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Sunday, September 23
08:00 AM - 05:00 PM

Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System

6th Annual Pediatric Device Innovation Symposium - Using Real World Evidence to Drive Pediatric Innovation

On August 31, 2017 the Food and Drug Administration issued the finalized guidance for medical device developers’ use of real-world evidence (RWE) and real-world data (RWD) to gain FDA approval for their medical devices. On September 23, one day before The MedTech Conference, join stakeholders from the industry, government, academia and patient groups for the nation’s leading pediatric innovation symposium where we will focus on how we can best use RWE to drive pediatric device innovation. Now in its sixth year, the one-day symposium, hosted by Children’s National Health System, brings together key leaders in the device space to stimulate pediatric device innovation and bring solutions to market faster for the benefit of children everywhere. Another highlight is a pediatric medical device pitch competition. It’s a results-driven day that MedTech Conference attendees won’t want to miss. Learn more at www.pediatric-device-symposium.org
6th Annual Pediatric Device Innovation Symposium - Using Real World Evidence to Drive Pediatric Innovation On August 31, 2017 the Food and Drug Administration issued the finalized guidance for medica...
12:00 PM - 07:00 PM

Registration Open & Badge Pick Up

12:30 PM - 05:00 PM

U.S. Market Access Seminar

Please be aware that lunch will not be served.
This event is closed to the press.

The U.S. Market Access Seminar is a pre-program for international delegates attending The MedTech Conference. It will address key issues for non-U.S. medtech companies seeking to launch products in the U.S. market. Instructors will cover regulatory and reimbursement pathways as well as perspectives about the changing landscapes in each of these areas in the U.S.

Agenda

12:30-12:35 p.m. Welcome (William Saraille, Sidley Austin)

12:35-1:05 p.m. Overview: Doing Business in the U.S. (Bruce Ellsworth, SelectUSA)

1:05-2:50 p.m. Navigating the FDA (Jim Macemon, Chief Operating Officer at DNAe and Biotech Primer Course Instructor)
- Medical device classifications
- Regulatory process for medical device approvals

2:50-3:00 p.m. Break

3:00-4:30 p.m. Pathways for Reimbursement
- 3:00-4:00 p.m. Overview of Reimbursement Pathways in the U.S. (William Saraille, Sidley Austin)
- 4:00-4:30 p.m. U.S. Commercial Payer Strategies (Stephen Hull)

4:30-5:00 p.m. State-Level Considerations (Commonwealth of Pennsylvania)
Please be aware that lunch will not be served. This event is closed to the press. The U.S. Market Access Seminar is a pre-program for international delegates attending The MedTech Conference. It will...
05:00 PM - 07:00 PM

International Reception (open to all attendees)

Kick off The MedTech Conference by meeting our esteemed guests from around the world in a casual setting. Brief remarks will be provided to welcome high-level government officials and all international participants in Philadelphia. This reception is open to all attendees.
Kick off The MedTech Conference by meeting our esteemed guests from around the world in a casual setting. Brief remarks will be provided to welcome high-level government officials and all internationa...
06:30 PM - 10:00 PM

MedTech Insight Awards 2018

Make your mark at the inaugural Medtech Insight Awards, a prestigious evening celebrating excellence among companies, teams, and individuals driving positive change across the medtech industry.

Held on the eve of and in partnership with The MedTech Conference in Philadelphia, the Medtech Insight Awards will honor and applaud those who, through their passion and unwavering commitment, are driven to cure, inform, minimize treatment burden, and make human lives better.

Categories recognize achievements across the device and diagnostics industries, from technological innovations and partnerships, to emerging markets, to the more personal accomplishments of teams and individuals.

Entries for the Medtech Insight Awards are now open - join distinguished leaders in the medtech industry from all corners of the globe. Nominate yourself or colleagues for this prestigious recognition.


6:30 pm Cocktail hour in the Stratus Rooftop Lounge
7:45 pm Welcome speech and dinner served in the Lafayette Ballroom
8:20 pm Awards Ceremony
8:45 pm Networking dessert and tea and coffee stations
10:00 pm Event ends

For more information, please visit: https://pharmaintelligence.informa.com/events/awards/medtech-insight-awards-2018

**Separate registration required**
Make your mark at the inaugural Medtech Insight Awards, a prestigious evening celebrating excellence among companies, teams, and individuals driving positive change across the medtech industry. Held ...
Monday, September 24
08:15 AM - 01:00 PM

AdvaMed Accel Leadership Seminar (by invitation only)

The AdvaMed Accel Leadership Seminar provides insights into early and emerging-growth medical technology company executives as they bring innovations to market. Leading medtech CEOs share lessons on managing innovation and preparing businesses for long-term growth and commercialization. The program also features a preview of the MedTech Innovator competition with start-up companies vying for the audience vote and the Virginia Shimer Rybski Memorial Award, presented to the winning company during a networking lunch.


7:45 AM Registration and Coffee


8:15 AM Welcome Remarks

Martha Shadan, Chairwoman of the Board, IlluminOss Medical, Inc.
Chairwoman, AdvaMed Accel Board of Directors


8:30 AM Alternative to the Exit: Start-ups Building Long-Term Value
Successful early to mid-stage commercial companies are thinking long-term about pipeline development and strategic acquisitions to build value and attract long-term investors. Organizational expansion and development of international markets is also a critical aspect of building long-term value, at a time with limited options for an early exit. Continued private placement of capital, strategic partnerships and IPOs will be discussed with companies facing those decisions or that have remained independent through their growth phase.

Moderator: David Uffer, Senior Partner, Alira Health
Gerald R. Mattys, Chief Executive Officer, Tactile Medical
Dr. Dolev Rafaeli, President and Chief Executive Officer, STRATA Skin Sciences, Inc.
Mark Throdahl, President and Chief Executive Officer, OrthoPediatrics

9:30 AM Networking Break

9:45 AM Lessons in Leadership: An Interview with CEO Joe Almeida
For the past two years, Joe Almeida has been spearheading business transformation and reinvigorating a culture of innovation at Baxter. This interview will explore Baxter’s recent evolution, and how Joe is restoring patient-centric innovation as a top priority at this iconic industry leader. He will also share his thoughts on the general state and trajectory of the medtech industry.

Joe Almeida, Chairman, President and Chief Executive Officer, Baxter

Introduced by: Anne Sissel, Vice President and Head, Baxter Ventures
Moderated by: David Cassak, Co-Editor-in-Chief and Managing Partner, MedTech Strategist


10:45 AM MedTech Innovator: Preliminary Competition and Execution Award
A select group of MedTech Innovator Semi-Finalists companies will pitch for the audience vote to win the MedTech Innovator Execution Competition, presented to the company in the Accelerator Program that demonstrates the strongest execution plan and potential. The winner will receive the Virginia Shimer Rybski Memorial Award. As a scientist and serial entrepreneur, Virginia Shimer Rybski worked for and founded several companies before becoming the President and CEO of Regenesis Biomedical, Inc. In the spirit of this dynamic woman, this award was created by AdvaMed Accel in 2013 to encourage the enthusiastic pursuit of business excellence in the medical technology industry and recognize the potential of a promising entrepreneurial company.

Host: Paul Grand, Chief Executive Officer MedTech Innovator

Judges:
James Kaiser, Strategist, Corporate Venture Group, HOYA Corporation
Tracy MacNeal, President, XimedicaDx / EVP, Corporate Development, Ximedica
Jenell Robinson, Vice President, Clinical Value and Provider Relations, MedTech Innovator
Dr. Alan Russell, Director, Disruptive Health Technology Institute, Carnegie Mellon University
Lily Yeung, Vice President, Molex Ventures

Presenting Companies:
AtaCor- Rick Sanghera, Chief Executive Officer
AuriGen – Tony O'Halloran, Co-Founder and Chief Technology Officer
PhotoniCare - Ryan Shelton, Chief Executive Officer and Co-Founder
PercuSense - Brian Kannard, Chief Executive Officer
Pneumonics - Ken Bernstein, Founder and Chief Executive Officer


12:00 PM Networking Lunch - Sponsored by Medmarc

12:30 PM MedTech Innovator Execution Award Ceremony

Virginia Shimer Rybski Memorial Award
Presented by: Paul Grand, Chief Executive Officer, MedTech Innovator
George Ayd, Assistant Vice President, Business Development and Marketing, Medmarc


1:00 PM Adjourn
The AdvaMed Accel Leadership Seminar provides insights into early and emerging-growth medical technology company executives as they bring innovations to market. Leading medtech CEOs share lessons on m...
Speakers
  • Joe Almeida, Chairman, President and Chief Executive Officer, Baxter (Speaker)
  • Paul Grand, CEO, MedTech Innovator (Speaker)
  • Gerald Mattys, Chief Executive Officer, Tactile Medical (Speaker)
  • See More..
08:30 AM - 09:30 AM

Accel Leadership Seminar - Alternative to the Exit: Start-ups Building Long-Term Value

This session is part of the AdvaMed Accel Leadership Seminar, an invitation only program. Attendees that requested an invite and were confirmed will have a ticket printed with their registration badge to attend.

Successful early to mid-stage commercial companies are thinking long-term about pipeline development and strategic acquisitions to build value and attract long-term investors. Organizational expansion and development of international markets is also a critical aspect of building long-term value, at a time with limited options for an early exit. Continued private placement of capital, strategic partnerships and IPOs will be discussed with companies facing those decisions or that have remained independent through their growth phase.
This session is part of the AdvaMed Accel Leadership Seminar, an invitation only program. Attendees that requested an invite and were confirmed will have a ticket printed with their registration badge...
Speakers
  • Gerald Mattys, Chief Executive Officer, Tactile Medical (Speaker)
  • Dolev Rafaeli, Chief Executive Officer and Board Member, STRATA Skin Sciences (Speaker)
  • Mark Throdahl, President and Chief Executive Officer, OrthoPediatrics (Speaker)
  • See More..
09:00 AM - 04:00 PM

MedDevice Development Course (separate registration required)

The MedDevice Development Primer Course is a one-day preparatory course designed for new medtech industry professionals seeking an introductory industry understanding. Instructed by Jim Macemon, a medical device expert, this course examines all aspects of medical device development. Starting with the regulatory environment, attendees compare how the FDA and EU classify devices by risk and the various approval pathways each class of device must undertake before receiving market approval. With an understanding of the regulatory considerations, the five phases of medical device development – market opportunity, evaluation, design, verification and manufacturing – are described in detail. The course concludes with a discussion of the medical device approval process and Q&A session. Participants will gain an enhanced understanding of the process required to bring a new medical device to market in the US. Take a look at the course agenda - https://biotechprimer.com/wp-content/uploads/2018/03/MedDevice-Primer-Agenda.pdf.

Biotech Primer delivers in-house, customized courses and online courses on medical devices and molecular diagnostics. This course is offered at a special The MedTech Conference discounted rate of $595. If you have any questions about any of Biotech Primer’s courses, contact Emily Sullivan at sullivan@biotechprimer.com. There is a separate registration and fee for this course in addition to the conference. You must pre-register - there are no walk-ins allowed. Click here to register: https://biotechprimer.com/calendar/medical-device-development/
The MedDevice Development Primer Course is a one-day preparatory course designed for new medtech industry professionals seeking an introductory industry understanding. Instructed by Jim Macemon, a med...
09:30 AM - 11:00 AM

Pediatric Devices: Critical Next Steps After FDA’s Public Workshop

Meet key leaders on pediatric device development issues including representatives from Pediatric Device Consortia, investors, leading academics, device industry CEOs and Dr. Vasum Peiris, Chief Medical Officer – Pediatrics and Special Populations who will provide a high-level overview of the recent FDA public meeting on pediatric device development. Join this important session to discuss innovative solutions for pediatric device development and contribute to discussion on the important next steps for moving solutions forward.
Meet key leaders on pediatric device development issues including representatives from Pediatric Device Consortia, investors, leading academics, device industry CEOs and Dr. Vasum Peiris, Chief Medica...
Speakers
  • Vasum Peiris, Chief Medical Officer - Pediatrics and Special Populations, Office of the Center Director, Center for Devices and Radiological Health, FDA (Speaker)
09:45 AM - 10:45 AM

Accel Leadership Seminar - Lessons in Leadership: An Interview with CEO Joe Almeida

Accel Leadership Seminar Panel Session

This session is part of the AdvaMed Accel Leadership Seminar, which is an invitation only program. Attendees that requested an invite and were confirmed will have a ticket printed with their registration badge to attend.

