Where to Start with Your Device Idea (and Other Entrepreneurial Pursuits!)

In this episode of BackTable ENT, Dr. Shah and Dr. Agan interview Dr. Keith Matheny, a physician-entrepreneur and a fellow ENT.

First, Dr. Matheny discusses his personal device innovation and business journey. He started medical practice with no formal business background or training and had to learn these skills on-the-job during his first private practice job. After observing the need in his field for business consulting, he created US ENT, a formal consulting company, to help other ENT practices grow and develop different departments. US ENT later transformed into a group purchasing organization and was able to partner with medical suppliers to give physicians discounts on materials. During this time, he was also able to test new ENT devices and provide his input to large medical device companies; these experiences prompted him to venture into the field of device innovation and begin patenting his ideas.

Acquiring knowledgeable and supportive partners is essential for developing new devices. Dr. Matheny recommends reaching out to device representatives of major medical device companies in order to be introduced to their business development teams. However, he notes that major medical device companies do not specialize in early-stage development. For this reason, partnering with a startup business may be more productive when developing a product prototype. For every person an innovator discusses his idea with, a non-disclosure agreement (NDA) should be signed in order to ensure the integrity of information sharing. Additionally, innovators should file a patent as soon as they have a solid idea; patent lawyers are useful resources and can help innovators find angles that make their ideas different from previous devices. Although Dr. Mathey encourages innovators to seek funding from healthcare investors, venture capitalists, and private equity companies, he warns listeners against letting outside forces take control over a majority of their company.

Once a prototype is created, the product can be tested in the setting of a medical practice through the proper IRB channels. It is important to follow FDA regulations during this time period. For devices that are similar to pre-existing devices on the market, they can be classified as Class I exempt devices if all predicate devices are listed in the application. Approval for Class I exempt devices will follow in a few short months. However, for brand new devices, a formal study will need to be conducted before it can be used in human patients, thus invoking a longer approval time.