Medical Device Link.

LSTAT System: The Business of Saving Lives. The greatest reward that medical device manufacturers can hope for is that their product offers a solution to a critical medical problem. In this respect, the Life Support for Trauma and Transport (LSTAT) system, one of this year’s winners in the category of critical-care and emergency medicine products, goes above and beyond the call of duty: it saves lives.

The LSTAT system is an individualized, portable, networked intensive care unit (ICU) and surgical table in a "smart" patient platform that supports time-critical decision making with the fewest number of people possible. Integrated within the LSTAT system are state-of-the-art defibrillator, ventilator, suction, three-channel fluid and drug-infusion pump, point-of-care blood chemistry analyzer, and patient monitoring subsystems. The platform also incorporates onboard power and oxygen subsystems. The medical subsystems are further integrated onto a common information architecture that captures, stores, and transmits continuous, real-time, multidevice, multiparameter, time-synchronized patient data. The LSTAT system was designed and manufactured by Integrated Medical Systems Inc. (IMS; Signal Hill, CA).

The LSTAT system is beginning to be used in both hospital and prehospital operational evaluations by medical teams consisting of surgeons, anesthesiologists, critical-care nurses, and medics in the United States and abroad. It is intended to provide earlier, continuous, and flexible care for the critically ill and injured, from as close to the site of injury as possible, through transport, definitive care (for example, surgery), and recovery. The LSTAT system is first being adopted on an in-hospital basis, with migration to prehospital and emergency medical service, rehabilitation, and eventually home caregivers to come.

According to David D. Hood, president of IMS, the LSTAT was originally developed to save the lives of soldiers. "Two years after the United States entered the Persian Gulf," he explains, "the Defense Advanced Research Projects Agency (DARPA) called a special meeting of the Department of Defense, the U.S. Army, and the medical technology industry. The purpose of this meeting was to find a solution to the battlefield’s lengthening medical supply trail and the decreasing number of military medical personnel."

What emerged was the concept for the LSTAT system, which was designed and developed by the aerospace and defense company Northrop Grumman Corp. (NGC, Los Angeles). Funding for the development of the LSTAT was made possible through a cooperative agreement among NGC, DARPA, and the U.S. Army, says Hood. "A cooperative agreement is a new type of government contracting that imposes the minimum number of requirements and permits the maximum amount of creativity to rapidly develop and deploy advanced solutions for the military’s most pressing problems," he explains. "The LSTAT program has been a successful example of this new type of contracting."

Being in business to save lives certainly served NGC well. The LSTAT system soon generated market interest, and a demand emerged for the LSTAT’s capability. "Trauma doesn’t care whether you’re military or civilian. It’s the number one cause of death and disability, so the applications extend well beyond the battlefield," says Hood. NGC realized that it had created a commercializable medical device and formed IMS.

To ensure that it was staffed with the technical and business expertise necessary, the new company drew upon the experienced personnel of NGC. "Key considerations in building the LSTAT development team were expertise in systems integration and information technologies, as well as in management, finance, accounting, contracting, and regulatory matters," says Hood. He also reports that while enhancements to the LSTAT continue to be funded by DARPA and the Army, IMS intends to fuel R&D for the commercial variant with a combination of company, customer, and partner funds.

In terms of marketing strategy, the company has planned carefully. "Market research began in the early stages of concept and design, and involved studying the needs and trends of the critical-care market, as well as engaging focus groups, sponsored research, and frequent interaction with select civilian and military medical personnel, customers, and suppliers," says Hood. "Extensive input toward product enhancements, variants, and new products continues to be generated by demonstrations, evaluations, and use of the LSTAT system. In addition, IMS continues to leverage media visibility and an extensive professional network to attract lead users, distributors, and buyers. We are also pursuing comarketing arrangements with suppliers, partners, distributors, and customers."

About winning a 2001 MDEA, Hood says, "It's a badge of honor we're proud to show our customers and suppliers. We're pleased and proud to be recognized and, most of all, hope that the visibility will help bring early, continuous, and flexible care to the patients who need it."

Other MDEA winners in the category of critical-care and emergency medicine products include the following products.

Radical Signal Extraction Technology (SET) pulse oximeter, a system designed to noninvasively monitor functional oxygen saturation of arterial hemoglobin and pulse rate.

Radical Signal Extraction Technology (SET) pulse oximeter, a pulse oximetry system designed to noninvasively monitor functional oxygen saturation of arterial hemoglobin and pulse rate in adult, pediatric, and neonatal patients during motion and low perfusion. This product was designed by Masimo Corp. (Irvine, CA) and I.N. Incorporated (Los Alamitos, CA), and is manufactured by Masimo Corp.

XCalibur mobile transporter 6, a mobile patient transporter formed from composite materials, making the unit light in weight but capable of bearing substantial loads. The Xcalibur was designed and manufactured by Ferno-Washington Inc. (Wilmington, OH).

Dental Instruments, Equipment, and Supplies

Waterpik Flosser, a lightweight handheld device that uses a gentle filament action to reach between teeth and below the gum line to remove dental plaque associated with gingivitis.

BriteSmile 2000: Service with a Smile. Sometimes, innovations in medical technology make it possible for manufacturers to develop a product that will take their company to a whole new level of profitability. The BriteSmile 2000 teeth-whitening system, one of this year’s winners in the category of dental instruments, equipment, and supplies, did just that for BriteSmile Inc. (Walnut Creek, CA). It offers true innovation in terms of technology and distribution. Development of the system enabled BriteSmile to change its business plan from that of a dental-equipment supply company to a supplier of whitening services in its own whitening centers by providing a low-cost, high-throughput whitening procedure that can be easily taught to dental professionals.

The BriteSmile 2000’s light-activated teeth-whitening method takes less time than any other procedure in practice. Total whitening time is 1.5 hours, compared with 2.5 hours in a dental office or many weeks for take-home products. The BriteSmile 2000 also achieves a greater amount of whitening than these other procedures-7-15 shades of improvement, compared with 3-7 shades for in-office procedures and 3-5 shades for take-home products.

To investors, this technology promised high profitability as well as high customer satisfaction. But company executives had faith in their company’s technology from a much earlier date. A recent company release states that the market for teeth whitening in the United States exceeds $1 billion annually. According to John W. Warner, PhD, director of research and development and chief scientist for BriteSmile, "The development of the BriteSmile 2000 system was the entire R&D effort of the company in the early months of its existence. Funding for the project came from the company’s principals through private sales of stock."

