While most of market for additive manufacturing technologies is in product design and prototyping, a niche of custom-made, one-of-a-kind implantable devices is growing. Using a patient's actual anatomical dimensions reseachers could draw up CAD files and print out customized implantable devices.
USA-based Oxford Performance Materials (OPM) was founded in 2000 as a supplier of PEKK (polyetherketoneketone) polymer compounds. PEKK is an ultra high performance polymer used in biomedical implants and other highly demanding applications.
In 2006 OPM began developing Additive Manufacturing technologies. In 2011, under its OsteoFab brand, OPM produced and shipped its first custom-made long term implantable medical device using select laser sintering (SLS) additive manufacturing. The device is a cranial maxillo-facial (CMF) plate for skull reconstruction. Using a P800 SLS machine from EOS, researchers are able to create devices from the patient's CT or MRI scan without the aid of tooling. The "rough" 3D printed surface is also thought to improve osteointegration.
On Feb.18, 2013, OPM announced that it has received FDA 510(k) clearance for the OsteoFab Patient Specific Cranial Device (OPSCD). The OPSCD is manufactured from PEKK, which is biocompatible, mechanically similar to bone, and radiolucent so as not to interfere with X-Ray equipment. This is also the first 3D printed, non-metal implant to receive this approval.
The OsteoFab technology is ideal for one-of implants specifically shaped to each patient's anatomy. One very desirable use of patient specific implants and the indication for the OPSCD is cranial implants to replace bony voids in the skull due to trauma or disease. FDA clearance of this device marks the first approval for an additively manufactured polymer implant. Furthermore, OPM has recently completed testing which confirms that the OsteoFab implant surface is, in fact, osteoconductive.
In addition to its own devices, the company offers bespoke part production for its customers. And if OPM receives a CAD file on a Friday a device can be built by the Tuesday and shipped the following Friday. So the typical turnaround time is under two weeks.
According to Scott DeFelice, President and CEO of OPM, this is just the beginning. The company is seeking well-qualified partners to commercialize more specific implant products at lower overall cost to the patient and healthcare provider. With all this knowhow, it's not surprising that OPM will become one of the major orthopaedic companies to deliver customized, low-cost polymer implants to surgeons around the world.
Posted in 3D Printing Applications
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