5 Year Reflective

MDIC MEDICAL DEVICE INNOVATION CONSORTIUM Align. Achieve. Accelerate.

FIVE YEAR REFLECTIVE

SEPTEMBER 2018

FIVE YEAR REFLECTIVE

LETTER FROM THE PRESIDENT AND CEO At MDIC, we’re proud to be the first-ever publicprivate partnership created with the sole objective of advancing medical device regulatory science.

Throughout the years we have coordinated the development of methods, tools, and resources used in managing the total product life cycle of a medical device to improve patient access to safe and effective cutting-edge medical technology. This year marks our 5th year anniversary and I’m honored to share that MDIC has transformed quite dramatically from when we convened our first board meeting in 2013. We started with only a handful of programs and now we have over a dozen areas that we’re focused on in support of improving the medical technology environment.

1

One of our newest initiatives, the National Evaluation System for health Technology Coordinating Center (NESTcc) has been operating for a year now and is on its way to becoming a fully operational and sustainable coordinating center.

Each year, we will continue to evolve our organization and grow our initiatives in order to fulfill our commitment to helping patients receive innovative, safe, and effective therapies at a lower cost and in less time.

Pamela Goldberg President and CEO

SEPTEMBER 2018

BECOMING MDIC Dale Wahlstrom, former President and CEO of LifeScence Alley and Jeff Shuren, Director of the Center for Devices and Radiological Health at FDA , recognized there was a challenge of rebuilding trust and relationships between the medical device industry and the FDA. In an effort to address this challenge, Wahlstrom and Shuren agreed to begin a conversation between CDRH and a group of industry experts in Minnesota to identify how that challenge might be addressed.

LifeScience Alley/Medical Alley initiated the discussions by bringing a group together to explore solutions with Shuren and his team. Quickly noticing the significance of this effort, Shuren and Wahlstrom identified the need for someone to be a leader in this endeavor. Bill Hawkins assumed the

role of Chairman and together, the three worked with an expanding number of industry organizations to support the vision of building what is today known as the Medical Device Innovation Consortium (MDIC).

Wahlstrom served as the interim MDIC President and CEO and with the help of Shuren, the two led a team through the finalization of details and drafts which directed the formal creation of what is today known as MDIC. In 2012, Articles of Incorporation were filed with the State of Minnesota and in 2013 the organization gained project staff and its first full-time executive, Bill Murray who served as the President and CEO. 2

FIVE YEAR REFLECTIVE

THE EARLY YEARS Articles of Inc. filed in August

2012

2011

Memorandum of Understanding submitted in December

3

MDIC at LifeScience Alley Conference on December 5

Launched MDIC website on November 12

2012

2012

Created a business plan in October

2012

2012

MDIC nationwide rollout in December in Washington, D.C.

SEPTEMBER 2018

Convened first Board meeting on February 26 – approved bylaws, budget, admin structure.

Confirmed initial work priorities.

Convened third Board meeting on September 12 and reviewed project structure and plans.

2013

2012

Responded to membership requests

2013

2013

Held second full Board meeting – approved scope of projects.

With project staff and a fulltime President and CEO on board, the year 2013 marked the official start of business for MDIC. Over the last five years, MDIC has focused on regulatory science and created several projects and initiatives to support its mission.

4

FIVE YEAR REFLECTIVE

COMMITTED TO PATIENTS Through its public-private partnership, MDIC aims to advance regulatory science in the medical device industry. By coordinating the development of methods, tools, and resources used in managing the total product life cycle of a medical device, MDIC is committed to improving patient access to safe and effective cutting-edge medical technology and promoting public health.

MDIC has been designed to pursue several strategies to support its mission. These strategies facilitate stakeholder collaboration to expedite regulatory science innovation and ensure broad-based benefits.

Create a forum for collaboration and dialogue 5

Make strategic investments in regulatory science

Provide tools to drive costeffective innovation

SEPTEMBER 2018

Science of Patient Input

Case for Quality

Computer Modeling and Simulation

Work supports science, not policy.