Warner reports that the design and prototyping efforts for the BriteSmile 2000 were finished within six months of approaching IDEO (Chicago), the product design firm involved with the project. "We needed a very fast development effort," he explains. "IDEO has the advantage of having a wide variety of engineering, design, and human factors expertise available for any given project. Having worked with them before, we were aware of their abilities to put an enormous amount of resources and energy into the early stages of product development."

The distribution platform of the BriteSmile 2000 is as important to the system’s success as the whitening process. "BriteSmile does not sell its whitening systems. Instead, the company provides a teeth-whitening service through its own professional whitening centers and participating dentists," says Warner.

As for the company’s newly bestowed honor, Warner believes that "our status as an MDEA winner demonstrates just how advanced the BriteSmile 2000 technology is."

The Waterpik Flosser: Ergonomics for Dental Care. Products purchased and used by consumers are often very different from those intended for professional use, with greater attention to functional and design elements appropriate to such a broad user base. Such is the case with the Waterpik Flosser, a lightweight handheld device that uses a gentle filament action to reach between teeth and below the gum line to remove dental plaque associated with gingivitis. Designed by Volan Design (Boulder, CO) and Waterpik Technologies (Ft. Collins, CO), and manufactured by Waterpik Technologies, the flosser earned an MDEA in the category of dental instruments, equipment, and supplies.

The original concept of the flosser was developed in conjunction with a dentist who was seeking a product to aid consumers in flossing regularly. The primary goal of the project was to create an ergonomically comfortable and aesthetically appropriate product that would be easier to use than conventional floss.

The project was championed internally by Waterpik's new products and oral care marketing groups. It was funded internally by Waterpik's new product and engineering department, which each year receives about 4-6% of the company's annual revenues.

"This was a project that had to compete for finite R&D resources against other projects within the company, including those for water filtration, showers, and so on," says Greg Volan, principal of Volan Design. "The project had to be justified at several points during its development, with checkpoints at the completion of investigative exploration, preliminary business plan, and final business plan.

"Final justification came after the company had performed projectable volumetric market research and price elasticity studies," says Volan. "Overall, market acceptance was off the charts. The company that performed the market research had never had a product register a higher purchase intent."

The initial product development team was formed from an internal group called the innovation lab. After the project showed potential for becoming a viable technology with sufficient revenue potential, the company created a budget for the project and assembled a formal cross-functional product development team that included Volan Design for industrial design, ergonomics, and engineering support. The skill sets of those named to the group bridged marketing, engineering, industrial design, oral care, clinical studies, marketing research, manufacturing, and sales.

As is often the case during the development phase of a medical product, the team sometimes found it necessary to make midcourse corrections. "At one point, the team realized that its costed bill of materials was too close to that of competitive products on the market," recalls Volan. "So the team redesigned the product in order to provide a greater cost margin between the Waterpik Flosser and its nearest competitor."

The team also developed a thorough product planning matrix in order to identify features and attributes that could be "turned on or off" in an effort to affect the product's projected price point. The final form of the flosser consists of a soft-grip handle that accepts a single AA battery; a cartridge containing a month’s supply of replaceable flossing tips; and a stand or charging base, depending upon model. Also available is a set of color-coded, snap-on hygienic sleeves so that multiple family members can share the device without sharing germs.

The ergonomic design of the unit evolved as an extension of the user's fingertip, making it easy to aim the tip when it is in the mouth and out of view. This allows the tip to reach comfortably into the areas where plaque forms. The unbreakable tip was specifically engineered to be flexible enough to provide a whip-like action without irritating the gums. The styling of the handle incorporates a gentle S-curve that keeps the flosser from rolling and the tip from touching the countertop. Its soft-touch surfaces add color and style while providing improved grip for wet hands.

The product was first made commercially available in March 2000. Its release came at a critical time in Waterpik’s business development. The company had recently spun off from its parent, Allegheny Teledyne, and the flosser was the first product of the newly independent company. The product's initial market success and exposure brought much needed PR and revenue during a time of great change. The flosser represents an opportunity to demonstrate to the market that the company is still an innovative one that can produce winning products.

To market its new product, Waterpik created promotional events and sought out endorsements from the professional oral health community. "The company worked hard to introduce the flosser to dental professionals and hygienists," says Volan, "because those are the people who can influence the consumer for behavioral change." The company's strategy created both a push and a pull for the product.

For Volan Design, involvement in an MDEA-winning product constitutes a strong asset, says Volan. "As the product design and development firm, our design work is validated by such an award. When combined with market success, such acknowledgment by industry and our peers builds confidence among our clients that we can succeed on their behalf."

From Waterpik's perspective, winning the MDEA adds credibility to the product, says Volan. "Waterpik can proudly trumpet this achievement in all of its marketing efforts. And, of course, the company's investors, shareholders, and directors can all take pride in what the new products team was able to achieve. When used in consumer advertising, winning an MDEA will definitely enhance the marketability of the flosser."

Finished Packaging

Prompt L-Pop, a dental adhesive system with contents divided into three compartments, enables dental professionals to etch, prime, and bond in a single step.

Prompt L-Pop: The Customer Is Number One. Everybody knows that generating good sales means having to say, "The customer’s always right." 3M ESPE AG (Seefeld, Germany) has taken that idea to heart in a big way, and it’s paid off. The company’s Prompt L-Pop dental adhesive system won a 2001 MDEA in the category of finished packaging. More importantly, however, the Prompt L-Pop introduces a new generation of products-and a whole lot of growth potential-for 3M ESPE.

Prompt L-Pop is the only adhesive system that enables dental professionals to etch, prime, and bond in a single step-all in seconds. It has been demonstrated to provide a reliable bond direct restorative materials and tooth structure. The product is designed to bond between dentin and enamel to composite filling materials and fissure sealants. Its single-patient packaging eliminates bottles and evaporation as well as cross-contamination.

The concept for the Prompt L-Pop was developed during a strategic planning session in 1997. "At that time, none of our products for bonding restorations directly to the tooth surface were able to gain a significant market share," says Oliver Frey of 3M ESPE. "We found the reason to be that a large number of products for this purpose were already on the market. However, the problem with existing products was that they did not take the customer’s needs into consideration. Not only were they time-consuming and complicated to use, but it was difficult for the practitioner to distinguish them in terms of advantages and disadvantages."

In light of this discovery, the chemical R&D department at 3M ESPE went to work on developing an entirely new concept for the direct adhesion of filling materials to enamel and dentin. The goal was to produce a system that would simplify the bonding procedure, save the customer time, and be compatible with almost all existing direct-restoration materials.

