2019 MDIC Annual Report

MEDICAL DEVICE INNOVATION CONSORTIUM

ANNUAL REPORT 2019

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MDIC 2019 ANNUAL REPORT

TABLE OF CONTENTS A LETTER FROM THE MDIC PRESIDENT & CEO AND THE MDIC BOARD CHAIRMAN. . . . 4 MDIC’S INITIATIVES AND PROGRAMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Clinical Science . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Clinical Diagnostics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Early Feasibility Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Science of Patient Input. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Data Science and Technology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Case for Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Computational Modeling & Simulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Cybersecurity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 External Evidence Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Health Economics and Patient Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 The National Evaluation System for health Technology Coordinating Center (NESTcc). . . 14

EVENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 MEMBERSHIP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 FINANCIAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 STAFF. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 BOARD OF DIRECTORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

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MDIC 2019 ANNUAL REPORT

A LETTER FROM THE MDIC PRESIDENT & CEO AND THE MDIC BOARD CHAIRMAN Dear MDIC members, partners and stakeholders, We would like to thank you for another year of your support and commitment to our shared mission of advancing medical device regulatory science for patient benefit. We continue to experience strong growth within our organization, which demonstrates our positive impact on the medical device ecosystem. The expansion of our programs and initiatives also represents our adaptability to an ever-changing landscape in the MedTech industry and sets us up to best serve patients, our members, and the medical technology community as a whole.

This 2019 Annual Report showcases both quantitative and qualitative accomplishments as well as opportunities for us to lean into our strengths and assets to solve critical challenges in medical device regulatory science. Some of the key highlights of this report include the expansion of our Case for Quality and cybersecurity programs, completion of new harmonized education materials for the use of surrogate samples, publication of several patient engagement resources, and FDA’s recognition of NESTcc as a Collaborative Community.

We want you to read this report to share in our enthusiasm for the important work we do while recognizing that our work is never finished. Our accomplishments would not be possible without the hard work and expertise from our partners across industry, academia, government, healthcare systems, and patient advocacy groups. We look forward to leveraging our shared knowledge and resources to continue to provide patients with access to innovative, safe, and effective medical technologies.

Sincerely,

Nadim Yared President & CEO, CVRx MDIC Chairman

Pamela Goldberg President & CEO, MDIC

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MDIC 2019 ANNUAL REPORT

MDIC’S INITIATIVES AND PROGRAMS MDIC operates initiatives focused on four key areas: Clinical Science, Data Science and Technology, Health Economics and Patient Value, and the National Evaluation System for health Technology Coordinating Center (NESTcc).

Here we present 2019’s updates and accomplishments of each initiative and the programs that fall within the initiatives, when applicable.

CLINICAL SCIENCE The Clinical Science initiative, which is foundational to us as an organization, addresses the 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 design, and encouraging the collection of adequate and appropriate clinical and patient preference data.

Programs: • Clinical Diagnostics • Early Feasibility Studies • Science of Patient Input

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MDIC 2019 ANNUAL REPORT

professionals on how to use the framework.

The modules include recommendations on how to use the framework and case studies for selecting surrogate samples.

IVD Clinical Evidence Framework Published

A panel at MDIC’s 2019 Annual Public Forum discusses “SHIELD: Leading the way to IVD Semantic Interoperability”

2019 Clinical Science Year in Review: CLINICAL DIAGNOSTICS The Clinical Diagnostics initiative focuses on projects that are intended to improve diagnostic testing and product development using novel regulatory science approaches developed through collaboration among MDIC stakeholders. Providing a predictable path for innovation will help patients benefit through quicker access to more costeffective advanced diagnostic technologies.

Harmonized Education for Surrogate Samples Completed The MDIC Surrogate Samples Framework proposes uniform terminology and recommendations where surrogate samples might be justifiably used in IVD validation studies. In 2019, our harmonized education materials for FDA and industry were completed. These modules are intended to provide the same education to FDA reviewers, industry R&D, and regulatory

The Framework for Developing Clinical Evidence for Regulatory and Coverage Assessments in In Vitro Diagnostics (IVDs) was completed and released.

