2020 MDIC Annual Report

MDIC ANNUAL REPORT

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TABLE OF CONTENTS 1 A LETTER FROM THE MDIC PRESIDENT & CEO AND THE MDIC BOARD CHAIRMAN

2 MDIC RESPONDS TO COVID-19 2 3

New Tools, Resources, and Projects

MDIC’S INITIATIVES AND PROGRAMS

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Clinical Science

9 Data Science and Technology 14

Health Economics and Patient Value

15 National Evaluation System for Health Technology Coordinating Center (NESTcc)

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EVENTS

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Annual Public Forum

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MEMBERSHIP

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FINANCIAL INFORMATION

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MDIC STAFF

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BOARD OF DIRECTORS

MDIC ANNUAL REPORT 2020

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A LETTER FROM THE MDIC PRESIDENT & CEO AND THE MDIC BOARD CHAIRMAN Dear MDIC members, partners, and stakeholders, After a year unlike any other, we are grateful for your continued support and commitment to our shared mission of advancing medical device regulatory science for patient benefit. Your flexibility and partnership enabled us to adapt to the changing needs of the medical device ecosystem and to continue on our path toward our mission.

NADIM YARED PRESIDENT & CEO, CVRX MDIC CHAIRMAN

While we were unable to engage with stakeholders in person this year, we have expanded our reach to unprecedented levels virtually. Nearly 1,200 attendees from around the world joined our Annual Public Forum virtual series. We have deployed new tools to facilitate communication and collaboration within MDIC and with our stakeholders in this changing environment. We are proud of the critical outputs we have continued to deliver to the medical device industry during a public health crisis, when our work is more important than ever.

Some of the key highlights of this report include MDIC’s response to COVID-19, release of the Early Feasibility Studies Tool Kit for sites and sponsors, recognition with the RAPS Patient-Centered Health Award, our first Cybersecurity Threat Modeling Bootcamp, and opening access to NESTcc’s Research Network for sponsor-funded research projects.

PAMELA GOLDBERG

PRESIDENT & CEO, MDIC

As you read through this report, we want you to be proud of the work we have accomplished together, and enthusiastic about what is yet to come. Our ability to deliver on your needs, while adapting to changing conditions, is only possible because of the collaborative work and expertise with you, our partners across industry, academia, government, healthcare systems, and patient advocacy groups. We look forward to taking our new knowledge and resources from a challenging 2020 and applying them to our future work as we continue to grow while providing tools for patients to have access to innovative, safe, and effective medical technologies.

NADIM YARED PRESIDENT & CEO, CVRX MDIC CHAIRMAN

PAMELA GOLDBERG PRESIDENT & CEO, MDIC

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MDIC ANNUAL REPORT 2020

MDIC RESPONDS TO COVID-19 When the COVID-19 pandemic struck the United States in Spring 2020, MDIC quickly pivoted to lead the medical device ecosystem during this time of uncertainty. MDIC: • Provided a forum for responding to the pandemic • Kept members and stakeholders engaged and informed • Developed new COVID-19 tools and resources

A FORUM FOR PANDEMIC RESPONSE MDIC provided a forum for the U.S. Food and Drug Administration (FDA), industry, and other stakeholders to coordinate the response to the pandemic and develop strategies for continuing medical device development, including in vitro diagnostics (IVDs) for use in COVID-19 testing and clinical research.

In Early Feasibility Studies (EFS), for example, investigators were able to explain the realities and challenges sites were facing to FDA and industry during MDIC’s regular meetings about the EFS program. These discussions and MDIC’s advocacy resulted in regulatory changes to protect participants, such as remote monitoring through telehealth, and other changes that enabled EFS to continue with less missing data and more compliance.

VIRTUAL EVENTS The 2020 Annual Public Forum was held as a series of virtual webinars over three months, drawing nearly 1,200 attendees. MDIC’s first Patient Engagement Forum brought together 119 stakeholders virtually to focus on communicating benefit-risk and uncertainty with patients for medical devices. MDIC also transitioned other live events to virtual events.

NEW TOOLS, RESOURCES, AND PROJECT In response to the pandemic, MDIC developed a COVID-19 resources page, resources for SARS-CoV-2/COVID-19 laboratory test coding, and a discussion tool for patients considering a medical procedure during the pandemic.

MDIC also launched the COVID-19 Real-World Evidence (RWE) project, which is bringing stakeholders together to create strong, integrated data systems capable of generating real-world data (RWD) that the FDA will accept in regulatory submissions.

Many of these accomplishments are also covered in more detail in other parts of this annual report.

