Those of us who went through the Biodesign fellowship in recent years have heard many times how ridiculous it is to start a medical device company out of the program in the current environment. When my teammate, Shreya Mehta, and I told people that we were planning to do just that with an implantable device that was going to require clinical trials, a non-trivial FDA process, and third-party reimbursement, people looked at us like we were certifiably insane. So when we first went out looking for funding for Zenflow in late 2014, we knew we were going to have to bring our A-game and cast a broad net. Having witnessed a mass exodus of investors from early-stage medtech to the seemingly greener pastures of Healthcare IT and Consumer Software, we began compiling a long list of non-traditional investors, accelerators, and grant opportunities. As I had spent some time in the software world beforehand, I was familiar with Y Combinator (YC), the accelerator that started accelerators, and the place where startup unicorns – or even decacorns like Dropbox – were supposedly born. But why would this shrine to hackers that fully embraces Marc Andreesen’s “Software is eating the world” philosophy want anything to do with a company that has a purely mechanical product and comes from an industry that is not eating the world, but rather being eaten by it? Our hopes were not high to say the least. But sure enough, right there on YC’s Requests For Startups page was a beacon of hope: “Medical devices also seem like fertile ground for startups.” So you’re telling me there’s a chance!
Being CEO is filled with challenges and lessons, and part of the job is learning along the way. Navigating the uncertainty of the burgeoning fertility field further sets the stage for many important lessons to share. At a recent SBAA tableside chat, Biodesign alumni had the opportunity to sit down and hear first-hand from Lissa Goldenstein, CEO of ARC Fertility, on the many lessons learned in her 12 years of experience as a CEO of 4 companies, both public and private. She answered questions about her path to the CEO role, the challenges of bringing a new technology to the fertility market and, in particular, her lessons on navigating the FDA clearance process.
A year ago this month, our community tragically and prematurely lost one of its greatest leaders. In honor of Ferolyn, and to keep her strong spirit of mentorship alive, we decided to revisit this blog post from 2010 [reprinted in full below]. Back then, little did I know that what we wrote would still be one of the highest-ranking hits on Google under Ferolyn’s name and that it would even be quoted in one of her obituaries. Back then, the MedTechWomen organization was in its infancy, and these Biodesign Alumni Tableside Chat events were one of the only ways for us to glean such meaningful advice from mentors like Ferolyn.
On October 28, 2015, a gathering of the Stanford Biodesign Alumni association, the current Biodesign fellows, and Women in Medtech members, was treated to a delightful fireside chat on the Neuromodulation frontier. The panelists shared a wide array of perspectives first-hand: from entrepreneurs building exciting neurostimulation products, to leaders of publicly traded companies marketing neuromodulation devices and even included the venture capital perspective on the future of this promising field of bioelectronic medicines. Hosted graciously at the T3 Advisors’ office in Palo Alto, this event was a treat for the audience who were entirely engaged in a lively discussion over cocktails.
On Monday, November 19th, Biodesign Alumni got to hear one of the most incredible turnaround stories in medtech history when Fred Khosravi, John Buckley, Greg Casciaro and Hank Plain shared the story of AccessClosure. Brought back from the brink several times (once after chance encounter in a department store checkout line) this story has the makings of a Hollywood cliffhanger and left the audience in awe.
Medical device development has been burdened lately by a high regulatory burden and an increasing uncertainty around reimbursement [1, 2]. In reaction to this, consumer medical devices with minimal regulatory burden that are mostly self-pay and self-treat, have garnered significant interest from the medical device community.
In a panel discussion moderated by Josh Makower, MD (Co-founder of Stanford Biodesign Innovation Program, Founder of ExploraMed incubator, and General Partner at New Enterprise Associates) and hosted by Wilson Sonsini Goodrich and Rosati (WSGR) and Silicon Valley Bank (SVB), the question of whether the grass is really greener was posed to a panel of four guests with diverse backgrounds that brought multiple perspectives to this question. Comprising the panel were Asha Nayak, MD (Global Medical Director at Intel Corp), Charles Wang, MD (Co-founder and COO of Lumo Bodytech), Karl Ronn (Co-founder and Board of Directors Member at Butterfly Health), and Karen Long (President and CEO at Nuelle).
You don’t have to look far to find stories of the tension that can form between a CEO and their investors. What doesn’t always get as much attention as these dramatic tales, however, are the stories where each role finds their complement in the other, providing the stability that allows a startup to fight through a sea of obstacles and ultimately achieve success. At a recent SBAA tableside chat, Biodesign alumni had the opportunity to sit down and hear firsthand of one such supportive partnership between Intersect ENT’s CEO Lisa Earnhardt and lead investor Dana Mead of KPCB. They shared with us both the highs and lows that brought Intersect ENT from an early-stage startup all the way to achieving an increasingly rare medtech IPO.