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.
Wal-Mart will hold its second Made in the USA Open Call July 7-8, at its headquarters in Bentonville, Ark. The event will be a repeat effort by the world’s biggest seller of consumer goods to increase the amount of US-made products it sells in Wal-Mart stores, in Sam’s Club members-only wholesale outlets, and on walmart.com.
From design feasibility, to development, to production, having the right information to make good decisions can ultimately keep a product from failing validation. The key is highly focused information that doesn’t come from conventional, statistics-based tests but from accelerated stress testing.
There’s a good chance that a few of the things mentioned here won't fully come to fruition in 2015 but rather much later down the line. However, as Malcolm X once said, "The future belongs to those who prepare for it today."
Focus on Fundamentals consists of 45-minute on-line classes that cover a host of technologies. You learn without leaving the comfort of your desk. All classes are taught by subject-matter experts and all are archived. So if you can't attend live, attend at your convenience.