Dean Kamen poses with Johnson & Johnson Global Medical Solutions Group worldwide chairman Karen Licitra.

Photograph by Carolyn Bick

Dean Kamen is perhaps most commonly known for having invented the Segway, but he’s also invented a prosthetic robotic arm, a portable dialysis system and a robotic wheelchair that can climb stairs.

As much an advocate for children’s science education as he is a celebrity entrepreneur, Kamen is well-practiced in seeing ideas from concept to fruition. He’s given multiple talks on the TED stage and in 1989 founded the non-profit organization FIRST (For Inspiration and Recognition of Science and Technology) which aims to push kids toward careers in science.

Attending MassDevice.com’s Big 100 East 2013 conference in Waltham, Mass., this week, he took some time to talk to us about the challenges and rewards of working with medical devices, and offered some thoughts on how to maintain the U.S.’s status as a global medtech leader.

MassDevice: What’s the best thing about working in the medical device industry?

Dean Kamen: The best thing about working within the medical device industry and medical devices is that when  you get one that works, it helps people build better lives. When you build a consumer product, you’re always wondering, "Was it really worth taking the amount of time and resources and energy and environmental stuff to make this thing?"

When you make a device that gives people quality of life or dignity or the ability to go live at home, you get letters from kids – "My grandmother’s home again because of your home dialysis" – and you get letters from grandmas – "My granddaughter’s wearing your product and now she’s happy and healthy." There’s very few products that you can work on where, if it works, you know in the end it’s a big deal.

There’s lots of ways to make some kind of consumer product where you might be able to make a buck, but did you make a difference? If you make medical stuff and it works you’ve made a difference.

MassDevice: What’s the hardest thing about working in the medical device industry?

DK: Unlike consumer products, failure is not an option. You’ve got to make sure you get it right, because if your product fails it’s not like, "Oh, give them back their $39 dollars and get another 1."

If you build critical stuff, it’s got to work and it’s got to work all the time. The pressure’s always on, because it’s got to be good, it’s got to be reliable, but it’s also got to be available, you got to be done, it’s got to be affordable, you got to be able to make them, you’ve got to be able to get them approved.

It’s a tough set of bars you have to jump over because you’re dealing with people’s lives.

MassDevice: What do medical device companies need to do in order to keep global medtech superiority in the U.S.?

DK: That’s easy. If you want to maintain leadership in the world in medical devices you need to create the next generation of innovators. You’ve got to create the smartest group of passionate people that are willing to risk their time, their resources, their reputation, to work on problems that literally are a matter of life and death.

If you don’t have the best technologists with the best focus, with the best perspective, with the best confidence that it’s okay to try to reach even though sometimes you stumble, you’re not going to stay on top.

MassDevice: What does the FDA need to do in order to ensure that the U.S. maintains leadership in medical devices?

DK: The most important thing the FDA needs to do is recognize that we have the same goal. We’re partners. In order for some American that desperately needs some medical device to ever get it, 2 things have to happen: It has to be invented and it has to be approved.

If the FDA takes the position that any amount of risk is too much risk and they prevent doctors and patients from being able to take what they might think is a reasonable risk as an alternative to their condition, the product won’t be available. And if it becomes known to industry that it is so difficult to jump over the bar that they set, then a lot of great minds will go work on other projects where they can bring their products to market. It’s a lot easier to make video games than it is to make medical products.

I think the FDA has to recognize that industry is not the evil empire. Industry is there to deliver products to the public and the FDA should be there to help them do that. If the FDA and industry can work together, the American public will get better products sooner, at lower cost, than if industry and the FDA don’t trust each other or are fighting with each other. When that happens, everybody loses, and we can’t afford to lose.

MassDevice: What’s one of the biggest mistakes young companies make?

DK: I don’t think there’s just 1. I think assuming that you can easily build a new medical product and make sure it meets all of the requirements of being safe and reliable and affordable and usable is very hard to do. You need a lot of skill, a lot of experience, a lot of discipline to make it happen and if you’re looking for a shortcut, go to some other industry.

The medical device industry is a place where serious innovators spend a serious amount of time and energy to make a difference. To me it’s about the only place that’s really worth doing it.