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.
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.
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.
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:
Get to market.
STAY in market.
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!
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.
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.
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.
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.)
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.
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.
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.)
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.
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.
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.”
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.
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.)
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:
Why patents should be developed in view of the regulatory pathway; the investment should be proportional and consistent with risk.
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.
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.
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.
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