The PDMA Handbook of New Product Development

26.4. What Is the Impetus Behind Human Factors? Who Thinks This Is Important?

Many organizations require, or at least highly recommend, the implementation of an HFE program during product development. These organizations have discovered the benefits of human performance requirements when integrated early in the design process.

Good HFE practices are of such concern to the FDA that they have incorporated a requirement in 21CFR 820.30. The FDA has been an advocate of HFE since 1975, with early concern stemming from use errors in anesthesia delivery. Per the Code of Federal Regulations (CFR), manufacturers are required to establish and maintain procedures "to ensure that the design requirements are appropriate and address the intended use of the device, including the needs of the user and patient" (820.30c) and "for verifying and validating the device design to ensure that the devices conform to the user needs and intended uses with the production units tested under actual or simulated use conditions" (820.30g). This requires a process to be in place that ensures adequate consideration of human factors in the design and development of medical devices.

The United States Army has an extensive MANPRINT (MANpower and PeRsonnel INTegration) program. MANPRINT is the Army's human systems integration program that fulfills the requirements of DoD Directive 5000.2. This is a comprehensive program that integrates manpower, personnel capabilities, training, system safety, health hazards, human ...