Event Calendar

Agenda

Device Research & Regulatory Conference

The Premier Conference for Device Professionals

April 4 and 5, 2019 / Device Basics Preconference Workshop April 3, 2019 (11:30 a.m. - 5:00 p.m.)

 For a printable PDF agenda, click here


Device Basics Pre-Conference Workshop- Optional ½ Day Workshop - Wednesday 

                        lessons learned. Topics will include IDEs, PMAs, GCP and compliance strategies.
4:00 - 5:00       Question & Answer Session
Faculty will discuss current issues related to device research sourced from attendee questions submitted both before and during the program.

11:30 – 12:00     Registration 

12:00 – 12:10     Welcome

12:10 – 2:10      Demystifying Medical Devices

 Donna Headlee, RN, BSN, CCRP, Program Co-Chairperson 

 This session will provide a basic overview of the regulations guiding medical device research and development. Topics include: FDA Regulations, risk categorizations of IDE studies, adverse event reporting, device classification, and marketing applications (PMAs, 510(k)s and HDEs).

2:00 – 2:20 Break

2:20 – 3:20     IDE Device Study Reimbursement Process 

Michael Sanchez, Principal Advisor, MA, CCA, Pivotal Reimbursement Consulting

This presentation will provide attendees with key insights for better understanding Medicare’s IDE device regulations and best-practices for the successful execution of reimbursement during the conduct of medical device studies. Clinical trial coverage and billing rules are challenging and can vary based on the regulatory status of the device study. Therefore the presenter will address Medicare requirements for the common types of device research studies including Category A and B designated IDEs, post-approvals, and those under CMS' Coverage with Evidence Development (CED) paradigm. Topics include the submission of IDE and CED study coverage requests to CMS' central office, the process for local Medicare contractor notification, and requirements for compliant clinical trial billing by research site providers.

3:20 – 4:20     Steps to Begin an Investigator-Initiated and Sponsored Medical Device Study

Harvey M. Arbit, PharmD, MBA, RAC, CCRP, President, Arbit Consulting, LLC

There is a process that should be followed before beginning an investigator-initiated device study. The first question to be asked is “Is this a medical device?” A risk determination is essential to determine if an IDE application is submitted or to follow the abbreviated IDE requirements. The IRB has a significant role in the IDE process that is regulated by FDA. In an investigator-initiated study, the investigator is likely to also be the IDE sponsor which requires compliance with investigator and sponsor regulations.

4:20– 5:00     Question and Answer Session

Course Faculty

This session is an opportunity to discuss questions and answers related to the topics presented in pre conference. In addition, to highlight key points.


Main Conference Day One - Thursday 

7:30 - 8:00 Registration and Continental Breakfast

8:00 - 8:15     Program Welcome and Introduction

Kathi Durdon, MA, CCRP, Director, CNY Biotech Accelerator, Upstate Medical University, Syracuse, NY

8:15 - 9:15     The Ethics of Medical Device Innovation: Renewing our Focus on the Research Subject

Quincy J. Byrdsong, EdD, CIP, CCRP, Executive Director for Research Administration, WellStar Research Institute
The Center for Devices and Radiological Health (CDRH) protect the American public by providing regulatory safeguards that provide the peace of mind that the products are both safe to use and work as intended. However, those individuals who volunteer to subject themselves to the testing of these devices have to be considered with untiring ethical clarity as well. Dr. Byrdsong will chronicle the history of medical device research and address ethical considerations which are still prevalent in the age of medical device innovation.

9:15 - 10:15     Overview of the “De Novo” Process

Moj Eram, PhD, MasterControl Strategic Partner, Co-founder and Sr. Partner, Sage Bio, MasterControl, Inc. and Sage BioPartners
Dr. Eram will provide an overview of the FDA De Novo process to include discussion of the purpose of De Novo, De Novo Classification and submission. Dr. Eram will also provide an overview of documentation and data requirements, including format and content as well as providing an overview of benefit-risk assessment and guidance documents.

10:15 - 10:35 Break

10:35 - 11:30     What is HUD and HDE?

Donna Headlee, RN, BSN, CCRP, Program Co-Chairperson
What is an H-D-E and H-U-D and how the programs are related. This session will discuss HUDS and HDEs, the approval threshold for an HDE, the contents of an HDE application and the review process. We will conclude with a discussion of considerations for IRB oversight for use of HUD devices.

