IE 11 is not supported. For an optimal experience visit our site on another browser.

Human Factors Research Adds Human Element, Credibility to FDA Medical Device Approval Process

/ Source: GlobeNewswire

SAN MARCOS, Calif., April 26, 2011 (GLOBE NEWSWIRE) -- For the past two decades, Dr. Joely Gardner, founder of Human Factors Research, has been a leader in evaluating the usability of web sites, software and consumer products.

Now the board certified, licensed psychologist is applying the depth and breadth of her professional experience to help medical device manufacturers meet new Food and Drug Administration requirements to show that consumers and health care professionals can use their products effectively and safely.

 As a neutral third-party researcher Gardner and her firm have years of experience developing research protocols and analyzing consumer as well as biomed products for U.S. and international companies.

Clients, including Gateway Computers, Quest Diagnostics, Bespak Injectables in the UK, Hewlett Packard, Cardinal Health, Life Technologies, Fuel Cell Energy and JP Morgan Chase Bank, have benefited from Gardner's multidisciplinary approach that includes statistical analysis of quantitative results as well as interpretation of qualitative user feedback and comments.

"Numbers never tell the whole story, the 'why,'" she explained. "That is why you need human interaction to add depth to the numbers to increase the predictive validity of a study."

Usability is often associated with web design and general consumer products. But the FDA's HE 75, Human Factors Engineering – Design of Medical Devices focused attention on the need to include usability testing of medical devices to minimize the risk to users and reduce the number of recalls.

Many medical device firms do their own usability studies. But Gardner points out that data collected by neutral, third party researchers adds strength to the manufacturer's claims. 

Gardner is available to share her expertise and observations with others.

She has taught Measuring Customer Satisfaction at University of California, San Diego Graduate Business School Extension Program and teaches in the User Experience and Usability certificate program at Cal State Fullerton. A former member of the board of directors of the American Society for Quality, Gardner is available to speak on a variety of topics including validations studies of medical devices.

She recently spoke at the 6th annual Cognitive Science Conference at UCSD and is scheduled to make a presentation on WOW!: A Strategic Initiative at the San Diego Product Development and Management Association in May.

Human Factors Research is a 10-year-old consulting firm that specializes in bringing the voice of the customer into the product development and validation process. Gardner is the former director and U.S. practice manager of customer experience research for France Telecom R&D, one of the world's largest telecommunications companies. She also served as director of user experience research and West Coast practice manager for Rare Medium, an international web design firm based in Irvine, CA.

CONTACT: Joely Gardner, president Human Factors Research (760) 650-9096 Email: