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Archives for March 2019

Leveraging Customer Support to Understand Customer Needs

I’d gladly highlight Resmed as a medical device company that understands how to use their customer service data to continuously improve their products and services.

Sarah Wright, Resmed Director of Global Customer Support, is really, really good at her job – and as a presenter, which is why she’s returning as part of our faculty in May 2019.

I’ll let her tell the story, below (see video, slides and transcript), but the main point that so few medical device manufacturers fully leverage is this: “Data from support services, if stitched together, provides actionable business insight. It can inform how you market your products. It should inform how you prioritize feature enhancements. And it can reveal which customers you stand to lose.”

Leveraging Customer Support to Understand Customer Needs
Presented by Sarah Wright, Director, Global Customer Support, ResMed
at 10x for Design and Manufacturing – San Diego 2018


Click for the slides and transcript. »

Medical Device Change Management Best Practices

Should you do a letter-to-file? It might allow you to make a change without notifying the FDA.

But having “avoid FDA notifications” as a motivating factor is a bad idea, says regulatory expert Michael Drues.

He said, “Several medical device companies tell their R&D engineers, “If you’re going to change a device, only change it to the point we can handle that change internally, doing a letter-to-file. Don’t change it to the point we have to notify the FDA.”

Can you think of any better way to prevent or hamstring development than putting a limitation on your R&D engineers?

Best Practices for Medical Device Change Management
Presented by Michael Drues and Jon Speer
at 10x for Design and Manufacturing – San Diego 2018


Click for the transcript. »

How To Use Human Factors To Mitigate User Risk

MaryBeth Privitera is impressive.

She co-chairs the AAMI human engineering committee, is the Human Factors and Research Principal for HS Design, and teaches biomedical engineering at University of Cincinnati.

Naturally, she gave an excellent talk at 10x in October, here for your education.

Managing the Big Risk – The User
presented October 11, 2018 by MaryBeth Privitera, PhD FIDSA


Click for the slides and transcript. »