This framework is intended to help IVD manufacturers make decisions on how to develop credible evidence of analytical validity, clinical validity, and clinical utility.

As part of the communication efforts for the Framework, MDIC participated in a poster presentation at the American Association of Clinical Chemistry Annual Scientific meeting and organized a panel discussion with representatives from FDA, payers, and industry at the Regulatory Affairs Professionals Society annual meeting.

Phase I Milestones Reached in Cancer Genomic Somatic Reference Samples (SRS) Project The goal of the SRS project is to create physical reference samples that can be made available to the public to improve the accuracy, reliability, and transparency of Next Generation Sequencing (NGS)based oncology tests. In 2019, a landscape analysis report, Somatic Variant Reference Samples for NGS, Landscape of Available Reference Samples, was released at the American Association of Cancer Research meeting and the SRS Prioritized Variant List was published and released. A request for information leading to the creation of a request for proposals (RFP) was completed.

The committee continues to make its selection of vendor(s) to manufacture the somatic reference samples.

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MDIC 2019 ANNUAL REPORT

EARLY FEASIBILITY STUDIES The Early Feasibility Studies (EFS) program aims to develop tools and best practices for EFS for sponsors and clinical researchers in order to drive overall EFS efficiency and support continuous assessment of EFS efficiency and effectiveness for US patients.

Recruitment for EFS Demonstration Pilot Completed By the end of 2019, 31 sites and 15 sponsors were enrolled in the MDIC EFS Site Network Demonstration Pilot.

MDIC’s role is to connect EFS sponsors and sites, provide EFS tools, and collect and disseminate metrics on EFS studies, tool implementation, and impact. The EFS Working Group will use those trends and data from the pilot to update EFS tools and best practices to further facilitate U.S. patient first-in-world access to innovative medical technologies.

MDIC EFS Site Network Demonstration Pilot Enrollment in 2019

31 Sites

15 Sponsors

EFS Newsletter Launched EFS Express—a monthly email newsletter— was launched and 11 editions were published. EFS Express is a mechanism by which to engage and inform the EFS community with updates on the EFS Site Network Demonstration Pilot, educational materials, and event schedules and recaps.

2017/2018 EFS Metrics Collected To understand the evolution of the EFS landscape, MDIC repeated the exercise of gathering EFS performance metrics from sponsors including IDE, IRB approval, contract execution, budget execution and first patient enrollment timing. Sponsors provided data from nine early feasibility studies conducted at 60 sites. The recent data showed a two-month reduction in time from IRB approval to first patient enrollment. However, the total average time of approximately eight months greatly exceeded MDIC’s target of four months. Additionally, contract and budget negotiations between sites and sponsors remained a challenge and thus remain a focus area for the EFS program.

Master Clinical Trial Agreement Template Revision MDIC and Baylor Scott & White Research Institute hosted a virtual roundtable to further refine the EFS Master Clinical Trial Agreement (MCTA) template. A revised version of the template was released in 2019.

Communications Activities As part of the EFS communication efforts, a number of workshops, meetings, and webinars on various topics were held, including site best practices and IRB/ICF workshops, a metrics presentation at the MDIC Annual Public Forum, a virtual legal roundtable focused on contracting, and a symposium on implementation strategies for EFS held at the Transcatheter Valve Therapies Structural Heart Summit.

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MDIC 2019 ANNUAL REPORT

SCIENCE OF PATIENT INPUT

Draft Report Completed on Research Collaboration to Move Clinical Trials from Generic p-value of 0.05 to TherapySpecific Patient-Values

The Science of Patient (SPI) Input program aims to advance the art and science of patient engagement in regulatory science, including advances in methodologies and tactical considerations for integrating the patient’s perspective and preferences in the design, clinical development, and regulatory review of innovative medical technologies.

