Office desktop printers are revolutionizing orthopedic implant manufacturing.
Most surprising is how this change in process has fueled creative and increasingly sophisticated implant designs.
Desktop production machines are spitting out complex geometric structures with porous surfaces, tortuous internal channels and internal support structures that are impossible to fabricate using traditional manufacturing.
Oh yes, and they are linking up with digital imaging data to build patient-specific, customized implants.
3D printing is a brave new world for companies, physicians and patients.
It is also, however, a potentially lucrative opportunity for plaintiffs’ lawyers.
Enter, the Food and Drug Administration.
New FDA Guidance Document
On December 5, 2017 the FDA released its most recent version of the May 10, 2016 guidance document for companies (or clinics, for that matter) that wish to use 3D printing—also known as additive manufacturing (AM)—to create medical devices.
Their guidance is “leapfrog guidance,” meaning that it represents the agency’s initial thoughts and may change as more information comes available.
The document “Technical Considerations for Additive Manufactured Medical Devices—Guidance for Industry and Food and Drug Administration Staff” is available here.
More than 100 3D printed medical devices have made it through the FDA gauntlet for commercialization. Among these are patient-matched devices, knee replacements and cranial implants.
The FDA even approved the first drug produced on a 3D printer.
But, as the authors of the report state, these submissions are “likely just the tip of the iceberg given the exponential growth of innovative research in this field.”
On the horizon are 3D printed skin cells for burn patients or even 3D printed replacement tissues, bone and organs.
The Liability Issues
Richard Rubenstein, partner and nationally recognized product liability attorney with the Wilson Elser Moskowitz Edelman & Dicker Law Firm in New York City, raised several concerns in his December 19, 2017 National Law Review blog on the FDA’s role in regulating 3D printed medical devices, drugs or biologics.
As Rubenstein noted, FDA oversight of traditional manufacturing and testing of medical devices gives companies important protections. “Compliance with FDA regulations offers tremendous protection to the manufacturers against product liability claims.”
