How companies create ‘disruptive’ medical devices

por Lisa Chamoff, Contributing Reporter | June 14, 2018
Business Affairs Medical Devices
An important first step in medical device design is going into the operating room and watching surgical procedures.

Four panelists discussing the “Secrets of Disruptive Medical Device Design” at MD&M East in New York City this week all used clinical observation as the foundation of their designs.

Kevin Fitzgerald, senior R&D manager at Medtronic, said observation is also good for looking at how doctors use the product you’re looking to replace, but there is a challenge in creating something that currently doesn’t exist.

“The way we manage that is still to see how the surgeons and the staff operate, and their environment, with the tools they currently have, and then really try and focus our observations and open-ended questions on ‘What do you need that you don’t have today?’” Fitzgerald said. “And then at the right time, we start introducing some of these concepts to them and have them hold it, use it in a prototype lab to make sure that we’re on the right path.”

Fitzgerald noted it was important to not direct clinicians on how to use devices and software.

“It can be very awkward, but it’s essential to make sure that you’re actually developing something that they’re going to use in their natural environment where they don’t have a coach in the background,” Fitzgerald said.

Olivier Richart, president and chief executive officer of Selenium Medical, said he has designers go outside of healthcare environments – to the grocery store or even makeup counters – to observe how everyday consumers interact with and use products.

There is a challenge in determining what clinicians really want, the panelists noted. Ken Horton, director of research and development at Medtronic, said it’s the company’s obligation to tease ideas out of customers and find out what’s at the root of their comments.

“It’s incumbent upon all of us to reach back to these folks to ask questions and to truly understand what the drivers of these statements are,” Horton said.

It can also be tricky to validate ideas that are truly disruptive.

Matt Miller, lead industrial designer at Ethicon, a Johnson & Johnson company, said his team tries to create prototypes early, using virtual reality tools or less expensive 3D printed parts, so if they fail, they can quickly get on the right track or move on to the next idea.

“It’s not always really easy to understand how disruptive it’s going to be or if they really like it that next day, until you get through multiple iterations,” Miller said. “I think you can keep building to get closer to that finalized design.”

Richart also spoke about the importance of having employees with diverse backgrounds and experiences so that they can bring something unique to the table.

“I guess I have one or two project managers coming from the medical business,” Richart said. “They are all coming from different things because I have this medical business background. We know the FDA, we know the European Union regulations, so we can give them the tips and tricks to get through the regulatory process.”

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