According to Frey, the development team for the Prompt L-Pop initially consisted of a chemist, a chemical engineer, and a lab assistant. "Once the chemistry had been developed and the initial performance of the prototype met our goals, the next step was to determine its shelf life," says Frey. "It was during this evaluation that we discovered the components of the product had to be stored in two separate containers to prevent a loss of bond strength. So our technical R&D and packaging experts collaborated to solve this problem. The solution was the innovative blister packaging that, together with the material properties of Prompt L-Pop, were key to our market success."

These weren’t the only secrets behind the company’s success. 3M ESPE also performed extensive market research in preparation for the launch of Prompt L-Pop. Frey reports that the product was tested in a variety of trials throughout Europe and the United States in the months before market launch. "In addition, we held an international symposium on the new self-etching adhesive six months before product launch, and also distributed symposium proceedings to universities and interested dentists."

But 3M ESPE didn’t stop there. According to Frey, the company conducted a survey of more than 14,000 dental practitioners in 10 countries during the product launch. Participants were given an opportunity to test 20 Prompt L-Pops free of charge under everyday surgery conditions. In return, they were asked to answer a questionnaire. "The survey results showed that the Prompt L-Pop was rated very high with regard to ease of use, time-saving benefits, and hygiene," says Frey. And of course, the customer is always right.

The other MDEA winner in the category of finished packaging is the Kabiven multichamber parenteral nutrition packaging system. The Kabiven system is a finished package designed to hold a total nutrient admixture in a single container of three chambers separated by inner seals. The design of the system simplifies preparation and allows room-temperature storage for 24 months prior to mixing. The product was designed and manufactured by Fresenius Kabi (Uppsala, Sweden).

General Hospital Devices and Therapeutic Products

The Acapella chest physical therapy device, which combines the benefits of positive-pressure therapy and airway vibrations to mobilize pulmonary secretions. The product is intended for patients with lung disease and associated secretory problems.

Acapella: Better Than Planned. Once in a while, projects progress according to plan. On rare occasions, projects far exceed expectations.

This is the case for MDEA winner Acapella, a device designed and manufactured by DHD Healthcare (Wampsville, NY) that patients with chronic obstructive pulmonary disease (COPD, often associated with years of smoking or cystic fibrosis) breathe into. The device sends vibrations into the patient’s lungs, thereby loosening and removing mucus.

Acapella was designed as a complement to DHD’s existing positive expiatory pressure therapy product, and the device has better than delivered on DHD’s hopes.

"Business plans are often, at best, educated guesses," says Fred Richards, DHD’s director of marketing and business development. "A general rule companies follow before pursuing development of a product is that they want a return on their investment in three to five years. Acapella is doing extremely well-much better than forecast. We were able to maintain the sell price that we needed to justify the project, and we’re selling twice as many units as planned.

"The key is that we’re selling not just a product, but a new therapy," Richards continues. "The normal way to remove secretions is by postural drainage and clapping, in which a therapist literally cups her hand and pounds on the patient’s chest and back to loosen and release secretions. Our therapy involves a patient simply breathing into a device, and the device then triggers a process that releases those secretions. This newer therapy has been accepted much more quickly than we anticipated it would be."

The reason for that acceptance is twofold. First, the product works better than other products on the market because of its end user-influenced design, says Richards. And second, Acapella’s advantages over competitors-and the results of numerous studies demonstrating the value of PEP therapy-have been advertised heavily to respiratory therapists and pulmonologists through medical journals and trade shows.

Competing products marketed to the 15 million Americans who suffer from COPD have two design limitations that DHD strove to overcome. "We talked with users and clinicians, and they said there were two problems," explains Richards. "Patients have to blow hard to get such devices to work, and they have to hold the device in a special position. These patients are very sick; such a device is too fickle.

"Our biggest design challenges were achieving independence of gravity so that patients wouldn’t have to sit in a special position and making sure that the device would work at low airflow rates. From an engineering perspective, the latter challenge was the more difficult," says Richards. "It took our internal engineering group and Product Genesis Inc. (Cambridge, MA), our product development firm, nearly two-and-a-half years to finalize the product. It was hard to keep everyone on target because our company launches one to two new products every year, and all of our new products compete with one another for resources. Fortunately, our business plan, working relationship with Product Genesis, and perceived payback were strong."

A nice bonus is stronger sales of DHD’s first PEP product as well. "We’ve even seen better sales of our original product as a result of advertising Acapella," reports Richards. "The original product still has good fundamentals. With Acapella, we just added another flavor."

Goldenberg Snarecoil Needle: Physician Insight. Medical professionals have a long history of direct involvement in the conception, design, and development of medical products. This year, one product that resulted from just such professional expertise was the Goldenberg Snarecoil needle, which earned MDEA honors in the category of general hospital devices and therapeutic products.

The Goldenberg Snarecoil needle is a sterile, disposable, single-use device that is intended for use in obtaining bone-marrow specimens. Typically, this device would be used by a physician in an outpatient setting with the patient under local anesthesia. The device was designed by Alec S. Goldenberg, MD, director of the hematology clinic at Bellevue Hospital Center (New York City), and is manufactured by Ranfac Corp. (Avon, MA).

Bone-marrow specimens are necessary to diagnose and plan the treatment for patients suffering from various blood disorders such as leukemia, Hodgkin’s disease, hypoplasia, and myeloma. As performed with conventional bone-marrow needles, bone marrow biopsy procedures have been known to be gruesome and very painful. According to published clinical studies, the results of more than 50% of bone-marrow procedures are inadequate .

"Dr. Goldenberg performs bone-marrow biopsy procedures on a daily basis as part of his medical practice," says George J. Hattub, Ranfac's director of quality assurance and regulatory affairs. "The concept of the Snarecoil needle came to him out of true compassion for his patients." Ranfac provided the funding and development expertise necessary to take Dr. Goldenberg's invention from the conceptual stage through finished production. "Ranfac's business philosophy comes from the top. Bob Adler, the company's president and CEO, has always insisted on reinvesting a significant portion of sales revenues back into R&D for promising medical device technologies," says Hattub. "Funding for the development, engineering, manufacturing, and commercialization of the Snarecoil needle came from these revenues.

"When assembling the project team for the Goldenberg Snarecoil needle," says Hattub, "we chose members whose talents and personalities complemented one another. We knew that we were privileged to work on a challenging project that was truly going to help people and make a difference. That vision helped us to overcome obstacles as they were encountered."

The Goldenberg Snarecoil needle received FDA 510(k) clearance in December 1998, but was not made commercially available until April 2000. According to Hattub, Ranfac took a novel approach to introduction and marketing of the product. "Rather than introduce it at a typical medical device show, we timed the introduction to occur at the 1999 convention of the American Society for Hematology (ASH), where we knew most of the exhibitors would be pharmaceutical companies showing pills and liquids." The company took a large number of samples, together with materials that allowed simulated use of the device.

"We encouraged physicians to feel and use the product-something most of the other exhibitors couldn't do-and thereby made our exhibit engaging and interesting," says Hattub. "Over the course of the three days at that show, our people barely had time to eat or take breaks because there was so much activity at the booth."

The second phase of the company's marketing plan was to demonstrate the product to pathologists and nurses. "Pathologists interpret the results obtained from bone-marrow biopsies, so they actually judge the efficacy of those procedures," says Hattub. "Likewise, nurses deal with the pain and anxiety that patients experience during such procedures, and they are in position to be advocates on behalf of patients."

Finally, Ranfac introduced the Goldenberg Snarecoil needle among cancer patient support groups and associations. "Companies rarely use such a direct approach," says Hattub, "because patients don't typically question why their physicians are using a particular medical device. But in the case of cancer, it is very important to mitigate all sources of anxiety, pain, and trauma."

For Ranfac, winning the 2001 MDEA for the Goldenberg Snarecoil needle is the "the icing on the cake," says Hattub. "From an engineering and manufacturing perspective, such an award is satisfying and demonstrates the validity of our work. That's also significant from a marketing perspective, because Ranfac has an OEM division. We manufacture and private-label products for some of the largest medical device and pharmaceutical companies, and we're also working with entrepreneurial companies to help develop and refine their ideas. Winning this award will help these efforts by creating more exposure and enhancing Ranfac's prestige."

Other 2001 winners in the category of general hospital devices and therapeutic products include the following products.

The Grab 'n Go III portable medical oxygen system, a device that combines an oxygen cylinder with an integrated regulator and content gauge to increase ease of use and safety. The system was designed by Western Medica (Westlake, OH), a Scott Fetzer company, and Lewellen Design Inc. (Wooster, OH), and is manufactured by Western Medica.

The Protectiv Acuvance IV safety catheter, a sterile, nonpyrogenic, nontoxic, single-use IV catheter device that incorporates a passive safety feature to provide protection from accidental needlestick injuries. This MDEA-winning product was designed by Ethicon Endo-Surgery Vascular Access (Cincinnati), a Johnson & Johnson company, and BioPlexus (Tolland, CT), and is manufactured by Ethicon Endo-Surgery Vascular Access.

Implant and Tissue-Replacement Products

Nucleus 24 Contour, a cochlear implant that safely places 22 stimulating electrodes adjacent to the inner wall of the cochlea. The system is designed to provide useful hearing for patients with severe to profound hearing loss.

Nucleus 24 Contour: Teaming Up for Success. For many of this year’s MDEA winners, success comes down to one thing-good teamwork. Whether in the form of partnerships, strategic alliances, or interdepartmental collaboration, teamwork is the key to developing innovative products. One company that takes teamwork very seriously is Cochlear Ltd. (Sydney, Australia). In fact, the company culture is based entirely around team effort. One result of that effort is the Nucleus 24 Contour cochlear implant, a 2001 MDEA winner in the category of implant and tissue-replacement products.

The Nucleus 24 Contour has an electrode array that safely places 22 stimulating electrodes adjacent to the inner wall of the cochlea without the use of invasive bands or positioners. The system is designed to provide useful hearing to people with severe to profound hearing loss. The implant operates by receiving sound encoded in a radio frequency link, sent from a speech processor that is worn externally. Next, the implant decodes the information into electrical impulses that activate any of the 22 electrodes on the array to stimulate the underlying nerve cells. The resulting patterns of stimulation are perceived as sound and speech by the user.

The Cochlear team ethic was vital in developing the concept for the Nucleus 24 Contour system. Peter Gibson, senior project manager for Cochlear, explains: "The potential benefits of an electrode array that brings the stimulating contacts near the neural cells in the modiolus were being canvassed industrywide throughout the early 1990s. We decided to set up a research project specifically to develop a new perimodiolar array based on theoretical expectations of improved performance and the knowledge that this was the direction in which industry was heading. The project was immediately championed by the vice presidents of R&D and marketing, and received strong support from company executives throughout development."

The company made a team effort even in the championing process, which enabled the Nucleus 24 Contour project team to move forward with development. "Think how hard it would’ve been if we had to convince the company to go along with us one department at a time," Gibson notes.

Company support was also instrumental in attaining the financing necessary to begin development. According to Gibson, the Nucleus 24 Contour project was funded both internally and by the Cooperative Research Centre for Cochlear Implant and Hearing Aid Innovation (Melbourne, Australia).

The project team at Cochlear was faced with the challenge of developing a tiny array with 22 separate electrodes that could be easily placed within the cochlea and with minimal trauma. The solution was an innovative mix of biocompatible materials knowledge and inspired mechanical design. The surgeon drills a small hole, less than 0.1" (or 2 mm) in the bottom turn of the cochlea. The electrode is introduced using a platinum stylet which straightens the array but still keeps it flexible. The outer side of the array is smooth silicone so that it can easily slip along the outer wall of the cochlea. Once the electrode is inserted, the surgeon withdraws the stylet and the electrode gently curls against the inner wall of the cochlea.

Again, teamwork laid the foundation for overcoming challenges in design and development. "In 1994, the project team was really only one person specifically recruited to conduct research on the perimodiolar electrode array and develop a few concepts," says Gibson. "The research was supplemented with input from a number of engineers and technicians over the next few years. Then in 1998, the project team was formally established with the goal of bringing the concept to market. Key considerations for the group were to apply the right skills to the tasks and to ensure that the people would operate effectively as a team." Over the next 12 months, more people were assigned to the project as required by the expanding workload, says Gibson. This team worked extensively with surgeons in cochlear implant clinics around the world during human trials until market release.

"Receiving a 2001 MDEA rewards our team members for all their hard work. Our MDEA-winning status is regarded as a significant achievement within the company," notes Gibson. "It’s also beneficial in establishing strong vendor partnerships. This award is considered prestigious by our materials suppliers, who are pleased to be associated with such recognition."

Other 2001 MDEA winners in the category of implant and tissue-replacement products include the following.

The Ancure endograft system, a less-invasive method used to treat abdominal aortic aneurysm without traditional surgical techniques and with less trauma to patients. It was designed by Stirling Design (Aptos, CA) and Guidant Corp. (Indianapolis), and is manufactured by Guidant Corp.

The HELEX septal occluder, a permanently implanted prosthesis for minimally invasive closure of atrial septal defects in pediatric and adult patients. It was designed and is manufactured by W. L. Gore and Associates (Flagstaff, AZ).

