Why You Should Eventually Attend 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.
For what level? 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.
If you haven’t attended a 10x Medical Device event yet, make 2020 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!
The Agenda
Attend and join our tightly knit group of industry professionals.
Download schedule
April or May 2022
Before the Conference
+ one day
Day 1
+ plus two days
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: How to Choose the Best Medical Device Pathway to Market
So you’ve determined the classification of your medical device or in vitro diagnostic and now it’s time to select a regulatory pathway to market. Pretty straightforward decision, right? If your technology is basically the same as an existing device, you choose 510k. If not, then PMA. End of discussion, right?
Not necessarily. Sure, you can follow in the footsteps of the many device makers who have gone before you. Or better yet, you can evaluate all the potential options available and select the path that gives your product the best chance to succeed in an increasingly competitive and challenging market.
In this workshop, we will explore all pathways to market — including the little-known and little-used ones — and discuss how to decide which to use when. Using the case study approach, these questions and others will be presented in an interactive fashion including:
What are all the pathways to market and the advantages and disadvantages of each?
How do I decide which one to use and when?
If my device is class III, is the PMA my only option? If my device is class II, is the 510k my only option?
How does the Breakthrough Devices Program (BDP) and Safer Technologies Program (STeP) affect pathway options?
Can I market a device without any FDA oversight whatsoever?
If someone else brought a similar device to market using one pathway, must I use the same pathway?
Must I choose only one pathway? Can I use multiple pathways for the same device at the same time?
How can I use label expansions to bring my device to market with less time, money and risk?
How can I get my device on to the market and make it more difficult for my competitors at the same time?
How do I integrate regulatory strategy with reimbursement strategy, product liability strategy, IP strategy, etc.?
Bottom line: not only are there multiple pathways to market but there advantages and disadvantages to each pathway one. You can combine them, mix and match them, do very interesting things with them… all examples of competitive regulatory strategy. So, unless you understand all of the different possible pathways to market for your device — not just the most common ones – and the advantages and disadvantages to each, how can you decide when to use or not use each one? There are many more possibilities than most people think and learning how best to use them is creative regulatory strategy!
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: Are You Afraid of the Three New Risk Requirements for 2020?
You already have a risk management procedure, and you already have risk management training, but do you know how to update your training and procedures for all three of the new risk management requirements?
Yes, there are three:
ISO 14971:2019 – December 16, 2019 (49 pages)
ISO/TR 24971:2020 – February 2, 2020 (100 pages)
EU MDR Annex 1 – May 26, 2020 (Sections 1-9)
The last time we had a major change in risk management requirements was in 2012. EN ISO 14971:2012 was published, and everyone learned the hard way about the 7 deviations. Nearly 100% of device companies received a non-conformity related risk management due to one of those 7 deviations. This year, instead of one standard change, there are three changes.
You can read the 150 pages of new material, identify gaps in your procedure, edit your procedure, and create a training for every design engineer in your company. Then you can start to update all of your risk management files for the FDA and CE Marking.
We revised our risk management procedure twice, updated our risk management training webinar, and we’re hosting a new webinar on February 10, 2020. If you need help with a plan to update your risk management files, you could also attend our 3-hour workshop at Joe Hage’s 10x Medical Device Conference in San Diego on April 14.
The workshop will have 3 parts. Rob Packard will explain what changed in Part 1. Mary Vater will explain the impact of these changes on your software development documentation. During Part 3, we will open the workshop to an extra long Q&A session to answer your specific questions.
You might be curious why we are devoting one-third of the workshop to software development. EN ISO 14971:2012 only used the word “software” once in the body of the standard, and 13 times in the annexes; while ISO 14971:2019 uses the word “software” 8 times, and ISO/TR 24971:2020 uses the word “software” 46 times. There is more emphasis on the application of risk management, because integrating devices with software applications is the single biggest trend in our industry. We also know that documenting software risk management is your weakness.
3-Hour Workshop: The Essentials for Medical Device Marketing Success
I used to say, “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.”
And while that’s still true, the incomparable Ted Rubin will join me on stage for the three hours. Ted is a force of nature, a highly sought-after speaker on the international circuit.
