2018 MDIC Annual Report

Medical Device Innovation Consortium

ANNUAL REPORT 2018

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MDIC Annual Report 2018

A Letter from the MDIC President & CEO and the MDIC Board Chairman Dear Members, MDIC has experienced tremendous growth and change in our first five years, but our mission has remained the same: advancing medical device regulatory science for patient benefit. We are proud to bring together more than 60 member organizations to focus on areas that matter to patients, members, and the medical technology field as a whole. It is crucial to bring together government, industry, academia, and patients to holistically address pressing issues related to medical device regulation.

Michael R. Minogue CEO & Chairman, Abiomed MDIC Chairman

For the first time in MDIC’s history, we are presenting the last year’s milestones and accomplishments in this Annual Report.

This report helps quantify and demonstrate the impact we had over the last year and helps us identify opportunities for growth and improvement. Some of the key highlights from this report include launching initiatives such as External Evidence Methods and Health Economics and Patient Access, announcing NESTcc’s Real-World Evidence Test-Cases, and publishing a number of tools and resources for stakeholders.

We have also initiated a new working group focused on cybersecurity for medical devices. These accomplishments would not have been possible without the dedicated MDIC and NESTcc teams and member organizations.

While we are proud of the accomplishments detailed in this report, we also look forward to implementing our new strategic plan for the next three to five years to help prioritize our efforts for maximum positive impact. Our strategic plan will enable us to set clear and transparent goals, improve accountability, and establish a game plan to execute our mission.

Pamela Goldberg President and CEO. MDIC

Together we are excited to see this organization continue its trajectory and help patients receive access to innovative, safe, effective medical technologies.

MDIC Annual Report 2018

Contents Initiatives

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Events

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Membership

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Financial Highlights

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Board of Directors

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Staff

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MDIC Annual Report 2018

Our Initiatives

MDIC’s Initiatives and Programs

MDIC operates leading initiatives and related programs focused on four areas: Clinical Science, Data Science and Technology, Health Economics and Patient Access, and the National Evaluation System for health Technology Coordinating Center (NESTcc).

Here we present 2018’s updates and accomplishments of each initiative and the programs that fall under the initiatives, when applicable.

Clinical Science 2018 CLINICAL SCIENCE YEAR IN REVIEW:

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.

Legal EFS Tool Developed and Published For the first time, the EFS Contracts Working Group set out to develop an EFS-specific Master Clinical Trial Agreement (MCTA) to facilitate efficiencies in the EFS contracting process. Diverse stakeholders including industry, care provider organizations, and regulators engaged in the development of the MCTA, which is intended to provide a starting point for contract negotiations with a priori agreement of 90% or greater and allow both parties to focus remaining legal resources on the remaining 10% (or less) of the EFS MCTA requiring negotiation. The EFS MCTA is publicly available on the MDIC website for both medical technology and care provider EFS participants.

Enrollment Opened for the EFS Site Network Pilot With the availability of the EFS tools, MDIC has launched the EFS Site Network Pilot, as the first phase of establishing a National EFS Consortium. In 2018, twenty-one sites enrolled in the pilot with more than 15 partners including sponsors, FDA, and CMS. The Pilot aims to demonstrate the impact of the available tools on administrative timelines such as contract execution, IRB approval, and patient enrollment. Industry sponsors who were ready to initiate

MDIC Annual Report 2018

a cardiovascular EFS, and committed to the use of some or all of the EFS tools were invited to be considered for participation. Sponsors must be committed to achieving the EFS Pilot goal of ”60/60/60” and are expected to collect pre-defined key performance tracking metrics to evaluate the effectiveness of the tools.

Clinical sites are expected to work diligently to overcome EFS administrative challenges at their institutions that may impact the time to first patient enrollment. It is expected that sites will dedicate sufficient research, clinical and administrative resources, have the necessary infrastructure and expertise and will work diligently to efficiently screen and enroll patients.

The EFS program is committed to creating a learning environment where successful experiences are shared to improve the overall efficiency of conducting EFS. A “60/60/60” goal has been defined as a compilation of three core goals reflecting timely patient access: 60 days in parallel to (a) execute the EFS Clinical Trial Agreement, and (b) gain IRB approval; with the next 60 days to achieve first patient enrolled.

