Stuart Randle, president and CEO of Lexington-based GI Dynamics, has a long career in medical devices under his belt. Originally a mechanical engineer with a degree from Cornell University, Randle got into the device world during his MBA studies at Northwestern University and never looked back.
Before joining GI Dynamics, which recently released positive results from a small pilot study of its Endobarrier system that showed significant weight loss in morbidly obese patients, Randle put in stints at ACT Medical Inc. (where he was president and CEO), Allegiance healthcare Corp. (where he helped engineer a spinoff from Baxter) and a 10-year tenure at Baxter in a variety of management positions.
We talked with Randle about the latest news on GI Dynamics’ innovative new device, a plastic gut liner and flow restrictor combination that restricts the passage of food from the stomach to the intestine and prevents its absorption in the gut; managing the day-to-day stresses of running a startup; and what the medical device industry might look like in 20 years.
MassDevice: You’ve said that the opportunity to build GI Dynamics from the ground up was very appealing to you. What made it a good bet and a good fit for you personally?
Stuart Randle: What made it a good bet was that it’s a technology that has the potential to solve enormous clinical problems for which there are not great solutions.
One of the things that’s unique about it is its multiple potential indications, meaning it’s a platform from which we could address obesity and weight as well as Type 2 diabetes and could think about tailoring it for specific sub-sets within those two vast patient populations.
MassDevice: how do you manage what you’ve termed the “massive emotional fluctuations” inherent in helming a startup?
SR: I’m partially blessed with good genes, in that by nature I’m a pretty even-keeled person. I kind of accept the fact that there are going to be very, very good days and some pretty bad days. It’s important as the leader of an organization that you put your best face forward.
MassDevice: What drew you into medical devices in the first place?
SR: I was at graduate school at Northwestern in Chicago [Ed.’s note: Randle has an MBA degree from the Kellogg Graduate School of Management at Northwestern University]. One of the reasons I went back to graduate school was to examine technologies. I wanted to put some technical skills to work, so why not work in a field where you can really help people? I had a summer job at Baxter during graduate school and that kind of led me into the medical device sphere.
MassDevice: You’ve had some positive results from clinical trials. Are there other studies underway and what’s the estimated timetable for putting before the FDA for approval?
SR: We have other studies under way, one weight loss and one diabetes study in South America, and we anticipate a diabetes study in Europe later this year.
At the same time we’re in conversations with the FDA and other regulatory agencies around the world and we generally don’t comment about timing.
We’ve spent more time in Europe, quite frankly. We’re working in Europe right now with physicians and consultants in various countries where we want to initially commercialize.
MassDevice: Where do you see the next generation of innovation in bariatrics?
SR: I think the next generation is actually going to be combinations of things. Lee Kaplan, a physician at Mass. General Hospital, has said that a gastric bypass procedure is actually five different operations and the reason it’s so effective is it’s five different mechanisms of action at work. I think the next generation of technologies is going to be combinations of devices, combinations of drugs and combinations of devices and drugs, all focused on effecting multiple mechanisms of action simultaneously — and less invasively than surgery.
MassDevice: What’s the biggest leadership lesson you’ve learned, and how and where did you learn it?
{IMAGELEFT:http://www.massdevice.com/sites/default/wp-content/uploads/headshots/Randle_Stuart_100x100.jpg}SR: It goes back to dealing with bad days and how you put that good face forward. At one of the earlier organizations I ran at Baxter, I had a few hundred people working for me and I used to have a breakfast with randomly selected people. At one of those breakfasts, someone said to me, ‘When you’re in a bad mood, we know it between the time you enter the door and get to your desk.’ Part of leading is always trying to be very, very positive and trying to project the opportunities and the positive things we’re doing every day.
MassDevice: What strategies and tactics have you adopted to deal with the economic downturn?
SR: As a venture-backed company, having capital is of increasing importance. Right now the ability to get new capital is exceedingly difficult and therefore making sure one has sufficient capital and continuing to look for capital is very important right now — and certainly more important than it has been since we started the company.
MassDevice: We’re in a period of great flux in the medical industry. What do you think the medical device business will look like in 20 years?
SR: Twenty years is a very, very long time, given the rate of the advances in this industry. In 20 years it will be increasingly robust. You’ll see a lot more technology in use around the world at a lower cost and more integration between drugs and devices. The reason I think it’s going to be really robust is, take nanotechnology as an example. As that becomes more usable in the device industry, you’ll be able to provide much better therapy at a much lower cost. And 20 years from now, lower cost is going to be exceedingly important.
MassDevice: In your view, what’s the biggest challenge confronting the devices industry, and how should the industry respond?
SR: They get an undeserved rap for the cost of new technology. The cost savings that come from that new technology aren’t often taken into account. It’s not as bad as pharma, but they do get a bit of a bad rap. Some of this new technology that will wind its way into the devices industry will allow for advances that will significantly lower their cost and allow for application to a much broader patient population.
MassDevice: How will the rising prevalence of gift bans affect the selling of medical devices?
SR: That’s going to play out a little bit. The pendulum has swung from one extreme to the other extreme. In the device world, historically there has been very, very close collaboration with physicians, which I would argue is necessary for the development of new technologies. I think some of the new legislation has gone a little too far and I think it will come back.
It’s going to play out, but it’s hard to envision a scenario in which practicing physicians don’t play a role in the development of new medical devices. There will be more people looking at the actual roles that physicians play. What are the different roles they play in the development of drugs and devices? There won’t be one single set of rules for all physicians dealing with all companies.
MassDevice: When you’re building a team today, what areas do you put the most energy into?
SR: You want to get the best team you can. The thing is that timing of the needs varies.
Initially, we needed an outstanding technology team, then an outstanding clinical team, then an outstanding manufacturing and quality systems team. With a small company, it’s always very, very important to get the best people you can get. Our tack has always been to try to get the best people we need shortly before we need them, but with enough time for them to get in and learn what they need to know.