For the past two years, Joe Almeida has been spearheading business transformation and reinvigorating a culture of innovation at Baxter. This interview will explore Baxter’s recent evolution, and how Joe is restoring patient-centric innovation as a top priority at this iconic industry leader. He will also share his thoughts on the general state and trajectory of the medtech industry.
Accel Leadership Seminar Panel Session This session is part of the AdvaMed Accel Leadership Seminar, which is an invitation only program. Attendees that requested an invite and were confirmed will ha...
Speakers
  • Joe Almeida, Chairman, President and Chief Executive Officer, Baxter (Speaker)
  • David Cassak,, Co-Editor-in-Chief and Managing Partner, MedTech Strategist (Moderator)
  • Anne Sissel, Vice President and Head / Baxter Ventures, Baxter Healthcare Corporation (Introduction By)
10:00 AM - 05:00 PM

MedTech Connect Partnering Open

The MedTech Conference is pleased to offer MedTech Connect – a desktop portal and mobile networking platform for scheduling one-on-one meetings, to all full-access attendees. Users can search for other attendees, request meetings based on mutually agreeable times and build a personalized conference schedule.

MedTech Connect is the premier partnering tool to help maximize business development opportunities for investors, medtech companies, start-ups, academics and other industry stakeholders.

MedTech Connect will launch in summer 2018.
The MedTech Conference is pleased to offer MedTech Connect – a desktop portal and mobile networking platform for scheduling one-on-one meetings, to all full-access attendees. Users can search for othe...
10:00 AM - 06:00 PM

Speaker Ready Room Open

10:30 AM - 11:45 AM

Vertical Integration in Health Care: What It Means for Business in Medtech

Accelerated by budget challenges, a rapidly accelerating competitive landscape and a continuously evolving health care value chain, vertical integration is one of the hottest trends in the health care industry. This panel brings together a variety of players in the consolidating payer, provider and manufacturer segments to discuss the strategies at work, the drivers behind them, and the endpoints and implications for medtech companies.
Accelerated by budget challenges, a rapidly accelerating competitive landscape and a continuously evolving health care value chain, vertical integration is one of the hottest trends in the health care...
Speakers
  • Kevin Conroy, CEO, Exact Sciences (Speaker)
  • Ted Langan, Sr. Vice President, UnitedHealth Group – Optum SP Sales, Optum (Speaker)
  • Anthony Spero, President of Ascend Health & COO of Partners Pharmacy, Ascend Health, Partners Pharmacy (Speaker)
  • See More..
10:45 AM - 12:00 PM

Accel Leadership Seminar - MedTech Innovator: Preliminary Competition and Execution Award

This session is part of the AdvaMed Accel Leadership Seminar, which is an invitation only program. Attendees that requested an invite and were confirmed will have a ticket printed with their registration badge to attend

A select group of MedTech Innovator Semi-Finalists companies will pitch for the audience vote to win the MedTech Innovator Execution Competition, presented to the company in the Accelerator Program that demonstrates the strongest execution plan and potential. The winner will receive the Virginia Shimer Rybski Memorial Award. As a scientist and serial entrepreneur, Virginia Shimer Rybski worked for and founded several companies before becoming the President and CEO of Regenesis Biomedical, Inc. In the spirit of this dynamic woman, this award was created by AdvaMed Accel in 2013 to encourage the enthusiastic pursuit of business excellence in the medical technology industry and recognize the potential of a promising entrepreneurial company.
This session is part of the AdvaMed Accel Leadership Seminar, which is an invitation only program. Attendees that requested an invite and were confirmed will have a ticket printed with their registrat...
Speakers
  • Paul Grand, CEO, MedTech Innovator (Host)
  • James Kaiser, Strategist, Corporate Venture Group, HOYA Corporation (Judge)
  • Tracy MacNeal, XimedicaDx / EVP, Corporate Development,, Ximedica (Judge)
  • See More..
11:00 AM - 12:15 PM

Advances in Leveraging Real-World Evidence (RWE) through NESTcc Test-Cases

The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is working to accelerate the development and translation of new and safe health technologies, leveraging Real-World Evidence (RWE), and innovative research. Guided by this mission, NESTcc launched its test-case initiative in 2018 to answer industry questions, test the capabilities of its Data Network, and identify where NESTcc can reduce transaction costs.

To achieve these goals, NESTcc has matched test-case projects to its initial set of 11 Network Collaborators committed to advancing the use of high-quality Real-World Data (RWD) from various sources, including electronic health records (EHRs), pharmacies, public and private claims, registries, and patient-generated data. Responding to questions submitted by industry partners, Network Collaborators will determine their ability to capture data needed to support a range of studies and analysis.

Dr. Rachael Fleurence,Executive Director, National Evaluation System for health Technology Coordinating Center Medical Device Innovation Consortium, will lead the discussion, providing an overview of test-case projects. Dr. Jeffrey Shuren, Director of the FDA's Center for Devices and Radiological Health (CDRH), will provide a regulatory perspective on expectations for test-cases. Dr. Michelle McMurry-Heath and Jay Donosky will shed light on the value of test-cases from an industry perspective, while Adrian Hernandez will share insights as a participating Network Collaborator.
The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is working to accelerate the development and transl...
Speakers
  • Jay Donosky, Clinical Affairs Leader, Cardiac Category, W.L. Gore & Associates (Speaker)
  • Rachael Fleurence, Executive Director, National Evaluation System for Health Technology Coordinating Center (Speaker)
  • Adrian Hernandez, Vice Dean for Clinical Research, Duke University School of Medicine (Speaker)
  • See More..
12:00 PM - 02:00 PM

Implementation of the New European Medical Technology Regulations: Is Anyone Ready?

The European Union adopted new regulations for medical devices and in vitro diagnostics last year and is currently in the process of implementation. The new regulations fundamentally change not only the process for regulatory approval process for medical technology in the EU, but also will have a dramatic impact on the number of products that will need to undergo review. It remains to be seen during the implementation process the many far-reaching consequences that will occur, but undoubtedly there will be an enormous impact on all phases of the CE mark process, including pre-market approval, data requirements and post-market surveillance and inspections.

Major concerns about the pace of the implementation process and the capacity of the EU’s notified bodies to conduct the necessary reviews by May 2020 (MDs) and May 2022 (IVDs) are beginning to surface. How these concerns are addressed is of vital importance to patients and the medical technology industry. Can the EU implement these regulations in a timely manner, in accordance with the aggressive schedule that currently exists? Will notified bodies have sufficient expertise and capacity to test your products in a timely manner, particularly when the implementation process to date has not yet provided much definition of the standards or requirements they will need to utilize? How will the ongoing implementation process continue to shape the requirements? Will the slow pace of implementation require enactment of relief measures to ensure product approvals aren’t backlogged or that products can remain on the market in the EU while awaiting review? Is your company ready to comply with the new regulations? The expert panel, with representatives from government, consultants and industry will provide the information you need to answer these questions and deal more effectively with this complex landscape.
The European Union adopted new regulations for medical devices and in vitro diagnostics last year and is currently in the process of implementation. The new regulations fundamentally change not only t...
Speakers
  • Vicki Anastasi, Vice President and Global Head, Medical Device and Diagnostics Research, ICON plc (Speaker)
  • Dr. Almut Frohlich, Legal Advisor — Medical Device Safety, German Federal Ministry of Health (Speaker)
  • Niall MacAleenan, Deputy Director, Head of Medical Devices Department, Health Products Regulatory Authority (HPRA) (Speaker)
  • See More..
12:30 PM - 01:30 PM

The Trump Trade War with China: What it Means for Your Business

A former senior official in the Office of the US Trade Representative, Ralph Ives, and a former medical technology company representative, Zach Helzer, will explain the legal basis for President Trump’s actions, the products being hit by a 25 percent tariff increase, the process for seeking exclusion from the tariffs, and possible new trade action to come. These two members of AdvaMed’s Global Policy staff will provide a brief summary of US and China trade actions and respond to questions.
A former senior official in the Office of the US Trade Representative, Ralph Ives, and a former medical technology company representative, Zach Helzer, will explain the legal basis for President Trump...
Speakers
  • Zachary Helzer, Associate Vice President, Global Strategy and Analysis, AdvaMed (Speaker)
  • Ralph Ives, Executive Vice President, Global Strategy & Analysis, AdvaMed (Speaker)
  • Claire Reade, Senior Counsel, Arnold & Porter (Speaker)
12:30 PM - 02:15 PM

Current Efforts for Corporate and Medical Device Cybersecurity

Cybersecurity practices continue to evolve for corporations and medical device development and maintenance. This session will begin with a case-study of a cybersecurity event that struck FedEx and the response taken, and lessons learned, by the company. The session will then move to a discussion about medical device cybersecurity with a focus on efforts currently underway by the Healthcare Sector Cybersecurity Council, including an update on a Joint Strategy Plan that responds to recommendations made by the HHS Cybersecurity Task Force. The session will conclude with a moderated discussion with the presenters and an audience Q&A.
Cybersecurity practices continue to evolve for corporations and medical device development and maintenance. This session will begin with a case-study of a cybersecurity event that struck FedEx and the...
Speakers
  • Greg Garcia, Executive Director, Health Sector Coordinating Council (Speaker)
  • Jim Jacobson, Chief Product & Solution Security Officer, Siemens Healthineers (Speaker)
  • Colin Morgan, Director, R&D & Product Security, Johnson & Johnson Information Security & Risk Management (Speaker)
  • See More..
01:00 PM - 02:15 PM

Brazil: Challenges and Choices in Health Care

Given the current political, economic and social realities faced in Brazil, this panel will examine current health care conditions in the country, the consequences for the nation’s health care system, an understanding of questions related to the system’s sustainability, the identification of priorities in correcting systemic distortions and, finally, the contribution being made by supplemental health care, organized as a productive supply chain. Considerations will consider the restructuring of Brazilian health care in a way that places elements of civil society at the disposal of the government to promote effective decision-making and guarantee the survival of the system per the design originally laid out by the Brazilian Constitution.
Given the current political, economic and social realities faced in Brazil, this panel will examine current health care conditions in the country, the consequences for the nation’s health care system,...
Speakers
  • Francisco Balestrin Andrade, Chairman, Anahp (Speaker)
  • Adriano Caldas, Vice President, Johnson & Johnson Medical Brazil, but representing ABIMED in this event (Speaker)
  • Claudio Lottenberg, United Healthcare (Speaker)
  • See More..
01:00 PM - 02:15 PM

What Payers Want: Smart Approaches to Demonstrate Value

Showing value in medtech can be challenging, especially as providers and payers are shifting from a volume based payment environment to new models that create new risks and rewards. Knowing the types of evidence and outcomes payers want to see is key to patient access and adequate reimbursement. Hear from leading experts at major payers on how they view medtech evidence development and the role real world evidence collection can play in making the value case.
Showing value in medtech can be challenging, especially as providers and payers are shifting from a volume based payment environment to new models that create new risks and rewards. Knowing the types ...
Speakers
  • Naomi Aronson, Executive Director, Clinical Evaluation, Innovation and Policy, Office of Clinical Affairs, Blue Cross Blue Shield Association (Speaker)
  • Marc Boutin, Chief Executive Officer, National Health Council (Speaker)
  • Leigh Ann Bruhn, Vice President, Avalere (Speaker)
  • See More..
01:00 PM - 02:15 PM

Dx Investors: What the Future Holds

Hear the latest from long time diagnostics investors and investors advisors as they contemplate the advances being made in the diagnostics field in precision medicine, point of care diagnostics and the evolving case for value, against the backdrop of policy and market challenges and opportunities.
Hear the latest from long time diagnostics investors and investors advisors as they contemplate the advances being made in the diagnostics field in precision medicine, point of care diagnostics and th...
Speakers
  • Steve Beuchaw, Executive Director, Morgan Stanley | Research (Speaker)
  • Donna Hochberg, Partner, Health Advances, LLC (Speaker)
  • Eric Lev, Partner, Ampersand Capital (Speaker)
  • See More..
01:15 PM - 02:00 PM

