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Articles from 2002 In December

Customized pressure-sensitive tapes.

A line of pressure- sensitive tape and foam products offers customized solutions to the design engineering community. Pro Tapes & Specialties Inc. (Edison, NJ; 800/345-0234) complements its line of single- and double-coated foam tape with foam-tape skiving to accommodate critical thickness specifications. Adhesives can be custom-applied on one or both sides of a wide range of substrates. The tape parts can be supplied in sheet-fed, perforated, or roll form, or as individual pieces. Width tolerances of ±0.001 in. are possible with rewind slitting, while lathe slitting can produce widths as narrow as 1Ž16 in.

Polymer alternative available for a wide range of applications.

Polymer alternative available for a wide range of applications. A premium ethylene propylene diene monomer (EPDM) is designed for high-performance products and continuous-cure extrusion applications. G&E Blended 565 EPDM from Goldsmith & Eggleton Inc. (Wadsworth, OH; 800/321-0954) is manufactured in accordance with a quality management system certified to ISO 9001:2000. Featuring tightly controlled specifications, the ethylene and the ethylidene norbornene are measured and controlled through the entire manufacturing process, giving this grade excellent repeatable processing characteristics. Blended 565 EPDM can also be colored easily, allowing for many product applications.

Unlocking the Future of Combination Products

Originally Published MDDI December 2002


The regulatory scheme for combination products is outdated and inflexible. Despite FDA's best efforts, further legislative reform may ultimately be required.

For many years, combination products were regarded as an important but oddball area of medical product regulation. Though worthy of explicit recognition in the Safe Medical Devices Act of 1990, combination products were still perceived as a somewhat theoretical regulatory problem. To be sure, such products—which combine key aspects of a drug, device, or biological—existed in 1990. But for the most part, they were seen as products of the future, whose potential was yet to be realized.

At the end of 2002, we can safely say that the future is here. The enormous success of drug-eluting stents has brought combination products to the foreground. This new prominence has shown, however, that the existing regulatory approach to combination products is woefully inadequate.

As noted in the lead news story on page 18 of this issue, both FDA and Congress have made significant efforts to correct this deficiency. Early this year, FDA established a central program exclusively to manage the review process for these products. And in its medical device legislation last October, Congress made the combination devices program a formal entity within the office of the commissioner.

While these efforts are a good start, much work remains to be done to improve the smooth regulation of these cutting-edge technologies. One area that must be speedily addressed is the so-called Intercenter Agreements that have governed the regulatory pathways of combination products. As FDA recently stated, "the evolution in technology and scientific knowledge about the mode of action of medical products has in some cases pushed the usefulness of the current Intercenter Agreements past their limits."

The agency expects to update these agreements in the coming months. A thornier problem will be how to update the central concept of "primary mode of action." This is the idea that the main source of a product's therapeutic or diagnostic effect—drug, device, or biological—determines which center should regulate it. But when basing the regulatory framework for combination products on this concept in 1990, Congress did not clearly define the phrase—assuming such definition is even possible.

As the Product Jurisdiction Officer in the agency's Office of the Ombudsman, Suzanne O'Shea is intimately familiar with the concept. At the annual meeting of the Regulatory Affairs Professional Society in Washington, DC, last October, she described in detail the problems it poses. Though assigning products to centers based on the product's primary mode of action may be logical, it is not practical. As O'Shea said, this approach "doesn't allow us to assign combination products based on center resources and expertise."

In addition, the primary mode of action is often unclear. "Lots of people have lots of views of what primary mode of action means. . . . [But] what happens if we don't know how a product works? That happens more frequently than we would like." Even if the primary mode of action is eventually understood, it can be too late to change the decision. "Not so infrequently," said O'Shea, "we find out that we would have made a different decision earlier on. [But] we are very bound by precedent."

FDA held a public hearing on combination products on November 25 specifically to discuss these and related issues. Ideally, the agency will find a workaround solution to the problem of primary mode of action. If not, the future of combination products may once again be within the hands of Congress.

The Editors

Copyright ©2002 Medical Device & Diagnostic Industry

Technical papers for composite formulators.

