OPM was just recently accredited as a foreign medical device manufacturer by the Japanese Ministry of Health, Labour, and Welfare. With this international development, they will also be creating OPM Asia in partnership with JSR Corp. of Tokyo. JSR is known for their strength in the life sciences industry in Asia, including a personalized medicine ecosystem, 3D software, drug discovery, and more.
The license will allow the new partners to market and manufacture medical devices in the following countries, with products expected to be on the Asian market by 2019 in:
- Japan
- China
- Taiwan
- Korea
- Brunei Darussalam
- Cambodia
- Lao PDR
- Malaysia
- Myanmar
- Philippines
- Singapore
- Thailand
- Vietnam
- India
“OPM has a broad technology platform built on PEKK polymer,” Scott DeFelice, the CEO and Chairman of Oxford Performance Materials, told 3DPrint.com. “With our establishment of OPM Japan we can now exploit our technology in a highly attractive market.”
“PEKK is a true high-performance polymer with highly unique attributes such as biocompatibility, purity, osteoconductivity, antibacterial properties and of course we have developed a proprietary method to 3D print with it. In our view as a materials company everything starts with having a polymer with the right attributes and PEKK does this uniquely.”
3D printed PEKK OsteoFab implant
With their ongoing use of PEKK, the OPM team produces implants very similar to bone that are osteoconductive and encourage the growth of natural bone once implanted. It is also radiolucent—meaning that it works well for patients having MRIs as well.
“If a material has the same modulus as bone, it does less damage and is healthier for the bone. For instance, metal can damage the bony interface,” said DeFelice, who will also be OPM Asia’s CEO, as well as one of their board members.
OPM offers comprehensive services around the world, also serving as an OEM and regulatory filer. When PEKK was originally created by DuPont, OPM was approved to make their own OXPEKK material, and since then they have patented OXPEKK LTS for 3D printing medical implants.
“We can go from a proprietary polymer to device to distribution,” continued DeFelice. “It’s sort of what you have to do with something so fundamentally different, something disruptive. In medtech, there’s so much vested cost in development, so it’s really hard to buy in to new materials and processes. You have to do a lot of it yourself.”
“Companies don’t always have the capability and infrastructure to innovate. We have to develop proof and go to companies with a good package.”
With the OPM and JSR partnership in place, they also intend to expand into other areas:
“Independent surgical centers are growing, and we are building a business model around those models,” said DeFelice. “They offer clinical efficacy at a lower cost, which is core to our business model.”
“You’re catching us as we are internationalizing our technology,” he said. “We’ve established a global best-in-class technology that made it through the rigorous U.S. FDA regulatory system. We are already selling implants globally, and now we are ready to expand.”
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[Source: MDDI; Images: OPM]