Identifying medical device user needs
To market any type of product successfully, it's important to identify how people will use it and what difference it will make in their lives. Understanding user needs is especially key when it comes to medical device design and development. The right choices when creating a new medical product can make all the difference in both regulatory compliance and its effectiveness in treatment.
User needs and regulation
"The FDA takes user needs into account when applying quality system requirements."
As laid out in a guidance document issued in March 1997, the U.S. Food and Drug Administration takes user needs into account when applying quality system requirements for design controls. This set of quality practices and procedures focuses on whether a device meets standards for design inputs – the physical and performance characteristics that influence design – and human factors, or how people interact with the product. These controls apply to all Class II and Class III devices, as well as several Class I products, such as:
- Automated devices that rely on computer software.
- Tracheobronchial suction catheters
- Protective restraints.
- Surgeon's gloves.
- Manual radionuclide applicator systems.
- Radionuclide teletherapy sources.
For organizations in medical product design and development, the FDA's mandates mean they must explicitly define how a new device will be employed, demonstrate that it is built to fulfill its purpose and stay vigilant for possible issues with design controls. These kinds of problems were the leading reason for recalls between 2003 and 2012, according to a report from the FDA's Center for Devices and Radiological Health.
The FDA acknowledged that since medical products have a wide array of applications, design requirements cannot be universal. For every product, manufacturers must consider how it will be put to work and make engineering choices accordingly. The agency emphasized that setting clear requirements is the most crucial part of design control, since it allows managers to address any problems early in the process, saving an organization a great deal of money in the long run.
Establishing device requirements
Medical device makers can ensure that products are built with user needs at the forefront by setting up stringent approaches to design and creating extensive documentation to direct those processes. These documents should present the user needs and intended uses for a device, outlining verifiable design input requirements and providing a checklist for usability testing.
The nature of the requirements differs based on the type of product, so it's vital to make the appropriate adjustments according to the complexity of a device and the risk it presents to patients. For instance, if user needs call for a blood glucose sensor that is portable, then designers must think carefully about what parameters are acceptable for the product's weight and size.
Meanwhile, human factors engineering concentrates on reducing the likelihood of errors or failures, making a device as safe and effective as possible. Everything from medical user interface design to packaging can have implications for the people who rely on a product.
User needs are a key concern throughout the medical device product development process. Thoughtful healthcare usability design principles and a robust strategy for applying them to every device result in better outcomes for life sciences organizations when bringing new products to market.