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In large part, the future of medical injection molding in the United States depends on its ability to innovate in leading-edge mold manufacturing. Mold designers and manufacturers must respond to requirements for more cost-effective medical device components, high quality parts, and smaller parts, in addition to other trends.

PlasticsToday Staff

March 30, 2012

5 Min Read
What's the future of medical mold making in the US?

In large part, the future of medical injection molding in the United States depends on its ability to innovate in leading-edge mold manufacturing. Mold designers and manufacturers must respond to requirements for more cost-effective medical device components, high quality parts, and smaller parts, in addition to other trends.

One of the long-time leading players is Bill Kushmaul, who started Tech Mold in Tempe, AZ in partnership with Steve Uhlman, founder of Tech Plastics (eventually the Tech Group) in 1972. Initial targets included

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The future is bright for US mold makers, although more medical devices are being made in China, says Kushmaul.

electronics and personal computer markets. Over time, the company began focusing on high-volume, high-cavitation molds for packaging (caps and closures, dispensers), the medical disposable industry and personal care/consumer markets.

Tech Mold is the mold maker of choice for two recent demonstrations in hot runner side gating for syringe molds. Mold-Masters developed Melt-Cube, a linear side gating system that allows 20% higher pitch density than circular systems and is designed for easy tip replacement in the press.  Tech Mold built the mold for a demonstration at NPE2012 (April 1-5) in the CBW booth (#3169), where a 16-cavity automated system will be producing a 5-6cc polypropylene medical syringe with IML that integrates graphics with anti-piracy features. Tech Mold also supplied the mold for a Husky Injection Molding Systems demonstration of its  Ultra SideGate hot runner at  the Fakuma International Trade Fair in Germany last October.  The mold was running polyoxymethylene (POM) resin producing a 0.5 gram medical cap with 1.25 millimeter wall thickness.

Plastics Today discussed the future of mold making for the medical market with Kushmaul on the eve of NPE2012 in Orlando, FL (April 1-5). He stresses that he comes from a perspective of a manufacturer of very high-cavitation molds for the medical disposable market, and that the medical market comprises many more opportunities for mold makers including lower cavitation molds for other types of medical devices, durable instrumentation, and other applications. Many opportunities are emerging, for example, in micro molded medical products, as reported by Plastics Today.

PT: What's important to your customers today? 

 Kushmaul: Faster cycle times, higher output/throughput. They want more parts faster but with a greater level of quality and accuracy, not just cavity-to-cavity tolerance accuracy but dimension-to-dimension accuracy.  And they want these higher-cavitation molds to fit within the same footprint as their current molding machines will handle - they don't want to buy new molding equipment to achieve this.

What's driving medical OEMs back into the molding business after bailing on this 20 years ago?

Twenty years ago Baxter closed its molding facility in Southern California and put all the work into the Tech Group's medical molding facility.  The cycle for this activity tends to be about five years on the short cycle end and 20 years in the long cycle for companies to alter their business model with respect to whether they 'make or buy.' It's a 'make or buy' wheel. The medical OEM has its own molding operation because they feel it gives them control, so they invest in state-of-the-art molding machines and in-house molding. Then they realize that they're giving their molding operations free rent in their facility, and that they'd rather invest in their medical business - designing new products, marketing and selling their products, and that manufacturing takes a lot of resources they'd rather put other places.

So they go to the custom molders, which means buyers get involved and their job is to buy cheaper and cheaper, and ultimately tooling becomes the realm of the custom molder, and the mold maker is left dealing with people at the OEM who might not have engineering expertise to understand the role of the mold maker in the overall success of the product.

Today's trend is to outsource moldmaking from the OEM. However, the OEM is placing more and greater demands on the moldmaker for tighter dimensions and features, with minimal costs.

The medical moldmaking business has seen a complete paradigm shift, and these greater demands being made on the mold maker that supplies these high-volume medical molds has added time to the design process that ultimately eats into the lead time for the mold build. Then on the back end, you have the mold validation process to meet FDA requirements which in many cases takes longer than the actual mold build. Tech Mold has a molding facility in which we can validate molds either in our machines or in the customer's machine that is shipped to us for the validation process.

This makes it tough for small shops to serve the medical market on this level. They're stretched for resources and in many cases don't have the equipment. The types of molds that Tech Mold builds can be extremely large and complex. Bigger molds mean a bigger risk.

What types of molds are in greater demand for you from your customers?

Obviously larger cavitation and  stack molds that can increase productivity without the need to add more presses; we also see the need for in-mold assembly and two-shot molds;  we are also working with press suppliers to pursue cube molds; overall higher cavitation for faster cycles with higher CPKs.

We're also building a lot of prototype molds to evaluate marketing's projections and expectations for a new product, and to launch a product. In one case a customer purchased four, four-cavity full-scale prototype molds to evaluate then launch the product prior to building a high-cavitation production mold. That's where the real innovation starts.

Generally, the expectations from customers have become greater over the past decade. In many cases, as large corporations have thinned out their workforce, they expect more of us as their moldmaker, to solve their problems that the OEM's engineering staff used to work out before they came to us.

Do you see any specific threats to the medical market in the U.S.?

China is still the looming economic giant.  China is still a threat, even to the medical market. There are more and more devices and disposables being manufactured in China. When a health-care worker came to our shop last fall to give us all our flu shots, he had a box full of syringes with 'made in China' on the box. How much influence will China have on the medical industry remains to be seen.  But that's what will impact the moldmaking business.  I personally believe the business will be dynamic in the future, and looking through 2012 glasses it looks bright.

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