Your medical device product development team has been designing the latest product and you’ve been reminded that you need to hold a design review. “It’s required by medical device design controls,” one of your colleagues points out. You sigh and start planning to hold the design review.
Why Hold a Design Review
Both FDA 21 CFR 820 and ISO 13485 require design reviews. While the language in the guidance documents implies technically based reviews, the FDA in particular, has been auditing for project level reviews which include a large cross-functional review group. These meetings can result in a huge delay to the project. There is considerable time spent on scheduling meetings and creating a massive presentation that doesn’t necessarily add value to the product. In addition, getting signatures from all the different individuals can lead to more delays. While you need these types of reviews periodically, they don’t always address the design elements.
Design reviews are actually part of good engineering design practices. When you’ve created the requirements and started designing the product, the design review provides feedback on whether you are on track or if you have missed the intent of the requirements.
I have seen technically based design reviews function effectively in medical device software development. What do they do differently?
- They have their own design review process which is tailored to reviewing requirements and how the designed software meets those requirements. They can be applied to the lowest level of code on up to the fully integrated software design.
- The independent reviewer has the expertise to understand the requirements, the design, and the testing (as appropriate).
- Meetings are kept small to foster discussion and improvements.
- Signatures are kept to a minimum.
You might say hardware doesn’t have the same level of flexibility as software, so you can’t keep the design review small. We typically find that companies implement design reviews for hardware based on large reviews because they haven’t built flexibility into their process.
The following are some ways to make your design review process more effective:
- Use different types of design reviews, within your process, based on what is needed for the project. For example, you may use project reviews and engineering/technical reviews. (IEC 61160 Design Reviews is a potential resource for different types of design reviews.)
- Ensure your design review process is documented and that it allows for different types of design reviews. The independent reviewer doesn’t always need to be from Quality. The design review should be flexible enough to include the most appropriate independent reviewer
- Define minimum functional groups to attend the different types of reviews. Clearly define who signs as an attendee, while minimizing the number of approvers.
- Include some project level reviews to ensure the overall product meets the requirements of cross-functional groups in the organization.
Given the hassle of putting a system level design review together, no wonder teams consider them a project checklist, rather than as a tool for improving the product. Make your process flexible enough to cover the different types of design reviews needed during product development rather than an afterthought.