Product development is a complex process that involves making a multitude of decisions and choices, with all the potential for error that entails. Given that, it’s not surprising that organizations like the FDA or the ISO 13485 standard require medical product designers to build design reviews into their development process. After all, it’s still the best way to ensure that your products are safe, reliable, and effective (and also stay on time and on budget)!
But first, what is a design review?
According to the Design Control Guidance for Medical Device Manufacturers document from the FDA, design reviews are primarily intended to:
How often should I do a design review? And when?
Who should be involved?
CLEIO further exceeds the regulatory requirements by also bringing a member of its Quality Assurance team on as a reviewer. That way, we can be confident that we have people on board with a higher-level and outside perspective, while still ensuring that the design reviews are conducted properly and rigorously. Besides, it’s always good for the QA team to have an in-depth knowledge of the product development progress.
What does a design review look like in practice?
Team meetings to present and review the design
Independent review of the materials by each reviewer
How reviews are documented
To make sure that nothing gets forgotten when documenting their design reviews, the CLEIO team created a template that contains the following sections and fields:
How design reviews can make a real difference: the case of BJ Nimo DragonVision
On the BJ Nimo DragonVision project, we saw firsthand how important it is to have a rigorous design review process that truly works!
Ongoing design reviews
BJ Nimo sought out CLEIO’s expertise to develop an ophthalmic diagnostic tool. Since the product included a circuit board with around 20 complex functionalities, CLEIO quickly realized that design reviews would need to be conducted throughout the development process. In fact, they would have to be almost constant, since the product required approval from the NMPA.