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In today’s orthopedic landscape, starting down the product design pathway without input from surgeons is a recipe for disaster.
“There are nuances that an engineer or project management team might not fully grasp until the product is in the hands of surgeons,” said Vadim Gurevich, President and CEO of GLW Medical Innovation. “Involving surgeons in the initial stages of the design process establishes a crucial feedback loop that optimizes a device’s performance in practice.”
Gurevich said a surgeon-driven design approach is fundamental to achieving success in product development projects. “Assembling a team of physicians who take part in a thoughtful exchange of ideas with engineers can significantly accelerate the design cycle,” he said. “Engineers crave that information, and it provides immense value to the device company.”
Having been involved in the design and launch of orthopedic products for over two decades, Gurevich can attest that surgeon engagement consistently correlates with product success. “Selecting the best surgeons for these projects is paramount and requires careful consideration,” he said.
Assembling the Right Team
Finding the right mix of personalities and clinical backgrounds is vital to a design team’s success, according to Gurevich. He recruits surgeons with various levels of experience to gain valuable insights into how products will be used, what design improvements are needed and the features that matter most to the end users.
Don’t shy away from collaborating with younger surgeons when assembling your team, Gurevich noted. He said France had traditionally been a hub of surgical innovation, thanks in part to surgeons who view themselves as artists rather than simply practitioners. He’s noticed that younger surgeons in the United States are beginning to adopt a similar mentality and have a noticeable openness to adapt procedures and explore new surgical approaches.
“They’re more interested in the quality and artistry of their procedures over sheer volume or financial gain,” he said.
Gurevich attributes some of this change in attitude to the interactions among surgeons on social networking outlets and the ability to immediately show off examples of their techniques on platforms like LinkedIn. “Surgeons used to publish their work in peer-reviewed journals,” he said. “Now, they share it at will. The publishing process has become democratized.”
The surgeons included on a device design team must also like each other and be able to work collaboratively, Gurevich noted. “One surgeon shouldn’t dominate the conversation,” he said.
Recruiting surgeons who will be a good fit therefore requires more than sending a series of emails or scheduling virtual meetings. It demands networking at society meetings to engage with potential collaborators and find out who they are and how they work.
Take surgeons out to dinner to get a sense of their personalities, clinical interests and communication skills. Are they published in respected journals? What is their level of research output? How do they handle criticism? Finding out will help you zero in on prime candidates.
Gurevich often sits in on education sessions at society meetings to assess a surgeon’s presentation chops and how well they manage questions from the crowd — and perhaps light criticism from their colleagues. “Those are essential skills in the orthopedic product development process,” he noted.
Gurevich pointed out that surgeons within the same specialty have varying clinical preferences and interests. “Understanding the practices of each surgeon is essential to ensuring that those involved in device development will be users of the product that’s being designed,” he said. “Bringing surgeons on board who won’t use the product is counterproductive.”
Conducting virtual meetings and hands-on sessions in cadaver labs allows you to gather important surgeon feedback during the early stages of the design process. “With the right approach and timely execution, product development can be streamlined to as little as 18 months from start to finish, with actively engaged surgeons playing a pivotal role in the process,” Gurevich said.
The insights he received from his team of surgeon collaborators were key to identifying a design flaw in the early versions of GLW’s Apollo AFX ankle fracture plating system. They told Gurevich that the handles of the kit’s instruments needed a grippy surface so they could be manipulated properly during surgery.
“It was surprising because I thought the instruments worked well,” he said. “But the surgeons told me they were designed without considering they’d be wearing surgical gloves while using them. That’s something we wouldn’t have otherwise known.”
Aligned Incentives
Gurevich acknowledged that some orthopedic companies engage surgeons for reasons unrelated to improved product improvement. He frowns on financial incentives and “pay-to-play” arrangements in which physicians receive substantial compensation without contributing significantly to the design of new devices.
He also pointed out that many surgeons within the industry are genuinely motivated to improve patient care by contributing to the development of better devices. Gurevich wants to partner with them.
To ensure he does, he limits design teams to six physicians and caps royalty payments to a total of 6% that is split among the members. He also won’t pay surgeons for the usage of products they’ve helped design.
“This approach maintains transparency and fairness while fostering genuine collaboration toward product improvement,” he said.
What Surgeons Want
Stefano Bini, M.D., has completed thousands of successful knee replacement procedures without the benefit of robotic assistance. However, he acknowledges that robotics allows surgeons to adjust a knee’s alignment to exact specifications before bone cuts are made.
“Now you’ve changed the procedure for the better,” said Dr. Bini, Clinical Professor at UCSF’s Department of Orthopaedic Surgery and Founder and Chair of the Digital Orthopaedics Conference San Francisco. “Even minor deviations in accuracy during knee replacements, as little as two or three degrees, can significantly impact soft tissue balance and patient comfort. Restoring proper kinematic alignment with robotic assistance can make a notable difference in how patients perceive their recoveries.”
Striving for excellent outcomes should be the standard, Dr. Bini noted. He said surgeons must acknowledge this level of performance and constantly ask themselves if they could achieve better outcomes.
He also believes that they should have the opportunity to work with technology in the operating room that offers fundamental improvement to the way they currently perform surgery.
Dr. Bini said technological enhancements are essential in pushing patient care forward and must maintain surgeon agency. “Give surgeons several emerging options to choose from, but let them pick the technology that they want to work with,” he added. “They need to know that they’re doing the best job possible and making a positive difference on patient outcomes. Ultimately, that’s what matters most.”
