The Virtual MedTech Conference program features a variety of cross-cutting sessions covering regulatory affairs, legal issues, business strategies and much more. View a comprehensive list of on-demand and livestreamed sessions below.

Topics: Global; Market Access, Payment & Health Care Delivery Issues

Worldwide, Health Technology Approval (HTA) bodies were originally set up as a filter between the manufacturers of Medical Devices and Health Care payer systems, as a screening process to ensure Payers were better informed if Devices were safe for patients, effective and a value for the money.   

Some focused more on safety and efficacy approvals, but as we entered the 21st century, health care costs have grown enormously while GDP growths have not.  There is simply no bottomless pit of money in health care for payers to fund every new device the surgeon wants to use, and there has been a very strong movement across the world to look at the added value before approving a new treatment in the health care system.  

While the National Institute for Health & Care Excellence (NICE) in the UK is widely seen as a gold standard for clinical and economic assessment of medical technologies, several countries like France, Germany, Canada, Australia, Japan, South Korea and USA among others have developed their own methodologies and approaches to determine the true value and impact of a new medical treatment in their health care system, based on their national policies and priorities. Essentially, all countries are facing an economic crunch due to rising health care costs and looking for appropriate tools to determine which medical technologies and therapies are producing best “health care value” for their population. This has given rise to the value based health care movement resulting in a quest to migrate from cost-based to value based health care systems. 

  • Moderator: Michael Branagan-HarrisCEODevice Access UK 
  • Amit KukrejaVice President, Global Marketing & Market AccessSecond Sight Medical Products 
  • Peter LynchVP, Global AccessDexcom, Inc. 
  • Kuo TongFormer Managing DirectorNavigant 
  • John WestDirectorPellerehealth 

Topics: Digital Technologies

This session will provide a landscape of the approaches that Health Authorities around the globe are taking with respect to regulating medical devices that incorporate Artificial Intelligence.  Artificial Intelligence has the potential to change the health care paradigm in terms of providing more detailed and patient-specific information and improving patient outcomes.   The ability of hospitals and payers to harness the vast amount of information available to tailor treatments for patients, including drug regimens, surgical procedures, post-treatment follow up approaches, etc. is enormous and growing daily. Partnerships looking at harnessing data are becoming more common.  Google is working with Ascension to store and analyze the data of millions of patients in an effort to improve medical services.  In addition, a collaboration between Amazon, JPMorgan Chase and Berkshire Hathaway is seeking to lower health care costs for the companies’ employees and deliver advancements for all patients.  But the inclusion of these technologies in medical devices is more complicated, and the maintenance of evidentiary standards is key to protecting patients and ensuring safety.  Concepts being utilized by leading regulators will be discussed, with a spotlilght on sharing approaches and focusing on opportunities for global harmonization. 

  • Moderator: Zach RothsteinVice President for Technology & Regulatory AffairsAdvaMed 
  • Diane JohnsonDigital Health Policy LeadJohnson & Johnson Medical Devices  
  • Marc LamoureuxManager, Digital Health Division, Medical Devices DirectorateHealth Canada (invited) 
  • Bakul PatelAssociate Center Director for Digital Health, at the Center for Devices and Radiological Health 

Topics: Global

After 20 years of continuous human presence on the International Space Station, countries from around the world are getting ready to send humans farther into our solar system, beyond Earth’s orbit. Technologies required to support long-duration missions, such as to Mars and back to the moon, will be critical to the next 50 years of space exploration.   

The Canadian Space Agency, numerous innovative Canadian medical technology companies and the National Research Council of Canada, are performing key research to develop and incorporate novel medical devices solutions for long-duration human spaceflight. Cutting-edge microgravity research and space-relevant clinical expertise are critical to ensure an autonomous crew health care system. Canadian scientists, clinicians and specialists have developed and demonstrated new devices for remote clinical care including point of care diagnostics and real-time astronaut monitoring.   

While of direct value for space application, these next generation medical devices can also help address health care support for viral pandemic situations such as COVID-19. Discover how Canadian scientists are contributing to the creation of automated rapid virus detection and diagnostic, that can provide test results in less than two hours and can be easily deployed in remote areas; and, how advances in virtual care can enable remote vital sign monitoring and mental health assessment to support clinical decisions. 

  • Moderator: Diane CotéPresident and CEOMEDTEQ 
  • Parsa FamiliCEONovatek International 
  • Pierre-Alexandre FournierCEOHexoskin 
  • David Saint-JacquesAstronautCanadian Space Agency 
  • Teodor VeresDirector of Research and DevelopmentNational Research Council Canada 

Topics: Market Access, Payment & Health Care Delivery Issues               

Breakthrough designation can be a crucial classification for device manufacturers to obtain from the FDA. Through recent rulemaking at CMS, the breakthrough designation now affords companies an easier path to incremental payment for a period of time following product launch. Further rulemaking may define the coverage environment for new, breakthrough technologies, which could have significant impact on patient access to therapies and overall commercialization of products.  As the breakthrough device designation evolves to take on greater significance for reimbursement, this panel will explore the planning, actions, and other factors taken into consideration by device manufacturers as they develop product introduction and reimbursement planning strategies for novel new devices.

  • Moderator: Amy Palatiello, MPH, Strategic Reimbursement Consultant, Medtronic

Topics: Business Strategies        

With the establishment of the Expedited Access Program and the new Breakthrough Devices Program, FDA introduced a powerful mechanism for treating life-threatening and irreversibly debilitating diseases. In cases where there is an unmet clinical need, FDA understands that the benefit risk equation is different and it’s important to both stimulate and support innovation. This creates an opportunity for greater collaboration between FDA and industry on creative solutions and enables a shift from premarket requirements to postmarket, resulting in faster approval for new devices with earlier access to patients, while maintaining safety and effectiveness. But how do medical device and diagnostics companies take advantage of this pathway? Three key opinion leaders will deliver a series of brief presentations followed by a panel discussion to explore how the Breakthrough Devices Program is changing the way medical device and diagnostics companies work with FDA.

  • Moderator: Seth Goldenberg, PhD, VP of Vault Medical Devices & Diagnostics, Veeva
  • Owen Faris, PhD, Principal Deputy Director, Office of Product Evaluation & Quality, CDRH, FDA
  • Alan Flake, MD, FACS, FAAP, Children’s Hospital of Philadelphia
  • Renee Mitchell, Regulatory Affairs Manager, Boston Scientific

Topics: Regulatory, Quality and Good Manufacturing Practices

Join us for an exclusive peek into FDA’s Center for Devices and Radiological Health (CDRH) during our Tuesday afternoon CDRH Town Hall. This is a rare opportunity to interact directly with Dr. Jeffrey Shuren and other senior office leaders from CDRH. After Dr. Shuren provides an update on CDRH priorities, including the ways in which CDRH is responding to COVID-19, panelists will answer specific questions from the audience. Take advantage of this session and get answers to all of your burning questions directly from CDRH.

  • Moderator: Janet Trunzo, Senior Advisor to the President and Senior Executive Vice President Technology and Regulatory Affair, AdvaMed
  • Heather Agler, Senior Program Manager, All Hazards Readiness and Cybersecurity Program, Office of Strategic Partnerships and Technology Innovation, CDRH, FDA
  • Daniel Caños, Director, Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality, CDRH, FDA
  • Douglas Kelly, Deputy Center Director for Science; CDRH Chief Scientist, CDRH, FDA
  • William H. Maisel, MD, MPH, Chief Medical Officer and Director, Office of Product Evaluation and Quality, CDRH, FDA
  • Ariel Seeley, Associate Director for Regulatory Documents and Special Projects, Office of Policy, CDRH, FDA
  • Jeff Shuren, MD, JD, Director, CDRH, US Food and Drug Administration
  • Tim Stenzel, Director, OHT7: Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality, CDRH, FDA
  • Michelle E. Tarver, MD, PhD, Director, Patient Science and Engagement Program, Office of Strategic Partnerships and Technology Innovation, CDRH, FDA

Topics: Regulatory, Quality and Good Manufacturing Practices; Global

Hundreds of new regulations in the forms of policies, guidelines, standards and announcements were released in 2019. The most significant and long awaited 680 extension will usher NMPA into a new level of reform. These updates and changes have impacts not only on new submissions, but also approved and renewal products in the time to market, cost savings, and the fundamental way of thinking about China regulatory and clinical requirements. The session will provide a review of the latest updates from NMPA in China Medical and IVD Devices in regulatory submission and technical review as well as postmarket requirements.

  1. Understand the key regulatory and clinical requirement changes that took place in 2020 and implications
  2. 680 extension changes on mandatory local type testing, third party test report acceptance
  3. 2020 technical standards updates and their implications on the product design phase
  4. NMPA international harmonization efforts in IMDRF in clinical evaluation, Overseas Clinical Data Acceptance, piloted real-world data, conditional approval with postmarket data collection and reducing the requirements of clinical trial
  5. Other key updates in MAH, UDI, SaMD and AI, CDx guidelines
  6. Postmarket surveillance updates in AE, Recall, Overseas Inspection
  • Moderator: Grace Palma, MBA, CEO, China Med Device, LLC
  • Andrew Chen, Partner, Arnold & Porter Xin Sun, Professor and Director, Clinical Epidemiology and Evidence-Based Medicine Research Center, West China School of Medicine
  • Shamiram Feinglass, MD, MPH, VP GAMA, Danaher
  • Jane Lin, Head of Regulatory Affairs, Asia Pacific, Johnson & Johnson Medical
  • Lindsay Tao, MD, Corporate Director, Global Health Policy, Johnson & Johnson
  • Diane Wurzburger, JD, Executive, Regulatory Affairs Americas & Global Strategic Policy, GE Healthcare

Topics: Market Access, Payment & Health Care Delivery Issues, Global

Market Access in China represents a tremendous opportunity for multinational companies, and at the same time presents ever changing policy barriers that challenge these same import businesses.  As China seeks to reduce distribution markups and reduce costs to the health care system, “Volume Based Procurement” threatens multinational sales and investment in China.  The VBP focus on price alone is a departure from the general tenet of what is known about “good procurement and tendering practices for Medical devices” that have a clear focus on value, and are not solely focused on initial acquisition cost, which consider the longer-term benefits and outcomes for patients. The panel will explore the impact of VBP on patients’ access to quality medical technologies and competition among medical technology firms – both MNCs and domestic Chinese.

  • Moderator: Eric Rugo, Vice President, Government Affairs & Health Policy, Stryker

Topics: Market Access, Payment & Health Care Delivery Issues

“Collaboration” is an often used (and misused) term when it comes to the implementation of value based care programs. What does it really mean? What are real world examples of effective collaboration and how can the lessons learned from these examples be implemented in health care organizations?

This presentation will provide real-world examples for how health plans, providers and medtech companies can work together to build platforms that enable deeper levels of trust, collaboration, effective contract performance evaluation and execution of actionable care management strategies. We will also discuss strategies to overcome the most critical barriers to effective collaboration, with an emphasis on strategic alignment, agreement on key performance metrics and balancing care recommendations across business, quality, cost and access considerations to achieve near-term ROI requirements with long-term strategic initiatives.

  • Moderator: David Gregory, MPA, FACHE, Principal, Healthcare Consulting Leader, Baker Tilly

Topics: Global

Companies often inquire where to go outside of the better known, larger markets to launch their innovative products.  This panel will explore some of the lesser traveled, and not as often considered options in this regard.  These markets offer good opportunities for the launch of innovative products, and may be a better fit for some than the more traditional launching markets.  This panel of seasoned executives will discuss the pros and cons of global markets such as Israel, Australia, Canada, Ireland and Central America from both a regulatory approval perspective and a commercial market perspective, and examine the benefits of launching your product in these markets.

  • Moderator: Mark Speers, Managing Director, Health Advances LLC

Topics: Public Affairs/Communications

There was no perfect “playbook” to follow to manage crisis when COVID-19 hit, but the organizations which had a foundation of crisis management in place before the pandemic hit are seeing greater success when it comes to protecting their people and their brand.

The current COVID-19 environment has brought effective crisis management to the forefront in the medical device world. Lessons learned today will help support your organization for years to come.

This interactive session will bring industry crisis experts to the room to share the good-the bad-the ugly of how industries are performing.

Participants will learn real-life examples and tools to help understand the best practices for protecting a brand and the people who are the heart and soul of any organization. As part of the presentation, attendees will also learn best practices for developing a crisis communication plan, a crisis team and examples of effective messaging and leadership.

  • Bob McNaney, Senior Vice President, Padilla

Topics: Regulatory, Quality and Good Manufacturing Practices 

Rapidly evolving technology in the last decade revolutionized them medtech space. Novel, advanced, interconnected medical devices now plays a central role in advancing quality of health care. On the other hand, these innovations can also increase cybersecurity risks. It is a shared responsibility across the ecosystem to ensure cybersecurity of devices and diagnostics, related services and platforms, and there by to protect the patients. Manufacturers and HDOs are now working both independently as well as joint force in pre-competitive space to address cybersecurity vulnerabilities and threats. Recent medical device regulatory guidance from FDA and its global counterparts confirms the need to tackle cybersecurity concerns with multipronged approaches. This session will address premarket and postmarket strategies relevant to cybersecurity risk management, with interactive discussion on:

  1. Updates and perspectives from FDA
  2. An overview of new tools and frameworks being collaboratively developed by the community
  3. Cybersecurity communication to patients – lessons learned
  4. Global regulatory landscape on medical device cybersecurity and harmonization efforts
  • Moderator: Jithesh Veetil, PhD, Program Director, Data Science & Technology, Medical Device Innovation Consortium (MDIC)
  • Suzanne Schwartz, MD, MBA, Deputy Director Office of Strategic Partnerships & Technology Innovation, CDRH, FDA
  • Rob Suarez, Director, Product Security, BD (Becton, Dickinson, and Company)
  • Margie Zuk, Senior Principal Cybersecurity Engineer, MITRE

Topics: Digital Technologies      

Medtech companies are under increasing pressure to improve efficiency, reduce costs and demonstrate value from health care providers, patients, and payers. These pressures have a direct impact on medtech companies’ margins and profitability, with Deloitte reporting that the ROCE (return on capital employed) for medical device companies almost halved (from 14% to 6%) between 2008 and 2016. 

In parallel, medtech executives are being bombarded by the promise and threat of digital in equal measure. The association with digital as the primary driver of innovation, lure of generating large volumes of real-world evidences (RWE), connectivity heralding the dawn of IoMT, and services that lead to new revenue streams has resulted in an urge to invest in ‘developing digital.’ 

This was true 9 months ago. Since then, the demand for digital has shot up due to the COVID-19 global pandemic, with increased adoption of telemedicine, remote patient monitoring and connected medical devices to support the full spectrum of conditions, not just for COVID-19. 

This session will ‘Decode Digital’ for senior executives and directors of medtech companies. It will provide practical advice on mapping the spectrum of opportunities available to medtech companies when looking to realize the benefits of investment in digital technology. Leaders from medtech will demonstrate how to navigate related complexities, including enhancing medical device capability, creating operational efficiencies, improving patient outcomes and creating valuable services around devices. Experts will give specific examples of how digital health solutions have been developed to address COVID-19.