#MedTechCon Tweetup

Meet and hangout with your Twitter friends in person! Savvy social media users will gather to talk about lifesaving
and life-changing innovations and what’s coming next at the intersection of health care and technology. Follow along at #MedTechCon!
Meet and hangout with your Twitter friends in person! Savvy social media users will gather to talk about lifesaving and life-changing innovations and what’s coming next at the intersection of health ...
02:00 PM - 03:45 PM

MedTech Innovator Partnering Session (Invitation Only)

A special opportunity at The MedTech Conference to meet and network with the 50 early and mid-stage startups in the MedTech Innovator Showcase, selected as the most transformative devices, diagnostics and digital health companies from over 700 applicants! (Invitation-only)
A special opportunity at The MedTech Conference to meet and network with the 50 early and mid-stage startups in the MedTech Innovator Showcase, selected as the most transformative devices, diagnostics...
02:30 PM - 03:45 PM

State of the Art Global Best Regulatory Practices for Medical Device Regulators

Medical device regulators around the world are increasing their implementation of Good Regulatory Practices to more effectively fulfill their mandates. This panel will explore the WHO guidance for GRP and the WHO Model Regulatory Framework, with updates of how leading MD regulators are leveraging GRP with improved regulatory efficacy including in the United States and Brazil.
Medical device regulators around the world are increasing their implementation of Good Regulatory Practices to more effectively fulfill their mandates. This panel will explore the WHO guidance for GRP...
Speakers
  • Renato Porto, Director, Brazilian Health Surveillance Agency (Speaker)
  • Jeff Shuren, Director, FDA, CDRH, U.S. (Speaker)
  • John Wilkinson, Director of Devices, Medicines and Healthcare products Regulatory Agency (MHRA), U.K. (Speaker)
  • See More..
02:30 PM - 03:45 PM

Developing the Next Generation of Healthcare: What the Future Looks Like and Who Will Provide and Pay for It

From precision medicine, connected platforms and apps to artificial intelligence, data and media, the future of healthcare is changing rapidly. With new people-centric advances that drive better customer experiences and adherence, patient outcomes are improving. But what’s next for healthcare? Who is driving innovation? Who are tomorrow’s healthcare providers? And how will payors cover the next generation of healthcare?

This panel will bring together innovators from across industries and business segments to discuss their experiences in developing the future of healthcare. Panelists will discuss how their companies approach care, the challenges they have faced in developing new solutions, and how current innovations will affect the future of care and the medical device industry in years to come. Panelists will address topics ranging from the regulatory, privacy, data ownership and risk issues associated with next-generation care to using technological and big data advances to fuel value-based payment models.

Whether you are an executive currently pursuing new digital health initiatives or an emerging company with an exciting new platform, this panel discussion will provide valuable insight into the how and why of innovation in healthcare.
From precision medicine, connected platforms and apps to artificial intelligence, data and media, the future of healthcare is changing rapidly. With new people-centric advances that drive better custo...
Speakers
  • Todd Usen, President, Medical Systems Group, Olympus (Speaker)
  • Rick Valencia, President, Qualcomm Life (Speaker)
  • Alonzo Weems, Eli Lilly & Co. (Speaker)
  • See More..
02:30 PM - 03:45 PM

EY Pulse of the Industry

A decade since the financial crisis, the medtech industry has re-established steady growth rates and record levels of venture capital investment. However, medtech has yet to fully realize the potential of new digital technologies to transform the industry. Connected devices will capture and analyze data to deliver personalized care and improved outcomes, while presenting new challenges in customer engagement, data management and cybersecurity. EY’s 12th annual Pulse of the in industry medical technology report examines each of these topics and will be the foundation for the panel conversation where we’ll explore how medtechs can best seize the opportunities and avoid the dangers ahead.
A decade since the financial crisis, the medtech industry has re-established steady growth rates and record levels of venture capital investment. However, medtech has yet to fully realize the potentia...
Speakers
  • John Babitt, Partner - Life Sciences Transactions, EY (Speaker)
  • John Carlson, Flex (Speaker)
  • Deb Kilpatrick, CEO, Evidation Health (Speaker)
  • See More..
02:30 PM - 03:45 PM

Value Based Care Arrangements—Results-based Contracts in Action

As hospitals, physicians, and plans move into new value based care models, medtech and diagnostic companies are doing all they can to stay relevant and make their case for value. Medtech companies want to be seen as partners and set contracts based on their value with terms tied to patient outcomes and shared risk/rewards. But how are they doing this? Hear from companies on the cutting edge of value contracting.
As hospitals, physicians, and plans move into new value based care models, medtech and diagnostic companies are doing all they can to stay relevant and make their case for value. Medtech companies wan...
Speakers
  • Ron Collins, Vice President, Supply Chain, University of Tennessee Medical Center, Knoxville, Tenn. (Speaker)
  • Andy Davis, Health Actuarial Lead, Life Sciences, Deloitte (Speaker)
  • Myla Maloney, Premier (Speaker)
  • See More..
02:45 PM - 03:15 PM

Women in Diagnostics Meetup

Join women leaders in the diagnostic sector to discuss emerging technological trends and the future of diagnostics, including molecular diagnostics and personalized medicine. Network with your peers and discuss the current investment climate and what innovative companies, big and small, can expect in the coming years.

2018 Host: Jennifer Paine, Executive Vice President, Ortho Clinical Diagnostics, Inc.
Join women leaders in the diagnostic sector to discuss emerging technological trends and the future of diagnostics, including molecular diagnostics and personalized medicine. Network with your peers ...
04:00 PM - 05:15 PM

M&A Perspectives: Compelling Technology Meets Strategic Fit

From discovery to acquisition to integration, relationships between small and large companies evolve throughout the M&A process. This panel will explore the various stages of partnership that lead to the successful development and execution of an M&A deal. Experienced corporate leaders will share broad perspectives on the strategic importance of M&A and key aspects of identifying and building a relationship with the right company and technology. The panel will also focus on integration with a case study of Smith & Nephew’s acquisition of Rotation Medical.
From discovery to acquisition to integration, relationships between small and large companies evolve throughout the M&A process. This panel will explore the various stages of partnership that lead to...
Speakers
  • Charlie Attlan, Sr VP, Corporate Strategy and Business Development, Boston Scientific Corp. (Speaker)
  • Scott Schaffner, Sr. VP Global Marketing, Sports Medicine, Smith & Nephew (Speaker)
  • Martha Shadan, Chairwoman of the Board, IlluminOss Medical Inc. (Speaker)
  • See More..
04:00 PM - 05:15 PM

Competing for Innovation - Brazil, India and China

This session will provide a comparative summary of the health systems and markets in Brazil, China and India with a view to highlighting dynamics and policies that maximize health access and innovation.
This session will provide a comparative summary of the health systems and markets in Brazil, China and India with a view to highlighting dynamics and policies that maximize health access and innovatio...
Speakers
  • Anthony Cino, Vice President, Albright Stonebridge Group (Speaker)
  • Yashdeep Kumar, Vice President, Global Innovation Programs, Stryker (Speaker)
  • Parashar Patel, Vice President, Global Health Policy, Boston Scientific (Speaker)
  • See More..
04:00 PM - 05:15 PM

Introducing New and Innovative Technology into the Supply Chain through a GPO

An excellent opportunity to learn from GPOs and suppliers how to successfully work with and launch new and innovative technologies in the GPO environment. Does a GPO work for your product and market implementation strategies? Three GPOs and three suppliers will overview briefly overview and discuss their processes and successes, as well as lessons learned.

Want to learn more and talk to representatives from Vizient, Premier and HealthTrust directly? Join us for a meet and greet on Tuesday morning from 9:00 am - 11:00 am in the Exhibit Hall (Academic Tech Transfer Zone - #125)
An excellent opportunity to learn from GPOs and suppliers how to successfully work with and launch new and innovative technologies in the GPO environment. Does a GPO work for your product and market i...
Speakers
  • Bernard Bartoszek, Owner, Corporate Contracting &Consulting. LLCc (Speaker)
  • Becky Foret, Senior Director, Sourcing Ops - Surgical, Vizient (Speaker)
  • John Gribbin, CEO, Curable (Speaker)
  • See More..
04:00 PM - 05:15 PM

Companion Diagnostics: Trends and Perspectives

As trends move increasingly toward more personalized medicine, diagnostics -- including companion diagnostic tests and complementary diagnostics are becoming more prevalent, in oncology and other therapeutic areas. This panel will explore the current state of companion diagnostics and beyond. Panelists will offer a range of perspectives - including test developers, payers, providers, patients and pharmaceutical companies. This panel will discuss emerging trends in diagnostics and address the challenges of aligning the incentives of various stakeholders.
As trends move increasingly toward more personalized medicine, diagnostics -- including companion diagnostic tests and complementary diagnostics are becoming more prevalent, in oncology and other ther...
Speakers
  • Jeff Allen, President and CEO, Friends of Cancer Research (Speaker)
  • Lena Chaihorsky, V.P. Payer Innovation, Alva10 (Speaker)
  • Ralph Riley, Global Co Diagnostics Market Access Leader, Janssen Global Services, Inc. (Speaker)
  • See More..
04:00 PM - 05:15 PM

CDRH Innovation Information Session

Hear how CDRH Innovation provides early regulatory assistance to innovators and small businesses, and facilitates activities to accelerate patient access to safe, effective, and innovative medical devices. This interactive presentation and discussion forum will allow small companies to understand the Payor Communications Task Force and other resources available through CDRH Innovation to navigate complexregulatory and coverage evidentiary requirements.
Hear how CDRH Innovation provides early regulatory assistance to innovators and small businesses, and facilitates activities to accelerate patient access to safe, effective, and innovative medical dev...
Speakers
  • Ken Skodacek, Deputy Ombudsman (acting), FDA/CDRH (Speaker)
  • Liz Spurgin, Vice President, Health Economics & Patient Access, Medical Device Innovation Consortium (Speaker)
04:15 PM - 05:00 PM

Leadership – Attracting, Developing and Perpetuating Outstanding Leadership (Featuring 2018 AdvaMed Lifetime Achievement Award Recipient, Vernon R. Loucks, Jr.)

Vernon “Vern” Loucks rose through the ranks at Baxter and served twenty years at its helm as Chairman and CEO. During his tenure, Vern was known for successfully identifying and developing new markets – especially outside the US – and for attracting and mentoring great future leaders. He knew when to acquire companies, where to enter or expand markets, and when to spin-out businesses into successful new companies. Under his leadership, Baxter created exceptional shareholder value and revenues more than quadrupled to nearly $6 billion. Vern also knew how to find and develop great talent. He often hired people with little prior industry experience, and he was known for empowering young leaders with significant responsibilities including the running of business units. His actions often encouraged executives to leave Baxter and build and run companies of their own as he hired and developed so many great young leaders that it was not possible to keep them all. Vern and Baxter are known for having the most prolific and successful alumni organization in the industry. Among the companies that have been led by veterans of “Vern’s army” are Boston Scientific, Edwards Lifesciences, RTI Surgical, Beckman Coulter, American Medical Systems, Genzyme, Caremark, Allegience, McKesson Corporation, Hill-Rom, Ivenix, GI Dynamics, Lundbeck, PathoGenesis and Ovation Pharmaceuticals, to name a few. Join us for a fun and interactive discussion with Vern and three of his highly successful proteges, Joe Almeida, Lester Knight and Mike Mussallem. Vern and our panel will talk about leadership and what makes a great leader.
Vernon “Vern” Loucks rose through the ranks at Baxter and served twenty years at its helm as Chairman and CEO. During his tenure, Vern was known for successfully identifying and developing new market...
Speakers
  • Joe Almeida, Chairman, President and Chief Executive Officer, Baxter (Speaker)
  • Lester Knight, Founding Partner & Chairman, RoundTable Healthcare Partners (Speaker)
  • Vernon Loucks, Former Chairman and Chief Executive Officer, Baxter International Inc. (Speaker)
  • See More..
04:30 PM - 05:30 PM

Women's Executive Network Reception

The AdvaMed Women’s Executive Network is an initiative
promoting and cultivating women in executive leadership roles
across the medical technology industry. The network aims to
integrate women leaders from AdvaMed member companies
into the association’s work and to support the industry as it
emphasizes both diversity and elevating women into senior
leadership positions. Since its official launch in 2014, WEN has
grown exponentially, with a strong Leadership Circle consisting
of senior women executives from across the industry and a
larger community of several thousand.
The AdvaMed Women’s Executive Network is an initiative promoting and cultivating women in executive leadership roles across the medical technology industry. The network aims to integrate women leaders...
05:30 PM - 07:00 PM

Welcome Reception

Tuesday, September 25
07:00 AM - 07:00 PM

07:30 AM - 09:00 AM

Plenary Breakfast

The Advanced Medical Technology Association (AdvaMed) will convene the annual meeting of the medical technology industry in Philadelphia, PA this September 24-26 and bestow its highest honor – The Lifetime Achievement Award – upon former Baxter CEO and Chairman Vernon R. Loucks, Jr.

