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Clinical Trial Events

Outsourcing in Clinical Trials: Medical Devices USA 2025

Jun 3–4

Jun 3–4, 2025 Ended

Minneapolis Marriott West · Minneapolis, MN · In person

Hear fresh insight on regulatory changes and hottest technologies impacting MedTech trials. The 2-day event connects industry leaders, providing cutting-edge insights and navigating the evolving landscape of medical device trials. Presentations and panel discussions cover industry trends, outsourcing challenges, and AI regulations. Attendees can gain expert knowledge, network, and gain actionable strategies. This event is a must-attend for the medical device and diagnostics community.

Venue
Minneapolis Marriott West
Program
34 sessions
27 speakers

Agenda

Times in Minneapolis (CDT)
Tue, Jun 3 Wed, Jun 4

  1. 8:00 AM

    45 min

    Other

    Registration and refreshments

  2. 8:45 AM

    15 min

    Other

    Chairperson’s opening remarks

  3. 9:00 AM

    30 min

    Keynote

    NASA’s James Webb Space Telescope: lessons for health care from the edge of time

    Jon Arenberg, Northrop Grumman

  4. 9:30 AM

    45 min

    Panel

    Keynote panel discussion: Transforming care: advancing medical devices for a smarter, connected future

    Dave Ribble, GlobalData Monika McDole-Russell, Medtronic Kristian Killian, VitaTek Nikhil A. Khadabadi, Eclevar Michael Morton, Medical Alley

  5. 10:15 AM

    45 min

    Break

    Morning Refreshments & Networking

  6. 11:00 AM

    30 min

    Talk

    Exploring regulatory pathways for AI in clinical studies: the PCCP approach and FDA methodologies

    Tarek Haddad, Medtronic

  7. 11:30 AM

    30 min

    Talk

    2025 state of the Medical Device Industry Report

    Mark Voigt, Greenlight Guru

  8. 12:00 PM

    30 min

    Panel

    Panel discussion: Overcoming ethical challenges in AI and big data for clinical trials

    Mac McKeen, University of Minnesota Ivan Pandiyan, GE Healthcare Catherine Longworth, GlobalData Tarek Haddad, Medtronic

  9. 12:30 PM

    60 min

    Break

    Lunch

  10. 1:30 PM

    30 min

    Talk

    Navigating USA regulations for device-drug combination products

    Jennifer Bolton, Boston Scientific

  11. 2:00 PM

    30 min

    Talk

    Fostering positive CRO relationships: tips and best practice

    Samantha Stevenson, MED Institute

  12. 2:30 PM

    30 min

    Talk

    Revolutionizing clinical trial operations by expanding globally and streamlining processes

    Michelle Wetherby, Terumo Neuro

  13. 3:00 PM

    15 min

    Talk

    AI-powered medical device trials: universal EDC for EU MDR & FDA compliance

    Nikhil A. Khadabadi, Eclevar

  14. 3:15 PM

    30 min

    Break

    Afternoon Networking & Refreshments

  15. 3:45 PM

    30 min

    Talk

    Key partnerships for your clinical trial: What are the most important considerations?

    Sarah Gallagher, Melodi Health

  16. 4:15 PM

    30 min

    Talk

    Approved and abandoned: why 90% of devices die without lifecycle strategy

    Jaishankar Kutty, RQM+

  17. 4:45 PM

    45 min

    Panel

    Panel discussion: The intersection of geopolitics, U.S. health policy, and the medical device industry

    Divya Raman, Teleflex Jennifer Bolton, Boston Scientific Catherine Longworth, GlobalData

  18. 5:30 PM

    Networking

    Chairman’s Closing Remarks & Drinks Reception

  1. 8:00 AM

    60 min

    Other

    Registration and refreshments

  2. 9:00 AM

    45 min

    Panel

    Panel discussion: Maximizing market access in Europe: navigating EU MDR and crafting global strategies

    Divya Raman, Teleflex Jason Neff, AtriCure Lisa Griffin Vincent, GT Metabolic Dave Ribble, GlobalData

  3. 9:45 AM

    30 min

    Talk

    Leveraging technology for seamless collaboration

    Catherine Tyner, AG Mednet

  4. 10:15 AM

    30 min

    Talk

    Live Virtual Session with Q&A: Reimbursement strategies in medical device clinical trials: bridging regulatory and payer expectations

    Shay Levav, IceCure Medical

  5. 10:45 AM

    45 min

    Break

    Morning Refreshments & Networking

  6. 11:30 AM

    30 min

    Talk

    Cybersecurity in machine learning medical devices (MLMD): new threats and vulnerabilities

    Pat Baird, Philips

  7. 12:00 PM

    30 min

    Fireside chat

    Fireside chat: Building a clinical program for your medical device

    Lisa Griffin Vincent, GT Metabolic

  8. 12:30 PM

    30 min

    Talk

    Responsibly leveraging AI and real-time data in post-market surveillance

    Monika McDole-Russell, Medtronic

  9. 1:00 PM

    60 min

    Break

    Networking Lunch

  10. 2:00 PM

    30 min

    Panel

    Panel discussion: Economic pressures: innovating under budget constrains

    Al Crouse, CVRx Dave Ribble, GlobalData Sameer Kumar, HabitAware Inc

  11. 2:30 PM

    30 min

    Talk

    Patient-centric design: engaging end users in development

    Sarah Mische, Avivomed

  12. 3:00 PM

    30 min

    Talk

    Case study: Bringing a consumer digital health device to market – developing software, building credibility, and navigating regulations

    Sameer Kumar, HabitAware Inc Aneela Idnani, HabitAware Inc.

  13. 3:30 PM

    30 min

    Break

    Afternoon Refreshments, Networking & Prize Draw

  14. 4:00 PM

    30 min

    Talk

    Leveraging legal and regulatory filings to develop customer and competitor insights

    Dave Ribble, GlobalData

  15. 4:30 PM

    60 min

    Roundtable

    Problem-solving roundtable discussions

    Sarah Mische, Avivomed Hatice Bilgic Lim, Philips

  16. 5:30 PM

    Other

    Close of Conference

Speakers