The 3D printing market is transforming the medical device industry and has the potential to impact the biotech industry. There’s plenty of excitement about its potential to change the way we think of organ procurement longterm. But in a presentation at the Stanford Medicine X conference, Katherine Stephenson of the Stanford University Center for Design Research sought to balance the hype and put its present and future role in medicine into context.
She noted that its value as a research and development tool tends to get overlooked. And yet, its applications from prototyping and the use of moulds for medical devices accounts for the majority of the sector’s revenues. It is much more affordable to model design ideas for medical devices. Manufacturers can do rigorous testing on their design ideas and have an affordable way to make revisions without having to assume a huge risk.
Stephenson said that of the 82 FDA cleared devices using 3D printing technology, most of them have tend to be low areas of mechanical stress, mainly for the face and head such as braces, hearing aids and skull implants. The military is making use of the technology to develop customized parts for service men and women, particularly for things like jaw implants.
Among the considerable challenges ahead are regulatory and ethical hurdles. Stephenson said although the FDA has said it will continue to treat 3D-printed technology as a standard medical device manufacturing process, they have not yet dealt with 3D printing from a customization standpoint. But by adding 3D printing technology to their facilities, hospitals are essentially adding a medical device factory.
If something goes wrong with the 3D printed device and there’s an injury, who is ultimately responsible? The hospital? The surgeon? The person who developed the 3D printing software? The person who took the measurements and entered them on the computer? Or the schmuck who hit the print button? It’s a potential nightmare for hospital administrators and one they will not be eager to adopt anytime soon. Talk about the downside risks of convergence.
Then there’s insurance reimbursement. “We have to figure out how will we bill this to an insurance company,” Stephenson said. She noted that it takes about three to four years to get FDA clearance for a medical device and another five to 10 years to get a billing code to use for reimbursement.
On the biotechnology front, 3D printed organs represent a much greater challenge because of the complexities associated with developing cells and tissue. Much of the work has been in scaffolding and trying to get 100 percent cell densities. Companies like Biobots and Organovo, (which had a rough ride on the stockmarket over the summer ) are supporting R&D for drug development. Stephenson noted that Organovo’s development of a 3D printed kidney cell provides a useful way to simulate a kidney cell.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Acknowledging Gartner’s hype cycle, Stephenson said the reality is that we are decades away from a 3D printed, customizable heart. Although the inherent challenges of developing the appropriate tissue are one thing, hospital workflows will need to master the process of identifying patients to avoid patient ID mix ups.
