Surgical Precision Medical Manufacturing Gains a Foothold in the Valley

Spine and joint surgery have come a long way in the past decade or two. So has the technology necessary to turn raw plastic and metal into precision surgical components.

Take Marox Corp. in Holyoke, which performs precision machining for a number of companies that design and distribute implants and instruments for the spine, hips, and knees, from anterior cervical plates and titanium screws used in spinal fusion to devices that drill into the knee and hip during joint replacement surgery.

“The most recent emerging technology is motion preservation,” said Brad Rosenkranz, vice president of sales and marketing for the second-generation family business, referring to technology that allows smoother, low-friction movement between titanium and plastic implants and the natural bone of the spine and joints — technology that would be useless without the skilled, high-precision manufacturing process that Marox specializes in.

“Other companies do the design and market these products to hospitals and surgeons, but they come to us for the production,” Rosenkranz said. “The larger companies — Medtronic, Zimmer, Johnson & Johnson — do their own in-house machining and precision, but the vast majority outsource those things, and that’s where we come into play.”

“We work closely with our customers to determine the next products to come down the pipeline, and we work with them at the earliest stages to get involved with emerging technology,” Rosenkranz said. “That’s important because technology is always changing, and we want to be at the forefront of it.”

Marox is only one of several companies in the region performing such work. Consider Texcel in East Longmeadow, which also boasts a far-flung roster of clients who would rather focus on engineering new products without the burden of actually mass-producing them.

“The focus at Texcel is to be the strategic manufacturing partner for emerging medical device companies,” said Larry Derose, the company’s founder and CEO, adding that Texcel’s specific expertise is in implantable medical devices such as neural stimulators, drug-infusion devices, and orthopedic implants.

“Our mission is to fulfill the needs of these companies that are seeking a source to manufacture their complete device all the way through final packaging,” he added.

That, in a nutshell, is the most common model in the Pioneer Valley’s healthy and growing medical manufacturing industry, one that has seen many companies become contractors for regional, national, and international firms that design and engineer such equipment. “These are companies that don’t have that manufacturing capability,” Derose said, “and don’t want to have it.”

This month, The Healthcare News examines this niche that is blossoming in Western Mass. — and why some people feel that the region could someday be known for creating medical devices as much as for manufacturing the creations of others.

Local Partnerships

Blackstone Medical is a rare local example of a firm that designs medical products and provides a steady flow of machining work to area manufacturers. The Springfield company actually designs and develops implants and instruments for spinal surgery, but partners with companies such as Marox and Accellent in Brimfield for the actual machining.

“We decided we would take a step up in the food chain and create a company that actually develops products and markets them to the end user, but outsources manufacturing needs to local machine shops and contract manufacturers that specialize in medical devices,” said Blackstone co-founder Bill Lyons.

When Lyons and his brothers launched Blackstone 11 years ago, spinal surgery was just beginning a remarkable wave of innovation that hasn’t abated, meaning companies that design such products, as well as those that manufacture them, are looking at bright futures. But for now, the Pioneer Valley is dominated by the latter group.

“There’s a fairly significant divide in Western Mass. today” between plentiful manufacturers and scarce engineers, Lyons said. “Hopefully, we might someday see a group of companies that develop, engineer, and design their own products, sell them using their own marketing capabilities, and either manufacture them in-house or contract them out to local machine shops.”

The regional disconnect between the ability to manufacture products and the ability to design and develop them partly explains why Blackstone is virtually alone in engineering products for market; it also explains why Blackstone’s design component is primarily based in New Jersey, which Lyons called a “hotbed” for orthopedic engineering.

Ellen Bemben, president of the Regional Technology Corp. based in Springfield, admits there’s a skill gap in Western Mass. when it comes to engineering medical products, but she added that the RTC has the situation on its radar, recognizing the potential of cultivating such an industry in the region.

“I’ve heard from our medical device manufacturers, and they’re very concerned about having experienced design engineers available to them,” Bemben said. “Even though we have students coming out of our universities as top-notch engineers, they’re not experienced, and a number of companies have had to import help.”

She noted that one company in the area currently has 15 employees but six job openings — that is, six high-paying engineering jobs — that it’s unable to fill. “People say there aren’t any jobs here, but there are actually a lot of jobs. It’s a matter of getting the word out and coordinating the workforce.”

The problem is a classic chicken-and-egg scenario. Theoretically, a healthy supply of companies that design medical devices could draw young talent to the region and retain local engineering graduates; meanwhile, such companies would be persuaded to relocate here if they recognized a skilled workforce – but each potential trend seems to be waiting on the other.

“There’s a growing supply out there,” Bemben said. “We’re well aware of the workforce requirements, and we’re also trying to develop a profile of exactly what kind of workforce a medical device manufacturing company needs.”

Choosing a Path

When people — including economic planners — talk about biotechnology, Lyons said, they often have no idea of the breadth of the industry, which includes life sciences, medical devices, pharmaceuticals, software development, and other niches. He maintains that medical device manufacturing is the facet with the most potential to become a hub based in Western Mass.

“There’s a myriad of industries that fall under the term ‘biotechnology,’” he said. “We have to pick one of those industries and go after it. We have to be specific and look at what the skill basis is regionally to support it.

“How can we support a pharmaceutical initiative if we don’t have that skill basis?” he continued. “But we do have a long, storied history in manufacturing things made of metal and plastic. Efforts to create a base for biotechnology in this area should be focused on medical dev-ices, which utilizes an existing skill base.”

Derose said such companies would already have the non-engineering resources they need, noting that Texcel provides key services beyond simple manufacturing.
“We produce not only the product, but the documentation the customer needs to support its application to the FDA for market approval,” he said.

In addition, “we get involved early on with a client to assist in what we call ‘design for manufacturability’; that means helping the client bridge the gap from the early concept to a design that can be manufactured in volume. That’s all based on our resources and understanding of the technologies needed to build some of these devices in higher volumes. Our goal is to be a manufacturing partner for companies that have no interest in manufacturing for themselves.”

Proponents of the industry say the sky’s the limit when it comes to new technology, too.

“We’re building sophisticated devices like implantable neural stimulators for stroke recovery, hypertension, and gastric disorders,” Derose said of his 20-year-old company.

Still, if Western Mass. wants to grow this industry, time is of the essence, Bemben said, noting that Bristol Myers Squibb is building a facility in Fort Devens in Eastern Mass., and Advanced Micro Devices is building in Saratoga, N.Y., both of which could conceivably draw talent from Western Mass. “I’m not panicked,” she said. “It’s just a matter of getting things coordinated here.”

“I think the challenge for Western Mass. is to get one or two companies like Blackstone here to develop a core of experienced medical devices professionals, and then spin off that with entrepreneurial startups,” Lyons said. “We have the manufacturing expertise; what we don’t have is the design and development expertise. We have graduates coming from UMass and other colleges, but we don’t have the companies in place to get them over the finish line.

“We kind of need a champion,” he concluded, “someone willing to make a bet on this region and start to create those opportunities and make it easy for people to remain here.”

A company, in other words, with a little spine.