Agenda

SCHEDULE

The Agenda

Attend and join our tightly knit group of industry professionals.

Download schedule
  • April 11 Before the Conference
  • April 12 Day 1
  • April 13 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: Reimbursement and Health Economics

Nic is going to change this one up this year. He’ll still spend a few minutes laying the basis of how healthcare really works in the USA but this year he’s going to spend more time with each of you discussing the real-world implications of coding and coverage of your device/diagnostic.

Nic Anderson

8:30 AM

(Optional)

3-Hour Workshop: 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 Workshop: How Machine Learning Can Whisk You Through FDA Submissions

1:30 PM

(Optional)

3-Hour Workshop: TBD

5:30 PM

KEYNOTE: MAURIZIO VECCHIONE

Two-time 10x alumnus Maurizio Vecchione joins us this year as our keynote. Why? Because each time he speaks he earns a standing ovation and leaves my audience in awe.

Maurizio reported directly to Bill Gates for more than seven years as Executive Vice President of Global Good & Research. His career spans 30+ years in climate technology, global and public health, with a deep focus on improving the lives of the world’s most vulnerable people.

I’m proud to call him my friend. If you’re unable to make the whole event, join us for his Tuesday evening keynote at least!

Maurizio Vecchione

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

How I Fought the DOJ Lawsuit Against My Medical Device Company

9:40 AM

How AI Will Save Healthcare

10:10 AM

Fast Round: Close and Personal with 4 Guests

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

Health 3.0: What Does It Look Like + How Will It Affect Your Device Economics?

11:30 AM

Health 3.0 Implications for Your Reimbursement Strategies

12:00 PM

Lunch

1:00 PM

How to Know When a Potential Investor is Serious

1:30 PM

Innovator Spotlight: How We Developed the Holy Grail for Endometriosis Diagnoses

2:00 PM

Fast Round: Close and Personal with 4 Guests

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

Actually Using AL/ML to Improve RA/QA Performance Today

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

EU Changes The Rules Again! Now What?

4:00 PM

TBD

Details to follow.

You?

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

How to Gain Better Access to Healthcare Decision Makers

9:40 AM

Commercial Success, Growing Pains

10:10 AM

Let's Talk Quality

10:30 AM

Break

11:00 AM

Why Did FDA Reject Your Rationale for No Usability Testing?

If anyone can explain why, it’s Rob. He writes, “90% of usability testing submitted to the FDA is unacceptable and the root cause is simply a failure to understand the human factors process.”

And continues, “Unlike CE Marking technical files, the FDA does not require a usability engineering file for all products.

Instead, the FDA determines if usability testing is required based upon a comparison of your device’s user interface and a competitor’s user interface (i.e. predicate device user interface). If the user interface is identical, then usability testing may not be required.

Instead, your company should be able to write a rationale for not doing usability testing based upon equivalence with the predicate device. If there are differences in your user interface, you will need to provide use-related risk analysis (URRA), identify critical tasks, implement risk controls, and provide verification testing to demonstrate the effectiveness of the risk controls.

Even if your device is “easier to use” or “simpler”, you still need to provide the documentation to support this claim in your submission. The FDA also does not allow comparative claims in your marketing for 510(k) cleared devices. Comparative claims require the support of clinical data.”

Rob will show you the 10 steps to deliver what you need to FDA and proceed without nasty surprises.

Rob Packard

11:30 AM

Cybersecurity Panel: The New Bare Minimums For Your Business

12:00 PM

Lunch

1:00 PM

TBD

Details to follow.

You?

1:30 PM

The Perfect Prototype Doesn't Exist: Why Lean Prototyping Works Today

Ty will challenge the commonly held belief that a perfect prototype is necessary for success. Instead, we will explore the benefits of lean prototyping – a methodology that prioritizes speed, efficiency, and learning over perfection. Ty will dispel myths and misconceptions surrounding prototyping, and demonstrate how this approach can lead to quicker, more cost-effective development of medical devices.

Ty Hagler

2:00 PM

Fast Round: Close and Personal with 4 Guests

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

TBD

Details to follow.

You?

3:15 PM

Intellectual Property

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!