Annually presented by AdvaMed, The Lifetime Achievement Award recognizes an individual that has had a monumental impact and made a lasting influence on the medical technology industry. Candidates must have demonstrated industry leadership with activities and actions that have an impact far beyond their own company, employees, products and the patients they serve. The award recognizes individuals with sustained activity in such areas as industry leadership, innovation, discovery, commercialization, entrepreneurship, philanthropy, venture capital/capital formation and prolonged contributions to the medical technology industry. Previous recipients include:

2013 – John W. Brown, Chairman Emeritus, Stryker Corporation
2014 – Earl Bakken, Co-Founder, Medtronic
2015 – Dr. Thomas Fogarty, Cardiovascular Surgeon, Innovator and Entrepreneur
2016 – John Abele and Pete Nicholas, Co-Founders, Boston Scientific
2017 – John “Jack” Wareham, former Beckman Coulter CEO and Chairman

Vernon “Vern” Loucks answered a "help wanted" ad placed in the Chicago Tribune and in 1966 began employment as the Assistant to the President and CEO (William Graham) of what is now Baxter International. Under Graham's tutelage, Vern quickly rose through the ranks at Baxter; in 1968 he was named VP of International Business; in 1980 he was named CEO and in 1987, Chairman. He retired from Baxter at the end of 1999. Under his leadership, Baxter created exceptional shareholder value and revenues more than quadrupled to nearly $6 billion. He often hired people with little prior industry experience, and he was known for empowering young leaders with total responsibility for the running of business units. His actions often gave encouraged executives confidence to leave Baxter and to build and run companies of their own. He hired and developed so many great young leaders that it was not possible to keep them all.

Vern and Baxter are known for having the most prolific and successful alumni organization in the industry. Among the companies that have been led by veterans of “Vern’s army” are Boston Scientific, Edwards Lifesciences, RTI Surgical, Beckman Coulter, American Medical Systems, Genzyme, Caremark, Allegiance, PharMEDium, Applera, McKesson Corporation, Hill-Rom, Ivenix, GI Dynamics, Lundbeck, PathoGenesis and Ovation Pharmaceuticals, to name a few. Vern has remained active after his Baxter retirement. He is a Co-Founder of Aethena Group and has been its Chairman since 2000. In addition to advising numerous individuals and corporations, Vern has served on the boards of Anheuser-Busch, Emerson, MedAssets and Quaker Oats and as CEO of Segway.
The Advanced Medical Technology Association (AdvaMed) will convene the annual meeting of the medical technology industry in Philadelphia, PA this September 24-26 and bestow its highest honor – The Lif...
08:00 AM - 05:00 PM

Speaker Ready Room Open

09:00 AM - 05:30 PM

MedTech Connect Partnering Open

The MedTech Conference is pleased to offer MedTech Connect – a desktop portal and mobile networking platform for scheduling one-on-one meetings, to all full-access attendees. Users can search for other attendees, request meetings based on mutually agreeable times and build a personalized conference schedule.

MedTech Connect is the premier partnering tool to help maximize business development opportunities for investors, medtech companies, start-ups, academics and other industry stakeholders.

MedTech Connect will launch in summer 2018.
The MedTech Conference is pleased to offer MedTech Connect – a desktop portal and mobile networking platform for scheduling one-on-one meetings, to all full-access attendees. Users can search for othe...
09:00 AM - 07:00 PM

Exhibit Hall Open

09:10 AM - 09:40 AM

Outlook & Prospects for the Mexican MedTech Sector in the AMLO Era

Challenges and opportunities in Mexico’s medtech policy environment. How can industry, regulators and policy-makers work together to promote better access to both advanced and basic technologies while also accounting for the financial sustainability of the Mexican health care system? What should be the health care priorities for the new government and how can the medtech industry contribute to a productive dialogue? What impact could NAFTA negotiations have on medtech policy and business landscape?
Challenges and opportunities in Mexico’s medtech policy environment. How can industry, regulators and policy-makers work together to promote better access to both advanced and basic technologies while...
Speakers
  • Fernando Oliveros, Vice President and General Manager, Mexico, Medtronic (Speaker)
  • Enrique Ruelas, Senior Advisor, Albright Stonebridge Group (Speaker)
  • Antonio Ortiz-Mena, Senior Vice President, Albright Stonebridge Group (Moderator)
09:10 AM - 10:00 AM

The MedTech Innovator Showcase - Health Care IT and Digital Health

MedTech Innovator has selected this year’s 50 most transformative early-stage device, diagnostic and digital health companies. These top 50 companies will be featured at The MedTech Conference in a series of 11 interactive sessions on a special stage in the Exhibit Hall. Each session featured four or five companies under a common technology theme and will highlight their technology and investment opportunity.
MedTech Innovator has selected this year’s 50 most transformative early-stage device, diagnostic and digital health companies. These top 50 companies will be featured at The MedTech Conference in a se...
Speakers
  • Philip Golz, Spire (Speaker)
  • Ankur Gupta, CEO, Spect (Speaker)
  • Bryan Haardt, CEO, Decisio Health (Speaker)
  • See More..
09:15 AM - 09:45 AM

Innovation Transforming Health Care

Long recognized as the special sauce or the gem that stands out and makes AdvaMed’s annual MedTech Conference special,
is our CEOs Unplugged series. Featuring industry leading CEOs and thought leaders, each CEOs Unplugged panel
discusses timely, relevant and valuable topics in an intimate and interactive setting.
This session, the kick-off to our 2018 CEOs Unplugged series, will appropriately address the conference theme of how Innovation
is Transforming Health Care. Innovation is fueling AI, big data and machine learning as well as robotics and enhanced patient
empowerment. At the same time, health systems have adopted value based care and a new paradigm of collaborations has developed between manufacturers, providers, payers and academia. Innovation is truly transforming both health care discovery and health care delivery. This panel will discuss the broad and impactful role innovation is playing in transforming
health care.
Long recognized as the special sauce or the gem that stands out and makes AdvaMed’s annual MedTech Conference special, is our CEOs Unplugged series. Featuring industry leading CEOs and thought leader...
Speakers
  • Rupam Chaudhury, Global Industry Vertical Head, Medical Devices and Pharmaceutical Manufacturing, Tata Consultancy Services (Moderator)
09:15 AM - 10:30 AM

Rethinking the Way FDA Regulates Digital Health Devices: FDA’s Software Precertification Program

The FDA is looking at new and more efficient ways to regulate software-based medical technologies. Learn about how to get involved in the agency’s Pre-Cert program, aimed at tackling how best to assess safety and effectiveness of this growing trend of medical devices without inhibiting patient access. Come join the session to work through topics and provide input to the pre-cert program
The FDA is looking at new and more efficient ways to regulate software-based medical technologies. Learn about how to get involved in the agency’s Pre-Cert program, aimed at tackling how best to asses...
Speakers
  • Bakul Patel, Associate Director for Digital Health, FDA (Speaker)
09:15 AM - 12:15 PM

China Regulatory and Reimbursement Environment

China Regulatory CNDA Session – Era of Transformation
Chaired by Grace Fu Palma, CEO – China Med Device, LLC


9:15 AM
Overview of CFDA Major Restructuring and Updates in 2018 – Complete Product Life Cycle
Key summary updates on major areas of RA/QA:
RA: pathways for foreign companies: innovation, special zones, type testing, legal registration holder vs contract manufacturing, acceptable international reports vs mandated local testing.
QA: QMS and post market compliance changes, overseas inspection: summary of history lessons, tips and process to prepare for overseas inspections.

Grace Fu Palma, CEO, China Med Device, LLC

9:55 AM
Overview of Recent Clinical Requirement Changes and Looking Ahead to 2019
Clinical evidence requirements: clinical trial/evaluation, international clinical data, multi-center trial, etc.

Lindsay Tao, MD, Corporate Director, Global Health Policy, Johnson & Johnson

10:15 AM
Panel Discussion: Lessons Learned and Best Practice in Times of CNDA Transformation

Moderator: Grace Palma, CEO, China Med Device, LLC
Katy Peterson, Manager International Regulatory Affairs, Boston Scientific
Michael Pfleger, VP, Alcon Laboratories, Inc.
Lindsay Tao, MD, Corporate Director, Global Health Policy, Johnson & Johnson
Nicole Taylor Smith, Senior Director, Global Regulatory Affairs Policy and Intelligence Medical Devices, Johnson & Johnson




China Reimbursement & Payment Session – Era of Reform
Stephen Hull, Founder, Hull Associates LLC

11:00 AM
Key Commercial Success Factor: Role of Public Reimbursement System

Grace Fu Palma, CEO, China Med Device, LLC


11:10 AM
China Reimbursement System 101
Basic framework and concepts: new product reimbursement and patient cash pay, Greenbook code role, private insurance etc. What are the different types of reimbursement systems in China?

Stephen Hull, Founder, Hull Associates LLC


11:20 AM
Overview of China Health Care Reimbursement Reform

Yingyao Chen, Professor of Health Services at the School of Public Health, Fudan University (FUSPH), Director of the Key Lab of Health Technology Assessment (National Health Commission) at Fudan University


11:30 AM
Public and Private Reimbursement System and Changes: Relationship between Public Tender and Charge Codes and Reimbursement
Process for manufacturers to work with provincial authorities to support from a new patient charge code to reimbursement code
Relationship between patient charge code/reimbursement

Lynn Jiao, Vice President & China Executive Director, AdvaMed


11:50 AM
Private Hospitals Reimbursement System

Guilin Zhan, MD, Professor and Head of Dept. of International Affair of Huaxia Eye Hospital Group, Xiamen, China


12:00 PM
Panel Discussion - Lessons Learned and Best Practice in Times of China Reimbursement Reform
Moderator: Stephen Hull, Founder, Hull Associates LLC

Yingyao Chen, Professor of Health Services at the School of Public Health, Fudan University (FUSPH), Director of the Key Lab of Health Technology Assessment (National Health Commission) at Fudan University
Lynn Jiao, Vice President & China Executive Director, AdvaMed
Grace Fu Palma, CEO, China Med Device, LLC
Guilin Zhan, MD, Professor and Head of Dept. of International Affair of Huaxia Eye Hospital Group, Xiamen, China
China Regulatory CNDA Session – Era of Transformation Chaired by Grace Fu Palma, CEO – China Med Device, LLC 9:15 AM Overview of CFDA Major Restructuring and Updates in 2018 – Complete Product Life...
Speakers
  • Stephen Hull, Principal, Hull Associates, LLC (Speaker)
  • Lynn Jiao, Vice President & China Executive Director, AdvaMed (Speaker)
  • Katy Peterson, Manager International Regulatory Affairs, Boston Scientific (Speaker)
  • See More..
09:30 AM - 10:00 AM

Home Respiratory Therapy: Getting Patients Access to the Right Device at the Right Time

Panel:
Moderator
• Rolf Benirschke | CEO, Legacy Health Strategies
Speakers
• Erin R Narewski, D.O. | Assistant Professor of Pulmonary and Critical Care Medicine, Lewis Katz School of Medicine at Temple University
• Cindy Gasparo | COPD Patient
• Jamie Sullivan | VP Public Policy, COPD Foundation
• Larissa D’Andrea | Senior Director of Government Affairs, ResMed

Featured Sponsor: ResMed
Panel: Moderator • Rolf Benirschke | CEO, Legacy Health Strategies Speakers • Erin R Narewski, D.O. | Assistant Professor of Pulmonary and Critical Care Medicine, Lewis Katz School of Medicine at Te...
09:45 AM - 11:00 AM

