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Combo Therapy Helps Paralyzed Rats Walk

Then they gave the rats drugs that act on serotonin and administered low levels of electrical currents to the area below the spinal cord injury. This combination sparked walking in the rats' hind legs. The continual treadmill therapy during the course of weeks helped the rats regain weight-bearing walking, but they were not able to walk on their own due to the spinal cord injury. Although this is early-stage research, it could have implications for neuroprosthetic devices in terms of how the devices activate the spinal cord's rhythmic circuitry.

White Paper Highlights Microbial Control for Device Manufacturing

Environmental testing and monitoring programs are essential elements in medical device manufacturing facilities. Companies must understand industrial sterilization and contamination control procedures to bring products to market on time and on budget. A new white paper titled "Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers" reviews the key elements of a best-practice environmental testing program for medical device manufacturing. Authored by Steven Wieczorek, head of environmental testing, monitoring, and certification groups at Microtest Laboratories (Agawam, MA) , the white paper spotlights sterilization standards, FDA requirements, and the critical factors for maintaining controlled environments. Topics include what is required, viable versus nonviable particulates, sampling plans, validation management, sterilization programs, cost and product savings, critical factors, and the benefits of experience. The paper also discusses how these challenges can be met with the assistance of an update-to-date testing laboratory. In attempting to meet regulatory demands from sources such as the FDA, the greatest challenge for medical device manufacturers can be determining what is required to achieve compliance. How must manufacturers design, implement, certify, and maintain correct sterilization and environmental monitoring programs? Unfortunately, there is no single reference document that U.S. manufacturers can rely on to help them design, validate, and demonstrate room-class compliance. The purpose of this white paper is to contribute to manufacturers' knowledge about compliance requirements.

Supplier Hones Medical Device Capabilities

MD&M MIDWEST 2009: FIRST-TIME EXHIBITORS

Supplier Hones Medical Device Capabilities
Bob Michaels

Medical device processing equipment at Trinity Biomedical is used to wash and sterilize components after machining.

When it comes to serving the medical device industry, Trinity Biomedical Inc. (Menomonee Falls, WI) is on a mission to improve the quality of human life. “We believe that we can bring world-class quality to top medical manufacturing and cleanroom assemblies while having a chance to save lives in the process,” says Tom McAdams, general manager of Trinity. To that end, the company specializes in wire forming, automated ultrasonic washing and passivation, cleanroom assembly and packaging, and advanced machining for medical device applications.


Founded by Fred Reich in 1965, Trinity’s parent company, Reich Tool & Design Inc. (RTD), began to receive medical orders soon after its establishment. In the years to come, Reich Tool & Design would grow to provide a range of medical components and services to complement its cleanroom and machining operations, such as medical stampings, fixtures, and gauges; prototyping for manufacturability; reverse engineering; and product R&D.

Following Fred Reich’s retirement in 1999, his sons Fritz and Brett took the helm as president and vice president, respectively, helping to expand the company’s reach into the medical device manufacturing sector. With approximately 30% of RTD’s business concentrated in aerospace, medical, and energy products, the firm recognized the importance of expanding its medical business, according to McAdams. As a result, he joined the Reich brothers in founding Trinity Biomedical in 2008.

“We have spent the last few years honing our skills and assembling a medical manufacturing team to handle the most critical machining, assembly, and medical device projects,” McAdams remarks. With experience in the manufacture of wire forms, cannulae, and guidewires, and in such services as citric passivation and sterilization, the company devotes most of its production output to major research colleges and device companies throughout the country.

Since its inception, the vendor has modernized its equipment base many times over while undertaking several expansions to accommodate its growing business. From the construction of a 2000-sq-ft facility in 1995, the company expanded to 17,000 sq ft in 1998 and again to 23,000 sq ft in 2002. In 2007, the RTD Innovation Center, an ISO 9001:2000–certified facility that houses both RTD and Trinity, opened with 52,000 sq ft of space, including cleanrooms ranging from Class 100,000 to Class 10,000. “At Trinity Biomedical, we are able to rapid prototype a new design or reverse-engineer a product from inception to final packaging within our cleanroom’s large footprint,” McAdams notes. To pursue its mission of saving lives, the company will soon be adding a second cleanroom with approximately 2500 sq ft of Class 10,000 floor space.

Trinity Biomedical Inc.
www.trinitybiomedical.com
Booth #4038


Copyright ©2009 Medical Product Manufacturing News

Contractor Puts Its Stamp on Medical Device Components

MD&M MIDWEST 2009: FIRST-TIME EXHIBITORS

Contractor Puts Its Stamp on Medical Device Components
Bob Michaels

Perfection Spring & Stamping offers clips, contacts, terminals, brackets, heat sinks, chassis, and fasteners for medical applications.

Founded by Louis and Barbara Kahn, Perfection Spring & Stamping Corp. (Mount Prospect, IL) started out in 1955 with $10,000 in capital for the purchase of a coiling machine, a “very used” four-slice machine, some old toolroom equipment, and a garage on Pulaski Ave. While Louis went on the road during the day to sell parts, Barbara ran the machines at night. From those humble beginnings, the pair laid the groundwork for what the manufacturer has become today: a provider of custom stampings, springs, wire forms, assemblies, prototypes, and tooling for short-run and high-volume production requirements.


Once up and running, the company began to serve industrial customers such as A.B. Dick, Bell & Howell, Warwick Television, and RCA, branching out to the medical device manufacturing sector in the early 1990s. “Our customer base spans many different markets, which has allowed us to serve the medical market,” remarks Joshua Kahn, son of Louis Kahn and the firm’s executive vice president of sales.

In its first foray into the medical device market, Perfection Spring & Stamping provided brackets for an MRI machine and a range of parts for durable medical equipment. Since then, the company has worked with companies to offer custom parts for pharmaceutical dispensing machines, disposable speculums, patient-handling systems, and hazmat containers for disposable syringes. “As we work with engineers from the development stage through prototype and then on to production, we are able to provide high-quality engineered components to our customers, allowing them to build cost-effective products for their customers,” Kahn says.

Offering a range of components, including clips, contacts, terminals, brackets, heat sinks, chassis, covers, and fasteners manufactured from standard and precious raw materials, the single-source supplier performs a variety of metal-forming applications under one roof.

At MD&M Midwest, the manufacturer will highlight what it dubs “engineered cost savings.” “By early involvement [with customers], we can put our expertise to work at the design stage for custom metal components, often eliminating secondary and finishing operations, part weight, and other supply-chain costs,” Kahn explains. “Ultimately, we position ourselves as though we were a division of every company we do business with and apply the same focus to engineered-product cost reduction as do our customers.

Perfection Spring & Stamping Corp.
www.pss-corp.com
Booth #4428


Copyright ©2009 Medical Product Manufacturing News

Agency Speaks the Medtech Language

MD&M MIDWEST 2009: FIRST-TIME EXHIBITORS

Agency Speaks the Medtech Language

Bob Michaels

Whether an OEM markets catheters in the United States, Röntgengeräte (x-ray machines) in Germany, instrumentation chirurgicale (surgical instrumentation) in France, or 输液器械 (shuye qixie; IV devices) in China, the chances are that it will require foreign-language assistance. The device maker will likely rely on an international body of research, adhere to international standards, contract with foreign businesses, and sell its products abroad. That’s where Linguanational Translations Inc. (Chicago) comes into play.


“In my experience, the medical device industry has a significant need for translation service providers,” remarks Janie Markos, Linguanational’s president. “This is especially so since the research and development process is costly, requiring companies to handle their R&D procedures overseas where it is more cost-efficient. For this reason, all documentation must be in the native language of the country the R&D is being handled in.”

To meet the needs of an increasingly globalized economy, the company offers an array of services, including the translation of medical device operator manuals, user guides, product instructions, standard operating procedures, and patents. It also offers translations for multilingual product packaging, marketing material, contracts, leases, and articles.

Specializing in more than 100 languages—from Spanish and Russian to Japanese and Korean and most everything in between—the company employs native-speaking linguists with industry expertise in a range of fields. In addition to providing translations and on-site interpretation for business meetings, Linguanational provides back-translation, Web site translation and localization, transcription, voice-overs, cultural reviews and consulting, and typesetting, layout, and desktop publishing.

