LOWELL -- For many medical device startups, the road from bright idea to the marketplace involves a catch-22.
Venture capitalists often want to see a product before investing. On the other hand, newly-hatched firms may not have access to the resources required to engineer a product that will attract the kind of funding needed.
Enter the newly created Massachusetts Medical Device Development Center, or "M2D2" as it is known, located in the plastics engineering department of UMass Lowell and headed by Professor Stephen McCarthy.
"There are a lot of medical devices that have been invented, but can't make it to clinical trials because of insufficient funding," McCarthy said. "We feel that if we can help get those medical devices to the point where they're more attractive to venture capital, then we help new companies form, create jobs and generate technologies that will help save lives,"
Indeed, M2D2's first tenant, Perfusion Technology LLC, has developed what the company's CEO, Albert Kyle, says is "a breakthrough in the treatment of the brain." Perfusion, now based in Lawrence, will be relocating to the campus sometime in May.
The company's groundbreaking technology seeks to overcome the difficulty of delivering cancer (and other) drugs past what's known as the "blood-brain barrier," a means the body uses to keep toxins from affecting the brain via the bloodstream.
Kyle, his partner Dr. Ulrich Herken, and researchers operating in places as far flung as Ohio and the British Virgin Islands have developed a technique using an IV-administered drug coupled with non-invasive ultrasound that they believe will allow drugs such as Carmustine to be successful in treating brain tumor patients.
A prototype has been designed, and two studies at Massachusetts General Hospital have shown that Perfusion's technology allows large molecules (as most newer drugs are comprised of) to pass through the blood-brain barrier in rats. A human feasibility study is slated to begin in Germany.
But the possibilities for treatment go beyond cancer. Diagnosis and treatment of other brain disorders, such as stroke, epilepsy and Parkinson's disease may also be aided by the new technology.
Within weeks of the alliance between Perfusion Technology and M2D2, a collaboration sprung up between Herken, McCarthy and UMass neuroscientist Tom Shea. Shea and McCarthy had been experimenting with a method of encapsulating pharmaceuticals inside extremely small packages called "nanospheres" in hopes of targeting tumors more effectively.
Today, the three men are experimenting with a drug delivery system that combines the use of nanospheres with Perfusion Technology's ultrasound technique.
Asked why Perfusion Technology chose M2D2 for a business incubator, Kyle said, "This is about as close to a one-stop shop that I could imagine... they have an integrated approach -- laboratory facilities, investigators (and) technical staff."
On-site and available to companies that M2D2 sponsors is a design center housing powerful computers with the latest software; full-scale manufacturing equipment that can make many of the parts needed for a prototype medical device; and a materials lab that can custom-tailor plastics such as tungsten-imbued material that will show up on an X-ray if needed.
"The medical device industry in Massachusetts is very profitable, and one of the last remaining manufacturing operations in Massachusetts, and we're at risk of losing it to other states," said McCarthy, adding that M2D2 hopes that it can impart enough advantage to medical device companies so that they will stay in Massachusetts.
M2D2 got its start in June 2005 with a $135,000 grant from UMass, appropriated by UMass president Jack Wilson. McCarthy is a founder, along with Tom Summer, president of industry group MassMEDIC; adviser Hooks Johnston; Rebecca Loveland of the UMass Donahue Institute; and Sheila Noone, director of clinical research at UMass Medical Center in Worcester.