Using Data to Make Your Value Case

The ability to advance your value case can be critical in ensuring provider, patient and caregiver access to your technologies. Learn the role that data can play in this process. A panel of medical technology and data experts will provide helpful insights into their use of various types of data to substantiate their value case to payers and to positively impact coverage and payment determinations.
The ability to advance your value case can be critical in ensuring provider, patient and caregiver access to your technologies. Learn the role that data can play in this process. A panel of medical te...
Speakers
  • Andrew Baker, Senior Director, Health Policy & Reimbursement, Stryker (Speaker)
  • Shayan Bhattacharyya, Director, Strategic Relations, Blue Health Intelligence (Speaker)
  • Mary Jo Braid-Forbes, President, Braid-Forbes Health Research (Speaker)
  • See More..
09:50 AM - 10:20 AM

Health@250

Health@250 is a national research initiative led by A.T. Kearney that explores a range of possible outcomes for the future of US health out to the year 2026, when the nation marks its 250th anniversary. As the United States faces an aging society, spiraling health costs, and a rampant opioid epidemic, the Health@250 report assesses a confluence of demographic, scientific, technological, societal, and business trends that are intersecting in remarkable ways and could radically transform the US health sector as we know it—with specific implications for the medtech industry—over the next decade. An era of innovation is dawning, but while it promises to increase wellness, decrease disease, and set new standards for managing human health and conducting business, multiple challenges need to be overcome to seize these opportunities and secure the brightest possible future. In light of the seven drivers of change identified and explored in the Health@250 report, this gathering of senior executives will examine the accompanying possibilities and risks for medtech.
Health@250 is a national research initiative led by A.T. Kearney that explores a range of possible outcomes for the future of US health out to the year 2026, when the nation marks its 250th anniversar...
Speakers
  • William Tribe, Partner, A.T. Kearney (Speaker)
09:55 AM - 10:35 AM

The Right Health Care the Right Way: Reducing Low-Value Care

Billions of dollars are wasted annually in the United States on “low value” health care services such as unnecessary diagnostic tests, trips to the emergency room, and avoidable surgeries. However, based on research from the Center for Health Solutions, four avenues emerge for reducing low-value care.

• Providing the right care: Curbing services that offer few or no patient benefits
• Delivering care in the right setting: Curtailing unwarranted emergency department utilization
• Delivering care safely: Tackling safety failures
• Providing care in the right way: Rooting out operational inefficiencies

In each of these areas, the effective use of technology can make a difference. Medtech companies have a tremendous role to play in reducing low-value care. A panel of medtech specialists will discuss the opportunity for medtech to help deliver the right care, in the right setting, safely and in the right way.
Billions of dollars are wasted annually in the United States on “low value” health care services such as unnecessary diagnostic tests, trips to the emergency room, and avoidable surgeries. However, ba...
Speakers
  • Nacho Abia, President & CEO, Olympus (Speaker)
  • David Perez, President and CEO, Terumo BCT (Speaker)
  • Dow Wilson, President and Chief Executive Officer, Varian Medical Systems (Speaker)
  • See More..
10:00 AM - 10:20 AM

Top Trends Impacting Commercial Models in 2019

Top Trends Impacting Commercial Models in 2019

Sales and marketing organizations are moving beyond traditional sales representatives and being forced to rethink their commercial models. Those companies that embrace innovative investment strategies can produce sales growth that is 3X the industry average. They’re more agile, investing in new roles and finding new ways to differentiate themselves from the competition.

Join us for an in-depth look at the top trends in key commercial investment areas that can help you plan for 2019 such as:

• Expanding key account management to innovate and differentiate at large accounts
• Deploying software and IT sales specialists to sell connected devices and help hospitals leverage data analytics
• Expanding field marketing to sharpen value propositions and messages
• Deploying lower-paid junior reps to expand field coverage and execute routine (fulfillment) activities while decreasing traditional selling costs

Audience Takeaways
• Practical insights that can be applied within your own organization
• Frameworks and tools to uncover potential opportunities and gaps in your commercial model
• Highlights from the latest research on go-to-customer strategy and industry trends
Top Trends Impacting Commercial Models in 2019 Sales and marketing organizations are moving beyond traditional sales representatives and being forced to rethink their commercial models. Those compan...
Speakers
  • Craig Ackerman, Principal, The Alexander Group (Speaker)
10:00 AM - 10:30 AM

Commercial Operations Journey To Accelerate Product Adoption Through Customer Experience & Insights

KCI, a wound care company committed to advancing the science of healing, “re-wired” US commercial operations to transform to a customer experience and insights driven organization. The transformation journey aims to help commercial teams deliver differentiated, meaningful and unified experiences across the customer journey. The company is making bets in digital engagement and data analytics to create a 360 view of the customer driving micro-targeting, personalization, better continuum of care and value based outcomes for providers and patients.

Join KCI’s Ray Berglund, VP Global Commercial Operations & Digital Customer Infrastructure and Cognizant’s Vyom Bhuta, Global Partner Commercial Life Sciences for a fire side chat.
KCI, a wound care company committed to advancing the science of healing, “re-wired” US commercial operations to transform to a customer experience and insights driven organization. The transformation ...
Speakers
  • Ray Berglund, VP Global Commercial Operations & Digital Customer Infrastructure, KCI an Acelity Company (Speaker)
  • Vyom Bhuta, Global Partner - Commercial Life Sciences, Cognizant (Speaker)
10:00 AM - 10:45 AM

Innovation Pavilion: Perfecting Partnerships

When building a medtech company, investments and partnerships are going to be a key element to your startup success. In today's ever-changing regulatory and financing environment it is becoming increasingly important to engage early in the process. How can you adapt your business strategy to ensure you're setting your company up for fruitful partnerships? How are investors adapting their financing strategies and business models to accommodate new realities and positioning themselves for long-term success? Join a panel of medtech investors and business develop professionals as they discuss their approaches to partnering in medtech.
When building a medtech company, investments and partnerships are going to be a key element to your startup success. In today's ever-changing regulatory and financing environment it is becoming increa...
10:00 AM - 11:15 AM

The Power of Value in Fundraising and Market Adoption

To capture scarce investment capital and the attention of strategic partners, early-stage companies must demonstrate a compelling value proposition backed by clinical data. While this is no small feat in today’s environment, companies that execute a sound regulatory, reimbursement and commercialization strategy are finding the capital and partners to succeed. Learn the keys to success from these experienced executives, investors and strategic partners.
To capture scarce investment capital and the attention of strategic partners, early-stage companies must demonstrate a compelling value proposition backed by clinical data. While this is no small fea...
Speakers
  • Mike Favet, Managing Director - Medical Technologies, KCK (Speaker)
  • Tom Gordon, Managing Director, Silicon Valley Bank (Speaker)
  • Fred McCoy, President and CEO, NeuroTronik Limited, NeuroTronik, Inc. (Speaker)
  • See More..
10:05 AM - 10:45 AM

The MedTech Innovator Showcase - Point of Care

MedTech Innovator has selected this year’s 50 most transformative early-stage device, diagnostic and digital health companies. These top 50 companies will be featured at The MedTech Conference in a series of 11 interactive sessions on a special stage in the Exhibit Hall. Each session featured four or five companies under a common technology theme and will highlight their technology and investment opportunity.
MedTech Innovator has selected this year’s 50 most transformative early-stage device, diagnostic and digital health companies. These top 50 companies will be featured at The MedTech Conference in a se...
Speakers
  • Benjamin Casavant, Co-Founder, Tasso (Speaker)
  • Matt Mayer, CEO, Footbeat (Speaker)
  • Vivek Ramakrishnan, President, AxioSonic (Speaker)
  • See More..
10:30 AM - 11:00 AM

Commercial Operations Journey to Accelerate Product Adoption Through Customer Experience & Insights

KCI, a wound care company committed to advancing the science of healing, “re-wired” US commercial operations to transform to a customer experience and insights driven organization. The transformation journey aims to help commercial teams deliver differentiated, meaningful and unified experiences across the customer journey. The company is making bets in digital engagement and data analytics to create a 360 view of the customer driving micro-targeting, personalization, better continuum of care and value based outcomes for providers and patients.
KCI, a wound care company committed to advancing the science of healing, “re-wired” US commercial operations to transform to a customer experience and insights driven organization. The transformation ...
Speakers
  • Vyom Bhuta, Global Partner - Commercial Life Sciences, Cognizant (Speaker)
10:30 AM - 11:00 AM

Women in Orthopedic/Surgical Meetup

Join women leaders in the orthopedic and surgical sectors to discuss emerging technological trends and the future of orthopedic treatment therapies and surgical tools. Network with your peers and discuss the current investment climate and what innovative companies, big and small, can expect in the coming years.

2018 Host: Yin Becker, VP Communications and Public Affairs, Stryker
Join women leaders in the orthopedic and surgical sectors to discuss emerging technological trends and the future of orthopedic treatment therapies and surgical tools. Network with your peers and dis...
10:30 AM - 11:00 AM

Why does Pt Engagement matter – A Patient’s Perspective

Featured Sponsor: Abiomed

Panel:
Moderator
• Rolf Benirschke | CEO, Legacy Health Strategies
Speakers
• Melissa Schooley, Senior Director, Government Affairs, Abiomed
• Shannon Russell, Patient Advocate Manager, Abiomed
• Joella Bobak, Patient Advocate for Abiomed
Featured Sponsor: Abiomed Panel: Moderator • Rolf Benirschke | CEO, Legacy Health Strategies Speakers • Melissa Schooley, Senior Director, Government Affairs, Abiomed • Shannon Russell, Patient Adv...
10:30 AM - 11:00 AM

10:30 AM - 11:30 AM

Digital Health is Here. What’s Next?

As new technologies emerge and the ability to leverage large quantities of data continues to advance, the delivery of health care and population management are benefiting in profound ways. Hear from experts that are driving this transformation about their views and insights into what the future of digital health holds.
As new technologies emerge and the ability to leverage large quantities of data continues to advance, the delivery of health care and population management are benefiting in profound ways. Hear from e...
Speakers
  • Joseph DeVivo, CEO, InTouch Health (Speaker)
  • Harsh Dharwad, VP and CTO, Nihon Kohden America (Speaker)
  • Mick Farrell, CEO, ResMed (Moderator)
10:45 AM - 11:30 AM

The Medtech Solutions Buzz: How Real Is It?

Many leaders in the medtech industry often talk about transitioning from “products” to “solutions.” Although this evolution generically makes sense (particularly as more digitally connected products enable more holistic ways to treat medical conditions), there is wide uncertainty about what this transformation actually means for the industry or for individual companies. Are we just talking about a marketing play or a fundamental business model shift? What exactly are the types of “solutions” to be developing and how does it vary by market segment? When is it time to aggressively invest in “solutions”? How will pricing models evolve and where will outcome-based pricing likely proliferate as an enabling trend? How do large medtechs scale advantage in offering “solutions” impact small
and mid-sized players? Despite the buzz about solutions, the lack of clear case examples or success stories makes it particularly difficult for industry executives to know whether to aggressively move forward in investing in solutions, let alone what solution to build and when to do so. This session will discuss the case examples and learnings from several leading industry executives on tackling the “solutions buzz”, including how to define “winning” solutions as well as predictions on their future role in the industry.
Many leaders in the medtech industry often talk about transitioning from “products” to “solutions.” Although this evolution generically makes sense (particularly as more digitally connected products e...
Speakers
  • Jonas Funk, Managing Director, L.E.K. Consulting (Moderator)
10:45 AM - 12:15 PM

Inspection Evolution: FDARA, Program Alignment and Beyond

The inspection landscape is experiencing a major shift. FDARA section 702 gives firms advance notice of the type and timing of inspections and FDA feedback on the steps firms take to address inspection findings. Program Alignment creates a device-specific inspection cadre with aligned direction from CDRH and ORA. And FDA’s push towards global harmonization now includes replacement of 21 CFR Part 820 with ISO 13485:2016. Against this dynamic backdrop, attendees will learn:
o How FDA is operationalizing new inspection requirements in FDARA section 702
o How Program Alignment is driving investigator expertise and a unified CDRH-ORA inspection strategy
o How FDA is moving towards adoption of ISO 13485:2016 and the impact on device quality inspections
o How MDSAP provides a model for an internationally-harmonized approach to premarket and postmarket device oversight
o How quality is increasingly replacing compliance as FDA’s metric for manufacturer performance
The inspection landscape is experiencing a major shift. FDARA section 702 gives firms advance notice of the type and timing of inspections and FDA feedback on the steps firms take to address inspecti...
Speakers
  • Gina Brackett, Director, Compliance Branch, Office of Medical Device & Radiological Health Operations, Division 1/East, FDA (Speaker)
  • Arduino Frankovic, Director of Investigations Branch, Medical Device and Radiological Health Operations/Division 1-East, Office of Regulatory Affairs, FDA (Speaker)
  • William Maisel, FDA (Speaker)
  • See More..
10:50 AM - 11:30 AM