In 2018, collaborators from MDIC, FDA, MIT, RTI Health Solutions, and the Michael J. Fox Foundation for Parkinson’s Research completed a patient preference study in persons with Parkinson’s disease and used the data from that preference study to test the MIT model for using patient preference information to set the p-values of a clinical trial. In 2019, the MDIC SPI Statistics and Outcomes Working Group developed a draft report in collaboration with the Center for Medical Technology Policy (CMTP) to document lessons learned from this project, including guidelines to integrate patient preferences in the statistical design of clinical trials.

Several Patient Engagement Resources Published SPI working groups published several draft and final resources: • Landscape Literature Review of Existing Work in Patient Engagement in Clinical Trials • Survey Report on Patient Engagement in Clinical Trials

Milestones Achieved in Heart Failure Project

• Best Practices for Communicating Benefit, Risk, and Uncertainty (Draft Report) • Development and launch of survey of patient engagement methods used by the Patient-Centered Outcomes Research Institute (PCORI)-funded medical device researchers Patients shared their unique experiences with medical devices and their perspectives on the medical device industry at MDIC’s 2019 Annual Public Forum.

In 2018, SPI launched an engagement to understand patient preferences in patients with heart failure. In 2019, MDIC partners, medical device manufacturers, heart failure patients, and patient preference experts selected a target study population, the recruitment strategies and types of treatments to be compared in the study with appropriate heart failure study attributes, developed the study protocol, and completed pretesting of the preference survey instrument.

Communications Activities Representatives of MDIC’s SPI program had the opportunity to present at a Patients as Partners conference, the Association of Clinical Research Professionals conference, the MedTech conference, the World Parkinson’s Congress, the Excite International Summit, and the Professional Society for Health Economics and Outcomes Research.

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MDIC 2019 ANNUAL REPORT

DATA SCIENCE AND TECHNOLOGY The Data Science and Technology initiative works to fulfill the promise of advances in data analysis by creating tools and methods to use advanced data analysis techniques and new technology to accelerate the collection of clinical data, remove barriers to patient access, and monitor product safety, quality, and effectiveness.

Programs: • Case for Quality • Computational Modeling & Simulation • Cybersecurity • External Evidence Methods

2019 Data Science and Technology Year in Review: The Data Science and Technology Advisory Committee was formed in November 2019 to gather input from government, industry, and non-profit stakeholders to identify high-value data science and technology initiatives and recommend strategic priorities and future directions for MDIC. The committee will focus on modeling and simulation, external evidence methods, cybersecurity, interoperability, artificial intelligence and machine learning, and other technology-based initiatives for devices and diagnostics. In 2020, the committee will develop a multi-year roadmap with recommended areas of focus required to advance regulatory science for patient benefit. The current committee will serve a two-year term.

CASE FOR QUALITY MDIC’s Case for Quality (CfQ) is setting a cultural shift in motion to focus the medical device ecosystem on sustained product quality that enhances patient safety and outcomes and adds value to stakeholder organizations. Through the collaboration of ongoing working groups, representatives from FDA and medical device manufacturers of every size are developing practices, tools, and metrics to enhance product design and manufacturing processes and inform regulatory practices.

Case for Quality Voluntary Improvement Program Governance and Charter Established A governing committee, charter, and initial membership were established. The number of active participants increased to 59 active sites across 27 companies. Of the active sites, 39 percent are located internationally (outside of the United States) and 7 percent are recognized by FDA as small businesses.

CfQ Governance by the Numbers

59 Sites 27 Companies 39% International 7% Small Business PAGE 9

MDIC 2019 ANNUAL REPORT New CfQ Working Groups Created Seven new working groups were launched to address the following needs within the Voluntary Improvement Program: • Additional Regulatory Benefits • Performance Measures • Reappraisals • Multi-Site Appraisals • Medical Device Context • Program Features • EU Agencies

Communications and Training Activities Program representatives convened a wide variety of events: three CfQ forums, a presentation at the MDIC Annual Public Forum, two CfQ webinars, bi-weekly VIP Alignment and VIP Appraiser calls, and monthly participant calls. The team trained an additional 35 industry staff and 16 FDA staff on internal appraisals.