SERVING THE MEDICAL DEVICE ECOSYSTEM DESPITE THE PANDEMIC

COVID-19 resources page to keep members and stakeholders informed

Quick pivot to virtual events, including Annual Public Forum and Patient Engagement Forum

New resources and tools for patients, SARS-CoV-2/ COVID-19 laboratory test coding

New COVID-19 RWE project

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MDIC’S INITIATIVES AND PROGRAMS MDIC improves the processes for development, assessment, and review of new medical devices through initiatives and programs in four areas: CLINICAL SCIENCE DATA SCIENCE AND TECHNOLOGY HEALTH ECONOMICS AND PATIENT VALUE NATIONAL EVALUATION SYSTEM FOR HEALTH TECHNOLOGY COORDINATING CENTER (NESTCC)

Here we present the 2020 accomplishments of these initiatives and programs.

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MDIC ANNUAL REPORT 2020

CLINICAL SCIENCE The Clinical Science initiative addresses the biggest barriers to collecting adequate clinical evidence in support of new medical technology by: • Creating blueprints for innovative clinical trial techniques • Developing standards and metrics for effective clinical trial designs • Encouraging the collection of adequate and appropriate clinical and patient preference data

PROGRAMS: • Clinical Diagnostics • Early Feasibility Studies • Science of Patient Input • SHIELD

2020 CLINICAL SCIENCE YEAR IN REVIEW CLINICAL DIAGNOSTICS Providing a predictable path for innovation in clinical diagnostics gives patients quicker access to more advanced and cost-effective diagnostic technologies in less time. The Clinical Diagnostics program works on projects to improve diagnostic testing and product development using novel regulatory science approaches developed through collaboration between MDIC stakeholders.

Projects on RWE MDIC conducted several projects to facilitate the use of RWE in regulatory submissions for IVDs. IVD RWE GENERATION FRAMEWORK Created through a collaborative process between MDIC, FDA’s Center for Devices and Radiological Health (CDRH), and industry, the IVD RWE generation framework aims to help industry and FDA consider when and how RWD might be incorporated into product development and regulatory decision-making in support of clearance or approval of IVDs. The framework also outlines considerations for appropriate designs and statistical methods for generating RWE for regulatory submissions.

We hope the framework will stir the conversations and actions needed to facilitate greater use of real-world evidence in regulatory decisionmaking, and ultimately, accelerate patient and healthcare provider access to innovative IVDs that are safe and effective.

— DANELLE MILLER, JD Chair, MDIC IVD Real-World Evidence Working Group Vice President of Global Regulatory Policy & Intelligence, Roche Diagnostics

MDIC ANNUAL REPORT 2020

COVID-19 RWE PROJECT The COVID-19 RWE project is creating strong, integrated data systems capable of generating RWD that the FDA will accept in regulatory submissions. IVD manufacturers, FDA, and hospitals are working together to develop clinical protocols on practical RWE for use in regulatory submissions.

PROCESS FOR CONVERTING EMERGENCY USE AUTHORIZATION IVDS TO FULL MARKET STATUS The “Open Hand” project is working with sponsors and the FDA to pave a path to use IVD RWE to convert emergency use authorizations (EUAs) to full marketing status. The project seeks to: • Develop a transparent process to evaluate new technology and methods • Capture “the how” to share with the community while staying in the pre-competitive space and protecting proprietary information • Create educational modules on using IVD RWE in the regulatory process • Capture learnings in peer-reviewed publications COMMUNICATION ACTIVITIES MDIC held: • A workshop to help sponsors of IVD products approved under an EUA advance to full market status using RWE • A meeting to discuss the role of RWE in coverage and payment decisions for devices and diagnostics Participants in the workshop explored key considerations for using RWD to generate RWE to help support IVD products in advancing from EUA to full marketing status.

Cancer Somatic Reference Samples Project MDIC completed the business plan for developing reference samples that can be made available to the public to improve the accuracy, reliability, and

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transparency of next-generation sequencing– based IVD oncology tests. The plan calls for engineering and validating 54 priority cancer mutations for these tests.

Artificial Intelligence and Machine Learning for In Vitro Diagnostics Launched in 2020, the new Artificial Intelligence and Machine Learning Program for In Vitro Diagnostics is focusing on the regulatory framework for iterative postlaunch improvements in IVDs that use artificial intelligence or machine learning. The working group is developing: • A glossary of terms associated with artificial intelligence and machine learning to provide a standardized vocabulary • Templates for software prespecifications to enable a software developer to explain the anticipated modifications to be implemented once the software is in use • An algorithm change protocol that will include plans for monitoring, data management, algorithm training, algorithm update, and rollback • A framework that will include the glossary, templates for software prespecifications, and algorithm change protocol, as well as background information and context

Resources for COVID-19 Laboratory Test Coding In response to the requirement for daily COVID-19 test reporting, the Systematic Harmonization and Interoperability Enhancement for Lab Data (SHIELD) program developed a web page with links to resources for laboratory test coding and links to help with technical issues. SHIELD focuses on harmonizing authoritative semantic data standards so that all labs can “describe the same test the same way, every time.”

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MDIC ANNUAL REPORT 2020

EARLY FEASIBILITY STUDIES The Early Feasibility Studies (EFS) initiative develops tools and best practices to help sponsors and clinical research sites improve the overall efficiency of U.S. EFS. The program also supports continuous assessment of EFS efficiency and effectiveness for U.S. patients.