The MedTech Innovator Showcase - Respiratory Supportive Care

MedTech Innovator has selected this year’s 50 most transformative early-stage device, diagnostic and digital health companies. These top 50 companies will be featured at The MedTech Conference in a series of 11 interactive sessions on a special stage in the Exhibit Hall. Each session featured four or five companies under a common technology theme and will highlight their technology and investment opportunity.
MedTech Innovator has selected this year’s 50 most transformative early-stage device, diagnostic and digital health companies. These top 50 companies will be featured at The MedTech Conference in a se...
Speakers
  • Ken Bernstein, Founder & CEO, Pneumonics, Inc. (Speaker)
  • Nick Delmonico, Co-Founder, Strados Labs (Speaker)
  • Doug Evans, CEO, LungPacer (Speaker)
  • See More..
11:00 AM - 11:20 AM

Human Factors Testing- Streamlining the Iterative Re-design Process

What happens when you perform Human Factors Testing on your medical device and you need to improve the User Interface design?
I bet many of you have run into typical challenges when collaborating with either graphic designers or software developers when faced with this task.
Software Developers often see designs evolve in an ivory tower and then land on their desks as long and detailed PDFs with UI specifications. Most of the time, matching the UI specifications with what can be achieved on the target hardware is dubious and time-consuming.
Graphic Designers, on the other hand, are mostly concerned about coming up with the best design they can think of. What’s possible in reality can be hard for them to fathom until they see their designs come to life on the actual device.
The real problem, however, is that this inefficient way of working causes the end user to pay the ultimate price in worse overall user experience. Collaboration between designers and developers in an effective workflow fosters and boosts product innovation and ultimately leads to a better user experience.
During this showcase, learn what solutions are readily available to streamline the iterative re-design process when performing your Human Factors Testing.
What happens when you perform Human Factors Testing on your medical device and you need to improve the User Interface design? I bet many of you have run into typical challenges when collaborating wi...
Speakers
  • Roger Mazzella, Senior Product Manager, Medical, The Qt Company (Speaker)
  • Petref Saraci, Product Manager, The Qt Company (Speaker)
11:00 AM - 11:45 AM

Innovation Pavilion: HealthTech @ JLABS

At JLABS, we help entrepreneurs, scientists and now technologists navigate the trenches of being a startup in an industry dominated by large corporations by offering expertise, access and infrastructure through a no-strings-attached model. In this session, Kate Merton, Head of JLABS @ NYC and Boston, will discuss the key challenges HealthTech entrepreneurs face, and how the new HealthTech @ JLABS program will provide access to Johnson & Johnson Innovation's unparalleled healthcare expertise and call upon our key technology partners to provide unique insights on consumer, payer and provider pain points and the solutions they are seeking.
At JLABS, we help entrepreneurs, scientists and now technologists navigate the trenches of being a startup in an industry dominated by large corporations by offering expertise, access and infrastructu...
11:10 AM - 11:40 AM

MedTech Partnerships – Avoiding Pitfalls When Working With Pharma, Providers and Tech

Medical device companies are increasingly finding scenarios to partner with entities outside of the device space. In addition, precision medicine and advancements in drug delivery technologies present a multitude of opportunities to partner with pharmaceutical companies. While these new developments are exciting, they present numerous challenges and raise the stakes in collaborations and partnerships. To complicate matters, advancements in digital health are blurring the lines between the tech and medical device industries. How can device companies avoid some of the common and not so common pitfalls in working with companies from different industries? Join us for an interactive, informative and thought provoking session which will guide you through the web of issues of a medtech partnership and make it work in your favor.
Medical device companies are increasingly finding scenarios to partner with entities outside of the device space. In addition, precision medicine and advancements in drug delivery technologies presen...
Speakers
  • Michele Buenafe, Partner, Morgan Lewis (Speaker)
  • Kathleen McDermott, Partner, Morgan Lewis (Speaker)
11:15 AM - 12:15 PM

Telling of Tales: Personal Insights from Successful and Serial Entrepreneurs

Does it get easier with time? Is experience worth its weight in gold? How do you learn from mistakes and not just survive but thrive in doing so? In an industry full of sophisticated and complex medical technologies, achieving success requires great leadership, vision, grit and determination. Success also requires ingenuity as well as common sense, curiosity with the proper mix of practicality, and the discipline to know the difference between what is necessary vs. what is interesting. Panelists will share their thoughts, strategies, visions, experiences and perhaps even a few secrets from their successful medical technology/life science career paths. This panel includes an experienced private equity banker with multiple successes in building market-leading companies in the healthcare industry, an entrepreneurial leader turned venture capitalist known for building and growing high-quality life science companies and the co-founder of Kensey Nash Corporation (now DSM) a company recognized for its willingness to try new ideas and the persistence to stay focused and driven.
Does it get easier with time? Is experience worth its weight in gold? How do you learn from mistakes and not just survive but thrive in doing so? In an industry full of sophisticated and complex me...
Speakers
  • Jane Hollingsworth, Managing Partner, Militia Hill Ventures (Speaker)
  • John Nash, Co-founder, Kensey Nash Corp (Speaker)
  • Bernie Rudnick, Managing Partner, CapGenic Advisors (Speaker)
  • See More..
11:30 AM - 12:00 PM

Women in Cardiovascular Meetup

Join women leaders in the cardiovascular sector to discuss emerging technological trends and the future of cardiovascular treatment therapies, diagnostics and services. Network with your peers and discuss the current investment climate and what innovative companies, big and small, can expect in the coming years.
Join women leaders in the cardiovascular sector to discuss emerging technological trends and the future of cardiovascular treatment therapies, diagnostics and services. Network with your peers and dis...
11:30 AM - 12:00 PM

How Innovation Changes Lives

Featured Sponsors: Operation Smile (Johnson and Johnson) and Varian

Panel:
Moderator:
• Rolf Benirschke | CEO, Legacy Health Strategies
Speakers
• Jordon Swanson, Operation Smile
• Jack Weber, Patient Advocate for Varian
Featured Sponsors: Operation Smile (Johnson and Johnson) and Varian Panel: Moderator: • Rolf Benirschke | CEO, Legacy Health Strategies Speakers • Jordon Swanson, Operation Smile • Jack Weber, Patie...
11:30 AM - 12:30 PM

Much Ado About Brexit - A Conversation with UK Health Minister Lord O'Shaughnessy on the Future of Health Care in the UK

The UK will leave the European Union on March 29th, 2019 and the UK government is working closely with the medical technology industry to ensure a smooth transition. In parallel, the UK is investing to strengthen its position as the home of health innovation – including an increase to the government R&D budget of $100 billion over 10 years.

Join this event to learn:
• what happens when the UK exits the EU
• what businesses need to do to prepare
• what we are likely to see in the upcoming 10-year plan for the UK’s National Health Service, which serves 60 million people and is building novel partnerships with industry
• how the UK is investing to support early diagnosis, healthy aging, and artificial intelligence (AI)
• how medtech innovators can work with the NHS to co-design the future of health care in the UK
The UK will leave the European Union on March 29th, 2019 and the UK government is working closely with the medical technology industry to ensure a smooth transition. In parallel, the UK is investing t...
Speakers
  • Lord O'Shaughnessy, Parliamentary Under Secretary of State for Health, Department of Health (UK) (Speaker)
11:35 AM - 12:25 PM

The MedTech Innovator Showcase - Orthopedics

MedTech Innovator has selected this year’s 50 most transformative early-stage device, diagnostic and digital health companies. These top 50 companies will be featured at The MedTech Conference in a series of 11 interactive sessions on a special stage in the Exhibit Hall. Each session featured four or five companies under a common technology theme and will highlight their technology and investment opportunity.
MedTech Innovator has selected this year’s 50 most transformative early-stage device, diagnostic and digital health companies. These top 50 companies will be featured at The MedTech Conference in a se...
Speakers
  • Charles Allan, CEO, MY01 (Speaker)
  • Zack Eberwein, Co-Founder & CEO, Embrace Orthopaedics (Speaker)
  • Michelle Laflamme, CEO, Emovi (Speaker)
  • See More..
11:40 AM - 12:25 PM

Establishing An Innovative, Ethical and Winning Culture

As our industry continues to create innovations that are transforming health care, we are doing so in an environment that is experiencing constant change, seeing new standards, adopting to new regulations and facing growing global competition. Establishing and maintaining the right culture may be the one most important and steady factor that determines success. In this session with some of our industry’s most respected executives, we will ask what they do to foster and promote innovation while operating to high ethical standards and achieving successful bottom-line financials. How do leaders influence the people within their organization so that the right decisions are made, employees respond properly to challenges, pressures and change.


Your corporate culture sets standards for what is good and bad, acceptable and unacceptable, and culture determines what will be incentivized, rewarded and encouraged and what is to be discouraged, prohibited and even punished. A good culture proliferates an entire organization and these executives have the added challenge of leading multi-national organizations/business units. This will not a debate between strategy and culture, but an engaging and lively discussion among executives that oversee innovative market leaders, bringing life-changing innovations to patients in an ethical, responsible and successful manner.
As our industry continues to create innovations that are transforming health care, we are doing so in an environment that is experiencing constant change, seeing new standards, adopting to new regulat...
Speakers
  • Denny Durmis, VP, Head of Region Americas - Radiology and Interventional, Bayer Healthcare (Speaker)
  • Caroll Neubauer, Chairman and CEO, B. Braun Medical Inc. (Speaker)
  • David Pacitti, President and CEO North America, Siemens Healthineers (Speaker)
11:50 AM - 12:20 PM

Convergence of Technologies and Consumer Focus Inspires New Models of Innovation

Patients, more than ever, expect their interaction with medical products to be easy and intuitive. The role that those factors play in compliance and adoption is significant. MedTech companies are expertly focused on finding therapeutic options to clinical problems. But they are not typically experts in connectivity technologies, or in emerging sensor development for example. Co-locating clinical expertise and technology expertise can enable innovation beyond traditional limitations. John Carlson and Mark Michels share their experiences in the journey that Philips and Flex have taken together in innovation, and the impact it has had on a product recently launched, and on how Philips thinks about Innovation.

John Carlson, President, Flex Health Solutions
Mark Michels, Business Leader, Health Sleep Solutions, Philips Respironics
Patients, more than ever, expect their interaction with medical products to be easy and intuitive. The role that those factors play in compliance and adoption is significant. MedTech companies are e...
Speakers
  • John Carlson, Flex (Speaker)
  • Mark Michels, Business Leader, Healthy Sleep Solutions, Philips Respironics (Speaker)
12:00 PM - 12:20 PM

MedTech on the Cloud Frontier: How the Rapidly Changing Industry is Demanding a Solution that can Support the Pace, Unpredictability and Increasing Demands

The rapid transformation of the medical device industry from new regulatory requirements, navigating complex global supply chains, capturing clinical information, to managing risk is making an organization’s ability to respond and adapt is critical. Modern systems must provide greater visibility between functional areas which can help reduce operational overhead, improve internal processes, and enable greater compliance – without sacrificing day-to-day performance.

Join us to explore a holistic approach to improving clinical, quality, and commercial processes across an organization.

