Appendix 4: Commentary on What is Accessibility? And What Does it Have to do with Medical Device Design?

Having spent the past 15 years working to better identify, understand and resolve problems with use of medical devices, we understand many of the issues and problems associated with improving the “usability” of medical device design for the “intended” user. But what is meant by “accessibility” and how can it successfully be incorporated into device design?

The medical device manufacturing industry in the U.S. is large and diverse, with several large manufacturers and many specialized small ones. The majority of device manufacturers are small, with fewer than 20 employees. FDA currently lists over 80,000 different brands and models of medical devices manufactured by more than 10,000 device companies.

Medical devices include a wide range of products – from expensive, complex equipment (such as x-ray machines) to simple items (such as bandages). These vary dramatically in complexity, packaging, and application. The industry is constantly producing new innovations, which causes relatively short life cycles for many products as well as intense competition among manufacturers.

Stimulating the medical device industry to consistently follow human factors engineering design principles has been difficult and only been partially successful. FDA’s Quality System Regulation of 1996 provided a mandate for manufacturers to design devices which met the needs of the intended users. And in 2000, CDRH published specific guidance to further help manufacturers address hazards related to medical device use during device design and development. Although both were widely published and promoted, only limited progress has been made in establishing human factors engineering as a consistent and visible component of device design.

For “accessible interfaces” in medical device design to be successfully encouraged, the first step will be to clearly articulate the need. Device designers typically work within constraints established by the company’s business plan. They must balance competing priorities to bring about the most cost-effective and marketable device design, including its user interface. The accessibility community must therefore help the medical device design and development community by succinctly describing accessibility both in general as well as for different types of disadvantaged users and specific devices. The following questions would help define these issues:

• Who are these disabled users for which accessible designs could be helpful?
• What could disabled users accomplish with accessible devices?
• How do disabilities currently affect use of medical devices?
• What modifications would address the existing accessibility issues?
• How have accessibility solutions been successfully applied to other domains?