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 manufacturing
Things everyone ought to know about working cross-functionally
Why starting from scratch may be better
Who needs to be looking at design controls and when they should be looking
The difference between a design review and a stage review
What Tom got to see that helped him understand how things worked
What to look for on the manufacturing floor
Using the design control process strategically

Memorable 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 LinkedIn

Etienne Nichols LinkedIn

Greenlight Guru Academy

MedTech Excellence Community

Greenlight Guru

Building Your Design Controls (and Pitfalls to Avoid)

Global Medical Device Podcast powered by Greenlight Guru

Building Your Design Controls (and Pitfalls to Avoid)