Laser powder bed fusion (LPBF) firm EOS has released a Medical Device Master File that will make it easier for customers to achieve regulatory success. The file will essentially be Mad Libs for FDA approvals. By including relevant, validated data for the M290 printer, it lets users, device manufacturers, and AM services submit their own data in this Master File. That expedites the process of moving forward with production and getting approval.
At the same time, companies can piggyback on the Master File without having to disclose their proprietary designs or other innovations to EOS or others. The company thinks that this will be the most relevant for “hip cups, tibial trays and spinal cages.” This step should speed up regulatory approvals, time to market, and implants businesses. Because the machine data part of the file has been pre-approved, it will be less work for clients in terms of preparation and approvals. There will also be significantly less testing needed for approvals, since that has already been done.
Davy Orye, head of Additive Minds EMEA at EOS, stated:
“At EOS, we are committed to supporting our customers throughout their regulatory journey. With the EOS Medical Device Master File, we aim to help manufacturers navigate complex approval processes more efficiently, leveraging years of experience in supporting customers with the medical device approval process and ensuring complete confidence in compliance.”
Medical devices is a fast moving and quickly growing market for additive. According to AM Research, it should reach $16.5 billion in revenues by 2034. Across the orthopedics sector, new devices are being approved all the time, and millions of them are to be 3D printed. Lower costs, better osseointegration, improved blood flow to the implant, quicker healing, and lower stock are just some of the things being observed in 3D printed medical devices. From the largest companies in the industry to the smallest startups and individual inventors, 3D printing is being used for many medical devices.
Stryker has invested over one billion in additive, while others are making new devices in record time. Oncology trauma is one area where 3D printing could make more of an impact going forward. The ability to develop a versatile device that can fill a niche quickly is also impactful. For example, by changing the device’s modulus, stress shearing can be avoided. The magic of additive means that this same device can have an optimized texture for better integration, while also being smaller than conventional devices. Around the corner is a potential personalized device revolution. While we can’t be sure that this will happen long-term, compassionate use authorization cases where new devices are made for new patients are taking place. We can see that very cutting-edge work is being done there. These emergent special cases should also lead to new devices in the future.
By speeding up the adoption of medical device 3D printing, EOS is taking a smart step forward here. This work is sure to make existing Team EOS customers happier. At the same time, startups not yet wedded to an LPBF OEM could be persuaded to pick EOS because it would be faster and cheaper. This seems, therefore, to make good business sense as well. Such incremental steps are just what we need to move us forward, bit by bit.
Images courtesy of EOS.
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