MDIC plays an active role connecting EFS sponsors and sites, providing EFS tools, and collecting and disseminating metrics on EFS tool implementation and impact. MDIC’s EFS Working Group will use 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.

21st Century Cures Paper Published in JACC Cardiovascular Interventions Authors from FDA, CMS, Mayo Clinic, DarmouthHitchock Medical Center, Columbia University Medical Center, Baylor Scott and White Health, and MDIC published a paper in JACC: Cardiovascular Interventions, entitled, “The 21st Century Cures Act and Early Feasibility Studies for Cardiovascular Devices: What Have We Learned, Where Do We Need to Go?”

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Barriers to EFS implementation at the clinical site level remain despite the inclusion of an EFS initiative in the 21st Century Cures Act enacted by the U.S. Congress in 2016. In the paper, the authors reviewed those existing barriers and outlined a pilot program to better facilitate EFS.

Clinical Diagnostics The Clinical Diagnostics program focuses on projects that are intended to improve diagnostic testing and product development using novel regulatory science approaches developed through collaboration between MDIC stakeholders.

Providing a predictable path for innovation will help patients benefit through quicker access to more cost-effective advanced diagnostic technologies in less time.

Cancer Genomic Somatic Reference Samples (SRS) Project Initiated The SRS project began in early 2018 with the goal 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. A kick-off meeting was held in June 2018 and twenty organizations engaged in the ongoing initiative. This multi-stakeholder project includes representatives and technical assistance from: FDA: CDRH and CDER, CDC: Division of Laboratory Systems, CMS: CAG, NGS diagnostic test manufacturers, pharmaceutical companies, professional societies, academic institutions, and biorepositories.

Surrogate Samples Framework Accepted to Become CLSI Standard The MDIC Surrogate Samples Framework, which proposes uniform terminology and recommendations where surrogate samples might be justifiably used in IVD validation studies, was accepted by the Clinical and Laboratory

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MDIC Annual Report 2018

Standards Institute (CLSI) to begin the process of becoming a standard. The completed standard, EP:39 Surrogate Sample Framework is expected to be completed in Q4 2020.

with previous experience with DBS and patients with severe symptoms are willing to accept more risk in exchange for smaller, faster clinical trials.

Science of Patient Input

Patient Preferences in Heart Failure Study Initiated

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.

FDA Broad Agency Announcement (BAA) Awarded for SPI Work MDIC was awarded an $880,000 2-year FDA BAA contract to develop a Framework for Patient Input in Medical Device Clinical Trials. This is a two-year project to advance methods to integrate patient input into the design of clinical trials, advance a transformative method for integrating patient preferences into the statistical design of clinical trials, and synthesize practical considerations for reducing the patient burden of participation in clinical trials. This project will develop and emphasize evidence-based tools for engaging with patients in the design of clinical trials.

Research Collaboration to Move Clinical Trials from Generic p-value of 0.05 to TherapySpecific Patient-Values Completed 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. The team received surveys from 2,740 respondents and found that patients

MDIC Science of Patient Input launched a new study to understand patient preferences in patients with heart failure. The primary objective of the study is to advance the science of regulatory patient preference assessment by giving medical device industry sponsors, regulatory agencies, and preference assessment experts another example of a disease-specific patient preference study. The project involves six sponsor companies, CDRH, the Duke Clinical Research Institute, and patients as partners.

Data Science and Technology 2018 DATA SCIENCE AND TECHNOLOGY YEAR IN REVIEW:

Case for Quality MDIC’s Case for Quality (CfQ) is promoting 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 stakeholders’ 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.

New CfQ Working Groups Established In 2018, MDIC’s Case for Quality launched four new working groups to support projects within the CfQ: • Redesign CAPA - Leverages cross-

MDIC Annual Report 2018

industry best practices and collaboration to fundamentally recast Corrective And Preventive Action (CAPA) as a continuous improvement (CI) framework • Leadership Engagement - Influences CEOs and senior leaders of medical device companies to participate in quality initiatives in a meaningful way to effect change in their organizations and the industry. Promotes Quality as a “strategic priority” for all parts of an organization through strong leadership, strategic alignment, and tone at the top.

• Quality as a Career - Establishes a Quality discipline at the college/university level and educates students on the benefits of making Quality a foundational start to a successful career within the MedTech industry • Create an Industry Safe Space - Creates a

non-competitive, collaborative, and sanctionfree environment enabling open discussions on a variety of critical improvement initiatives Support of the CDRH Voluntary Medical Device Manufacturing and Product Quality Program Pilot Continued MDIC continued to support CDRH’s CfQ pilot, the CDRH Voluntary Medical Device Manufacturing and Product Quality Program Pilot, by promoting the program via webinars and public presentations. MDIC also assured that the stakeholders had a voice in the evolving program.

At the end of 2018, CDRH announced their intention to scale the pilot to a full program in 2019 and rebranded it the Case for Quality Voluntary Improvement Program (CFQ VIP).

2018 CFQ VIP Involvement A Total of 37 Sites Were Enrolled in the Pilot in 2018

14% Are FDA Recognized Small Businesses

37 Active Sites Over 20 Companies

Post-Appraisal Survey Results

*No sites indicated having a negative experience, only positive and neutral

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5 Multi-Site Appraisals

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MDIC Annual Report 2018

NESTcc Test-Case Submitted The CfQ program supported the submission of Cardiovascular ImpLantable Electrode CompArative Reliability (CLEAR), a Test-Case based on the CFQ Analytics working group efforts.

Computational Modeling and Simulation The Computational Modeling and Simulation (CM&S) program was developed to achieve the delivery of medical product solutions in a responsible, patient-sparing way by using computer modeling and simulation as valid scientific evidence. This approach is intended to balance the desire for certainty in a

thrombosis during medical device development.

Ultimately, this work will benefit the patient by enhancing medical device and technology evaluation. Deliverables of this Working Group include experimental results, models, set-up definitions, and a documented report from multisite studies.

Results from Blood Damage Simulations Analyzed Over the past year, the computational modeling participants from both blood damage subgroups were tasked with providing independent predictions of fluid flow and blood damage under two flow scenarios: one being more conducive to hemolysis and the other being more conducive to thrombosis. This exercise was designed to reveal how the choice of the mathematical model and other model input parameters would impact predictions for the flow patterns and blood damage. The team is in the midst of providing model “metadata” to facilitate this comparison.

Another goal of the exercise is to identify best practices for modeling blood flow and blood damage, i.e. validate the models. To this end, the results of the hemolysis simulations are being compared to in vitro data provide by FDA scientists. The FDA system for thrombosis generation is still under development.

Ultimately, this work will benefit the patient by enhancing medical device and technology evaluation. device’s performance with the desire to limit the delay in patient access associated with increased certainty.

Blood Damage Modeling Working Group Established The MDIC CM&S Blood Damage Modeling Working Group was created to establish regulatory-grade models of mechanical blood damage, primarily focusing on hemolysis and thrombosis. The group includes partners from the medical device and simulation software industries, NIH, and FDA. This effort will provide resources, such as gold standard data sets, aimed at reducing the potential for hemolysis and

Cybersecurity MDIC recognizes that cybersecurity is critical infrastructure vital to the United States.

Cybersecurity threats can have a debilitating effect on security, national economic security, and national public health or safety. As such, MDIC is focused on making meaningful contributions to advance cybersecurity as it relates to medical devices.

MDIC Annual Report 2018

In 2018, MDIC launched a new cybersecurity program to advance coordinated vulnerability reporting across the medical device ecosystem and maximize product quality and patient safety.

from medical device companies that have implemented vulnerability reporting portals and processes into a final report and presentation at the MDIC Annual Public Forum.

Some medical device manufacturers have implemented coordinated cybersecurity vulnerability portals and processes as one tool in their overall threat detection and response

MDIC worked with the law firms, Debevoise & Plimpton and Alvarez & Marsal, to produce a Coordinated Vulnerability Reporting Playbook focused on vulnerability reporting portals, systems, and processes.

