Medical & Dental

Leading 3D printing enterprises respond to FDA guidance for medical sector

3D printing for healthcare and medical applications is an area where significant progress has already been made.

The recent statement by FDA Commissioner Dr. Scott Gottlieb on 3D printing for the medical sector also reaffirmed the agency’s commitment to a “new era of 3D printing of medical products.”

3D Printing Industry asked some of the enterprises leading this new era for their reaction to the FDA’s guidance for manufacturers submitting 3D printed devices for approval.

Laura Gilmour, global medical business development manager at EOS

The FDA finalizing their technical guidance document on additive manufacturing means a lot for the industry, since the medical sector was an early adopter of additive manufacturing for device production.

As the wording in this document confirms, the FDA recognizes the importance of the interaction between material, machine, and process for a quality part; this is already a central pillar of the way EOS develops processes and supports our customers.

EOS’s rigorously tested systems give manufacturers in the medical field the ability to change variables in the process while maintaining the guidance given by the FDA. It is refreshing to see the U.S. regulatory body acknowledge the importance of material, machine and process interaction to provide high quality medical devices to patients.

EOS and Autodesk Within 3D printed hip joint implants.
EOS and Autodesk Within 3D printed hip joint implants.

Todd Pietila, Sr. Business Development Manager, Hospital 3D Printing at Materialise

Materialise has been closely following the recommendations put forward by the FDA and we applaud their efforts to provide advice based on in-depth research on Additive Manufacturing for medical applications. We believe in the FDA’s commitment to supporting the development of 3D Printing and the promises it holds, ensuring safe and effective implementation of 3D printing applications in hospitals.

Medical applications of 3D printing presented by Jay Morris M.D. Codirector Clinical 3D Printing Lab of the Mayo Clinic during the 2017 Materialise World Summit. Photo by Michael Petch.
Medical applications of 3D printing presented by Jay Morris M.D. Codirector Clinical 3D Printing Lab of the Mayo Clinic during the 2017 Materialise World Summit. Photo by Michael Petch.

Kate Clancy, Consultant, 3DHEALS

The finalization of this document provides a clearer path through the regulatory wilderness. This is especially important for start-ups that may be new to understanding FDA regulations. It raises considerations that may have not been identified.

It offers clearer guidance on what should be validated and what standards to use within the medical device manufacturing process to enable regulatory approval/clearance. This is paramount in an industry that is waiting on regulatory agencies to respond to the current innovations.

More information about 3DHEALS is available here.

Kim Torluemke, VP Quality and Regulatory, 3D Systems, Healthcare

With over 25 years of experience in the healthcare industry, 3D Systems strives to exceed customer’s expectation with products and services that allow the maximum level of confidence.

With a robust quality management system and a breadth of experience in regulatory compliance, 3D Systems has supported a significant amount of the 3D printed medical devices on the market and is dedicated to enhancing treatment for children and adults though our use of 3D printing technologies. We continue to engage with regulatory bodies to ensure compliance, and support evolvement of regulation during this exciting time of advancing precision medicine.

Katie Weimer and Mike Rensberger of 3D Systems hold a 3D printed surgical model used in the operation on conjoined MacDonald twins. Photo via CNN
Katie Weimer and Mike Rensberger of 3D Systems hold a 3D printed surgical model used in the operation on conjoined MacDonald twins. Photo via CNN

What do you think is the most notable medical, dental or healthcare application of 3D printing? Tell us and make your nomination for the 2018 3D Printing Industry Awards here.

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Featured image shows Materialise patient-specific implants, 3D-printed in titanium for maxillofacial surgery. The implants received clearance for the U.S. market in September 2017.

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