In Pursuit of Failure

Originally Published MDDI February 2003

EDITOR'S PAGE

The medical device industry cannot deliver anything close to perfection unless it expects failure.

As NASA begins the massive task of finding and piecing together debris from the space shuttle Columbia, we are reminded of the many surprising similarities between the aerospace and medical device industries. Both involve life-or-death products, require the highest level of quality assurance, are subject to intense regulatory scrutiny, and rely on advanced technology for their most spectacular successes. 

Both, too, are subject to terrible failures. Granted, the scale of disaster in the aerospace industry dwarfs any failures the device industry can produce, at least in terms of immediacy and visibility. But for both industries, failures are viewed by the public as unacceptable. Accidents can happen in other industries, but not in these two. 

As the investigation into the Columbia disaster proceeds, the medical device industry can learn much by watching closely. This failure analysis will be conducted on a very public stage, and on a scale rarely seen. 

To gain from this example, though, the device industry must apply the lessons learned to the smallest scale. The mentality should be that no failure, however small or seemingly insignificant, should go unsolved. Too often are FDA inspectional observations and warning letters issued due to poor complaint-handling procedures. In this area, at least, the agency is right to hold companies to the strictest standards. Only by investigating and understanding all the small failures can the large ones be avoided. 

Moreover, the expectation and analysis of failure must be built into the product development process itself. Hazard analysis tools such as failure mode and effects analysis and fault tree analysis should be second nature to all engineers. So, too, should be an intimate understanding of how systems fail. 

Paradoxically, while the public expects perfection, the medical device industry cannot deliver anything close to it unless it expects failure. An imagination of disaster is a prerequisite for any engineer.

To help further this process, MD&DI will be publishing in upcoming issues a number of articles that bear on the processes and procedures of failure and hazard analysis. In this issue, for instance, beginning on page 64, author Mike Schmidt addresses risk management. Because Schmidt's article deals with one clause of an ISO standard, readers might consider this article to be for specialists only. Nothing could be further from the truth. We urge all readers involved in the development of medical devices to read the article, for the stakes are high indeed.

In addition, be on the lookout for a retrospective series on the subject on MD&DI's Web page, at www.devicelink.com/mddi. This series will highlight the best articles on this topic from the past 10 years of MD&DI and its sister publications.

More on Author Forums
In last month's issue, we directed readers to our new Author Forums on the MD&DI Web site. Now you can communicate directly with the authors and share your thoughts with other readers as well. We're pleased to report that the forums are up and running, and already seeing activity. 
For this month's issues, the following authors will be prepared to respond to your comments and questions:

• Rich Rosen, “Project Advisory Boards,” p. 38.
• Jeffrey Shapiro, “FDA's Regulation of Analyte-Specific Reagents,”p. 44.
• Mike Schmidt, “Establishing Overall Risk for Medical Devices,”p. 64.

To go directly to the forums, simply type www.devicelink.com/phpbb into the address box of your Web browser. Although we will eventually require registration with Medical Device Link to post, for the time being, no membership is required. And you may give your feedback on any article in the issue, regardless of whether the article's author has agreed to respond. Feel free to post your comments for the world, or simply to read what others have posted. We look forward to seeing you there.

The Editors

Copyright ©2003 Medical Device & Diagnostic Industry