EFS Tool Kit MDIC’s EFS tools and resources help sponsor companies and clinical research sites simplify and standardize the way EFS are conducted in the United States. To make accessing the tools and resources easier, MDIC put them together in the MDIC EFS Tool Kit, which includes: • Sponsor and site success stories • Best practices • Master Clinical Trial Agreement (MCTA) template • Patient informed consent form template • Contract language and negotiation tools • Information tools for institutional review boards (IRBs), site study staff, and patients

Monthly Email Newsletter EFS Express, a monthly email newsletter, engages and informs the EFS community with updates on the EFS program and success stories of sponsors and sites. Success stories highlight the MDIC tool(s) used and how the sponsor or site used the tool to improve the efficiency of EFS.

EFS Budgeting Workshop and Working Group To improve the efficiency of sponsor-site budget negotiations, MDIC held a budgeting best practices workshop and then formed a budgeting working group. The workshop brought sponsors, sites, and representatives of FDA’s CDRH and MDIC together to share EFS budgeting best practices and discuss steps to streamline budget negotiations. MDIC then established an EFS budgeting working group to develop recommendations for standardizing and communicating budgeting approaches throughout the medical device clinical trial ecosystem.

Expansion into the Neurovascular Space With the increase in the number of innovative neurosurgical devices under development, the new EFS Neurovascular Steering Committee, chaired by Chip Hance, BS, MBA, and Adnan Siddiqui, MD, PhD, FACS, FAHA, FAANS, will help sponsors and sites working in the neurosurgical space conduct EFS studies.

The new EFS Cardiology Steering Committee is chaired by Rick Geoffrion and Jaime Walkowiak, JD.

MDIC ANNUAL REPORT 2020

SCIENCE OF PATIENT INPUT The Science of Patient Input (SPI) program advances the art and science of patient engagement in the development, premarket approval, and postmarket evaluation of medical devices. Projects focus on incorporating the patient’s perspective and preferences in devices, amplifying the patient voice.

Resources to Improve Communication With Patients MDIC released two reports to help investigators, other clinical research staff, and healthcare providers communicate more effectively with patients about medical devices.

PATIENT PERSPECTIVES IN CLINICAL TRIAL DESIGN AND RESEARCH Incorporating Patient Perspectives in Clinical Trial Design and Research: A White Paper by the Science of Patient Input (SPI) Program shares the perspectives of Margaret Sheehan and Anne Cohn Donnelly, two patients with Parkinson’s disease, on how sponsors can effectively engage patients as partners throughout the clinical trial process. This was part of MDIC’s Patient Centered Outcomes Research project, which included representatives from the Michael J. Fox Foundation for Parkinson’s Research, FDA, and Massachusetts Institute of Technology.

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Communicating Benefit, Risk, and Uncertainty for Medical Devices The Best Practices for Communicating Benefit, Risk, and Uncertainty for Medical Devices Report provides evidence-based best practices for enhancing communication with patients about medical devices so that patients can make informed treatment decisions. Developed

by MDIC’s SPI Communication Working Group, the report identifies characteristics of providers and patients and how the ways in which the scientific and medical information is disseminated can affect patients’ comprehension and decision-making.

Patient Discussion Tool MDIC developed a Discussion Guide for patients considering a medical procedure during COVID-19 for patient use in talking to healthcare providers. Patients, patient advocates, and medical and scientific experts collaborated on the patient discussion tool. The web page featuring the guide also has links to other patient resources about COVID-19.

Patients considering a medical device need to understand the implications of available treatment options. This report helps decision-makers better understand how to communicate in ways that will resonate with patients.

—SCOTT GOATES, PHD Senior Advisor of Health Economics and Outcomes Research, Abbott Chair, Science of Patient Input Communication Working Group

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MDIC ANNUAL REPORT 2020

Patient-Centered Health Award

MDIC’s first Patient Engagement Forum (virtual) brought together 119 patients, patient advocates, medical device leaders, regulators, healthcare providers, payers, and experts.

The Regulatory Affairs Professional Society (RAPS) gave MDIC the 2020 Patient-Centered Health Award. This award recognizes groups, organizations, or individuals that have made a significant impact to advance patientcentered policy, product development, or regulatory decision-making.

Patient Engagement Forum MDIC’s first Patient Engagement Forum (virtual) brought together 119 patients, patient advocates, medical device leaders, regulators, healthcare providers, payers, and experts in communication and shared decision-making to learn and share challenges and best practices for communicating with patients.

Participants focused on communicating benefit-risk of and uncertainty about medical devices.

Presentation on Heart Failure Devices The MDIC Annual Public Forum included a presentation on “Patient Preferences for Heart Failure Devices: A Collaborative Study.” Study results will strengthen MDIC’s efforts to promote regulatory science and develop a framework for patient input in the design of medical device clinical trials.

