DIY Commercialization, with Olympic Ophthalmics’ Michael Gertner, MD

Many medical device start-ups seek acquisition to secure the financial and operational resources they need to obtain regulatory approval and gain market access.

Michael Gertner, MD, founder and CEO of Olympic Ophthalmics, took the more difficult path: he developed and began commercialization of iTEAR 100 himself.

His noninvasive neurostimulation device treats all types of dry eye disease, and he wanted to make certain it got into the hands of as many patients as possible—not ignored by a large, acquiring eye care company.

To do so, Dr. Gertner assembled a small but mighty team of investors and, in 2017, launched Olympic Ophthalmics. iTEAR 100 received Food and Drug Administration clearance under the de novo pathway in 2020. It’s based on technology similar to what’s been used successfully in cardiology, orthopedics, pain management, and other therapeutic areas: electrical pulses stimulate the external nasal nerve, which prompts tear production.

Dr. Gertner and team are currently conducting a post-market study in patients with previously undiagnosed dry eye, using iTEAR 100 as a first-line treatment. The second generation of the device, which he says will be submitted to the FDA “shortly,” connects to a smartphone app, which allows for easier prescription management.

Listen to the podcast today to hear Dr. Gertner and host Paul Karpecki, OD, FAAO, talk in depth about iTEAR 100, its path to clearance, and why Dr. Gertner shifted his career from general surgeon to eye care innovator.

Ground they cover includes:

  • The hurdles Olympic Ophthalmics overcame when obtaining market access, including a 30-day prescription restriction and COVID-19–related supply chain issues.
  • Gertner’s career trajectory, which took him from medicine to medical devices (he is the first inventor on more than 200 patents).
  • How Allergan’s TruTear device, which it discontinued in 2020, influenced his work.