Anatomic Implants
Having your first product cleared by the FDA would represent the launchpad for most start-ups.
It would be validation of the company’s processes, approach and expertise. There would be cause for the founders to think they did it once and so they can do it again.
But for Anatomic Implants, it will be the end of the road. The company expects its Anatomic Great Toe Joint product to receive FDA 510(k) clearance by the end of the year.
Then, in co-founder David Nutter’s own words, “The future for Anatomic Implants is putting the Anatomic Great Toe Joint in a good home with another orthopaedic company to buy it from us once we get FDA clearance and let them help patients by bringing it to market.”
Metal additive manufacturing OEM AddUp is helping them to see this mission through. AddUp, in the last 18 months, established a medical advisory board that is helping the company refine its services to the medical industry. A strategy was put in place to build on AddUp’s existing play in the sector, with one idea being to identify a novel medical application and support a company through the FDA 510(k) clearance process.
“Allen Younger, our sales leader for the medical space, has been in additive for ten-plus years, mostly in the medical segment, and he’s built a great deal of relationships,” explained AddUp Deputy CEO Nick Estock. “So, as we brought this idea forward, he knew somebody that had a perfect fit. He called David up, said we have this idea, we want to partner with somebody with a novel product and help you bring it to market.”
It was perfect timing. Anatomic Implants – a start-up founded by David and his dad, Dr. Scott W. Nutter – had by now been working on the development of the Anatomic Great Toe Joint, 1st metatarsophalangeal (MTP) joint, for five years. Additive manufacturing had been decided as the manufacturing method a long time ago, but Anatomic Implants had never been able to find the right partner. Eighteen months ago, it was at somewhat of an impasse.
“It just fell in my lap,” David said. “AddUp came along at the right time. We’ve been helping them validate their machines, get the OQPQ validations – that has to be done to get the validation of our parts – and we hope to start testing things within the next two and a half months.”
As the partnership was finalised in October, AddUp invested into the Anatomic Implants business, and will now provide the manufacturing expertise to help get the product commercialised. Using AddUp’s FormUp 350 metal 3D printing platform, the Anatomic Great Toe Joint is manufactured in Ti64, selected in accordance with ASTM International’s F3001 Standard Specification.
With AddUp taking care of the manufacturing, the partners are now preparing for the comprehensive review of safety and performance data of the Anatomic Great Toe Joint to ensure it is ‘substantially equivalent’ to implants already on the market. FDA clearance is anticipated by the end of 2024, but not before tests have been carried out to assess biocompatibility, instrument reprocessing, cleaning and sterilisation.
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What then will be taken to market is a 1st MTP joint that is believed to be the first to be developed with metal 3D printing technology. It is said to replicate the human anatomy ‘nearly perfectly’ thanks to complex lattice geometries, enabled by a technology that also facilitates osteointegration through porosity. This capacity for osseointegration will give the implant a much higher chance of bonding to the bone, ensuring a successful surgery and reducing the likelihood of the implant being rejected by the body.
“The bone in-growth properties that a net structure can give you with 3D printing, you can’t get that lattice structure [with conventional technologies],” David said. “3D printing is omni directional, it’s the most important thing in getting that structure, it’s integral.”
The use of 3D printing has allowed Anatomic Implants to manufacture in the most accurate way, according to the company. In the development of the device, Anatomic Implants used laser scanning on human bones to capture data which was manipulated to create the STL file, then leaning on 3D printing to output this data in its true form.
Once the design was settled on, it was then about finding the right partner to help Anatomic Implants bring the project to fruition. With its ISO 13485 quality management certification, industrial backing and medical sector experience, that turned out to be AddUp.
“What we understand is how to optimise the orientation, support structures, parameters, etc, to produce the best possible products,” Estock said. “The design is outside of our scope, but we help them go through that manufacturing process. That’s when we can start to grab hold of a project and pull it through that industrialisation process.”
As Anatomic Implants will tell you, it’s very necessary that this know-how and capacity is in place. The company had tried and subsequently failed to get this far with two other 3D printing companies, but now partnered with AddUp, there’s an expectance that FDA 510(k) clearance will be secured.
What David and his father see before them is an 800 million USD global market for MTP toe joint reconstruction that isn’t being as well-served as it should be. Patients are experiencing hallux rigidus, where arthritis has become so bad that the cartilage has been worn away and bone is now at risk of fusing to bone, and hallux valgus, where a bunion has developed and is pushing the big toe into the other toe. The big toe, because of its role as a main point of balance, is likely to be the first part of the foot to develop arthritis. And if you live long enough, you’ll probably experience it.
Inspired by the use of the technology for spinal and maxillofacial implants, Anatomic Implants has moved to fill an industry gap.
“We’re seeing these new 3D printing technologies come down further into the smaller joints, filling these gaps that need to be met,” David finished. “The bigger companies tackle the bigger problems and smaller start-ups, like me and my dad, we’ll go capitalise on a market that is underserved.”