MDIC ANNUAL REPORT 2020

PROGRAMS:

DATA SCIENCE AND TECHNOLOGY

• 5G-Enabled Health Technologies

The Data Science and Technology initiative creates tools and methods to use advanced data analysis techniques and new technology to:

• Computational Modeling and Simulation

• Accelerate the collection of clinical data • Remove barriers to patient access • Monitor product safety, quality, and effectiveness

2020 DATA SCIENCE AND TECHNOLOGY YEAR IN REVIEW 5G-ENABLED HEALTH TECHNOLOGIES 5G networks will change the way medical evaluation and treatment are conducted, creating both opportunities and challenges for device research, development, manufacturing, and assessment. The 5G-Enabled Health Technologies project, launched in 2020, will facilitate the future development of novel medical device technology based on 5G networks, while ensuring patient safety.

The 5G-Enabled Healthcare Technologies Working Group is developing a 5G implementation roadmap. The roadmap will specify open regulatory research questions and knowledge gaps that should be addressed to facilitate the integration of 5G technology into medical devices and accelerate the availability of 5G-enabled devices to patients.

CASE FOR QUALITY COLLABORATIVE COMMUNITY In 2020, MDIC launched the Case for Quality Collaborative Community program, which FDA

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• Case for Quality Collaborative Community

• Cybersecurity • External Evidence Methods • Pathology Innovation Collaborative Community

later recognized as a collaborative community and joined as a participant. The Case for Quality Collaborative Community brings together the FDA and other medical device stakeholders to enhance device quality and patient safety through recognition and support of best practices for consistent quality manufacturing. This program allows the FDA to identify high-quality device manufacturers and allocate its resources to assist device manufacturers in increasing their quality.

The FDA is committed to working with diverse stakeholders to help ensure that patients and healthcare providers have access to safe, effective, and high-quality medical devices…We continue to believe that collaborative communities can contribute to improvements in areas affecting patients and healthcare in the United States.

— FRANCISCO VICENTY Case for Quality Collaborative Community program manager, CDRH, FDA

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MDIC ANNUAL REPORT 2020

Culture of Quality Workstream The Leadership Engagement Playbook, part of the culture of quality workstream, highlights best practices and tools to help leaders move their companies from a culture of compliance to a culture of quality. The playbook: • Describes 10 best practices for a culture of quality • Helps leaders determine which concepts, processes, techniques, and practices to implement • Provides a framework for piloting the best practices

Corrective and Preventive Action Process Improvement Pilot Study The CAPA (Corrective and Preventive Action) Process Improvement Pilot Study, launched in 2020, enrolled more than 20 device manufacturers. The pilot study seeks to recast the CAPA process as a continuous improvement process and make it less burdensome while also driving higher product quality. It is based on a prior MDIC white paper on CAPA process improvement.

Accelerate Sustainable Capability Pilot Study Designed to help device manufacturers improve performance and compliance, the Accelerate Sustainable Capability (ASC) Pilot Study was launched in 2020. Developed in collaboration with the medical device industry, the Information Systems Audit and Control Association, and FDA, the pilot study is open to device manufacturers that: • Self-identify major deficiencies with the quality system regulation • Received an FDA Form 483 during a recent inspection, or • Received an FDA advisory action

Three device manufacturers enrolled in the study in 2020.

MDIC also published the Accelerate Sustainable Capability (ASC) Pilot Study: Pilot Site Playbook and held a webinar about the ASC Pilot Study. The playbook provides details about the ASC Pilot Study, including initial and ongoing activities, FDA inspections, confidentiality controls, and handling of safety issues.

Medical Device Information and Sharing Project The Medical Device Information and Sharing (MDIAS) project, launched in 2020, focuses on improving healthcare outcomes by building a data-sharing collaboration to analyze and share medical device data from various public and nonpublic sources. An independent, trusted third party will collect and analyze these data, which can be used to identify trends in and provide insights on device quality and safety.

Advanced Manufacturing Landscape Analysis The Advanced Manufacturing Landscape Analysis will support the establishment of an Advanced Manufacturing Clearinghouse program. Industries such as aerospace, defense, automotive, and commercial semiconductor are being analyzed to identify advanced technologies and methods that support more integrated, effective and efficient, less costly and less burdensome design, manufacturing, supply chain, quality, and regulatory operations than the medical device industry. The analysis will be completed in 2021.

We recognize that every company has a unique culture and set of challenges, which is why it was critical for this [leadership engagement] playbook to offer a customizable set of solutions.”

—PAMELA GOLDBERG MDIC President and CEO

MDIC ANNUAL REPORT 2020

Voluntary Improvement Program Working Groups

ENRICHMENT Industry Advisory Council

MDIC relaunched the Voluntary Improvement Program working groups, which focus on enhancing participation in and the benefit of the Voluntary Improvement Program by leveraging a proven maturity model.

