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 standards such as ISO 13485 require medical product designers to integrate design reviews throughout the development process. After all, design reviews remain one of the most effective ways to ensure that your products are safe, reliable, and effective (while also staying within timelines and budget constraints).
But first, what is a design review?
A design review is an evaluation of part of a product by a group of reviewers. The reviewers take a critical look at what has been done and the decisions that have been made during the development, and voice their concerns. They identify existing and potential problems, discuss the best ways to address them, and develop a plan to implement corrective actions.
According to the Design Control Guidance for Medical Device Manufacturers document from the FDA, design reviews are primarily intended to:
- Provide a systematic assessment of the development results, including the device design, the associated designs for production and the support processes
- Assess project progress
- Provide feedback to designers on existing or emerging problems
- Confirm that the project is ready to move on to the next stage of development
How many design reviews should be done? And when?
Arguably, the right answer is “whenever you need to”. That’s not a very helpful response, but the truth is that there is no ideal frequency for conducting design reviews. It depends on the project and how complex it is.
At CLEIO, we ensure that design reviews are an integral part of our product development process by identifying specific steps and key elements that require evaluation. We differentiate between two types of reviews:
Design reviews
End-of-phase reviews
Who should be involved in design reviews?
Choosing the right participants for each design review is almost as important as selecting the product development team itself. Naturally, those directly involved in designing the part of the product under evaluation should participate in the review. They are best positioned to explain their work, approach, and the decisions made throughout the process.
But remember when we told you in our co-creation article about how important it is to have an outside perspective when developing your product? Well, the same goes for design reviews. At least one external person should participate, which is also one of the FDA and ISO 13485 requirements for design reviews.
When we say an external person, that could be a consultant from outside the company or someone on the development team who’s not working directly on the part of the project being evaluated. What matters is that they have technical skills and experience that rival (or ideally, exceed) those of the designers, and that they are sufficiently independent to express their concerns freely.
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.
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What does a design review look like in practice?
Choosing the appropriate format
- Team meetings: Meetings are organized to present and meticulously review the design.
- Independent review: Each reviewer conducts an independent assessment of the design materials, ensuring comprehensive oversight.
- Feature testing: The goal is to validate the design functionality.
Defining the objective
- Confirm that user needs or design inputs are well defined.
- Ensure the design aligns with product specifications and enables the product to meet the targeted efficacy and reliability.
- Identify opportunities to improve the design or even the development process itself.
- Verify that safety issues have been addressed.
Preparing the review
How should design reviews be documented?
While the FDA and ISO 13485 mandate that designers document their design reviews, they do not specify a standard format. Essentially, the documentation should include general information about the reviews (date, participants, etc.), as well as a description of the issues or questions that were raised, the decisions that were made to address them, and the method for implementing corrective actions.
- Product or project identification details
- Design review date and duration, if relevant
- Names of all the participants, including the independent reviewer
- Objectives of the design review
- Minutes of the discussion
- Actions items detailing responsibility and deadlines
- References to the documents used (presentations, images, reports and other assets)
CLEIO not only documents every design review but also meticulously tracks all documents related to product design, maintaining their organization within the Design History File (DHF) Index. This index serves as a comprehensive table of contents for the project and allows us to gather everything in one place. This approach is very useful for assembling the product design folder required for FDA submissions.
How design reviews can make a real difference: the case of BJ Nimo DragonVision
The BJ Nimo DragonVision project clearly showed how important it is to implement a rigorous design review process that truly works.
Why ongoing design reviews were essential for this project
A small mistake that could have derailed the schedule
Assessment of the design reviews for the project
identified, with suggestions made to address them