Two technical papers focus on the use of Poly bd resins in adhesives and electrical applications, respectively. The Poly bd resins from Sartomer Co. (Exton, PA; 610/594-7360) provide formulation flexibility, extremely high water repellency, good low- and high-temperature properties, and excellent adhesion to all substrates. Each technical paper is written for composite formulators, featuring in-depth technical data and useful findings that they can immediately apply to improve both processes and products. Illustrative tables and figures make it easy to scan for key information.

Industry Snapshot

Originally Published MDDI December 2002

From manufacturing and business developments to regulatory and reimbursement activities—key developments and events are captured in this year's .

Compiled by the editors of Medical Device & Diagnostic Industry

The past 12 months were marked by a number of significant events that are shaping the medical device industry's future. Legislation was passed intended to streamline agency oversight and ensure adequate resources for regulation, and a new FDA commissioner was named. The device industry has also proven to have resiliency in uncertain and challenging economic times.

The following pages provide a graphic representation of the industry's current state and identify milestones of the past year.

Copyright ©2002 Medical Device & Diagnostic Industry

Laminating and die-cutting system designed for delicate materials

. A laminating and die-cutting system uses a PID loop to control tension. The Sheet-Fed Laminating/Die-Cutting System from Contech (Goddard, KS; 800/961-6449) processes delicate materials easily and efficiently. Sheets of foam are fed by an automatic sheet-feeder module through a water-heated laminating station. Two layers of adhesive are applied to the top of the material while a substrate is laminated to the bottom. An optically registered die-cutter then cuts out the final product at close tolerances. The final product is removed from the matrix by a knockout station onto a side- exiting conveyor.

Medical Industries Offer Safe Harbor in Stormy Economy

Originally Published MDDI December 2002

In today's uncertain times, medical device and IVD professionals enjoy a relatively calm job market.

Gregg Nighswonger

Despite an unstable economy, sizable layoffs, and the year's wave of corporate and accounting scandals, most respondents to MD&DI's 14th annual salary survey feel relatively secure in their jobs. More than two-thirds of respondents reported feeling as secure in their jobs as they did last year, while 15% indicated they feel more secure—approximately the same as responses received last year. Additionally, more than 90% of respondents reported receiving a raise from their current employer, and more than half received a bonus last year.


MD&DI's annual salary survey presents a statistical portrait of the publication's readership, which includes professionals working full time in medical device and IVD manufacturing. A number of key factors are considered in the selection of survey participants. These include job segment, demographics, and such professional qualifications as education level and experience, among others.

Most respondents (90%) are employed by organizations that produce only medical devices, 5% work for manufacturers making only in vitro diagnostic products, and 5% work for manufacturers that produce both.

This year's typical survey respondent is a white male who is about 44 years old. He is highly educated, works approximately 48 hours a week, and supervises 5.3 employees. He earns $89,900 annually, and received a 6.3% salary increase with his last raise—slightly less than a typical respondent last year. The average male respondent has worked for the same company for approximately 8 years and has been involved in the industry for nearly 13 years.

In comparison, the typical female respondent is about 42 years of age, is also well educated, and works full time for a device manufacturer. She typically works more than 46 hours per week, and supervises 3 employees. She has worked for the same organization for approximately 7 years, and has been in the industry for more than 11 years. Her annual salary is $76,700, and she also received a 6.3% raise last year.


Figure 1. Average salary levels for each region are shown in yellow, total compensation in black, and percent increases of the last raise in white.

Where a respondent works is still a significant factor in the salary received. Figure 1 compares compensation levels and salary increases among the major regions of the United States—West, Midwest, South, and Northeast. The highest salary and total compensation levels were found in the West, and the lowest average salary level was found in the Midwest. Although the lowest total compensation level was reported in the South, the highest average salary increases (6.6%) were also found in that region. The lowest increases were in the Midwest (5.5%).


Figure 2. Types of compensation offered, by company sales volume.

A competitive salary generally exerts significant influence over a respondent's feelings of job satisfaction. When asked whether the amount they are being paid is "too much," "too little," or "about right," 69% of respondents said their compensation is "about right," while 29% believe their compensation to be "too little." Asked to rate their level of job satisfaction on a five-point scale where 5 is "very satisfied," respondents gave their current jobs an average rating of 3.8.

