Medical Device Link.

MDEA Finalists Exhibit Advanced Diagnostics, Improved Surgical Devices

After evaluating more than 100 products submitted to the 2000 Medical Design Excellence Awards (MDEA) competition, a jury of medical device industry experts has selected 29 finalists representing the competition's 10 categories. Now in its third year, the design competition rewards innovation and engineering excellence in medical product design and manufacturing. The awards program is organized by Canon Communications and sponsored by Medical Device & Diagnostic Industry magazine.

Corporate sponsorship for the 2000 MDEA competition is being provided by DuPont Tyvek (Wilmington, DE), a supplier of sterile packaging materials for medical products; Eastman Chemical Products (Kingsport, TN), a supplier of medical-grade resins, plasticizers, and packaging materials; and Medsource Technologies (Minneapolis), a firm that specializes in full-service outsourcing and complete project management for medical device manufacturing.

The nine-member jury—with expertise in biomedical engineering, human factors engineering, industrial design, medicine, nursing, packaging, and diagnostics—convened during the Medical Design & Manufacturing (MD&M) West 2000 Conference and Exposition this past January in Anaheim, CA. The jurors evaluated the submissions on the basis of design and engineering innovation, cost-effectiveness, benefits to users and patients, appropriate aesthetics, and business impact.

Increased demand for intuitive user interfaces

Commenting on the trends reflected in this year's product submissions, jury chair Michael E. Wiklund said, "In addition to evaluating many devices intended for use in operating rooms or sophisticated laboratories, the panel reviewed a large number of products designed for use in doctors' offices, ambulances, or even in homes. For such products, users can be expected to have relatively less medical knowledge and experience with special technology." Wiklund, a human factors engineering consultant with the American Institutes for Research (Concord, MA), observed that the trend toward alternate-site use "places an increased demand on designers to produce user interfaces that are intuitive and error resistant."

Weighing less than 20 lb, a portable ultrasound system for cardiac imaging was designed by EDGE Product Development and Acuson. It is one of three finalists in the Radiological and Electromechanical Devices category.

Overall, devices designed with significant consideration of the user's needs received high marks from the jurors. "What impressed me about some of the products was the degree of detail to which the designers and engineers studied various aspects of a problem and how best to meet the needs of the end-user," said juror Herbert Voigt, president of the Biomedical Engineering Society and associate professor at Boston University's department of biomedical engineering.

After reviewing entries in the category of rehabilitation and assistive-technology devices, juror Corinna Lathan, PhD, president and CEO of AnthroTronix Inc. (Wheaton, MD) and associate professor of biomedical engineering at the Catholic University of America (Washington, DC), said, "Good design of medical devices needs to take into account many factors about the consumer. What is the level of experience of the person using it? Where will he or she be using it? There was clear attention to these systems-level issues in the finalist products."

Supporting the move of medical professionals toward procedures that minimize patient trauma and reduce hospital stays, many of the finalist products were created to improve minimally invasive surgical procedures. "Devices such as the Sew-Right, Ti-Knot, and AutoSonix system have taken engineering advances into the operating room and permitted a broader range of endoscopic applications," said Eliot S. Lazar, MD, president of elCON Medical (Buffalo, NY). "With these forward-thinking products, surgery is more efficient, less traumatic, and permits quicker and easier patient recovery."

Devices in many of the categories were considered innovative for their small size and portability. "At least five of the finalists wouldn't have been possible five years ago," said juror Douglas Anderson, CEO of Optos plc and chairman of the design firm of Crombie Anderson Associates Ltd. (both in Dunfermline, Scotland). He credited recent advances in component miniaturization for making possible the smaller, less-expensive devices that have recently reached the market.

Miniaturization is key feature of diagnostic devices

Component miniaturization and portability were certainly key features of many of the diagnostic devices submitted to the competition. Examples of this trend included the Careside Analyzer blood-testing system, selected as a finalist for its small footprint, ability to deliver accurate results in minutes, and data storage and transmission capabilities. "We are seeing more point-of-care diagnostic devices that eliminate the need to send patients or materials to the lab and reduce the cost and time required for patient care," added juror Joseph Dyro, PhD, president of Biomedical Resource Group (Setauket, NY), professor of biomedical engineering at Touro College (Dix Hills, NY), and associate professor of anesthesiology at the State University of New York at Stony Brook.