#makeCAPAcool (CAPA Process Improvement) Program CAPA Framework Published Stakeholders developed and aligned around a new framework to recast the Corrective and Preventive Action (CAPA) process as a Continuous Improvement process and to design a less burdensome process that drives higher product quality and improved patient safety. The Framework summarizes the team’s initial findings and recommendations, including a proposed framework for risk-based improvement.

Strategy for New CAPA Framework Designed The strategy includes pilot site selection, a formal pilot playbook, standardized data collection systems, regulatory change management strategy, and an audit

memo to communicate the Framework to regulators evaluating a site’s CAPA process.

Accelerated Sustainable Capability Pilot Study Program Launch Milestones Achieved The Accelerated Sustainable Capability pilot study tests the expansion of the Case for Quality Voluntary Improvement Program to aid underperforming medical device manufacturing sites. Following the approval of a Broad Agency Award, a team consisting of MDIC, FDA, and industry was formed. Through a series of face-to-face meetings, they evaluated various elements of the pilot study in detail and aligned around strategy for a successful study. Site enrollment into the pilot study is expected to begin in summer 2020.

C-Suite Leadership Engagement Leadership Engagement Workstream Developed The Leadership Engagement Working Group focuses on promoting quality as a strategic priority for all parts of an organization through strong leadership, strategic alignment, and tone at the top. The working group identified and aggregated best practices across ten companies, including communications, behaviors, metrics, and strategy, and is in the process of developing a draft of the playbook to aid executive leaders in establishing a healthy and effective culture of quality within their organization.

Quality as a Career Mission Statement Developed The mission of the Quality as a Career program is to accelerate the next generation of critical-thinking professionals grounded in the science of quality by immersing students in real-world

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MDIC 2019 ANNUAL REPORT

experiences, thus engaging students in “Quality as a Career.”

Pilot Program Initiated at Xavier University Thirteen students enrolled in the webbased Global Regulatory and Legal Requirements of Quality course at Xavier University. More than 90 industry volunteers taught, graded homework and exams, and mentored the students. Students from 16 universities around the world enrolled in the January 2020 cohort. AstraZeneca and Merck signed on to teach the programs on campus at Xavier University and La Salle University, respectively.

COMPUTATIONAL MODELING & SIMULATION

CYBERSECURITY MDIC recognizes that cybersecurity is critical infrastructure for the United States. Cybersecurity threats can have a debilitating effect on security, national economic security, and national public health and safety. As such, MDIC is focused on making meaningful contributions to advance cybersecurity as it relates to medical devices.

MDIC Awarded FDA Grant for New Cybersecurity Resources

The ENRICHMENT in silico Clinical Trial Project Launched MDIC is now a part of the ENRICHMENT in silico Clinical Trial Project—a shared mission among leading cardiovascular researchers, educators, medical device developers, regulatory agencies, and practicing cardiologists to develop and validate highly accurate personalized digital human heart models. This is a proof of concept project to further evaluate the use of MDIC Virtual Patients derived using computational modeling and simulation (CM&S).

Good Simulation Practices in Health Technologies

evaluation of health technologies and current simulation practices, as well as gathering input to inform the development of good simulation practice recommendations for the community.

In Sept 2019, FDA awarded a grant to MDIC for a project that will focus on threat modeling for medical devices and diagnostics. MDIC, in collaboration with FDA, will work with cybersecurity experts from the medical device industry, other industries, academia, and non-profit organizations to develop a threat modeling playbook and a bootcamp series for healthcare stakeholders.

Threat modeling expert Adam Shostack leads a training at MDIC headquarters to prepare subject matter experts to lead cybersecurity threat modeling bootcamps that will be hosted by MDIC in 2020.

