“In general, these timelines have improved since our initial report, as a recent study by USC Biodesign has demonstrated,” he said. The USC Biodesign report (“Interstates and Autobahns: Global Medtech Innovation and Regulation in the Digital Age,” March 2022) found that the median time from concept to FDA decision for novel medical products was about 2½ years for 510(k) approvals and about 5½ years for De Novo approvals. The report also noted that the FDA has responded more effectively to advances in innovation than regulatory authorities in Europe.
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May 2023Business Basics
When it comes to bringing ideas to fruition, physician innovators must learn a lot along the way. Dr. Kozin advised that, given the complexity of surgical device development, clinician innovators should be comfortable in seeking outside expert support.
“We needed support to undertake market analyses and design business strategies,” he said. “To address this, we created a multidisciplinary commercialization team that included experts who had specific business expertise.”
Dr. Klein pointed out the importance of making sure that the team an inventor puts together is of the highest quality. “Once you identify really good people to partner with on good ideas, the next steps will come together much more easily.”
Once you identify really good people to partner with on good ideas, the next steps will come together much more easily. —Adam M. Klein, MD
What kind of money can a doctor make from these innovations? “There’s money to be made, but it’s not as easy as one would hope. It takes a lot of time, dedication, and hard work,” said Dr. Klein. “We’re supported in the academic sector by the resources of the university when it comes to patenting and early-stage market analysis, which takes the initial financial risk away from the inventors. In exchange, the university and the department each earn a piece of the financial pie.” In general, he added, drug innovation tends to be more lucrative than medical device innovation.
Dr. Kozin doesn’t believe that otolaryngologists should consider doing innovation work for financial incentives. “While the goal of any innovation work may be to bring a novel device to market and develop a commercially viable product, this process may take a decade or more of work and ultimately result in minimal personal financial reward,” he said. “Instead, the work should be done because the individual is passionate about the idea and impacting patient care.