MassMEDIC, the trade association for the Massachusetts medical device industry, hosted a program this morning built around integrating the “human factor” into device design. The FDA’s 2011 draft guidance (promised to be made final this year) includes the usability of medical devices as one criterion in device approval.

The presenters, from the consulting firm Contiuum and the drug company Sanofi, noted that successful devices (including those which deliver medication) must not only satisfy the fundamental standards of safety and efficacy, but also must be sufficiency appealing to the user (whether a member of the public or health care professional) in order to gain traction in a competitive, consumer-marketplace. “The success of a product depends on your users.”

The panel noted anecdotal experiences wherein products which were both safe and efficacious nonetheless failed in the marketplace because they did not address human factors: is the physical design sufficiently appealing to reinforce use, are the cognitive factors so clear that the manner of use is understandable and comfortable, does the device achieve an emotional reaction in the hands of the user.

Techniques for having usability march hand-in-hand with product design include integrating the human factor early in the design process, undertaking biometric and other studies of devices in actual use (even if they are nonfunctional “dummy” devices), and testing, redesigning and testing again.

Certain products, particularly those not analogous to those already in the marketplace, require careful writing of instructions for use. In these cases, the FDA will focus on the instructions both for their own understanding and in order to make sure that the product in the marketplace will perform safely and as the engineers anticipate.

The emphasis on usability and the consideration of human factors in the design of products reflects society’s growing “consumer” emphasis. Products will not be successful unless they are used as intended, notwithstanding their theoretical efficacy; utilization in the hands of the consumer requires consumer buy-in which in turn depends upon both ease of use and a positive human-emotional reaction to the user experience. It is interesting to hear engineers engaged in the “softer side” of product development but, it seems, the blending of human factors into device development is becoming a standard goal, and the only question is: how can you make sure the engineers are sufficiently exposed to that aspect so that the ultimate products are successful in the marketplace.