Medical Device Industry Thrives

New England has long been recognized as a major hub for biotechnology and pharmaceuticals. What isn't as well known is that New England is also a major player in the medical device industry. It's an industry that has proven itself able to weather the ups and downs of the general economy, which makes it a good risk for job stability. Chemical engineers are in demand in this industry--as are chemists (C&EN, July 19, page 35)--and play a vital role in keeping it creative and profitable.

"Massachusetts has the second largest concentration of medical device companies in the U.S.," says Thomas J. Sommer, president of the Massachusetts Medical Device Industry Council (MassMEDIC).

"We have a large number of world-class research institutions spinning out new technology; teaching hospitals that are providing clinical expertise for the development of these products; and a trained, skilled workforce, thanks to the educational institutions in this area. There is also a strong venture-capital community that is interested in supporting emerging medical technology. New England has been able to leverage these factors to provide a supportive environment."

The center of the New England medical device industry is in Massachusetts, starting with the greater Boston metro area and extending from the northwest suburbs to the south, with additional activity in Rhode Island, Connecticut, and southern New Hampshire. "If you look at the concentration of the cluster, it's west and north of the city, although Johnson & Johnson and Haemonetics have significant facilities on the south shore," Sommer says.

Massachusetts consistently ranks among the top states by a number of measures, according to a 2004 report, "Medical Devices: Supporting the Massachusetts Economy (PDF format)," conducted by the University of Massachusetts (UMass) for MassMEDIC. Many of the major medical device companies are located in the state, including Boston Scientific, Smith & Nephew Endoscopy, Tyco Healthcare, and Philips Medical Systems. According to U.S. Census Bureau business data cited in the study, 221 establishments had more than 20,000 payroll employees and a total payroll of $1.16 billion in March 2001, the most recent data available.

The medical device industry is so prevalent in Massachusetts in that it "comprises a larger part of the state's economy than it does the national economy," according to the UMass report. In 2001, 6.1 of every 1,000 workers in Massachusetts were employed in the medical device industry, compared with 2.6 nationwide.

The medical device industry had a substantial "ripple effect" on the state's economy in 2002, the UMass report determined. Every 100 jobs were associated with another 79 jobs in related industries, creating 36,000 total jobs. Every dollar of industry output was linked to 45 cents of output from associated Massachusetts firms. The UMass report estimated that the total economic impact of the medical device industry on the state was $7.3 billion.

This is all good news for chemical engineers, whose knowledge of both chemistry and engineering contribute to developing devices and procedures to address medical problems. The aging of the population and the focus on health issues have influenced the demand for better medical devices and sophisticated equipment. However, that demand is also accompanied by concerns about cost efficiency and effectiveness.

"Chemical engineers are trained to solve problems," says Terri A. Camesano, assistant professor of chemical engineering at Worcester Polytechnic Institute, in Massachusetts. "Those skill sets--combined with knowledge in engineering fundamentals of mass and heat transfer, fluid mechanics, colloid and surface science, and reaction engineering--prepare chemical engineers to adapt themselves to the needs of various industries, including the medical device industry."

Chemical engineers with pharmaceutical and biotechnology experience are well positioned for careers in the medical device industry because of their expertise in drug development and process development. "The industry hires people with a wide spectrum of skills," Sommer says, "from people with high school diplomas and associate degrees to work in manufacturing and assembly to college graduates to work in management. But those who have an engineering background are highly valued."

Camesano agrees. For example, "chemical engineers work on noninvasive biosensors for glucose determination and oxygen monitoring by using their knowledge of mass transfer and chemical reactions at surfaces. This unique combination of a broad undergraduate curriculum with a focus on problem-solving skills gives chemical engineers an advantage in the medical device industry," she says.

Joseph Mullings, president and chief executive officer of the Mullings Group in Norwalk, Conn., a search firm that specializes in recruiting for the medical device, pharmaceutical, and biotechnology industries, sees a trend in the medical device marketplace with the interaction between physical and biological systems. "Companies are paying close attention to the business opportunities arising from the combination of devices, cells, drugs, and how it offers a superior solution to treating disease," he says.

