Oxford Performance Materials (OPM) uses advanced 3D printing techniques to make mission-critical parts for the aerospace sector, as well as replacement sections of human skulls. This approach is transformational for its customer—and for the company’s IT organization.
3D printing was not in the game plan in 2000 when the company, which is based in South Windsor, Conn., was founded by Scott DeFelice, who now is President, CEO and Chairman. The mandate was to exploit a molecule-polyetherketoneketone (PEKK) that, when formed into polymers, has a unique and highly useful mix of characteristics. For instance, skull replacement segments made of PEKK are bio-compatible and oxi-conductive, which means that bones can grow on them.
Oxford became interested in 3D printing in 2006. Before then, traditional approaches were used to mold the PEKK polymer into the desired shape. Though useful, these procedures weren’t precise enough to help in all cases.
DeFelice says the company, which is private, won early contracts from the U.S. Air Force to create 3D printing technologies. It subsequently attracted venture capital funding. At that point, surgeons who had been using OPM for conventionally manufactured orthopedic products asked whether it would be possible to marry patient CAT scans to 3D printers.
The answer was yes.
Selective Laser Cintering Process
The data was fed into a high-performance 3D printer using a process called selective laser cintering. In this process, a laser heats a mass of the PEKK polymer to a point just below liquefaction and then conforms it to shapes dictated by 3D CAD files in aerospace uses or CAT scans in orthopedic operations. This creates a perfect airplane part or skull segment—or the entire thing.
OPM printers run under white-room conditions. A printing session can produce hundreds of unique objects, such as differently configured skull fragments, and can take 12 to 36 hours. DeFelice says that the plan is for the orthopedic division to gradually work its way down the body.
OPM has one printer from OES in its biomedical division and two in the aerospace division, with a third coming.
Anthony Vicari, an analyst for Lux Research, reports that the FDA approved OPM for a printed medical implant, is ISO 9001-certified for aerospace manufacturing, and has developed and published design-for-manufacturing rules for 3D printed parts. The rules are for its materials, which were developed in partnership with Northrop Grumman.
The medical and aerospace industries are at the leading edge of industries moving 3D printing from prototyping to actual production. In some high-tech sectors, production runs are relatively small and products are highly customized. This leads to higher per-item costs. However, that premium is offset by eliminating the tooling costs necessary to create the objects using traditional methods, Vicari points out.
DeFelice adds that OPM’s approach is often optimal even at high volumes due to the complex nature of the designs and PEKK’s unique and demanding properties. It would difficult or impossible to produce some objects using traditional methods, he says, regardless of the size of the production run.
Selective laser cintering and electron beam forming will drive the 3D printing category, which will grow from $2.5 billion now to $12.2 billion in 2025, according to Lux. This five-fold increase, Vicari says, is a conservative estimate because it is based on the mere evolution of today’s approaches and assumes no unforeseen technical breakthroughs.
New Responsibilities for IT
Using 3D printing for production dramatically enlarges the role of the IT organization. Traditionally, IT has had only sporadic control over the machinery that produces a company’s products. At OPM, however, the two-person IT staff handles traditional chores and, in conjunction with consultants from ADNET Technologies, also runs the tools that create the company’s products.
DeFelice says that, typically, manufacturing equipment is sporadically networked to each other and to companywide LANs. Connectivity is bolted on as needed—and not necessarily in a consistent or ubiquitous manner. 3D printing, however, is the extension of an IT-based function that has connectivity in its DNA. This gives the IT department a central role at OMP.
IT has a new layer of responsibility as 3D printing moves from creating prototypes to actually replacing other production methods. Now, personnel must understand IT standards and protocols, as well as the regulatory requirements of the products being produced.
For OPM, these requirements include Current Good Manufacturing Practice (CGMP) standards, IS0 1345, AS9100, Process Validation Standards, Custom Standards, Access Validation Standards and Frozen Planning Standards, DeFelice reports. “The IT person in an additive manufacturing business should be sitting next to the quality director and the manufacturing guy at the table,” he says.
DeFelice suggested that IT should see the opportunity—and challenge—as the organization’s already important role grows even more vital and mission-critical in the high-performance 3D printing sector.
“If somebody upgrades something that is not part of a validated process and it crashes, and all of a sudden a million-dollar production run has been wiped out, that’s a very big deal,” he says. “Understanding that becomes a reason to make a lot more money if you’re an IT person—or to get fired if you don’t understand.”