Training Lacking For Medical Device Workers

April 22, 2008
| By Pete Daly |
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GRAND RAPIDS — Medical device manufacturers in West Michigan have little trouble finding hourly workers for their plants, a result of the decline in Michigan of the major manufacturing industries such as automobiles and office furniture.

There is one hitch: Medical device manufacturing is very different from making file cabinets or auto parts, and there is no general training available here to help prepare people interested in production jobs in the growing industry.

Help may soon be on the way, with GRCC "taking the lead," said Rich Cook, Venture Center director at the West Michigan Science & Technology Initiative.

"There is no standardized way for a (machine) operator in the medical device area to obtain anything like certification, but Dan (Keyes) has some thoughts along that line," added Cook.

Keyes, quality manager for Training Solutions at Grand Rapids Community College, is working with WMSTI now to plan a half-day conference at GRCC on June 17 for businesses interested in diversifying into medical device manufacturing.

A lot of issues will be on the table at that conference, but one of the most important ones is availability of qualified workers. The training for medical device machine operators is "highly technical — usually quite different from normal manufacturing," said Cook. He said he has heard from representatives of companies that are members of the local Medical Device Consortium that finding trained workers is one of their main challenges.

The Medical Device Consortium was organized by WMSTI last year to promote and support the growth of medical device manufacturing in West Michigan.

ATEK Medical is a member of the consortium. Its president, Chris Oleksy, said ATEK management is very impressed with the quality of its hourly employees, but few hourly job applicants in West Michigan have had any experience working in medical device manufacturing.

The end result of medical manufacturing is "serving patients, not making brake shoes. You're dealing with patient safety, so quality absolutely has to be job one," said Oleksy.

The extensive details and depth involved in the training that leads to medical device production certification are hard to teach people on the job, he added.

MedBio Inc., an injection molding company on South Division in Grand Rapids, is also a member of the consortium. It has 50 employees and produces plastic components used in medical devices. Its injection molding is done in a class 100,000 clean room, and the assembly is done in an even cleaner environment: a class 10,000 clean room.

"It would be very helpful to have some kind of shared training opportunities," said Ron Williams, chairman of MedBio Inc.

Williams said business is good and MedBio has been "hiring steadily." This year the company expects to grow more and hire more people. To have hourly job applicants who have had some training in metrology, quality control systems, statistical process control and validation procedures "would be very helpful to us," he said.

Strict FDA regulations drive quality assurance processes in medical device manufacturing. FDA 820 explains the detailed regulations that govern the methods, facilities and controls used in the manufacture, packaging, labeling, storage and installation of all finished devices intended for human use to ensure they will be "safe and effective."

Keyes said there are actually three levels of regulations. The highest level of strict requirements pertains to finished devices that are actually used inside a patient. The next level pertains to devices that touch the patient, and the third level are devices used in close proximity to patients.

He said FDA 820 applies to OEMs and Tier One suppliers — but they are required to ensure that their Tier Two and Tier Three suppliers also adhere to the regulations. The process starts on the plant floor.

There is also a specific set of "current good manufacturing practices" that are spelled out for the medical device industry. Keyes noted there is also a specific ISO quality management system just for medical devices: ISO 13485:2003. Probably most workers in American industrial plants have heard of ISO 9001, but few outside of medical manufacturing have heard of ISO 13485:2003.

ISO 9001 "is a good start, but not good enough" for medical device production, noted Keyes.

He noted that representatives of the Medical Device Consortium will be useful as "what I call the voice of the customer, to look at developing training at two levels." The first is training people for future employment in medical device manufacturing, and the second level is aimed at people who are already employed in the industry but need more training.

The conference on the morning of June 17 at the Applied Technology Center on the downtown GRCC campus should yield valuable input for development of the training plans, as well as provide the companies and individuals in attendance with basic facts they need to know before attempting to go into medical device manufacturing.

Information on registration for the conference is available at Under “Quick Reference,” scroll down to “Continuing Education & Professional Development.”

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