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

“Proove Biosciences, which sold dubious DNA tests to predict addiction risk, sells off assets as CEO departs amid criminal probe” read the August 31, 2017 headline in Stat News.

The article was filled with false allegations, says our keynote speaker, but the damage had already been done.

According to a website called The Truth About Proove Biosciences, disgruntled ex-employees created false allegations against Proove in 2015 and filed a whistle-blower lawsuit in 2015 (which was rejected by the government in 2016).

Brian explains, “The former employees STAT News to publish the misinformation, grouping Proove in a governmental inquiry involving giants Myriad Genetics, Genomic Health, Natera, and Invitae.

In June 2017, the FBI delivered a subpoena for documents, and by August 2017, Proove Biosciences was placed into court-ordered receivership.

As our keynote this evening, Brian will answer publicly the question he gets so often, “What on Earth Happened to Proove Biosciences?”

He’s committed to setting the record straight and helping others not fall victim to “post-truth,” “fake news,” and “misinformation.” If you’re a business executive, business owner, or entrepreneur, you’ll value this riveting keynote presentation, followed immediately by our two-hour food and drink reception. (Two drink tickets included with your registration.)

Brian Meshkin

• 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 Wednesday night for our keynote and reception.

We’d love to see you!

Come to our Reception!

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

Joe Hage

Dr. Mulumudi is Division Chief of Medicine & Medical Director of Interventional Cardiology at Providence Regional Medical Center and companies are trying to sell him stuff all the time.

In fact, he’s presently a Principal Investigator (PI) for six companies right now, compensating him to cover incremental costs he incurs to run and document your clinical trials.

In this engaging interview, 10x host Joe Hage will ask Mahesh what you really need to know if you’re going to get your device into his hospital system.

And a personal note from Joe: Mahesh taught me more about the nuances of selling to an ACO hospital versus a DRG hospital in twenty minutes than I’ve learned in six years. You’ll love this discussion and I’m grateful he’s joining our faculty.

Mahesh Mulumudi MDJoe Hage

Medical Device Entrepreneurship: Lessons learned from medical device start-up world

The presentation will cover several important topics which need consideration when launching a medical device start-up, including:

• Medical device new product development
• Technology and product idea generation process
• Venture capital (VC) funding, process and sources
• SBIR funding, process and successful grant writing tips
• Intellectual property (IP) roadmap for start-ups, how to optimally protect ideas, discussion of new changes in patent law
• Regulatory approval of new devices

Dorin Panescu

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!

10x

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

Details to follow.

Paula Rutledge

In today’s evolving healthcare landscape, it is essential that medical device companies utilize all data available to them in order to get to the truth of the customer experience and evolve their overall offering to best meet those needs. In her 10x presentation, Sarah will speak to leveraging customer support to develop a holistic view of the end-user with real-life examples and actionable insights for improving the patient experience via optimized support systems – a presentation based on her depth of experience in customer service, focused on her time at ResMed as she’s built out teams to uncover and work with these insights.

Sarah Wright

What does “operational excellence” mean, anyhow? Is it a buzzword? A fad? Some managerial mumbo jumbo?

Our speaker, Joseph Anderson, President of the Institute for Process Excellence, doesn’t think so. And he’s here to tell you why.

Joseph Anderson

ISO 11607 requires that a medical device packaging system allow sterilization, provide physical protection and maintain sterility up to when the package is opened and to the point of use.

Every terminally sterilized medical device company, including combination drugs & devices, must deal with over 115 FDA and EU packaging requirements—and counting—to stay compliant and prepare for FDA or EU inspections. Incorrectly designed & tested packaging may not receive regulatory clearance and add risk not only to the business launch objectives, but ultimately to the patients.

This ISO 11607 standard is a FDA-recognized consensus standards and European normative standards for CE marking. The ISO 11607 standards are in two parts:

1. ISO 11607-1: Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems addressing packaging materials and design; and,
2. ISO 11607-2: Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes addressing packaging process validations.

These standards are revised and updated every few years and have been amended in late 2018 for a 2019 release.
• Does your packaging validation comply with the 115 “shall” statements?
• Will you be ready for revisions to requirements that could be issued as soon as Q1-2019?
• Do you know when FDA needs updated information about your medical device packaging?

Join us for this enlightening talk and decipher the new critical elements and pave a path forward to validation success with a vetted process that yields minimal risk and ensures ISO 11607-2019 compliance.

Jan Gates

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!

