Brendan O’Leary provides consulting services on digital health and medical device regulatory strategy to technology developers, healthcare organizations, trade and professional associations, and other stakeholders.

Brendan worked at the FDA for 14 years in a variety of roles, most recently as the founding Deputy Director of the Digital Health Center of Excellence and as its Acting Director throughout 2022. Brendan contributed to hundreds of precedent-setting decisions and co-authored dozens of policy documents that continue to provide the foundation for the FDA's digital health efforts. He frequently represented the FDA on digital health and other topics through presentations at conferences and professional society meetings, press interviews, and interactions with Congress.

At the FDA, Brendan championed and led successful efforts to increase regulatory flexibility for lower-risk technologies while advancing policies and regulatory approaches that promoted the use of safety-enhancing software engineering techniques in the medical technology industry, especially practices related to continuous integration and continuous delivery (CI/CD). He drove policy efforts to enable rapid modification and continuous learning techniques for artificial intelligence and machine learning technologies, and he worked with Congress and other stakeholders to extend these efforts to all medical devices with legislation passed and signed into law in December 2022.

Brendan also made significant contributions to the federal government's response to SARS-CoV-2.

He continues to promote regulatory approaches that improve medical device interoperability, improve user access to medical device data, provide users with more control over home-use medical devices, facilitate open-source development of medical device software, and appropriately increase over-the-counter access to medical technologies.

Early in his career, Brendan designed and developed tools that were used by NASA astronauts to repair the Hubble Space Telescope. He holds a B.S. in Mechanical Engineering from the University of Maryland, College Park.

Brendan lives in Maryland with his wife, Jessica, and their dog, Bear.

Experience

U.S. Food and Drug Administration (FDA)

Silver Spring, MD
Various Positions (see below)
Apr 2009 – Apr 2023

Acting Director, Digital Health Center of Excellence

Feb 2022 – Jan 2023

Deputy Director, Digital Health Center of Excellence

Nov 2019 – Apr 2023

Diagnostics Expert, COVID-19 Response

Mar 2020 – Jul 2020

  • Led FDA’s participation in the US Government’s independent evaluation of serology tests with the National Cancer Institute (NCI) and the Centers for Disease Control and Prevention (CDC). This first-of-a-kind effort to provide fast and trustworthy data generated directly by the US Government to support regulatory decisions for in vitro diagnostic testing has resulted in more than 30 devices becoming available to the public, including at the point of care. It has supported FDA’s regulatory decisions for more than 100 devices, and it has helped to ensure that high volume tests already on the market continue to provide accurate results. Built a statistical analysis pipeline that automatically analyzed the results of all evaluations to generate full evaluation reports and line data files. Coauthored the evaluation reports. Established a process for integrating the program with openFDA to provide evaluation results to the public via both a web page and an Application Programming Interface (API) after regulatory decisions have been made.

  • Briefed the FDA Commissioner, the Department of Health and Human Services (HHS) Deputy Chief of Staff for Policy, congressional oversight committee staff, and the press on serological testing.

  • Drafted strategy documents provided by the FDA to the Office of the Vice President and other US Government stakeholders, including a document related to ensuring adequate serology testing quality and capacity as well as a document on testing strategies and how the prevalence of a disease or condition impacts the clinical utility of a diagnostic test.

  • Authored and maintained FDA’s web page on EUA Authorized Serology Test Performance to accurately, accessibly, and objectively convey complex scientific and statistical concepts and data to the public.

  • Supported other aspects of the government’s response to the pandemic, including shortage mitigation and management, stakeholder engagement, and comparative performance analyses of nucleic acid and antigen tests for SARS-CoV-2.

Director, Division of Program Operations and Management

CDRH Office of In Vitro Diagnostics and Radiological Health
Apr 2018 – Nov 2019

Deputy Director, Division of Program Operations and Management

CDRH Office of In Vitro Diagnostics and Radiological Health
Jul 2014 – Apr 2018

Public Health and Policy Analyst

Division of Program Operations and Management
CDRH Office of In Vitro Diagnostics and Radiological Health
Nov 2012 – Jul 2014

  • Established and led the office’s initiative to develop strategies to ensure safety in digital health and medical device software.

