Fostering Medical Innovation in the Clinical Setting: Piedmont Innovations & GCMI

Who better to address unmet clinical needs and life-changing improvements to medical devices of all types than clinicians themselves? Piedmont Healthcare and GCMI embark on a journey to create a self-sustaining innovation enterprise: concept to commercialization.

All I.J. was trying to do was celebrate a friend’s wedding at the beach. Just 10 feet from the sidewalk, I.J. and her wheelchair got stuck in the sand. For three hours. No one could hear her calls for help. So there she sat, stranded.

“I.J. told us first, foremost and repeatedly, ‘I don’t want to always be asking for help no matter where I need or want to go,’” says Patrick Strane, Program Manager at The Global Center for Medical Innovation (GCMI). “While highly specialized wheelchairs for athletic use including the beach have existed for years, I.J. identified the need for an accessory item that enables users of the most common type of wheelchairs (80 percent of the market) to extricate themselves from situations like the one in which I.J. found herself. This is particularly important for users who unexpectedly, yet temporarily, find themselves in a wheelchair and are novice users.”

Patrick Strane

How many people haven’t ever enjoyed a walk on the beach because their mobility devices literally cannot “go” there? How many others have been stranded when their wheelchair enters a condition from which they can’t extricate themselves? Whatever the number, the answer is too many.

The Piedmont Innovation Center is doing something about it through a partnership with GCMI. Launched in 2016, the Piedmont Innovation Center intends to change the way healthcare is delivered by advancing medical technology and investing time and resources into physician innovators.

“Piedmont Healthcare wanted to provide a pathway for our staff to develop their medical device ideas,” says John Henson, Piedmont Healthcare Chief of Oncology Services. “Initially we knew we would need a partner to help us successfully navigate the process, concept to commercialization. We found that partner in GCMI.”

Dr. Jayne Morgan, MD

According to Dr. Jayne Morgan, Director of Cardiovascular Research for Piedmont Heart Institute, the entire Piedmont staff is encouraged to pitch their ideas. One winner is funded each year via Piedmont; GCMI provides the project management and infrastructure.

A mobility solution inspired by I.J.’s unmet need was the first project selected for the Piedmont / GCMI development process.

“We all tried to walk a mile in I.J.’s shoes,” says Mike Fisher, GCMI director of product development. “With the help of I.J.’s physician Dr. Catherine Woodhouse, MD, a practicing specialist with Piedmont Internal Medicine, five members of the GCMI project team spent a week in a wheelchair just like hers. We all felt her pain, literally and figuratively. Our shoulders ached when we got stuck trying to access places off the beaten path, a luxury so many take for granted.”

“Through the Piedmont Innovation Center, our clinicians can conceptualize new devices and solutions that have the potential to transform medicine here in Atlanta and all over the world once they’ve come to fruition,” said Dr. Charles Brown, III, chief medical officer of the physician enterprise, Piedmont Healthcare. “With the resources and support services available [through GCMI], clinicians will have all the tools they need to bring their idea from concept to market.”

How does GCMI best meet Piedmont Innovation’s needs?

According to Piedmont Healthcare, the GCMI partnership allows physicians, nurses and technicians with an interest in technological innovation and entrepreneurship to bring new, potentially life-saving ideas to life through the Piedmont Innovation Center. GCMI works with clinicians at Piedmont to facilitate education, design, engineering and prototyping, as well as general medical device commercialization.

“One of GCMI’s top capabilities lies in their ability to support new medical device prototyping within their Midtown Atlanta facility,” says Henson. “They provide the design, development and commercialization pathway expertise required to determine if something has enough value potential to foster through to the next waypoint. Mike [Fisher] and Patrick are highly responsive, highly accountable and as passionate about these projects as we are.”

Dr. John Henson, MD

“Healthcare organizations across the country are trying to commercialize good ideas coming out of the hospital setting from levels of one project per year up to some with programs robust enough to warrant partnerships with venture capital groups,” Henson says. “We wanted to to do the same. With GCMI we are now investing in a pathway for the development of innovation and commercialization. This has been a great advancement for our organization.”

Early results and next steps

“I think the process we follow has helped refine Piedmont’s efforts, resulting in positive traction gained in IP protection, designing for manufacturability, prototyping and now testing,” Patrick says. “The process has helped Dr. Woodhouse, Piedmont Innovation and the GCMI team progress in a way not previously seen. It has reignited the passion for the project, which is now getting feedback from more than 100 different users.”

“If we are able to fund something to commercialization and bring that revenue back to the hospital system and fund other projects, that will improve not only employee engagement but also provide a source of revenue for the hospital,” says Dr. Morgan. “This will give the Piedmont Innovation Center a solid chance to be self sustaining: creating revenue, not just consuming it.”

“Typically new medical devices take a minimum of five years to achieve commercialization and begin to generate revenue,” Henson says. “Getting to the big goal will take time and we are taking a long view. Because our ownership and equity numbers with our hospital innovators are very generous we hope to encourage more staff to get involved.”

Converting clinical ideas into clinical and commercial reality

Clinicians with novel ideas for new, or significantly improved devices rarely understand the complexity of taking an invention or an initial prototype and turning that into a regulated product. There is usually a lot of education and discussion around that process.

“Front line clinicians are uniquely qualified to identify unmet needs be it an IV start kit, a wheelchair, or CardioMEMS HF system to improve the quality of life and outcomes,” says Tiffany Wilson, CEO of GCMI and T3 Labs. “But the IP discovery and protection, addressable market assessment, efficiency in design (including controls and quality systems, ‘manufacturability’ and design history file requirements), prototyping and eventually testing on the path to FDA approval are insurmountable without the right team. Meeting unmet needs in the medical device innovation process, concept to commercialization, is where GCMI delivers value for our partners including, and especially, our hometown heroes at Piedmont Healthcare.”

Are you a physician, engineer or startup with an idea for a new medical technology? Contact GCMI today to connect with experts across the medical device ecosystem who can provide the guidance you need to advance your product’s journey from concept through commercialization. Email info@devices.net.