AliveCor CEO Dave Albert is our keynote speaker!

72 patents ago, Harvard-educated David interrupted his medical degree and switched to engineering to invent a heart monitor for his father, Carl Albert – who just happened to be next in line for the US Presidency at one point!

Dave’s since sold two companies. AliveCor is his third.


To hear him speak is a Who’s Who in the medical device industry. The companies and people with whom he’s worked! The enormous revenue potential in his latest invention and, perhaps, insights he can share to inspire your own path of terrific success!

David is a delightful man, fascinating storyteller, and my friend. Please, spend May 10th with us, in person, in San Diego for his keynote presentation.

Then stay for the rest of the 10x Medical Device Conference to learn from – and get to know – my family of most trusted advisors in virtually every functional discipline you need to run a successful medical device enterprise.

Are you a First Timer?

If you haven’t attended a 10x Medical Device event yet, make 2022 the year you do.
Wear jeans, indulge in our famous ice cream social, relax with movie clips between medical device networking sessions, and enjoy music videos in the background during the breaks.

In short, come!

But what is the 10x Medical Device Conference?

10x Medical Device Conference is the cross-functional event where the medical device industry unites to grow your skills, network, and profit.

It’s designed to foster strong professional relationships among medical device players eager to learn smarter ways to do things with industry-leading resources. This will be our eleventh event.

For what level is the 10x Medical Device Conference geared? This medical device event is geared equally for senior and junior level professionals in the medical device industry. If you’re senior, you’ll return with ideas the team can use. If junior, you’ll return with specific lessons, materials, and action items to do your job better.

Want the full 10x Medical Device Conference backstory? Then click here.


On a tight budget?

You may qualify for a discounted price.
See pricing below.

The Agenda

Attend and join our tightly knit group of industry professionals.

Download schedule
  • May 10 Before the Conference
  • May 11 Day 1
  • May 12 Day 2

7:30 AM

Registration

Our medical device conference registration table will be open all day. We encourage you to check-in with us before 5:15 PM if you’re joining us for the keynote presentation at 5:30 PM.

10x

8:15 AM

(Optional)

3-Hour Workshop: Today's Health Economics and Reimbursement Landscape

“The FDA gives you permission to sell your technology, but it doesn’t give us a single reason why we should buy it.” 

– An official from the Centers for Medicare and Medicaid Services (CMS)
Innumerable medical devices and diagnostics make it all the way through proof-of-concept, venture capital funding, patenting, and FDA clearance only to be denied coverage and reimbursement by CMS and private payers. A myth still abounds that FDA clearance is the ultimate hurdle. Those believing this myth, however, sail over the FDA hurdle only to smash into the wall that is the payer system. Where’s the disconnect? 

Health economics is an area of research that manufacturers often want to ignore when developing a new product – and it’s killing them.
What’s more, reimbursement rules are continually changing, and your established value proposition has to be continually updated and re-proven to adapt to the changing market environment. This, even if your product has a history of successful market access and utilization. 

In this workshop, Nic will share his secrets for obtaining reimbursement – or getting paid – by any one of a number of customers. The morning will be filled with case studies providing concrete examples of what to do – and what not to do – to achieve and maintain market success. This is a session you shouldn’t miss.

Nic Anderson

8:30 AM

(Optional)

3-Hour Workshop: The Essentials for Medical Device Marketing Success

If you or members of your team work in the marketing of medical devices, we heartily recommend you take this 3-hour workshop with Joe Hage, veteran medical device marketing expert, leader of the Medical Devices Group at MedicalDevicesGroup.net, and host of the family of 10x Medical Device events.”

If you leave the session without a different mindset about how to approach your medical device marketing in this day and age, then we’ve done something really, really wrong.

Bonus! At the end of the workshop, interested registrants will have the option to get a one-on-one hour-long consultation for just $100.

Joe Hage

1:15 PM

(Optional)

3-Hour Therapy: Regulatory, Quality, and Grief Management

We know. Regulatory and Quality are grief-inducing.

That’s why, Medical Devices Group favorites Rob Packard and Michelle Lott will, for the first time, team up to present ways to enhance your regulatory and quality strategies to:

  1. Get to market.

  2. STAY in market.

  3. Keep a smile on your organization’s face.

We might have a couch there for some lucky guests to tell the Good Doctors their symptoms for quick diagnoses!

Join us!

Packard/Lott

1:30 PM

(Optional)

3-Hour Workshop: Vital, Smarter Onshoring for a Post-COVID World

Global Supply Chain Economics Have Changed.

COVID flipped supply chain economics on its head. The smartest minds have figured this out… and moved onshore. Isn’t It time you did, too?

Join Extron founder Sandeep Duggal and Business Development Expert Paul D’Souza for this vital conversation to “shore up” your economics with a supply chain resilient to even the worst, pandemic-like disruptions.

They’ll discuss Last-Mile Manufacturing, among other topics.

If your organization manufactures, fulfills orders, handles returns, or considers free-trials (demos) that risk returns and reprocessing, this is the workshop to attend.

Sandeep Duggal

5:30 PM

KEYNOTE: DAVE ALBERT

Medical Devices Group friend Dave Albert will officially kickoff our eleventh 10x Medical Device Conference with the topic, “How Did AliveCor Become So Darn Successful?”

To meet Dave is to love him. What an engaging speaker and delightful man.

Please. You really must come, at least for his presentation and the reception that immediately follows.

Dr. David Albert

6:15 PM

2-Hour Welcome Reception

• 2-hour reception and networking with our sponsors, exhibitors, and guests
• Two drink tickets, light food included 

EVERYONE IS WELCOME!
Can’t make the whole event but want to mingle and learn? No problem, join us Tuesday night for our keynote and reception. 

We’d love to see you!

Come to our Reception!

7:45 AM

Breakfast

9:00 AM

Conference Opens

Conference Host Joe Hage welcomes you to the conference and sets the stage for a productive and enjoyable two-day event.

Joe Hage

9:10 AM

Update on Artificial Intelligence and Relevance to Medical Devices

Artificial intelligence continues to make progress in certain areas of medicine and healthcare, especially medical image interpretation and decision support.
Machine intelligence can create innovative insights in medical device design and application to improve health care delivery.
The human cognition-machine intelligence dyad will be essential for the future of medical device development and deployment.

Anthony Chang

9:40 AM

How to Immunize Your Business Against a Rapidly Mutating Market

Details to follow but Gunter is “all over” this topic.

1. How systems and processes mutate
2. Why you should chat more
3. Finding the hidden resource in your firm

Gunter Wessels

10:10 AM

Fast Round: Meet 4 Companies That Can Help You Right Away, Part 1

Click here to apply for one of the limited Fast Round spots.
This is how a ‘Fast Round’ works:

  • It’ll be just you and Joe onstage, both sitting on bar stools.
  • Joe will ask questions, the kind he’d ask if he walked up to your trade show booth.
  • Joe won’t prepare in advance. In fact, the less he knows, the better.
  • Joe will start with this question: “So who are you and what do you do?”
  • Questions will flow naturally from there.
  • Joe may also ask (so be prepared): “Teach us something about your work (but not in any way self-promotional) that you believe the average guest in our audience may not know.”
  • If you choose to bring something onstage, it will be small enough for you to carry on and off the stage.
  • You’ll need to fill out a simple one-page template. During our time, we’ll project it onscreen to aid visual learners. It will also appear in show photographs (and can subsequently be used for your social media efforts).
  • It will be recorded and professionally edited for your later use, however you see fit.

It’ll be fun, casual, and a real crowd-pleaser. Starring you!

A sample Fast Round, below, with the balance here on YouTube. Should we feature you too?
(A modest additional charge assessed to cover production costs.)

10x

10:30 AM

Break

During our short break, meet exhibitors who have the technologies and skills to get you to market smarter – and faster!

Break

11:00 AM

Tectonic Shift in Terminal Sterilization Landscape

Terminal Sterilization is the last and most crucial stage of medical device manufacturing.

Within the last couple of years, major events have taken place within Terminal Sterilization, causing major disruptions in supply chains within the medical device industry. We’ll talk about those.

While all major terminal sterilization methods are the best method depending on type of device, important consideration must be given in determining optimal sterilization along with long term implications of method selected.

Jeff Sauter

11:30 AM

Commercial Success, Growing Pains, and Picking Markets

Rick is Chief Medical Officer for Briotech, which produces a potent, pure, stable, and safe disinfectant, HOCl, precisely identical to a small infection-fighting molecule produced in every white blood cell in the human body. Briotech makes it at industrial scale using distributed global mini-factories remotely monitored for precise quality control in places like Mumbai, Helsinki, Lima, and Bucharest.

Briotech cares a great deal about safe drinking water as a human right and is are working with multiple partners in emerging economies on clean water and disinfection provisioning for slums, refugee camps, hospitals, and schools.