  • Oversaw all office determinations of whether or not products met the legal definition of a medical device and prioritized related enforcement actions.

  • Led the Division of Radiological Health’s review of a high-profile recall using mechanical engineering, radiological device, and policy expertise.

  • Oversaw the successful execution of multi-million-dollar IT contracts for the Center.

Reviewer, Artificial Pancreas Project

Division of Chemistry and Toxicology Devices
CDRH Office of In Vitro Diagnostics and Radiological Health
Temporary Assignment from Jul 2012 – Nov 2012

Policy Advisor

CDRH Office of the Center Director
Temporary Assignment from Apr 2012 – Jun 2012

Mechanical Engineer and Lead Reviewer

Division of Radiological Health
CDRH Office of In Vitro Diagnostics and Radiological Health
Apr 2009 – Nov 2012

ATK Space Systems (now Northrop Grumman Space Systems)

Beltsville, MD
Various Positions (see below)
May 2007 – Apr 2009

Mechanical Design Engineer

Aug 2008 – Apr 2009

Engineered two Crew Aids and Tools successfully used on a spacewalk to repair and upgrade the Hubble Space Telescope Imaging Spectrograph in May 2009.

Mechanical Design Co-Operative Engineering Student

Part time from May 2007 – Aug 2008

Supported the Hubble Space Telescope Servicing Mission 4.

Recognition and Awards

U.S. Food and Drug Administration
2022:

FDA/CDRH Process Improvement Group Award (Medical Device User Fee Amendment IV Assessment CDRH Team)

2021:

FDA Scientific Achievement Award: Excellence in Analytical Science for scientific excellence, innovation, and dedication in collaborating with the National Cancer Institute on a groundbreaking program to ensure accurate serology tests for SARS-CoV-2

FDA Commissioner’s Special Citation Group Award (COVID-19 Serology Team)

2018:

Competitively selected for the Federal Executive Institute’s Leadership for a Democratic Society Program

FDA/CDRH Excellence in Training and Development Group Award (Least Burdensome Training: Case Study Practice)

2017:

FDA/CDRH Lireka P. Joseph Group Award for Excellence in Public Health Communication or Education (User Fee Communication and Training Implementation Group)

2016:

FDA Outstanding Service Individual Award for exceptional leadership across a broad range of mission-critical programs

FDA/CDRH Excellence in Training and Development Group Award (Reviewer Certification Training Program)

FDA/CDRH Excellence in Stakeholder Communication and Education Group Award (Artificial Pancreas Project)

FDA Commissioner’s Special Citation Group Award (Autosomal Recessive Carrier Screening Review Team)

2015:

FDA/CDRH Guidance/Policy/Regulation Development Excellence Group Award (Radiology Mobile Apps Group)

2014:

FDA/CDRH Process Improvement Group Award (DocMan IT Project Team)

2013:

FDA/CDRH Excellence in Premarket Team Review Award

2012:

Commissioner’s Special Citation Group Award (Mobile Apps Working Group)

FDA/CDRH Special Recognition Group Award (510(k) Draft Guidance Development Team)

FDA/CDRH Special Recognition Group Award (Third Party Inspection Audit Team)

FDA Group Recognition Award (Division of Radiological Health)

2011:

FDA/CDRH Group Recognition Award (510(k) Working Group)

2010:

FDA Outstanding Service Individual Award for Promoting and Protecting Public Health

University of Maryland, College Park
2005 - '08:

Banneker-Key full academic scholarship

Gemstone Honors Research Program

Honors Program

2007:

Mechanical Engineering Department Outstanding Co-op of the Year

Pi Tau Sigma Mechanical Engineering Honor Society, Tau Mu Chapter

Golden Key International Honour Society

Other
2002:

Eagle Scout

Education

University of Maryland, College Park

B.S. in Mechanical Engineering with Honors
Sep 2005 – Aug 2008

Professional Societies and Affiliations

  • Federal Executive Institute Alumni Association (FEIAA)

  • American Society of Mechanical Engineers (ASME)

  • Institute of Electrical and Electronics Engineers (IEEE)

  • American Society for Quality (ASQ)

  • Regulatory Affairs Professionals Society (RAPS)

Additional Skills, Training, and Education

  • Experienced in R / tidyverse / shiny, docker / docker-compose, MATLAB, Visual Basic for Applications (VBA), Java (Android application development), Python, HTML / JavaScript / CSS, Visual Basic, MacOS, Linux, Windows 10, iOS, and Android

  • Learning the Rust programming language

  • Federal Executive Institute Leadership for a Democratic Society Program (LDS-449, Fall 2018)

  • Certified as an American Society for Quality Certified Quality Auditor (ASQ-CQA) (Jun 2016 – Jun 2020) and Six Sigma Green Belt (ASQ-CSSGB)

  • “Executive Leadership Program” (Graduate School USA, 2011–2012)

  • Graduate-level coursework in medical robotics

  • Advanced coursework in material properties, mechanical failure analysis, computerized optimization of mechanical systems design, and control systems engineering

Open Source Software

  1. Brendan O’Leary. mdufa: Structured Data on FDA’s Medical Device User Fee Program Performance. R Package, January 2024.

  2. Brendan O’Leary. ctdl: Clinical Trials Downloader. R Package, March 2023.

  3. Brendan O’Leary. fdadata: Access public information from the FDA website. R Package, October 2022.

  4. Brendan O’Leary. dxr: Diagnostic product evaluation in R. R Package, May 2022.

Publications and Presentations

Publications

  1. Ligia A. Pinto, Ribhi Shawar, Brendan O’Leary, Troy J. Kemp, James Cherry, Natalie Thornburg, Cheryl N. Miller, Pamela S. Gallagher, Timothy Stenzel, Brittany Schuck, S. Michele Owen, Marina Kondratovich, Panayampalli S. Satheshkumar, Amy Schuh, Sandra Lester, M. Cristina Cassetti, Norman E. Sharpless, Steven Gitterman, and Douglas R. Lowy. A trans-governmental collaboration to independently evaluate SARS-CoV-2 serology assays. Microbiology Spectrum, 10(1):e01564–21, January 2022.

  2. Ribhi Shawar, Brendan O’Leary, Troy J. Kemp, James Cherry, S. Michele Owen, Pamela S. Gallagher, Natalie Thornburg, Marina Kondratovich, Subbian Satheshkumar Panayampalli, Amy Schuh, et al. A trans-governmental collaborative effort to independently evaluate SARS-CoV-2 serology assays using well-characterized sample panels. In Open Forum Infectious Diseases, volume 7, pages S851–S851. Oxford University Press US, 2020.

  3. Aldo Badano, Wei-Chung Cheng, Brendan O’Leary, and Kyle J Myers. Cutting-edge technology: Part II: Pre-clinical assessment of medical displays for regulatory evaluation. Information Display, 27(4):28, 2011.

  4. Steve Caperna, Christopher Cheng, Junghee Cho, Victoria Fan, Avishkar Luthra, Brendan O’Leary, Jansen Sheng, Andrew Sun, Lee Stearns, Roni Tessler, Paul Wong, and Jimmy Yeh. A navigation and object location device for the blind. Gemstone Undergraduate Team Research, 2009.

  5. Christopher Cheng, Brendan O’Leary, Lee Stearns, Steve Caperna, Junghee Cho, Victoria Fan, Avishkar Luthra, Andrew Sun, Roni Tessler, Paul Wong, Jimmy Yeh, Bobby Bobo, Rama Chellappa, and Cha-Min Tang. Developing a real-time identify-and-locate system for the blind. Presented at the Workshop on Computer Vision Applications for the Visually Impaired. Presented at the Workshop on Computer Vision Applications for the Visually Impaired, Marseilles, France, 2008.

