Molding a New Role in the Device Community
Today's Molders Combine Their Expertise With an Array of Value-Added Services
Many of today’s molders are assuming increasing responsibility, especially with assembly. Photo courtesy of Phillips Plastics Corp.
Part of this evolution stems from a changing OEM viewpoint. Many manufacturers are starting to reevaluate the costs of keeping expensive tooling and machinery in-house, and realize that it’s difficult to stay on top of investing in new technology. Another driver of outsourcing is that many OEMs have cut back on work forces, particularly engineering staff, and therefore need external assistance to achieve objectives.
Ultimately, many OEMs are finding it’s much more cost effective to farm the work out to a more experienced company that is knowledgeable about the materials, machinery, tooling and molding process.
On the supplier side, many companies are subsequently observing these trends, focusing on how to anticipate OEM needs and devising creative solutions to challenges facing any medical device company that wants to capture a large share of a successful market. Suppliers are ready to meet these challenges, but they are still adapting to their newer, more active role in assuring regulatory compliance, validation and testing, among other newer responsibilities, while keeping an eye on costs (see “Molders Feel the Price Squeeze” on page 76).
“The more you take over in the product line, the more regulatory responsibility you have,” noted Joe Pack, vice president of sales and marketing for Moll Industries in Dallas, TX. “Validation is a lot harder, too, and that’s a cost we have to bear. Ten years ago, we didn’t have this responsibility and now we do. Now we even have a director of quality and regulatory on our staff.”
While OEMs focus on consolidating their own focus in-house, the opposite is occurring among many of their molding partners. In the past years, the industry has seen what once was a group of small companies—with only a few large molding contract manufacturers—change drastically into savvy operations that are figuring out how to tackle complex OEM product needs while offering value. In the 1990s, Pack recalled, only about 20% of molders were taking on extremely large contract manufacturing projects. Now, about 70%-80% of molders are taking on such projects due to their investments in improving supply chain management and adding value-added services.
Molding Industry Consolidates, Evolves
In the past few years, as with much of the medical device industry, some smaller molding/plastic companies have been acquired by larger conglomerates in a push to offer more technology and service. In some cases, this has been very successful; in others, integration has been thrown together haphazardly and is not structured soundly. Therefore, all of today’s molders are carefully weighing their business strategies.
“Our growth, as a result of our focus on medical device manufacturing, has been organic rather than through an acquisition strategy,” noted Barbara Tischart, director of business development for SMC Molding and Manufacturing in Somerset, WI. “It may take a bit longer, but it is more integrated because of the foundation of gained experience and relationships.” She believes that opportunities still exist for companies that want to focus entirely on the plastics molding process, and feels that those who specialize can compete in a national and global marketplace.
Many experts believe that niche players should still have no problems finding work on short-run jobs. Since the larger companies may not want to continually change tooling to accommodate these smaller projects, the smaller molding companies that invest in the technology process can find ways to prosper among the larger competitors. Smaller companies can compete and be well suited to shorter productions and smaller quantities. Systems, staffing, equipment selection and cost/pricing models can all be fine-tuned for this particular style of business. Furthermore, some smaller companies are also finding additional work by collaborating with bigger molders as well as by focusing on gaining new business from smaller startup OEMs—these companies are often willing to incur more of the risk associated with handing off projects to smaller companies that can’t necessarily afford to make huge investments to quality and compliance initiatives.
In general, however, more OEMs are looking to molding partners to provide a higher level of service and, in turn, molding companies are broadening their horizons to offer more value wherever possible.
The Value of a Good Partner
Many molders are finding the solution to gaining more business and remain competitive is to add value wherever they can—not only in the manufacturing process, but beyond.
An array of molding solutions are available to OEMs today because technology and expertise are at an all-time high in terms of innovation. In some cases, companies are adding features to components that will enable a multi-piece assembly to feed through automated systems more easily. According to Tim Reis, vice president of healthcare marketing for the Bethel, VT-based GW Plastics, this time-saving process could shave off as much as 10% from the bottom line.
