Mastering the Medtech Exit: The Truth From Those Who’ve Done It
Hit Up the FDA ASAP
With over 30 years of industry experience, Bruce Shook, the former CEO of Vesper Medical and Intact Vascular, both of which exited to Philips, emphasizes the importance of engaging with the FDA early on. Utilize the Q-Sub process to outline the in-vitro, in-vivo, and clinical requirements you’ll need to meet in order to reach your next major milestone.
Know Your Clinical Endpoints
You won’t find many people with more hands-on medtech experience than Dr. Scott Wolf, the entrepreneur and investor who founded Aerin Medical and ZELTIQ Aesthetics, the maker of CoolSculpting. Scott urges entrepreneurs to be thoughtful and careful about defining clinical and regulatory endpoints. They are more than simply the components that allow you to achieve FDA clearance or approval; they also need to be the things patients and physicians care about most.
It’s All About the Early Wins
Startup entrepreneur extraordinaire Mike Wallace is the co-founder and CEO of Devoro Medical, an early-stage medical device company focused on peripheral thrombectomy, which exited to Boston Scientific.
Mike’s wisdom? Budding entrepreneurs should score early wins with short-duration 510(k) products before graduating to PMAs. Go after the latter once you know you have the patience and the passion to pursue longer-duration projects. Even under ideal circumstances, success in medtech requires stubborn, unrelenting focus and drive, so be strategic when committing to new projects.
Size Matters, But Bigger Isn’t Always Better
Garheng Kong is the innovative founder and Managing Partner of HealthQuest Capital, a private asset firm focused on providing growth capital to companies transforming the healthcare industry. Garheng sees up to 1,000 investment opportunities in any given year, so he understands what it takes to attract the right investors.
Garheng emphasizes that when it comes to syndication, bigger is not always better. Two or three syndicate investors is a good number; anything beyond that can be problematic. Maintaining a small number of investors helps to ensure everyone’s voice can be heard.
Hiring Top Talent Goes a Long Way
Bob Paulson is the CEO of Sonex Health and former CEO of NxThera, which sold to Boston Scientific. He emphasizes the importance of surrounding yourself with the strongest team possible.
Build a great team. Look specifically for people who have “been there and done that” in your space. Developing a solid group of people with relevant experience in your specific regulatory, clinical, commercial, and reimbursement pathways is essential when creating a startup that others will want to acquire.
Build It and They Will Come
Robert Kline is the Chairman of ThermoTek and has exited multiple medtech companies over the last decade to strategics such as Hologic and Becton Dickinson. He encourages entrepreneurs to look beyond the exit, creating a commercially viable product with a measurable market impact.
So many individual factors have to line up perfectly for an exit to work out; securing regulatory approval isn’t necessarily the finish line. Build a self-sustaining business and the investors will come.
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