Presentations

  1. Julia Harris, Caroline Pearson, Devin Mann, Ateev Mehrotra, Brendan O'Leary, Cara Tenenbaum, and Anuja Vaidya. The Future of Remote Patient Monitoring. A panel discussion hosted by the Bipartisan Policy Center and the Peterson Center on Healthcare, January 2024. A recording of this discussion is available online.

  2. Brendan O'Leary. Regulatory considerations for digital surrogate endpoint response biomarkers. A presentation at the EverythingALS Digital Biomarkers Summit, July 2023. This presentation has been adapted into a blog post.

  3. Craig Coombs, Zane Liu, and Brendan O'Leary. Digital Health. A panel discussion at the 2023 MDMA FDA Forum, March 2023.

  4. Brendan O'Leary. FDA's Progress on Digital Health. A presentation at the DiabetesMine Innovation Days D-Data Exchange, November 2022.

  5. Brendan O'Leary, Thierry Sirdey, and Maggie Henkin. Software Products with Multiple Functions. A presentation and panel discussion at the APEC Roundtable Dialogue on Global Regulatory Convergence for Medical Devices & Accelerating Digital Health Regulatory Convergence in the Asia-Pacific, November 2022.

  6. Brendan O'Leary, Cassie Scherer, and Jaesoon Choi. Software Change Management. A presentation and panel discussion at the APEC Roundtable Dialogue on Global Regulatory Convergence for Medical Devices & Accelerating Digital Health Regulatory Convergence in the Asia-Pacific, November 2022.

  7. Alexander Fleming, Alberto Gutierrez, Yiduo Wu, Zane Arp, Bradley M. Thompson, and Brendan O’Leary. Regulation of Diabetes Technology. A presentation and panel discussion at the Diabetes Technology Meeting, November 2022.

  8. Diane Johnson, Yuri Maricich, Brendan O’Leary, Cybil Roehrenbeck, and Cassie Scherer. Artificial Intelligence in Medical Devices: Post Pandemic Implications. A panel discussion at The MedTech Conference, October 2022. This panel discussion received media coverage from Fierce Biotech and MedicalDesign & Outsourcing.

  9. Srinath Adusumalli, Don Cutlip, Jodi Akin, Ami Bhatt, Ian Meredith, and Brendan O’Leary. Moving Primary Care from the Clinic to the Pharmacy/Retail Store: Impact on the Medical Device Ecosystem. A panel discussion at the Dartmouth Device Development Symposium, October 2022.

  10. Robert Kazmierski, Adam Jacobs, Aaron V. Kaplan, Lauren Baker, Brendan O’Leary, Jessica Paulsen, and Sam Surette. Medical Device-Smart App Driven Management: Navigating new Landscapes Leveraging AI & Machine Learning, addressing cybersecurity concerns: A Fictitious Case Study. A panel discussion at the Dartmouth Device Development Symposium, October 2022.

  11. Brendan O’Leary. Digital therapeutics regulation. Presented at the DTx East conference, September 2022. This presentation received media coverage from STAT and pharmaphorum.

  12. Jeffrey Shuren, Michellle Tarver, Brendan O’Leary, Daniel Caños, and Edward Margerrison. CDRH town hall. A panel discussion at the Medical Device Innovation Consortium (MDIC) Annual Public Forum, September 2022.

  13. Brendan O’Leary, Anindita Saha, Amy McDonough, Cassie Scherer, and Heather Benz. Digital health technologies for healthcare: Advancing innovation and regulatory science through global collaboration. A panel discussion at the Medical Device Innovation Consortium (MDIC) Annual Public Forum, September 2022.

