WASHINGTON — If, after a nasty accident, you have to have a plate implanted in your skull, wouldn't you prefer to have one that is custom made?
Thanks to polyetherketoneketone polymers, 3-D printing technology and the Food and Drug Administration's approval of the OsteoFab patient-specific cranial device, that is entirely possible.
Oxford Performance Materials, in South Windsor, Conn., traditionally sold PEKK as a raw material or in a semi-finished form, but the company began developing additive manufacturing technologies in 2006 after reading several articles by surgeons saying, "If only we could … ," according to OPM President and CEO Scott DeFelice.
OPM started by looking at the powder-based 3-D printing process and, after six years and "many millions" in internal investment, came up with a cranial implant manufacturing process for custom building a product to fit each patient.
After a craniotomy, CT scans from the hospital are sent to Connecticut, where the OPM engineering team uses them to create printable computer-aided-design flies with all the details, down to the screw holes, for implantation. A surgeon electronically reviews and approves the design and it is printed in OPM's biomedical clean rooms, built in 2011, using a selective laser sintering 3-D printer.
"Once we get a file, we can get it to a customer within two weeks," DeFelice said. "The actual manufacturing time is about a day, but there are lots of quality control and regulatory requirements to be met."
The entire treatment, from arrival in the surgical room to the final implantation, can take several months and cost between $8,000 and $15,000, but it provides benefits unmatched by other medical devices, DeFelice said. Since the implant is custom-built to fit the patient, the surgery itself is quicker with no last-minute device modifications, which saves money and helps reduce the chance of complications, he said. As an implantable polymer, PEKK is biocompatible, mechanically similar to bone, osteoconductive and radiolucent, cutting down on noise in future X-rays.
While most of the magic behind OsteoFab is in the proprietary PEKK polymer and the manufacturing process, the FDA "approves devices, not a polymer," so OPM has to map out future plans one device at a time.
"We went with the cranial implant for first approval because the need was the most compelling," DeFelice said. "But this is just the beginning. There's really no part of the body that will go untouched by this."
Looking ahead, DeFelice is interested in applying the OsteoFab technology to the diabetic foot market, replacing bones that have virtually turned to powder because of diabetes, as well as spinal trauma and radical joint revision.
In the meantime, OPM plans to continue offering its proprietary implant-grade PEKK in bars and pellets for injection molding and machining.
"We're migrating from being a material supplier — which we still do — to an orthopedic supplier directly to hospitals.," DeFelice said. "We still have a very broad biomedical product line that's got well-established processability and good regulatory approval. There are three cleared grades, barium sulfate, carbon and then OsteoFab," DeFelice said, which is uncommon among manufactures, who generally prefer to deal only with OEMs and refuse to sell directly to molders.
"So the molders have been pushed out and haven't been able to do development. That's something we do differently," he said. "We will sell to molders and other smart people looking at problems, not just the OEMs, who don't always have a lot of processing knowledge."