The Risk/Award RatioThe Risk/Award Ratio
Originally Published MDDI June 2001Editor's Page Behind the Glory of Awards Lie Some Tough Decisions
June 1, 2001
Originally Published MDDI June 2001
Editor's Page
Behind the Glory of Awards Lie Some Tough Decisions
As readers of this issue's special section on the Medical Design Excellence Awards will note, the 2001 gold and silver award winners represent some truly admirable feats in the design of medical products. But what will not be evident to the casual eye is the hard work, wrenching choices, and even high drama involved in the selection process. The 2001 MDEA jurors pictured on this page spent many hours studying and discussing the materials submitted by the awards candidates. The final decisions were of course the hardest ones. The jurors were all aware of a degree of risk in their ultimate choices. While the design features they were applauding were clear, they could not assess the safety and efficacy of the products or the ultimate acceptance of the products in the marketplace. By definition, such assessments are outside the scope of the MDEA competition. But like it or not, the decisions of the jurors are inevitably measured against those familiar criteria. That the jurors were willing to assume this risk is a testament to their dedication to the medical device industry. Risk, of course, is what the medical device industry is all about. No device can successfully tackle significant healthcare problems without addressing it. Just before this issue went to press, the jurors encountered a vivid example of this reality. One of this year's winning products was a highly innovative surgical device from Guidant, the Ancure endograft system. This product built on several advanced design concepts to treat abdominal aortic aneurysms without requiring the large incisions typical of traditional surgical treatment. However, two months after the awards judging, Guidant responded to a number of adverse events involving the device by voluntarily suspending production and recalling all inventory. Such an action does not necessarily mean that the device is flawed or that its design features are not in fact worthy of recognition. Rather, it reflects the reality that taking on very difficult challenges such as aneurysm repair involves great risk. For the jurors, learning of these developments meant they had yet another difficult choice to make. The rules of the MDEA competition require that a product already be on the market in order to be given an award, and allow for withdrawal of an award if the product goes off the market. So, despite their recognition of the many virtues of the product, and the possibility that it will soon return to the market, the jurors agreed that it was incumbent upon them to withdraw the award. To us, such a decision is what makes the MDEA program so valuable to industry. Like medical device manufacturers themselves, the jurors are willing both to take risks and to take responsibility for their decisions. We applaud both Guidant and the jurors for their honorable courses of action. |
Copyright ©2001 Medical Device & Diagnostic Industry
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