Session Preview

Check out some of the sessions we're offering at this year's conference!

Health care providers and payers are rapidly changing their care delivery and payment models in response to regulatory, market and financial trends. The COVID-19 pandemic has also impacted how health care providers and payers define the value of medical technologies and solutions. What does this mean for the future of value based care (VBC) arrangements between medtechs and their provider and payer customers? This session will discuss customer attitudes, perceptions, expectations and readiness for medtech VBC partnerships and provide a framework upon which medtech companies can construct, negotiate and implement effective VBC arrangements to better deliver and demonstrate values to customers. 

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.  This session will provide a perspective on the health tech ecosystem in Latin America. Latin America’s startup and innovation ecosystem has shown significant development in the past 5 years and some hubs like SanPaulo’s FinTech ecosystem are already considered Top 5 in the world according to the Fintech Index 2020. SanPaulo’s hub is following a similar journey with Healthtechs.   The startup ecosystem dedicated to the health care market is booming in Latin America and this symposium intends to bring the vision from key stakeholders in the region to create a truly anywhere open innovation organization that leverages the best initiatives from this region. 

Turning a great technology or digital solution into a commercial success requires a multitude of inputs that must work together.  Reimbursement and market access are critically important factors, but so are the business model and market positioning, all of which must align with the regulatory and product development pathway. With so many things to consider in creating the go-to-market strategy, what comes first? How can the perspectives of all the clinical and financial stakeholders be understood and anticipated?  How important is market size in selecting the commercial entry point?  What will de-risk the market opportunity for investors and convince them that my technology is worth funding?   In this session, panelists will address these questions from the payer, user and investor perspectives to provide companies with a credible roadmap for realizing the value of their innovations. 

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Many policies, regulations, guidelines, standards and announcements in regulatory and clinical affairs have been introduced across the complete product life cycle from new submissions, modifications, renewals to post market surveillance. The Amendment of the major regulation — Decree 680 is finally adopted, ushering in a new era where “easier access and stricter regulation” becomes possible. NMPA unveiled the first-of-its kind policies to allow importing unapproved drugs and medical devices to 2 geographic pilot areas: Hainan & Greater Bay Area (GBA). The Real-World Data, continuous implementation of China UDI system, the new e-filing system and AI guidance and more. With NMPA continuous reform, how can manufacturers or inventors be proactively prepared to shorten their time to market and stay up to date? 

While the COVID-19 pandemic has affected the lives of everyone around the globe, it has further brought to light the power of digital solutions in health care. We have seen accelerated adoption of technology across the entire healt hcare sector as novel digital technologies and applications have been utilized to treat patients. Hospitals, health systems and industry along with leading technology companies are leaning in to better understand and enhance the total experience across the health care journey. As we come to the intersection of data as the great connector, we wonder how HCPs and industry can work together to address the needs of patients and health care systems around the world. How can industry help HCPs gain better access to data to help improve outcomes? How can HCPs help provide insights for better, more interconnected networks to improve workflow and deeper insights? As we look ahead, join us as we address how we can all be well positioned to make the most of this momentum to drive our digital solutions. 

Join our panel as they progress and the drivers behind securing value and outcome based contracts with payers for IVDs. Reimbursement for IVD tests has consistently been based on the cost of performing the tests in the laboratory, rather than its derived value; often inconsiderate of other cost factors associated with the execution of the test. With the COVID pandemic bringing further visibility to the need and value of diagnostics, has the pursuit of value based pricing and outcomes based pricing contracts with payers gained new momentum? VBP will gain more importance in the future, however, successes to-date are still anecdotal, and challenges remain without well-structured policies in place. Our panelist will share concrete experiences and insights on payer behavior. Questions to be explored by the panel include: What is the payer mindset behind accelerating and defining standard criteria for VBP for IVDs? What role does industry play in driving broader acceptance of VBP in the IVD space? (When) Will VBP become the norm for IVD tests? What are the key criteria payers are looking at and what evidence is needed? How do you demonstrate meaningful clinical utility? What strategies can be employed until standard policies are in place?