The report addressed the importance of CVD policies for medical device manufacturers and stakeholders across the medical device ecosystem, including the creation of publicly available online portals to solicit vulnerability information. Subsequently, collaborating with experts from industry, FDA and legal experts, MDIC released an interactive hypothetical case study video on coordinated vulnerability disclosure practices (November 2018).

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MDIC believes that coordinated cybersecurity vulnerability processes and portals are integral to a comprehensive approach to counteract cybersecurity threats. process. These portals and processes enable manufacturers to receive findings from researchers regarding potential vulnerabilities in a device. However, the majority of medical device manufacturers do not have portals or defined processes to receive these findings and to act on this information in a timely way.

MDIC believes that coordinated cybersecurity vulnerability processes and portals are integral to a comprehensive approach to counteract cybersecurity threats.

Advancing Coordinated Vulnerability Disclosure (CVD) Report Released The Cybersecurity team released a request for proposals (RFP) to find external partners who could help synthesize case studies and learnings

External Evidence Methods This External Evidence Methods (EEM) program aims to establish a more predictable pathway for use of external evidence methods, such as new, 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 (RWD), 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.

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MDIC Annual Report 2018

MDIC/CDRH Held Meeting on the “Virtual Patient” Methodology In April 2018, an MDIC/CDRH working meeting was held on the FDA’s White Oak campus to discuss the virtual patient discount prior methodology.

This meeting included presentations by Dr. Tarek Haddad (Medtronic), Dr. Laura Thompson (FDA), and Dr. Xu (Sherry) Yan (FDA). The focus of the meeting was to better understand the published methodology and its limitations.

EEM Program Formally Launched at APF The External Evidence Methods (EEM) project was formally initiated at the 2018 MDIC Annual Public Forum (APF). Meeting participants identified the need to catalog existing methods and develop new methods for incorporating external evidence in quantitative device safety and effectiveness assessments.

Health Economics and Patient Access (HEPA) 2018 HEALTH ECONOMICS AND PATIENT ACCESS YEAR IN REVIEW: As a new initiative that launched over the summer of 2018, much of HEPA’s year was spent on building awareness and support.

MDIC’s HEPA representatives recruited members for a HEPA advisory group. The initiative also built stakeholder support for HEPA internally with MDIC’s SPI and NESTcc initiatives and externally with stakeholders from other organizations like AdvaMed and MDMA. Steering Committee Activities MDIC’s HEPA representatives met individually, at least once, with each steering committee member to introduce MDIC and the objectives of the HEPA initiative, understand reimbursement challenges

Liz Spurgin (right), MDIC’s vice president of Health Economics and Patient Access, joined Ricardo Johnson from Healthworx (left) and Ken Skodacek of FDA’s CDRH (center) to discuss the challenges of the reimbursement environment at The MedTech Conference in September.

for each industry member company’s portfolio, and gather priority areas for engagement. The HEPA Steering Committee then gathered in person and via conference call several times in 2018 to establish and rank shared industry and regulatory priorities and set a framework for 2019 activities.

Member Survey on Health Economics Issues The HEPA Steering Committee initiated design of a steering committee member survey to further define “pain points” with both CMS and private payer coverage processes.

The National Evaluation System for Health Technology Coordinating Center (NESTcc) 2018 NESTCC YEAR IN REVIEW: NESTcc experienced its busiest year to date.

The Coordinating Center augmented many activities that were key components to fulfilling its mission to accelerate the development and translation of new and safe health technologies, leveraging Real-Word Evidence and innovative research.

MDIC Annual Report 2018

Data Strategy Meeting Held & Data Network Launched In February 2018, NESTcc hosted its first Data Strategy Convening to solicit input from stakeholders, including NESTcc Network, on key operating principles and processes. Key decisions made during this multi-stakeholder meeting included the ability for Network Collaborators to choose which studies to participate in, being financially compensated for time, and scientific involvement and input into the activities. The Data Strategy Convening helped lay the foundation for the launch of the NESTcc Data Network.

