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Wednesday, April 11, 2007
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What's the (Ease of) Use?
 FDA wants device manufacturers to employ usability-engineering principles in their designs. Those who fail to do so may run afoul of the agency.
But that’s not the only reason to take ease of use into account when designing a medical product. A properly designed product that does not present any use problems also enhances patient safety and saves time and aggravation. Both of these factors will make users want to keep using it.
And, judging from what jurors of the 2007 Medical Design Excellence Awards are saying, good usability is key to winning a design award. No matter how good an idea is, they say, if you can’t design it in a way that’s easy to use, it won’t reach its potential.
“One impression that I got from this year’s entries is that substantially more attention has been given to usability,” says juror Craig Jackson, PhD, president of Hemosaga Diagnostics (San Diego). “Users of medical devices commonly work under stressful circumstances. Whether the stress is related to complications associated with a patient or the environment in which performance demands are intense because of cost-cutting measures, the opportunity for errors always exists. Design for simplicity of operation, robustness of the device performance, or, for in vitro diagnostics devices, detection and correction of errors, is improving. The trend of integrating new technologies is evident, as is the demand for convenience and ease of use.”
Improved usability may be a result of more disciplines being integrated into the product development process, says juror Mary Beth Privitera. She is assistant professor of biomedical engineering at the University of Cincinnati’s Medical Device Innovation and Entrepreneurship Program.
“Many submissions highlighted detailed research efforts to prove their device efficacy while maintaining user-centered device design,” she says. “Medical product design is further evolving to better integrate all of the disciplines participating. These include but are not limited to manufacturers, clinicians, engineers, business developers, and industrial designers. This integration has resulted in the development of devices that are based in scientific knowledge and usability, and that consider the overall life cycle of the device.”
Usability is also a theme that runs through the three articles on design trends that are included in MD&DI’s coverage of this year’s award winners. One covers products that represent a significant transformation from the previous standard of care, with improved usability being a big part of why. Another covers products that derive increased capabilities, and usability, from their software. And a third covers devices that are ingenious for their simplicity and ease of use.
All of these pieces contain a variety of valuable design lessons. But there’s one consistent theme: Ease of use is an exceedingly important design principle.
Erik Swain
erik.swain@cancom.com
MDEA
Transforming Medical Practice
By Erik Swain
Some MDEA winners use design principles and technological advances that could change the future of certain treatments.
MDEA
Design Excellence Under the Hood
By Sherrie Conroy
For some award-winning devices, unseen features such as software or wireless connectivity helped pushed them to the top.
MDEA
Make it Simple, Make it Right
By Heather Thompson
Users respond to simple innovations that make a device easy to use. But achieving such simplicity isn’t always easy.
Extrusion
Demanding More from Extrusion Technology
By Joyce Laird
Extrusion companies are getting creative to meet customer demands for small-diameter and custom tubing.
More from this issue of MD&DI
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Clinical Trials Design
 FDA and CMS have different needs for their approval processes. Device makers must design clinical trials that satisfy both agencies carefully.
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Product Development Insight
 Good software user interface aesthetics can reinforce for a user that the device is professional, innovative, and high quality.
Washington Wrap-Up
Although FDA finally posted TMJI’s response to a warning letter on its Web site, the firm thinks the reaction from the agency was too little, too late.
Sneak a Peek at Our Blog
AdvaMed released a statement criticizing CMS’ new rule on competitive bidding. AdvaMed said that the rule could cause patient access to medical technology to be compromised. However, AdvaMed said it wants to work with CMS and patient groups to come up with a solution that benefits everyone.
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