Medical molding: 
Do we have all the right people?

February 03, 2010

Only the wise will successfully brave the powerful waves of the medical market. If you’re planning on moving forward in this sector, make sure you have an experienced set of swimmers.

You’ve done the research; the markets are there and forecasts are for steady growth, regardless of the economy. You’ve coordinated with manufacturing, sales, quality, purchasing, accounting, and a couple of consultants. After long meetings in the executive conference room, everyone agrees that it makes sense. Starting next quarter you are going after a share of the medical market.

Then, the boss (who you’ve managed to keep out of the details for the most part) calls you and asks, “Do we have all the right people to make this happen according to the plan?” Hmm. You’re trying to remember. We talked quite a bit about that, but what did we decide? You agree to provide a status report on that at next week’s staff meeting, along with any recommendations.
Where do you start?

First, accept the fact that you are going to have to bring in some key people. Brian Payson, VP of business development for Nypro’s healthcare unit (Clinton, MA), notes that there are many obstacles for a company entering the medical market. For example, capital requirements for cleanrooms, molding machines, and ancillary equipment are extensive. “All of that investment was necessary for Nypro, but I can guarantee you that the growth we have achieved has been because we had the right people,” Payson emphasizes. “For us, I would say one of the key players is the program manager.” At Nypro, the PM leads a team that may include QA engineers, automation engineers, injection molding and tooling experts, operations members, and others.

In this snapshot of job trends in the medical market, hiring continues to rise despite poor economic conditions.

When should you think about bringing in these key people? It cannot be too early, according to John Grecco, senior design engineer for Stryker Orthopaedics (HQ in Kalamazoo, MI). From the perspective of this $7 billion global market leader, developing early relationships with suppliers is key. “The most critical part of our process is the front end. We want to work with companies that have a culture similar to ours already in place—i.e., approved quality systems and engineers that will be able to support the design process.”

“If I had to pick one position to bring on board first, it would be the quality manager,” advises Jeff Somple, president of Mack Molding’s Northern Operations (Arlington, VT). “Most processors have a culture that values quality, along with a lot of other things. In the medical field, quality must come first, and second, and third.” For a company entering the medical field, the quality manager should be a change agent who has been through this process before. He or she is going to need to develop processes, write procedures, and rewrite job descriptions. This person should be familiar with everything that goes into passing an FDA audit. Everything must be validated, from the procedures to the equipment to the software, and

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