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Post-Market Data: What You Need to Know

A lot of companies do risk management ONLY when making changes to a product. That’s going to change, says Principal Consultant at Gish Consulting, Christine Zomorodian. Regulators are looking at new requirements for risk-based clinical evidence of performance and safety for both new and existing products.

Anne Leijsen, Head of Medical Writing at Factory CRO, takes you through the new product development lifecycle — the interaction between risk management, clinical evaluation and post-market surveillance. She shows you how to collect post-market data and what to DO with it.

Post-Market Data: What You Need to Knows
Presented by Christine Zomorodian and Anne Leijsen
at 10x for Design and Manufacturing – San Diego 2018


Click for the slides and transcript. »

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. »

Building a Better Wearable Device and Getting it Cleared Through FDA

Building a Better Wearable Device and Getting it Cleared Through FDA
presented October 12, 2018 by Walt Maclay, President, Voler Systems



Click for the slides. »

How To Bring Medical Device Software Development Out Of The Dark Ages

Continuous Integration: Bring Medical Device Software Development Out of the Dark Ages
presented October 12, 2018 by Jeff Gable, Founder and Principal, Gable Technology


Jeff Gable: Most medical device companies develop embedded software like it’s 1995. Let’s learn from modern DevOps practices to drastically improve software quality and reduce development time. If you agree, let’s get started.

Click for the slides and transcript. »

A New Take on Prototyping that Could Save You Millions

A New Take on Prototyping that Could Save You Millions
presented October 12, 2018 by Doug Fankell, PhD, Structural Integrity Associates, Inc.


Dr. Fankell: Arlen is much more in the energy tissue interaction world. So hitting it with lasers, hitting it with ultrasound, things like that. I’m much more in the looking at the structural mechanics’ side of things.

Editor’s Note: Doug gives a fantastic presentation. At its conclusion, a lively conversation breaks out about predictive modeling versus simulation (from Arlen Ward’s presentation the day before) in bringing your medical device to market in the most efficient and cost-effective manner.

Click for the slides and transcript. »

How to be Innovative on a Budget using Simulation

How to be Innovative on a Budget using Simulation
presented October 11, 2018 by Arlen Ward, PhD, PE, from System Insight Engineering


Dr. Ward: What can we do besides standard-issue testing an animal labs to get answers in a more cost effective manner?

Anyone that has ever built or designed a device from the ground up know, when it’s a sketch on a napkin, it’s cheap to change things. When it’s production tooling, that’s when people start to cry.

If it’s 1x in the concept phase, by the time you get to the production and test side of things, it’s 500 to 1000 times what the cost was in the beginning. So you do simulation work first.

Click for the slides and transcript. »

How the world’s largest medical center invests in medical device innovation (and how you can benefit!)

How the world’s largest medical center invests in medical device innovation
(and how you can benefit!)
presented October 12, 2018 by Lance Black, MD, from Texas Medical Center in Houston


Dr. Lance Black: So, because we don’t take equity, we don’t charge.

We’ve had companies come through who are your typical accelerator companies all the way to companies who are 30, 50 strong, who’ve raised their Series A, Series B, who want to use Houston as either their US launching pad or a new sales channel, or just a new market that they can evaluate.

When you have 10 million patient visits per year, [we’re our] own market, as you can imagine.
Click for the slides and transcript. »

5 Key Questions to Determine if That Contract Manufacturer is a Good Fit for You

Five Key Questions to Determine if that Contract Manufacturer is a Good Fit for You
presented April 5, 2018 by Mark Rutkiewicz, VP, Quality at Innovize


Mark Rutkiewicz: We’ll start with the five questions here.

The basic starting point that everybody typically has is the baseline – what’s the cost? And if you make the selection just on cost, you may, in about a year, be very sorry about what decision you made.

There are a lot of other things also. You might be looking at the quality system and the technical expertise associated with that contract manufacturer. There are many types of contract manufacturers doing:

  • Box builds
  • Part assembly
  • Catheter assembly

Click for the slides and transcript. »