“In an economically interconnected world, companies demand translation services to be able to compete in the global market,” Markos says.

Linguanational Translations Inc.
www.linguanational.com
Booth #3917


Copyright ©2009 Medical Product Manufacturing News

Revised Standard Details Cytotoxicity Testing of Materials

A revised standard from the Association for the Advancement of Medical Instrumentation (AAMI) provides medical device manufacturers with information on how to improve the safety of medical device materials. An update of the 1999 edition of ANSI/AAMI/ISO standard 10993-5:2009, Biological Evaluation of Medical Devices--Part 5: Tests for in vitro Cytotoxicity advises manufacturers on how to use in vitro cytotoxicity testing to cost-effectively and efficiently evaluate medical device materials for potential harm. In vitro cytotoxicity testing involves placing a device or material in a solvent at a certain temperature for a period of time. While the solvent is usually a serum-supplemented cell culture medium, other types of solvents such as saline can be used. "That wash of the device/material is applied to cell cultures, and those cell cultures are examined to determine whether the cells are still living," remarks Lisa Olson, vice president and general manager of WuXi AppTec Inc. (St. Paul, MN) and co-chair of the AAMI biological evaluation working group 05, which played an active role in the development of the international standard. "If the cells are living, that is a good thing. It indicates that there is nothing in the device that is actively killing them off." The revised standard contains new information to promote more-objective testing. "An important change in the standard is the emphasis placed on quantitative methods of cytotoxicity testing that generate actual values related to the viability of the cells, whereas previously, qualitative means that microscopically evaluated morphological changes were primarily relied upon," says Vana S. Poolava, manager of standards development and communication for Philips Healthcare (Bothell, WA) and co-chair of the AAMI biological evaluation working group 05. Extraction testing, for example, requires visual examination of a cell line in the culture and evaluations of the cells' health. "It is subjective, Olson says. "We wanted to get into more quantitative methodologies so it doesn't matter if it is person A or B, and come up with an actual number." Olson believes that as companies develop materials and processes, many of them will use the standard as a simple check before they commence with animal studies.

Switch Maker Gets a Grip on User-Interface Controls

MD&M MIDWEST 2009: FIRST-TIME EXHIBITORS

Switch Maker Gets a Grip on User-Interface Controls
Stephanie Steward

DeltaTech Controls provides switches, wireless and moveable-mount controls, and imaging displays.

Off-highway equipment, such as tractors, may not seem like it has anything in common with medical equipment. But the two industries have almost identical shock, vibration, and electromagnetic compatibility requirements for manufacturing controls, according to Matthew Via, key account manager for DeltaTech Controls (Shakopee, MN). Because of the similarities between the two industries, DeltaTech was able to transfer its skill set early on in order to branch into medical equipment component manufacturing. Specializing in user-interface components, the firm has been making switches and displays for medical products since 1992.


It initially provided custom switch panels and switch-integration services for large, complex products, and supplied switches for handheld devices. In recent years, however, the company has focused on providing magnetic and contactless technology for joysticks for such medical applications as wheelchair and advanced operating table controls. To meet customer demand, the company now also produces user-interface components for such digital imaging equipment as MRI, CT, and ultrasound systems. Moreover, DeltaTech is using its expertise to offer subassembly services and to supply components for patient-monitoring equipment.

Patient-monitoring equipment is becoming a source of growth for the company’s advanced display manufacturing capabilities. Because the cost of display technology has decreased and the processing power has increased to provide more functionality, both the size of the displays and the number of applications for them are increasing.

“Customers using 3-in. displays are now asking for 5- or 10-in. displays,” Via says. And, following the lead of the patient-monitoring equipment market, more imaging equipment makers are seeking to incorporate displays with machine controls, he adds.

While displays are getting larger, switch technology, like many aspects of medical devices, has continued to get smaller. More customers are asking for wireless user-interface controls or controlled-area network controls, which involve less wiring. These components give users more freedom of movement when using the products, Via says. “The growth in wireless is due to customers wanting to get interface controls closer to, or even on, the operator or surgeon themselves so that they and the machine can move to the patient, unencumbered by wires.”