A noninvasive detection system for carpal tunnel syndrome developed by NeuroMetrix and Product Genesis is one of three finalists in the General Hospital Devices and Therapeutic Products category.

Jurors observed that many of the device companies participating in the competition gave significant consideration to environmental issues. Juror Donald Barcan, president of Donbar Industries (Long Valley, NJ), noted that both small and large companies have made source reduction a priority. Craig Jackson, PhD, a medical diagnostics research and development consultant, added that "The attention some companies paid to using environmentally friendly packaging is very pleasing to see. Hopefully, packaging with minimally adverse effects on the environment will one day be so common that it no longer receives comment."

The designers and engineers responsible for this year's finalist products are clearly being rewarded for embracing the "form follows function" philosophy and creating devices with appealing—yet appropriate—aesthetics. As Wiklund observed, "A common denominator among many of the products selected as finalists is their elegant integration of superb functionality and the kind of creature comforts normally associated with consumer products. Many of the entries feature a sculptured form that is both ergonomically correct and attractive to the eye."

The 2000 Medical Design Excellence Awards winners will be announced and displayed at the MD&M East Exposition, June 6­8, 2000, in New York City. For more information about the competition, call Canon Communications at 310/996-9434 or visit the program's Web site at http:// www.MDEAwards.com. —Amy Allen

In Brief

The United States Department of Commerce is sponsoring two medical device trade missions to Australia, Taiwan, Malaysia, and Singapore. The trade missions are centered on a series of one-on-one business appointments with potential buyers, agents, and distributors....The Industrial Automation Control Products and Systems section of NEMA is sponsoring a one-year test to evaluate a program to provide free access to industry standards over the Internet. A brief description of each standard and a link to the document is provided on the Web page. The service will be available through 2000 at http://www.nema.org/engineering/icsstandards.html.... MedSource Technologies Inc. (Minneapolis) has acquired Tenax (Danbury, CT), the medical device division of Bespak plc (King's Lynn, Norfolk, UK). Tenax, an ISO 9001­ and EN 46001­certified company, provides high-volume production molding, assembly, and packaging services....Specialty chemicals maker Rhodia (Cranbury, NJ) has purchased a range of specialty silicones from Applied Silicone Corp. (Ventura, CA). The transaction excludes silicones dedicated to breast implant applications, which will remain with Applied Silicone Corp.... Haemotronic S.p.A. (Mirandola, MO, Italy) has announced that it is restructuring operations as concerns its production for the U.S. market. The company will now distribute products directly from its recently expanded 18,000-m² facilities in Mirandola and Carbonara. It produces PVC-free pouches, parenteral bags, and a range of IV components....Custom injection molder Alltrista Unimark Plastics Co. (Greer, SC) has received two customer honors for high standards in supplier performance. The awards are a Supplier Quality Systems rating from Ethicon (Somerville, NJ), a division of Johnson & Johnson (New Brunswick, NJ), and the Omnimark award from Gillette (Boston)....Construction of a manufacturing facility dedicated to a new jumbo polyester film extrusion line for Klöckner Pentaplast of America (Gordonsville, WV) has begun. The $6 million, 54,000-sq-ft facility will initially employ 25 people and will add 16 million lb of polyester to the company's annual output....Trace Laboratories-Central (Palatine, IL), a diversified testing laboratory, and TÜV Rheinland of North America Inc. (Newtown, CT), an international certification and compliance services provider, have formed a cooperative relationship to offer a range of testing and certification services to manufacturers....Paul Kiefel GmbH (Freilassing, Germany) was awarded the 1999 Baxter Supplier Award for its high-frequency and thermocontact welding machines. The company's machines are used to weld plastic films for a line of infusion, blood, and dialysis bags supplied by the Baxter Group (Deerfield, IL). The Baxter Group cited the reliability and efficiency of Kiefel's machines as key factors in its decision....The Vacuum Insulation Association (Arlington, VA) was recently formed to promote communication, research, and education regarding the commercial use of vacuum insulation technology. Members of the new international trade association include component material suppliers as well as fabricators and end-users of vacuum insulation products....PRA International Inc. (Vienna, VA) has acquired Arcam, a contract research organization based in Paris. Under the conditions of the agreement, Arcam will operate using the PRA name. PRA International Inc. provides a range of clinical trials management and product development planning services to medical device, pharmaceutical, and biotechnology companies worldwide....FDA has amended labeling requirements for aluminum content in large-volume parenterals, small-volume parenterals, and pharmacy bulk packages used in total parenteral nutrition (TPN) therapy. The decision was prompted by new evidence linking the use of parenteral drug products containing aluminum to toxic accumulation of aluminum in the tissues of patients on TNP therapy.

Careful Planning Is Key to Accelerating Product Development

The demand for specialty products combined with rapid changes in technology present a challenge to medical device manufacturers: how to accelerate new product design to maintain competitiveness. Vytas Pazemenas, president of Aubrey Group (Irvine, CA), a medical device engineering firm, emphasized this sense of urgency during a conference session at MD&M West.

Knowing the costs of faster product development at the outset can help motivate both the development team and management, Pazemenas said. A financial model can show the effect of performance shortfalls, delays in product introduction, and increases in product and development costs. The results of financial modeling can then be used in determining suitable trade-offs that will ensure the product is produced on time and on budget.

There are several elements to consider when increasing development speed, Pazemenas said. The "fuzzy front end," or the time from identification of need to product development, is "an area of exceptional opportunity for cycle-time reduction." He offers a number of different strategies to reduce delays. Companies should first measure the time involved, thereby calculating the cost of delay. Companies can also start working on a product's design before planning is finished. Developing new technologies as separate projects and having a master plan for new product development are two more ways of saving time.

To accelerate time to market, companies can enact concurrent development by working on marketing, engineering, and regulatory affairs simultaneously. Another time-saving measure is to assume excess capacity, including having extra people available to quickly finish tasks. Maintaining clear scheduling objectives and planning for small iteration loops instead of large ones can help, according to Pazemenas.

Once a company has organized for speed, it must define the right product. Seeking customer input by involving them in discussions is the starting point. Risk/hazard analysis should be done automatically very early in the process to avoid potential problems with FDA. Teams should also define the performance requirements clearly and keep product specifications flexible to accommodate time constraints. Successful designs and techniques should be reused.

Make regulatory approval part of the product strategy by adding a regulatory affairs expert to the development team, Pazemenas added.

"Technology and market forces will demand faster development times in the future, so industry can't rest on its laurels," said Pazemenas. However, he urged companies to carefully consider the attendant risks before rushing to shorten development times. "You have to involve more people at the same time, so it's messier. As a result, more management attention is required." ­David Bowen

PVC Defections Continue

Despite reassurances from a large segment of the scientific community that the potential health and safety hazards of PVC are vastly overstated, the material's privileged position within the medical device industry continues to erode.

Tenet Healthcare Corp., the nation's second-largest healthcare provider, recently announced that it would develop a purchasing policy favoring the use of PVC-free and phthalate-free disposables in its hospitals. Equally momentous was the decision of Baxter International to sign a memorandum with a group of shareholders underscoring its commitment to "explore and develop alternatives to PVC products." It should be noted that Baxter has stressed that its move away from PVC had "nothing to do with the unwarranted concern raised by activist groups regarding the safety of PVC." That clarification did not prevent the signing from becoming a watershed event for many in industry, however.

"Baxter's decision was a milestone," says Hermann Koch, product manager at Germany-based Sengewald Verpackungen, a supplier of coextruded polypropylene film that can be used as an alternative to PVC in medical fluid bags. "It had a big influence on other companies to think very seriously about the PVC issue," explains Koch.

Economical and easy to fabricate and sterilize, PVC remains the most widely used polymer in presterilized single-use medical applications. To make PVC flexible, plasticizers such as DEHP are added. When lipid-containing fluids like blood are stored in PVC containers, these plasticizers can migrate into the body in the fluid. Some groups, such as Health Care Without Harm, have claimed that such exposure to plasticizers is toxic.

PVC remains the polymer of choice for a range of medical devices, but health and ecological concerns are prompting some firms to seek alternative materials.

Last year, these concerns led the European Commission to ban soft PVC containing phthalates from toys that would be put in babies' mouths. The commission is currently conducting a horizontal cradle-to-grave life cycle study of PVC in nonmedical applications. Results are expected to be released by the end of this year.