The ENRICHMENT in Silico Clinical Trial (ENRICHMENT) is a collaborative research project led by investigators from FDA and Dassault Systèmes along with a wide range of stakeholders from industry, academia, and healthcare delivery organizations. The project aims to use the Living Heart simulated 3D heart model to examine the use of heart simulation as a source of digital evidence for new cardiovascular device approvals.

Two Case for Quality Forums Case for Quality forums provide updates on the activities of the Case for Quality Collaborative Community. In 2020, MDIC held two forums.

COMPUTATIONAL MODELING AND SIMULATION Computer modeling and simulation can facilitate the development of medical devices in a responsible, patient-sparing way that balances the desire for certainty in the device performance and limiting the delay in patient access associated with increased certainty. The Computer Modeling and Simulation Program explores ways to use computer modeling and simulation as valid scientific evidence for medical devices, with a focus on validation requirements for demonstrating regulatorygrade simulation results.

MDIC is coordinating an industry advisory council to provide an industry perspective on new clinical trial methodology and tools being developed through ENRICHMENT. The council will provide guidance and input on the relevance and utility of ENRICHMENT’s approaches to the regulatory process.

Survey on 5-Year Roadmap MDIC is developing a revised 5-year strategic roadmap for the Computational Modeling and Simulation Program. The roadmap will determine the milestones needed to achieve quick and predictable access for patients to innovative, yet safe and effective technologies enabled by computational modeling and simulation evidence. MDIC conducted a survey to gain stakeholder input for the roadmap.

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MDIC ANNUAL REPORT 2020

CYBERSECURITY Device manufacturers must address cybersecurity as part of their ongoing efforts to ensure the safety and effectiveness of medical devices across their lifecycle. MDIC’s Cybersecurity Program focuses on identifying priorities to help the medical device industry ensure device safety and effectiveness.

Threat Modeling Project: Training and Playbook With funding from FDA, MDIC is providing training and developing a playbook to help device manufacturers manage cybersecurity risks throughout the device lifecycle. First, MDIC held a “train-the-trainers” program to develop experts within the industry who can train others to ensure structured, systematic, and comprehensive approaches to threat modeling in device development.

Then MDIC held the first of two threat modeling bootcamps, a free five-day intensive workshop for technical and regulatory professionals. The second bootcamp will be held in 2021.

Also, MDIC started work on a threat modeling playbook in collaboration with the MITRE Corporation. The playbook will serve as a blueprint to strengthen security throughout the total product life cycle.

MedTech Industry Benchmarking MDIC is working with medical device manufacturers to reduce overall cybersecurity risk by developing a common method and rubric to measure cybersecurity maturity and benchmark across the medical technology industry. As part of this project, MDIC will publish a benchmark report baselining the industry’s cybersecurity maturity.

This project is a natural next step to the MedTech Joint Security Plan and will leverage its guidance to enable medical technology companies, healthcare delivery organizations, and other stakeholders to establish long-term strategic plans to increase their cybersecurity maturity and track their progress. MDIC released a request for proposals to recruit a partner to assist in collecting, synthesizing, and reporting on healthcare industry maturity data and learnings received from medical device companies that leverage the MedTech Joint Security Plan.

EXTERNAL EVIDENCE METHODS The External Evidence Methods (EEM) program aims to establish a more predictable pathway for use of EEM to support regulatory decisions and decisions by medical device manufacturers. EEM include the use of innovative (Frequentist/Bayesian) methods and catalog existing methods for fusing evidence from data external to a clinical trial. External data include RWD, RWE, engineering modeling and simulation, and similar device clinical trial data.

External Evidence Methods Framework The External Evidence Methods Framework helps stakeholders navigate their way through the nuts and bolts of leveraging external data.

It catalogs different sources of external data and some traditional and novel statistical methods applicable to the design and analysis of a clinical study in which external data play a role. The framework also provides references to actual past studies leveraging external data in which some of these statistical methods were successfully applied to support the approval or clearance of medical devices, or the modification of their indications.

MDIC ANNUAL REPORT 2020

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PATHOLOGY INNOVATION COLLABORATIVE COMMUNITY The Pathology Innovation Collaborative Community, launched in 2020, is a regulatory science initiative that aims to modernize the clinical practice of pathology by: • Facilitating innovations in digital pathology • Advancing evaluation of safety and effectiveness • Harmonizing approaches The collaborative community, comprising stakeholders including FDA, academia, industry, healthcare providers, patients, and advocacy groups, works in the pre-competitive space. Its work will include: • Digital pathology, including but not limited to machine learning and artificial intelligence • Imaging informatics • Engineering • Computational and data sciences • RWD/RWE research Participants will develop key performance indicators to monitor and communicate progress on how pre-competitive regulatory science can drive innovation in pathology.

“To improve patient care, we need to apply the best possible science as an input into regulatory activities. Many experts have recognized this tremendous opportunity and contributed to create this community.”

