Device Research & Regulatory Conference

2025 Agenda Coming Soon! 

Preconference Half-Day Workshop

*Requires Add-on Registration to Main Program

Preconference Speakers:

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

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

Donna Headlee, RN, BSN, CCRP, FDA Retired Branch Chief, PPB

Preconference Agenda

11:30 – 12:00: Registration and Welcome

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

Kathi Durdon, MA, CCRP, Executive Director, CNY Biotech Accelerator, and Angie Rock, MBA, CCRP, Director, Clinical Operations, BIOTRONIK, Inc.

  • Overview of Medical Device Through Terminology
  • Medical Device Regulations & Device Classification
  • Good Clinical Practice

2:00 - 2:20: Break

2:20 - 3:20: Roles and Responsibilities / Study Monitoring

Angie Rock, MBA, CCRP, Director, Clinical Operations, BIOTRONIK

3:20 - 4:20: Overview of Premarket Submissions, Selecting, Preparing and Submitting the Application in the Correct Pathway

Donna Headlee, RN, BSN, CCRP, FDA Retired Branch Chief, PPB

Several types of premarket submissions can be submitted to CDRH. In order to legally market a device in the US, the most common forms of premarket submissions to CDRH are the 510 (k) premarket notification submission, the PMA premarket approval and the De Novo Reclassification. This session will provide an overview of the various marketing pathways and discuss some best practices and strategies for submitting a premarket application.

 4:20 - 5:00: Q&A

Main Conference

Day One - Thursday 

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

8:30 - 8:40: Program Welcome and Introduction

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

8:40 - 9:40: ISO 14155:2020 Overview and Comparison to FDA IDE Regulations

Joy Frestedt, PhD, RAC, CPI, FRAPS, FACRP, President and CEO, Frestedt Inc.

The FDA recognizes the ISO 14155:2020 international standard as a recognized consensus standard for good clinical practice (GCP) during medical device clinical trials. Investigational Device Exemptions allow an investigational device to cross state lines for use in clinical trials and the FDA regulations require these trials to follow GCP. This presentation will review the similarities and differences between the ISO 14155 international standard and the specific FDA IDE regulations in the US.

9:40 - 10:40: Appropriate Use of Voluntary Consensus Standards and the Conformity Assessment Program

Shelby Skoog, PhD, Biomedical Engineer, Center for Devices and Radiological Health (CDRH), FDA

A reliance upon consensus standards reduces regulatory burden, streamlines conformity assessment, enhances device quality and promotes global harmonization. When manufacturers cite FDA recognized standards, uncertainty about conformity assessment documentation is reduced and less paperwork is required. This session introduces the audience to the practical aspects of citing standards in device submissions and offers tips on why and how to participate in the Accreditation Scheme for Conformity Assessment (ASCA), CDRH’s new initiative to streamline conformity assessment in device review.

10:40 - 11:00: Break

11:00 - 12:00: Lessons Learned: IDE Case Study

Donna Headlee, RN, BSN, CCRP, FDA Retired Branch Chief, PPB

This session will use a case study to discuss Investigational Device Exemption’s (IDE) regulatory framework including risk determination and navigating the IDE regulatory process.

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

1:00 - 2:00: Impact of the European Union General Data Protection Regulation and Other Privacy Laws on Clinical Research

David Peloquin, JD, Ropes & Gray LLP

In recent years, the European Union, as well as several other countries and U.S. states, have adopted stringent data privacy laws. These laws have had a profound effect on clinical research activities. This session will explore how the European Union’s General Data Protection Regulation (“GDPR”) applies to clinical research conducted in the European Economic Area. It will also explore the effects of emerging U.S. state privacy laws on clinical research.

2:00 - 3:00: The Ethics and Regulation of Medical Device Innovation
Quincy J. Byrdsong, EdD, CIP, CCRP, Vice Provost for Health Affairs, Lipscomb University
With the projected rapid growth in medical device development, oversight of medical device research becomes increasingly important. As a rigorous compliance environment will provide a key component of this oversight, the often blurred lines between care and research in medical device research present ethical challenges as well. 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.

3:00 - 4:00: Day 1 Speakers Panel Discussion

Course Faculty
This panel discussion allows 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: Privacy & Confidentiality in the Age of Mobile Apps and Connected Devices
Robert Romanchuk, BSHS, CIP, Ethical Research Solutions, LLC

The widespread use of mobile apps and connected devices has become ubiquitous in clinical research, especially in the era of decentralized trials, further complicating the considerations of privacy and confidentiality in the protections of research subjects. This session will describe the scope and reach of digital devices and apps, their regulatory status and oversight, and zero in on how their use impacts subject privacy and confidentiality.

9:00 - 10:00: Investigator-Initiated Device Studies – Key Concepts and Unique Challenges

Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality & Safety, Dartmouth Health 

This presentation will focus on device studies that are sponsored by a single investigator. Navigating the regulatory landscape, from both the sponsor and investigator role, requires a specific level of expertise. Appreciating the operational fundamentals while anticipating potential barriers are essential to finding success in this area. This presentation will focus on these areas, providing educational content that aims to enhance the audience’s device skillset within the context of investigator-initiated trials.

10:00 - 10:20: AM Break

10:20 - 11:20: Effective Management of Clinical Trial Financials

Sandra Sarafin, BA, CCRP, Director of Research Business Services, OhioHealth Research Institute

Ms. Sarafin will discuss how to create comprehensive internal budgets to ensure costs for trials are covered, share sponsor negotiation strategies, and discuss how to manage finances post award. This session will also cover medical device implications in budgeting and contracting.

11:30 - 12:20: Collaboration for Effective Monitoring Visits

Larissa Mitchell, CCRP, Senior Clinical Research Associate, ICON

This talk will discuss ways for effective and increased collaboration between site staff and monitors for both onsite and remote monitoring visits.

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

1:10 - 2:10: Use of Clinical Adjudication for Determination of the True Infection Status in the Absence of Reference Standard

Shailee Rasania, MPh, MBA, M.S, CCRP, Clinical Operations Manager, Inflammatix, Inc.

Use of clinical adjudication in clinical trial design is increasing since past decade. One of the biggest challenges we face in conduct of clinical trials in infectious disease domain is the absence of true gold standard/ reference standard to determine the true infection status. Using clinical adjudicators is becoming a popular solution to this problem. Many companies have successfully used clinical adjudication as reference standard for their FDA submission and has led path for this method to become widely accepted in clinical trials.

2:10 - 3:10: Introduction to Statistics in Medical Device Research

Austin Collins, MS, Senior SAS Programmer, Biomedical Statistical Consulting

This presentation will provide an introduction and overview of clinical trial statistics. Descriptive statistics, multiple types of statistical testing, power calculations, and survival analysis will all be covered. The end of the presentation will explore a few example journal articles

3:10 - 4:00: Day 2 Speaker Panel Discussion

Course Faculty

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