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will build upon existing bodies of work and will leverage subcommittee members’ knowledge and experience from similar initiatives, including PCORnet, Sentinel, and MDEpiNet. Round 2 Test-Case Concepts Solicited In July 2018, NESTcc solicited a second round of Test-Case concepts, including calls for both broad and targeted patient generated health data (PGD) projects, from medical device stakeholders, including industry groups, health systems, government organizations, non-profits, and academic institutions.

The second round of Test-Cases are intended to assess the feasibility for key stakeholders to work with the NESTcc Data Network’s Real-World Data (RWD) sources to support a range of studies and analyses, as well as address high priority areas of interest for NESTcc, including requirements outlined in MDUFA IV and the U.S. Food and Drug Administration (FDA) Reauthorization Act of 2017 (FDARA).

NESTcc Staff Expanded In 2018, NESTcc significantly expanded its team, adding two Project Managers to oversee TestCase projects and Governance, respectively, and a Communications Manager.

Governing Chair and Vice Chair Appointed: Michelle McMurry-Heath & Adrian Hernandez In September 2018, NESTcc announced the appointment of Michelle McMurry-Heath, MD, PhD

Data Quality and Methods Subcommittee Formed In June 2018, NESTcc formed Data Quality & Methods Subcommittees to support NESTcc’s efforts to conduct efficient, timely, and highquality real-world evidence studies for medical devices. Each subcommittee will develop Data Quality and Methods Protocol Frameworks, design processes for demonstrating conformance to these Frameworks, and make recommendations for their implementation.

Data Quality and Methods Protocol Frameworks

NESTcc Chief of Staff, Rachel Rath, presented at CDRH’s Patient Engagement Advisory Committee meeting on challenges with registries and opportunities with NESTcc.

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MDIC Annual Report 2018

(Johnson & Johnson, AdvaMed Representative) as Chair of the NESTcc Governing Committee with Adrian Hernandez, MD, MHS (Duke University School of Medicine) serving as Vice Chair.

As NESTcc Governing Committee Chair, Dr. McMurry-Heath will be responsible for engaging key stakeholders to ensure success in meeting NESTcc milestones, as well as chairing and presiding over Governing Committee meetings.

Dr. Hernandez, serving as the NESTcc Governing Committee Vice Chair, will also be responsible for engaging key stakeholders to ensure NESTcc’s success, as well as presiding over NESTcc Governing Committee meetings in the Chair’s absence, and assuming the role of Governing Committee Chair upon completion of a two-year term.

Michelle McMurry-Heath, MD, PhD

Chair, NESTcc Governing Committee

Adrian Hernandez, MD, MHS

Vice Chair, NESTcc Governing Committee

Round 1 Test-Cases Announced In November 2018, NESTcc announced its first eight Real-World Evidence Test-Cases.

These Test-Cases will answer questions of importance to the medical device ecosystem through collaborations between NESTcc Network Collaborators and participating industry partners.

The eight projects include both 510(k) and premarket approval regulatory pathways, and address devices across five disease areas.

Active Surveillance Task Force Established In December 2018, the NESTcc Governing Committee approved the establishment of a small, multi-stakeholder Active Surveillance Task Force tasked with establishing a blueprint for leveraging NESTcc’s work to advance active surveillance and subsequently launch NESTcc’s first active surveillance projects. Task Force membership includes key stakeholder representation from patients, clinicians, health systems, the FDA, payers, and the medical device industry.

In the fall of 2018, NESTcc received additional funding from the US Food and Drug Administration (FDA) to conduct active surveillance activities.

MDIC Annual Report 2018

Events In 2018

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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.

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.

MDICx Series 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 12 MDICx webinars in 2018 on a range of topics pertinent to its initiatives, including quarterly updates on the CDRH CfQ pilot, a series on generating quantitative patient preference information to inform productdevelopment and regulatory reviews, and a review of the variants considered for somatic reference samples.

1. MDIC Annual Public Forum / September 5

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At the 2018 APF, MDIC celebrated five years of work and presented updates on its initiatives. FDA Commissioner Scott Gottlieb, CDRH Director Jeff Shuren, and Applico Founder and CEO Alex Moazed were among the presenters of several topics of interest to the medical device ecosystem including.