This panel will discuss FDA’s new Digital Health Center of Excellence, and how FDA envisions enabling to utilization of software in the medical health ecosystem.  For example, Software-as-a-medical device (SaMD) is an emerging component of the health care continuum, and the ubiquitous proliferation of smart phones means that we have an additional mechanism for engaging patients and improving patient outcomes.  The agile nature of software makes the process novel for both health authorities and software developers, especially when the software is regulated as a medical device.  A regulatory approach that provides for updating and refining software while maintaining patient safety, clarity of effectiveness, labeling and reliability, is needed.  Evaluating needs versus current paradigms is important. This session will discuss the current state, gaps, and discuss plans for future consideration, especially as it relates to developing regulatory approaches for software devices in the United States, including novel approaches to regulating devices that incorporate artificial intelligence and machine learning, clinical decision support software that is not regulated, and FDA’s Precert Program. 

Medicare coverage of new technologies is dependent on the clinical evidence available at the time of a coverage determination. This applies to all technologies including FDA-designated breakthrough devices. A potential new coverage pathway, known as the Medicare Coverage for Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” (CMS-3372-P), could streamline Medicare’s coverage, coding  and reimbursement processes for breakthrough technologies by providing immediate national Medicare coverage for a period of four years post-FDA approval. Under the framework for this new pathway, once the MCIT period concludes, Medicare still can decide whether to continue coverage permanently, or even potentially to non-cover the device. However, the future of this new breakthrough coverage pathway is unclear.  Regardless, for most new technologies, including breakthrough devices, manufacturers are responsible for generating evidence to satisfy Medicare’s coverage criteria. Providers already face many data collection requirements to satisfy quality and performance metrics under other quality and payment frameworks. Data requirements for regulatory and coverage decisions is also oftentimes siloed between stakeholders, resulting in duplicative efforts for providers. And data collection is costly, particularly if the onus is on one stakeholder to stand up. In this session, panelists including the device industry, FDA, and payers, will discuss opportunities to encourage additional data collection, consider how to align data collection that can inform both regulatory and coverage decisions, and strategize how costs to support data collection could be shared across stakeholders. At the time of this submission, the MCIT pathway remains under review and has a tentative implementation date of December 15, 2021. There are also attempts to codify the rule through Cures 2.0 legislation. 

Over the last few years with the growth of the Baby Boomer population – and significantly increased during the pandemic – there is a growing drive for providing care in home and community-based settings. This session will explore the role of technologies in supporting the delivery of home and community-based care and describe current models and trends in health care delivery. Opportunities for digital health technologies to support payers, providers and patients in advancing care coordination and care management in home and community-based settings will be described. Further, the potential for digital health technologies to promote access to care for vulnerable populations and to address health care equity in communities will be explored.  The session would focus on issues such as: Linking DHTs to home and community-based care, especially those for patient- and family-centered payment models (many of which explicitly mention the importance of technology). Profiling broadband coverage issues and the importance of expanding broadband coverage, especially in rural and medically underserved areas. Ways equity could be improved and help high-need/vulnerable populations and facilitate a move to more patient-centered health care service delivery. The session would include the perspective of a DHT used in home and community-based care. 

This session will introduce the ASCA Pilot, a new, voluntary initiative designed to enhance FDA’s approach to conformity assessment in premarket review. The Pilot is expected to increase FDA’s confidence in test methods and results from ASCA-accredited testing laboratories in device submissions, which means that manufacturers should generally see fewer requests for additional information regarding testing methods. This in turn helps lead to a more consistent, efficient and least burdensome approach to device review. This session will explain the benefits of the Pilot and offer instructions on how manufacturers can effectively participate. This includes the appropriate use of FDA-recognized consensus standards and declarations of conformity, as well as a step-by-step tutorial on how to compile an ASCA submission. 

While patient care has always been the central focus of medtech, the industry has historically stopped short of direct engagement with the patient. A variety of reasons have driven this – it was believed to be too complex, too expensive or too far outside of the typical expertise. Recent years have brought a change as industry leaders are recognizing the power of patient engagement to encourage diagnosis, facilitate therapy interest, motivate decisions and ultimately achieve better outcomes. Tools available to medtech to engage patients have evolved utilizing technology and digital channels in addition to the traditional means. When viewed in the context of COVID and the rising imperative to ensure patients are diagnosed and safely cared for, patient engagement has never been more critical for medtech. Join a panel of medtech leaders as they share the ways in which their companies are pioneering patient engagement. 

