Getting a New Medical Device Off the Ground

Aardvark’s inspectors can work faster and deliver easier-to-understand results thanks to a software upgrade provided by Ventures.

Bringing a new medical device to market involves much more than having a good idea. Does the product infringe on existing patents? Can it clear regulatory hurdles? Can it be economically mass produced? With the explosive growth of the life sciences industry in Indiana, answering these questions has become increasingly important.

Rose-Hulman Ventures, 316 Product Development and GMI Corporation all specialize in helping entrepreneurs and companies launch new products – often medical devices and equipment. Leaders from these organizations shared their insights at an October, 2017 meeting of the Indiana Health Industries Forum, a trade association representing the state’s life sciences industry.

At Ventures, the earliest steps of medical device design involve asking clients a lot of questions, says Elizabeth Hagerman, vice president of corporate engagement for Rose-Hulman Institute of Technology.

“Asking questions about what they’re trying to achieve can change the whole game,” she says, adding that her experience shows there is often a significant gap between a client’s initial idea and a final working prototype.

It’s also important for clients to keep an open mind about the design process, says Greg Ottinger, vice president of business development at GMI Corporation, an Indianapolis-based contract manufacturer of electro-mechanical devices. When clients come to GMI with complete plans already in place, “that’s a red flag,” he says, adding that GMI prefers to do its own assessment of a new product to ensure there are no hidden problems that will delay or prevent a smooth product launch.

Jake Flagle, president and founder of 316 Product Development, an engineering consulting firm, stresses the importance of talking to all potential users of a proposed device – from doctors and technicians to delivery handlers and those who toss the device away after it has been used – during the design phase. This, along with a thorough understanding of competing products, gives you the full picture you need to create the best possible device, he says.

The forum also stressed the importance of being aware of regulatory requirements and communicating frequently with clients to avoid surprises on delivery day.

Ottinger and Flagle, both Rose-Hulman alumni, also have professional experience as Ventures clients. Flagle worked with Ventures when he was an engineer for Hologic, a Massachusetts-based medical device company. Ottinger, a 1985 mechanical engineering graduate, has hired former interns and continues to work closely with Ventures through Hologic and NICO, an Indianapolis-based maker of brain surgery equipment.

Kristin Jones, president and CEO of IHIF and moderator of the October panel, says the discussion also cast light on the role Rose-Hulman plays in Indiana’s $63-billion life sciences industry. Ventures has helped develop numerous medical devices, including a minimally invasive brain tumor removal system for NICO, a heart health-monitoring device for Arrhythmotech, a system for preventing potentially dangerous drug interactions for Sano Informed Prescribing and medical devices for improved skin biopsies and wound irrigation for doctors at Indiana University, to name a few. Additionally, Rose-Hulman graduates continue to fill leadership positions in the industry in Indiana and around the world.

“Rose-Hulman students come out of there with such good applied industry experience that you don’t see at other universities,” Jones says. “They can really get in there and help people.”