Breaking the Mold

Today’s Medical Device Molding Contract Manufacturers Are Growing to Stay Ahead of Market Demands

Christopher Delporte
Group Editor

New molding processes allow Mack Molding to provide ergonomic soft-grip handles for Stryker Orthopaedics’ Triathlon knee system. The grips are insert molded with a double overmold and provide surgical operating instruments with a lightweight, soft-touch surface that’s also strong and easier to use. Photo courtesy of Mack Molding.

It seems that molding, in some way, impacts practically every sector of the medical device market.

Very often, a patient or healthcare provider’s most common interaction with a medical device in the healthcare setting is a molded product. From handles for surgical instruments used in orthopedics to IV tubes, fluid bags, micro-sized catheters for cardiovascular procedures and a litany of other applications, there’s plenty of opportunity to keep the molding industry busy—and then some. The industry is served by many companies with a medical device focus. Yet, lured by predictions of steady growth, many molders with experience in other fields—most notably automotive—are taking the plunge into the seemingly attractive, though highly regulated and demanding, sea of medical device opportunity.

“Everyone’s getting on the medical bandwagon in the plastics industry,” said Chetan Patel, president and co-founder of SMC Ltd., a Somerset, WI-based contract manufacturer and molder, adding that 96% of his company’s business is in the healthcare space. “There are a lot of companies that traditionally have not been [in medical devices], and they’re now entering. It’s much more difficult today to serve four or five industries simultaneously. But if you’re going to get into medical, you really have to know the industry and make every effort to understand the demands.”

One company that’s seen its share of the medical device molding market grow is Mack Molding in Arlington, VT. Founded more than 80 years ago, the company serves a variety of sectors, including the computer and transportation industries. It has seen medical devices grow from less than 10% a few  years ago to more than 30% today, according to Stefan Rasch, the  company’s director of application  development.

Rasch described what he sees as some of the “gateways” to entering the device market that companies must consider before diving in. “It’s not to be underestimated. This isn’t just injection molding for the sake of injection molding,” he said. “There are certain barrier levels in providing services to the industry, in large part because of the regulations that are involved. You need to have ISO 13485 process quality. You need sufficient staff to deal with the regulatory issues, in addition to compliance engineers. They need to be part of your infrastructure so you can handle the medical customer base.”

George Blank, president of The MedTech Group in South Plainfield, NJ, agreed, adding that “marketing alone doesn’t get the job done” when forming new business partnerships. He said OEMs are looking beyond basic capabilities to find contract manufacturers with quantifiable results.

“Marketing is good, but customers want to know what’s happening on the shop floor. That’s one of the big changes,” he said. “The stakes are higher. There’s a lot of risk in medical products and OEMs want to know that if you’re supplying the plastic parts all the way to the finished product, there’s going to be reliability and efficacy.”

Blank noted that his company is experiencing more scrutiny from potential OEM partners, and that it’s no longer the case that the lowest bid is the only determining factor in securing new business.

“One of the largest trends we’ve seen is a greater move on the part of customers for due diligence,” he added. “Before customers do business, they’ll audit us. Customers want to know without a doubt that you can meet their requirements. They examine your quality system, your capabilities, in addition to the discipline inside your operations. Do you have the right people? Are they qualified? OEMs understand that very well, as they have parallel processes within their own organizations. Are you registered with the FDA? Do you have clean facilities? Can you prove it? Things like that are part of the due diligence process.”

Meeting Expectations

For those companies that choose to brave the onerous demands that medical device OEMs expect from their contract manufacturers and suppliers, differentiation from similarly equipped competition is the name of the game. 

Given the increasing competition cited by molders who spoke with Medical Product Outsourcing, the requirements to deliver OEMs consistent quality at lower costs and faster turnaround times have become a challenge. As is the case with other sectors of medical device outsourcing, molding companies turn to a range of full-service design and manufacturing services to provide added value. The advantage belongs to the company that’s not only able to improve product quality and produce more at a minimum cost, but also one that can combine high-tech molding with low-cost production.

Greg Riemer, vice president of business development for the Molded Rubber and Plastic Corp. (MRPC) in Butler, WI, said all his customers consistently look for “faster, better and cheaper” ways to do business.

“In our world, those are pretty big drivers. Staying on top of it is the everyday struggle of our business,” he said. “We’re continually working with raw material suppliers and toolmakers to improve our processes and optimize our systems to reduce internal lead times.”

