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 Tuesday 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

India is the fastest growing major economy in the world for the last three years and its GDP will exceed that of France and UK this year. Its med tech companies have been growing at over 16 percent per year and now the Indian government has launched a healthcare insurance program to cover 500 million poor citizens. Gunjan will highlight the risks and rewards of working in this exciting new market.

Attendees will learn whether they should enter or expand their presence in India in 2019 or wait. They will learn what makes India unique in terms of both risks and rewards.

Gunjan Bagla

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!

With Paula’s extensive knowledge as a medical device recruiter, she outlines essential need to know ingredients when hiring or looking to be hired within the medical device community.

You will learn:

• How to approach startups
• How to find medical device startups
• Best times to hire
• Expectations and finances involved

Paula Rutledge

There can be a disconnect between medical device manufacturers and the patients using their devices. Sarah will discuss how ResMed is driving better patient outcomes by offering services that bridge the gap between medical device manufacturers and the patients who use them.

Sarah Wright

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

Millions of people live connected to billions of bags every year. These bags are dumb but what if they were smart. As a patient who has lived attached to medical bags for 35+ years the idea of treating a bag as a wearable is exciting. If we could measure what comes out the body then we could better understand what to put in our bodies. Michael has built a smart care management company from the patient perspective. It intrigues me that in healthcare we end up delivering solutions to end users as opposed to building them with all the end users. Michael will examine how 11Health is built on an everyone included model of care.

Patients can be innovators
Shit matters
Everyone included model of care is the future of healthcare
Moving from fee for service revenue models to outcomes based care.

Michael Seres

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

We are familiar with the FDA’s MAUDE (Manufacturer and User Facility Device Experience) Database for medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. This searchable database is accessible on the FDA website and has been a valuable tool for doctors, designers, manufacturers and anyone interested in the safety of medical technology products.

A recent news investigation revealed that FDA had an obscure controversial “alternative summary reporting” program that was not available to the public. It was a vast database, collecting 1.1 million or more medical product reports since 2016. This talk will describe the news investigation findings and FDA’s promise to end this program and provide transparency which will contribute to greater public awareness of medical product adverse events.

Richard Meyst

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

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

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

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

There’s a way to use claims data and analytics to understand your competitors’ pricing, help you with contract negotiations, mitigate risk in pricing strategies and we’ll tell you how.

1. Develop more informed pricing and contracting models and strategies

2. Arm teams with a view of reimbursement rates across the competitive landscape

3. Monitor and respond to market changes

4. Drive utilization by helping providers maximize reimbursement

Emily MortimerAnja Maciagiewicz

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

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

In recent years, FDA has prioritized including the patient’s voice in medical device development and regulatory decision-making.  One of these priorities falls under CDRH’s Patient Preference Initiative (PPI).  But, what does the PPI program really mean for the medical device industry?  Though FDA has encouraged sponsors to include patient experience data throughout the total product lifecycle, sponsors may be unsure about how best to implement PPI activities.  As proposed by FDA, there are many ways patients may potentially influence medical device development, clinical trial design, and regulatory decision-making. This presentation will focus on how the medical device industry may leverage the use of PPI data throughout the total product lifecycle.  In addition, FDA guidance and expectations regarding PPI data in regulatory strategy will be discussed.  Finally, the challenges facing the medical device industry to implement PPI activities and meet FDA’s expectations will be reviewed.

Takeaway #1:  Patient experience data has the potential to positively impact the medical device total product lifecycle

Takeaway #2:  There remain significant challenges to the medical device industry to implement FDA’s patient preference initiative activities.

Dr. Carrie Kuehn

You may have thought your Unique Device Identification (UDI) crisis was over… NOT SO! If you market Class I devices in the U.S. or devices of any class in the European Union, your work is not done.

UDI initiatives for medical devices and in vitro diagnostics are now international hot topics and how you, as a manufacturer, respond will affect your bottom line in the coming years. Regulatory UDI requirements started with the U.S., spread to the European Union, and are now emerging in Australia, Saudi Arabia, South Korea, China, and elsewhere. In parallel, your commercial business partners are starting to revise their contracts to specify UDI be placed on products and be included in electronically published product catalogs.

Gary will help sort out these UDI challenges; focus in on the EU UDI regulations, summarize the U.S. and other regulatory and commercial UDI requirements, and describe a holistic approach to take on these global UDI challenges.

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