  • Moderator: Heiko Visarius, PhD, Managing Director, VISARTIS Healthcare GmbH
  • John O’Brien, Chair of Irish Medtech Association, CEO, S3 Connected Health
  • Bharat Tewarie, MD, Founder, Boston BioPharma Consultants

Topics: In Vitro Diagnostics Tests & Technologies  

From early in the pandemic, the diagnostic companies mobilized, practically overnight, to help ensure our country would have the tests necessary to combat COVID-19. Like never before we are seeing each day how testing is serves as a front-line tool in the fight against disease. In the battle against COVID-19, clinicians and public health officials are leveraging diagnostics to determine active infections, identify those who have been exposed for whom an immune response has been triggered, provide disease surveillance and assist in vaccine development and efficacy testing efforts. By mid-August, diagnostic manufacturers are shipped over 1.4 million molecular tests per day to hospital, public health, and reference laboratories around the country.

In furtherance of the diagnostics industry’s effort to support our nation’s COVID-19 response, AdvaMed, in partnership with 13 leading commercial diagnostics manufacturers, launched the AdvaMed COVID Testing Supply Registry help state and federal governments in their pandemic responses by providing real-time, actionable data on tests and testing supplies being shipped around the country. Widely recognized by policy makers as the critical source of testing supply information, the Registry demonstrated the diagnostic industry’s commitment to our nation’s COVID response.

Join us for a conversation with diagnostics industry leaders to learn more about the industry’s mobilization to support patient care and public health.

  • Moderator:  Vincent A. Forlenza, Executive Chairman of the Board, BD
  • Christopher Riley, Danaher Vice President & Group Executive, DH Diagnostics LLC
  • Matt Sause, President and CEO, Roche Diagnostics Corporation North America
  • Kevin Thornal, President, Diagnostic Solutions, Hologic, Inc.
  • Andrea F. Wainer, Executive Vice President, Rapid and Molecular Diagnostics, Abbott

Topics: Business Strategies

The health care system will see exponential changes in the next two decades as advanced digital technologies, empowered consumers, and radically interoperable data become the norm.  Medtech companies that develop technologies to capitalize on these trends will have a competitive advantage. Partnerships between providers and medtech manufacturers can deliver value through connected care within and beyond the four walls of the hospital. The panel will discuss findings from Deloitte’s recent research on what the hospital of the future will look like, research on virtual health technology adoption, and research on consumer adoption of technologies as care shifts outside the hospital.

  • Moderator: Glenn Snyder, MedTech Segment Leader, Deloitte Consulting LLP
  • Lisa Earnhardt, Executive Vice President, Medical Devices, Abbott
  • Guru Gurushankar, World Wide Lead: Medical Devices, Amazon Web Services
  • Aimee Quirk, CEO, innovationOchsner
  • Venk Varadan, Co-Founder and CEO, Nanowear
  • Vindell Washington, Chief Clinical Officer, Verily Life Sciences

Topics: Market Access, Payment & Health Care Delivery Issues

In this session, you will experience a moderated discussion with senior officials from Aetna,  FasterCures, and BCBSA regarding the evidence payers expect to be included in medtech companies’ submissions for reimbursement listings. Many SME manufacturers of innovative medical technology products have limited experience in developing successful submissions for reimbursement listings with major U.S. payers and are not sufficiently aware of the data/evidence required, which in many cases are not the exact same requirements as needed for regulatory approval. This session will provide insight into the types of evidence that should be included in a submission to maximize the probability of achieving a listing.

  • Moderator: Leslie Levin, Chief Executive and Scientific Officer, EXCITE International
  • Naomi Aronson, Executive Director of Clinical Evaluation, Innovation, and Policy, Blue Cross and Blue Shield Association
  • Anita Nosratieh, Associate Director, FasterCures
  • Bob McDonough, Head of Clinical Policy Research & Development, Aetna

Topics: Market Access, Payment & Health Care Delivery Issues 

The COVID-19 pandemic has seen vastly increased and highly innovative use of remote patient monitoring beyond hospital settings into the home and workplace. The question now being asked is whether this will truly transform health care provision. Moderated by leading Forbes journalist Bruce Japsen, this panel will discuss this topic from all angles – technical, regulatory and patient experience – as well as the prospects in different countries. Setting the scene will be LifeSignals CEO Surendar Magar, one of the original developers of DSP and Wi-Fi chips, who will present his vision for the future of wireless patient monitoring. In particular, how the next generation of low-cost wearable medical biosensor technology will overcome the existing technological and cost barriers to using wireless and enable seamless capture and storage of clinical quality, near real-time patient vital sign data independent of location. Telehealth and Digital Medicare Payment Policy Lead Richard Price will give an overview of how Medicare coverage and reimbursement policy has changed dramatically for telehealth and remote patient monitoring in response to the public health emergency. He will also discuss some of the findings of a new AdvaMed study making recommendations for improving Medicare’s coverage of digital health technologies to ensure that their benefits are available to patients.  Additional panelists will report on the international landscape post-COVID-19, lessons learned, as well as how regulators responded with unprecedented speed and flexibility to COVID-19 and whether this represents a resetting of the regulatory system. 

