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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



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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.

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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.

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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.

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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.
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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

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New FDA Guidelines Affecting Your Medical Device Development

Bob Marshall Sings “The Regulatory Blues”
(You’ll want to hear this.)

I had a pre-submission meeting
so I went down to Silver Springs.
I took documents, and drawings,
and lots of other things.
They said, “Go home, boy.
Wait until the telephone rings.”

I got the Regulatory Blues.
About to lose my mind.
I’m waiting on some data
no one can seem to find.
Now my 510(k) submission
is running three months behind.

I got a call last week.
Said they were coming for an inspection.
Someone down at the hospital
got a real bad infection.
Now they’re telling me
I got to recall the whole collection.

Tried to renew my registration.
I just sent it in the mail.
Because every time I went online,
their website would fail.
Now they’re putting me in handcuffs,
and taking me to jail…

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How Product Design, Technology and Manufacturing Change on Miniaturized Medical Devices


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How Blockchain Will Change the Way You Develop Medical Devices


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AI, Robotics, and the Smart Factory Floor

Carl Zeiss Vision Care produces custom-ordered lenses. They get raw material, form the glass, run it through finishing operations and quality controls.

Their analytics and rules engine monitors everything: The labor, the production, the quality, the equipment, and the environment.

The data indicates when the factory’s about to fail, giving them a window to schedule maintenance, reschedule, and look for operational excellence.

“This is a current example of smart manufacturing in medical devices,” 10x for ENGINEERS presenter Srihari Yamanoor says. “In some places, it’s like, ‘Oh, this doesn’t happen in our industry.’ But it is happening. Right now.”

Watch his presentation and learn about the inevitable.


Click here for the slides and transcript. »