Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development

3D printing can impact new product development and manufacturing. It’s a technology that is hot in many different industries, including medical device development. It’s been around for several decades, and now more than 85 devices are on the market that have been 3D printed, including a 3D-printed medication. While it’s not a new technology, there are new guidance considerations from the FDA on this subject. Mike Drues, President of Vascular Sciences, works with overseeing organizations including Health Canada and the FDA and helps people in the medical device industry navigate regulations. He’s worked with 3D printing for a long time, and he has a lot of valuable insight to share. Some of the topics that you’ll hear about on today’s episode include: ● Why 3D printing matters from an FDA standpoint ● Some of the advantages of 3D printing, and how it relates to personalized medicine. ● Some of the potential ramifications of hospitals and other medical providers becoming “medical device manufacturers” by using 3D printing on-site. ● A few common criticisms of 3D printing, along with Mike’s observations on how they can or will be overcome. ● Examples of real-world ways that 3D printing is being used currently. ● Tips for those who are considering using 3D printing technology for creating medical devices.