Tom Podesta, vice president of sales and marketing healthcare for The Tech Group, a division of West Pharmaceutical Services, Inc., in Scottsdale, AZ, additionally reported that his division is assuming assembly duties for as many as 70% of applications the company helps produce. “Each year, our capacity expands,” he said. “Ten years ago, we maybe put one or two parts together and packaged it. Now we’re doing 20-component assemblies, and we can do anything from manual to automated assembly.”
Automation is another burgeoning area of interest. With the cost of labor rising, many molders are finding that automated technology is often a more cost-efficient replacement for personnel working the machines—especially since human handling always leaves room for the risk of variable results on a manufacturing run.
Injection molding remains a top request by OEMs turning to outside help, and with good reason. This technique offers the ability to produce high volumes in a repeatable fashion, while delivering high quality, but the growing sophistication of technology—injection molding alone can have as many as 40 different subsets of offerings—means it’s not often affordable to invest in the technology and personnel needed to sustain these initiatives.
As an offshoot, micromolding has also gained momentum in the medical device industry, thanks to the adoption of minimally invasive surgical techniques. “We’re molding components that are challenging technology in general,” said Scott Herbert, president of Rapidwerks, a micromolding specialty company based in Pleasanton, CA. “With parts becoming smaller, tolerances become smaller and more critical. The vast majority of injection molding companies is overleveraged with the wrong equipment if they’re looking to downsize and make smaller parts. Therefore, we’ve positioned our company to do just micromolding. Opportunities in this category are coming up weekly, if not daily.”
Multishot molding—molding with two or more materials—also has been increasingly used in new medical products because it offers the benefit of sealed surfaces, which is important for instruments and other items that come into contact with bodily fluids.
Molded Products Get a Face Lift
As molding capabilities improve and designs become more innovative, many molders and their customers are turning their design eye toward the aesthetics of a medical product.
Custom handles, through the use of soft touch pads, pockets, recesses and ergonomic design, are being widely used by medical OEMs seeking to differentiate their product. From a functional standpoint, many medical device companies are looking to design products that are longer and smaller to accommodate the growing use of minimally invasive surgery as well as our more obese population.
According to Michael Gauthier, president of Gauthier Biomedical in Grafton, WI, customized color options—along with varying durometers—are also allowing OEMs to code instruments and build brand identity. “We’ve got a lot of customers who come to us for customized instruments,” Gauthier said. “It’s not just a service in which we use a mold. We’ll work with them to find solutions to their problems. We have a wide variety of instruments to help them.”
Other newer ways for molders to make a customer’s product unique is through the addition of silicone markings, which enable identification, lot and code numbers to be molded directly into the material. Molding companies are using insert molding—a technique that involves putting an insert into the mold to build logos into a handle, for example—to further complement designs
“Product decoration is an innovative and growing area of the business. Multi-material molding, in-mold decorating, painting and pad printing all offer the marketplace fresh and exciting looking and feeling products,” said Jerry Heckendorn, sales and marketing manager for PTI Engineered Plastics in Clinton Township, MI.
In general, design has become more of a focus among molding companies, which are developing both in-house staffs and external resources to work with OEM customers at the earliest stage of product planning. “We work hand in hand with the OEM on design,” Herbert of Rapidwerks reported. “In today’s world, you have a lot of IP surrounding products and the OEMs are conscientious of it.” In many aspects, OEMs are finding that collaborating with their molding partners early on can save money down the line, since the molder is less concerned with product functionality than it is with manufacturability.
Since many molding service providers are adapting to market requirements by converting to a one-stop-shop business model, prototyping services are being added to many of these companies’ menus of offerings. Mark White, regional sales manager of ATS Automation Tooling Systems, headquartered in Cambridge, Ontario, Canada, reported that designers and toolmakers are using more CAD and mold flow modeling, as well as other advanced software in conjunction with rapid prototyping technologies such as FDM (fused deposition modeling)—often collaborating with subcontractors to accomplish timely design development.
