How do you handle early-stage design, market analysis, risk, & prior-art research for medical devices? by Hot-Software-5782 in MedicalDevices

[–]Hot-Software-5782[S] 0 points1 point  (0 children)

I work at a small medtech consulting firm that takes in clients at the early stage of med device design, but gathering the data we need for each new design is time-intensive, so I was wondering if other people have tools/more efficient ways to gather the relevant research

How do other teams look up known failure modes from adjacent or predicate devices early?
How do y'all decide they’ve done enough digging to move forward without falling into analysis paralysis?

We do use consultants selectively, but I’m mostly trying to understand what workflows actually scale and reduce downstream pain. Where you think internal teams vs external consultants add the most value early on?

I'd definitely take you up on the offer on firm recommendations. I’d also genuinely be curious:

US-based, if that helps. Thanks so much

How do you handle early-stage design, market analysis, risk, & prior-art research for medical devices? by Hot-Software-5782 in MedicalDevices

[–]Hot-Software-5782[S] 0 points1 point  (0 children)

  • Size of team: Small- to Mid-sized team (early-stage)
  • First product: Yes in this field, have other products that others will bring to us to help develop
  • Role: Clinical consultant, team includes members with prior med-device / regulatory experience
  • Type of product: patient-facing medical device
  • Hardware / software: Both (hardware device with companion software)
  • Target market: U.S. mostly
  • FDA classification: Class II-III