Governed by a Board of Directors Helps patients gain access to medical technologies sooner

Clinical Trial Science

Clinical Diagnostics

Cybersecurity

Hosts an Annual Public Forum to inform and engage the public on new projects and program updates

3K+ $35M+ 60+ subscribers to MDIC’s electronic communications

funded for Patient Preference Research, Quality Improvement and the National Evaluation System for health Technology (NEST) Coordinating Center

participating membership organizations 6

FIVE YEAR REFLECTIVE

CASE FOR QUALITY In 2011, the FDA’s Center for Devices and Radiological Health (CDRH) launched the Case of Quality to shift medical device manufacturing from a culture of compliance to one of quality and of competitiveness based on quality. In support of these efforts, CDRH awarded MDIC a contract in 2015 to pool people, resources, and ideas to develop and research the tools, methods and practices that would make it possible to assess and medical device quality.

A key part of MDIC’s contribution to the Case for Quality is the testing and refinement of the use of a Maturity Model to measure quality and benchmark products and manufacturers.

7

In 2018, MDIC launched four new workstreams to continue the advancement of the Case for Quality.

• Redesign the CAPA Process as a Continuous Improvement Framework • Create a Cross-Industry “Safe Space” for information sharing and • By 2020, 85% of Medical Device CEOs Engaged in Quality Initiatives • Make Quality an Attractive First Step in your Career Case for Quality forums are used to encourage stakeholders to participate in discussion around opportunities for improving device quality within the industry.

SEPTEMBER 2018

CLINICAL DIAGNOSTICS Clinical Diagnostics (Clinical Dx) was established in 2015 when MDIC’s diagnostic company members expressed a desire for regulatory science tools that addressed the unique needs for IVD development and regulatory submission.

Clinical Dx projects 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.

Clinical Dx Projects Surrogate Samples Clinical Evidence IVD Real-Word Evidence Fingerstick Blueprint Cancer Genomic Somatic Reference Samples

Surrogate Sample Framework Published report September 2017 Submitted to the Clinical and Laboratory Standards Institute (CLSI) and is in the process of becoming an international standard. Their publication: EP:39, is expected to be published in October 2020.

8

FIVE YEAR REFLECTIVE

COMPUTATIONAL MODELING & SIMULATION Launched in 2014 Computation Modeling and Simulation (CM&S) enables the development of medical product solutions in a responsible, patient sparing way that balances the desire for certainty in the device performance while limiting the delay in patient access associated with increased certainty through the use of computer modeling and simulation as valid scientific evidence.

2015- 2016 Developed Virtual Patient Framework and Mock Submission 9

External Evidence Methods: Builds on the success of the Virtual Patient efforts and intends to expand on potential sources and approaches to incorporation of external evidence Estimated to launch in late 2018

2018- 2019 Finalizing the Blood Damage Modeling (Thrombosis and Hemolysis)

SEPTEMBER 2018

CLINICAL TRIAL SCIENCE The MDIC Clinical Trial Science (CTS) program began as Clinical Trial Innovation and Reform (CTIR), one of three inaugural projects launched at MDIC in 2014. In 2016, MDIC launch the Application of Clinical Trial Practices (ACTP) project as a program to implement tools developed in MDIC regulatory science initiatives through pilot programs and demonstration projects. In 2017, the CTIR and ACTP programs were combined into CTS with the vision of advancing regulatory science through innovations in medical device clinical trial efficiency and cost-effectiveness.

CTS Projects

Early Feasibility Study (EFS)

Virtual Patient (VP)

Clinical Trial Design Efficiencies 10

FIVE YEAR REFLECTIVE

SCIENCE OF PATIENT INPUT The MDIC Science of Patient Input (SPI) initiative started as the Patient Centered Benefit-Risk (PCBR) project, one of three inaugural projects MDIC launched in 2014. The purpose of the PCBR project was to advance the field of patient preference assessment and the application of patient preference information regarding probable benefits and probable risks of a proposed medical device to premarket submissions and decisions.

The Science of Patient Input initiative was launched in 2017 with the vision to provide a venue for continued collaboration to advance the art and science of patient engagement in regulatory science, including advances in methodologies and tactical considerations for integrating patient perspectives and preferences in the design, clinical 11

development and regulatory review of innovative medical technologies.