Rick Lockett

12:00 PM

Lunch

1:00 PM

Yes, Fewer FDA Recalls but How Many Near Misses?

FDA doesn’t track near misses, but consider what happened to Peloton last year.

Joseph Anderson

1:30 PM

Managing Returns: Perhaps Your Biggest Supply Chain Issue

Managing returns is the number one reason Paul’s supply chain company lands a new client. Often, they ignore the issue until it’s too late.

Gates/D'Souza

2:00 PM

Fast Round: Meet 4 Companies That Can Help You Right Away, Part 2

Click here to apply for one of the limited Fast Round spots.
This is how a ‘Fast Round’ works:

  • It’ll be just you and Joe onstage, both sitting on bar stools.
  • Joe will ask questions, the kind he’d ask if he walked up to your trade show booth.
  • Joe won’t prepare in advance. In fact, the less he knows, the better.
  • Joe will start with this question: “So who are you and what do you do?”
  • Questions will flow naturally from there.
  • Joe may also ask (so be prepared): “Teach us something about your work (but not in any way self-promotional) that you believe the average guest in our audience may not know.”
  • If you choose to bring something onstage, it will be small enough for you to carry on and off the stage.
  • You’ll need to fill out a simple one-page template. During our time, we’ll project it onscreen to aid visual learners. It will also appear in show photographs (and can subsequently be used for your social media efforts).
  • It will be recorded and professionally edited for your later use, however you see fit.

It’ll be fun, casual, and a real crowd-pleaser. Starring you!

A sample Fast Round, below, with the balance here on YouTube. Should we feature you too?
(A modest additional charge assessed to cover production costs.)

10x

2:20 PM

Pre-Submission Roleplay with FDA

You have precisely 60 minutes to show FDA what you have and learn if they feel your evidence will be sufficient for a successful 510(k) submission.

It’s not a chat session. It’s not “building relationships and getting early buy-in.” And you don’t want to ask questions to which you already know the answer or – worse – to which you really don’t want to know the answer.

Larry Stevens, formerly FDA, will roleplay his reaction to the questions Rob Packard and Michelle Lott in this simulated pre-submission meeting.

Fun and educational!

Larry StevensMichelle Lott RACRob Packard

2:50 PM

Ice Cream Social (Very Important!)

No offense to our speakers, but this is my favorite part of every 10x.

Make your own sundae with all the toppings! Yay!

Ice Cream Social!

3:30 PM

Top 7 Misconceptions about Intended Use Validation

This session would potentially bore you… if it weren’t Kris presenting it.

Fact is, if your Non-Product IUV Program isn’t properly set up, executed, documented and maintained, then it becomes a Big Problem when it comes time for submittals/audits.

Non-product software validation activities can easily slip through the cracks… because the compliance aspects are often misunderstood, set aside for later or simply forgotten. We are going to clear up these top misconceptions.

You’ll be glad you had your ice cream!

Kris Kelly

4:00 PM

We Need To Talk About COVID

Joe will lead an audience conversation about what we, as a medical device industry, learned about ourselves and our businesses these past two years.

Joe Hage

4:30 PM

Day 1 Program Concludes

Take a break in the sun. Or refresh yourself for the evening. Whatever you like… it’s free play.

Sunshine!

6:00 PM

Group Dinner (buy your own)

7:45 AM

Breakfast

9:00 AM

Conference Resumes

Joe recaps main takeaways from day one and kicks off our second day of education and networking with your fellow medical device industry leaders.

Joe Hage

9:10 AM

Innovations, Insights from a Seasoned Venture Capitalist

9:40 AM

How to Land the Strategic Partner of Your Dreams

10:10 AM

Growth & Capital Strategies for Medical Devices - Sell, buy, HOLD or HODL?

My very impressive friend Vivek won our 2016 Manufacturer’s Showcase as the most promising company that year. Imagine my delight when he told me this year:

“I have raised over $20M in the last few years, sell into 90 countries, have a 50 person full time team, sell direct into the US and manage 35 global distributors. Also, I have declined on several acquisition offers, made our first acquisition last year and several more to come.”

Come and learn from Vivek!

Vivek Kopparthi

10:40 AM

Break

11:00 AM

This EU Regulation Status Check May Actually Cheer You Up

Bassil Akra will share up-to-the-minute details about upcoming EU regulation dates and changes.