In Vitro Diagnostics

The eScreen drugs-of-abuse testing system, a networked point-of-care system that scans, reads, and writes assay results from drugs-of-abuse tests, and then sends the confidential results to a remote recipient via a secure Internet connection.

The eScreen System: Waiting Out Investors. When dealing with start-ups, investors often want to see company officers investing their own money before they'll throw in funding. But it takes a special type of company leader to hang tough with an emerging and potentially risky technology.

Hanging tough now seems to be paying off for Murray I. Lappe, MD, founder of eScreen Inc. (Overland Park, KS). The company was founded around a single product, the eScreen drugs-of-abuse testing system. Lappe's own acute sense of the market need for the product played a key role in his ability to stay the course.

"Employers need to know ASAP whether their employees are drug free, and many cannot use a worker until a negative, drug-free result is returned," says Lappe. "To understand why, just consider the possibility of an airline pilot who takes a random drug test-and then spends the next two days flying before his test comes back positive."

Most drugs-of-abuse testing is performed in centralized laboratories and requires as many as two to three days to get results. With nearly 50 million drug tests performed each year, this represents about 100 million days lost to waiting for drug-test results, Lappe notes.

Ideally, he says, workers would be tested and the results would be available immediately. If the results were negative, the worker would be cleared for work without delay. But in the retail sector, applicants often take the required preemployment drug screen and then go back to work elsewhere while waiting for the callback three days later.

Lappe spent a long time considering such issues before launching into product development. "When rapid pregnancy tests were developed, about 10 years ago, I began to ponder the technology and process that would be required to implement an employment screening test using similar immunoassay methods," he says.

"Unlike point-of-care technologies used by healthcare professionals for patients in clinical settings, drugs-of-abuse testing poses a number of logistical and forensic complications that need to be accommodated in the design of the product. In the case of a home pregnancy test, for instance, the operator, the donor of the sample, and the customer for the test result are the same person. But in drugs-of-abuse point-of-collection testing, the operator is a healthcare professional, the donor of the sample is an employee, and the customer is the employer. Each party to this transaction has unique needs and obligations-and the test result must be considered highly confidential."

Building a product development team for a new technology to address such issues presented some complications, says Lappe. "If eScreen or any other point-of-collection test is wildly successful, the losers are the drug-testing laboratories," he notes. "Even so, eScreen's initial development team consisted of laboratory marketing experts who were already leaders in their field but were willing to take a chance on a new technology cannibalizing their business. More than 20 top-level laboratory salespeople have come to eScreen because they see the future here."

Funding development of the eScreen system was also no mean feat. "I've been in the laboratory data management business since 1989, and I've used all the profits from my business since 1998 to fund R&D for the eScreen system," says Lappe.

By late 1999 the development team had created a working prototype, and the company was spun off as a separate entity. Bank debt borrowed against the cash flow of the parent company took eScreen through its earliest stages, but soon the new company was in need of a half-million dollars a month.

"Selling equity in the new company was the only solution, but we went to venture capital and high-net-worth individuals with little success. Nearly everyone we made a presentation to wanted to invest-but ultimately it boiled down to valuation."

In the end, it was Lappe's faith in the value of the company's technology that kept it moving forward. "Keeping control of the company was important to me, so I sold many of my personal assets to fund the next round of financing. By mid-2000 several strategic investors were anxious to invest. When one strategic investor came forward, its competitors scrambled to find a place at the table."

The eScreen received the first FDA clearance under the new "Prescription Workplace Drugs of Abuse Guidelines," becoming the first digital point-of-collection drugs-of-abuse testing system on the market. The product was first made commercially available in May 2000.

In developing and marketing such a new product, there's no replacement for experience, says Lappe. "We did market research, but we have been serving the industry since 1989, and our customers have consistently asked for one thing-faster results. We have analyzed the point-of-care technologies for drugs of abuse every year since 1992. So we were able to address the barriers to acceptance as an integral part of our product design and development."

Applying the right technology to the right obstacles was a key factor in creating the eScreen system. "Ultimately, drugs-of-abuse testing is an information science," says Lappe. "So whether the testing is conducted in a lab or at a remote site, it requires an information solution applied to analytical methods."

In this light, says Lappe, the greatest challenge was converting an analog assay to a digital assay. "However, the reward has been great. Solve the analog to digital conversion, and the customers will come."

For his young company, Lappe says that money and execution risks are the greatest challenges to getting to market. But sometimes company leaders also have to be open to fundamental changes in their business. "We have had to change our thinking from that of a service provider to that of a product and service provider," says Lappe.

Lappe expects that his product's MDEA-winning status will "add credibility in this critical stage of product introduction to the market. Investors will see this as a sign of success.

"It's also a good touchstone-a reality check," he says. "We knew we had something really special. It's nice to know someone else thinks so too-especially smart people who see a lot of really cool products."

The other MDEA-winning product in the category of in vitro diagnostics is the BenchMark automated histology staining system, a modular automated system for staining tissue samples on glass microscope slides. The BenchMark system was designed and is manufactured by Ventana Medical Systems Inc. (Tucson, AZ).

Over-the-Counter and Self-Care Products

TravelMate, a noninvasive female urinary device designed to reduce the need to self-catheterize prior to travel.

TravelMate: Keeping It in the Family. Sometimes, an entrepreneur's enthuiasm for funding development of a product can be infectious. That was the case for the TravelMate, a noninvasive urinary device designed to provide an alternative to handheld female urinals and external catheters for women, which earned a 2001 MDEA in the category of over-the-counter and self-care products.

"The development of the TravelMate was funded privately through family members who were persuaded by our market research," says Charles Robertson, principal designer at Caring Hands Inc. (Hayden, ID).

"Through our market research, we learned that some women had a need to urinate without using a traditional urinary catheter, wearing incontinence briefs, or lowering their pants," says Robertson. "We designed the TravelMate to meet that need. Based on the information we had at the time, we projected the product would generate enough sales to exceed the cost of its R&D."

According to Robertson, the TravelMate offers many of the advantages of external urinary catheters, without the problem of uncomfortable methods of attachment. Because it is noninvasive, however, there is less risk of urinary-tract infection. And unlike a female urinal, there is no attached reservoir to get in the way, which means that it can be positioned for better comfort. The TravelMate can be used while standing or, by attaching latex rubber tubing and a urine collection bag, it can be used while seated.

Having a good product, however, doesn't necessarily ensure success. For that, Robertson says, the company took a lesson from the failures of others. "We consulted with the development team leader for the innovative Instead menstrual cup and followed much of his advice regarding the manufacturing and marketing of feminine hygiene products," says Robertson. "The maker of that product filed for bankruptcy within three years of its introduction. We wanted to learn what mistakes they had made so as to avoid them."

