Medical device panel outlines pathways to market

Physicians often dream of creating new devices to help their patients, but few are able to bring a device to market. At a panel discussion earlier this month at Boston Children’s Hospital, an entrepreneur, a venture capitalist and medical device industry experts offered advice for inventors who want to make their medical device a commercial reality. Here’s some of what they had to say.

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Ibraheem Badejo

Ibraheem Badejo, PhD, Director of New Ventures at J&J innovations, likes to think of each investment as a marriage, and makes sure to meet inventors in person. He looks into their LinkedIn profiles, runs a Google search of their names, and reads their published work. Badejo’s device development teams are a hybrid of his own personnel and the inventor’s team, so deciding whether or not the dynamics will work is extremely important.

He also advised: “If your device is a platform technology, choose one application and move it along.” In agreement was fellow panelist Kurt Dasse, PhD, President and CEO of GeNO, LLC., a biopharmaceutical company focused on pulmonary and cardiac diseases. Dasse said that platform technologies—those with numerous potential applications—are the only kind of technology that excites him. Still, he stressed that investors want to see you’ve placed a bet on one of your device’s uses and moved forward with a study.

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Maria Berkman

Maria Berkman, MD, MBA, operations manager at Broadview Ventures, says her team of venture philanthropists places a lot of emphasis on data. While it may be impossible to do a large-scale experiment with a prototype device, it is crucial to obtain some meaningful data and run a preliminary animal study.

When she’s evaluating a potential new team, Berkman looks for more than just scientific know-how: strong management is key. “We look for a team with strong leadership,” she said. She also emphasized that someone on the team ought to have a significant financial stake in the company, which demonstrates commitment.

Berkman added that it is crucial to have intellectual property protection (IP) before approaching investors. Most will not even consider your idea if you don’t have it. Before you start to think too far ahead, pursue the appropriate legal protection.

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Ron Lancaster

Ron Lancaster, Director of Corporate Research at Boston Scientific, also warns against excessive zeal. “I say this with the utmost respect,” he said, “but beware of ‘entrepreneur syndrome.’ ” When he hears a pitch for a new product, Lancaster looks for a balance between reality and enthusiasm. He also advises inventors to take a broad view of their product’s application. How is the device incorporated into the larger spectrum of care for that disease or need? Be able to vividly describe the problem, the opportunity and the solution so your potential investors will want to take that leap of faith.

Lancaster emphasized the importance of defining your involvement with the project. How much time and interest do you have? Do you foresee your company being acquired, or are you committed for the long haul? “Have an exit strategy,” he advised. That includes being ready to collaborate: “Collaboration— between academics, inventors, investors and manufacturers—is the future.”

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Kurt Dasse

Rather than make improvements to existing medical devices, look for a need that remains unmet and build a solution where there is market potential, advised Kurt Dasse, President and CEO of GeNO, LLC.

Dasse has experience creating devices and running companies, so he knows the importance of both the academic-scientist brain and the business management brain. Turning a product line into a business means establishing quality systems, manuals, documentation, and navigating the Food and Drug Administration (FDA). “Technical expertise is important every step of the way,” he said.

At the same time, inventors should keep their vision front and center. “Your business plan is not your vision,” he said. A lot of people confuse the two, but your vision should be broader than your business plan. You should always be thinking about your long-term goal and the inherent value of your medical device in the grand scheme of things.

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Pedro delNido

Medical device market trends

Panel moderator Pedro del Nido, MD, chair of the Department of Cardiac Surgery at Boston Children’s Hospital, asked the panelists what trends they are currently observing in the market for medical devices. All agreed that health IT is king. Patient monitoring devices, mobile devices and “smart” devices that link with one another are on the rise. Also popular are companion devices—devices that complement existing devices—and improved versions of common medical devices.

FDA: Friend or foe?

del Nido offered advice from his experience working with the FDA. As Dasse pointed out, the approval process for pediatric devices can take four times as long as the process for adult devices. “The FDA doesn’t see a lot of pediatric proposals,” del Nido explained, “so they approach them very conservatively. Talk to them—early—and let them know you understand their concerns.”