The Theranos 483s: What We Can Learn

David Amor, MS, CQA, principal at his firm Medgineering, kicked off the 2016 10x Medical Device Conference with a riveting talk about the Theranos 483 warning letters.

It was also a courageous talk – Former Theranos employees refused to give a presentation for fear of litigation and reprisals from the company.

David covered what a warning letter or 483 remediation project is, what a quality deficiency is, and how you can resolve them in a positive collaboration with FDA.

I also invited David back to present (with Jon Speer from at the 10x Medical Device Conference for 2017, our fifth annual event. Prices are deeply discounted this far ahead of the event if you’d like to register. (Full refunds until Valentine’s Day.)

Click for the transcript and slides. »

A Cure for Aging?

Dr. Bill Andrews, CEO of Sierra Sciences, and Liz Parrish, CEO of BioViva Sciences, discussed “A Cure for Aging?” at this year’s 10x Medical Device Conference.

Liz starts with a statistic: 100,000 people die of aging each day, noting, until recent history humans would die from infectious diseases. As science improves, so does our ability to live longer – until we die of complications from old age.

Can we cure these complications?

Bill gives easy-to-understand insight into the role of telomeres in our death and his work with Telomerase, an enzyme at the core of his work to extend human life.

Treating biological aging as a disease, Bill and Liz combined forces to create BioViva Fiji and are building a large-scale production facility and clinic to provide a gene-therapy approach to cure aging.

They expect human trials in a year’s time.

Click for the transcript and slides. »

3D-Printed Medical Devices

Katie Weimer from 3D Systems gave us a gift: The most informative update on where we are with 3D printing for medical devices.

Katie explained 3D printing is now commonly used for anatomical models, personalized surgery, patient-specific implants, bracing and casting, mass customization of medical devices (like hearing-aids), regenerative medicine, and bio-printing.

Download the slides and transcript. »

How and Why We Must Challenge FDA

Veteran device CEO Joseph Gulfo says, “The FDA must be challenged (when appropriate) because it operates in a highly political environment and has strayed from its original mandate.”

The original mandate, according to Section 1003 of the Federal Food, Drug, and Cosmetic Act, is to “promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner [and that] there is reasonable assurance of the safety and effectiveness of devices intended for human use.”

But today’s FDA does much more than that – and that’s the problem.

Here’s his paper, “The Proper Role of the FDA for the 21st Century.”

And here you can email Dr. Joseph Gulfo directly to see how you can help on this important crusade.

Click for Joe’s slides and transcript. »

Best Time to Sell Your Medical Device Company

Deborah Douglas spoke at our fourth 10x Medical Device Conference in May 2016.

A main takeaway for me seems obvious but those who go-it-alone probably ignore it: Multiple bidders make for higher prices. Deb said, “For an average seller, our firm will talk to 300-400 buyers.”

Watch her full presentation below and click through for the slides and transcript.

A must read for any seller. »

How to Give a Medical Device Pitch

I sat through a terrible pitch last week. Too bad he didn’t watch this 10x video first.

Click for transcript. »

Substantial Equivalence: The FDA, CMS, and Patents

This 19-minute compilation from 2014’s 10x Medical Device Conference features Ed Black, Tom KraMer, Pat Kullmann, Doug Limbach, and Bruce MacFarlane on the tricky path for device innovation.

On one hand, you want to be THE SAME.
• If you’re substantially equivalent to an existing device, you get to save on clinical trials.
• And you likely shorten the time for FDA clearance.

On the other hand, you want to be DIFFERENT.
• If you’re materially the same as an existing device, why should CMS give you a reimbursement code?
• If you’re materially the same, do you deserve a patent?

Click for the slides and transcript »

FDA on Cybersecurity

Suzanne Schwartz CDRH FDAFDA’s Suzanne Schwartz, MD, MBA, the Director of Emergency Preparedness/Operations and Medical Countermeasures in the Center for Devices and Radiological Health (CDRH), discussed medical device cybersecurity at the 2015 10x Medical Device Conference in San Diego.

Cybersecurity is a subject about which the medical device community needs to become much more vigilant, she contends.

Suzanne took questions from the audience. Below is the video replay.

And you can click through for her slides and the transcript. They’re free.

Click for the slides and transcript »

Medical Device Conference as Potluck

conference potluck

A perfect analogy for the 10x Medical Device Conference came when my mother asked, “Who was on stage?”

I answered, “I have formal speakers, but everyone is ‘on stage’ because everyone brings their own ‘dish’ to the ‘potluck.’ They bring their skills and expertise. My guests can sample everything.”

If you read alumni reviews, you’ll see how much we emphasize building long-lasting relationships with the kind of folks with whom you’d want to build relationships.

Thought-provoking speakers too. (See reviews.)

Join us next year if that sounds good for you.

DARPA and Your Medical Devices

medical device conference richard satava md

Rick Satava, Professor Emeritus of Surgery at the University of Washington, is in high demand.

He served in three combat missions during his 23 years as a combat surgeon in the military and spent 14 years at DARPA, the Defense Advanced Research Projects Agency.

His speech last year was among the best received at the 10x Conference. See it here.

Click for the slides and transcript »