Design History File Ready Ideation

A Guidebook for Medical Innovators

Design controls are essential to medical device product development. Can they be too much too soon? Do they hinder iteration and creativity? We built this free guidebook and tools to fill a critical gap for medical innovators.

For a preview, here are a few of the topics addressed:

  • Medical device due diligence

  • A reimagined and iterative design process

  • Prototyping and human factors engineering

  • A visual approach to risk management


Fill out the form to download your free guidebook to Design History File Ready Ideation. We also include printable canvases and a link to our demonstration digital canvas.

Design History File Ready Ideation Guidebook


A huge thank you to Jon Speer of Greenlight Guru for highlighting the Design History File Ready Ideation methodology on his podcast, Global Medical Device.

SoundCloud | Apple Podcasts | Episode Webpage

Andrew DiMeo Global Medical Device Podcast