Recommended Reference

Understanding of human physical capabilities and limitations is fundamental to the design of effective medical devices Anthropometry is the science of measuring and quantifying various human physical traits, such as size, weight, proportion, mobility, and strength. Biomechanics is the use of laws of physics and engineering principles to study various body segments as they move and are acted upon by internal and external forces Most of the anthropometric and biomechanical information available today is not specific to health care professionals, patients, or medical devices General Considerations Medical device design should account for the physical sizes of people Data on body-size distributions of males and females Reference information for tools used to assess the risk of musculoskeletal injury associated with work performed in clinical environments Medical domain has unique anthropometric challenges Implanted component In some cases, anthropometric information in the public domain is not detailed enough to be of value Example: ear dimensions for headset design (proprietary data) Example: Unilead precordial array used for resting 12-lead ECG Anthropometric Design Guidance Good anthropometric design of medical devices should accommodate as wide a range of human physical dimensions as is possible In most cases, the design of medical tools, equipment, and workstations ought to accommodate adults ranging in size from a 5th percentile female to a 95th percentile male Accommodate larger percentages of the population if a) the device involves critical functions b) there are safety issues associated with not accommodating extremes c) the user population has large physical diversity d) device usability and functionality is not compromised e) the costs of doing so are not excessiv