Since the TravelMate was first made commercially available in September 2000, Caring Hands has been taking advantage of one marketing tool not available to that earlier company. "We've been marketing our product on the Internet and through several small companies," Robertson notes. "We continue to use the Internet for market research."

Radiological and Electromechanical Devices

Echo-Coat: Making a Vision Visible. When it comes to getting support for a product development project, there's nothing like having the interest of company leaders. In the case of Echo-Coat ultrasound needles, the drive came from the very top. Designed and manufactured by STS Biopolymers Inc. (Henrietta, NY), Echo-Coat needles earned an MDEA in the category of radiological and electromechanical devices.

"STS Biopolymers is a privately held company," notes product manager Susan Stalls. "Two of the owners had an interest in this technology-one has a background in ultrasound contrast agents and the other an extensive background in coating technology. It was their interest and insistence that led the company to pursue this project as a company focus."

Echo-Coat ultrasound needles are coated to render the shaft visible with ultrasound imaging. This enables the devices to be used under ultrasound guidance during aspirations, biopsies, localizations, and amniocentesis procedures. Physicians in radiology private practice or in hospital settings use the needles to obtain cytology and histopathology samples or to facilitate surgical procedures.

With strong support from the top of the company, the entire project was funded through internal R&D dollars. The company also relied on its internal expertise to make the owners' vision a reality. "We drew on the expertise of all our personnel," says Stalls, "including polymer chemists, chemical engineers, a radiology professor, and a resident expert in coating technology."

The result of their efforts is the Echo-Coat ultrasound coating, a unique microporous structure that acts by trapping microbubbles of air on the surface to reflect sound waves back to the transducer even when the needle is at a very steep angle in relation to the transducer. These reflections enable the needle to be clearly visible along its entire shaft. After gaining FDA clearance and CE mark approval in 1999, the coated needles were first made commercially available in March 2000.

Successful development of the award-winning Echo-Coat needles offers STS Biopolymers a new marketing direction. "This is the company's first finished product available directly to the end-user," says Stalls. "The company is primarily a technology-transfer firm that develops coatings for medical products and provides either coating services or coating materials that manufacturers can apply. But for this product, we have advertised in a variety of publications, conducted direct-mail campaigns, attended trade shows, and signed on distributors that provide global coverage. We've also presented the needles at trade show workshops and featured them on our company Web site."

In those settings, says Stalls, the advantages of having an award-winning product are obvious. "Winning an MDEA award will definitely give our distributors something to boast about!" she concludes.

Other products awarded 2001MDEA honors in the category of radiological and electromechanical devices include the following.

Beta-Cath, an interventional cardiology product intended to prevent or treat restenosis following balloon angioplasty or coronary stenting procedures in the cardiac catheterization laboratory. The Beta-Cath was designed by Novoste Corp. (Norcross, GA) and the Innovation Factory (Norcross, GA), and is manufactured by Novoste Corp.

The DirectView CR 800 system, a radiographic digital image capture and processing system intended to facilitate wide electronic distribution of x-ray images to radiologists for diagnostic use. This product was designed and is manufactured by Eastman Kodak Co. (Rochester, NY).

Rehabilitation and Assistive-Technology Products

Claro and WatchPilot: Following a Pharmaceutical Model. The expression "location is everything" figures prominently in real estate, and-surprisingly-location played a critical role in the development of one of the 2001 MDEA winners’ design.

Phonak Inc. (Warrenville, IL), which designs hearing aids, introduced an AudioZoom feature in 1995 that enabled its digital hearing aids to filter out extraneous background noise so that users can focus fully on conversation. Its product also includes preset listening programs that users can select to aid hearing in different environments-on the phone, in lecture halls, etc.

"It’s difficult to put all of those features in one tiny device; so we had a remote control that users would carry with them to adjust the device," reports Laura Voll, marketing director for Phonak. "The only reservation-the only criticism-users had about the product was that carrying the remote control was inconvenient; they sometimes forgot to take it with them."

A few years later, an engineer in Phonak’s research and development laboratories in Switzerland, located in the heart of the watch district, had a brainstorm. "He called us and asked, 'Do you think people would like it if we put the remote control in a wristwatch?’" recalls Voll. "We immediately knew the concept was a winner."

HELiOS personal oxygen system, a high-efficiency liquid oxygen system designed for ambulatory or mobile use, which weighs only 3.5 lb when full and incorporates the first pneumatically driven 4-to-1 conservation-ratio oxygen conserver.

Phonak won a 2001 MDEA for its Claro digital hearing aid and its WatchPilot remote control. The Claro’s signal-processing system integrates 20 overlapping bands of sound corresponding to the 20 critical bands by which the ear processes sound in speech frequencies, allowing the device to control loudness and adjust amplification when background noise overwhelms speech. By turning one of four buttons on the WatchPilot, users can adjust their hearing device to a quiet or noisy listening environment, switch to a program preset by their hearing professional for special situations like telephone conversations, or select an automatic option that matches the appropriate program to the current noise level.

"The Claro and WatchPilot have been phenomenally well received," says Voll, attributing strong sales to the company’s revamped marketing efforts.

While in the past the company promoted its products directly to hearing-care professionals, several years ago Phonak turned its marketing philosophy on its ear. "We’ve started following a pharmaceutical model," reports Voll. "Consumers have to buy hearing devices through a licensed professional, and we’ve brought about 2000 of the nation’s hearing professionals to our training facilities to help them become comfortable with the software and the hearing aid. There are 12,000 hearing-care professionals in the United States, but there aren’t that many hearing professionals out there to do marketing for us."

Instead, Phonak has reached a much broader audience more effectively with targeted print advertisements. "More than 20 million Americans-one in 10-has a significant hearing loss and could benefit from wearing hearing aids," says Voll. "But fewer than 20% currently use a device." By advertising in magazines such as Modern Maturity, New Choices, Reader’s Digest, and Good Housekeeping, Phonak takes its message directly to its core markets. "We’ve also dabbled in TV and radio advertising, but we keep coming back to a regular print media schedule because that has provided the best results."

Indeed, for each of the past five years Phonak’s gross revenues have leaped 30%. "Our main advertising message has been that our company restores communication-not just hearing. We let people rejoin society," says Voll. The addition of the MDEA to Phonak’s trophy case will be another message for prospective customers. "Customers care about technology and innovation, and the MDEA reinforces the idea that this product possesses those qualities. We’ll promote winning the MDEA through PR efforts and in our advertising. It’s one more distinction for our product line."