MDIC in partnership with FDA and Avicenna Alliance is promoting a discussion around modeling and simulation practices by industry and the development of a framework for evaluating and assessing the utility of computational modeling and simulation in health technologies. A joint workshop is being planned with the key focus on the role of computational modeling and simulation in the regulatory

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Communications Activities Representatives from the Cybersecurity initiative led or participated in panel sessions at the MedTech Conference, Health Sector Coordinating Council Joint Cybersecurity Working Group meeting, and FDA/CMS Summit.

EXTERNAL EVIDENCE METHODS The External Evidence Methods (EEM) initiative aims to establish a more predictable pathway for use of external evidence methods, such as innovative (Frequentist/Bayesian) methods, and to catalog existing methods for evidence fusion from data external to a clinical trial.

These external data include but are not limited to real-world data, Real-World Evidence (RWE), engineering modeling and simulation, and similar device clinical trial data that support regulatory medical device decisions and other stakeholder decisions.

The EEM program builds and expands on the success of MDIC Virtual Patient project and FDA Mock Submission using the Virtual Patient model.

EEM Executives and Fellows Meeting Held In April 2019, the EEM program convened more than 70 subject matter experts from FDA, industry, and non-profit organizations to discuss existing methods and identify gaps for the use of external data. A working group of industry and FDA experts is now developing the MDIC External Evidence Methods Framework, scheduled for release in Spring 2021.

ALLIANCE FOR DIGITAL PATHOLOGY MDIC, as a part of a broader alliance in digital pathology including FDA and the Digital Pathology Association, is working to prioritize the areas of digital pathology and artificial intelligence in which MDIC can bring industry, government, insurance companies, and patients together to collaborate on several new projects. This alliance is a voluntary and temporary collaboration to identify and create concrete, practical deliverables and relevant strategic aims that are of shared interest to the whole field of digital pathology.

Program Updates MDIC participated in initial discussions with FDA in July 2019 and contributed to additional discussions held at the International Digital Pathology Conference (PathVisions) in October 2019. In November 2019, MDIC convened an executives and fellows meeting with more than 60 digital pathology/AI experts from industry, FDA, the National Institutes of Health (NIH), the National Cancer Institute, academia, and patient-advocacy and non-profit organizations including the American College of Radiology, Friends of Cancer Research, and PCORI, to brainstorm strategies for advancing regulatory science for digital pathology.

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MDIC 2019 ANNUAL REPORT

HEALTH ECONOMICS AND PATIENT VALUE MDIC’s Health Economics and Patient Value (HEPV) initiative, previously called Health Economics and Patient Access, was established in 2018. This initiative aims to create predictability and transparency of evidence requirements for coverage, speed patient access, and amplify the patient voice in the selection of treatment options. Building off successful projects in regulatory science, the MDIC Board identified an equally important need to create predictability within CMS and private payer evidentiary processes. HEPV is developing projects and focusing on tools to increase predictability of payer scientific and evidentiary requirements.

MDIC surveyed 34 medical device and diagnostic industry stakeholders on how their companies navigate the coverage process for innovative technologies with public and private payers.

Within the survey responses, MDIC found that the major reimbursement challenges for industry fell in the following categories: • Lack of transparency in private payer evidentiary requirements • Lag between FDA approval and private payer coverage • Lag between CMS coverage decision and coding and/or payment decisions • Patient preference data included in regulatory decision-making is not considered for coverage MDIC also identified the following key factors impacting patient access:

Health Economics and Patient Value: 2019 Accomplishments

• FDA approval or clearance • Private payer coverage

Health Economics and Patient Value Member Survey

• Local coverage

Following initial meetings to define the objectives of the HEPV initiative, understand reimbursement challenges, and gather priority areas for engagement, the HEPV steering committee initiated a survey to further define “pain points” with both CMS and private payer coverage processes.

• National coverage These responses will help inform the HEPV committee on where to best collaborate on process improvements and enhancements to coverage decisionmaking methodologies.

