For medical device design, the US FDA is interested in what is the final finished medical device and the process that led the manufacturer to the final design of the device, the device design process. Specifically, FDA wants manufacturers to ensure that the original user needs are met by the final finished medical device. To ensure manufacturers are designing products that meet user needs, FDA requires medical devices to be designed according to design controls, as regulated under 21 CFR 820.30. Design controls regulations are a set of requirements that allow manufacturers to control the way a device is developed.
What are Design Controls?
Design controls are a set of quality procedures implemented by the manufacturer to control the design process. After discovery or early feasibility, manufacturers must begin documenting the progress on the device design. Manufacturers are required to document user needs and what are the device features (or design inputs) that meet those needs. As the device goes through prototyping and safety testing, manufacturers must monitor and record all changes and assess how these changes impact the user needs and design inputs. After the final device prototype is made the manufacturer must test to ensure all user needs and design inputs are met.
Once the manufacturer believes the device prototype meets all user needs then the device must be tested to determine if the final device meets the user’s needs as intended. This final set of testing is the “verification and validation testing.” Verification refers to all testing that verifies if the device outputs meet the originally intended device inputs (i.e. features of the device). Validation refers to all testing that validates if the device itself meets the needs of the user (i.e. delivery of therapeutic effect).
Why Does the FDA Regulate the Medical Device Design Process?
Design controls work by ensuring a device is manufactured to meet the needs of the patient or physician. Historically, manufacturers have set out to deliver a device with an intended purpose but during design, a different product gets developed. This type of product may not meet the customer’s needs. When that happens, there can be a misuse of the product, misbranding or labeling issues, or even recalls. Medical device design controls help ensure manufacturers have a development methodology that prevents these errors.
Design controls are a very useful tool for manufacturers because it formalizes the development process and provides teams a framework for medical device product development. However, this formalization may not be helpful for R&D engineers early in the research of the products because medical device design controls require heavy documentation and a very defined scope for development. FDA requires manufacturers to implement design controls after feasibility or once a prototype is ready for market.
DeviceLab and the Medical Device Design Process
The medical device design process is highly regulated to ensure the right products are brought to market. Because design controls are required per FDA regulations, they should be implemented as part of an integrated quality management system. DeviceLab can help with the implementation of design controls or the development of medical devices. Contact us today to schedule your personal free and confidential consultation.