David S Edelman, MD. Doctor’s Hospital, Coral Gables, Florida
Many surgeons have excellent ideas that would enhance the progress of surgical technology. However, there is little published information available on the protection of intellectual property. A single access port was designed and the development process is described.
In early 2008, the author met with a chemical-biomedical engineer to explore the development of a single access port. Designs were drawn, patents were queried and when an acceptable device was agreed upon, molds were made. I.P. Attorneys were hired to protect the rights of all parties.
The device and molds were modified until an acceptable prototype was made. The device was used in lab animals under strict guidelines for FDA application. After initial FDA approval, the device was safely used in a patient. Further modifications were made and final FDA approval was granted in September 2010. Ten consectutive, non-randomized, acute and chronic SPA cholecystectomy were done without any complications and with excellent results.
The safe design of a new device is described with emphasis on protecting the intellectual property rights of the surgeon.
Program Number: P420