The business model for medical device startups is said to be in jeopardy, and it’s the topic du jour at conferences everywhere, as entrepreneurs are complaining bitterly about arbitrary FDA regulators and tight-fisted insurers. Much of this industry’s spirit of innovation and entrepreneurship is migrating overseas, it is often said.
Yesterday, I heard all that and more when I stopped by a conference that featured a couple of big names—Beckie Robertson, a veteran med device investor and managing director with Menlo Park, CA-based Versant Ventures, and Rob Michiels, the former president of CoreValve, the Irvine, CA-based maker of an aortic valve device that was acquired by Medtronic for $700 million two years ago. These two talked about the pros and cons of commercializing new medical technologies overseas first, at a conference in Bothell, WA organized by the Washington Biotechnology & Biomedical Association.
One of Robertson’s slides in particular caught my attention, about four new business models she sees in which entrepreneurs can find a way forward during this turbulent stretch for medical device companies. Here are thumbnail sketches of the models she described:
1. Non-regulated medical technology. This is pretty much an end-run around the FDA, which determines which medical devices are fit for sale in the U.S. But not every piece of equipment that helps people is actually a medical device. One example Robertson cited, which Versant invested in, is a Fremont, CA-based company called Alter-G. It makes a treadmill that reduces pressure on joints of people who are undergoing rehab from knee or hip surgery. This treadmill works for people who are struggling to regain their balance, which also makes it useful for, say, Parkinson’s patients who are trying to regain strength. While this isn’t really a medical device that falls under regulatory purview, it is having a “tremendous impact” on patients, Robertson says. She adds: “We’ll continue to see more companies fit this category.”
2. “Small ball” med device companies. These are the kind of companies that don’t really require the deep pockets of venture capitalists, and therefore, can provide pretty successful returns for entrepreneurs who achieve an otherwise modest-looking acquisition. It usually involves a passionate engineer, paired up with a physician who really understands the needs of patients, Robertson said. One recent example she cited was Ross Creek Medical, a company that developed an implant for shoulder surgeries. The device required less than $10 million to develop and the company was ultimately sold to a large buyer—she didn’t say who—for $35 million. It was “a very nice outcome,” Robertson said. “These kinds of businesses have been historically overlooked,” she said. She added: “In this marketplace, you either need to think very big, or very small and incremental, or go home,” she said.
One more example of “small ball” medical devices I’ve seen lately in Seattle—Mirador Biomedical, which raised a little over $1 million and won FDA approval for