— JOE LENNERZ, MD, PHD Medical Director, Center for Integrated Diagnostics, Massachusetts General Hospital Associate Professor, Harvard Medical School

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MDIC ANNUAL REPORT 2020

HEALTH ECONOMICS AND PATIENT VALUE The Health Economics and Patient Value initiative focuses on speeding up patient access to medical devices and amplifying the patient voice in selection of treatment options by: • Creating predictable and transparent evidence requirements for coverage • Improving pathways for coverage, coding, and payment

2020 HEALTH ECONOMICS AND PATIENT VALUE YEAR IN REVIEW Stakeholder Meeting MDIC brought stakeholders together for a meeting to discuss the role of RWE in coverage and payment decisions for devices and diagnostics. Participants included the Centers for Medicare & Medicaid (CMS), commercial payers, and several health technology assessment organizations. The meeting created the foundation for a public forum to be conducted in 2021.

Interviews With Stakeholders The Patient Preference Research Working Group commissioned a series of confidential interviews with a number of payers and health technology assessment organizations to understand if and how they use patient

preference information in their evidence and coverage recommendations. Analysis of the interviews identified opportunities for education and communication.

New Vice President MDIC welcomed Jo Carol Hiatt, MD, MBA, as vice president of the Health Economics and Patient Value (HEPV) initiative. Dr. Hiatt brings 30+ years of experience working both directly with patients and from the administrative perspective to improve their access to innovative medical care. She has worked closely with FDA, researchers, clinicians, policymakers, and other stakeholders to review and assess health technologies for both public and private coverage.

An approved or cleared device without reimbursement doesn’t benefit patients. MDIC’s HEPV initiative facilitates conversations with payers and other members of the ecosystem to better understand evidence requirements for payer coverage decisions so we can improve patient access.

—JO CAROL HIATT, MD, MBA Vice President, Health Economics and Patient Value

MDIC ANNUAL REPORT 2020

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2020 NESTCC YEAR IN REVIEW Enabling Sponsored Research

NATIONAL EVALUATION SYSTEM FOR HEALTH TECHNOLOGY COORDINATING CENTER (NESTCC) The NESTcc initiative works with stakeholders across the medical device ecosystem, including FDA, to catalyze the timely, reliable, and costeffective development of RWE to enhance regulatory and clinical decision-making. NESTcc serves as a: • Coordinating center, established by the FDA, offering services to organizations seeking to sponsor medical device and technology research based on high-quality RWD • Collaborative community working together to unite stakeholders around common needs and initiatives

High-quality evidence is needed to inform clinical decisionmaking and keep patients safe. NESTcc is at the forefront driving transformative and scientifically sound research, and the ecosystem stands to benefit from the evidence resulting from NESTcc’s growth.

—ADRIAN HERNANDEZ, MD, MHS Professor of Medicine, Duke School of Medicine, Vice Dean and Executive Director, Duke Clinical Research Institute Chair, NESTcc Governing Committee

Early NESTcc work has demonstrated the use of and provided proof of concept for reliable, relevant, and timely RWE in medical device development and evaluation.

NESTcc established a research network of internationally recognized institutions with access to robust RWD and launched 21 testcase research projects across multiple device types, regulatory pathways, and disease areas.

In June 2020, NESTcc opened access to its research network for sponsor-funded research projects. Sponsors, including industry, regulators, patient groups, payers, and other organizations, can conduct RWE research through NESTcc to evaluate medical devices across the total product life cycle. NESTcc connects sponsors with expert investigators and diverse sets of RWD, guiding research through strategic consulting to ensure that project milestones and evidentiary requirements are met, using our Quality and Methods frameworks.

NESTcc Collaborative Community The NESTcc Collaborative Community also advanced its work in 2020, announcing its yearone focus on the adoption of unique device identifiers (UDI). Comprising representatives from across the medical device ecosystem, the NESTcc Collaborative Community develops thought leadership and understanding on important initiatives. The community: • Identifies issues for collective action • Convenes stakeholders to build evidence and develop strategy • Engages the ecosystem to act upon recommendations, standards, and implementation guidelines • Monitors the impact of the work

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MDIC ANNUAL REPORT 2020

Two New Frameworks NESTcc released its Research Methods Framework and Data Quality Framework in 2020. The frameworks build upon existing bodies of work and leverage the knowledge and experiences of NESTcc subcommittee members. They serve as guides for medical device ecosystem stakeholders seeking to collaborate with NESTcc to ensure the quality of data and research methodology.

NESTCC RESEARCH METHODS FRAMEWORK The NESTcc Research Methods Framework promotes the overall design, execution, and evaluation of research studies with RWD. It outlines key principles and evidentiary requirements for disease and device information, target population and patient selection, study outcomes and procedures, monitoring, and statistical analysis.

NESTCC DATA QUALITY FRAMEWORK The NESTcc Data Quality Framework focuses primarily on the use of electronic health record (EHR) data in the clinical care setting.

