Understanding Medical Device and Diagnostic Development Processes and Contemporary Realities: Lessons Learned from COVID-19

This webinar series draws from our popular Medical Device Development course. The five sessions will cover the fundamentals of device and diagnostic development presented through the lens of challenges posed by the COVID-19 pandemic. Experts will address topics ranging from the identification of clinical need for devices and diagnostics to implementation and post-market surveillance in a changing regulatory environment, including emergency use authorization (EUA). Leading professionals and innovators will share their experiences over the past year, and course faculty will facilitate conversations that highlight key principles.

Session Dates & Descriptions

Each session will include talks by innovators, followed by facilitated discussion and time for questions from course participants.

May 26, 12:00-1:30pm: Fundamental Components of Medical Device and Diagnostic Development within a COVID-19 World

Join us as we lay the groundwork for this five-part series, with a focus on how the COVID-19 pandemic has challenged conventional medical device and diagnostic pathways. Speakers will share their experiences from the frontlines–from managing evolving clinical needs with diverse approaches to innovation, to supporting an infrastructure of medical device and diagnostic development planning and implementation.

Featured Speakers:

• Frederick Schoen, MD, PhD
  Professor of Pathology and Health Sciences and Technology, Brigham and Women’s Hospital
• Erica Shenoy, MD, PhD
  Associate Chief, Infection Control Unit, Massachusetts General Hospital
• Erin McKenna, MBA
  Operating Partner, Translational Innovation Fund (TIF), Mass General Brigham
• Ben Linville-Engler, MS
  Industry and Certificate Director, System Design and Management, Massachusetts Institute of Technology

June 2, 12:00-1:30pm: Diagnostics

In Session 2, we’ll explore the development and implementation of diagnostics during the COVID-19 pandemic, including the technical aspects of developing, validating, and scaling solutions. Additionally, speakers will share their experiences coordinating and collaborating with multiple stakeholders (e.g., government, private, nonprofit entities) to identify truly implementable diagnostics.

Featured Speakers:

• Glenn A. Miller, PhD
  Market Sector Leader for Radiology, Anesthesiology, Neurology, Neurosurgery and Psychiatry, Mass General Brigham
• Mara Aspinall, MBA
  Managing Director, Health Catalysts Group
  Professor of Practice, Arizona State University
• Matthew McKnight, MPP, MBA
  Chief Commercial Officer, Ginkgo Bioworks, Inc.

June 9, 12:00-1:30pm: Protecting the Workforce: Personal Protective Equipment (PPE) and Beyond

In Session 3, we’ll explore how medical device developers responded to the challenge of protecting the workforce in times of fluctuating needs and uncertain supply chains. Join us as we unpack the frontline challenges of managing supplies and integrating novel solutions into existing clinical processes, as well as the complexities of rapid engineering and following the deployment of new technologies through an EUA process.

Featured Speakers:

• Sepi Hashemi, MS
  Program Manager, Mass General Brigham Innovation
• Matthew Beatty, BS
  Research and Design Engineer, Massachusetts General Hospital

June 16, 12:00-1:30pm: Ventilation Solutions

In Session 4, we’ll explore how clinicians and innovators responded to the critical shortage of ventilators needed to treat patients hospitalized with severe COVID-19 symptoms. Come hear how new solutions for ventilating patients were conceived, evaluated, and implemented amidst evolving patient and provider needs during the pandemic.

Featured Speakers:

• Erin McKenna, MBA
  Operating Partner, Translational Innovation Fund (TIF), Mass General Brigham
• Jesslyn Lenox, MHA, RRT-NPS, AE-C
  Director of Pulmonary Services, Brigham and Women’s Hospital
• Keith Romano, MD, PhD
  Pulmonary and Critical Care, Brigham and Women’s Hospital

June 23, 12:00-1:30pm: Looking Ahead: Perspectives on Lessons Learned and Potential Future Impacts

Join us as we conclude our five-part series with a panel of speakers responsible for strategic planning and response throughout the COVID-19 pandemic. They will reflect on lessons learned and potential future impacts on medical diagnostic and device development and implementation, including: coordinating and planning supply chain strategies for improving future pandemic readiness, addressing equity and access in clinical care, and increasing utility of healthcare IT solutions.

Featured Speakers:

• Thea James, MD
  Associate Professor of Emergency Medicine, Boston University School of Medicine
  Associate Chief Medical Officer, Vice President of Mission, and Director of the Violence Intervention Advocacy Program (VIAP), Boston Medical Center
• Philip Licari, MBA
  Former Vice President for Operations, Mass General Brigham
• Sara Silacci, BA
  Chief Strategy Officer and Senior Managing Director for Digital Health and Connected Systems, Massachusetts General Hospital

Audience

This series is designed for individuals interested in medical device and diagnostic innovation. A brief introduction to device and diagnostic development and translation will be provided, and supplemental resources will be recommended for those who are interested in further training. Former Medical Device Development course participants are welcome to register.

We believe that the research community is strengthened by understanding how a number of factors including gender identity, sexual orientation, race and ethnicity, socioeconomic status, culture, religion, national origin, language, disability, and age shape the environment in which we live and work, affect each of our personal identities, and impacts all areas of human health.

Eligibility

There are no eligibility requirements for this series.

For those who are less familiar with the fields of medical device and diagnostic development, we recommend the following resources:

• FDA Coronavirus (COVID-19) and Medical Devices Website
• “The Impact of COVID-19 on The Medical Device Industry” by Shrinidh Joshi
• Yock, P., Zenios, S., Makower, J., Brinton, T.J., Kumar, U.N., Jay Watkins F.T., Denend, L., Krummel, T.M., Kurihara C.Q. (2015). “Biodesign: The Process of Innovating Medical Technologies,” 2nd Edition. Cambridge, UK: Cambridge University Press.

Fee

• Free for Harvard-affiliated schools and institutions
• There is no fee to participate in session 5
• CTSA member: $94 per session OR $338 for all five sessions
  (Note: this is a 25% discount off the standard fee.)
• Non-CTSA member: $125 per session OR $450 for all five sessions
• Cancellation and Refund Policy [PDF]