Adhering to FDA regulations on the manufacture of medical devices might be simpler when it’s more complicated.
That is to say: When manufacturers work in the traditional mode of large-scale, industrial production, they know the rules and are prepared to work under them. But what about when the manufacturing process becomes simpler – as in the case of 3D printing? How do the rules apply to that new frontier?
3D printing, or additive manufacturing (AM), offers device makers a range of potential advantages. They can be more innovative in design, address needs in a more customized way, and deliver products directly at the point of use. AM opens the door to offerings that would previously have been cost-inefficient because of scale.
But from a regulatory standpoint, AM is uncertain territory. Device manufacturers must navigate a landscape where few new rules have been written, but some old rules may apply in new ways.
One way some health organizations have addressed that challenge has been to sidestep it – by sticking to the uses of AM that are not regulated, such as collaborative “makerspace” design environments, printed biologics that can permit testing without touching patients or using animals, and even tangible medical models of patients’ internal structures, based on CT scans, that help physicians prepare for surgery without traumatic explorations.
But to realize AM’s full potential to change care, its users must venture into the realm of regulated device classes. These devices, which “touch the patient,” may follow different paths to market, but they all have to meet the FDA’s pre-market and post-market requirements.
What does that mean for AM? It depends on how a company uses it. Some AM strategies create major change in a product offering; some don’t. Some AM strategies rewrite the map of a company’s supply chain; some leave it intact. When you combine those two variables, the outcomes lead to a collection of possible frameworks – from stasis, where product and supply chain remain mostly as-is, to business model evolution, which radically recasts both.
A company on a static path may use AM only for operations like rapid prototyping, and its regulatory concerns might be limited to design controls, process validation, and production and process controls. A company that uses AM to evolve its business model, perhaps through mass customization at the point of use, might also have to address rules on pre-market approval and notification, Quality System Regulations (QSRs), or labeling.
With AM rapidly adding capabilities—and with more and more competitors actively exploring its potential—regulation should not be a reason to shy away from its use. As with any regulatory challenge, the path forward involves discrete, thoughtful steps. Start by defining the strategic aim that AM is meant to advance. Does carrying out that strategy involve “printing” a regulated device or component? If so, what class? How will AM’s impact extend beyond actual fabrication to alter your design process, testing methods, supply chain, and business model? With these considerations mapped clearly, it becomes easier to follow FDA protocols for submission, approval, and post-market compliance.