  14. Johan Ordish, Brendan O’Leary, Lin Anle, David Hau, Rolf Oberlin Hansen, and David Wotton. Current regulatory approaches to AI and medical devices. A panel discussion at the International Medical Device Regulator’s Forum (IMDRF) and Global Medical Technology Alliance (GMTA) Joint Workshop, September 2022.

  15. Brendan O’Leary. US FDA’s perspective: Artificial intelligence and machine learning – Can "one size" fit all? Presented at the International Medical Device Regulator’s Forum (IMDRF) and Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association Joint Workshop, September 2022.

  16. Brendan O’Leary, Martin Meyer, Vince McCauley, Robert Turpin, David Hau, and David Wotton. Artificial intelligence and machine learning: Can "one size" fit all? A panel discussion at the International Medical Device Regulator’s Forum (IMDRF) and Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association Joint Workshop, September 2022.

  17. Brendan O’Leary. Considerations and possible framework for software as a medical device risk categorization. Presented at the Latin America Forum on Conformity Assessment for Medical Devices – SaMD, August 2022.

  18. Sven Jungmann, Anne Sophie Geier, Tonya N. Dowd, and Brendan O’Leary. Digital health for all: Scaling digital across borders. A panel discussion at Health For All: A Digital Health Forum from G4A, June 2022.

  19. Brendan O’Leary, Damien McPhillips, Szymon Perkowski, and Aaron Dunbar. FDA Digital Health Software Precertification Pilot (Pre-Cert). Presented at the AFDO/RAPS Healthcare Products Collaborative 2022 MedCon Conference, May 2022. This presentation received media coverage from the Regulatory Affairs Professional Society.

  20. Brendan O’Leary. FDA regulation of AI/ML-enabled medical devices. Presented at the 2022 Medical Device Software Development Summit, May 2022.

  21. Brendan O’Leary. Digital Health Overview. Presented at the Consumer Technology Association (CTA) Health Division FDA Working Group, May 2022.

  22. Reena Philip, Alain Silk, Kelly Oliner, Kris Roth, and Brendan O’Leary. Implementing Least Burdensome: From principles to practice. Presented at the FDA-Industry IVD Roundtable, May 2018.

  23. Brendan O’Leary. A brief overview of the 3rd Party Review Program. Presented at the Spring 2018 Meeting of AdvaMedDx, May 2018.

  24. Brendan O’Leary. A brief update on the 3rd Party Review Program. Presented at the Spring 2018 Regulatory Policy and Strategy Meeting of the Medical Imaging Technology Alliance (MITA), April 2018.

  25. Danelle Miller and Brendan O’Leary. 21st Century Cures Act – Key highlights and implementation activities. Presented at the FDA-Industry IVD Roundtable, June 2017.

  26. Brendan O’Leary. New IVD work instructions clarify cybersecurity review practices. Presented at the Office of In Vitro Diagnostics and Radiological Health All-Hands Meeting, May 2017.

  27. Brendan O’Leary. Strengthen the 3rd Party Premarket Review Program. Presented at the FDA-Industry Discussions on MDUFA IV Reauthorization, January 2016. Meeting minutes are available here.

  28. Brendan O’Leary. Scale the CDRH Digital Health Program. Presented at the FDA-Industry Discussions on MDUFA IV Reauthorization, January 2016. Meeting minutes are available here.

  29. Jeremy Logue, Brendan O’Leary, and Sara Aguel. Center for Devices and Radiological Health premarket IT systems overview. Presented at the FDA-Industry Discussions on MDUFA IV Reauthorization, October 2015. Meeting minutes are available here.

  30. Brendan O’Leary. New cybersecurity guidance – What it means for industry. Presented at the FDA-Industry IVD Roundtable, November 2014.

  31. Brendan O’Leary. Draft mobile medical applications guidance. Presented at the Association of Medical Diagnostics Manufacturers (AMDM) Annual Meeting, April 2013.

  32. Geoffrey Clapp and Brendan O’Leary. Complying with federal regulations. Presented at the Office of the National Coordinator for Health Information Technology Health Tech Innovator Workshop, October 2012.