If you leave our 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 with Joe for just $100.
• 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!
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 5 Companies That Can Help You Right Away, Part 1
Click here to apply for one of the twenty 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: “Tell us your name, where you work, and why we should care.”
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 three minutes, 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!
Here’s an sample Fast Round. Should we feature you too?
(A modest additional charge assessed to cover production costs.)
How to Avoid the Single Biggest Medtech Marketing Mistake
I’m delighted to welcome Tom back. He spoke at my very first 10x Medical Device Conference way back in 2013.
Thinking that clinicians care deeply about, have anxiously been awaiting, or can’t live without your new technology and the unsolvable problem it allegedly solves is a recipe for disaster.
In his presentation, veteran medtech marketer Tom McCall will share how to jump start the effectiveness of your marketing programs by:
1. Understanding the true value you bring to the market — and realizing nobody cares
2. Learning the importance of motivating through emotion and persuading through reason
3. Breaking down barriers to connect with clinicians
Building Greater Intimacy with Clients and Profit from ROR (Return on Relationship)
In a connection economy, relationships are the new currency. If you want to continue to reach your Medical Device customers in this hyper-competitive age of social media, your marketing needs to focus on building relationships. Your metrics need to expand beyond ROI to include ROR: Return on Relationship™, #ROR. While ROI is simple dollars and cents, ROR is about people…including the value (both perceived and real) that will accrue over time through connection, loyalty, recommendations, and sharing.
Rob is among the first people I met when I inherited the Medical Devices Group back in 2011.
From Rob’s LinkedIn profile:
Rob Packard is a regulatory consultant specializing in 510(k) submissions and helping start-up medical device companies with quality and regulatory requirements. The most favorite part of his job is training others.
Rob has 25 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions.
Specialties: 510(k) Submissions, FDA eCopy, Public Speaking, Distance Learning, Risk Management, Design Controls, MDSAP, CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy.
Fast Round: Meet 5 Companies That Can Help You Right Away, Part 2
Click here to apply for one of the twenty 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: “Tell us your name, where you work, and why we should care.”
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 three minutes, 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!
Here’s an sample Fast Round. Should we feature you too?
(A modest additional charge assessed to cover production costs.)
Innovation is Just Good Business – Here’s How to Make it Happen
Despite having a focus, a leader, a strategy, even a burning passion to be more innovative – most companies fail to innovate in a way that delivers a commercial outcome. Why is that? What are the blockers and how do companies deliver innovative solutions on a repeated basis?
In this talk we’ll explain an innovation process, which is based on design-thinking best practices, that is being used by some of the world’s leading medtech companies to not just solve tough problems but ensure that they are solving the right problems. The process, known as the BRIGHT process, steps companies through 3 definite steps in exploring the problem space before switching to three steps dedicated to exploring the solution space. This framework allows companies to take risks, explore and learn without jeopardizing their business or their brand.
Most companies, especially medical companies, become very good at managing and reducing risk. But it is often these risk-management procedures that can permeate parts of the business where risk is an essential element to innovate. The BRIGHT process is ideal for regulated industries and in this talk we will unpack several actual examples of how leading medtech companies are using the BRIGHT process to ensure ‘innovation is just good business.’
Fast Round: Meet 5 Companies That Can Help You Right Away, Part 3
Click here to apply for one of the twenty 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: “Tell us your name, where you work, and why we should care.”
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 three minutes, 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!
Here’s an sample Fast Round. 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. During this presentation, events leading to these disruptions will be addressed. 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. This presentation will encompass current landscape as well as future of Terminal Sterilization.”
“Important considerations when determining optimal sterilization method, current landscape of Terminal Sterilization industry Sustainability for the future.”
Details to follow but Mike is “all over” this topic.
Evaluation and Testing within a Risk Management Process (ISO 10993-1)
Changes within the last couple years and the implications with the MDR and the FDA
Fast Round: Meet 5 Companies That Can Help You Right Away, Part 4
Click here to apply for one of the twenty 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: “Tell us your name, where you work, and why we should care.”
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 three minutes, 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!
Here’s an sample Fast Round. Should we feature you too?
(A modest additional charge assessed to cover production costs.)
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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