Pathfinder: Getting Off on the Right Foot. For some medical products, getting the attention of the end-user can be a boon to product marketing. That's certainly the case for the Pathfinder prosthetic foot, which offers some innovative and highly desirable features for lower-limb amputees who have moderate to high activity levels. The Pathfinder combines shock absorption and energy storage capabilities with a unique ankle motion to provide users with a greater range of motion, less fatigue, and improved balance. Designed and manufactured by Ohio Willow Wood Co. (Mt. Sterling, OH), the Pathfinder earned a 2001 MDEA in the category of rehabilitation and assistive-technology products.

The Pathfinder evolved through a lengthy evaluation of several prototypes. The objective was to develop a product that would offer improved energy storage and return, shock absorption, increased stability, range of motion, and a smooth transition from heel strike to toe off. The result was a triangular design, a closed shape with three main sides. The three sides-the pneumatic heel spring, the composite toe springs, and the composite foot plate-are connected at three main joints-the toe connectors, the heel connector, and the proximal connector. The advantage of the triangular design is that each side acts synergistically with the others to provide an optimal gait.

The Pathfinder enabled Ohio Willow Wood to enter a segment of the prosthetic market where it had not previously been a competitor. According to the company, several production features of the Pathfinder can be incorporated into existing product lines, thereby also enhancing the performance of those products.

According to Mark Ford, director of marketing at Ohio Willow Wood, marketing of the Pathfinder has been extraordinary for the prosthetic industry. "Our marketing began with a teaser print and Web ad campaign leading up to the product's launch in March 2000," says Ford. "Without saying anything about the product or the company, the teasers were designed to create a buzz about a product about to be introduced."

The trade show launch consisted of a three-room display, including a 30-seat theater showing a high-impact video and a demonstration area where amputees showed the product in use. "Before allowing customers to purchase the product, we also required that they attend a certification seminar," notes Ford. "The seminar was designed to train prosthetics professionals on the correct use of this new technology, but it also served to enhance the perception that the product is innovative."

Since the launch of the Pathfinder, Ohio Willow Wood has used a variety of media to promote its award-winning product. "Our print ads have been targeted to both prosthetic facilities and amputees, and have been changed several times to show the product in use in a multitude of ways," says Ford. "We also increased our direct mail approach and redesigned our Web site to focus heavily on the Pathfinder for the six months immediately after its release. The site includes limited technical information, but focuses on a group of amputees who have worn the product for quite some time. By marketing directly to amputees, this approach enhances our pull strategy."

Ford says that winning an MDEA "further legitimizes the successful efforts of everyone at Ohio Willow Wood. This award reinforces to everyone in the prosthetic industry the true innovation that goes on within our company."

A third MDEA winner in the category of rehabilitation and assistive-technology products is the HELiOS personal oxygen system, a high-efficiency liquid oxygen system designed for ambulatory or mobile use. The portable HELiOS unit weighs only 3.5 lb when full and incorporates the first pneumatically driven 4-to-1 conservation-ratio oxygen conserver. This product was designed by Tyco Healthcare Puritan-Bennett (Indianapolis) and Omnica Corp. (Irvine, CA), and is manufactured by Tyco Healthcare Puritan-Bennett.

Surgical Equipment, Instruments, and Supplies

Mammotome: A Winning Team. Partnering makes business dreams reality for many companies today, and Ethicon Endo-Surgery Inc. (Cincinnati) recently partnered with a number of other firms to bring to life the MDEA award-winning Mammotome. The Mammotome, a handheld, minimally invasive, ultrasonically guided breast biopsy system, allows doctors to gather breast tissue through an incision the size of a match head.

"One of our biggest challenges in bringing this product to market was creating a global product platform that would meet the current and future needs for breast biopsies," says Mike Murray, group team leader in research and development for Ethicon Endo-Surgery. In the United States, many breast biopsies are performed via x-ray guided systems, and patients are immobilized on a prone or upright stereotactic table. In most other countries, physicians primarily use ultrasound imaging of the breast, which is why the Ethicon team-in cooperation with its European, Japanese and other international partners-concentrated its efforts on developing a handheld product to be used with ultrasonic-imaging modalities.

Another challenge quickly arose, however. "The Mammotome is the first piece of capital equipment that Ethicon Endo-Surgery has designed from the ground up," reports Murray. "Our other products have entered our product line through acquisitions, and we’ve made updates and modifications, but this is the first time we started at square one. We didn’t have a strong base of electrical development here at the time we started developing Mammotome; so we partnered with Herbst LaZar Bell (Chicago) for initial concept and design. They took us to the alpha or initial prototype model stage. We then brought in Plexus-Technology Group (Neenah, WI) to handle the electronic development and software. Plexus also manufactures the product for us."

Ethicon’s internal departments played crucial roles in the device’s development as well. As a handheld cutting device, the Mammotome had to be designed to give radiologists and surgeons great control. "We needed to excel in human interface with this device; so we brought in our industrial design group from the very beginning," reports Murray. The device features an interactive touch-screen that shows instructions and graphics in six languages.

The company’s global partners were instrumental in helping to develop a user-friendly device that would succeed internationally as well. "Very early on in the development process we sent our European marketing partners prototypes of the device so that they could get customer feedback," explains Murray. "We also used the Internet to get feedback on the graphics we were developing to ensure that they were user friendly. Plus, our partners came to the United States to participate in product reviews." Also participating in the market studies and user groups were engineers from the development team so that they could see first-hand how end users would interact with prototypes.

Other internal groups, including packaging (responsible for writing multilingual product use manuals), marketing, and regulatory affairs, whose efforts allowed Ethicon to win all regulatory certifications within months after completed testing, also aided the cause.

Throughout the process, communication was key. The Internet played a starring role. "We developed a website that our teams at Ethicon and Plexus used to transfer documents, update specifications, and review engineering changes," says Murray. "We also had weekly conference calls, but the website really kept us on target. Especially in the final stages when we were conducting validation testing, the website was invaluable in saving us time. We could instantaneously review and approve documents rather than waiting on next-day mail services."

Having a single source where all team members can access the latest documents and receive the newest updates is key to creating a successful launch, says Greg Beltran, medical marketing manager for Plexus. "We assign a single project manager to each program and that person not only manages the resources and takes responsibility for the success of the program, but he or she also serves as a single communications point for the customer, in this case, Ethicon," adds Chris Rozewski, technical marketing manager for Plexus. "We also rely on our custom-developed open-issues list (OIL) management tool. OIL manages all open issues in real time. All team members can contribute issues to the list, and it incorporates corrective actions and dates by which the issues must be fixed. OIL drives decision-making at the weekly meetings."