2015 Published the MDIC PCBR Framework 2016 Launched a collaborative project with CDRH, MIT, RTI Health Solutions and the Michael J. Fox Foundation for Parkinson’s Research: A novel method for incorporation of patient-centered outcomes research (PCOR) in clinical trial design

SEPTEMBER 2018

CYBERSECURITY MDIC recognizes cybersecurity as a national critical infrastructure, dynamic frontier and a shared responsibility to protect public health and safety. In 2018 MDIC launched a cybersecurity initiative to advance coordinated vulnerability reporting across the medical device ecosystem to maximize product quality and patient safety.

MDIC is focused on making meaningful contributions to advance cybersecurity as it relates to medical devices.

Highlights

MDIC is developing a Coordinated Vulnerability Report to inform best practices and identify opportunities.

MDIC became a member of the Healthcare Sector Coordinating Council Cyber Working Group and Task Group related to Medical Devices.

12

FIVE YEAR REFLECTIVE

NESTcc In September 2016, the FDA awarded MDIC a grant for the NEST Coordinating Center (NESTcc) to support the sustainable generation and use of timely, reliable, and cost-effective Real-World Evidence (RWE) throughout the medical device lifecycle, using Real-World Data (RWD) that meets robust methodological standards.

NESTcc focuses on four Strategic Priority areas: Governance, Role, Value, and Stakeholder Engagement.

Governance Ø Establish NESTcc Governing Committee Ø Ensure optimal governance across all stakeholders

13

Role Ø Develop Strategic Plan for NESTcc Ø Establish NESTcc data network and making the case for RWE

Value

Engagement

Ø Initiate planning for sustainability Ø Outline and defining NESTcc services

Ø Engage key stakeholders to develop NESTcc strategy and goals Ø Ensure key stakeholder buy-in and feedback

SEPTEMBER 2018

2015

Clinician Groups

NEST envisioned as a voluntary data network of collaborators by Planning Board

2016

Industry

Payers

FDA awarded grant for NESTcc to MDIC NESTcc

Executive Director of NESTcc named

2017

NESTcc Governing Committee selected NESTcc Strategic and Operational Plan developed

2018

Initial NESTcc Data Network formed and testing initiated

Patient Groups

Regulators Health Systems

NESTcc Data Quality and Methods Subcommittees formed

14

FIVE YEAR REFLECTIVE

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.

The first public forum was held in June of 2014 and reported on only three projects: Computational Modeling and Simulation, Patient Centered Benefit-Risk Assessment and Clinical Trial Innovation and Reform. 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.

15

SEPTEMBER 2018

BOARD OF DIRECTORS Michael R. Minogue ABIOMED

Pamela Goldberg MDIC

Rick Geoffrion Mitralign

Chip Hance Regatta Medical

Peter Arduini Integra Life Sciences

Tanisha Carino FasterCures

Ross Jaffe Versant Ventures

Jijo James Johnson & Johnson

Mark Carlson Abbott

Tamara Syrek Jensen CMS

Steve Ferguson Cook Group

Krishna Kandarpa NIH

16

FIVE YEAR REFLECTIVE

BOARD OF DIRECTORS Richard E. Kuntz Medtronic

Caroll Neubauer

Bryan Olin LivaNova

Randall Schiestl Boston Scientific

Joe Selby PCORI

Jeff Shuren

17

B. Braun of America

CDRH/FDA

Linda Peters Becton Dickinson

Beth Staub Stryker

Peter Saltonstall NORD

Nadim Yared CVRx

SEPTEMBER 2018

MDIC STAFF PAMELA GOLDBERG President & CEO

CAROLYN HILLER Program Director

TIFFANY ABUSHAIKHA NESTcc Project Manager

LEAH McCONNELL Director, Marketing and Communications

TOM ANDERSON NESTcc Communications Manager TARIQ BAHICH Finance Assistant STEPHANIE CHRISTOPHER Program Director DANIELLE DUFFY Director, Operations RACHAEL FLEURENCE, NESTcc Executive Director JESSICA GASVODA NESTcc Project Manager

HEATHER MORRIS Executive Assistant RACHEL RATH NESTcc Deputy Director DAN SCHWARTZ, Acting Program Director LIZ SPURGIN VP, Health Economics and Patient Access RACHEL STIVERS NESTcc Project Coordinator LISA GRIFFIN VINCENT Acting VP, Clinical Science and Technology 18

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