As Reis of GW Plastics noted, “OEMs are becoming smarter and realizing they need to involve us early in the process to take advantage of our knowledge. Since they’re tightening the purse strings, a lot of their internal capability isn’t there anymore. If we do our job right early in the process, we affect speed to market, product cost and product quality.”
Strengthening the Chain
The growth of outsourcing has also led many molding companies to become a more integral part of their customers’ teams by developing supply chain management strategies. Molders that work with overseas partners are wisely working closely with them to validate processes to ensure components are compliant before they ever reach US soil. At the same time, they are working more closely with OEM customers throughout the entire product development process to provide input at each stage and offer solutions to pressing problems.
A variety of experienced personnel are needed for today’s molding manufacturing operations—and many OEMs are turning to molders as they reduce their own work forces. Photo courtesy of ATS Automation Tooling Systems.
Indeed, integration and diversification are two buzzwords permeating the molding landscape. The Hi-Tech Group in Anaheim, CA has strengthened its relationships with customers by adding engineers to its sales force. The value of this strategy, noted Bill Sherman, president of HTG’s rubber group, is that these specialized personnel can talk about both the product details and operational process without having to hand off the relationship to yet another person down the line.
“The goal that’s changed is that nobody wants to deal with a used car salesman mentality anymore—the customers want someone who can really talk with them,” Sherman explained. Cutting down on middlemen helps reduce cost and streamline processes, saving all involved money and time.
Sherman’s company also has strengthened its customer service offerings by developing an in-house technical committee that meets monthly to evaluate new technologies and cost-reducing measures. Using lean manufacturing and six sigma principles, the Hi-Tech Group can boast that it hasn’t increased prices for customers in its rubber division in the past 10 years.
Philips Plastics Corporation has also paid attention to the growing need for robust solutions. The company approaches its own supply chain management by using a score card system for material suppliers—in which surveys and audits are employed—and sets up quarterly meetings with key customers to assess performance metrics such as cost, quality and delivery.
“The product life cycle continues to be short. That makes time to market critical. Customers want support through all phases of a program and they want to outsource as much as possible. That’s one of our competitive advantages; we can take them from design to prototyping to production—instead of three phases, we can combine them and reduce time to market,” noted Dave Thoreson, plant manager for Philips Plastic Corporation Medical Molding and Assembly in Menomonie, WI.
Down the Line
On top of all the value-added services that molding companies are pushing to offer their OEM customers, the industry is still constantly looking at investing in making even more technology improvements and material offerings to prepare for the innovative designs that OEMs are sure to concept in the future.
Many companies that traditionally used metal in their designs are now turning to molders to create solutions using plastic to replace metal components because resins typically offer flexibility and can be less expensive than metals.
As molded items get smaller, a keen attention to detail is imperative. Photo courtesy of GW Plastics.
According to Heckendorn of PTI, until lately, only sterile “disposable” products were manufactured out of plastics. However, relatively new engineered resins are now available for repeatable autoclaving. This presents various opportunities to help customers save costs and make their components more lightweight, while also offering more design flexibility.
Furthermore, molders are evaluating other newer technologies that enable parts to be made more lightweight without compromising the piece’s integrity. MuCell technology is one area of interest because it introduces gas into materials to minimize part weight and material usage, Reis reported.
Another technology gaining momentum in concert with molding is the use of embedded RFID tags. Since RFID offers part traceability, many companies are looking to integrate this technology into a molded component or during the assembly phase.
One of the major challenges the molding industry will face is the lack of talent to continue fostering all these innovative ideas and practices. Patel of SMC observed that many young people in the United States are simply no longer interested in learning the mechanical side of manufacturing. Even though significant productivity increases have occurred in the molding industry, interest in the trades—such as tooling, plastics and machining—has diminished.
Regardless, with the plastics industry expected to continue on its healthy pattern of double-digit growth, molders should find no shortage of work in years to come.