Originally Published EMDM October 2005
Regional Focus: New England
New England Cultivates Its Med-Tech Heritage
World-class educational resources, a manufacturing tradition, and dedicated workforce continue to build a foundation for success in the region
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If the world is indeed flat, as New York Times columnist Thomas L. Friedman writes in his recent book chronicling globalization, medical device manufacturers have yet one more reason to defy distances and look across the pond. Specifically, they should consider tapping into the riches of New England to fulfill some of their outsourcing needs. The cradle of the United States has a storied manufacturing tradition, many envied academic institutions, and long historical ties with medical technology.
Composed of six states—Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont—the region has a total population of approximately 14 million, making up less than 5% of the US population, based on 2003 US Census data. Yet an estimated 36,000 people in New England work in medical manufacturing.
The seeds of manufacturing were planted soon after the first settlers arrived. Early New Englanders found it difficult to farm the land in large lots, as was common in the South. By 1750, shipbuilding, fishing, and trade were the main sources of income. In their business dealings, residents gained a reputation for hard work, thrift, and ingenuity. When the Industrial Revolution reached America in the early 19th century, these traits came in quite handy. New factories sprang up in Massachusetts, Connecticut, and Rhode Island to produce such goods as clothing, rifles, and clocks.
In the 20th century, aerospace and military manufacturing plants were added to the mix, building the area’s reputation for precision metal machining and product design. Today, the area is host to many medical device manufacturers. Many OEMs that used to primarily serve the aerospace industry have found that their skills in machining and metal fabrication lend themselves to medical device design and production.
According to a 2004 report by the Biomedical Engineering and Alliance Consortium (BEACON; Hartford, CT), at least 314 medical device companies can be found along the I-91 corridor, a highway that crosses a large portion of western Massachusetts and central Connecticut. BEACON’s report goes on to say that the availability of precision manufacturing facilities, the proximity to Boston and New York, and access to universities and medical centres are among the advantages of operating a medical device manufacturing business in the vicinity of this route. Frank O’Brien, president of O’Brien Compliance (Lowell, MA), sums it up by saying, “With medical device manufacturing, it always comes down to venture capital and doctors with ideas.”
The Cream of the Crop
Many New England–based medical device company executives say that the area’s workforce is beyond compare. Most attribute the volume of highly skilled workers to the large number of universities in the area. Worcester Polytechnic Institute (WPI), MIT, the University of Connecticut’s Institute of Material Sciences, Northeastern, and the University of Massachusetts at Lowell are among the schools that manufacturers work with to bring the best and brightest to their facilities.
“Some of the best design engineers for medical devices are in this area. They know the technology, they know metals, they know coatings that can be put on metals,” says George Keeler, president of Tech-Etch Inc. (Plymouth, MA). “We’ve got skilled talent in electromechanical, analogue, and digital engineering,” adds Joseph Carlone, president and CEO of Linemaster Switch Corp. (Woodstock, CT).
Many companies have made concentrated efforts to work with local educational systems to recruit employees. NP Medical, a supplier of disposable fluid control products based in Clinton, MA, gains access to cutting-edge medical technology by partnering with WPI’s bioengineering institute.
Suppliers are also very vocal about their respect for the workers. “I’m really proud of the workforce in this area,” states Jim Binch, president and CEO of Memry Corp. (Bethel CT). “[Firms tend to] have productive, dedicated workforces with very low turnover rates.” Other manufacturers agree. “I’m here because of the people,” says Robert Bubencik, president of Eagle Stainless Steel (Franklin, MA). “We have a lot of smart people who are willing to learn and want to work with us.”
A Veritable Smorgasbord
There’s a mind-boggling array of manufacturers and suppliers in New England. From automation to sensors, from polymers to metals, from tubing to flexible circuit boards—all can be found within just a few hours’ drive of Boston. Many companies with a global presence are headquartered in the region, such as Millipore (Billerica, MA), Nypro Inc. (Clinton, MA), Memry Corp. (Bethel, CT), and MicroSpec Corp. (Peterborough, NH).