Attendees will have the opportunity to learn through this hybrid presentation of discussion and demo about:

• The measurable impact of today’s fragmented solutions
• How unifying systems across functional areas provides value and quality, without limiting features and functionality
• The opportunity to gain real-time visibility into documents and processes

Presenters:
• Melonie Warfel, Vice President Medical Devices & Diagnostics, Veeva Systems
• Richard Chu, Solution Consultant, Medical Devices & Diagnostics, Veeva Systems
The rapid transformation of the medical device industry from new regulatory requirements, navigating complex global supply chains, capturing clinical information, to managing risk is making an organiz...
12:30 PM - 02:00 PM

Plenary Lunch

Innovative payers, providers and industry are transforming how health care will be delivered in the decades to come. Join us for a thought-provoking discussion on the need for collaborative
business models and the challenges we face collectively. AdvaMed’s CEO, Scott Whitaker, will also deliver a State of the Industry address
Innovative payers, providers and industry are transforming how health care will be delivered in the decades to come. Join us for a thought-provoking discussion on the need for collaborative business m...
02:10 PM - 02:40 PM

Top 4 Prediction for Global Medical Devices Industry in 2019

This session will cover the top 4 predictions that will impact the medical technology industry in 2019 and what different stakeholders in the ecosystem need to be aware of to plan for success.

Frost & Sullivan reveals the top 4 predictions to be as follows:

1. Patient at the Core of Innovation: 25% of top companies and 45% of start-ups are exploring patient care gaps across care continuum to develop new devices to address the unmet needs.
2. Artificial Intelligence in mainstream clinician-patient interaction- from hand-held, home care devices to diagnostic and surgical solutions:AI solutions will be involved in diagnosis and treatment of non-chronic diseases to drive better health for all individuals, not just patients.
3. Servitization will be key for Top-line growth of Medtech Giants: around 80% of the top 25 medical device companies would have expanded their service portfolio to support top-line growth in mature segments.
4. Are GAFA the new medical device companies? Which are the implications for the different industry stakeholder?: The launch of new business models, partnerships, devices, and surgical solutions by Google, Apple, Facebook and Amazon (GAFA) will change the dynamics of the conventional medical device treatment world.

Key benefits of attending this session:
• Discover the shift in focus from clinician to patients, from products to services, and from product differentiation to disruptive innovation that are new for the medical device industry.
• Learn the market opportunity arising from the top four predictions.
• Find out investment trends by starts ups, portfolio expansion trends by R&D.
• Explore partnerships and acquisitions of the Medtech giants.

The panel discussion will focus on:
• Market trends for the new devices, services, solutions and business models.
• Difficulty from design to market and solutions to overcome.
• Adoption trends from health systems.
This session will cover the top 4 predictions that will impact the medical technology industry in 2019 and what different stakeholders in the ecosystem need to be aware of to plan for success. Frost ...
Speakers
  • Reenita Das, Frost & Sullivan (Moderator)
02:10 PM - 02:45 PM

Leadership Views on Diagnostics

CEOs of leading diagnostics companies from the AdvaMedDx Board of Directors share perspectives on the opportunities they see for future innovation and growth in the field and the policy and market changes that must be altered or embraced to ensure advancement.
CEOs of leading diagnostics companies from the AdvaMedDx Board of Directors share perspectives on the opportunities they see for future innovation and growth in the field and the policy and market cha...
Speakers
  • Ramon Benet, Chief Executive Officer, Instrumentation Laboratory (IL) (Speaker)
  • Matthew McManus, President & CEO, Asuragen (Speaker)
  • Norman Schwartz, Chairman of the Board, President and Chief Executive Officer, Bio-Rad (Speaker)
  • See More..
02:10 PM - 02:50 PM

The MedTech Innovator Showcase - Oncology

MedTech Innovator has selected this year’s 50 most transformative early-stage device, diagnostic and digital health companies. These top 50 companies will be featured at The MedTech Conference in a series of 11 interactive sessions on a special stage in the Exhibit Hall. Each session featured four or five companies under a common technology theme and will highlight their technology and investment opportunity.
MedTech Innovator has selected this year’s 50 most transformative early-stage device, diagnostic and digital health companies. These top 50 companies will be featured at The MedTech Conference in a se...
Speakers
  • Liberty Foreman, CEO, BeamLine Diagnostics (Speaker)
  • Christopher Kent, President & CEO, ODS Medical (Speaker)
  • Matthew Likens, President & CEO, GT Medical Technologies (Speaker)
  • See More..
02:15 PM - 02:45 PM

Listening to the Voice of the Patient

Featured Sponsor: Legacy Health Strategies and B. Braun Medical

Panel:
Moderator
• Rolf Benirschke | CEO, Legacy Health Strategies
Speakers
• Jeff Straton
• Julie Bauer
• Paula Toth
Featured Sponsor: Legacy Health Strategies and B. Braun Medical Panel: Moderator • Rolf Benirschke | CEO, Legacy Health Strategies Speakers • Jeff Straton • Julie Bauer • Paula Toth
02:15 PM - 03:00 PM

Innovation Pavilion: This Little Med Device Goes to Market: The Changing World of Evidence

Michelle McMurry-Heath, WW Vice President Global Regulatory Affairs and International Clinical Evidence (GRACE)

Beyond the challenges associated with gaining regulatory approval, there are hurdles to overcome as you enter the real world with your innovation. Many of these challenges can be addressed through understanding the non-clinical as well as clinical situation and building integrated plans to quantify and communicate the value of your solution with evidence, drive market access, reimbursement and adoption.
Michelle McMurry-Heath, WW Vice President Global Regulatory Affairs and International Clinical Evidence (GRACE) Beyond the challenges associated with gaining regulatory approval, there are hurdles to...
Speakers
  • Michelle McMurry-Heath, WW Vice President Regulatory and Clinical Affairs, Johnson & Johnson (Speaker)
02:15 PM - 03:15 PM

Non-Dilutive Government Funding Meetup

All small and emerging companies are invited to learn about government funding opportunities and interact with NIH SBIR Program Officers and DOD military program health care experts.

GUESTS:
Christine L. Densmore, MS, Director, SBIR/STTR Programs, Director, Training and Fellowship Programs, Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases

Stephanie Fertig, MBA, Director, NINDS Small Business Programs, National Institute of Neurological Disorders and Stroke

Dave Hood, President and CEO, DH3 & Associates, Former Senior Advisor to Principal Assistant for Acquisition US Army MRMC, Former Co-Founder and President of IMS (Co-inventor of Product Line)

William (Bill) Howell, Chief Operating Officer, Medical Technology Enterprise Consortium (MTEC), Former Principal Assistant for Acquisition, US Army Medical Research and Material Command

Todd Merchak, Program Specialist, Office of Program Evaluation and Strategic Partnerships, National Institute of Biomedical Imaging and Bioengineering, National
Institutes of Health, DHHS

Deepa Narayanan, Program Director, National Cancer Institute, SBIR Development Center

Ashim Subedee, PhD, Program Director, NCI Small Business Innovation Research (SBIR) Development Center
All small and emerging companies are invited to learn about government funding opportunities and interact with NIH SBIR Program Officers and DOD military program health care experts. GUESTS: Christin...
02:15 PM - 03:30 PM

MedTech Innovation: Driving the Next Frontier of Competitiveness through R&D Transformation

Increasing competitive and cost pressures, policy changes, and the shift to value-based care are all impacting how medtech companies invest in R&D and make new product development decisions. Incremental improvements are no longer enough. New data-enabled and technological platforms are becoming increasingly important as well as the need for evidence- based metrics in an industry focused on value. Learn about early findings from a survey sponsored by AdvaMed & Deloitte on how companies are transforming their R&D engines.
In this session:
• Find out what Medtech companies view as their top strategic priorities and R&D challenges over the next 3 - 5 years
• Learn how the market shift to value-based care is impacting innovation decisions and R&D operations
• Explore which policy and regulatory areas have the most influence on new product development
• Discover how medtech companies allocate R&D investments across core innovation versus transformational innovation
• Learn which sources of innovation medtech companies view as most effective and how that impacts investment decisions
Increasing competitive and cost pressures, policy changes, and the shift to value-based care are all impacting how medtech companies invest in R&D and make new product development decisions. Increment...
Speakers
  • Eric Agdeppa, Director of Innovation, Hill-Rom (Speaker)
  • Joe DuPay, Sr. Vice President, R&D and Operations, CVRx (Speaker)
  • Bill Murray, Medical Device Specialist Leader, Deloitte (Moderator)
02:15 PM - 03:30 PM

Critical Decisions On the Road from Concept to Commercialization

The road to commercialization is paved with good intentions, but like life - it’s a road full of potholes and for medical technology innovations these include compliance, development, regulatory and other challenges. Entrepreneurs are not always prepared for the reality of the challenges encountered along this difficult and complicated pathway that includes development, preclinical and clinical, trials, regulatory, quality, scaling, production, compliance and other matters. This panel includes a world-renowned cardiovascular surgeon that is a serial inventor with more than 90 US granted or pending patents; A board-certified anesthesiologist and intensive care specialist with more than 25 years of healthcare experience in global environments and preclinical and clinical development, regulatory, quality and patient safety; the leader of an organization dedicated to enabling entrepreneurs and organizations successfully deploy medical technology products in the world; and a legal expert that has focused her practice on the intersection of technology, regulation and healthcare and been involved in medical technology for over 25 years. We will discuss the most critical decisions faced in taking a product from concept to commercialization.
The road to commercialization is paved with good intentions, but like life - it’s a road full of potholes and for medical technology innovations these include compliance, development, regulatory and o...
Speakers
  • Randy Barko, President and CEO, Ximedica (Speaker)
  • Billy Cohn, VP, Medical Devices and Executive Director, CDI @ TMC, Johnson & Johnson (Speaker)
  • Marcus Schabacker, President & Chief Executive Officer, ECRI Institute (Speaker)
  • See More..
02:15 PM - 03:45 PM

FDA and Industry Outside the Regulatory Box

The medical technology industry continues to evolve at a rapid pace. New technologies such as digital health and 3-D printing, taken with FDA’s growing focus on firms’ quality culture, require new regulatory approaches. In response, FDA has launched a set of innovative programs that break from conventional medical device review and oversight. These programs offer the promise of streamlined approaches that promote the introduction, improvement, and distribution of devices from manufacturers that know and show strong quality practices. This session will highlight these FDA programs and consider how they might progress from pilots to permanent initiatives, and how FDA will develop new approaches to support innovation and good quality practice.
The medical technology industry continues to evolve at a rapid pace. New technologies such as digital health and 3-D printing, taken with FDA’s growing focus on firms’ quality culture, require new reg...
Speakers
  • Stephanie Christopher, Program Director, CfQ & SPI, Medical Device Innovation Consortium (MDIC) (Speaker)
  • Diane Johnson, Johnson & Johnson (Speaker)
  • Bakul Patel, Associate Director for Digital Health, FDA (Speaker)
  • See More..
02:30 PM - 03:45 PM

Is Trump Trade Policy Shaking Up or Breaking Up the Global Trading System?

This panel will bring together three trade experts and a moderator, all of whom held key positions in the Office of the United States Trade Representative. In an informal conversation, they will provide a foundation to understand the current international trading system and address the panel’s title from various perspectives. You will be the judge of the impact of the President’s policies.
This panel will bring together three trade experts and a moderator, all of whom held key positions in the Office of the United States Trade Representative. In an informal conversation, they will prov...
Speakers
  • Elizabeth Baltzan, Principal, American Phoenix Trade Advisory Services PLLC (Speaker)
  • Claire Reade, Senior Counsel, Arnold & Porter (Speaker)
  • Barbara Weisel, Managing Director, Rock Creek Global Advisors (Speaker)
  • See More..
02:30 PM - 03:45 PM

CMS Town Hall

We are pleased to announce that we will be holding a CMS Town Hall session again at The
MedTech Conference, featuring representatives from the Centers for Medicare and Medicaid
Services (CMS). Senior CMS leaders will participate in an open Q&A session covering
developments pertaining to medical technologies including Medicare coverage, new payment
models and patient access to new technologies.
We are pleased to announce that we will be holding a CMS Town Hall session again at The MedTech Conference, featuring representatives from the Centers for Medicare and Medicaid Services (CMS). Senior ...
Speakers
  • Amy Bassano, Deputy Director, Center for Medicare and Medicaid Innovation, CMS (Speaker)
  • Carol Blackford, Director, Hospital and Ambulatory Policy Group, CMS (Speaker)
  • Tamara Syrek Jensen, Director, Coverage and Analysis Grou, CMS (Speaker)
  • See More..
02:50 PM - 03:20 PM

Quality as a Driver of Innovation

One of the top priorities for FDA's medical devices center is a focus on quality. Launched in 2011, the FDA Case for Quality initiative is working with industry stakeholders recognize regulatory compliance as a baseline and promote manufacturers' implementation of critical-to-quality practices during device design and production to improve product quality and patient safety. From a CEO perspective, Quality can become the front end driver of innovation and brand differentiation as well as increasing operational efficiency and effectiveness positively impacting profitability. This session will explore executives’ experiences and insights from their company’s quality journey as well as their own personal careers.
One of the top priorities for FDA's medical devices center is a focus on quality. Launched in 2011, the FDA Case for Quality initiative is working with industry stakeholders recognize regulatory compl...
Speakers
  • Peter Arduini, President and Chief Executive Officer, Integra Life Sciences (Speaker)
  • George Serafin, National Managing Principal, Healthcare and Life Sciences, Grant Thornton (Moderator)
02:50 PM - 03:20 PM

Servitization - Path to Higher Revenues, Enhance Customer Experience and Improved Bottom Line

The fascinating world of IoT has transformed the concept of a product.

