For this 3D printing manufacturer, a complex implant is a piece of cake

Back in 2013, Oxford Performance Materials’ biomedical division got FDA clearance for the first 3D polymeric implant for cranial reconstruction. A year later it won clearance for its 3D printed facial device.

What makes them unique is that they are patient-specific. In fact, OPM Biomedical is the first and only company to receive FDA 510(k) clearance for 3D printed patient-specific polymeric implants and has a total of four 510 (k) clearances. In doing so, the company is merging two trends in the medtech world – the demand for patient-specific implants, especially in orthopedics and the wider use and interest in 3D printed medical devices.

In fact, the overall, global 3D printed medical devices market is projected to reach $1.88 billion by 2022 from $840 million in 2017, at a compound annual growth rate of 17.5 percent, according to a report by Research and Markets.

Since the first cranial implant clearance in 2013, OPM has shipped close to 1,500 cranial implants, said Severine Zygmont, president of OPM Biomedical in a recent interview. She noted that unlike implants made through conventional manufacturing processes, the company’s 3-D printed process can handle complex implants without adding costs.

The implants could be complex from a geometry perspective involving channels, lattice structures, and organic shapes for example, which would make them either impossible to be produced using traditional machining, molding, and casting techniques, she said.

“If even possible using such conventional processes, it would cost a fortune,” Zygmont declared adding that it may require additional assembly, welding, and post processing.

The other advantage of 3d printed implants is that large implants can be made in one piece.

By Arundhati Parmar | MedCity News

Image Credit: OPM Biomedical


About Peter Coffaro 603 Articles
A growth-driven and strategic executive, Peter Coffaro commands more than 20 years of progressive management success within the medical device industry. As a District Sales Manager for Stryker Orthopaedics, Peter was responsible for managing and directing a regional sales force to achieve sales and profit goals within the Rocky Mountain region. Previously, he was the Director of Sales & Marketing for Amp Orthopedics. In this role, Peter was responsible for planning, developing, and leading all sales and marketing initiatives. Peter is a former orthopedic distributor in the Pacific Northwest. He has also worked with DePuy Orthopaedics as well as Zimmer, and held positions in sales, sales training, and sales management. Peter has an extensive background in organizational development, business development, sales management, negotiating and P&L management. Peter holds a B.S. degree in Biology from Northern Illinois University.

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