A number of companies providing switches and sensors are located in the area. Hypertronics (Hudson, MA) offers modular, circular, PCB, and off-the-shelf connectors to medical OEMs. The company’s core technology revolves around Hypertac, a patented contact system where the shape of the contact sleeve is formed by wires strung at an angle to the socket’s axis. When the pin is inserted into this sleeve, the wires stretch around it, providing a number of linear contact paths and 360° of wrap. “Using this technology, the connector is impervious to shock and vibration, and will last for millions of fretting cycles,” says executive vice president Stuart Morris-Hipkins. “Each socket, no matter how small, has at least five wires, so we can achieve high currents,” adds medical industry manager Arnie Feinberg.
Another switch-making company is Linemaster Switch Corp. (Woodstock, CT). Founded in the 1930s, the firm provides foot switches for medical applications. Its latest products include infrared and linear wireless foot switches, both of which are geared toward creating a “wireless operating room.”
There are also a high number of polymer suppliers and plastics manufacturers in the area. Memry Corp., a provider of shape-memory alloy solutions for more than 20 years, recently acquired Putnam Plastics in order to offer more sophisticated polymers as well as total component assembly. “We’re increasingly combining shape-memory with polymer extrusions,” says Memry Corp. CEO Binch. He has rave reviews for local polymer supplier Foster Corp. (Putnam, CT), which offers a full line of medical-grade thermoplastic and fluoropolymer compounds for extrusion and injection molding.
Flow Control Products
Other New England manufacturers focus on components such as filters, check valves, and pumps. NP Medical, a division of Nypro Inc., offers antisiphon and needleless valves among an array of fluid control products. In a move to broaden its scope, the company recently purchased a line of IV filtration products from long-time customer Millipore. The Lee Co. (Westbrook, CT) supplies components that includes a range of solenoid valves, dual-metering flow control valves, and dispensing pumps.
Several firms supply high-precision services in metal fabrication, etching, and tubing. Tech-Etch uses photoetching, chemical milling, and laser machining to manufacture precision parts for medical use. The company also produces flexible printed circuits, which have been used in ultrasound equipment and other patient-monitoring devices. High-tolerance thermoplastic tubing can be found at Dunn Industries Inc. (Manchester, NH). Specializing in the extrusion of medical-grade tubing, the company offers tubing in sizes as small as 0.01-in. OD × 0.005-in. ID and as large as 0.25 in.
But wait, there’s more. Much more. A host of other leading suppliers to med-tech manufacturers are profiled throughout this section. In addition, more than 100 New England–based companies can be sourced in our online directory at www.devicelink.com/company/euro/index.html.
Kerk Motion Products Inc.
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The compact design of a leadscrew-based linear actuator allows for its easy positioning in such medical industrial applications as autodispensing and packaging systems, and instrumentation. The Mini ScrewRail developed by Kerk Motion Products Inc. (Hollis, NH) consists of a precision-rolled leadscrew, supported by sealed bearings and contained within a concentric steel guide rail, which drives an integrated nut bushing. Because all alignment requirements are provided by the actuator design, the unit’s support and positioning are less critical than is the case with traditional slide assemblies. The actuator is available with an outside diameter of 0.375 in.
The proprietary Kerkote TFE coating applied to the leadscrew and guide rail minimizes drag torque and extends wear life, while Kerkite high-performance polymers used in construction make the entire assembly self-lubricating and maintenance free. The actuator comes with a wide range of screw leads and in standard or custom mounting configurations.
New England Precision Grinding Inc.
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Precision wire and tubing manufacturing services are offered to medical device manufacturers by an ISO 9001:2000–certified contractor. New England Precision Grinding Inc. (Holliston, MA) uses proprietary machining technologies to fabricate wire and wire products.
Tight-tolerance medical wire made of Type 304 stainless steel, nitinol, or other materials can be supplied in sizes as small as 0.003 in. diam and in lengths of 60–73 in. In producing wire components, the company handles every aspect of a project from procurement of the raw materials to providing product-finishing services.
The proprietary Accu-Point technology is used to produce multifaceted tips on the ends of small-diameter wire and tubing. In addition, a new microprecision grinding service focuses on the fabrication of intricate components.