11:30 - 12:30     ClinicalTrials.gov: Understanding Clinical Trial Disclosure Requirements

Kristina Elliott, MLS, Web Content and Outreach Coordinator, ICF (contractor to ClinicalTrials.gov/National Library of Medicine/National Institutes of Health)
This talk provides an overview of key laws and policies requiring registration and results submission to ClinicalTrials.gov. Includes examples, best practices, and resources to help ensure success in meeting submission requirements.

12:30 - 1:30 Lunch

1:30 - 2:30     Post Market Clinical Follow Up (PMCF): Is it always a clinical study?

Caitlyn Seidl, BS, CCRP, Director, Clinical Affairs, K2M, Inc.
This presentation will provide a high level overview of the PMCF regulations and discuss the different strategies to collect data to support EU regulations.

2:30 - 3:30     Clinical Evaluation Reports (CERs) and Clinical Evidence – EU MDR Compliance

Jon Gimbel, PhD, Director and CER Business Unit Lead, Regulatory & Quality Solutions
This presentation will provide an overview of a company’s experience with submission to notified bodies of the EU MDR 2020 compliance requirements (MEDDEV 2.7/1 Rev 4) involving Clinical Evaluation Reports (CERs) and clinical data.

3:30 - 4:30     Panel Discussion

This panel discussion will allow attendees an opportunity to query regulatory experts as an open interchange of hot topics, compelling questions, and day-to-day issues.


Main Conference Day Two - Friday
7:30 - 8:00     Registration and Continental Breakfast

8:00 - 9:00     Challenges of Optimizing Interactions in the Increasingly Generationally-Diverse Clinical Research Arena

Barbara C. van der Schalle, MS, Clinical Training Manager, Leidos Biomedical Research, Inc.
Generation Z, the Post Millennials, are the latest addition to the already extremely generationally-diverse American clinical research arena. Their preferences for critical workplace parameters, including their aspirations, attitude toward technology, attitudes towards their career and communication media preferences will further diversify the workplace experience. Ms. Van der Schalle will discuss the challenge of optimizing integration of the five generations currently in the American workplace.

9:00 - 10:00     Tales from the Trenches: Impacting Patient Reported Outcomes

David Eilers, BS, Adjunct Faculty, Syracuse University, Whitman School of Management
Clinical research works best when it meets regulatory requirements, energizes the clinical team involved and has a positive impact on patient reported outcomes. However what’s usually missing from this “triple win” is a clear innovation process that empowers staff members.

Incorporating research from a recent New England Journal of Medicine Catalyst study; Dave will present real-life examples of what works, how to form a cross-functional team and how to overcome the barriers to innovation that exist in every institution and across the continuum of care.

10:00 - 10:20     Break

10:20 – 11:20     Risk Management Principles and Their Application in Clinical Research

Patricia M. Beers Block, MDEd (Distance), BS, BS, Instructor, Rutgers the State University of New Jersey
Risk management is a practical approach for managing valuable and limited resources that might be impacted by clinical research activities. This presentation will summarize the principles of a risk management program, and provide practical suggestions for successfully identifying and managing many of the more common risks that are associated with clinical research.

11:20 - 12:20     The Role of the Bill of Materials (BOM) in the Medical Device Product Design Approval Process

Tamara Burch-Williams, BS, MS, Clinical Software Implementation Manager, MasterControl, Inc.
Creating and maintaining a BOM (Bill of Materials) can present a series of approvals. In addition, the engineering of a BOM can introduce complexities. Ms. Burch-Williams presentation will highlight some pain points during BOM creation and how this process can be created to allow for ease of engineering. This will also highlight document organizations in conjunction with BOM components.

12:20 - 1:20     Lunch

1:20 - 2:20     A Multifaceted Approach to Risk-Based Monitoring

Angie Rock, MBA, CCRP, Senior Manager, Clinical Research Associate Group, Biotronik, Inc.
A comprehensive risk-based monitoring program includes multiple aspects to evaluate and define site and study performance. Ms. Rock will explore approaches and considerations for implementing a risk-based monitoring program including those unique to medical device studies. The resulting risk-based monitoring data is a powerful tool that can be used to inform project team decision making as well as future site selection decisions.

2:20 - 3:20     FDA Inspection Case Study

Donna Headlee, RN, BSN, CCRP, Program Co-Chairperson
This session will test your knowledge of regulatory framework for medical device research and development. It will be a highly interactive, competitive session

3:20 - 4:00     Question & Answer Session and Discussion

This interactive session will allow the participants to discuss issues related to medical device investigational studies.