Marketplace more challenging than regulatory approval for new medical devices

SAN DIEGO — Medical devices have a solid track record of approval. Risk for failure comes afterward, when the devices go to market, according to speakers on a panel dedicated to the ophthalmology innovation cycle.

“Where medical devices run into tough times is when you have to go and sell it,” Andy Corley, a principal for Yelroc Consulting, said at the Ophthalmology Innovation Summit at ASCRS here.

Because numbers “always look better on paper,” one has to maintain a balance between “optimism, realism and fantasy,” making sure to deliver a financial forecast that is achievable, Corley said.

Corneal inlays are an example in the ophthalmology space of a device that went through the whole development process, but are “struggling” in the ophthalmology marketplace, Tom Frinzi, worldwide president, surgical, Johnson & Johnson Vision, said.

“Most companies underestimate the challenge when you move from a clinical phase to a commercial phase,” Frinzi said.

A product that is ready for commercialization needs to be able to “live in the market,” but anticipating that survivability is challenging, Jag Dosanjh, senior vice president, U.S. Eye Care, Allergan, said.

“On the drug side, there’s no doubt that the scale’s higher, costs are higher, and the timeline is often longer,” Dosanjh said. “An idea that is 7 years from launch sounds great, but what will the market look like in 7 years’ time?”

“When you’re sitting in the office, anything is possible,” Corley said. However, start-ups and early stage companies should keep “a commercial person on board all along the way to keep a reality check in the organization.” – by Patricia Nale, ELS

Reference: Ophthalmology innovation cycle panel discussion. Presented at: OIS@ASCRS; May 2, 2019; San Diego.

Disclosure: Corley is a principal for Yelroc Consulting. Dosanjh is senior vice president, U.S. Eye Care, Allergan. Frinzi is worldwide president, surgical, Johnson & Johnson Vision.