More countries around the world are consolidating procurement to drive down the price of medical technologies. While they have been successful, the impact on the total cost of health care has been limited. In some cases, the narrow focus on price, rather than value, has had a detrimental impact on the patient experience, the health care provider experience, and the system’s ability to access innovative technologies.  

In several countries where procurement consolidation has been happening for a while, health systems and procurement agencies are shifting their attention to how they can leverage procurement to improve key performance measures.   

This session will provide several examples of how procurement agencies around the world have leveraged value-based procurement to deliver greater value to the health care systems they support. 

Omnichannel allows medtech companies to create more personalized interactions with their customers: the right message, at the right time, through the right digital or physical channel. This leads to a “triumvirate” of positive change: a more engaged customer, a more engaged employee and positive impact on revenues. It relies on some fundamental shifts: introducing or reinforcing new channels such as digital marketing and inside sales to complement existing channels like sSalesforce and customer service, deploying advanced analytics models to create a 360 view of the customer and generate actionable insights like targeting and next action recommendations, and deploying new ways of working across the commercial team to improve seamless orchestration across channels (talent/training, process, technologies). The medtech industry is historically behind the curve compared to other industries (such as pharmaceuticals, banking, telcos and B2C) in deploying such an approach, but COVID-19 has accelerated the case for change. In this panel, we will explore how two trailblazing companies, Olympus Medical and GE Healthcare, have set up an omnichannel approach and learn from them the success factors and impact it is having on their customers and employees. 

The NIH Rapid Acceleration of Diagnostics (RADs) Tech Initiative was launched to speed innovation in the development and deployment of technologies for COVID-19 diagnostic testing. This multi-phase technology accelerator program is based on an “innovation funnel” design and has successfully developed and deployed new laboratory-based and point-of-care (POC) tests to help contain the COVID-19 global pandemic. This novel support structure, which has involved close collaboration among government, industry, non-profit, and academic partners, has succeeded in accelerating the typical years-long technology development and commercialization timeline to under 12 months. The NIH and its partner organizations aim to share best practices and lessons learned from this unique experience and model. 

The COVID-19 pandemic placed medtech at a crossroads between crisis and opportunity, and between the past and a still unknown future that will emerge. While many parts of the industry faced serious financial headwinds, investors exhibited bullish confidence in medtech through record levels of investment. In particular, new diagnostic tools and digital health enablers for at-home care and disease maintenance away from hospitals and clinics drove growth and will do so long after the current crisis abates. 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 15th annual Pulse of the Industry Medical Technology report examines each of these topics and will be the foundation for the panel conversation where we’ll explore how medtech companies can best seize the opportunities and avoid the dangers ahead. 

Continued strong sector fundamentals, improving end markets, new product launches and healthy pipelines have  led to a significant run up in valuations of private and public medtech assets. As a result, organizations have been adopting new and more advanced valuation techniques to appropriately evaluate potential acquisitions – both from the buy and sell side. Officials from some of the most successful medtech organizations will share insights and best practices for capturing and analyzing the most relevant aspects in designing a comprehensive buy and sell side valuation for M&A and what challenges remain, including the following:     

  • How are companies succeeding in competitive situations for attractive targets?   
  • What are the right analytical tools for evaluating complex economics globally, including payer dynamics and commercial risks?   
  • What levels of strategic and operational diligence are required to properly value?  
  • How are the capital markets (cheap credit, activist shareholders) affecting resource allocation for transformative M&A?  

The COVID-19 pandemic has forced health care systems to confront extraordinary challenges. At the height of the crisis, many hospitals cancelled or postponed elective surgeries to conserve critical resources. And patient fears of contracting COVID-19 in a medical setting resulted in a tidal wave of deferred care. Yet while the pandemic has introduced unprecedented challenges it has equally presented opportunities for coordination and collaboration across the health care ecosystem to meet the needs of patients. As we move toward recovery and reopening, health care leaders will be challenged to expand current capacity and capabilities to match tomorrow’s needs. How will we address a wave of health issues resulting from delayed care? Will digital connection remain the new normal? How will we ensure adequate supply to meet the future needs of patients and continue to ensure patient safety? And how can we create a more equitable health care system in the process? Join us as we share lessons learned and challenge ourselves to rebuild a better, smarter, stronger health care system.