  • Moderator: Bruce Japsen, Contributing Health Care Writer, Blogger, Forbes
  • Surendar Magar, PhD, President & CEO, Life Signals
  • Richard Price, Vice President, Payment and Health Care Delivery Policy, AdvaMed

Topics: Business Strategies        

This expert panel discussion will highlight actionable practices and policies to drive diverse participant representation (sex/gender, race/ethnicity, and age) in clinical studies, reflective of the population impacted by the disease or condition. Additionally, panelists will discuss retention and recruitment practices, patient engagement strategies that focus on increasing access and participation of minorities and women in clinical studies, and its applicability to real-world evidence (RWE), which is increasingly being used in regulatory decisions.  The panel will touch upon the different platforms that collect clinical data and which need to identify patient specific aspects and do so accurately as well as ensure that all patients are participating in registry efforts.

  • Moderator: Nada Hanafi, Chief Strategy Officer, Experien Group
  • Richardae Araojo, Associate Commissioner, Office of Minority Health and Health Equity, S. Food & Drug Administration
  • Michelle Tarver, MD, PhD, Director, Patient Science and Engagement Program, CDRH, FDA
  • Paul Underwood, Medical Director, Boston Scientific Corporation

Topics: Digital Technologies

Time and again, studies have shown that influencing patient behavior will improve outcomes.  However, as most people have experienced and the data supports, while short term change is easy, sustaining change over the long-term is nearly impossible. This is especially true in a world forever altered by COVID-19. To adapt to this new normal and embrace long-term change in the beyond, medtech will need to leverage both new technology-based solutions and partnerships to solve complex challenges. This will require cooperation across stakeholders to challenge traditional notions of treatment and health care, as well as the use and implementation of platforms, digital, and technology to foster collaboration and generate impact. Ultimately, medtech companies must ask themselves how can they collaborate and innovate in the now to own the nudge in the next and beyond? This panel will apply a now, next, and beyond framework to look at how emerging platforms, tools, and technologies are revolutionizing stakeholder collaboration and transforming patient behaviors to enhance outcomes. Representatives across medtech, including digital therapeutics, payers, and technology will bring to life the ways in which innovation can nudge the industry beyond the horizon of the possible into transformative health care.

  • Moderator: Susan Garfield, Principal, Commercial Leader, EY
  • Jeffrey Abraham, MSPT MBA, Vice President, Digital Health and Health IT, Health Advances
  • David Rhew, VMO & VP of Healthcare, Microsoft
  • Michael Sherman, CMO, Harvard Pilgrim

Topics: In Vitro Diagnostics Tests & Technologies           

The University of Toronto and the National Research Council of Canada have established a national innovation hub focused on microfluidics. Located in Toronto, Ontario, Canada, this hub, called the Centre for Research and Applications in Fluidic Technologies, or CRAFT, catalyzes on new discoveries to deliver tangible impact on the lives of Canadians by developing and commercializing biomedical technologies that can improve care for patients while reducing costs for the Canadian health system.

CRAFT researchers and scientists are world leaders in microfluidics and have mastered the science behind mixing tiny amounts of fluid on a small chip to achieve desired chemical or physical reactions, or to grow live cells in an environment that mimics the inside of the human body. In particular, CRAFT focuses on using microfluidic technologies to make advances in priority areas such as: shrinking the functions of medical laboratories onto a single small chip, allowing for rapid diagnosis of diseases; growing organ tissues on devices outside the body to test drugs or do research related to personalized medicine; and printing biological tissues that can be used to repair organs of the human body.

Hear how the value of scientists and clinicians added to the value of engineers can lead to a better, more global understanding of clinical reality for greater societal impact and ultimately, a better quality of life for patients.

Learn how CRAFT is leading the path to create a new kind of partnership facility capable of bringing microfluidic technologies from lab-scale prototypes to commercially viable products.

  • Moderator, Brian Lewis, President, Medtech Canada
  • Axel Guenther, Associate Professor, Applied Science & Engineering, University of Toronto
  • Teodor Veres, Director R&D, National Research Council Canada

Topics: Business Strategies        

This panel will include representatives from large, multi-national medical device companies (aggregators) and entrepreneurs (innovators). It will involve a robust discussion of the challenges associated with M&A interactions and what steps both parties can take to align incentives and understand key information needs.

  • Moderator: Charles Mathews, Principal, ClearView Healthcare Partners
  • Charlie Attlan, SVP, Corporate Strategy and Business Development, Boston Scientific
  • Lori Chmura, CEO, Dune Medical Devices
  • Peter Stebbins, Transactions Lead, Medical Devices, Johnson & Johnson

Topics: Global  

An international panel that will address the challenges and best practices regarding the implementation of disruptive Medical Technology innovations within the specificities of universal and fragmented health care systems.  The session will compare adoption of disruptive technologies within the Canadian, American and French health care systems based on the case of innovative start-up AKINOX.

