Connecticut startup company says it will soon offer 24-hour turnaround service
on custom cranial implants made from machined PEEK (polyetheretherketone)
billets. Current products on the market require four to five weeks for
"We can do
this because we don't outsource anything," says James Ketner, CEO of Kelyniam Global Inc. of Canton,
Custom Skull Implants (CSI) are designed and manufactured for each individual
patient to correct or replace bony voids in the cranial skeleton caused by
trauma or birth defects.
In a major
milestone, Kelyniam last month received clearance from the U.S. Food and Drug
Administration (FDA) to begin marketing its implants.
expects to ship its first custom implants in July or August, Ketner said in an
interview with Design News. He said
he could not divulge the names of the medical centers or surgeons he is working
cranial implants are a mushrooming technology because of developments in CAD
software and manufacturing processes.
Walter Reed Army Medical Center (WRAMC) in Washington, D.C. have been using
additive manufacturing processes to produce custom cranial implants for several
explored use of machined PEEK implants, but felt they were too expensive.
Instead they opted for implants made from titanium alloy using an electron beam
additive manufacturing (AM) process.
declined to comment on the cost of Kelyniam's implants, but said that machined
PEEK offers superior strength and materials' properties compared to implants
made with a laser sintering process.
He says the
key is in the molecular orientation you can achieve in the machining process.
In laser sintering, particles are formed into a large shape with a laser driven
by a CAD model.
important factor is the rapid turnaround. Surrounding bone material can shift
slightly after a few days, he says. Included in the 24-hour turnaround are a
stereolithography master and a machined polyacetal model to confirm fit.
In a letter
to shareholders last year, Ketner said that Kelyniam has the capacity to ship
1,500 implants (any type) per year. He projected theoretical revenues of $4.5
million based on that shipment level.
a publicly traded
company. Current stock prices are 30 cents a share.
Design collaboration now includes the entire value chain. From suppliers to customers, purchasing to outside experts, the collaborative design team includes internal and external groups. The design process now stretches across the globe in multiple software formats.
A new high-pressure injection-molding technology produces near-net shape parts with 2-inch-thick walls from high-performance materials like PEEK, PAI, and carbon-filled polymers. Parts show no voids, sinks, or porosity, have more consistent mechanical properties, and are stronger.
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