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 re-imagined and iterative design process

  • Prototyping and human factors engineering

  • A visual approach to risk management

Design history file (DHF) Ready Ideation is a toolset that encourages creative, evolutionary, and holistic design while at the same time building the foundation for formal design controls. 

DHF-Ready Ideation reduces the cost of retrospectively assembling a design history, makes the process of designing a medical device enjoyable, and reveals relationships across multiple business and technical perspectives that are typically difficult to realize.

 

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

Mentions

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

Thank you to Saul Marquez, host of the Outcomes Rocket Podcast, for having Dr. Andrew DiMeo on as a guest to talk about Design History File Ready Ideation!

Apple Podcasts | Episode Webpage

A Novel Guide in Medical Device Innovation - Design History File Ready Ideation

DHF - Design History File

In the earliest stages of developing a new medical device, especially from an entrepreneurial perspective, when we think FDA, it is often in the context of “Pathway to Approval.” Sure, we may realize that one day we will have a medical device company with a quality system in place. We may realize that we’ll have to someday be following Good Manufacturing Practices (GMP). And we are most certainly thinking about how we are going to get an FDA clearance or approval to market the new device. These are all looming in the future. It may be a surprise for some inventors and innovators that the design process itself is part of these regulations. They are impacting you now. They theoretically started yesterday.

An experienced medical device company well aware of design controls may have a different perspective but similar result. The idea of implementing them too early can seemingly constrain the project from the free form exploration that may be best suited outside the bounds of a “controlled” design process.

According to the FDA, the design history file shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part (21 CFR Part 820.30). Each manufacturer shall establish and maintain a DHF for each type of device.

It is this DHF that is the primary tool for ensuring the medical device was designed according to 21 CFR 820. If following ISO 13485 (recommended), the DHF then demonstrates design process is in accordance with that standard. The takeaway here is that a DHF is the key set of documents demonstrating the design of a medical device was controlled according to some standard.

Design History File-Ready Ideation is a set of tools that encourage creativity best practices while at the same time building the foundation of design controls. It is DHF “ready” because it is intended to be used long before the formal implementation of the QSR. It can also be used as a creative brief to build presentations and pitch decks. And it can continue on after crossing the dividing line into a controlled process, to persist the creative mindset throughout the development lifecycle.