Regulatory & Quality Perspectives of 3D Printing in the Medical Device Industry

What are the differences between 3D printing and additive manufacturing? What are the quality and regulatory considerations around 3D printing? What is FDA’s approach to whether or not this technology should be regulated?

In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences about the pros and cons of 3D printing in the medical device industry and key considerations manufacturers should make with regard to this technology. 

Some of the highlights of this episode include:

• Although additive manufacturing and 3D printing are often used interchangeably, Mike explains that 3D printing is a very broad category with at least a dozen different technologies under that category, including additive manufacturing.
• FDA describes 3D printing as, “a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete.”
• Classic or traditional manufacturing is more subtractive than additive. What if the intended patient population is for one person, can a clinical trial be performed for validation? Additive manufacturing poses regulatory and quality challenges.
• FDA has sought input from the medical device industry, manufacturers, healthcare providers and facilities to explore appropriate regulatory approaches for Point-of-Care (PoC) 3D printing of medical devices.
• For example, Mike discusses that the regulation of today was not intended for 3D printing face masks and other protective gear. The lack of regulation should not hold back manufacturers from getting products on the market and through FDA.
• FDA, as well as Mike, recommends software certification for people using 3D printing in a controlled environment to make safe and effective products.

Memorable quotes from this episode:

“There’s been now about 100, a little more, medical devices that have come through the FDA onto the market that have been 3D printed.” Mike Drues

“The phrase, ‘additive manufacturing,’ comes from the fact that many of these technologies, certainly not all, but many of them are based on layer-by-layer-by-layer technology.” Mike Drues

“Additive manufacturing is 3D printing, but not all 3D printing is additive manufacturing.” Jon Speer

“There’s two ways you can do a validation. One way is to validate the product. The way we do clinical trials today is we essentially validate the product, but the other way we can do a validation is to validate the process.” Mike Drues

“The blending of tech and med device, it’s scary on one hand, but it can be exciting, as well. I’m looking forward to seeing how this impacts and hopefully improves our health care in the world.” Jon Speer

Links:

FDA - 3D Printing of Medical Devices

FDA - Technical Considerations for Additive Manufactured Medical Devices Guidance

FDA’s Role in 3D Printing

FDA - Process of 3D Printing Medical Devices

FDA - 3D Printing Medical Devices at the Point of Care: Discussion Paper

FDA - Classify Your Medical Device

FDA - The 3Rs of 3D Printing: FDA's Role

PART 820 - Quality System Regulation (QSR)

Mike Drues on LinkedIn

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru Academy

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