Additive manufacturing, or 3D printing, is well on its way toward disrupting the medical device space. Media attention is exploding and the technology is rapidly evolving, but the laws and regulations are not keeping up. As adoption of 3-D printing gains more popularity and users of the technology expand (this includes hospitals and clinicians, as the use of 3-D printers in the hospital will gain traction), the industry needs to be ready.
In the medical device world, 3D printing has most commonly been used for rapid prototyping, and there have been clear benefits. The process enables the creation of more complex parts at a lower volume, thus reducing scrap and saving a manufacturer’s warehouse space and logistics costs. However, innovation has gone far beyond prototyping and into bioprinting organs (revolutionary, but many years away), surgical aids, models for diagnostics, and components and finished devices.
Customization at the user level raises a lot of liability questions, said Michael Bruyere, attorney at Freeman Mathis & Gary LLP, at the Inside 3D Printing Conference and Expo in New York City. Who will be liable for the design of a defective component or device? Does it fall on the device manufacturer? The clinician? The software designer? Does the printer have culpability? “I don’t think the law knows this yet, and FDA doesn’t either,” said Bruyere. “FDA is flummoxed.”
When assessing liability, several questions must be addressed, according to Courtney Stevens, senior staff attorney for loss control at Medmarc.
- Will there be patient contact?
- Will the printed product be sold?
- Is there a learned intermediary?
- How cutting edge is the technology?
- Is it in the public’s hands?
Whether or not the product will interact with the patient affects the level of risk. For rapid prototyping, the risk is minimal. When dealing with components and finished devices, the risk profile is very different, said Stevens. There are concerns about specific physical characteristics such as shelf life, tensile strength, and porosity, to name a few. Have change control procedures been followed? If a supplier makes the component, does the supplier provide a certificate of conformity?
For 3D-printed surgical aids, there is a product liability implication if the model is not manufactured correctly, because it could negatively affect a surgical procedure. Who prepares the CAD file? Who performs the printing—is it the manufacturer or the surgeon?
With so many possibilities for 3D printing in the medical device industry, there isn’t a one-size-fits-all solution from a legal perspective. Stevens advises that manufacturers be diligent with the information provided in their instructions for use, all product literature, and any product training for doctors. For now, the challenge remains that device manufacturers will have to wait and see how FDA puts a stake in the ground on this new frontier of manufacturing.