Medical molding: 
Do we have all the right people?

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.

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 there is no room for on-the-job-training.

If you are looking at the device side of the business, you will also need a regulatory compliance officer. This person must be an expert on medical regulations and the regulatory submittal process. Companies are increasingly looking for people who are certified in this position, such as the Certified Medical Device Compliance Professional (CMDCP) designation offered by the Center for Professional Innovation & Education (CfPIE). Both the QA manager and the RCO must come from an ISO 13485 background (see below).

Arlin Nelson, COO of Merit Medical Systems (South Jordan, UT), has some slightly different and perhaps even more practical advice for those who would take the medical business leap. While he agrees that your team must include top-notch quality, regulatory, technical, and sales people, he would make certain there was a financial director who really knows his stuff.

“Someone has to guide the financial models from day one, like revenue projections, costs, schedules, cash flow, and credit facilities,” he explains. “Moving into a new business sector will require you to balance your inputs and outputs. For example, there could be a tendency to bring in too many salespeople too soon.” Another, somewhat overlooked, key position is the supply chain manager. Industry consolidation means that products can suddenly no longer be available. “Having good sources is essential to our business model, and to managing our risk,” says Nelson.

With the United States still trying to emerge from a deep recession and unemployment hovering around 10%, are good people easier to find? In the U.S., a baby boomer (born from 1946-1964) turns 60 years old every 7.5 seconds. Overall around 4 million people in the United States will turn 60 each year for the next 15 years. That’s a demographic tidal wave that has caused a talent shortage for U.S. businesses, while also increasing the demand for quality healthcare.

A search of the word “medical” in Job Trends on Indeed.com produces a graph (opposite) showing the percentage of industry jobs the site finds after searching thousands of job sites. As you can see, the dip associated with the recession was very slight, and is already over. This illustrates the medical industry’s less cyclical nature and means that the answer is no, good people are not easier to find. Nelson agrees. “If you can bring in good managers who will dedicate themselves to the overall vision of the company, they will be leaders who can also develop talent internally. Those people are becoming increasingly hard to find, however.”

You’re ready
Entering the medical field is not easy, but it has been done. Find one or two companies in your space who have done it, and find out as much as you can about what they did. Learning from the mistakes and successes of others is smart business.

Mack Molding would make a good role model for anyone trying to enter the medical market. It has been around since 1920, but only began focusing on medical in 2000. Already this sector represents more than 30% of its business, and is growing fast. If you’re thinking about jumping in, Somple says the water’s fine. “But it’s also 10 ft deep and there’s no lifeguard, so you’d better know how to swim.”

So at the staff meeting, you report that you have consulted with industry experts representing your intended customers, suppliers, and other companies that have made the transition from non-medical. Based on your research, you recommend that the company bring in several key people to lead the new business venture, phased over the next year. The first person will be the director of quality and regulatory compliance, followed by a sales manager who knows the market. If you have a strong finance director who can devote the needed time to the project then you are okay there; otherwise, that position is a must. Finally, you recommend bringing in a program manager, engineers, and others in accordance with the budget and as the markets develop over the next 12 months. The boss nods his head. Well done, he says, and thank you.


The five key people you need now   
Basic qualifications:
1. 
Quality manager. Technical degree, thorough understanding of QSRs such as ISO 9000, ISO 13485, corrective and preventive actions, document and labeling control, internal and FDA audits.
2. 
Regulatory compliance officer. Technical or business degree, expert on medical regulations and regulatory submittals. Certification preferred—e.g., CMDCP.
3. 
Financial director. CPA or MBA preferred. Prior experience in managing budgets on the project, division, or business unit level.
4. 
Program manager. Engineering or business degree. At least five years managing the development and production of healthcare devices.
5. 
Sales managers. Degree preferred. Experience selling materials or devices in the medical industry. Look for someone who has sold to your intended market, products with similar sales cycles.

—Paul Sturgeon