May 28, 2014

Keith S. Karn, PhD, at the Conference on Human Factors for Drug-Device Combination Products

Keith S. Karn, PhD, Bresslergroup’s Director of User Research, drew on his extensive experience in both consumer product and medical device design for the presentation he gave earlier this month at the 2014 Human Factors for Drug-Device Combination Products Conference in Philadelphia. The thesis of his “Beyond Usability Testing: Integrating Human Factors Considerations Throughout Product Development” is: Combination products (products that combine a drug and a device to administer the drug) would be better-designed if we approached them more as we do consumer products.

This is especially timely now that cost pressures are pushing healthcare into the hands of untrained patients and lay caregivers in the home environment, resulting in medical devices moving farther into the realm of consumer products. While the FDA and IEC provide sound guidance on applying human factors and usability engineering through analysis, testing, and validation, they do not — and rightly so — tell companies how to design their products. Karn posits that companies developing medical devices, particularly combination devices, focus too much on the testing and validation at the end of the product development process and not enough on involving human factors professionals throughout the process.

This is detrimental, because the later you are in the process, the higher the difficulty and cost of making changes. Involving human factors professionals earlier results in improved product usability and increased benefits for manufacturers. This return on investment manifests itself in many ways, including reduced development costs, increased product sales, reduced errors, and reduced costs of training.