Health Economics and Patient Value Member Survey Reimbursement Challenges Lack of transparency in private payer evidentiary requirements

Lag between CMS coverage decision and coding and/or payment decisions

Lag between FDA approval and private payer coverage

Patient preference data included in regulatory decision-making is not considered for coverage

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Creation of Initial Working Groups The HEPV Steering Committee has developed three working groups to facilitate projects within this initiative aligned with three broad areas of focus where MDIC can make an impact within the RWE space. These working groups collaborate in the areas of RWE, Patient Preference Research, and the development of a playbook on evidentiary requirements that would be useful for industry and expected by payers.

The RWE Working Group is focused on RWE approaches that are scientific and have methodological rigor for use with payers; Payer acceptance and adoption of RWE into coverage and health technology assessment (HTA) evidence standards; and manufacturer awareness of RWE and capacity to develop RWE for coverage, reimbursement, and HTA purposes.

The Patient Preference Research Working Group is exploring methods to provide a more scientific and rigorous way to incorporate what’s important to patients that will better inform the health care decision-making process. The working group is focusing on CMS first then will explore the broader payer community.

The Playbook Working Group is identifying methods and tools to offer direction on evidence requirements that will be useful for industry/expected by payers. This may build on evidence generated for the FDA, but will ultimately go beyond that.

THE NATIONAL EVALUATION SYSTEM FOR HEALTH TECHNOLOGY COORDINATING CENTER (NESTcc) NESTcc works with stakeholders across the medical device ecosystem to catalyze the timely, reliable, and cost-effective development of RWE to enhance regulatory and clinical decision-making.

2019 NESTcc Year in Review: Active Surveillance Task Force Publicly Announced Following receipt of funding from FDA to conduct active surveillance activities and approval by the NESTcc Governing Committee and the MDIC board, NESTcc publicly announced the establishment of a multi-stakeholder Active Surveillance Task Force at the beginning of 2019. This task force will help guide NESTcc on the development of an Active Surveillance Roadmap and a cloud infrastructure system to support active surveillance projects.

Data Quality and Methods Frameworks Published for Public Comment The NESTcc Data Quality Subcommittee and Methods Subcommittee developed initial versions of the Data Quality Framework and Data Methods Framework.

The Frameworks were finalized in the fall of 2019 and are intended to serve as guides for medical device ecosystem stakeholders wishing to collaborate with NESTcc to ensure the quality of data and research methodology.

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Round 2 Test-Cases Announced In June of 2019, NESTcc announced 12 new RWE Test-Cases. This brings NESTcc’s TestCase portfolio to 20 projects that span the Total Project Life Cycle, leveraging multiple data sources, and including technologies of interest across nine disease areas and along the 510(k) and premarket approval regulatory pathways.

Eight of the 20 Test-Cases were launched in 2019.

NESTcc Named as a Collaborative Community NESTcc was announced as one of the first Collaborative Communities with participation by FDA. Collaborative Communities bring together medical

device stakeholders in a continuing forum of private- and public-sector members, which can include FDA, to achieve common outcomes, solve shared challenges, and leverage collective opportunities. FDA’s CDRH decides whether to participate in a Collaborative Community on a case-bycase basis, and the agency’s decision is influenced by the public health impact of the community, its alignment with CDRH’s regulatory mission, current priorities, and resources. NESTcc’s naming and CDRH’s participation were achieved by amending the NESTcc charter to align with the FDA’s Collaborative Communities Toolkit. Under the new charter, governing committee members represent their own perspectives as well as those of their larger communities, with the intention of ensuring diverse and distributed leadership of NESTcc.

