Event Calendar

Device Research

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2019 Agenda


Friday, September 27, 1:15 to 2:00           

Top 5 Clinical Trends in the Medical Device Industry in 2019 

New trends in technology are transforming the medical device industry, particularly in the way data is managed during clinical trials. Advanced technology is making clinical data management easier, so regulatory agencies are raising their expectations regarding clinical studies, primarily with trial master file (TMF) management. Specifically, more regulatory focus will be on accuracy, security, integrity, and inspection readiness of all TMF components. Also, the industry is trending toward managing all clinical activities electronically, making it more critical for companies to establish the TMF as a single point of truth. 709
Presenter: Patricia Santos-Serrao, RAC, Director, 
Product Strategry-Pharma and Biologics, MasterControl, Inc.

New trends in technology are transforming the medical device industry, particularly in the way data is managed during clinical trials. Advanced technology is making clinical data management easier, so regulatory agencies are raising their expectations regarding clinical studies, primarily with trial master file (TMF) management. Specifically, more regulatory focus will be on accuracy, security, integrity, and inspection readiness of all TMF components. Also, the industry is trending toward managing all clinical activities electronically, making it more critical for companies to establish the TMF as a single point of truth. 709

Presenter: Patricia Santos-Serrao, RAC, Director, Product Strategry-Pharma and Biologics, MasterControl, Inc.

Track: Device Research


Friday, September 27, 2:05 to 2:50                                          

Managing Risks for Medical Device Clinical Trials and Their Products

Medical device clinical trial managers must manage risks (i.e. things that could potentially go wrong) in their trials, and may also be involved in the product risk management process (as per ISO 14971, the harmonized standard for medical device in vitro diagnostic product risk managment) for the device under evaluation. This session will provide an overview of a) Project Management Institute’s® project risk management process and how it can be executed to achieve clinical trial objectives, b) the ISO 14971 product risk management process and how it is executed, and c) the vital roles of clinical data and the clinical trial manager for the product risk management process. 711

Presenter: Claudia Campbell-Matland, MS, PMP, Consultant & Managing Member, CNCM Consulting LLC

Track: Device Research 


Friday, September 27, 3:25 to 4:10                                          

Clinical Validation for a Medical Device Design Update

Ms. Downing will describe the R&D efforts that were required to enhance the capabilities of the Welch Allyn Spot Vision Screener (a device that objectively screens for the 6 risk factors of amblyopia). She will also cover the clinical validation that was required to prove that the updates were effective and that the device was still accurate. 713

Presenter: Lindsay Downing, BS, MS, CCRP, Senior Specialist, Clinical Affairs, Welch Allyn

Track: Device Research 


Friday, September 27, 4:15 to 5:00                                          

Building Quality Clinical Data into Premarket Approval (PMA) Applications

Devices that present the highest risk (Class III) to patients are generally regulated under the Premarket Approval (PMA) Program.  The PMA review process is a scientific and regulatory review to evaluate the reasonable safety and effectiveness of a new Class III medical device.  This evaluation is based on valid scientific evidence.  It is critical that valid scientific evidence is supported with high quality data.  This session will provide an introduction to the premarket program, valid scientific evidence and elements, and strategies of quality data. 715

Presenter: Donna Headlee, BSN, RN, CCRP

Track: Device Research 


Saturday, September 28, 8:30 to 9:15                                      

Longitudinal Device Studies and Enrollment/Retention

Mr. Wehage will discuss the design and development of a long-term device study.  Focus on the risks and mitigation for enrollment and retention issues at a study and throughout the course of a study will be presented. 717

Presenter: Scott Wehage, MS, CCRP, Clinical Project Manager, Becton Dickinson

Track: Device Research


Saturday, September 28, 9:20 to 10:05                                    

Source Verification in a Digital Environment

The use of electronic health record data in clinical investigations presents new challenges for source verification.  This talk will discuss the challenges and review the FDA guidance documents surrounding the use of electronic health record data and electronic source data. 719

Presenter: D. Maria Rhoades, MSN, CCRP, RN, Clinical Project Manager, AtriCure, Inc.

Track: Device Research 


Saturday, September 28 – 10:50 to 11:35

Medical Device Studies:  How to Consent and More from a Monitor and Study Coordinator Perspective

The monitor and the site research coordinator are a team.  Fully take advantage of your monitor’s knowledge on how to make your site have a smooth study execution which will help minimize your work and your stress level.  When the monitor is happy, the PI and site team will be happy with a clean monitor report and future studies will come your way as a result.  Ms. Diehl will review study etiquette, most common problem areas, how to overcome challenging study situations, and you will get inside intel of what the sponsor is focusing on during visits. 721

Presenter: Julie Diehl, BSc, CCRP, CMA, Senior Clinical Research Monitor, Medtronic

Track:  Device Research


Saturday, September 28, 11:40 to 12:25                                  

Documentation and Management Practices for Successful Post Marketing Regulatory Compliance

Early documentation in medical device design and research can lead to successful post-market launch regulatory compliance. Setting up a quality management system with regular review and surveillance is key to compliance. 723

Presenter: Jennifer Davagian, CCRP, President and CEO, Cristcot LLC

Track: Device Research