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

“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

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

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

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

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

• 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!

Breakfast

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

Joe Hage

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

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

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

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

Break

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

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

Lunch

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

Joseph Anderson

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

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

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

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!

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

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

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

Sunshine!

Dinner

Breakfast

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

Details to follow.

Maurizio Vecchione

Daniel Sheppard

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

Break

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

Bassil Akra

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

Lunch

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

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

Shannon Clark

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

Break

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

Details to follow.

Vidya Murthy

A little real-time feedback from you:
• 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

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!