Device manufacturers aren’t just building products but integrating their product lines with a portfolio of product-centric services. This integrated, holistic approach is called ‘servitization’.

How does servitization benefit device OEMs? Higher Customer Retention, New Revenue Models, Operational Excellence and the ability to control the entire supply chain for a product.

That said, servitization is a journey that begins at the product concept stage and needs in-depth deliberation at each stage of the development life-cycle.

Join us for an insightful session with leading industry experts who have architected & implemented servitization in the medical world.

Servitization is the future of connected healthcare and it is here to stay!
The fascinating world of IoT has transformed the concept of a product. Device manufacturers aren’t just building products but integrating their product lines with a portfolio of product-centric serv...
Speakers
  • Umesh Satyanarayana, Area Vice President, L&T Technology Services Limited (Speaker)
02:55 PM - 03:45 PM

The MedTech Innovator Showcase - Interventional Cardiology

MedTech Innovator has selected this year’s 50 most transformative early-stage device, diagnostic and digital health companies. These top 50 companies will be featured at The MedTech Conference in a series of 11 interactive sessions on a special stage in the Exhibit Hall. Each session featured four or five companies under a common technology theme and will highlight their technology and investment opportunity.
MedTech Innovator has selected this year’s 50 most transformative early-stage device, diagnostic and digital health companies. These top 50 companies will be featured at The MedTech Conference in a se...
Speakers
  • Francis Bellido, CEO, Soundbite Medical Solutions (Speaker)
  • James Corbett, CEO, CathWorks (Speaker)
  • Stefano Picone, Director of Finance, Conavi Medical (Speaker)
  • See More..
03:00 PM - 03:20 PM

Humans vs. AI: Who Will Drive Commercial Growth in Medtech?

AI and machine learning are being applied across different industries to inform and enhance all areas of customer insight and engagement. Many advanced analytical models on cross-sell and upsell, customer churn and customer journey, loyalty and next-best actions have become table stakes across industries as diverse as retail, transportation and hospitality, yet medtech companies are still mostly relying on rep relationships as the driving force of commercial success. Many still haven’t made any significant steps toward predictive analytics. Panelists will discuss their challenges and success with adopting advanced analytics to drive commercial success.
AI and machine learning are being applied across different industries to inform and enhance all areas of customer insight and engagement. Many advanced analytical models on cross-sell and upsell, cust...
Speakers
  • Maria Kliatchko, Principal, ZS Associates (Speaker)
03:15 PM - 04:00 PM

Innovation Pavilion: Philadelphia Area Innovation Ecosystem Panel

The Philadelphia innovation ecosystem is getting the love it finally deserves. With over $1.5B in venture funding invested in over 361 companies in the Greater Philadelphia region since 2013, and the recent announcement of the Johnson & Johnson Innovation, JPOD @ Philadelphia in partnership with Pennovation, the City of Brotherly Love has transitioned into a true innovation powerhouse. In this session, listen to local innovation leaders and experts discuss the growth, investment, and technologies that are driving Philadelphia innovation forward.
The Philadelphia innovation ecosystem is getting the love it finally deserves. With over $1.5B in venture funding invested in over 361 companies in the Greater Philadelphia region since 2013, and the ...
03:25 PM - 03:55 PM

Thinking About Taking Your Company Public? Raising Equity in the Current Environment

Taking a company public can be a great way to raise additional capital, but such a decision requires careful consideration. With the IPO market warming up, you can’t afford to miss hearing from this dynamic group of industry leaders addressing their experiences with running public companies - and taking companies public. Join us to hear these great lessons learned, regardless of your capital formation strategy.

Presented by the Women’s Executive Network
Taking a company public can be a great way to raise additional capital, but such a decision requires careful consideration. With the IPO market warming up, you can’t afford to miss hearing from this ...
Speakers
  • Mark Augusti, President & CEO, Conformis (Speaker)
  • Lisa Earnhardt, President & CEO, Intersect ENT (Speaker)
  • Lena Soderstrom, CEO, Senzime (Speaker)
  • See More..
03:30 PM - 04:00 PM

Are There Gender Differences in the Way People Sell, Manage or Lead?

A 10-year study sponsored by Sales Research Group Inc. sheds light on this very old but very current topic.
With more than 10,000 data points collected from both large and small companies, this discussion explores personality similarities and differences that affect performance.
This presentation is a must for executives who want to capitalize on a more diverse workplace.
The presentation will be led by Benson F. Smith, who has extensive experience in the medical device industry, serving as President and COO of C.R. Bard, and then President, CEO and Chairman of Teleflex.
Mr. Smith has also served as an author and speaker on this topic. He co-authored the best-selling "Discover Your Sales Strengths" book and has had more than 50 articles published while he was the head of Gallup's sales force effectiveness practice.
A 10-year study sponsored by Sales Research Group Inc. sheds light on this very old but very current topic. With more than 10,000 data points collected from both large and small companies, this discu...
Speakers
  • Benson Smith, Chairman, Teleflex Incorporated (Speaker)
03:30 PM - 04:00 PM

04:00 PM - 05:30 PM

Afternoon Plenary: MedTech Innovator Finals

The MedTech Conference is excited to welcome MedTech Innovator back to the plenary stage on the afternoon of Tuesday, September 25. Four finalist companies from the MedTech Innovator competition will present to a panel of industry–leading judges and compete for the audience vote to win $500,000 in prizes and the award of MedTech Innovator 2018!
MedTech Innovator is the industry’s nonprofit global competition and accelerator for medical device, digital health and diagnostic companies. Its mission is to improve the lives of patients by accelerating the growth of companies that are transforming the health care system. In 2018, MedTech Innovator, with the support of its partners and sponsors, will give out $500,000 in cash prizes, scholarships and in–kind awards.
The MedTech Conference and AdvaMed Accel are proud to partner with MedTech Innovator for the fourth consecutive year.
The MedTech Conference is excited to welcome MedTech Innovator back to the plenary stage on the afternoon of Tuesday, September 25. Four finalist companies from the MedTech Innovator competition will ...
Speakers
  • Paul Grand, CEO, MedTech Innovator (Host)
  • Linda Elkins, Chief Technical Officer, Gore Innovation Center, W. L. Gore & Associates (Judge)
  • Jennifer Kozak, Vice President, New Business Development, Johnson & Johnson (Judge)
  • See More..
05:00 PM - 07:00 PM

Chairmen's Networking Reception

Whether you're enjoying a pint of Guinness or a locally brewed craft beer, be sure to join us in the Exhibit Hall to check out the latest and greatest from our medtech exhibitors. Take advantage of this excellent networking opportunity with all of your colleagues, including members of the AdvaMed, AdvaMedDx and AdvaMed Accel Board of Directors.
Whether you're enjoying a pint of Guinness or a locally brewed craft beer, be sure to join us in the Exhibit Hall to check out the latest and greatest from our medtech exhibitors. Take advantage of th...
05:30 PM - 07:30 PM

MVPvets Networking Event

AdvaMed & MVPvets are hosting Veterans from the local area who will be participating in a career workshop followed by an opportunity to meet with professionals like yourself working in some of Health Innovation’s greatest companies. MVPvets sponsors and industry veterans are welcome to join us for a few moments at the conclusion of our workshop for an informal meet and greet hosted at the AdvaMed booth during the Chairmen's Reception. There’s no better way for a talented veteran to learn about the exciting work underway in today’s workplaces than to meet directly with those working in the field. And, there’s no better way for you to say thank you for your service than by stopping by to spend a few minutes talking with a veteran.

Please come by and meet some amazing people. Not only will you be making their day complete, but there’s also a possibility you could be meeting a new member for your own team!

RSVP at jmercer@mvpvets.org
AdvaMed & MVPvets are hosting Veterans from the local area who will be participating in a career workshop followed by an opportunity to meet with professionals like yourself working in some of Health ...
09:30 PM - 11:00 PM

MTC LIVE! (formerly MedTech After Party)

Wednesday, September 26
07:30 AM - 09:00 AM

Networking Breakfast hosted by MedTech Color

This Networking Breakfast hosted by MedTech Color will be held September 26th, 2018 in conjunction with The MedTech Conference. This is a time where senior African-American leaders and other under-represented groups from across the ecosystem will meet with members of the AdvaMed board and build community. Special additional thank you to AdvaMed for their sponsorship and Danaher Corporation for their generous platinum-level support. Register for the breakfast by clicking the box below.
This Networking Breakfast hosted by MedTech Color will be held September 26th, 2018 in conjunction with The MedTech Conference. This is a time where senior African-American leaders and other under-re...
08:00 AM - 09:00 AM

Networking Breakfast

08:00 AM - 12:00 PM

Speaker Ready Room Open

08:00 AM - 12:30 PM

MedTech Connect Partnering Open

The MedTech Conference is pleased to offer MedTech Connect – a desktop portal and mobile networking platform for scheduling one-on-one meetings, to all full-access attendees. Users can search for other attendees, request meetings based on mutually agreeable times and build a personalized conference schedule.

MedTech Connect is the premier partnering tool to help maximize business development opportunities for investors, medtech companies, start-ups, academics and other industry stakeholders.

MedTech Connect will launch in summer 2018.
The MedTech Conference is pleased to offer MedTech Connect – a desktop portal and mobile networking platform for scheduling one-on-one meetings, to all full-access attendees. Users can search for othe...
08:00 AM - 12:30 PM

Exhibit Hall Open

08:00 AM - 02:00 PM

08:15 AM - 09:15 AM

Patient Access to New Technologies: Is the Patient Voice Relevant?

As companies struggle to get their new technologies access to markets, the hurdles appear to continue to pile up in the form of clinical and health economics data collection. These efforts can be extremely costly in terms of time and resources, and many industry players are turning to less risky options, resulting in a potential decline in the development of new, innovative breakthrough therapies.

Regulators and third-party payers have been increasingly responsive to the demands of the patient community to take the patient’s perspective into consideration when making decisions that impact their access to new treatment options. Can the patient voice play a meaningful role in future access to technologies?
As companies struggle to get their new technologies access to markets, the hurdles appear to continue to pile up in the form of clinical and health economics data collection. These efforts can be extr...
Speakers
  • Jack Barrette, CEO, WEGO Health (Speaker)
  • Michelle Bulliard, Vice President, Global Head Real World Evidence Strategy Unit, IQVIA (Speaker)
  • Joseph Chin, Deputy Director, Coverage and Analysis Group, CMS (Speaker)
  • See More..
08:20 AM - 09:10 AM

The MedTech Innovator Showcase - Surgical Advancements

MedTech Innovator has selected this year’s 50 most transformative early-stage device, diagnostic and digital health companies. These top 50 companies will be featured at The MedTech Conference in a series of 11 interactive sessions on a special stage in the Exhibit Hall. Each session featured four or five companies under a common technology theme and will highlight their technology and investment opportunity.
MedTech Innovator has selected this year’s 50 most transformative early-stage device, diagnostic and digital health companies. These top 50 companies will be featured at The MedTech Conference in a se...
Speakers
  • Jeffery Basham, CEO, RFPi (Speaker)
  • Charlie Carroll, Senior Product Manager, Gauss Surgical (Speaker)
  • Hugh Crenshaw, CEO, Physcient (Speaker)
  • See More..
08:30 AM - 09:10 AM