Device Research
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2024 Agenda
Fri., Sept. 27 1:15 to 2:00 Track: Device Research
How Decentralized Clinical Trials Can Facilitate Trials Involving Medical Devices
Mr. Faget will explore the advantages and hurdles presented by decentralized clinical trials. Topics will include FDA’s draft guidance regarding decentralized clinical trials and telemedicine laws and regulations that must be considered when implementing such trials. 209
Presenter: Kyle Faget, JD, AB, Partner, Co-Chair Health Care Practice Group, Foley & Lardner, LLP
Fri., Sept. 27 2:05 to 2:50 Track: Device Research
Medical Device Clinical Evidence Needs with MDD to MDR Transition
Ms. Yohannan will discuss how the EU MDR came about, the overall differences between MDD and MDR and required changes to our safety; performance needs with clinical evidence generation; and why it’s important to plan clinical evidence generation immediately after preclinical studies of a device. We will consider planning of premarket and post-market clinical trials, registries, user surveys, and Real World Evidence collection, as well as vigilance reporting. 211
Presenter: Mary Sophy Yohannan, MBBS, CCRC, Director Medical Safety & Clinical Science, Bolt Medical, Inc.
Fri., Sept. 27 3:25 to 4:10 Track: Device Research
Cultural Considerations for Diversity in Clinical Research: A Global and Domestic Context
Join us for a discussion of aspects of culture to consider in the conduct of global clinical trials as well as some strategies for inclusion that can be used both abroad and domestically. 213
Presenter: Joy Beeler, MPH, CCRA, ACRP-CPM, Deputy Director, Office of Clinical Research Affairs, NIH, Divison of Microbiology & Infectious Diseases
Fri., Sept. 27 4: 15 to 5:00 Track: Device Research
Demystification of IVD Clinical Trials
Ms. Delabruere will discuss many aspects as they apply to IVD clinical trials including regulatory requirements of 812.2 (c), study design considerations and IRB requirement for review of Non-Significant Devices. Informed consent and use of leftover samples as well as submission of data to the FDA, will also be discussed 215
Presenter: Narvelle Delabruere, MS. BS, CCRC, Senior Clinical Program Manager, Hologic
Sat., Sept 28 8:30 to 9:15 Track: Device Research
Medical Device Clinical Research Risk Determination
Ms. Headlee will consider the risk classifications for medical device clinical research (Exempt, NSR and SR). She will also facilitate a discussion of helpful tips and best practices for navigating the IDE pathway. 217
Presenter: Donna Headlee, BSN, RN, CCRP, Recently Retired Branch Chief, FDA, CDRH, OCE, DICE, PPB
Sat., Sept 28 9:20 to 10:05 Track: Device Research
Artificial Intelligence/Machine Learning in Medical Device Studies
More and more investigational devices now have AI/ML algorithms embedded in them. In this session, Ms. Norman will discuss the basic of AI/ML in medical devices and how FDA is requiring clinical studies to be designed, as well as the operational challenges that are presented to sponsors and clinical sites due to these study designs. 219
Presenter: Dawn Norman, MS, Partner, MRC Global
Sat., Sept 28 10:50 to 11:35 Track: Device Research
Points to Consider for Medical Devices and ClinicalTrials.gov
Attendees will consider the rationale behind the requirements of study registration, discuss the unique requirements and considerations for medical devices and ClinicalTrials.gov registration. Ms. Ferrazzano Yaussy will also review the agencies requiring registration and requirements for clinical trials involving medical devices. 221
Presenter: Cristina Ferrazzano Yaussy, MPH, CCRP, Research Regulatory Affairs Specialist, Dartmouth-Hitchcock Medical Center
Sat., Sept 28 11:40 to 12:25 Track: Device Research
Looking through the Medical Device Sponsor’s Lens: Practical tools for assessing Lessons Learned and How to Operationalize for Future Studies
What happens when the research study is finally closed, and the study result is published or maybe not? Many times, Project Managers come out of this process with lots of bruises and blacklisted sites or shoutouts and stellar sites. Whiles this is good to know, this knowledge alone is not enough. Ms. Annan will discuss how to use effective tools to assess sites and investigator performances after study closure and how to operationalize the lessons learned for future studies based on a 5-year global medical device studies for about 500 subjects across 50 sites. 223
Presenter: Gladys Annan, MBA, BA, CCRP, PMP, Senior Manager, Clinical Research, STERIS Endoscopy