Fresh ideas are at the core of the medical-technology industry, but as Aidan Petrie saw during his tenure as chief innovation officer at Providence-based Ximedica LLC, even the most dazzling concepts are dependent on knowing how to navigate a highly regulated field.
Education can mean the difference between an idea that never takes off and one that makes an impact on the health care industry, experts say.
“To play in this space, you have to be pretty serious. The people that we’re working with are earnest, clever, they have incredible clinical insights, and they’re going to do well for this world, but you need guidance. You cannot go it alone,” Petrie said.
Petrie is now a managing partner at New England Medical Innovation Center, which has created a medical-technology leadership program to help guide medtech entrepreneurs through the medical-device commercialization process.
Organized in partnership with Real Jobs Rhode Island, the immersive program addresses business plans and product development, along with offering guidance on how to maintain a fundable business and how to introduce health-based technology to the market.
The innovation center crafted the series, which is free for Rhode Island residents, as a support tool for both fledgling businesses and the state’s medtech industry.
“We have developed the elements that we think are required for the program, we have pressure-tested those on investors … and have gone out to the best individuals to teach the components,” Petrie said. “We’re definitely utilizing the depth of knowledge that they have.”
Educating innovators has the potential to make a deep impact on Rhode Island’s economy, said Carol Malysz, executive director of RI Bio, a life sciences industry group whose members include Ximedica, EpiVax Inc., Amgen Inc. and the Rhode Island Quality Institute.
‘To play in this space, you have to be pretty serious.’
Aidan Petrie, New England Medical Innovation Center managing partner
Citing a 2016 Brookings Institute report titled “Rhode Island Innovates” that pinpointed medtech as a “critical segment” for economic growth, Malysz said the availability of practical knowledge is crucial.
“There is a lack of fundamental understanding about the processes required by the FDA alongside a business perspective that has been lacking, worsened by an absence of trained small-business leadership familiar with regulated product development,” she said.
Created with the expectation of success, the New England Medical Innovation Center’s program is intended to guide entrepreneurs through some of the most complex premarket steps.
“This is much deeper, much more rigorous, and more formalized than anything I’m aware of anywhere,” Petrie said. “They can achieve first funding, and then from there, have a road map that will allow them to take that concept device or digital product all the way to the Food and Drug Administration.”
Such educational opportunities can be invaluable for business ventures by people who may have extensive clinical or technological expertise but know relatively little about how to advance an idea to an exacting market, say some in the state’s medtech industry.
“I think specifically for entrepreneurs and startups it’s going to be just spectacular, because it covers a lot of aspects that [they] don’t consider when they go into business,” said Dom Messerli, CEO and president of Providence-based Lenoss Medical LLC. “I think the blind spots, the unknowns that really are the ones that NEMIC is able to point out to any startup business.”
Roberta Powell, founder and CEO of Q2Q Health, worked closely with the innovation center last fall as she was in the initial phases of starting her business. She hopes to officially launch her app at the beginning of next year. It’s designed to provide everyday consumers with information about potential drug interactions, and there’s an aggregate model to guide large companies and entities with the same information on a larger scale.
Rhode Island’s size, coupled with its academic assets, is an advantageous combination, Powell said.
“This state could be in theory a great testing ground for launching a business,” she said. “It’s so small, not only physically small but population-wise; you can kind of navigate the space easier than other larger states.”
Messerli’s company produces a disposable instrument kit paired with a biological implant used for spine surgery. The products were first used in a clinical setting last spring, and are now within a post-market clinical study. During that time, Lenoss hopes to enroll 26 patients who agree to the use of the kit and implant during their own surgeries. If all goes well, the products will see a limited release on the market.
For Messerli, a medical industry veteran, being able to access industry knowledge has resulted in numerous benefits for Lenoss, including education on fundraising and finding essential funds.
“For me it’s been a game changer just to be in the NEMIC environment,” he said.
RI Bio is now holding its own education series that will run through next March. The training, in partnership with Leadership Rhode Island and Bryant University, is designed to help companies develop their employees through better communication and problem-solving.
“The medtech field is one of innovation and change. Regulatory changes add to risk assessment and device requirements, and patient needs and expectations are continually evolving,” Malysz said. “Intense competition puts pressure on engineers to speed up product development. With all this rapid and continuous change, the need for continuing education is essential to keeping workers up to date on medical advances and their safe deployment.”
Elizabeth Graham is a PBN staff writer. Contact her at Graham@PBN.com.
