Additive manufacturing, more commonly referred to as 3D Printing, appears set to have a major impact on medical device manufacturing. Pricing on the printers themselves has dropped steadily over the last several years, even while the technology behind them has become more refined.

The idea that medical devices could be created on machines available for purchase on Amazon may seem farfetched, but the reality is it’s already happening. As of December 2015, the FDA had cleared more than 85 medical devices. Despite that, there was not a clear ruling on the regulations surrounding these devices until this past August when the FDA released draft guidance to manufactures. Almost immediately, though, companies such as AdvaMed, Johnson & Johnson, and Novartis requested clarification on the draft, complaining that it was unclear. 3D printers have the ability to reduce costs for both manufacturers and consumers while providing faster turnaround on products. However, as the capabilities of these printers expands, it will become imperative to have clear, consistent rulings on the regulations surrounding them from both the FDA and other governing bodies.

Sources:

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/3DPrintingofMedicalDevices/default.htm

http://www.raps.org/regulatory-focus/news/2014/05/19000/FDA-3D-Printing-Guidance-and-Meeting/

http://www.raps.org/Regulatory-Focus/News/2016/08/15/25604/3D-Medical-Device-Printing-Industry-Seeks-More-Clarity-From-FDA/