Design Review Dos and Don'ts

Posted in Regulatory and Compliance by Jamie Hartford on July 5, 2017

Follow these best practices to get the most out of your next design review.

Jamie Hartford

Design reviews are an important element laid out in FDA’s design control guidance for medical device manufacturers. The agency requires device makers to establish and maintain documented reviews of their design at various stages during the product development process, as spelled out in 21 CFR 820.30 Section E. But while FDA lays out a number of requirements for design reviews, much is left to the manufacturers’ discretion.

At the MD&M East conference in New York City last month, Stuart Brahm Kozlick, vice president of medical robotics at Canadian assistive robotics company Kinova, laid out a few dos and don’ts for design reviews. Here are a few of his best practices:

Learn best practices for medical device product development at the MD&M Minneapolis Conference, November 8–9, 2017.

Do Set Ground Rules

Design reviews are essentially meetings, and following good meeting etiquette can help set the tone and ensure success. Among Kozlick’s recommendations were setting a formal agenda, insisting participants arrive early, starting and ending the meeting on time, and turning off smartphones.

“For design reviews, one thing that works is you set your own rules before the game starts," he said.

Do Invite the Right People

It’s a no-brainer that the team working on the project should be involved in the design review, but besides subject matter experts and representatives from the various design functions, there are other people who should be in the room. 

“One thing to formalize right up front is who within the corporation is going to allow you to move from stage to stage, from gate to gate,” Kozlick said, adding that at his company, that group was called the product review committee. “They need to be involved in every single design review.”

He also recommended inviting an independent reviewer who did not work on the project to get an outside perspective.

“One really fun thing to do is when you’re having these really technical discussions is to bring in a finance person,” Kozlick said. “They’re going to pose questions that none of you have ever thought of.”

Don’t Neglect Logistics

Design reviews can take the form of a three-hour meeting or a two-day off-site affair, depending on the project and the stage, Kozlick said. In any case, paying attention to the details can go a long way.

Something as simple as blocking off meeting attendees’ schedules ahead of time can ensure that all relevant stakeholders show up on time and can stay for the entire meeting. Booking an appropriately sized room ensures no one has to stand. And, of course, don’t forget the munchies.

“One thing that works, if your budget allows, to help keep everyone there and attentive and happy is to serve food,” Kozlick said. “I promise you it’s a small amount to pay to keep people’s attention, keep people there, and keep them on track.”

Do Assign Homework

Not having all the right materials or information at hand can derail your design review, so ensure everyone knows what’s expected of them at the meeting up front.

“Make sure that everybody knows if they need to bring anything to the design review, if they need to present anything, if they need to be ready,” Kozlick said. “You don’t want to call on somebody that isn’t really prepared.”

Don’t Try to Do It All

Trying to fully engage in a design review and run the meeting can be a tall order, so Kozlick recommends seeking help.

“If you’re the subject matter expert and you have to focus on the review, it might be a good idea to bring in a facilitator,” he said.

That person can ensure the agenda is followed, keep notes, and otherwise make sure things run smoothly, so stakeholders can focus on the task at hand.

Do Lose Your Ego

Many people present in the design review will have played critical roles in the project, and as such, they may feel emotionally invested in the design. But during a design review, everyone needs to be open to constructive criticism.

“Check attitudes at the door,” Kozlick said. “Don’t take it personally if people start questioning some of your decisions. That’s the point of the design review.”

Don’t Be Afraid to Go Remote

While having all parties in the room might be ideal, don’t cut someone out of a design review simply because they’re remote or traveling.

“Virtual design reviews are a lot easier than you think,” Kozlick said.

Utilizing cloud-based programs like Google Documents, Microsoft Office 365, and video conferencing makes it possible to participate in design reviews from a distance.

“In this day and age, virtual design reviews shouldn’t be an obstacle, geography shouldn’t be an obstacle,” Kozlick said. “It’s not easy, but it’s not hard either.”

 

Jamie Hartford is director of content for medtech brands in UBM's Advanced Manufacturing Group. Reach her at jamie.hartford@ubm.com.

[image courtesy of ARTSYBEE/PIXABAY.COM]