery continues to grow across orthopedics. Earl Fender, Outgoing President and CEO of Vertiflex, shared the company’s story and noted that the benefits of MIS can be applied in an even broader context.
Vertiflex developed the Superion® Indirect Decompression System to treat lumbar spinal stenosis. Boston Scientific acquired the company in June 2019 for $465 million in cash.
As Fender told it, about a year into the company’s eight-year, $50 million IDE study, they realized they had a product that spine surgeons were no longer interested in using. Scrambling to find a place where the technology could benefit the provider and the patient, they approached interventional pain management doctors who were primarily doing spinal cord stimulation and ablations. The pain management doctors liked the product. The IDE results were good. In 2015, Vertiflex secured its PMA and reimbursement.
At first, Vertiflex primarily sold to interventional pain management doctors. Then, spine surgeons began to “push back” on Vertiflex selling to pain management physicians. Vertiflex’s concerted education for both types of physicians helped Superion gain adoption. Before its acquisition, spine surgeons made up 20% of Vertiflex’s sales.
“Having two groups of customers, on one hand, is challenging,” Fender said. “But note that it also expanded the number of acquisition targets.”
Fender provides three pieces of advice for companies that may find themselves in a similar situation:
1. MIS technologies can expand provider specialty and, therefore, expand your customer base.
2. No matter the specialty, companies are responsible for qualifying positions and positioning them for the best patient outcomes.
3. Any time you expand your provider base, you’ll run into politics.
We, too, believe that these trends will accelerate in the decade, with the largest orthopedic players adopting many of these technologies into their portfolios and others choosing to focus on one or two of the options.
Although COVID-19 is the backdrop for most conversations today, Young closed the discussion emphasizing the importance of orthopedic innovation.
“We are in an industry—despite the stress test—that remains innovative,” he said. “You can tell by the discussion today that even after this runs its course, which it will, surgeons will continue to move toward innovative products that deliver more reliable outcomes, safer outcomes, more reproducible outcomes and push the envelope in terms of patient satisfaction. That’s not going to stop.”
Carolyn LaWell is ORTHOWORLD's Chief Content Officer.