The framework considers data governance,

characteristics, capture, transformation, and curation, as well as other topics. Within the framework, the NESTcc allows collaborators to indicate progress toward achieving optimal data quality.

New and Expanded Working Groups To support its growing active surveillance efforts, NESTcc established two new working groups in 2020: • IT Cloud Working Group • Active Surveillance Methodology Working Group The IT Cloud Working Group is charged with designing and building the active surveillance cloud infrastructure platform that will be used to facilitate the collection and analysis of RWD for medical device safety signal detection and assessment. The Active Surveillance Methodology Working Group is charged with providing oversight and methodologic expertise as we build our cloud infrastructure, determining the strengths and weaknesses of currently used safety signal detection methodology.

From using artificial intelligence and machine learning for active surveillance to evaluating digital health tools for patient care, NESTcc is leading initiatives at the forefront of state-of-the-science, RWE clinical research for digital health technologies.

—SANDRA SIAMI, MPH Senior Vice President, NESTcc

MDIC ANNUAL REPORT 2020

Expansion of Governing Committee NESTcc expanded stakeholder perspectives on its governing committee by adding two new members representing digital health: David Feygin, PhD, MBA, chief digital health officer and vice president of IT digital health at Boston Scientific, and David Rhew, MD, chief medical officer and vice president of healthcare, Worldwide Commercial Business at Microsoft. Doctors Feygin and Rhew will help inform NESTcc’s approach to guiding work involving digital health tools.

NEST Forum The virtual NEST Forum included presentations of scientific findings from five of NESTcc’s RWE Test-Cases and provided a platform for stakeholders to learn about NESTcc’s research network and collaboration opportunities. The Forum also covered NESTcc’s progress toward fulfilling its Medical Device User Fee Amendments (MDUFA) IV commitments.

First International Network Collaborator NorthWest EHealth (NWEH) and Discover-NOW, the Health Data Research Hub for Real World Evidence, formed a partnership with NESTcc in 2020. Based in the United Kingdom, NWEH and Discover-NOW became the first international Network Collaborator to join the NESTcc Research Network.

New Senior Vice President Flora Sandra Siami, MPH, joined MDIC as senior vice president of NESTcc. She is guiding the strategy and operations for NESTcc programs and leading NESTcc’s efforts to become a trusted platform in the timely generation of RWE and a key partner in solving premarket and postmarket challenges in the medical technology space.

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MDIC ANNUAL REPORT 2020

ANNUAL PUBLIC FORUM

ANNUAL PUBLIC FORUM ATTENDANCE

The Annual Public Forum brings together MDIC members and the broader medical device and diagnostics community to discuss current trends in regulatory science and highlight the development of innovative regulatory science tools.

When the COVID-19 pandemic struck the United States in Spring 2020, MDIC had to quickly pivot and transition the 2020 Annual Public Forum from a live event to a series of virtual webinars held from June 18, 2020, to September 24, 2020.

60% FIRST-TIME ANNUAL PUBLIC FORUM ATTENDEES Headlined by a fireside chat with FDA Commissioner Stephen Hahn, MD, and featuring a CDRH Town Hall, the virtual Annual Public Forum drew 1,197 attendees.

Other covered topics included: • Cybersecurity • Case for Quality • Computational Modeling and Simulation

EVENTS

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• External Evidence Methods for Regulatory Decision-Making • NESTcc • Patient Preferences • RWE

11% 21%

41%

27% n

Government, academic, nonprofit, hospital

n

Non-member

n

Industry member

n

Other

MDIC ANNUAL REPORT 2020

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OTHER MDIC EVENTS MDIC’s initiatives and programs also held information sessions, forums, workshops, and other events.

222

119

46

Advancing EUA IVD Products Toward Full Marketing Status (in person)

ACCELERATE SUSTAINABLE CAPABILITY (ASC) INFORMATION SESSION

SCIENCE OF PATIENT INPUT

REPORT: COMMUNICATING BENEFIT/RISK FOR MEDICAL DEVICES WEBINAR INFORMATION SESSION

68

PARTICIPANTS IN OTHER MDIC EVENTS

79

MDIC | FDA WORKSHOP:

CASE FOR QUALITY FORUM (MARCH)

195

CASE FOR QUALITY FORUM (DECEMBER)

137

MDICX:

IVD RWE Draft Framework Public Comment

114

EST N COLLABORATIVE COMMUNITY: Emerging Issues in UDI Webinar

304

NESTCC FORUM

MDIC ANNUAL REPORT 2020

MEMBERSHIP

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MDIC members are leaders in the medical technology industry. MDIC focuses on providing patients with access to innovative medical technologies, so many of our members are companies that can help us do this. Member organizations are substantially involved in: • Medical and/or medical device research, development, treatment, or education • Promotion of public health, or • Regulatory science In 2020, MDIC welcomed 10 new members, including its first patient advocacy member.

