The European Unitary Patent Package

My friend Stephen Carter from Mewburn Ellis gave a 10-minute talk about the European Unitary Patent Package at the 10x Medical Device Conference in May 2016 – before the Brexit vote.

If you have a European patent, or aspirations to get a European patent or licenses, this is going to impact you.

Stephen explained, in Q1 2017 we should see a “single patent that gives you protection across the whole of the EU. We also expect a single Unified Patent Court with jurisdiction not only over this new European Unitary Patent but also over existing European patents that have already been granted.”

Watch the video for the implications to your business.

Click for the transcript and slides. »

How to Save Costs on Your 510(k) or PMA

Did you know 77% of the cost to develop a 510(k) device is spent in clinical research and regulatory submissions? It’s 80% for PMA devices.

“A lot of that cost is due to how poorly we handle data,” explained Jim Rogers, President of Nextrials, at the 10x Medical Device Conference.

Jim’s solution is “why didn’t we think of this before” simple: Re-purpose electronic health record (EHR) data as the source data for clinical research.

Jim: “FDA wrote a Guidance. It came out September 2013 to give people action items around using electronic source.” If you re-use the data you already have, you’ll:
• Eliminating duplication of data entry.
• Eliminating or reducing transcription errors.
• Remotely accessing your source data.

And Jim anticipates your question: “There’s so many EHR systems, how could we ever begin to integrate with them?” Watch the video for his answer.

Click for the transcript and slides. »

20 Introductions in 60 Minutes (2016)

A new and well-received feature we introduced in May 2016 was giving 20 of our guests three minutes to introduce themselves.

The video and transcript follow.

Click for links to their profiles and the transcript. »

Medical Internet of Things (IBM): Creating and Deploying Connected Medical Devices

It was a treat to feature IBM’s Kimberly Cobb at this year’s 10x Medical Device Conference.

Kim finds manufacturers who say, “We don’t want to be a medical device company any longer, we want to be a services company. We want our services to drive the demand for our devices.”

Are you among them?

Click for the transcript and slides. »

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. »