THE INTRODUCTION of the drug-eluting stent generated a lot of interest in coatings on medical devices, Mullings adds, because it was revolutionary: a drug-device combination. "Previously, coatings weren't a major factor in medical devices," he explains, "but people noticed when the drug-coated stent arrived and brought a projected $3 billion to $5 billion market with it." Drug-eluting stents are mesh tubes coated with a slow-release drug that helps to prevent coronary restenosis, a condition where the coronary artery renarrows after coronary angioplasty. Cordis and Boston Scientific are the major competitors in this market, although other companies' products are awaiting regulatory approval.

The value that chemical engineers bring to the medical device industry, Mullings says, is that they understand the chemistry involved in the scale-up process of putting a drug coating onto a porous product. "The subject of site-specific drug delivery versus the systemic approach of the past brings new challenges," he adds, "because the former allows for a more precise delivery of a series of drugs to a specific site. The challenges of the product and process development are substantial."

As with any industry, there has been pressure in the medical device industry to improve margins, be more competitive, and identify core competencies. As a result, it has consolidated and outsourced some manufacturing. That can be good for contract manufacturers like Memry Corp. in Bethel, Conn., which counts medical device makers Boston Scientific, Medtronic, and Guidant among its customers.

Memry provides design, engineering, development, and manufacturing services to the medical device and other industries using its nitinol shape-memory alloy technologies. Nitinol is a generic name for a family of nickel-titanium alloys; the name comes from nickel (Ni), titanium (Ti), and Naval Ordnance Laboratories, where the alloy was discovered. Shape- memory alloys expand in response to body temperature or electromagnetic fields, which makes them a useful material in an implanted device such as a stent.

Memry hires chemical engineers as well as industrial engineers, process engineers, and laser engineers, to name just a few. "As the end user wants more and customer demand increases, companies want to work with vendors that can contribute on many different levels and add value to their designs," says Jim Hartle, director of corporate communications. "We offer design consultation and support. When someone has an idea of what they want to do with nitinol, they'll come to us, and we'll make sure it's feasible. We have a skill set that is responsive.

"We're really a partner with the manufacturers. We're vested in what we do because we can see the product as it's going to be implemented in the field, knowing that it's going to be used in a medical procedure to help someone."

Mullings observes that outsourcing and consolidation have not affected the medical device industry as much as they have affected other industries. Mullings attributes this to the industry's highly regulated environment.

"You don't see the explosive growth to catch a wave because the Food & Drug Administration regulates how quickly you can bring a product to market. Companies have the infrastructure in place to bring a device to market as they phase out older devices. Bigger companies have the capacity and want to keep it in-house," he says.

As for future industry growth, Sommer says the markets that will likely experience the highest growth are orthopedics and implants, cardiac devices, and women's health products. Boston Scientific, for example, is developing an endosurgical unit in Marlborough, and Switzerland-based Straumann, which produces dental implants and dental tissue regeneration products, is building a new combined U.S. headquarters, training, and production center in Andover, Mass. "We've seen organizations growing here in the state over the past two or three years," he says.

Mullings agrees. "These markets specifically are taking on a wide range of challenges in the chemistry marketplace," he says. "There are issues like biocompatibility of implants, such as a hip or knee replacement; antimicrobial issues with sterilization; coatings for devices to navigate smaller devices into smaller places; coatings for drug release to treat various diseases; and gels and adhesives that are used for devices, especially in some of the microcatheters that are under development."

He adds: "Combination devices are becoming more common. Companies are submitting more applications to FDA for devices that combine a drug with a device, and FDA is becoming more savvy and regulating that space more closely."

There has always been a strong market for medical devices manufacturing in the U.S., Sommer says. "Our products have FDA approval, which is considered the gold standard. People all over the world want to be treated with and have access to U.S. devices because there is a level of safety and effectiveness that the FDA approval brings with it."

After all, Sommer observes, "people want to still be able to climb Mount Washington when they're 75."