Design Reviews are critical to the success of medical device product development.
So much so that the infamous Design Controls waterfall diagram shows a design review after every major design control stage.
Interestingly, there are a couple of schools of thought when it comes to the frequency of Design Reviews.
The “less is more” and the “more is better”.
Which camp are you in?
Design Reviews according to FDA and ISO
As a quick reminder, let me share what is stated about Design Reviews in FDA and ISO.
Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).
ISO 13485:2003 in section 7.3.4 Design and Development Review:
At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1)
a) to evaluate the ability of the results of design and development to meet requirements, and
b) to identify any problems and propose necessary actions.
Participants in such reviews shall included representatives of functions concerned with the design and development stage(s) being reviewed, as well as other specialist personnel (see 5.5.1 and 6.2.1).
Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4).
Pretty consistent explanations. Have Design Reviews at appropriate or suitable stages. Wonderfully ambiguous, right?
The Design Review Schools of Thought
As I mentioned above there are two pre-dominant schools of thought about how many and how often to conduct design reviews during medical device product development.
The “less is more” school of thought suggests that fewer design reviews during a project are better. There is acceptance that fewer design reviews will generally mean longer meetings to cover all the topics. The less is more approach means that several design control elements are likely to be bundled in a single design review.
The “more is better” school of thought suggests that more frequent design reviews are better. There is acceptance that this means more meetings with the tradeoff that the meetings can be shorter and to the point. More is better will likely mean that each individual design control element will be the subject of its own design review—sometimes multiple, intentional design reviews for an individual element.
Which school is better?
If you listened to the recent Global Medical Device Podcast on the topic of Design Reviews, then you heard me make a statement about slowing down, being more deliberate, and having more frequent and meaningful design reviews.
Yes, I’m in the “more is better” camp.
Let’s just say I’ve had at least a couple cases where we tried having less frequent design reviews to save time which didn’t work. Quite the opposite really.
I recently heard an anecdote from a medical device professional who is very adamant about having fewer design reviews (one of those “less is more” guys). He said he would rather have a couple design reviews that EACH last 1 – 2 days versus having twice as many which only last 60 – 90 minutes each.
Why does that make any sense?
Let me do some quick math . . .
Less Is More: 2 Design Reviews x 8 (at least) hours each = 16 hours of Design Reviews
More Is Better: 8 Design Reviews x 90 minutes each = 12 hours of Design Reviews
Maybe this isn’t an issue for math to resolve.
More is better! Here is why...
Let me tell you exactly why having more Design Reviews are better for your medical device product development efforts.
I've been part of teams that held design reviews that take one to two full days, and I've been part of teams that held multiple 60 - 90 minute design reviews many times throughout the project.
The one to two full day versions are not as productive. Here are a few reasons as to why:
Project activity is stalled while conducting design reviews.
Less frequent design reviews are generally longer because it takes longer to get the project team on the same page and up-to-date for the design review.
Longer design reviews often means you are cramming more topics, documents, issues, etc. into a single meeting.
Less frequent design reviews actually increase project risk because decisions have to be made to keep things going without the project team’s input in between the design reviews. And then having a design review several months later to review and discuss decisions that have been made could result in rework, let alone impact on the team morale and culture.
Longer design reviews are confusing. Product development is very dynamic. Things are moving and shaking all the time. Longer reviews with significant time in between with have a negative impact on team communication.
Design reviews should be part of the natural "flow" of product development. Shorter, more frequent design reviews have these benefits:
Meetings should ideally be kept to 60 - 90 minutes. Otherwise, you will lose the audience. Design Reviews are not an exception to this “rule.”
Design Reviews need to be interactive, productive, and represent current activities.
More frequent Design Reviews means your team is engaged and up to speed with that is happening.
More frequent Design Reviews are more focused and to the point.
More frequent Design Reviews help foster and improve communication with your project team.
Written By Jon Speer
Jon is the founder and VP QA/RA at greenlight.guru (quality management software exclusively for medical devices) & a medical device guru with over 18+ years industry experience. Jon knows bringing a device to market is hard, so he built greenlight.guru to make it easier. Click here to get our actionable medical device content delivered right to your inbox 1x per week.