It is interesting to note that among general and corporate managers, more than half of the respondents said they were "very satisfied" with their current position. And no respondent in this category is actively seeking a new job.

In addition to salary, total compensation includes the various benefits an individual receives. This year, salaries made up 74% of the value of total compensation packages reported by survey respondents. Although health, life, and dental insurance are the most common forms of added compensation, many employers still include stock options, education benefits, and pension plans. Figure 2 provides a summary of the most common forms of benefits provided to respondents as part of compensation.


Figure 3. Involvement in a merger or acquisition.

This year's survey identified that portion of respondents who have been involved in a merger or acquisition in the past year. They were then asked about their feelings of job security. As illustrated in Figure 3, nearly 35% of all respondents this year said their company had either been acquired by another firm or had been involved in a merger in the last year. Involvement in such activity, however, appears to have had little effect on respondents' feelings of job security. Figure 4 reflects the respondents' opinion of job security in comparison to whether or not they had been involved in either a merger or acquisition. Although 18% of all respondents reported feeling less secure in their jobs this year, that proportion does not vary by more than 2%, regardless of whether their organization was involved in a merger or acquisition.


Figure 4. Involvement in a merger or acquisition in the past year does not appear to influence job security.

Profiles are provided for each of the seven job categories included in the survey. These categories include: general and corporate management, marketing, product design engineering, production and manufacturing (including packaging and sterility assurance), quality assurance and quality control, regulatory and legal affairs, and research and development.

Details for each job category include median salary and total compensation levels, average raise and amount of most recent bonus, experience with mergers and acquisitions, feelings of job security, length of time with the firm, and job-seeking status. Salary averages are provided in relation to gender, years in the industry, number of employees supervised, and company size.


Not sure what you're worth? Use our salary approximation worksheet to get an idea.

The Salary Approximation Worksheet on page 60 can be used to predict an individual's annual salary. The worksheet helps illustrate the relative importance, or weight, of various factors that can influence an individual's salary level. These can include education, hours worked per week, and job responsibility, among others. It is interesting to note that, unlike years past, the worksheet for 2002 does not include gender as a factor in the salary prediction. Although male respondents still earn more per year than females, the gap is considerably smaller than it was one year ago—a difference of $13,200 this year, compared with $22,600 in 2001.

The salary worksheet applies only to full-time employees with salaries ranging from $30,000 to $180,000, and for whom salary represents at least 60% of the value of their total compensation package.


In conducting this year's survey, a form was designed jointly by MD&DI and Readex Research Inc. (Stillwater, MN) and mailed by Readex in July and August of this year. A total of 1375 surveys were mailed to medical device professionals. Of this number, 624 surveys were returned with usable responses, which provided a 45% response rate.

The survey results are based on the responses of 557 individuals who identified themselves as full-time professionals working for companies that manufacture medical devices or in vitro diagnostics. These responses were weighted during tabulation to reflect accurate population proportions that are representative of the 28,820 MD&DI recipients. In addition to being segmented according to the seven job functions outlined earlier, segments also reflected the respondents' level of responsibility as follows: CEOs and presidents, vice presidents and directors, department heads and supervisors, and engineers and scientists. The margin of error for percentages based on the 557 weighted responses used is ±4.1% at a 95% confidence level.


The 14th Annual MD&DI Salary Survey is available as a bound reprint that contains a copy of this article, tabular breakdowns for the industry as a whole, and previously unpublished tabular breakdowns for the seven surveyed job functions.

Copies cost $60 each. For more information or to place an order, contact the Reprints Desk, Canon Communications llc, 11444 W. Olympic Blvd., Los Angeles, CA 90064; 310/445-4200, fax 310/445-4299.

Gregg Nighswonger is senior editor of Medical Device & Diagnostic Industry.

Copyright ©2002 Medical Device & Diagnostic Industry

Rubber presses provide high-quality parts with excellent tolerances.

