DeviceTalks: Minnesota reveals the highs and lows of innovation

By Scott Wooldridge Last night’s DeviceTalks: Minnesota event in Minneapolis highlighted the risks and rewards of medical device entrepreneurship, contrasting the arcs of Kips Bay Medical (OTC:KIPS) and Aum Cardiovascular. Kips Bay founder & CEO Manny Villafaña, the medtech legend who started Guidant and St. Jude Medical (NYSE:STJ), told MassDevice.com publisher Brian Johnson that the company’s wind-down was precipitated by a tough financial landscape and regulatory environment. Villafaña this week stepped down as CEO, and the company’s shareholders and board have approved its dissolution plan. “I just spent 8 years in development of what I feel is a great technology, but I didn’t anticipate the regulatory path would be so difficult,” Villafaña said. “The FDA kept requiring more and more. And every time they raise the bar on you, that’s another $10 million to $15 million.” Part of the problem, he said, was that the company started in 2008, when it was very difficult to come up with capital due to the recession. “We raised some money, but it wasn’t enough,” he said. Villafaña said the Kips Bay setback was difficult, but he’s already working on founding a new venture. Villafaña “I’m not ready to retire; I love what I do and I still have the energy,” he said. He told the story of watching a heart transplant at a hospital in Spain, and seeing the old heart sitting o...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Food & Drug Administration (FDA) Funding Roundup AUM Cardiovascular DeviceTalks Kips Bay Medical Inc. Source Type: news