  • Moderator: Diane Coté, President and CEO, MEDTEQ
  • Michael Levy, President, Digital Health Institute for Transformation
  • Isabelle Magnin, Innovation Leader, Atrium Health – Georgia, USA
  • Kathy Malas, Associate CEO, Innovation & AI, University of Montreal Medical Center
  • Michel Nadeau, CEO, Tactio Health

Topics: In Vitro Diagnostics Tests & Technologies           

The rapidly changing diagnostics market creates a challenge for regulatory oversight to keep pace. COVID-19 has highlighted the critical role that diagnostics play in public health. As the need for diagnostics reform and harmonization of clinical laboratory tests is intensely debated among various stakeholders that represent manufacturers, practitioners, patients and regulators, industry leaders and those entering the market continue to monitor the developments in this space. Panelists will discuss potential legislative and regulatory reforms to IVD regulation, and its impact for large and start-up IVD manufacturers.

  • Moderator: Nathan Brown, Partner, Akin Gump Strauss Hauer & Feld LLP
  • Abram Barth, Associate General Counsel, Regulatory; Data Privacy Officer, GRAIL, Inc.
  • Elizabeth Hillebrenner, CDRH Chief of Staff, FDA
  • Lesley Maloney, Head of US Regulatory Policy and Global Policy Lead, Digital Health, Roche

Topics: In Vitro Diagnostics Tests & Technologies           

The immediate ramp-up and early integration of testing proved to be critical and influential during pandemic management decision making at the highest level. Yet, some governments and countries struggled while others were successful. This panel will discuss experiences with ramp-up of test production, distribution to different countries, supply shortages, and preparation for a next wave of COVID-19. Lessons learned will apply to expectations and preparation needs for future outbreaks of infectious diseases. What is needed to drive earlier implementation of testing? Can supply shortages be circumvented? Are there any broader, long-term concerns that need to be considered regarding development and access to non-COVID-19 related IVD tests? Does the role of testing during COVID-19 once and for all answer the question of the value of IVD?

Topics: Emerging Trends

  • Moderator: Danelle Miller, Vice President, Global Regulatory Policy & Intelligence, Roche Diagnostics
  • Robert Shipley, Fellow, Interventional Cardiology / Boston Scientific Corporation
  • Misti Malone, Director of Peripheral Interventional Devices Team, CDRH / FDA
  • Jill Marion, Deputy Office Director, Office of Clinical Evidence and Analysis, CDRH, Food and Drug Administration
  • Heather Colvin, Director, Evidence & Outcomes Policy, Medical Device Regulatory Affairs, Johnson & Johnson

Topics: Global; Regulatory, Quality and Good Manufacturing Practices

Implementation of the MDR/IVDR remains problematic. While the EU Commission deferred the MDR date of application to May 2021, many other deadlines in the regulation remain in place.  Despite the pre-eminent importance of IVDs in addressing the COVID-19 pandemic, IVDR implementation dates so far remain unchanged.  COVID-19 is negatively impacting MDR and IVDR implementation, including through the impairment of the ability to do in-person audits.  This panel will address the fundamental issues in MDR/IVDR implementation with an emphasis on how COVID-19 has impacted the regulatory landscape in the EU.  This panel will also offer perspective on difficulties that are being encountered in the implementation of MDR/IVDR and measures that may be utilized to ensure products can remain on the market in the EU. The panel will have a wide representation from industry, regulators, consultants and notified bodies. The session will provide a comprehensive update of the current landscape and inform on issues that are likely to unfold in the coming months and offer insight into how these may be addressed.

Topics: Global; Regulatory, Quality and Good Manufacturing Practices 

This session will review highlights of 2020 activities by IMDRF medical device regulatory authorities leading toward the goal of one standard, one test, accepted everywhere for every medical technology.

  • Moderator: Nicole Taylor Smith, Vice President, Global Regulatory Policy, Medtronic

Topics: Legal and Health Care Compliance Best Practices            

As medical technologies continue to advance, patient data is increasingly collected and leveraged to improve products and patient outcomes. At the same time, data protection laws continue to expand and create compliance challenges for medtech companies. For example, the California Consumer Privacy Act (CCPA) became effective on January 1 of this year and presents new compliance obligations and risks on medtech companies. The increasing frequency and severity of cybersecurity incidents also highlight the importance of developing and maintaining an up-to-date data protection compliance program.  Join us for an in-depth discussion of how data is changing the industry, the risks generated by new and emerging data protection laws and how to best manage those risks.

Topics: Market Access, Payment & Health Care Delivery Issues

Novel diagnostics are conceived to improve patient care and clinical outcomes.  Nevertheless, many of them do not rapidly reach their potential due to reimbursement challenges.  These challenges can be due to numerous factors due to misalignment of incentives, coding issues, competition and limited evidence available at the time of diagnostic test clearance.  This session explores ways novel diagnostic test developers and providers can assess whether reimbursement challenges will exist and clinical, commercial and policy approaches address these challenges.