Bassil Akra

11:30 AM

FDA Regulation: A Peek into AI Proposed Regulatory Framework

Artificial intelligence applications rely on diverse datasets to make informed decisions. As datasets grow, algorithms improve in sensitivity and specificity. The challenge remains, how to handle this from a regulatory perspective without hindering innovation and delaying products into the market?

The FDA is considering modifications to the Software as a Medical Device Pre-Specifications (SaMD) that would allow for changes to be made because of learning and adaptation. The FDA’s goal is to ensure that the safety and effectiveness of the software as a medical device is maintained.

In this discussion, Shawnnah will lead an overview of the Software as a Medical Device Pre-Specifications (SaMD) guidance(s) and how the proposed FDA framework allows for iterative improvements of artificial intelligence and machine learning-based software as a medical device, while assuring patient safety.

Shawnnah Monterrey

12:00 PM

Lunch

1:00 PM

When Did Medical Device Innovation Break Down (and How to Fix It)

Ty Hagler believes medical device innovation relies too heavily on process and neglects the skill of the practitioner. Do you agree?

He’ll explain how design thinking is an easy concept to grasp, and harder to master. What to look for.

Ty Hagler

1:30 PM

There's a Right Way and a Wrong Way To Do User-Centered Development

User-centered development of home- and professional-use devices, IVDs, and combination products

Shannon Clark

2:00 PM

Fast Round: Meet 4 Companies That Can Help You Right Away, Part 3

Click here to apply for one of the limited Fast Round spots.
This is how a ‘Fast Round’ works:

  • It’ll be just you and Joe onstage, both sitting on bar stools.
  • Joe will ask questions, the kind he’d ask if he walked up to your trade show booth.
  • Joe won’t prepare in advance. In fact, the less he knows, the better.
  • Joe will start with this question: “So who are you and what do you do?”
  • Questions will flow naturally from there.
  • Joe may also ask (so be prepared): “Teach us something about your work (but not in any way self-promotional) that you believe the average guest in our audience may not know.”
  • If you choose to bring something onstage, it will be small enough for you to carry on and off the stage.
  • You’ll need to fill out a simple one-page template. During our time, we’ll project it onscreen to aid visual learners. It will also appear in show photographs (and can subsequently be used for your social media efforts).
  • It will be recorded and professionally edited for your later use, however you see fit.

It’ll be fun, casual, and a real crowd-pleaser. Starring you!

A sample Fast Round, below, with the balance here on YouTube. Should we feature you too?
(A modest additional charge assessed to cover production costs.)

10x

2:20 PM

Break

2:45 PM

Patents and the FDA: Powerful Strategy or Only Hope?

A patent strategy is critical for medical device commercialization. So is an FDA strategy. But a patent strategy disjointed from the FDA strategy is no strategy at all.

There are traps for the unwary in separating these two components of medical device development. By elegantly considering a regulatory strategy in view of the patent strategy and vice versa you help build up your competitive advantages, reduce risk, and help minimize obstacles typical to successful commercialization and/or securing investment.

In this talk, you will learn:

  1. Why patents should be developed in view of the regulatory pathway; the investment should be proportional and consistent with risk.

  2. Why it’s critical your regulatory strategy is consistent with your patent strategy; don’t let things to say to government agency hurt in other areas.

  3. Why coordinated patent claims that are consistent with the scope of indications of use and patient population is one way to increase portfolio value and secure your revenue model.

Gregory Grissett

3:15 PM

We've Spent Billions on Cybersecurity. We Good Now?

3:45 PM

Closing Thoughts

A little real-time feedback from you:
• What were your major takeaways?
• What did you love?
• What can we improve for next time?
A special discount toward future 10x Medical Device Conferences will be available only at this time as a thank-you to those to stay until the end for the feedback session.

Joe Hage

4:00 PM

Program Ends (kind of)

It’s true, the two day-long program has concluded.

But the new relationships you formed are just beginning!

If you go back to work and don’t keep in touch with the people you met, well, why’d you come in the first place?

Go. Cement relationships. Build your network of medical device professionals on whom you can rely.

Many of today’s guests hail from my most trusted MDG Premium network. We meet weekly. Perhaps joining us is a good place to start.

You can join us at

MDG Premium here. And if you attended, I probably gave you a secret code for a discount. 🙂

You’re a 10x alumnus now! You can call me anytime, for anything.

I’m happy to know you.

Keep in touch!

