Special Edition: The Front End of Medical Device Innovation

Hi there,

We’re changing up our normal format for the Outrigger to share something special that has been years in the making. While Dr. Andrew DiMeo has been crafting and refining this idea since he joined Trig almost a year ago, it pulls from his deep expertise in medical device innovation as a career practitioner and educator. In keeping with his selfless passion for coaching others to make an impact, we’re giving it away for free to our community.

When Andrew joined Trig, he immediately helped us better understand the context and requirements for Design History File documentation for active client projects. He helped me understand that on the one hand, creativity could be constrained by doing too much too soon, while on the other, creative content is valuable to capture from one iteration to the next in the journey of medical device design.

The creative tension we’ve been trying to resolve is that so much of what we as industrial designers observe and create needs to be documented in an organized format. However, the purpose of that organization is not to meet a requirement today, it’s to ease the pain of a future transition into a regulated environment. This distinction matches the fluidity of the creative process with the rigor of documentation that is appropriate for the front end of medical innovation.

The solution to this challenge takes the shape of a canvas instead of a controlled document, similar to what the Business Model Canvas has done for the Business Plan.

Design History File Ready Ideation Guidebook Canvas Virtual

I had one of the first US editions of the Business Model Generation book by Alex Osterwalder, who, along with his collaborators, formulated the Business Model Canvas. With a single, powerful graphic, Alex brought clarity to the often murky and over complicated question of, “What is your business model?”  With Design History File Ready Ideation, this is what Andrew has done for the complex ecosystem of medical device design. Even if you’re not in the field of medical devices, I think you’ll find this fascinating, perhaps inspiring for mapping the complexities of your own industry. Check it out here: Design History File Ready Ideation Guidebook

BIOMED Device Boston

Andrew leads a discussion on evolutionary design on a BIOMEDevice Boston panel

As we hit the send button on this Outrigger, Andrew hopped on a plane to Logan International where he’s leading a panel discussion at BIOMEDevice Boston.  The topic of the panel is How Employing Evolutionary Design Can Help Satisfy Requirements for a Regulatory-Compliant Process.  There, Andrew will be joined by Galen Robertson, COO of 410 Medical, Juan Luis Crespo-Mariño, Professor at Tecnologica de Costa Rica, and Danny Gelfman, Senior Principal Solutions Designer at Medtronic.

Stephen Lindamood is hungry

Spring 2019 Core Values Awards

Mmm, its time for some tasty rocks. Yep, here at Trig we recognize our best and brightest with a painted rock. Oddly enough, it brings a few tears to our eyes. Read more

Until next time,

Ty Hagler

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