  • Moderator: Susan Van Meter, MA, Executive Director, AdvaMedDx
  • Stefan Walzer, Co-Founder, Medvance
  • Gabriel Bien-Willner, MD, PhD, Medical Director, MolDx (invited)

Topics: Business Strategies

NIH has launched SEED (Small business Education and Entrepreneurial Development) to strategically align academic research resources, dedicated funding for small businesses, and business and product development expertise to help entrepreneurial scientists move their promising discoveries through the early product development pipeline. For example, the NIH Phase 0 Proof of Concept consortium merges the strengths of high-impact research institutions with the expertise and resources of federal and private-sector product development partners to support innovators at 92 research institutions across 34 states and Puerto Rico. NIH’s Small Business Program, also known as America’s Seed Fund, provides over one billion dollars annually to small businesses to validate the potential health care potential of scientific discoveries and to test the feasibility of novel products and services resulting from these discoveries. This panel will highlight NIH’s strategic focus in early product development, resources and opportunities available to academic and small business innovators, and the ways strategic partners and investors and can partner with NIH to access novel technologies.

  • Moderator: Matthew McMahon, PhD, Director, SEED, National Institutes of Health (NIH)
  • Paula Bates, Professor, University of Louisville School of Medicine
  • Robert Raike, PhD, Chief DBS Scientist, Medtronic Brain Therapies
  • Kwame Ulmer, Principal, Ulmer Ventures

Topics: Business Strategies

More than 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 14th 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.

Topics: Business Strategies

  • Scott Daubin, Partner, Bain & Company
  • Trevor Gunn, VP, International Relations, Medtronic, Inc.
  • Roland Chong, Head of Global Supply Chain Processes & Trade Management, QIAGEN

Topics: Legal and Health Care Compliance Best Practices

Business development is a broad field that can cover everything from a distribution agreement, to a full acquisition of a company, to an integration of a new product, or a divestiture of an old one.  This session will cover the important role that compliance plays in business development due diligence, acquisition, integration, and divestiture activities for companies of all sizes, as well as the benefits of embedding compliance in Business Development teams and processes.  We’ll discuss different areas of priority for compliance professionals to focus on, as well as tools they can use for due diligence, integration, and divestiture activities.  We’ll also discuss the importance of collaboration with business development partners and other departments in order to leverage their due diligence activities for compliance purposes.  For example, when finance is reviewing the capitalization table for a company, compliance may be able to leverage that to get a better picture of HCP ownership in a company.  We will also cover best practices and hot topics in compliance as they relate to business development activities such as reporting acquisition payments for transparency purposes when an HCP is involved, levels of due diligence based on the deal and players, and building compliance provisions into acquisition and distribution agreements.

  • Moderator: Alicia Maltz, JD, CCEP, CHPC, Director, Health Care Compliance Officer – Business Development, Johnson & Johnson
  • John Kilcoyne, Chief Executive Officer, JenaValve
  • Matthew Wetzel, JD, Associate General Counsel, Compliance & Compliance Officer, GRAIL
  • James Wilson, General Manager, Wright Medical Technology Co. (Canada)

Topics: Global; Regulatory, Quality and Good Manufacturing Practices

Many COVID-19-related products and technologies distributed via special authorization will make the transition to marketed products in the coming months. How will regulatory agencies cope with the workload?  How can industry prepare? A panel of industry and regulators will discuss the transition and provide advice on ensuring a smooth road.

  • Moderator: Danelle Miller, Vice President, Global Regulatory Policy & Intelligence, Roche Diagnostics
  • Diane Johnson, Digital Health Policy Lead, Johnson & Johnson Medical Devices
  • William Maisel, MD, MPH, Chief Medical Officer and Director, Office of Product Evaluation and Quality, FDA/CDRH, S. Food and Drug Administration


Robotic-assisted surgery has been the focus of many medtech companies looking to usher in a revolutionary future of improved patient outcomes and increased surgical capability. Countless development dollars have gone into the space in both orthopedics and soft tissue, and outcomes continue to improve on commercial systems, with new robots and indications expanding rapidly. Despite a capital pitch and shifting priorities in hospitals, robotics remains a major focal point for the future. This panel will discuss how the promise of robotic assisted surgery can still be realized even in the face of COVID-19 uncertainty.

  • Moderator: Brian Chapman, Partner and Leader of ZS’s Medtech Practice, ZS Associates


The 2020 US Presidential Election will be the most data-intensive political operation in American History as both parties attempt to grapple with an overwhelmingly digitized society that has also become increasingly demographically diverse. Pollster Kristen Soltis Anderson will take the audience through the substantial shifts in American politics that have occurred in the twenty-first century caused by demographic trends, generational replacement and changing cultural attitudes.  

  • Kristen Soltis Anderson, Author, The Selfie Vote: Where Millennials Are Leading America (And How Republicans Can Keep Up)

While COVID-19 may have negatively impacted many medtech businesses, those who innovate their business models can thrive in “the new normal.” We’ll discuss new ways to engage physicians, clinicians and consumers that can help drive better health outcomes, improve satisfaction, and – potentially – lower cost.

The leaders in tomorrow’s market will likely take advantage of the rapid tilt towards virtual health, remote diagnostics, and testing.  We’ll also discuss how medtech should consider changing its clinical trials processes to adopt “virtual” capabilities.

This panel can talk about how COVID-19 can “accelerate the path to the future of health.”