Top Speakers

You'll Get To Know These Medical Device Leaders

Dr. David Albert

AliveCor Founder

AliveCor Chief Medical Officer, his KardiaMobile device records your EKG, detects Atrial Fibrillation

Anthony Chang

CHOC

Founder of Artificial Intelligence in Medicine and Global Convener for Transformation

Michelle Lott RAC

leanRAQA

Regulatory and quality management expert in FDA guidances and submissions, QMS, EU, and MDR

Maurizio Vecchione

Terasaki Biomedical

Chief Innovation Officer, Terasaki Institute for Biomedical Innovation; venture capital advisor and investor

Rick Lockett

Briotech

President and CEO, mass-produces HOCl, identical to a molecule produced in white blood cells

Shannon Clark

UserWise

User-centered development of home- and professional-use devices, IVDs, and combination products

Vivek Kopparthi

NeoLight

Cofounder & Exec Chair at NeoLight, Cofounder at PriZm Tx, Forbes 30under30

Bassil Akra

AKRA TEAM GmbH

Among the foremost experts in EU regulations for the medical device industry

Gunter Wessels

LiquidSMARTS

Passionate to the improvement of human performance and business practices in sales & marketing

Rob Packard

Medical Device Academy

Highly sought-after quality and regulatory consultant for device start-ups; loves training others

Jan Gates

PackWise Consulting

Sterile barrier (ISO11607-1 & -2), cold-chain shipping, validation planning, distribution testing

Sandeep Duggal

Extron

Expert in off/onshoring, manufacturing, fulfillment, returns, demos; operations

Nic Anderson

Health Economist

Accomplished health economist, expert in reimbursement and funding strategy

Vidya Murthy

Medcrypt

COO for cybersecurity provider for three of top five medical device companies

Daniel Sheppard

MedWorld Advisors

M&A advisor for the medical device, medical manufacturing, and digital health industries

Jeff Sauter

Steri-Tek

Optimizing Medical Device Sterilization with E-beam/X-Ray Technology

Larry Stevens

The FDA Group

Expert Witness for FDA regulation of medical devices; RA/QA/Clinical consultant to industry

Shawnnah Monterrey

BeanStock Ventures

CEO of an FDA-accredited third-party 510(k) reviewer and medical device software developer

Gregory Grissett

Offit Kurman IP Law

Friend and medical device patent strategy counselor gave alumni the best IP presentation I've seen

Ty Hagler

TRIG

Principal of NC-based industrial design firm specializing in consumer, devices, durable goods

Joseph Anderson

Institute For Process Excellence

Enterprise operational excellence: Training and standards

Paul D'Souza

Extron

Supply chain resilience, component-sourcing flexibility specialist for the medical device industry

Kris Kelly

Advantu

Leads software quality assurance and testing firm; expert in QMS process improvement

Joe Hage

Medical Devices Group

Your 10x Host, Chairman of the Medical Devices Group, and medical device marketing consultant

You?

Future Speaker

Apply or recommend a speaker or topic to shape this and future 10x events

Best Prices Available Now!

Low Risk: Generous refund policy if you need to cancel for any reason!
Discounts: Available for students, the unemployed, and groups of 3+.

$130

* HIGHER AT DOOR

Keynote + Reception Only 🍷

Event Highlight: Enjoy our keynote speaker and mingle with guests from around the world over food and drink.

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$1995

* EXCLUDES WORKSHOPS

Full Conference 🍨

Become part of our tightly knit 10x alumni network, discuss the latest topics with medical device experts, and eat ice cream!

Day pass: $1495

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$195

Workshops Only ☕

In-depth, three-hour-long deep dives taught by Medical Devices Group experts; morning and afternoon sessions sold separately.

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Special Offer

Send 3 for the price of 2!

  • With Workshops

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    each

  • Without Workshops

    $1330

    each

  • Keynote + one day

    $1085

    each

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What Alumni Say About 10x

Testimonials

I am never not going to go to 10x. This is a MUST ATTEND event.

John Eckberg

Cook Group

The people you pulled aside for us, and the relaxed, collaborative tone were excellent.

Brett Goldsmith

Nanomedical Diagnostics

I’ve never been to a conference where I made connections like this one.

Leonard Eisner

Medical device consultant

I hope other conferences “drop the pretense” and let people be themselves like 10x does.

Nicholas Anderson

Intermountain Health

The April 2018 event exceeded expectations. Top notch with lots of extras.

Jason Spencer

Henkel

My only regret is not inviting more people.

Rob Packard

Medical Device Academy

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