"Lessons learned on additives in soft PVC toys need to be applied to medical devices," says Joe Di Gangi, PhD, author of a Greenpeace report on the alleged dangers of plasticizers. "Why expose a vulnerable population such as patients to toxic chemicals when alternatives are readily available?"

The plastics industry counters that there are no studies proving that plasticizers can be harmful, and that cost-effective and safe alternatives to PVC simply do not exist. Last year their position was given a boost when a panel convened by the American Council on Science and Health and led by former surgeon general C. Everett Koop, MD, concluded that plasticizers are harmless even to people who have been exposed to high levels. "The burden of responsibility will weigh heavily on whatever group or individual advocates eliminating DEHP products without a safe, proven alternative," the report stated.

In an interview with MPMN, Robert Brookman, vice president of Teknor Apex, which supplies PVC, predicted that there won't be any wide-scale deselection of PVC in the U.S. medical market because few good alternatives to PVC exist. "It's either a cost issue or a performance issue, and often it's both," said Brookman. "PVC is really quite unique. Its clarity, flexibility, and ease of fabrication can't be matched by the alternatives, and most of them cost more anyway.

"The problem is that we are dealing not with medical science but with emotionalism," added Brookman. "We scientists see all this as a nonissue." Advocates of a ban on plasticizers obviously disagree, and they are not likely to cease their protest in the foreseeable future. —Karim Marouf

Transportation Packaging Test Methods Should Aim for Flexibility

One of the last things some device manufacturers think about when releasing a new product is the potential for damage during shipping. Addressing this issue, Dennis Young, senior consultant at Dennis Young & Associates Inc. (Grand Rapids, MI), observed that "the medical device manufacturer has the responsibility to know how its product is shipped....and what steps it goes through in order to get from the point of manufacture to the point of use."

In a session titled Transportation Testing for Medical Devices, presented during the Medical Design & Manufacturing (MD&M) West Conference and Exposition January 17­20 in Anaheim, CA, Young outlined the steps manufacturers need to take to ensure the effectiveness of their packaging. ISO 11607 outlines the manufacturer's responsibility to evaluate package performance by defining the limiting conditions, then by selecting appropriate testing methods. A company's "testing needs to be flexible enough to match what actually happens during shipping," he pointed out.

The use of a transportation simulator is one step that manufacturers can take to ensure the effectiveness of their packaging.

The logistical hazards that can affect the safe delivery of medical devices include dropping, vibration, and compression of the packaging container. The need to efficiently use storage facilities introduces a second set of hazards: stacking packages to efficiently use space and maintain an inventory, and the absence of atmospheric controls within the building can contribute to a loss of package integrity. Excessive atmospheric pressure and daily temperature and humidity cycling can also cause damage. The way a package is handled is yet another factor that must be considered. Packages are both intentionally (when they are palletized, loaded, or sorted) and accidentally dropped.

Three types of preshipment performance tests can be used to limit potential damage, according to Young. The first type is integrity testing, which challenges product and package strength. One such test is ISTA procedure 1A, the most commonly used package performance test in the world, according to Young. "People have found that if they have a package that passes this test, they'll rarely have problems."

The test is intended for small packages and is made up of a vibration test and a drop test. The vibration test uses a selected fixed frequency to bounce the package 14,200 times. The drop test involves dropping a package once on its corner, three times on an edge, and once on all six faces.

ISTA procedures 1G and 1H are designed for small and large packages and are identical to 1A, except that they use a random vibration test.

The second type of procedure is a general simulation test for small parcels that "simulates what goes on across fairly wide scopes of distribution events," said Young. ISTA test project 3C starts by drop-testing the package onto an object, followed by a compression test, a vibration test, and a second drop test without a hazard.

Focused simulation tests "link lab tests to specific measurements of environmental hazards," noted Young. Devices are used to record temperature, humidity, vibration, and pressure drop in the distribution environment. The data are then analyzed and applied to the drafting of appropriate tests.

Young announced at the meeting that a medical device distribution test procedure is currently under development by ISTA that will combine a screening test and a simulation test. —David Bowen

PVC PHOTO COURTESY OF HYDRO POLYMERS LTD.