Human factors should be incorporated into the product design throughout the product lifecycle as part of the benefit-risk profiling of a medical device or combination product, MHRA says.
The Medicines and Healthcare Regulatory Agency is advising devicemakers on what to consider when developing devices to eliminate design-related problems that contribute to unsafe or ineffective use in guidance released June 15.
The guidance maps out a comprehensive design process and steps manufacturers should take to reduce errors that could potentially lead to patient harm.
First, devices should be designed based on user need, and instructions for use should include design and development inputs with usability requirements based on intended use.
Formative studies are expected to be iterative so that information is learned from the earliest stages of development. Manufacturers are required to establish a usability engineering file as a part of device documentation to address evolving issues. Further design changes may be necessary following clinical studies.
Any changes to a product need to be evaluated, and manufacturers should consider and document additional human factor engineering studies.
Medicinal products that include a significant device component, either co-packaged with, or integral to the medicinal product, should be analyzed for risk and documented in the risk management plan.
In the case of combination products, where the device is marketed as an integral part of a single product, both the device and medicinal component will be regulated as a single product.
Any differences between the device used in pivotal clinical studies and that proposed for marketing should be clearly explained and additional human factor engineering studies may be required.