To understand how best to design these products, the company spends a significant amount of time interviewing medical equipment operators and videotaping them in action, noting repetitive movements in particular. This research has made the company adept at integrating ergonomics early on in the engineering design of its customers’ products. In addition to the touch and feel of the user controls, the company also considers the curves and lines of the controls and how they fit in with the overall design of the equipment. “There’s a growing trend to maintain brand, color, and shape, and to make new devices look like part of a common product line,” Via notes.

DeltaTech Controls
www.deltatechcontrols.com
Booth #1441


Copyright ©2009 Medical Product Manufacturing News

Should Medical Devices Multitask?

And are patients forced to spend more money because insurer's insist that home healthcare devices be for medical use only? That is the question asked today by the New York Times. The article, by Ashlee Vance, describes a patient with ALS (Lou Gehrig's Disease) who uses her iPhone to turn text into speech. She had a dedicated medical device to perform this task, but found the item and its price tag (the Medicare-approved device cost her $8000) rather clunky. In contrast, the patient says her iPhone is portable and works with her lifestyle. The logic for insurance companies is hard to refute. They cover medical devices and the hint that a device could do more (surf the Web, play video games) opens up paths for fraud. But consumers expect functionality to keep up with other technology in their homes and industry has not yet delivered. Further, the medical device industry is slow to lower costs on its products, often because those products are made at low volume, using research that serves a specific patient population. Again, the reasoning is logical. Medical device makers are hampered by regulatory restrictions, and reimbursement requirements. But such arguments, however reasonable, may not translate to a patient who must shoulder some cost or haggle for hours with insurance providers. If a healthy person had the choice to spend $8000 on a single-use machine or $300 (the approximate price of an iPhone) on a machine that performs the same task, plus has additional useful functions, that decision would be considered a no-brainer. Why, then, should we expect sick people to make a different decision? If Steve Jobs is right (and I'm inclined to say he is), then general purpose devices will continue to become more common among consumer devices. I've already talked about the increasing popularity of medical apps on smart phones. So what should industry do? What changes can (or should) it make to appeal to the growing body of patients that, above all, want to feel normal?  If consumer devices can fulfill medical needs and still sport sleek looks, multiple functions, and a lower price tag, where is the motivation to purchase heavily-researched but equally heavily-priced medical products?

Medical Device Sector Is Key to the Keystone State's Lehigh Valley

REGIONAL FOCUS: Pennsylvania
Medical Device Sector Is Key to the Keystone State's Lehigh Valley
 
From rust belt to high-tech hub, Pennsylvania's east is becoming one of the country's leading medical device manufacturing centers
 
Bob Michaels
 
69148.eps
A century ago, Pennsylvania was synonymous with industry. From Pittsburgh in the West to Bethlehem in the East, the commonwealth was dotted with coal mines, oil fields, steel mills, and textile and apparel factories. While traditional industrial manufacturing in Pennsylvania has declined over the decades, the service sectors have flourished. With a gross state product totaling $533 billion in 2008, among the largest in the United States, a lion's share of economic output has been concentrated in general services. And of all the service industries, some of the fastest growing ones are concentrated in the medical and health fields.

In 2005, Pennsylvania was ranked among the top-five U.S. states for medical device employment. Two years later, the Philadelphia metropolitan area ranked number three in the country in terms of total employment in the bioscience fields, including medical devices and equipment; drugs and pharmaceuticals; and research, testing, and medical laboratories. At the same time, 80% of the world's pharmaceutical companies were present in the region, which was also among the top-10 metropolitan areas for medical device and equipment employment. For Pennsylvania, the times they are a-changin'.

From Heavy Industry to High-Tech Haven

69149.tif
Less than an hour's drive from Philadelphia and about an hour and a half from New York City is one of the Mid-Atlantic region's up-and-coming biotech hubs: the Lehigh Valley. Between 1990 and 2003, medical device manufacturing was the seventh largest net jobs producer in the area. With a population of 635,000, two interstate highways, and an international airport, the area is well served by 11 colleges and universities that support a skilled workforce and a host of medical device firms and component suppliers. Boasting a medical device manufacturing base that fabricates a multitude of products, from electronic parts and tubing to IV components and vascular systems, the region is home to a variety of suppliers and OEM giants such as Olympus (Center Valley, PA; www.olympusamerica.com), a provider of medical-imaging technology.

