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The secret to FDA approval, and other insights, from a med tech CEO

on May 14, 2013

At the MedTech Investing Conference in Minneapolis last week, one panel discussion focused on alternative clinical and product development models. The panelists included Lisa Earnhardt, president and CEO of Intersect ENT, a venture-backed medical device company that develops treatment alternatives for ear, nose, and throat surgeons and patients. The company has two FDA-approved devices, including the Propel steroid-releasing implant, which offers localized, controlled drug delivery for chronic sinusitis patients.

After the panel, eMed caught up with Earnhardt for an interview. She shared tips on finding your customer, working with physicians, and collaborating with the FDA.

Figure out who your customer is – It used to be that the physician was the primary user of medical products, Earnhardt said. “But now,” she said, “you have to think more expansively about who are the stakeholders in the decision-making process.” Obviously, the physician remains important, Earnhardt said, but entrepreneurs should also consider the health care economic side of the equation. This could include hospital administration, payers, and patients. “It’s a much more complex set of considerations today,” Earnhardt said.

Work with physicians the right way – Entrepreneurs should involve physicians in their efforts early and often, Earnhardt said. These physicians should be able to advise entrepreneurs not just on product design, she said, but on strategy and other efforts. And they should be willing to go to the payer on behalf of the entrepreneur. It’s important for entrepreneurs to have a mix of academic physicians and private practice physicians in their arsenal, Earnhardt said. That’s because it’s important to make sure your technology fits a range of needs. Entrepreneurs can find these physician partners by attending physician meetings and seeking out key opinion leaders, Earnhardt said. “You end up being long-term partners,” she added.

Collaborate with the FDA – Getting approval from the U.S. Food and Drug Administration is a long process, Earnhardt said. But one way to make it easier is to foster a collaborative relationship with the FDA, she said. “Too many companies try to avoid [the FDA] at all costs,” Earnhardt said. Instead, it’s better to engage with them. Also, Earnhardt added, seek counsel from various regulatory consultants during the process. After all, she said, the process is an art, not a science.

Keep the faith – Never lose the initial passion and determination you felt for your company, Earnhardt said. Life science and digital health entrepreneurs in the United States are making great strides for patients, she said. And it’s the responsibility of these entrepreneurs to keep the faith in their efforts for the good of patients.

Category:  Ideation  Tags:  Entrepreneur, Intersect ENT, Company Profiles

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