Experts Advise Wannabe Medical Device Makers

September 3, 2008
| By Pete Daly |
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GRAND RAPIDS — West Michigan manufacturers who think there could be a more lucrative future for them in medical device-related products can pick up some useful information Sept. 10 at Grand Rapids Community College.

The West Michigan Science and Technology Initiative and GRCC are sponsoring the Medical Device Diversification Seminar from 7:30 a.m. to 1 p.m. at the GRCC Applied Technology Center at 151 Fountain St. NE in downtown Grand Rapids. The seminar originally was scheduled for early this summer but was rescheduled to Sept. 10.

It is open to any company that is not now involved in any medical device manufacturing but would like to check it out. About 100 individuals are registered but there is room for more; registrations will be accepted through Sept. 5.

A panel of technical experts representing West Michigan manufacturers already involved in medical device manufacturing will be on hand to offer advice and insight.

One of those experts is Nanci Eyke, who is the quality/regulatory manager at Tech Group in Walker, which manufactures injection-molded medical devices in use throughout the world.

Eyke has more than 25 years of experience in the health care industry, 15 in the FDA regulated biotechnology and medical device industries. Her career includes conducting basic and applied medical research at the Michigan Cancer Foundation, Wayne State University and Henry Ford Hospital. She is a graduate of Oakland University with a B.S. in medical technology, and Wayne State University where she earned an M.S. in biochemistry and an MBA. She has co authored more than 30 scientific articles and holds Biomedical Auditor and Six Sigma Black Belt Certifications from the American Society for Quality.

Eyke will provide an introduction to FDA regulations and ISO standards that apply to the medical device industry.

Some medical devices at first glance "seem quite simplistic," said Eyke — but government regulations pertaining to how they must be produced are anything but simplistic. She gave an example.

“You may have a very small plastic connector that might be used in an IV set. Maybe in the automotive world, you could tolerate a little bit of loose flash on that part from the plastic molding process,” she said.

But in the medical device world, it’s a very different story. "If that very small flash were to break off and get into a blood steam, it could cause a stroke."

Eyke will cover the medical device classifications and examples of each. She will also outline the process a device manufacturer must follow to legally market a medical device. Attendees will learn how to register their company and list products with the FDA. There are also requirements pertaining to ways medical devices are put on the market in the EU and Canada.

Other presenters at the seminar include John Kotwick of MedBio Inc. and John Vander Wall of Midwest Cleanroom Associates, who will lead a discussion on "Manufacturing Excellence." This breakout session will provide a description of the major differences between the manufacturing environment for medical devices compared to other markets. A “visual” tour will depict contrasts in manufacturing processes such as machining, metal forming, plastic injection molding and assembly. The “tour,” according to a WMSTI spokesperson, will include variations in clean room facilities and factors surrounding the reduction of "bio-burden," which is often an industry requirement.

While the focus is on the medical devices industry, Vander Wall's company has designed and built clean rooms for many different types of industries and purposes, not just medical applications but also micro-electronics and semi-conductors. Since Midwest Cleanroom Associates began in 1994, Vander Wall has worked with NASA, the Egyptian Army and many of the West Michigan companies that first got into medical device manufacturing.

Some of the clean rooms his staff experts have designed and built have had to meet ultra-stringent requirements, which is why VanderWall was selected to talk about manufacturing excellence.

Registration is $30 for members of the WMSTI and $45 for nonmembers. 

For more information and to register for the seminar, go to www.grcclearn.com.

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