30 min listen
Building Your Design Controls (and Pitfalls to Avoid)
FromGlobal Medical Device Podcast powered by Greenlight Guru
Building Your Design Controls (and Pitfalls to Avoid)
FromGlobal Medical Device Podcast powered by Greenlight Guru
ratings:
Length:
36 minutes
Released:
Mar 29, 2023
Format:
Podcast episode
Description
What do engineers need to understand about manufacturing? How can you apply that knowledge to design controls? On today’s episode, our guest Tom Rish covers the topic of Design Controls. Tom is the Director of Guru Services at Greenlight Guru and a Product Development Engineer in Orthopedics.Listen as we talk about the differences between user needs and design inputs and the pitfalls companies get into when building design controls. Tom also shares what he thinks people should understand about cross-functionality, why it sometimes makes sense to start from scratch, and using the design control process strategically.Some of the highlights of this episode include:Thinking in terms of manufacturingThings everyone ought to know about working cross-functionallyWhy starting from scratch may be betterWho needs to be looking at design controls and when they should be lookingThe difference between a design review and a stage reviewWhat Tom got to see that helped him understand how things workedWhat to look for on the manufacturing floorUsing the design control process strategicallyMemorable quotes from Tom Rish:“If you can get a tool in a certain spot you can do it, but if you can’t, you can’t.”“We like to say at Greenlight Guru: the outputs are the recipe.”“I think that a lot of times people use design reviews and stage reviews interchangeably.”“I can’t even put into words how valuable it was to go down to the manufacturing floor as an engineer.”Links:Tom Rish LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru
Released:
Mar 29, 2023
Format:
Podcast episode
Titles in the series (100)
Insider Tips and Best Practices Regarding the 510(k) Submission Process from a Former FDA Reviewer: One important piece of documentation that medical device companies rely on to get them through the regulatory process is the premarket notification 510(k). Since the FDA will refuse to accept submissions that are missing the appropriate documentation... by Global Medical Device Podcast powered by Greenlight Guru