  • Moderator: Glenn Snyder, Principal, Medtech Practice Leader, Deloitte Consulting LLP

Topics: Regulatory, Quality and Good Manufacturing Practices

In this interactive session, senior leadership within Health Canada’s Medical Devices Directorate will discuss the department’s key priorities, including COVID-19-related activities, and share insights on Health Canada’s dynamic approach to establish a flexible regulatory system that does not compromise on safety and is responsive to the needs of patients, industry and the health care system.   

Some areas of discussion include: 

  • Setting up a new organizational structure based on the lifecycle oversight of medical devices
  • Regulating medical devices during the COVID-19 pandemic
  • Regulating new technologies, such as continuously learning AI, in the pre and postmarket phases  
  • Developing regulations that facilitate more Canadian research on novel medical devices by enabling health care professional-led studies, and increased protection of patients participating in clinical trials, along with more access to information about the trial 
  • Considering the classification of devices to ensure that all devices are subject to requirements commensurate to the level of risk they pose to the health of Canadians 
  • Supporting efficient and effective use of devices throughout their lifecycle to improve patient outcomes e use of devices throughout their lifecycle to improve patient outcomes
  • Moderator: David Boudreau, Director General, Medical Devices Directorate, HPFB, Health Canada
  • Saira David, Director, Policy and International, Medical Devices Directorate, Health Canada
  • Emily Hollink, Executive Director, Post-Market Surveillance, Medical Devices Directorate, Health Canada
  • Marc Lamoureux, Manager, Digital Health Division, Medical Devices Directorate, Health Canada

Topics: Legal and Health Care Compliance Best Practices            

Situational ethics has reached epidemic proportions. All you need to do is pick up a newspaper or browse the internet, and you’ll see examples of leaders modifying their moral standards depending on specific situations and individual interests.

When situational ethics become commonplace, how long does it take for others to feel like it’s okay to operate in the gray?  

Several of the recent global anti-corruption cases, including those led by the US DOJ & the SEC, in medical device involved individuals who consciously or unconsciously rationalized bad decisions. In addition, the COVID-19 pandemic has resulted in opportunities that, when combined with incentive or pressure, may lead individuals to justify bad decisions.  

Leaders need to be aware of what those rationalizations look and sound like, and when they are most likely.  Lastly, leaders benefit from learning how to enhance an ethical culture further.

  • Moderator: Mary Holloway, President, DMH Ethics & Compliance Advisors
  • Ann Ford, BSN, JD, Partner, Hall Prangle & Schoonveld
  • Denis Jacob, VP, Deputy Chief Compliance Officer, Orthofix

Topics: Business Strategies

Hospital CFOs are driving discussions around the move to Value Based Health Care (VBHC). As part of this move, they are changing how they engage clinicians in evaluating the role medical devices play in reducing the total cost of care, improving quality and managing risk for specific patient populations. To be successful in a VBHC market, medtech manufacturers must understand where providers are on this journey (including the impacts of COVID-19 on how and where care is delivered and the kind of information they seek from their suppliers). The panelists will discuss:

  • Current research on the move to VBHC and physician engagement
  • How best in class medical device companies effectively engage customers based on their strategic VBHC and supply chain objectives
  • Opportunities for outcomes-based contracts that tie product pricing to real world performance
  • How to forge closer relationships between providers and suppliers to strengthen supply chain resiliency.

  • Moderator: Maria Shepherd, MBA, President & CEO, Medi-Vantage
  • Karen Conway, MA Science of Healthcare Delivery, Vice President Healthcare Value, GHX
  • Todd Nelson, Director, Partner Relationships and Chief Partnership Executive, Healthcare Financial Management Association (HFMA)
  • Kerry Gillespie, Healthcare Financial Operations Expert, Intermountain Healthcare
  • Rob Bull, VP Finance, Technology & Innovation, Chief Financial Officer, Southlake Regional Health Centre

Topics: Legal and Health Care Compliance Best Practices            

The focus of the plaintiff’s bar on women’s health has culminated in a wave of mass tort and multidistrict litigation (MDL) that has disproportionately affected the ability of life science and medtech companies to offer treatments designed to improve the health and lives of women. Plaintiffs’ lawyers have manipulated today’s far-reaching and fast-paced media environment, lack of federal restrictions on attorney advertising, and the MDL system to back companies into large settlements, even when science, causation and other issues critical to liability are missing. The result is that three out of five of the largest MDLs in the United States today target products specifically designed to promote women’s health. Litigation, often without any basis in science, has led to the withdrawal of many safe and effective drugs and devices.

Topics: Business Strategies

From the moment a new medtech company is formed, or a new technology is conceived, the potential to realize value in the form of price is (or should be) a critical question. With the emergence of new health care payment models and the integration of devices with data and insights, pricing strategy is more complicated than ever. The panel will discuss factors to consider in the pricing of medtech innovations, and present some case studies of creative pricing approaches.

  • Moderator: Amy Siegel, Co-Founder and Managing Partner, S2N Health
  • Martha Shadan, President & CEO, Miach Orthopaedics
  • Scott Schorer, President & CEO, GI Dynamics
  • Laurel Sweeney, Principal, Access Strategies, LLC