Agenda

Device Research & Regulatory Conference

The Premier Conference for Device Professionals

Main Program: April 28 and 29, 2022 

Special Half-day Preconference Workshop: April 27, 2022*


Pre-Conference Half-Day Workshop

*Requires Add-on Registration to Main Program

Speakers:

Angie Rock, MBA, CCRP, Director, Clinical Operations, Biotronik, Inc.

Kathi Durdon, MA, CCRP, Executive Director, CNY Biotech Accelerator


Agenda

11:30 – 12:00: Registration and Welcome

12:00 - 2:00: Device Regulations & Classification

  • Overview of Medical Device Through Terminology
  • Medical Device Regulations & Device Classification
  • Clinical Investigation Elements

2:00 - 2:20: Break

2:20 - 3:20: Regulatory Submissions Overview

  • The IDE
  • 510(k), De Novo, PMA, HUD/HDE

3:20 - 4:20 Roles and Responsibilities / Study Monitoring

 4:20 - 4:50: Q&A


Main Conference Day One - Thursday 

8:00 - 8:30: Registration and Continental Breakfast

8:30 - 8:40: Program Welcome and Introduction
Kathi Durdon, MA, CCRP, Executive Director, CNY Biotech Accelerator, Upstate Medical University, Syracuse, NY

8:40 - 9:40: Direct Sponsor Involvement in Clinical Trial Recruitment and Other Trial Activities
Mark Barnes, JD, LLM, Partner, Ropes & Gray, LLP
Mr. Barnes will cover how industry sponsors may become directly involved with trial participants, in activities such as trial recruitment, trial logistics and participant travel, media relations and “remote trials”. We will review the legal and ethical limitations on direct sponsor involvement with trial participants, and the risks of pre-approval product promotion, medical malpractice, and confusion of sponsor role with investigator role.

9:40 - 10:40: Utilization of Real World Evidence in Cardiac Lead Post-Approval Studies

Angie Rock, MBA, CCRP, Senior Manager, Clinical Research Group, Biotronik, Inc.
A collaboration consisting of the Food and Drug Administration (FDA), Industry, Academia, Heart Rhythm Society and American College of Cardiology have worked collectively to seek more efficient approaches to fulfilling FDA Condition of Approval Post-Approval Study requirements through the use of Real World Evidence as part of the Electrophysiology Predictable and Sustainable Implementation of National Registries (EP PASSION) project. Ms. Rock will provide an overview of the collaboration, BIOTRONIK’s approach and early success using Real World Evidence for registry studies

10:40 - 11:00: Break

11:00 - 12:00: Medical Device Event Reporting
Elsa Grace John, CMC, CCRP, Safety Specialist, Healthcore Inc. 
Ms. John will provide an overview of the use of product codes in post market review and medical device-specific adverse event reporting. Speaker will also discuss product code builder for import/export, and product recalls.

12:00 - 1:00: Lunch (Provided)

1:00 - 2:00: Lessons Learned De Novo Classification Pathway
Donna Headlee, RN, BSN, CCRP
The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. Ms. Headlee will provide an introduction to the De Novo pathway and identify best practices to optimize the use of the program through a case study discussion.

2:00 - 3:00: Digital Health and AI/ML – Current Pre-market Submission Trends
Dawn N. Norman, MS, Partner, MRC Global, LLC
As medical devices are constantly evolving, they are no longer just physical widgets but often are only softwares which analyze the data captured by a device.   In this discussion we will review how the Agency is currently viewing Artificial Intelligence (AI) and Machine Learning (ML) applications and discuss considerations for regulatory strategies and clinical study designs for pre-market submissions.     

3:00 - 3:20: Break 

3:20 - 4:20: Day 1 Speakers 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: Continental Breakfast

8:00 - 9:00: Improving Regulatory Processes through Collaboration

Pamela Goldberg, MBA, President and CEO, Medical Device Innovation Consortium (MDIC)
The Medical Device Innovation Consortium initiatives in Clinical Science attempt to address the biggest barriers to collecting adequate clinical evidence in the support of new medical technology by creating blueprints for innovative clinical trials techniques, developing standards and metrics for effective clinical trial designs and encouraging the collection of adequate and appropriate clinical and patient preference data. Recognizing where innovation is headed gives us the opportunity to address challenges that have the potential to impede progress in getting products to market.

9:00 - 10:00: The Ethics and Regulations of Medical Device Research: Treating a Patient or Experimenting on a Research Subject?
Quincy J. Byrdsong, EdD, CIP, CCRP,
Vice Provost for Health Affairs, Office of the Provost, Lipscomb University
Medical device research creates the blurring of lines as it relates to whether the individual is being giving a device to treat them or to answer research questions. Although these two situations are not always mutually exclusive, blurring these lines can cause ethical as well as regulatory dilemmas. This talk will look at case scenarios to determine the ethical and regulatory considerations of medical device research as well as strategies to ensure both ethical decision making and compliance are incorporated.

10:00 - 10:20: AM Break

10:20 – 11:20: Product Development Process Informs Clinical Trial Design

Michael Fisher, BS, MS, R&D Director, Global Center for Medical Innovation, Georgia Tech
Clinical trials are used to characterize the clinical value of a product or therapy. Controlling the risk
within a trial involving a de novo technology is accomplished in many ways – medical device design
& development processes, risk assessments, IRB review, protocols guiding clinical care, and
enhanced patient monitoring. Mr. Fisher will discuss the value of design controls for research
articles entering clinical trials and how to leverage the development work during the clinical
validation of the resulting test article.

11:20 - 12:20: Medical Device Industry Trends – 2022 and Beyond

Allyson Hein, MBA, Manager/Medical Device Industry Lead, Clarkston Consulting
As businesses look to 2022 and beyond, the pace of change in the medical device industry is only expected to increase. Evolving technological and digital capabilities coupled with a shifting regulatory landscape and advancing patient expectations are driving new trends in the industry with profound impacts to how medical device makers plan, operate, and commercialize their products. While presenting unique challenges to long-held business models, these trends open new opportunities to better engage patients, enter new markets, and grow the business. Ms. Hein will explore these trends and their impact to the industry and its future.

12:20 - 1:10: Lunch (Provided)

1:10 - 2:10: Cultural Considerations in Global Clinical Trials Management

Joy Beeler-Knights, MPH, CCRA, ACRP-CPM, Clinical Trials Project Manager III, Leidos Biomedical Research, Inc.
Join Ms. Beeler for a discussion of cultural aspects to consider when implementing and conducting clinical research studies internationally. Ms. Beeler-Knights will offer experience-based recommendations for addressing some concerns that may impact project timelines, protocol procedures/logistics, and interactions between site and sponsor staff.

2:10 - 3:10: Emerging Medical Device Trials and Their Impact on Patient Access, Clinical Options and Hospital Cost
Dana M. Austin, MSA, BSN, CCRP
, Lead Nurse Coordinator, WellStar Health System/Wellstar Research Institute
Ms. Austin will highlight and compare 5 emerging medical device trials, their therapeutic objectives and impact on patient access, clinical options and hospital cost and/or savings.

3:10 to 3:30: Break 

3:30 - 4:30: Question & Answer Session and Discussion

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