2. MDIC Case for Quality Forum / June 28 Kristen Tabar, VP of Corporate Quality for Toyota Motor North America shares how having respect for people and continuous improvement are ways that Toyota continuously improves their quality during MDIC’s Case for Quality Forum on June 28 in Washington, DC.

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MDIC Annual Report 2018

Membership

MDIC members are leaders in the medical technology industry.

MDIC focuses on providing patients 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 expertise in regulatory science.

MDIC Annual Report 2018

Membership

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MDIC Annual Report 2018

Financial Highlights Income

Expenses

Grant Revenue

Personnel Costs

Membership

Consulting/Contract Labor

Corporate Funding

Professional Fees

Other

Other

Project

Conferences, Meeting, Travel

MDIC Annual Report 2018

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Board of Directors 1

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Pater J. Arduini

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Tanisha Carino, Ph.D.

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Mark D. Carlson, MC

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Steve Ferguson

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Doug Fridsma

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Rick Gioffrion

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Pamela Goldberg

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Chip Hance

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Jijo James, MD, MPH

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Tamara Syrek Jensen, JD

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Name Kandarpa, MD, PhD

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Richard E. Kuntz, MD, MSc

President & CEO & Director Integra LifeSciences Executive Director FasterCures

Division Vice President & Chief Medical Officer Abbott

Chairman of the Board Cook Group Incorporated President & CEO AMIA President & CEO Mitralign, Inc.

President & CEO MDIC

CEORegatta Medical

Chief Medical Offier, Medical Devices John & Johnson

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

Director, Research Sciences and Strategic Directions NIBIB, NIH Senior Vice President & Chief Scientific, Clinical and Regulatory Officer Medtronic, Inc.

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MDIC Annual Report 2018

Board of Directors 13

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Dana McMahon

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Michael R. Minogue President, CEO, & Chairman ABIOMED

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Chief Legal Counsel Stryker

Caroll H. Neubauer

Chairman and CEO B. Braun of America Inc. and B. Braun Medical Inc.

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Bryan D. Olin, Ph.D

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Shacey Petrovic

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Peter Saltonstall

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Randall Schiestl

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Joe Selby, MD, MPH

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Jeffrey Shuren, MD, JD

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Nadim Yared

Senior Vice President Clinical, Quality & Regulatory Affairs | LivaNova Director, President & Chief Executive Officer | Insulet President & CEO National Organization for Rare Disorders (NORD)

Vice President, Global Technology | Boston Scientific Corporation Executive Director Patient-Centered Outcome Research Institute (PCORI) Director, Center for Devices and Radiological Health (CDRH) Food and Drug Administration

President and CEO CVRx

MDIC Annual Report 2018

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Staff

Tiffany Abushaikha

Pamela Goldberg

Rachel Rath

Tom Anderson

Sharon Graves

Liliana Rincon-Gonzalez

Tariq Bahich

Carolyn Hiller

Liz Spurgin

Aurelia Brooks

Taylor Jackson

Stephanie Christopher

Dure Kim

Project Manager, NESTcc Communications Manager, NESTcc Finance Manager Executive Assistant, NESTcc Program Director, Case for Quality & Science of Patient Input

Lenwood Faulcon

President & CEO

Subaward Manager, NESTcc Program Director, Clinical Diagnostics Communications Manager Project Manager, NESTcc

Leah McConnell

General Counsel

Director, Communications, Marketing & Membership

Rachael Fleurence

Brandon Miller

Jessica Gasvoda

Eddie Naming’ona

Executive Director, NESTcc Project Manager, NESTcc

Operations Assistant Finance Director

Chief of Staff, NESTcc Program Director, Clinical Science Vice President, Health Economics & Patient Access

Desiree’ Steele

Program Coordinator

Jithesh Veetil

Program Director, Data Science and Technology

LaMar Wilson

Executive Assistant

Robbert Zusterzeel

Data Network Director, NESTcc

MDIC Medical Device Innovation Consortium (MDIC) 1501 Wilson Blvd., Suite 910 Arlington, VA 22209 www.mdic.org