BetaTherm Sensors
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Disposable temperature probe assemblies are available to optimize monitoring accuracy and clinical hygiene standards in medical equipment and patient-monitoring applications. The products are supplied in a variety of configurations and custom as well as standard versions by BetaTherm Sensors. Headquartered in Galway, Ireland, the firm’s US facility is located in Shrewsbury, MA.
The negative-temperature-coefficient (NTC) thermistor sensors offer electrical sensitivity, durability, and interchangeability. The vinyl-capped sensors can be incorporated into catheters or invasive medical devices.
The 0.078-in. probes operate between –40° and 80°C with a tight temperature tolerance of ±0.1°C at 37°C. They come with many types of connectors, including Molex, Phono-style, and three-pin DIN, and with various resistance-versus-temperature characteristics, a selection of lead wires and lengths, and a custom choice of insulation.
Filtrona Extrusion
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High-pressure contrast-injection-line tubing products are designed to meet diverse medical device industry needs through a variety of configurations and flexibility levels. The three product families, offered by Filtrona Extrusion (Northborough, MA), are transparent to facilitate identification of contrast liquids, can be sterilized by EtO or gamma irradiation, deliver performance to 1200 psi, and feature a minimum bend radius of 1¼8 in.
Pexclear PVC tubing, the stiffest of the product line, has an inner diameter of 0.087 in. and outside diameter of 0.187 in. Combining polyurethane and nylon for flexibility and strength, two-layer DuoPex provides an alternative to stiffer PVC lines that can be difficult to handle during contrast-injection procedures. Premium Pexbraid nylon-braided polyurethane tubing, offering good pliancy and strength, measures 0.071 in. ID and 0.142 in. OD, as does DuoPex. Pexclear and DuoPex are supplied in standard and custom cut lengths and on spools; Pexbraid comes only in cut lengths.
Haydon Switch & Instrument Inc.
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Joining a line of hybrid motors is a series of very small advanced-technology linear actuators that include captive, noncaptive, and external linear designs. The products are available from Haydon Switch & Instrument Inc. (Waterbury, CT).
The customizable Size 8 21000-series actuators occupy a 0.8 sq. in. space and include many patented high-performance and -endurance features. They come in a wide variety of resolutions ranging from 0.0015 to 0.04 mm per step and deliver thrust up to 4.5 kg without compromising operating life. The devices can be microstepped for even finer resolution.
Engineering thermoplastics incorporated into the rotor drive nut through proprietary manufacturing processes, along with a stainless-steel acme leadscrew, make the motors very efficient and durable.
Potential applications for the 21000-series actuators include medical equipment, valve control, x-y tables, and handheld instruments.
Performance Motion Devices Inc.
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A motor-controlling IC with a precision velocity loop for three-phase brushless dc motors is designed for high-performance brushless-motor amplifiers used in medical automation and scientific instrumentation. The product is available from Performance Motion Devices Inc. (Lexington, MA).
The compact, intelligent, single-axis MC73110 operates in internal velocity profile mode, velocity mode with an external velocity command signal, or torque mode with an external torque command signal. It employs velocity feedback from either an encoder or a direct-input analogue tachometer signal, while a velocity scalar term, in conjunction with an averaging velocity estimator, makes possible control of motor speed and acceleration across a wide range of profiles. A velocity integrator loop can be enabled when position loop control characteristics are required. The device can be operated as a stand-alone intelligent motion IC or, via serial commands, as a programmable axis controller.
EAO Switch Corp.
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Bright blue key illumination generated by LEDs that enables use by the visually impaired is an option for a range of 12- and 16-key pads. Keypads in the S-series range, available from EAO Switch Corp. (Milford, CT), can also be customized with a blind pin locator on key 5 and optional raised characters. A dedicated-font option is available as well to enhance legibility.
Full keypad customization services offered for this series include full-color front-plate designs and laser engraving and marking. The pads can be supplied in standard, telephone, and hexidecimal II configurations, with anti-pull-off keys made of Zamak. The series is tested to 4 million operations and protected to IP67.
Foster Corp.
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A developer of specialty polymers has been issued a patent for a nanotechnology that enhances the mechanical properties of polymer composites. NanoMed compounds from Foster Corp. (Putnam, CT) combine nanoparticle and cross-linking technologies to increase strength, elongation, and flame-retardant properties in the polymer matrix.