MDIC ANNUAL REPORT 2020

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MDIC ANNUAL REPORT 2020

FINANCIAL INFORMATION

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INCOME

84%

15%

Grant Revenue

Membership

0.46%

.05%

Other

Project

EXPENSES

54%

3%

.68%

Operations/Management

Rent/Facilities

Meetings/Events

40%

1.9%

Project

Other

MDIC ANNUAL REPORT 2020

PAGE 23

MDIC STAFF Carol Allis Associate General Counsel

Taylor Jackson, PMP Senior Communications Manager

Tom Anderson Communications Manager, NESTcc

Dure Kim, PharmD Research Scientist, NESTcc

Zafar Azam Project Manager

Doug Kurschinski, MBA Director of Operations, NESTcc

Omar Badawi, PharmD, MPH, FCCM Director of Medical Device Safety

Sarah Mazzatenta Systems Coordinator, NESTcc

Tariq Bahich, MBA Controller

Sean McNabb, MA Director of Marketing, NESTcc

Alan Baumel Program Director, Advanced Manufacturing

Brandon Miller Operations Manager

Alexis Blyther, MBA Project Manager, HEPV

Alex Mills Executive Assistant

Aurelia Brooks Project Coordinator II, NESTcc

Liz Morgan Senior Business Development Manager, NESTcc

Keondae Ervin, MS Project Manager

Kanessa Pryor Executive Assistant, NESTcc

Lenwood Faulcon, Jr, MS, JD General Counsel

Liliana Rincon-Gonzalez, PhD Program Director, Clinical Science

Jessica Gasvoda Senior Project Manager, NESTcc

Leo Rivoal Marketing Coordinator

Robert Giffin, PhD Director of Research, NESTcc

Nicole Sansbury Senior Project Manager, NESTcc

Pamela Goldberg, MBA President and CEO

Joseph Sapiente Associate Vice President, Case for Quality

Sharon Graves, MBA Subaward Manager, NESTcc

Flora Sandra Siami, MPH Senior Vice President, NESTcc

LaTara Henry AVP, Human Resources

Richard Smith, MBA Director of Business Development, NESTcc

Jo Carol Hiatt, MD, MBA Vice President, HEPV

Desiree Steele Program Manager

Carolyn Hiller, MBA Program Director, Clinical Diagnostics

Calla Thompson, MA Marketing Manager, NESTcc

Jordan Hirsch Project Manager, NESTcc

Jithesh Veetil, PhD Program Director, Data Science and Technology

Jon Hunt, PhD Vice President, Clinical Science and Technology

Sherelyn White Recruiter/Human Resources Manager MDIC Staff as of May 17, 2021

BOARD OF DIRECTORS

PAGE 24

MDIC ANNUAL REPORT 2020

Andrew Cleeland

Steve Ferguson

Rick Geoffrion

Pamela Goldberg, MBA

Chip Hance

Jijo James, MD, MPH

Tamara Syrek Jensen, JD

Gary Johnson

Krishna Kandarpa, MD, PhD

CEO | Fogarty Institute for Innovation

President and CEO | MDIC

Director, Coverage and Analysis Group (CAG) | Centers for Medicare & Medicaid Services (CMS)

Samrat (“Sam”) S. Khichi, JD, MBA

Executive Vice President and General Counsel | BD

Chairman of the Board | Cook Group Incorporated

CEO | Regatta Medical

Vice President, Regulatory Affairs, Clinical Research and Health Economics & Reimbursement | Abbott

Richard E. Kuntz, MD, MSc

Senior Vice President, Chief Medical and Scientific Officer | Medtronic, Inc.

President and CEO | Cyrano Therapeutics, Inc.

Chief Medical Officer, Medical Devices | Johnson & Johnson

Director, Research Sciences and Strategic Directions | NIBIB, NIH

Michael R. Minogue

President, CEO, and Chairman | ABIOMED

MDIC ANNUAL REPORT 2020

Shacey Petrovic

Jody Powell

Peter Saltonstall

Randall Schiestl

Jeffrey Shuren, MD, JD

Jean R. Slutsky, PA, MSPH

Nadim Yared

Wes Cetnarowski, MD

Esther Krofah, MPP

Director, President and Chief Executive Officer | Insulet

Vice President, Global Technology | Boston Scientific Corporation

President and CEO | CVRx

Vice President, Global Regulatory Affairs and Quality Assurance | Stryker

Director, Center for Devices and Radiological Health (CDRH) | Food and Drug Administration (FDA)

SVP Scientific Affairs & Chief Medical Officer | B. Braun USA Medical

President and CEO | National Organization for Rare Disorders (NORD)

Chief Engagement and Dissemination Officer; Program Director | PCORI

Executive Director | Faster Cures, a Center of the Milken Institute

PAGE 25

MEDICAL DEVICE INNOVATION CONSORTIUM ANNUAL REPORT 2020 1501 Wilson Blvd. Suite 910 | Arlington, VA 22209 202.828.1600 info@mdic.org www.mdic.org