Dentists have been early adopters, said Joan Magrath, vice president of sales and engineering for Mack Molding Inc. Many now print crowns for patients right in their office, bypassing the need for temporary crowns and molding individual items that would otherwise take weeks.
“I've been on the 3-D printing bandwagon for many, many years. I was probably off by about five years in my prediction because it's hitting sooner than I thought it would, but I do think that technology has a long way to go and is making quantum leaps right now,” she said in June at the MD&M East trade show in New York.
People may be expecting more out of additive manufacturing technology than it's currently capable of and taking full advantage of it in a commercial capacity is going to take a little more time and patience, she said. The market still lacks a one machine for all or most material solutions, “but there's a lot of new stuff coming,” she said.
“I think it's getting there. You need the customer or the consumer to be on the adopting side of the technology too, and that's a lot of money for those guys to put out for equipment,” Magrath said. “We are challenged more and more by materials. And I think there is some waiting around to see what the regulatory landscape is going to look like in the long run.”
There has been bit of a standstill in regulations since additive manufacturing became mainstream just a few years ago, possibly holding up a medical 3-D printing revolution in the United States. Big companies like Hewlett-Packard and industry names such as Stratasys are slowly moving forward to exhibit at medical-related trade shows, but are cagey when it comes to discussing medical applications for their 3-D printers, usually citing medical as an application they are interested in but not getting specific.
But progress is being made on the regulatory front. The U.S. Food and Drug Administration has approved more than 80 individual 3-D printed medical devices under its 501(k) rules. But overall guidance or more sweeping regulations on 3-D printing has been slow to come from Washington.
It seemed it might not come at all — until May, when FDA released a draft guidance entitled “Technical Considerations for Additive Manufactured Devices.” The document, which builds on an October 2015 FDA workshop, outlines a basic framework for considering regulatory obligations in light of the differences presented by 3-D printing technology through every step and aspect of the medical device-making process: design, material control, printing and post-production, including cleaning, sterilizing, biocompatibility and labeling.
FDA attempts to cover all possible questions about 3-D printing in two main sections, Design and Manufacturing Considerations, which address technical considerations for fulfilling quality system requirements, and Device Testing Considerations, describing the type of information that should be included in premarket submissions for devices made with additive manufacturing.
The proposed regulations would be in addition to — not a replacement for — the agency's existing regulations for device review and approval, and will require an even more significant amount of information for approval than traditionally manufactured devices. The type and amount of data required “will vary depending on the intended use, risk profile, and classification and/or regulation for the device type.” Devices that are implanted, load bearing or available in standard sizes or patient matched are likely to require additional quality data.
The comment period on FDA's proposed 3-D printing guidance is open until Aug. 8.
