MedicalDesign&Outsourcing MedicalDesign&Outsourcing

Bill Betten has developed medical devices for decades, but he gained a deeper understanding after hearing a doctor speak the words "brain" and "tumor."

"It's a little different when it's going to be done to you," Betten recalled today during Medical Design & Outsourcing's latest podcast. (Hear more from Betten as editor Chris Newmarker interviews him at DeviceTalks Minnesota, Sept. 9–10 in Minneapolis. Go to minnesota.devicetalks.com and use the code “25OFF” to save 25% on the cost of registration.)

Betten's tumor, fortunately, was a benign meningioma, and he's presently four and a half months into a successful recovery from surgery. Now that he's past the health emergency, there are insights about medical devices that he once knew that he now feels to his core.

Hear more of Betten's insights in MDO's latest podcast, and find out more next week at DeviceTalks Minnesota.

FDA recently reported a startling fact: Most of the pediatric medical devices approved in fiscal 2017 were originally intended for adults. 

Health providers, especially in NICUs, are continually altering devices in order to do all they can to save infants and children, but the situation is not ideal, Michael Drues, a regulatory consultant based in Southern California, recently told Medical Design & Outsourcing in its latest podcast. Simply put, children grow; adults don't. 

"Clearly there needs to be more incentives. ... But I'd like to put the impetus on industry as well," Drues said. 

Drues suspects the trend toward personalized medicine will help. "Personalized medicine applies to people across the board. Whether they're 8 days old, or 8 months old, or 8 years old or 80 years old, it doesn't make any difference." 

Listen to Drues as he outlines some strategies to get a pediatric device to market faster.

Artificial intelligence presents a whole host of regulatory challenges when it comes to medical devices. 

Regulatory consultant Mike Drues says he has had clients forced to dumb down their AI technology, with U.S. FDA requiring they lock the algorithm. Drues sees locking the machine learning algorithm is a Band-Aid solution — not a longterm fix.

Drues offered some ideas about how to better regulate AI in medical devices during Medical Design & Outsourcing's latest podcast.

FDA in the U.S. is in the process of setting up a formal way for medical device companies to get nonbinding feedback about Form 483s, in which agency inspectors raise potential manufacturing process problems.

The proposed process actually standardizes what some in the industry have been doing for a long time: seeking nonbinding feedback from FDA about inspection results and proposed solutions, in the same way a company might hold a presubmission meeting, according to Mike Drues, a Southern California–based regulatory consultant who has worked with both companies and FDA.

Drues discussed the draft guidance during his latest podcast appearance with Medical Design & Outsourcing.

Demand is increasing for at-home digital health systems, where sensors follow people's health data and automatically turn them into real-time insights for themselves and their health providers. 

From ResMed and its connected CPAP technology to Clarify Medical getting user feedback for its light therapy system for skin conditions, medical device companies have started to score successes in at-home digital health, according to Scott Thielman, CTO of Product Creation Studio (Seattle). 

"We really need to focus on cultivating user experience — a great user experience that will be sticky, that will overcome the downsides of having to live with whatever this technology is in their lives. There's design work there to be done that we really need to lean in to and focus on to keep these innovations successful," Thielman said during Medical Design & Outsourcing's latest podcast.

The medical device industry has been taking a lot of heat lately when it comes to patient safety.

There's the recent International Consortium of Investigative Journalists' "Implant Files" report, as well as the documentary "Bleeding Edge" on Netflix. Both paint a picture of lax medical device regulation resulting in patients exposed to poorly tested implants.

Veteran regulatory consultant Michael Drues thinks the problems outlined in the reports echo concerns going all the way back to when the FDA started regulating medical devices in 1976.

They raise similar questions, too. "What do we do to prevent them? How do we prevent more from happening?" Drues said during his newest podcast with Medical Design & Outsourcing.