One supplier to the medical device industry in the area is Fluortek (Easton, PA; www.fluortek.com). Offering PTFE and thermoplastic extrusions, braid-reinforced catheter tubing, heat-shrink tubing, and component assembly services, the company provides a range of contract manufacturing services. Founded in 1980, the ISO 13485:2003-certified vendor boasts more than 50,000 sq ft of manufacturing space.

There are several advantages to being a medical component outsourcing company in eastern Pennsylvania, comments Karen Werkheiser, Fluortek's sales development manager. "The area provides good colleges nearby to provide an educated workforce. We also have good logistics--a shipping corridor in close proximity to New York City and Philadelphia--without major congestion. In addition, real estate and utilities costs are affordable, and business and real estate taxes are reasonable."

Located just down the road from Fluortek, B. Braun Inc. (Bethlehem, PA; www.bbraunusa.com) is headquartered in the same town that used to be home to Bethlehem Steel, once one of the country's largest steel manufacturers. While the old rusting steel mill along the Lehigh River is being converted into a tourist destination complete with a casino, museum, concert hall, shopping mall, and hotel, B. Braun is choosing to make use of the region's resources by providing a large palette of offerings to the medical device industry.

Delivering a range of contract manufacturing capabilities, the B. Braun OEM Div. serves device makers by designing, assembling, and packaging Class II and Class III medical devices. The company manufactures thousands of standard and specialty items, from components to custom trays. Services available for outsourcing include design and development, project management, manufacturing, packaging, sterilization, private labeling, and quality control.

"The Lehigh Valley area has an outstanding work ethic and pride," says Tom Black, B. Braun's vice president of sales and marketing. "The area also has a heritage of manufacturing." Like Fluortek's Werkheimer, he agrees that the area represents a logistical goldmine. "We enjoy proximity to pharmaceutical and medical device companies in the greater Philadelphia and metro New Jersey markets. With many transportation options, the region is a major distribution hub with ready access to highways, ports in New Jersey and Delaware, rail, and air transportation." B. Braun resides within a day's drive of nearly two-thirds of its customers and within reach of major U.S. markets.

Although Lehigh Valley's heavy industry is a thing of the past, its long history in the area is up front and personal for many people who live and work there. Coming from a family of steelworkers, Joe Horvath, vice president and general manager of Sanbor Corp. (Allentown, PA; www.sanbor.com), comments, "From the perspective of the old industrial base, Sanbor really started toward the end of the decline in the Lehigh Valley. Bethlehem Steel had already wound down. Caterpillar was nearing its end. Mack Truck manufacturing had pretty much already moved south."

Founded 20 years ago, the company flourished in the new environment. While its interconnect division manufactures electronic cable assemblies for a variety of industries, including medical, its medical division provides targeted manufacturing and assembly services that include printed circuit board assembly, plastics molding, and hardware assembly for such products as patient monitors, handheld instruments, and single-use disposables. With manufacturing facilities in China, Sanbor maintains its headquarters in Allentown, in addition to engineering, customer service, sales, and marketing departments.

Lehigh Valley Goes to School

For local manufacturers, one of the region's most important assets is its colleges and universities. B. Braun's Black emphasizes that excellent educational institutions from Boston to Washington, DC, including Lehigh University (Bethlehem, PA; www.lehigh.edu) within miles of its Bethlehem headquarters, are a boon to the medical device manufacturing industry.

A plethora of colleges and universities in the region support the industry's demand for a skilled, trained, and scientifically educated workforce, Werkheiser remarks. In addition to local institutions such as Lehigh University, Northampton Community College (Bethlehem, PA; www.northampton.edu), and Muhlenberg College (Allentown, PA; www.muhlenberg.edu), schools near the Lehigh Valley with biomedical engineering programs include Drexel University (Philadelphia; www.drexel.edu) and the University of Pennsylvania (Philadelphia; www.upenn.edu). Related programs are also offered at Pennsylvania State University (University Park, PA; www.psu.edu), with campuses throughout the commonwealth, and across the state at Carnegie Mellon University (Pittsburgh; www.cmu.edu) and the University of Pittsburgh (www.pitt.edu). Over the state line in nearby New Jersey are Rutgers University (New Brunswick; www.rutgers.edu) and the New Jersey Institute of Technology (Newark; www.njit.edu), many graduates of which work in Pennsylvania's medical device industry.

