HEADS UP: 3-D printing provides custom-made craniums

By Gayle S. Putrich
Staff Reporter

Published: April 2, 2013 1:18 pm ET
Updated: April 2, 2013 1:31 pm ET

Image By: Oxford Performance Materials OPM's custom-made, patient-specific OsteoFab cranial implant device

Related to this story

Topics Medical, Materials Suppliers

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."


Comments

HEADS UP: 3-D printing provides custom-made craniums

By Gayle S. Putrich
Staff Reporter

Published: April 2, 2013 1:18 pm ET
Updated: April 2, 2013 1:31 pm ET

Post Your Comments


Back to story


More stories

Image

New medical firm buys Clairson Plastics

September 19, 2014 4:33 pm ET

Custom injection molder Clairson Plastics is being sold to a new start-up that plans to dive into the medical market with a new dialyzer, a key...    More

Image

Dunkin' Donuts looking at PP to replace foam cups

September 19, 2014 3:22 pm ET

Dunkin' Donuts is testing a new polypropylene coffee cup that the company believes could help boost recycling.    More

Image

Foster building medical polymers plant

September 19, 2014 1:39 pm ET

Foster Delivery Science is investing $8 million in a new plant in Putnam, Conn., for production of medical polymer blends, as well as rods, film or...    More

Image

BP to restart damaged PTA unit in limited capacity by November

September 19, 2014 10:27 am ET

British Petroleum plc may restart its fire-damaged purified terephthalic acid (PTA) feedstock unit in South Carolina in late October or early...    More

Image

Bayer spinning off plastics business

September 18, 2014 8:49 am ET

Bayer AG will spin off its MaterialScience plastics group into a separate, publicly-traded company within the next 12 to 18 months.    More

Market Reports

Plastics Caps & Closures Market Report

The annual recap of top trends and future outlook for the plastics caps & closures market features interviews with industry thought leaders and Bill Wood’s economic forecast of trends in growing end markets. You will also gain insight on trends in caps design, materials, machinery, molds & tooling and reviews of mergers & acquisitions.

Learn more

Shale Gas Market - Analysis of North American Region

This report highlights the impact of shale-based natural gas on the North American plastics market and features an in-depth analysis of production trends in the United States during 2013 and a forecast for 2014 and beyond.

Learn more

Thermoformed Packaging 2014 Market Review & Outlook – North America

This in-depth report analyzes economic and market trends, legislative/regulatory activity impacting supply and demand, business opportunities and threats, materials pricing, manufacturing technology, as well as growth strategies being implemented by thermoformed packaging companies.

Learn more

Upcoming Plastics News Events

January 14, 2015 - January 14, 2015Plastics in Automotive

February 4, 2015 - February 6, 2015Plastics News Executive Forum 2015

More Events