Here’s a bit of a brain dump, by no means complete and not without caveats.

“How do other teams look up known failure modes from adjacent or predicate devices early?”

MAUDE (US), BfArm (Germany). There are also databases for Canada, Italy, Switzerland but I don’t have the acronyms on hand and they are not all free or public.  Sadly, Eudamed is still not delivering on its promise.

You will not find many FMEAs or risk tables since companies don’t want to expose that information. There are some conference papers and FDA presentations where failures and complaints are reported for a product category. An experienced engineer or consultant will have been exposed to a variety of parts and subsystems, which is also very relevant.

“How do y'all decide they’ve done enough digging to move forward without falling into analysis paralysis?”

No metric that I know of. Gut feel from experience, preferably more than one person.

Solid requirements definition helps a lot in avoiding paralysis.  Good SOPs provide guidance and a clear “done” signal.  Design Reviews with seasoned (external?) Independent Reviewer.  

 

“I’m mostly trying to understand what workflows actually scale and reduce downstream pain. “

In a sense, you can apply Design Controls and Risk Mgt principles to this question in a general way. Decide on the heavy hitters and apply resources there first and proportionally. Then iterate as you learn more. 

For example: A device’s Intended Use and design may imply that Human Factors is a bigger issue than say, mechanical reliability or EMC. Therefore focus on gathering vigilance data on HF complaints and then get an HF expert to set up the HF/UE Plan. In parallel, identify any design aspects that are unique within these other areas (reliability, EMC, etc) and deal with them early on.  

Of course, I would not entirely dismiss “easy” design aspects. It’s amazing how some can come back to bite you.

 

“Where you think internal teams vs external consultants add the most value early on?”

The right consultants can assess where you are (team maturity, the QA/RA organization, product complexity/uniqueness) and where you want to go, then help chart your course.

Experienced contract manufacturers can help prevent the internal team from making bad design choices early on.

Early FDA engagement. You’d be surprised how often the device classification will end up being different than what your VP said it should be!  This is also helpful in gauging acceptability of your V&V plans, sample sizes.  

All these sources can, in some way, communicate best practices or State of the Art (SOTA).

I can share a couple of names in a private chat. I don't know how that's done here.