– Derek Mathers, Business Development Manager, Worrell
You won’t hear about the FDA workshop that happened at their Maryland HQ three weeks ago on the news, but it (and workshops like it) will significantly affect the way that you receive medical treatment in the future. I attended this workshop to get the inside scoop on the way that 3D printing will affect medical technology, because as a product development consultant it is essential that I understand how manufacturing will be transformed over the coming years. If I could sum up these two days in one sentence, I would recommend that you start getting excited for a future of better, faster, and more personalized medicine.
Radical innovations will start in academia, diffuse to industry
Every major player in both the medical and 3D printing industry was in attendance in order to help formulate future FDA guidance for this new manufacturing technology. In addition to government, military, and private industry representation, universities from across the nation sent their best and brightest to explain what schools are doing to improve the technology. Here are two incredible examples:
• University of Michigan, Dr. Scott Hollister showed how they are saving infant lives by printing a bioresorbable splint to support a collapsed bronchitis.
• Wake Forest School of Regenerative Medicine, in collaboration with the U.S. Army, is now testing a skin printer in the field to repair soldiers’ burn wounds in a fraction of the time
You might have heard of a San Diego-based bioprinting company called Organovo (ONVO) that manufactures human tissues for pharmaceutical testing. In my conversation with Keith Murphy last week, their CEO, I discovered that they are actually working closely with Wake Forest Regenerative Medicine – Organovo designs the hardware or platform for bioprinting, and Wake Forest provides the research funding and scientific testing resources to maximize the application. From my discussions with these two organizations and the FDA, I believe this will be the model moving forward – research and development in academia, and scale/efficiency/quality developed in industry.
Metal printing is already revolutionizing surgery and improving care
Many people are familiar with the way that 3D printing is being used in hospitals to print anatomical models from MRI/CT scans so that surgeons can practice and hold a perfect replica of the surgery site in their hand. Two companies – 3D Systems, Materialise, and Oxford Performance Materials – are now taking this to another level. By printing titanium surgical guides, these companies are planning surgeries and designing custom-fit guides so the procedures are becoming exponentially more successful. Now, with FDA-certified materials, OPM prints custom titanium implantable structures in order to solve complex orthopedic problems.
The FDA is most worried about controls
Who will be actually hitting “print” on the 3D printers for surgical planning, implantable structures, and in the future organs? This was the FDA’s biggest concern from a control and liability standpoint – is the printing manufacturer to be held liable or the engineers/clinicians who are at the hospital designing the part? These issues will be answered by future guidance coming out from the FDA, but it seems that the FDA will regulate 3D printing the same way it does traditional manufacturing processes – examining materials, human factors, and technology on a case-by-case process to verify safety and efficacy. This is the future, and the FDA knows that being an innovator with this technology is not just a matter of improving healthcare, but a matter of national security.