"Fluortek has received technical support from Lehigh University students on several occasions and from Muhlenberg College," Werkheiser remarks. "It also maintains a collaborative relationship with the New Jersey Institute of Technology." The school is the alma mater of the company's R&D manager. In the last two years, the supplier's R&D department has also sponsored interns from Lafayette College (Easton, PA; www.lafayette.edu) and Rutgers University.

More than 50,000 students are enrolled at various colleges, universities, and technical training schools throughout the Lehigh Valley. The center of the life sciences industry in the region, however, is Lehigh University, the area's only research university. While the university was geared historically toward serving the steel industry in the Lehigh Valley, its focus has shifted as steel has disappeared and biotech has fluorished. Today, chemicals and life sciences are two particular areas of interest at the university. In recent years, Lehigh University has committed itself to increased participation in the life sciences, backing it up with significant investment activity.

In addition to Lehigh University, Northampton Community College plays a prominent role in supporting life sciences activity in the area.
Offering a biotechnology associate degree, the college is involved in life sciences workforce training that provides area businesses with experienced personnel.

Incubators Seed Start-Ups

Administered by the Lehigh Valley Economic Development Corp. (LVEDC; Bethlehem, PA; www.lehighvalley.org), the Southside Bethlehem Keystone Innovation Zone (KIZ) partners with local educational institutions to prepare students for participation in industry. "KIZs create 'knowledge neighborhoods' close to colleges and universities," remarks Margaret McConnell, LVEDC's director of marketing and communication. "In the case of the Southside Bethlehem KIZ, we partner with Lehigh University and Northampton Community College." The KIZ helps entrepreneurs and college graduates that work for business start-ups so that they remain in the area. Consisting of 14 partner organizations, the KIZ has funded more than $450,000 in technology-transfer grants to 24 start-ups, leveraging more than $11,000,000 in total investment.

"The KIZ offers incentives for medical device companies, including technology-transfer grants for start-ups and paid undergraduate and graduate student internships," McConnell explains. "Right now, we have at least five companies in the medical device area developing their products here in the zone. We are also working on a second incubator for companies to complement the Ben Franklin incubator."

The Ben Franklin Technology Partners of Northeastern Pennsylvania (BFTP/NEP; nep.benfranklin.org) supports early-stage technology firms and established manufacturers with funding, people, technology, university connections, and other resources. Serving a 21-county area, it is headquartered on the campus of Lehigh University and has regional offices in Lewisburg, Reading, and Wilkes-Barre.  

All three organizations have helped to revitalize the local economy, says Sanbor's Horvath. "In the '90s, they brought in a lot of high-tech industry, some of which was already here. These organizations provide a lot of seed money for a lot of venture capital and start-up companies." For example, Sanbor is working on a project with a local start-up, providing prototypes and preparing to begin production for a product developed in association with BFTP/NEP.

An array of companies in the Lehigh Valley--from start-ups to mature manufacturers--fabricate products for the medical device, diagnostics, biological, and pharmaceutical sectors, engaging in R&D, manufacturing, packaging, and distribution. If the dead hulk of Bethlehem Steel's former mill on the Lehigh River came to symbolize the decline of the Lehigh Valley at the end of the last century, the growth of the biotech industry in the region represents its potential future.


For more regional focus articles, go to devicelink.com/mpmn/region

Copyright ©2009 Medical Product Manufacturing News

Integra Buys Bankrupt Spinal Implant Company

The company will reveal more details about how the purchase of IST will affect its finances during a Q3 earnings call in November. IST manufactured spinal implants focused on minimally invasive surgery and motion preservation techniques. Integra plans on launching IST's Paramount MIS/open system for percutaneous lumbar fusion procedures in Q1 2010. Other IST products include the Cordant cervical anterior planting system and the Axient line for posterior dynamic stabilization. Integra Spine acquired the IST portfolio of more than 100 U.S. and foreign patents and patent applications, along with trademarks and patent license agreements.