WASHINGTON – Technological innovation is transforming surgery at a rapid pace. The question, according to Dr. Mark Talamini, is how can surgeons prepare for and participate in that transformation.
Dr. Talamini delivered the Excelsior Surgical Society/Edward D. Churchill Lecture at the annual clinical congress of the American College of Surgeons. He discussed his own early interest in medical technology, the trends in technological change, and the complex issues that face surgeons in maintaining currency in training and working to develop new devices.
The most profound change in surgery in recent decades has been the insertion of high-tech devices between the surgeon and the patient. There is now most commonly a physical distance between the patient’s body and the surgeon’s hands, and "the majority of surgical procedures involve the surgeon looking at a screen." Surgical tasks of dissecting, controlling bleeding, and suturing in particular have been all but transformed by devices.
The drive to introduce new surgical devices has come up against the stringent approval process of the Food and Drug Administration and has led to public criticism of that process. Dr. Talamini, who chairs the surgery department at the State University of New York at Stony Brook, and who has worked with the FDA for more than 10 years in various capacities, argued that there must be a correct balance between innovation and regulation. "We’ve got to have both. We cannot just have instruments released to the public without understanding what the issues are regarding safety and effectiveness. For the FDA, that is the mantra: safety and effectiveness." He added, "They have a tough task to figure out the balance between getting new things to the market to benefit patients and yet maintaining overall public safety."
Dr. Talamini asserted that the growing number and complexity of surgical instruments mean that surgeons may be falling behind in their skills without realizing it. He illustrated his point by posing specific questions about the use of some recently introduced instruments and polling the audience on correct use. In response to the many wrong answers, he asserted that "we don’t know as much as we think we do about surgical technology."
To address this problem of maintaining currency and training on innovative devices, Dr. Talamini mentioned the Fundamental Use of Surgical Energy (FUSE) program created by the Society of American Gastrointestinal and Endoscopic Surgeons. FUSE is a web-based educational and testing program for all operating room participants, including surgeons.
Dr. Talamini is particularly proud of the Center for the Future of Surgery located at the University of California, San Diego, which he was instrumental in developing. This center has a research suite for doctors and scientists to collaborate on innovative devices; training suites for the latest in surgical, robotic, laparoscopic, and microscopic techniques; and simulated operating rooms and emergency departments.
Dr. Talamini reflected on the complex relationship between innovative surgeons and device development and manufacturing companies. He cautioned the audience to consider some principles when engaging in technology development with industry. First, there would be no technological innovation without collaboration between the medical device industry and surgeons. But development and training cannot be simply a means of selling equipment. Education and sales must be clearly differentiated. In addition, disclosure and transparency are fundamental to maintaining public trust.
Finally, Dr. Talamini argued that conflict of interest in this area cannot be eliminated, but it must be managed to foster innovation.
Dr. Talamini had no disclosures.