Excitement is high for 3D printing medical devices, judging from the panel discussion at MD&M BIOMEDigital, “Innovative Applications of 3D Printing in Medtech.” Industry experts sat down with moderator Guarav Manchada, director of healthcare at Formlabs, and spoke about how additive manufacturing is evolving in the medtech arena. John Foody, manufacturing engineer from Corvia Medical; Beth Ripley, MD, PhD, director of VHA 3D Printing Network at VA Health Care Systems; and Sean McEligot, section head of medical device research and development at the Mayo Clinic, shared their thoughts and experiences about the advantages and challenges of 3D printing of medical devices as well as what they see for its future.
Despite sharing their excitement about the various ways in which they are using 3D printing at their respective organizations, the panelists were quick to agree with McEligot’s assessment that “there’s no ‘easy button’ on 3D printing.”
Ripley noted that the biggest bottleneck with the technology in her organization is finding people that understand it and can do the work. She said it is important to “convince your organization to kind of jump into this and show what they’re going to get because there’s a lot of upfront costs.” She explained that it is not just the cost of the printers that needs to be considered, but also the remodeling that might have to be done to accommodate the needs of the equipment, such as putting in HVAC or changing out electrical or even adjusting the ceiling clearance.
“So I would love for us all to continue to work towards that business case and be sharing that out across organizations so that those who are moving into the space have the help they need to be able to convince their leadership that on the other side of all that upfront cost and headache, there is a distinct reward to the patients who are going to benefit from those devices, widgets, or just even the R&D work that might go into the next greatest invention that changes healthcare,” she said.
McEligot spoke of the challenges needed to incorporate quality systems within his division. “In order to be able to support more innovative and more impactful projects with doctors, we needed to be able to provide products that could be used for an investigational device exemption,” he said. “You don’t have to be a registered medical device manufacturer to support an IDE, but you do have to have a quality system.”
He explained that back in 2008, when they started to build a quality system, it was difficult to do this “because the quality system consultants are used to setting up major manufacturing companies. They’re not used to setting up a one-of-a-kind quality system.”
McEligot said as Mayo Clinic is starting to move forward with its anatomical modeling unit, it had to register with FDA as a medical device manufacturer. As such, they will have to file 510(k) submissions and have auditable good manufacturing practices. “And so it’s going to be quite a wild ride over the next year or so,” he said.
Foody commented that he believes speed of production is one limitation of 3D printing. “A lot many current means would be much faster and more repeatable in terms of our variations, when it comes to things like injection molded parts,” he said.
In terms of where things would need to go, he said that having materials, machines, and software that are validatable so that they can be documented in a QMS system is important, as well as a better understanding of particulate-generation considerations. “Those are all very important things that we would need to understand before considering to implement this technology in a device such as ours, but I think I think it’s optimistic for the future, but maybe in a few years,” Foody said.