Tom Caron, vice president of sales and marketing for Donatelle, based in New Brighton, MN, said reducing the “product realization timeline,” without sacrificing quality or increasing cost is a main objective for his team.

“We have seen our lead times, in some cases, improve two-fold from where we were 18 to 24 months prior,” Caron said. “Successful programs begin with effective designs from the onset. OEMs achieve this best by developing alliances with their strategic partners. This type of partnership approach results in a win-win situation for all involved.”

Jon Spaeth, engineering manager for Hudson, WI-based Phillips Plastics, echoed Caron’s comments, adding that his company has placed increased emphasis on streamlining its processes so it can offer shorter lead times on deliverables.

Mack’s Rasch noted that his customers increasingly want to see a complete “bevy” of services. “We tend to do a lot of process and design development services,” he said. “Medical customers want investigation, design, development—all the human factors—right down to the point of doing the contract manufacturing and beyond, including fulfillment and distribution.”

The MedTech Group’s Blank agreed that earlier involvement has been a recurring trend for his company and is “critical” to a product’s success and, ultimately, to customer satisfaction.

Technology Makes It Possible

No matter how early a contract manufacturer gets involved in the process, the recipe for success isn’t complete without one key ingredient: technology.

Robotic systems, which have continued to drop in price, are helping molders reduce costs and deliver faster turnaround times for customers, particularly on high-volume production runs. Photo courtesy of SMC Ltd.

“Technology is a huge issue,” Patel said. “We believe technology is a huge asset and it can help solve a lot of our customers’ issues and concerns about product innovation.”

Materials and injection molding processes are continuously improving, as is our expertise with these processes, according to Larry Walck, director of new business development at Mack.

Riemer said key technology implementation plays an even more important role in an increasingly global marketplace. As companies in Asia and Latin America offer the lower costs that OEMs so clearly seek, higher levels of automation and robotics, for example, keep US-based companies competitive.

“We have tried to use, whenever possible, robotic systems, as opposed to having an operator at a molding machine loading or unloading parts,” Riemer said. “Being a custom supplier, we work with different projects; components and volumes vary. With high-volume, where we can justify the cost, we will use robotics. Where we can automate and reduce labor costs, we’re able to compete with offshore [outsourcing].”

“You get hydraulic reliability and the benefit of servomotor efficiency,” he said. “This is directed at trying to reduce the cost of energy, which is a major factor in the cost of injection molding. This generation of machines is at least 35% more efficient than traditional hydraulic machines.”

“When it comes to micromolding, for example, handling of the parts is critical. A system needs to be designed to mold, inspect and package the product sequentially,” Vadlamudi said. “Multi-stage molding—manufacturing of multi-material objects which are an assembly of single-material components—is another critical component. Every molding stage will add one material component and the molding sequence produces the finished object. The development of auxiliary equipment suited to obtain process control (eg, material dryers that can dry the least amounts of material, pressure and temperature sensors that can be used on the micro parts to understand and control the process) is yet another.”

The End Result

More OEMs now are getting involved with the development of products derived from liquid silicone rubber-based materials, which is a product niche for MRPC, Riemer said. Two-material molded components have applications in all areas of the device market, with orthopedics and cardiovascular being the two largest adopters, he explained.

Patel noted that SMC began working with silicones a few years ago. “Today, the liquid injection molding segment of our business is growing exponentially,” he added. “A key portion of our business is  two-shot silicone molding. We invested heavily in design and mold making, and today we’re running multiple machines.”

“True micromolding makes it possible to demonstrate process capability on tight tolerance components with micro features. Automation advancements have made it possible to handle both macro- and micro-size parts with higher precision,” he said. “For manufacturers that have invested in this technology and understand it, parts and assemblies that weren’t possible several years ago are now able to be consistently produced. The capabilities of micromolding, micromachining and micromanufacturing have supported the continued trend of product miniaturization, especially in medical implantables and vascular surgery.”

Mack also has been using a new generation of resins that are able to hold tighter tolerances and can be combined with metal components in the molded part.

Blank said one area still in development that “holds a lot of promise” are absorbable materials for special implants, including some derivatives of polycarbon used to create drug-eluting stents that are plastic based and better able to absorb medication than today’s standard metal stents.