The enhanced polymers are suitable for intravascular or balloon-type catheter applications that use Pebax or nylon shafts with flexible distal tips. Stiffness is increased relative to the tip for improved torque and control during procedures. Previous approaches for increasing shaft control have included increased reinforcement additives in the polymer, braided reinforcement structures, and multilayer shaft extrusions. The new technology allows for increased performance in thinner wall sections without substantial reductions in shaft toughness and elongation.
According to company president Larry Acquarulo, “Medical device companies are challenging material suppliers to provide more performance with less material. This allows them to develop smaller devices for less- invasive procedures. Our NanoMed compounds, and this patented nanotechnology in particular, are meeting this challenge by providing significantly increased polymer performance in small, thin sections.”
Kinetic Instruments Inc.
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A high-output LED curing light for benchtop assembly applications comes with wavelength-specific probes of 375, 395, and 470 nm. The system, offered by Kinetic Instruments Inc. (Bethel, CT), is designed to cure a wide range of UV adhesives. The SpotCure-B6 is also available in a portable configuration for field applications.
A convenient soldering-station design automatically turns on the light when the probe is removed from its holder and turns it off when it is replaced. A foot pedal can be used for hands-free operation. The system can be operated manually or by using selectable timed cycles.
HBControls Inc.
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Compact relays premounted on a DIN-rail clip constitute multizone heater control banks measuring just 3 × 9 in. The HBC-EZ-series relays accept ac or dc control inputs and are available with a preinstalled controller wiring harness for single-phase; three-phase, two-pole; or three-phase, three-pole applications.
The products are available through HBControls Inc. (Fall River, MA). Their features include zero cross-switching and a maximum output of 6 A per pole at an ambient temperature of 40°C. The dc model has an input control voltage range of 4–15 V, and the ac model has a corresponding range of 90– 140 V rms. Operating output voltage is 48– 660 V rms. Transient overvoltage protection up to 1200 V peak is provided.
Carrying UL, CSA, and CE approvals, these heater control banks are suited for such heating applications as medical devices and plastics molding.
TM Electronics Inc.
A nondestructive chamber-type leak tester for laboratory and quality control applications produces precise quantitative test results for blister cards. Designed by TM Electronics Inc. (Boylston, MA), the Solution-CBC chamber test system combines the sensitivity of pressure- or vacuum-decay leak testing with the simplicity of sealed fixtures. It is able to detect holes as small as 5 µm in blister card backings.
The easy-to-use, quick loading high-resolution pneumatic pressure or vacuum tester offers consistent, repeatable, and reliable readings in test cycles that can be completed in less than 30 seconds. Operators can store up to 100 different functional programs in the instrument and can link programs to create a sequence of application-specific tests. From the touch screen menu, they can control test parameters, view statistical analyses, and download files.
The system’s test fixture is custom designed to accommodate the user’s blister cards. Interchangeable test chambers are available to suit various card sizes and shapes.
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SF Medical
A designer and manufacturer supplies a variety of silicone rubber–based products to the medical device industry. The Pharma-Lim line of liquid-injection-moulded products from SF Medical (Hudson, MA) includes moulded triclamp ends; y-, t-, and cross-shape elbows; bottle stoppers with or without tubing; and custom tube manifolds.
The company’s US FDA–registered manufacturing facility includes moulding, die-cutting, braiding, and extruding equipment. Modern laser measurement technology is used to ensure uniformity and product integrity. All products and devices are manufactured to strict GMP requirements and meet USP Class VI specifications.
Sensortechnics Inc.
High-accuracy amplified pressure sensors are precision calibrated and temperature compensated using application-specific integrated circuit technologies. Offered in pressure-sensing ranges of 0–1 to 0–100 psi and 0–±1 to 0–±15 psi, sensors in the 50S series achieve an overall accuracy, including temperature effects, of ±0.5 to ±2% of full scale. They are engineered by Sensortechnics Inc., a firm headquartered in Pucheim, Germany, that operates a US sales office in Walpole, MA.
The OEM sensors are intended for use with air and noncorrosive gases in medical instrumentation and comply fully with the EN 61000-4-3, EN 61000-4-6, and EN 55011 standards for electromagnetic compatibility.
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