NESTcc’s 12 New Real-World Evidence Test-Cases • Assessment of the Value of Electronic Health Records Data for Identifying Implantable Cardiac Lead Failure • Characterization and Utilization of Therapeutic Cardiac Devices in Children with Congenital Heart Disease • Creation of a Patient-facing Mobile App for the SUI Surgery Registry Module within AQUIRE • Developing Objective Performance Criteria for Outcomes After Hip and Knee Replacement • Effect of the Apple Watch ECG and Irregular Rhythm Notification Detection Features on PatientReported Outcomes and Clinical Utilization: A Randomized, Controlled Trial • Estimating and Validating Diagnostic Cancer Biomarker IVD Test Panel Characteristics and Clinical Utility for Indeterminant Pulmonary Nodule Risk Stratification in Patients with Lung Cancer • Pediatric Clinical and Health Services Outcomes following Tympanostomy Tube Insertion • RWE Analysis for Pre-Market and Post Approval Studies of Annular Closure Device • Structured interviews of Lived ExperiencE in Patients (SLEEP study) Obstructive Sleep Apnea and Central Sleep Apnea • Synthetic Mid-Urethral Slings for Stress Urinary Incontinence in Women • Use of Real-World Data to Evaluate Clinical and Patient Outcomes by Use of a Mobile App for the Treatment of Insomnia and Depression • Use of Real-World Evidence to Characterize Patients with Uncontrolled Hypertension

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EVENTS ANNUAL PUBLIC FORUM The Annual Public Forum is an event where representatives from MDIC’s member organizations, along with FDA, CMS, NIH, patient advocacy organizations, and the broader medical device and diagnostic community, gather in our nation’s capital to discuss current trends in regulatory science and report on the progress MDIC has made in the ongoing development of regulatory science tools.

perspectives about what the medical device industry can do to continue to advance the art and science of patient input. FDA Acting Commissioner Ned Sharpless and CDRH Director Jeff Shuren were among the presenters of several topics of interest to the medical device ecosystem.

As MDIC has grown over the years, the Annual Public Forum continues to grow as well, as we provide updates on projects and activities associated with MDIC’s mission to advance medical device regulatory science for patient benefit.

At the 2019 Annual Public Forum, MDIC highlighted progress toward launching NEST 1.0, presented updates on its other initiatives, and convened a CDRH Town Hall and a panel of patients to provide their

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Annual Public Forum Attendance

59 43 34 53 47

Government/Academic

Industry

Non-member Speakers

Networking

MDIC 2019 ANNUAL REPORT

MDICx MDIC’s informative series of online teleconference workshops, the MDICx series, features emerging trends in medical technology regulatory science, MDIC projects, and subject matter experts sharing perspectives, progress, and opportunities.

MDIC held 13 MDICx webinars in 2019 on a range of topics pertinent to its initiatives,

including quarterly updates on the CDRH CfQ pilot, the launch of Clinical Diagnostics resources including the IVD Clinical Evidence Framework, Somatic Reference Samples Landscape Analysis, and Surrogate Samples Harmonized Education, a review of tools for advancing patient-centered medical device trials, EFS site best practices, and a history of RWE.

MDICx Webinars in 2019 • EFS Site Best Practices: Implementation Strategies from the Sponsor Perspective • History of Real-World Evidence: Changes in the Landscape, Challenges to Date, Preparing for the Future • Somatic Reference Samples Request for Proposals Q&A • IVD Clinical Evidence Framework—from the MDIC Clinical Diagnostics IVD Clinical Evidence Working Group • Update on the Case for Quality Voluntary Improvement Program (CFQ VIP) • Surrogate Samples Harmonized Education • EFS Site Best Practices: Lessons Learned from Sites Achieving “60/60/60” • Tools for Advancing Patient-Centered Medical Device Clinical Trials • MDICx: Somatic Reference Samples: Tumor Suppressor & Gene Signature Public Comment Period Announcement • Update on the Case for Quality Voluntary Improvement Program (CFQ VIP) • Somatic Reference Samples RFI Q&A • Overview of the CDRH 510(k) Improvement Project • MDICx: Clinical Dx Somatic Reference Samples Landscape Analysis

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MEMBERSHIP MDIC members are medical device and diagnostic companies of all sizes, government agencies, and patient advocacy groups. MDIC focuses on providing patients with access to innovative medical technologies so many of our members are companies that can help us serve this mission. Member organizations are substantially involved in medical and/or medical device research, development, treatment, or education; the promotion of public health; or regulatory science.