10x

Participants will learn:

• The current state of the healthcare market and value-based care
• The value-imperative and it’s impact on low price and differentiated strategies
• How healthcare provider groups consider value
• How you can market and sell in this environment without losing your shirt
• 3 steps to take first thing tomorrow

Gunter Wessels

We’ll explore the two basic questions related to IP development that medical device companies must be able to answer:
1. Is your core technology and revenue model adequately protected?
2. What is your risk position regarding your competitor’s patents?

LEARNING OBJECTIVES:

• Takeaway #1: Covering your core technology is a critical part of a robust patent strategy

• Takeaway #2: Securing patents and avoiding patents are two completely different issues; each requires your attention!

• Takeaway #3: Valuable patents must CLAIM an invention that is new, non-obvious, and commercially relevant.

• Takeaway #4: Patent infringement risk can disrupt your business; it is critical to have a clear risk position as you develop your products.

Greg Grissett

Catalia Health is a SF-based company that developed Mabu, an AI-powered robot for patients with chronic disease.

Mabu engages in daily tailored conversations with patients and securely sends data back to the healthcare organization that provides updates on how the patient is feeling, if they’re taking their meds, etc.

Takeaway #1: How pharma is using AI to “go beyond the pill.”

Takeaway #2: How robots are designed to interact with patients.

Cory Kidd

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

We live in a world where data can help us make more informed decisions about how to navigate traffic, who to date, what to buy, who to network with and how to better manage our finances.

But when it comes to our personal health and wellness, we have no roadmap. We need something to show us where we are in terms of our health, with landmarks for risks and opportunities. A GPS that makes it easier to move toward our personal health goals. A new way to look at health and life.

The future of healthcare is coming. This is what it looks like.

Emmanuel Fombu MD

The Global IoT in Healthcare Market is expected to reach US$ 322.77 by 2025, expanding at a CAGR of 20.6% from 2017 to 2025. The U.S. market represented the largest portion of the global IoT in healthcare market in 2016.

Tracking health information is vital for consumers whether the data comes from electrocardiograms, fetal monitors, blood glucose levels, or temperature monitors. Most of these measures require follow-up with primary healthcare professionals.

Convenience, efficiency, and automation define everything for which the Internet of Things (IoT) stands.

In this talk, “Connected Devices for Connected Health,” the challenges of marketing IoT products and solutions to the primary care market will be identified and approaches to those challenges will be discussed. Ways in which to leverage the value proposition of of better health, lower costs and improved consumer experience will be presented.

1. Takeaway #1: Understand the value proposition for IoT solutions in healthcare.
2. Takeaway #2: Understand why primary clinicians are resistant to using IoT products.
3. Takeaway #3: Learn which healthcare segments of the IoT are poised for great early growth.
4. Takeaway #4: Learn three marketing approaches to launch and sustain IoT in healthcare solutions.

Alex Grewer

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!

10x

FDA launched its Case for Quality program following an in-depth review of quality data from medical device companies. This valuable collection of information, along with the support of industry stakeholders, became the catalyst for a new initiative at the regulatory agency.

With a strong emphasis placed on collaboration with manufacturers—rather than just enforcement, FDA initiated the Case for Quality. What came next was a paradigm shift in regulatory focus from a compliance-only mindset, to one that enables, encourages, and elevates the production of true quality medical devices.

Greenlight Guru was given the opportunity to partner with FDA CDRH in 2018 to promote its Case for Quality initiative, and share the many benefits it offers to the medical device community. In this presentation, Jon Speer will be continuing those efforts as he takes a dive into the “what, why, and how” of this innovative program.

We’ll be discussing the following topics throughout the session:

• Overview of Case for Quality – What it is, why FDA are doing it, and how they are engaging
• Review recent and future pilot initiatives at CDRH associated with the Case for Quality program
• Discuss what this regulatory paradigm shift means and its impact on the medical device industry

Jon Speer

Details to follow.

Bankim Mehta

In early stage medical device companies, there is almost universally a dream of getting started with budding product awareness in the marketplace, to be followed quickly by strong interest and appetite on the part of industry king-pins. Developers hope to be sold, early on, to industry moguls who can nourish that seed of value, and take it forward with huge growth and flourishing profits.

That’s a sensible objective, and in this industry it CAN HAPPEN! However, it probably really does happen for 1 in 30 early stage companies we see in this industry. This program will focus on a step by step plan to prepare you company to have VALUE to buyers in the reasonably NEAR future as you develop.

Deb Douglas

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!

10x

TBD

You?

Details to follow but the change from MDD to MDR has an impact on your UDI work. Let Gary explain what you need to know.

Gary Saner

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