Surgeons are natural innovators and problem solvers, so it’s not surprising that many of them seek to develop better tools that can lead to better patient outcomes. John Uecker, MD, FACS, for example, isn’t the first surgeon to try to fix dirty scope lenses, but he co-founded a company, ClearCam, to turn an idea into a product. “Every surgeon has good ideas,” Dr. Uecker said. “We all want better outcomes and better ways to do things. There are steps that can help you transform an idea into a product.”
Dr. Uecker, chief of innovation and entrepreneurship and chief of minimally invasive surgery, the University of Texas Dell Medical School, Austin, was among the panelists for the Sunday, October 24, session Innovation Junction: Surgeons Have Great Ideas—How to Turn Those Ideas into Products. “Commercialization can be a daunting task,” he said, “but you break it down into pieces. Surgeons are a natural at this. And you eventually get to the fun stuff—creating prototypes.”
Becoming a successful innovator and entrepreneur is challenging, agreed Silvana Perretta, MD, professor of surgery, University of Strasbourg, and director, Business Engineering & Surgical Technologies (BEST) Innovation Program, Strasbourg, France. “Biomedical innovation stops and ends with the patient,” Dr. Perretta said. “The process of identifying a need, inventing a solution, and implementing it is a process that can be learned.”
The real challenge, she said, is turning innovation into a reality. Cardiac surgery largely missed that challenge as coronary artery stenting was developed and introduced in the 1970s. Cardiac surgeons continued to open chests while other specialists took over stenting. Cardiac procedures fell into a long decline that accelerated when transcatheter aortic valves were introduced in 2012.
“Mostly we are successful at showing students that there is always another way of doing things,” Dr. Perretta said. “That is the heart of innovation.”
Realizing that there are multiple solutions is the first step in commercializing an idea, added Marc Bessler, MD, FACS, professor of surgery at Columbia University, New York, NY. He founded EndObetes, a startup company developing endoscopic treatment devices for obesity and diabetes. “Surgeons are problem solvers,” he said. “We are confident, persistent, and analytical.”
The key to successful commercialization is to step outside the surgical world and think more like an engineer, Dr. Bessler continued. Surgeons know the problem and they know a solution. Engineers look for a problem, develop multiple solutions, and validate them with others.
The engineering approach is also useful when approaching regulatory issues. New medical devices must receive U.S. Food and Drug Administration (FDA) approval using one of two pathways. Devices that are similar to existing devices, such as a new surgical screw or a novel stapling device, usually follow the 510k pathway, which relies on a preexisting, approved device. Companies must walk a fine line between proving similarity to existing devices to the FDA while proving innovation to potential surgical customers and payors. New devices, such as a novel valve or implanted device, must use the premarket approval (PMA) pathway. PMA requires an investigational device exemption (IDE), followed by clinical trials to demonstrate safety and efficacy.
“Surgeons are innovative on a daily basis,” said Amir Szold, MD, FACS, inventor and chief medical officer, Human Xtensions, Tel Aviv, Israel. “We have to be, most of our tools are poorly designed. Medical device companies are 70 percent more likely to succeed if a physician is among the founders.”
Being a physician-founder is no guarantee of success, but there are ways to improve your chances, starting with never giving up, he said. Dr. Szold built a laparoscopic band prototype in 1989, which his university technology transfer office said was an idea with no market potential. When he came up with an endoscopic balloon that failed, he repurposed it to expand intrabdominal mesh implants and sold a successful product.
“‘Industry’ is not a bad word, and collaboration is necessary,” said Brian J. Dunkin, MD, FACS, chief medical officer for Boston Scientific Endoscopy, MA. “We, surgeons and industry, have the same mission to advance patient care.” Medical device companies could not survive without surgeon-innovators and inventors, he explained. And surgeons could not survive without medical device companies. “We don’t build the stuff we use in the [operating room] in our garages,” he said. “We need that collaboration for better surgery.”
This and other Clinical Congress 2021 sessions are available to registered attendees for on-demand viewing for a full year following Congress on the virtual meeting platform.
For a detailed discussion of this session, view an interview with the moderators, Dr. Uecker and Dr. Szold, by interviewer Frederick L. Greene, MD, FACS, Charlotte, NC.