A quick scan of course offerings and lecture titles at medical meetings shows that bioentrepreneurship is a growing phenomenon in the United States. With the expansion of technological capabilities, physicians and other researchers have come up with new products to meet unmet needs in medicine, be it drugs or devices. Bioentrepreneurship for otolaryngologists typically involves developing a new device to improve otolaryngologic surgery. ENT Today spoke with several bioentrepreneurs about the road to success.
Explore this issue:February 2009
Bioentrepreneurship involves taking technology from the mind of a researcher and bringing it to the marketplace. Typically the two pathways for doing this are patenting and proving a concept and licensing it with a larger company or using the new technology as the basis for a start-up company that may grow into a larger company or may be acquired in the future by a larger company, explained Donald A. Gonzales, MD. Dr. Gonzales, a bioentrepreneur, is founder and Chief Medical Officer of ENTrigue Surgical in San Antonio, TX. The company currently has one commercialized articulating sinus instrument, a stapler for septoplasty awaiting approval, and ongoing clinical trials for a middle turbinate medializer.
Becoming a Bioentrepreneur
Bioentrepreneurship may come about in any number of ways, but generally it involves identifying a product for an unmet need and considering whether it will benefit all the major stakeholders: patients, physicians, site of care, and payors, explained Thomas V. Ressemann, another bioentrepreneur, who is President and Chief Executive Officer of Entellus Medical, the company he co-founded with an otolaryngologist. Entellus’ first product is the FinESS Sinus Treatment System, an innovative, less invasive treatment for chronic sinusitis and acute sinusitis.
Mr. Ressemann gave a broad overview of how to go about bringing a product or service to the marketplace. Once an appropriate product or service is identified, a functional organization or business model is created and decisions are made about the associated people, resources, and time needed to bring the business model to the stakeholders, he continued. Intellectual property should be established. Once capital has been raised through appropriate sources and resources are in place, the product or service is developed, tested, and approved by regulatory bodies for marketing.
Identifying a clear regulatory path, clinical study path, and reimbursement path is critical, Mr. Ressemann said. It is also important to research whether the product can be delivered through existing distribution channels, he added.
Key Ingredients for Success
Experts interviewed for this article agreed that the first requirement is an idea for a product that meets the needs of the major stakeholders and is differentiated from other products on the marketplace. An equally important ingredient is involving the right people-including a good corporate attorney-in the fledgling organization. The idea must solve a real problem, and you must be persistent through all the roadblocks you will encounter, Dr. Gonzales said.