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FINANCIAL INFORMATION INCOME

EXPENSES Grant Revenue

Operations/Management

Membership

Rent/Facilities

Corporate Funding

Meetings/Events

Project

Other

Other

Project

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STAFF Tiffany Abushaikha, MS Senior Project Manager, NESTcc Carol Allis, JD Associate General Counsel Tom Anderson Communications Manager, NESTcc Tariq Bahich, MBA Senior Finance Manager Alan Baumel Program Director, Case for Quality

Sharon Graves, MBA Subaward Manager, NESTcc

Sean McNabb, MA Director of Marketing, NESTcc

Chris Hamilton Director of Business Development

Brandon Miller Operations Manager

LaTara Henry Director of Human Resources Carolyn Hiller, MBA Program Director, Clinical Diagnostics Jordan Hirsch Project Manager, NESTcc

Aurelia Brooks Executive Assistant, NESTcc

Jon Hunt, PhD Vice President, Clinical Science and Technology

Keondae Ervin, MS Project Manager, NESTcc

Taylor Jackson Communications Manager

Lenwood Faulcon, Jr., MS, JD General Counsel

Marlene Jordana, MS Project Manager

Jessica Gasvoda, MPH Senior Project Manager, NESTcc

Dure Kim, PharmD Project Manager, NESTcc

Pamela Goldberg, MBA President and CEO

Sarah Mazzatenta Systems Coordinator, NESTcc Leah McConnell Dergachev, MBA AVP, Communications, Marketing and Membership

Alex Mills Executive Assistant Liz Morgan Senior Business Development Manager, NESTcc Liliana Rincon-Gonzalez, PhD Program Director, Clinical Science Leo Rivoal Marketing Coordinator Flora Sandra Siami, MPH Senior Vice President, NESTcc Desiree Steele Project Manager Ron Taylor, MBA Finance Director Jithesh Veetil, PhD Program Director, Data Science and Technology Robbert Zusterzeel, MD, PhD, MPH Data Network Director, NESTcc MDIC Staff as of June 1, 2020

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BOARD OF DIRECTORS

Peter J. Arduini

Steve Ferguson

Rick Geoffrion

Pamela Goldberg, MBA

Chip Hance

Jijo James, MD, MPH

Tamara Syrek Jensen, JD

Gary Johnson

Krishna Kandarpa, MD, PhD

Samrat (“Sam”) S. Khichi, JD, MBA

Richard E. Kuntz, MD, MSc

Dana McMahon

President and CEO and Director Integra LifeSciences

CEO Regatta Medical

Director, Research Sciences and Strategic Directions NIBIB, NIH

Chairman of the Board Cook Group Incorporated

Chief Medical Officer, Medical Devices Johnson & Johnson

Executive Vice President and General Counsel BD

President and CEO Cyrano Therapeutics, Inc.

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

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

PAGE 22

President and CEO MDIC

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

Chief Legal Counsel Stryker

MDIC 2019 ANNUAL REPORT

Michael R. Minogue

Bryan D. Olin, PhD

Shacey Petrovic

Peter Saltonstall

Randall Schiestl

Jeffrey Shuren, MD, JD

Jean R. Slutsky, PA, MSPH

Nadim Yared

President, CEO, and Chairman ABIOMED

Vice President, Global Technology Boston Scientific Corporation

Wes Cetnarowski, MD

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

Senior Vice President, Clinical, Quality & Regulatory Affairs LivaNova

Director, President and Chief Executive Officer Insulet

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

Chief Engagement and Dissemination Officer and Program Director PCORI

Esther Krofah, MPP

Executive Director Faster Cures, a Center of the Milken Institute

PAGE 23

President and CEO National Organization for Rare Disorders (NORD)

President and CEO CVRx

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