Medical device makers turn to 3-D printable polymers for new product opportunities

Medical and dental device markers are hitting a wall when it comes to utilizing new materials because of federal regulations, Advanced Manufacturing reports.

Here's what you should know:

1. Steve Pollack, formerly of the FDA, now with Carbon, said medical device manufacturers stick to a small list of FDA approved materials. He said, "It's easier to get along and go along and not challenge FDA's comfort level with new materials."

2. Carbon and research labs across the country are turning to 3-D printable polymers. Polymers are currently a $100 million global market for additive manufacturing, with growth projected to hit $1.5 billion by 2027.

3. SmartTech Publishing Vice President of Research Scott Dunham — a company that focuses on additive manufacturing — believes 3-D printed polymers will revolutionize the field because they eliminate the need for multiple machines. For instance, dental models are created using several machines, with these polymers they can be created using one.

4. Carbon has created several dental models for planning procedures to date. The company recently partnered with Johnson & Johnson to create surgical tools.

5. Mr. Pollack said Carbon is going to begin making surgical guides to help with dental implants, and then grow into clinical diagnostics and resorbable materials.

Mr. Pollack described the plan as such, "Our approach is to crawl, walk and then run. Our strategy is to introduce these materials into the medical device ecosystem for devices with a low bar of concern, in the low-risk device category, where there’s not the long-term concern of implant challenge. Get manufacturers comfortable in that space, and get the FDA comfortable in that space."

6. If Carbon is successful with its initial efforts, Carbon wants to attempt a class II, 501(k) device that would be used in a patient. Mr. Pollack said polymers are "the most exciting opportunities."

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