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. »

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…

Click here for the slides and transcript. »

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


Click here for the slides and transcript. »

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. »

Turning Clinical Ideas into Market Opportunities with Howard Levin

It wasn’t until I transcribed Dr. Howard Levin‘s presentation at MDTX did I realize how much his past 15 years he packed into 25 minutes.

It was fantastic for anyone who ever works in bringing a medical device concept to market.

For credentials, Howard’s company Coridea issued 120 US patents, raised $100 million, and returned more than 1.4 billion to investors.

Have I got your attention? Then, by all means, watch the video below, and download the slides and transcript.


Click here for the slides and transcript. »

Why 2018 will be the Year You Embrace Continuous Connectivity

Nersi Nazari, 10x for ENGINEERS keynote speaker and CEO of VitalConnect, bet the fate of his company on the widespread adoption of continuous patient monitoring.

Sounds like a reasonable bet to me.

In his 40-minute keynote at 10x for ENGINEERS, Nersi said patients and consumers are accepting the technology and clinical evidence supports its efficacy. After all, the continuous monitoring of vital signs is not new. In critical care, life depends on it.

So how to make continuous monitoring portable, inexpensive, and effective?

Mr. Nazari answers that question and many more in this enlightening talk. Watch below and click through for the slides and transcript.


Click here for the slides and transcript. »

How To Become a True Medical Device Quality Professional

I was talking to Jon Speer from Greenlight Guru about how to become a true quality professional.

He shared, “I have a choice and the choice is purely up to me. I can choose to be status quo and be a checkboxer or I can elevate my game and focus on becoming a true quality professional.” Here’s a short video of our conversation.

Jon is giving a two-hour workshop, “How to Implement a Risk-based QMS to Comply with 13485 Leveraging ISO 14971,” April 3rd, 2018 at the Meadowlands. You can get the brochure on our homepage.

Click for the transcript. »

Medical Devices in China

“I can’t tell you how many companies said we just didn’t bother protecting in China because they don’t care. They’ll copy anyway,” said Landon Lack at this year’s 10x Medical Device Conference.

“You have to protect your IP in China. If you don’t protect your IP and China no one’s going to want to partner with you.”

You can catch his entire presentation here: