MEDICAL DEVICE MOLDING: Yea or Nay?

Molding plastic medical parts can represent several things to different processors: a transition from automotive work, for example, or a way into a new cutting-edge industry. But here’s what it’s not: a quick, recession-proof economic fix during tough times.

Ask the molders involved and they’ll tell you: Getting into medical device manufacturing takes time, financial resources, effort, and more.

“Being in the medical parts field gives you sustainable business, but it comes with some barriers, too, and a lot of molders don’t appreciate these” said Richard Boon, vice president of sales and marketing at custom molder Columbia Plastics Ltd., which began cleanroom medical parts molding a few years ago. “There’s a lot of upfront investment and work involved, long product development periods, many clinical trials, and ISO standards that preclude continuous product development.”

So, is it worth it? For the right processor, the answer is definitely yes. But are you the right processor?

No one doubts that the demand for medical parts is heading towards the stratosphere. According to figures from Cleveland, Ohio-based market research firm The Freedonia Group Inc., the value of the U.S. medical market alone will post eight per cent average annual growth through 2016. As the baby boom generation ages, demand for medical products will rise to US$575 billion in 2011 from US$412 billion in 2006, and to US$800 billion in 2016.

Wannabe medical parts molders have to clear a series of hurdles before even being considered for molding that first part, however. The first can be summed up in two words: financial stability.

“Any processor looking to get a medical devices contract absolutely has to have their finances in good order. Suppliers want to know the molder will be around for years to come, because the relationship between the two is meant to be a long one,” said Richard Boon. “For the same reason, the molder should perform its own due diligence on the supplier.”

A second criterion to pass: having the right manufacturing track record. “After financial stability, major parts suppliers are going to examine a molder’s manufacturing history,” said Len Czuba, president of product development firm Czuba Enterprises Inc. “It can be very hard to convince a company to give you medical parts contracts if you’ve never done this type of work before.” Experience with auto parts molding can help – but not as much as you might think. “Automotive molding has tight quality procedures, but not always tight enough to satisfy medical industry standards,” said Brenan Riehl, president and CEO of custom injection molder GW Plastics Inc., a leading U.S. medical parts manufacturer.

To get the contracts, then, it helps to have experience with medical parts – but how does a processor get that experience without having had a contract? Solving this Catch-22 isn’t as hard as it sounds. “If your company is new to medical molding, hiring people with experience in the field can help you get up to speed quickly, and also signals that you’re committed to being a serious player,” Len Czuba said. “Another good strategy is to find a start-up supply company and work together to grow the business.”

Having a history of good record keeping is essential also. “Part traceability is key in the medical device world, and process documentation is key to traceability,” Czuba continued. “Now more than ever before, the FDA is telling the device manufacturers that they need to hold the molders to the highest levels of quality and traceability. If a molder can’t show superior record-keeping skills, they’re finished before they’ve even started.”

The ability to provide a sterile manufacturing environment is another must-have. Contrary to what many think, however, not having a cleanroom doesn’t have to be a barrier to molders looking to enter medical. “Molders can start with so-called white rooms, which don’t require sophisticated air-quality monitoring and filtration systems, but are sterile enough to satisfy many medical device manufacturing requirements,” Brenan Riehl said.

Not that hitting sterility requirements isn’t vitally important. “More and more suppliers are compliant with ISO 13485 medical device standards, and they want their molders to meet that standard too,” said Richard Boon. “From the molder’s point of view, however, a problem with ISO 13485 is that it rules out continuous improvement. Once the molding process for a part is locked down, nothing can be changed without recertifying the whole part – not even to improve the cycle time.”

Assuming a processor clears these hurdles and eventually begins molding medical parts, a big bonus is that – absent bankruptcy or a catastrophic manufacturing screw-up – it’s hard to lose those contracts. “The last thing a part supplier wants is to take the time and trouble of qualifying a new molder for a contract,” said Richard Boon. “They don’t want the production hiccups that this entails, and certainly don’t want to have to bear the expense of moving the tooling to a new shop. Again, this is where the importance of a molder being financially stable comes into the picture.”

Another bonus: The above-mentioned manufacturing screw-ups are a little less likely in medical parts molding because the products themselves don’t change very often. “The program life cycles in medical molding tend to be quite long once production starts – longer than in automotive, for example – because, as a rule, the doctors and patients using these devices don’t like change,” said Brenan Riehl.

And as mentioned at the outset, medical parts manufacturing is inescapably a growth market. “The underlying demographics worldwide – an aging population – will drive growth for decades to come,” Reihl said. “By 2020, 54 million people globally will be 65 or older, making for a lot of potential customers.”

Sounds good so far, right? But what about the downsides? There are several, beginning with the costs that might be involved in getting a facility ready to mold medical devices. “Processors don’t always realize the money involved in converting their business model from, for example, auto parts production to medical parts,” Riehl said. “For GW Plastics, it was a 10-year process to transition from primarily auto molding to almost 75 per cent medical-related parts.”

Then there’s the generally uncertain nature of product development in the medical device industry. “There’s a high risk of medical parts never reaching the market due to the FDA nixing them somewhere along the way,” Riehl continued. “It’s a financial risk for the supplier, but also for the part molder, and it’s a risk that almost doesn’t exist in auto part molding.”

And even if the product ultimately does get the green light from the FDA, odds are that years will have gone by before it’s available to consumers and medical professionals – years in which the molder is not reaping the benefits from upfront investments.

The FDA can also make a molder’s life unpleasant in other ways. “In addition to coming down hard on molders dealing with the U.S., the FDA are getting much more proactive overseas,” said Len Czuba. “If you have foreign manufacturing facilities, the FDA are not shy in showing up at your doorstep and asking to see your records on medical devices.”

Speaking of overseas – if you think Chinese competition isn’t an issue in such a technically precise, documentation-driven industry, think again. “North American plastics processors often fail to realize that some of the major me
dical device suppliers have been in China for the past 30 years, and can mold the parts there for shipment to North America,” Czuba continued. “Latex rubber gloves, for example, are largely sourced in Malaysia.”

Still want to get involved, but aren’t sure how to get your foot in the door? Good first steps include getting familiar with medical device terminology; with relevant FDA regulations; and with the players in the industry, both big and small. “Also, start walking the floors at medical device tradeshows and find out what kind of parts the suppliers want”, Czuba said. “The odds of a molder being taken seriously as a medical parts maker improve if it can play to its strengths, too. If a company has made automotive lenses in the past, for example, it could consider transitioning into molding lenses for medical devices.”

In the end, choosing to invest in a medical parts molding future is a difficult “yea or nay” decision, and comes down to each plastics processor weighing its own particular strengths and weaknesses. “For qualified companies, medical device manufacturing is a very stable industry – not recession-proof, but recession-resistant,” said Richard Boon. “It provides sustainable business going forward, but comes at the expense of a lot of hard work and investment.”