Event Calendar

Device Research

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2018 Agenda

2019 Agenda Coming Soon! 

Friday, September 28, 1:15 to 2:00           

Total Product Lifecycle 

Understanding and planning for the Total Product Lifecycle of your medical device is becoming increasingly more important. This talk will dive into some key areas of TPLC and how that might impact your IDE and PMA. Ms. Pack will also go over the "life after PMA approval" and some tips for managing this process. 209

Presenter: Kathi Durdon, BA, MA, CCRP, Director of Operations, CNY Biotech Accelerator 

Track: Device Research


Friday, September 28, 2:05 to 2:50                                          

Data and Safety Monitoring Committees: The Important Role They Play

This presentation will provide an overview of the Data & Safety Monitoring Committee: its purpose, importance, and the critical role it plays in investigator initiated trials. Ms. Thompson will emphasize the importance of submitting clean and applicable data. Examples will be provided on how investigators, coordinators, regulatory and data managers play an integral role in providing data validation. Best practices currently utilized at the University of Miami Sylvester Comprehensive Cancer Center will serve as a focal point. 211

Presenter: Simmy Thompson-Lucas, MHP, CIP, CCRP, Director, Research Committee, University of Miami, Sylvester Comprehensive Cancer Center 

Track: Device Research 


Friday, September 28, 3:25 to 4:10                                          

Medical Device Single Audit Program (MDSAP): Basics and Update 

This presentation will discuss what MDSAP involves and who the key stakeholders are.  Ms. Rajkumar will review how MDSAP can impact auditing time and market access.  The latest updates for companies to transition to MDSAP certificates will be presented along with practical advice for industry preparing to get MDSAP certificates. 213

Presenter: Sam Rajkumar, MS, BScN, RN, Regulatory Affairs Specialist, Synaptive Medical

Track: Device Research 


Friday, September 28, 4:15 to 5:00                                          

Lessons Learned: Navigating the Medical Device Regulatory Process and the Implications of the Quality System and Design Controls

This presentation will be an interactive session discussing aspects of medical device classification, investigational studies, Quality System- Design Controls and CDRH’s Small Business Certification Program. 215

Presenter: Donna Headlee, BSN, RN, CCRP

Track: Device Research 


Saturday, September 29, 8:30 to 9:15                                      

Navigating the FDA 510(k) Submission Process to Successful Medical Device Clearance 

Ms. Davagian will provide an understanding of the classification of medical devices and FDA 510(k) submission process for marketing clearance in the United States. The presentation will also give an understanding of how the 510(k) submission can harm the market value of a medical device. Overviews of strategies for successful 510(k) submissions will also be discussed. 217

Presenter: Jennifer J. Davagian, President, Cristcot LLC

Track: Device Research


Saturday, September 29, 9:20 to 10:05                                    

IDE Infrastructure Mapping 

Ms. Seidl will discuss how to develop a robust study infrastructure that incorporates the requirements of the FDA, sponsor/CRO SOPs, IRB/EC requirements and needs of the site into one project plan. The objective of the infrastructure is to provide a tangible road map for study development that is all inclusive of local/national regs, sponsor SOPs, and site requirements. The session will demonstrate how to develop ins and outs of the infrastructure including but not limited to a project map, plan, master document list and task list. Having an infrastructure in place reduces the time to study start up and ensures project set up stays on track and considers every phase of a clinical trial. 219

Presenter: Caitlyn Seidl, BS, CCRP, Director, Clinical Affairs, K2M, Inc. 

Track: Device Research 


Saturday, September 29 – 10:50 to 11:35

Mobile Medical Devices in Research

Dr. Young will go over regulations and guidance related to mobile medical devices. Examples will then be given, which will include mobile apps. Finally, some mention will be given to possible risks or controversy that may arise from the use of such devices.  221

Presenter:  Jonathan Young, PhD., MS, CIP, CCRP, Senior Research Regulatory Operations Analyst, Rush University Medical Center

Track:  Device Research



Saturday, September 29, 11:40 to 12:25                                  

Balancing the (Clinical Trial) Budget

Approaches to developing, negotiating and managing clinical trial budgets will be discussed with an emphasis on maximizing site reimbursement and managing sponsor expectations. 223

Presenter: Tammy Floore, BSN, MBA, CCRP, RN, CPC-A, Research Nurse Coordinator, UCLA

Track: Device Research