The team effort has paid off in more than a strong-selling product that has been recognized for its design excellence. The Mammotome is the basis for a full line of new products that will include a stereotactic version, and versions of both the ultrasonic and stereotactic devices will be available in different sizes to allow flexibility for different-size lesions. "We developed the Mammotome as a platform for Ethicon so that as new technology comes available, we’ll be able to quickly update and add to our product line," says Murray.

Neptune: Building a Company-On Spec. Not every award-winning product is one the company originally set out to make. In the case of the Neptune waste-management system, a fortuitous series of events brought together just the right team to make this an MDEA-winning product for 2001.

The Neptune waste-management system is intended to be used in the operating room, pathology and surgical centers, emergency rooms, and doctors' offices to evacuate, collect, and dispose of hazardous surgical fluid waste as well as to evacuate smoke from electrocautery or laser devices. Designed by American Immuno Tech Inc. (AIT; Costa Mesa, CA), it is manufactured by Bio-Medical Devices Inc. (Costa Mesa, CA) for Stryker Instruments, a division of Stryker Corp. (Kalamazoo, MI).

Mammotome handheld breast biopsy system, a minimally invasive device that can be used to collect multiple biopsy samples with a single needle insertion into the breast.

But that wasn't the product AIT was meant to create. Founded in 1996 by its president, Alan Davidner, AIT was originally intended to develop an extracorporeal device to treat blood-borne infections. The concept was supported by growing concern over antibiotic-resistant organisms and a potential market conservatively estimated at $1.5 billion per year-but limited by a long R&D cycle with an equally long regulatory path. Faced with a need to provide cash flow to fund development of its primary product, the company needed a second product opportunity.

That opportunity was found when the idea for the Neptune system was brought to AIT’s sister company, Bio-Medical Devices, where Davidner serves as a principal. The bearer of the idea was Merle Knoll, a materials management analyst at the University of California, Irvine (UCI). She said that UCI's hospital was reevaluating its waste-management practices because of the 1994 state legislation requiring all hospitals to reduce the amount of solid waste designated for landfills by 50% by the year 2000.

Knoll observed that UCI incurred insurance, liability and other costs related to a potential fatal exposure incident at just less than $1 million. With such a market need-and some of the technology to develop a better waste-management system already in existence-Davidner seized on the chance to support his embryonic company.

Funding for the company was an ongoing challenge. According to David H. Mills, AIT's director of marketing and sales, "The company has so far been funded through private investment (approximately $4 million) and with the help of the investment banking firm Taurus Capital Group (approximately $4.3 million). Taurus structured a mezzanine round of financing through a broker-dealer network."

Mills credits company president Davidner with having the business acumen necessary to keep the company going. "By sharing services with its sister company, Bio-Medical Devices, AIT was able to minimize start-up costs and therefore offered no debt to potential investors," says Mills. "Instead, resources were focused in two areas: engineering and market awareness."

The product development team included "highly skilled and competent individuals who are focused and result oriented," says Mills. "The people that Alan hired included award-winning talents: engineers with design awards in their background, engineers who have designed the number one selling product in a particular field, an individual with two Oscars for scientific achievement in the motion picture business, a consultant with an Emmy for books on tape.

"Additionally, AIT planned to utilize Bio-Medical Devices for manufacturing its initial products," he notes. "This enabled AIT to focus its efforts on research, development, and marketing."

Premarketing of the Neptune system began even as development was under way, says Mills. "With an advanced stage prototype, AIT initiated clinical trials at UCI. But because of the rising awareness of the problems of waste management, getting interested parties to investigate Neptune was never an issue."

With the product in trials and premarketing promotion under way at various trade shows, AIT began to attract interest from a number of major medical companies that wanted to distribute the product or acquire the rights to the technology. "Because of its previous successful acquisition of a Bio-Medical Devices product, Stryker Instruments was the most aggressive and persistent party," says Mills. "As a result, after six months of repeated proposals, Stryker acquired the rights to the Neptune system for a minimum of approximately $40.3 million in January of 2000."

For AIT, winning an MDEA will offer many advantages. "This award reaffirms to our shareholders that the company is on the right track and poised for continued success," says Mills.

The award will also help Stryker to sell the Neptune system. "It communicates to hospitals that the system is worth investigating-and is arguably the best on the market," Mills adds. "Recent feedback from the market suggests that this product will be a tremendous success for Stryker. In fact, Stryker touted it in the company's annual report, and feedback from Stryker’s marketing department suggests that it could prove to be not only the company's most successful new product launch, but even the basis for a new stand-alone division for the corporation."

Not bad for a product built on spec.

Other MDEA-winning products in the category of surgical equipment, instruments, and supplies include the following.

The Aortic connector system, an implanted device that creates the proximal anastomosis of an aortic autologous vein graft, providing a minimally invasive method for bypass surgery and eliminating the need for hand suturing. This device was designed by redgroup (Minneapolis) and St. Jude Medical (St. Paul), and is manufactured by St. Jude Medical.

Aortic connector system, an implanted device that creates the proximal anastomosis of an aortic autologous vein graft, providing a minimally invasive method for bypass surgery and eliminating the need for hand suturing.

InsideView, an advanced video projection method that displays high-resolution images on a sterile disposable screen positioned within the surgical field, enabling physicians to operate with a simultaneous view of the internal operative site and their hands. Designed and manufactured by LSI Solutions (Rochester, NY).

The Tissuebond applicator and Tissuemed 180 lightsource system, a custom-designed applicator and light source that allow easy, controlled application of tissue sealant that is subsequently activated by a light. This system was designed by DCA Design Consultants (Warwick, UK) and Tissuemed Ltd. (Leeds, UK), and is manufactured by Tissuemed Ltd.

Conclusion

With 28 MDEA-winning products for 2001, there are a lot more stories to tell. The ones selected here, however, suggest that diversity and innovation are alive and well in the medical device industry. Whatever the size of a company-and whatever its business model-excellence in the design and development of medical products is an achievable goal.

The MDEA winners for 2001 will receive gold or silver award recognition at a ceremony on June 6, 2001, during the Medical Design & Manufacturing (MD&M) East 2001 Conference and Exposition to be held at the Jacob K. Javits Convention Center in New York City. Winning products will be on display in the MDEA booth throughout the show.

The MDEA program is presented by Canon Communications, publisher of MX. Sponsors of the 2001 competition are MedSource Technologies, DuPont Tyvek, Agion Technologies LLC, Battelle, Avail, Colorado Medtech, IBA Medical Sterilization & Analytical Labs, and Medical Device & Diagnostic Industry magazine.

The entry deadline for the 2002 MDEA competition is October 5, 2001. For further information about entering the competition, visit the MDEA Web site at http://www.MDEAwards.com.