Lessons in Design Excellence

Originally Published MDDI June 2002

EDITOR'S PAGE

Looking for ways to improve your business? Look no further than the winners of the fifth annual Medical Design Excellence Awards.

Since their inception in 1998, the Medical Design Excellence Awards have been a valuable barometer of trends in the industry. They have reflected not only innovation in engineering and industrial design, but in manufacturing techniques, materials applications, human factors science, and much more.

To judge by the quality of this year's gold award winners, the medical device industry is in top form. As we prepared our coverage for this issue of MD&DI, we were impressed by the high degree of diversity and innovation we found.

Among the compelling stories, for instance, is that of Geiger Medical's thermal cautery device. It is an outstanding example of how effective industrial design and an understanding of the market can turn around an entire company. For decades, the company's primary product was a hand-built device—a "transformer in a box"—that had become increasingly dated as the years passed. As the product aged, the fortunes of the company waned.

Under the guidance of new owner John Bottjer, the product was completely redesigned. In addition to upgrading the look of the device, the company also optimized the design for high-volume manufacturing. The end result has been a 600% increase in sales.

Just as effective design engineering and market insight can revive a tottering company, so can they kick start a new one. A gold-award winning disposable device for diagnosing sleep apnea is a case in point. The founders of the Tel Aviv–based company SLP saw a market opportunity in the huge numbers of undiagnosed sufferers of sleep apnea. Because diagnosing the condition requires an expensive and inconvenient stay in a sleep lab, only a small percentage of patients are tested.

By devising a small testing strip similar to an adhesive bandage, SLP overcame this significant hurdle to diagnosis. To do so, the company had to perform some remarkable feats of miniaturization. Though only about 5 in. long and 1 in. wide, the company's Kapton strip includes a microchip controller, three thermistors, a battery, and an electrochemical display, among other components. Though still in the early stages of commercialization, SLP's product holds the promise of significant cost savings and significantly better rates of diagnosis.

Perhaps the most innovative winner this year is, at first sight, deceptively simple. Align Technology's clear, removable orthodontic appliances are based on a simple insight. An adult wearer of braces, company cofounder Zia Chishti realized that the same straightening effect could be achieved much more conveniently and attractively by a series of gradually adjusted retainer-like aligners. The problem, though, was how to cost-effectively mass-produce such products.

The company's solution relied on some of the most advanced technologies available. Quite simply, Align's product would not have been feasible 10 years ago. One of these technologies is the Internet. It is a key part of the process of interacting with the clinician. Based on data generated by scanning impressions of the patient's teeth, Align models the course of treatment using a software program. The clinician is able to review the plan and adjust it as necessary. Once approved, the data are fed into a CAD/CAM program. Then another key technology, stereolithography, comes into play. Driven by the CAD/CAM data, the series of aligners are modeled by means of this rapid- prototyping technology. The aligners are then molded from the models.

Since the invention of stereolithography in the mid-1980s and of the World Wide Web in the mid-1990s, much has been made of their revolutionary potential. For all that has been accomplished by the medical device industry with these technologies, to our minds, Align's use of them is the most exciting to date.

Remarkably, these companies are just three of the winners of the 2002 Medical Design Excellence Awards. The rest of them also offer the industry a valuable lesson in medical device design. We encourage you to look deeper into their stories in this issue and on the awards Web site at www.mdeawards.com.

The Editors

Copyright ©2002 Medical Device & Diagnostic Industry