You've heard the skeptics. Academics do way too much research and not enough product development. Edmonton, Alberta-based Micralyne Inc., a manufacturer of micro-electro-mechanical systems (MEMS), is more optimistic, putting up CA$1.4 million (US$1.04 million) of its own money to scoop interesting medical research from the University of Alberta (U of A) and help it build up a manufacturing portfolio for medical device commercialization.
"There's lots of dollars for research; there's a little less for development to get those prototypes done in a way that is meaningful to the marketplace," Micralyne acting CEO Darrell Mathison told BioWorld MedTech. "We know what's going on in the medical world and that there is a great need for highly technical devices, but at higher volumes."
Mathison described Micralyne's foundry as "the bridge" between the medical prototypes that emerge from U of A research and their commercial development. The building blocks for that bridge are the machines that can turn out – among others things – tiny sensors for devices that measure blood or brain pressure or restore eyesight using small needles implanted behind the eyes.
Vital to medical device production at the university and elsewhere will be the purchase of a high-volume metal deposition tool developed by Coopersburg, Pa.-based OEM Group Inc. for applying thin films of gold, platinum or titanium onto the tiny "wafers" that are central to the electrical conductivity of micro- and nano-sized medical devices. Each must be uniformly sprayed, "from one edge of the wafer to the middle to the wafer's opposite side," Mathison explained.
"Some of them also have to be done in a vacuum; some may be a bare wafer or have six layers of development already incorporated. So . . . when you spray the gold on . . . it, you've ensured no adverse reaction occurs or destroys what you're trying to achieve using the device."
Cut up at the end of the spraying into "a thousand different pieces," the wafers must all be identical, said Mathison. They can't vary "between thick and thin or lumpy, or you'll be providing your customer with [a] substandard product."
So why can't Micralyne's four existing deposition tools do the job? Loaded manually, six wafers at a time, Mathison replied, these older tools deposit the metal film onto the wafers in about four hours, far slower than what is needed to up production volumes. Enter OEM Group's high deposition machine.
"The wafers arrive in stacks of 25 per cassette. After they're inserted into the machine, you simply push a button, and 30 minutes later, all 25 of them are done. Where maybe we could do 10,000 wafers a year using our existing tools, now we can do a quarter of a million," said Mathison.
Increasing their monthly yields of uniformly finished product (up to 20,000 per month), "becomes way cheaper for our customer, which means their market becomes more lucrative," added Mathison. "[In] the end, the patient actually gets the benefit of all this preparation, research and development."
A horse worth riding
At first glance, U of A's Fabrication and Characterization center, or nanoFAB, seems out of place in a landscape dominated by cattle ranches and cowboys. Flush with an additional CA$2 million from the federal and Alberta governments, nanoFAB focuses on academic and industrial applications of micro- and nanoscale fabricated devices – all of it done in 25,000 square feet of communal laboratory space.
That's far less than what is needed, said Mathison. "The new deposition tool would take up 10% to 20% of their entire clean room space. At 55,000 square feet – with the ability to add another 60,000 square feet – our foundry is well suited for future growth."
Micralyne is also one of only two or three foundries in the world with ISO13485 certification. More than tools or ISO documentation are needed, however, to meet the rising production demands from Micralyne's clients, approximately 50% of whom are in the medical field, said Mathison. Also needed are people, particularly "the constant flow each year of engineers and technicians from the [U of A] who can work in our foundry," said Mathison.
"We have the people. We just need to continue along the equipment path to move production into higher volumes. Otherwise, we'll just be outsourcing, which is not our preferred method. This is the horse to be riding."