Low-profile rubber presses are available up to 700 tn at 2000 psi, with platen sizes up to 36 x 36 in. The units, manufactured by ASB Industries Inc. (Barberton, OH; 330/753-8458), can be supplied with electric, oil, or steam heat platens. All critical dimensions are machined to exact specifications to assure the highest part-production tolerances. The presses are free-standing and can be quickly installed and easily moved, eliminating the need for a bit on the production floor.

Self-Generating Nanotubes Provide "Dial-Up" Properties

Originally Published MDDI December 2002


By manipulating the chirality of the material, researchers can control the direction in which the spiral-shaped nanotubes twist.
(click to enlarge)

Nanotubes have clearly come to be viewed as one of the more promising enabling technologies for advancing medical capabilities over the long term. Potential applications range from new methods of disease treatment to innovative plastics manufacturing techniques.

A Purdue University (West Lafeyette, IN) research team led by Hicham Fenniri, PhD, assistant professor of supramolecular chemistry, announced that it has identified a method for creating multiple "species" of nanotubes that possess unprecedented physical and chemical properties. They add that each species could lead to a different application.

The group also says they have developed a method for exerting control over the nanotubes' formation. This capability enables the team to virtually "dial up" the properties they wish their nanotubes to possess. The findings could expand the range of materials available for use on the nanoscale, according to the researchers.

Says Fenniri, "Instead of being limited to building blocks of one size, shape, and color, it's as though we now have a brickyard with many different varieties. This research could give a nanotechnologist a lot more materials for construction."

Part of the innovative approach taken by the Fenniri team has been to form the nanotubes from synthetic organic molecules. "By using synthetic chemistry, we have gained complete control over the formation of our nanotubes," Fenniri explains. "More control in the lab should give more options to industry."

One way the new nanotubes can be customized is by using them as scaffolding for other materials. The Purdue team's nanotubes look like spiral-shaped stacks of rings; each ring is made of six molecules shaped roughly like pie wedges. On the outside of the spiral, the team attaches other molecules, which hang off the tubes like charms on a charm bracelet. The attached molecules then lend their properties to the outside of the nanotube.

The group has also determined how to manipulate the chirality of the material. This allows the direction in which the spiral-shaped tubes twist to be controlled. The group explains that nature only twists molecules in one direction. The new technique, however, allows tubes to be made that twist in either direction. The result is that "left-handed" nanotubes can be created that have abilities not exhibited by the right-handed versions.

The team also identified some unexpected behaviors displayed by the custom nanotubes—such as self-generation. Says Fenniri, "We have found that the nanotubes promote their own formation. Such behavior is very reminiscent of living systems, in that they replicate and adapt to their environment."

They also found that by placing the raw materials from which nanotubes form into a test tube and adjusting such conditions as temperature and pressure, the nanotubes could organize themselves into one of many different configurations. Some of the formations that occurred had not been seen previously.

The relative ease of manipulating the properties of nanotubes makes Fenniri optimistic that many new applications will be possible. One possibility is to use the nanotubes in disease treatment. "Many drugs destroy infectious bacteria by poking holes in their cellular membranes and allowing their nutrients to leak out, just like pricking a hole in a balloon," he says. "Our nanotubes could also act in this manner, but in addition, they have the ability to lure the bacteria with a bait that guides them to the cell membrane where they can start destroying the cell."

Further research on the tubes' dial-up properties could lead to development of biosensors and drug-delivery systems. Says Fenniri, "Nanotechnology relies on our ability to control the behavior of matter at the molecular scale." He adds, "The versatility and robustness of our system is already pointing the way towards numerous applications in a fairly broad range of disciplines. It should help nanotubes on their way to becoming the nanoworld's jack-of-all-trades."

Copyright ©2002 Medical Device & Diagnostic Industry

Conductive ink designed for plated through-holes.

Creative Materials Inc. (Tyngsboro, MA; 978/649-4700) offers a screen-printable, electrically conductive ink and coating that is particularly useful for plated through-hole applications. The 122-22 system is designed to maintain stable viscosity during all application methods, and has a mild odor. The product features excellent adhesion to FR2, FR3, and FR4 printed circuit board substrates, as well as Kapton, Mylar, glass, and a variety of other substrates. Its applications include electroless plating, and EMI/RFI shielding of polyimide flexible circuits.