Pathways to market for medical devices

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You’ve got a great idea for a new medical device. After you’ve created the device and proved its usefulness in a clinical setting—a challenge in itself—the next step is getting your device to a commercial partner who can mass-produce and market it. Working through all of the regulatory hurdles, projecting the market for your product and figuring out your product’s long term potential can seem overwhelming.

“The more you know, the more prepared you will be,” says Pedro del Nido, MD, chair of the Department of Cardiac Surgery at Boston Children’s Hospital and principal investigator on the FDA-funded Boston Pediatric Device Consortium. “The more prepared you are, the more likely you will be successful.”

On January 6, 2015, from 5:30 to 7:30 p.m., del Nido will lead a panel discussion at Boston Children’s about moving medical devices from idea to commercial partnership, co-sponsored by Boston Children’s Technology and Innovation Development Office and the Innovation Acceleration Program. The panelists represent large corporations, entrepreneurs and start-ups, and investors:

• Ibraheem Badejo, PhD—Director, New Ventures, Johnson & Johnson Innovations
• Maria Berkman, MD, MBA—Broadview Ventures
• Kurt Dasse, PhD—President and CEO, GeNO, LLC
• Ron Lancaster—Director, Corporate Research, Boston Scientific

As reflected by the panelists, del Nido breaks down the three main pathways to market for a new medical device:

Large corporations (like Johnson & Johnson and Boston Scientific) tend to be parent companies to smaller, more specialized companies that focus on one type of new technology. They rarely invest in pediatric medical devices, because the market is so small, and prefer to wait for proof of a viable market. If they are interested, it may be integrate the technology into one of their own projects. It is very important to have these discussions up front, says del Nido.

Venture investors (like Berkman) look at original ideas that could form the basis of a new or existing startup company. They may have a lot of money to invest, but they will also want a large return (owning a significant portion of the profits, for example). Different investors have different strategies and preferences regarding when to invest: Some want to build and manage the team at an early stage, while others prefer to invest in something more established.

Start-ups and mid-size companies (like the ones Dasse, an accomplished entrepreneur, has made a career of creating) can be a safer alternative to larger corporations if your device has a smaller potential audience. You can also form your own start-up. Del Nido and his team in the Cardiac Surgery Research Lab have chosen this route for their new device, the Cardioport, and its partner device, a patch to close atrial septal defects. “Nine out of ten start-ups don’t make it,” warns del Nido. “You just need to know what you’re getting into.”

Inventors are not restricted to just one of these channels, del Nido notes. A hybrid approach can also be an effective route to market. “You could create a start-up to demonstrate a device’s viability and generate interest from a larger company,” says del Nido. “Then you could sell your device to that larger company.”

Del Nido notes that the FDA and the National Institutes of Health have proclaimed an interest in pediatric devices and are attempting to “push more of them to market.” Boston Children’s has partnered with these agencies for funding to develop child-specific instruments for heart surgery and other applications.

Though navigating the regulatory and distribution processes requires some business savvy, del Nido declares, “Anyone can be an innovator.”

The forum, free and open to the public, will take place at Boston Children’s Folkman Auditorium (Enders Building, 320 Longwood Avenue, Boston). It can also be viewed online via ConnectPro at https://meeting.childrens.harvard.edu/if/.

To RSVP, please e-mail tido@childrens.harvard.edu