Agenda

Device Research & Regulatory Conference

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, Retired Branch Chief, Premarket Programs Branch, Division of Industry and Consumer Education, Center of Devices and Radiological Health, Food and Drug Administration

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: The ODD couple: Clinical Risk Management via ISO 14155 and ISO 14971

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

The integration of device engineering risk concepts into clinical trial risk management activities is advancing at a fast clip. In addition, the identification of pre-defined and pre-quantified safety and performance acceptance criteria has become a required step in clinical evaluations. Putting these concepts together in the work required for clinical trials is new territory for us to explore together.

9:40 - 10:40: IDE’s Risk Determination

Donna Headlee, RN, BSN, CCRP, Retired Branch Chief, Premarket Programs Branch, Division of Industry and Consumer Education, Center of Devices and Radiological Health, Food and Drug Administration

This session will discuss Investigational Device Exemption’s (IDE) regulatory framework including risk determination and navigating the IDE regulatory process through real world examples. Additionally, we will discuss the STeP and Breakthrough Device Programs which provide patients and healthcare providers with timely access to devices that could provide more effective treatment or diagnosis or significantly improve the safety of currently available treatments or diagnostic by expediting their development, assessment, and review.

10:40 - 11:00: Break

11:00 - 12:00: Concept to Market for Medical Devices

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

This presentation will provide an overview from the perspective of a start-up company working to commercialize their medical device innovation and the steps they take as well as the barriers they face to get their safe and effective product to market. Topics will include customer discovery, use centered design, intellectual property protection and patents, risk-based regulatory pathway, valid scientific evidence, outsourcing and funding.

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

1:00 - 2:00: Session Title TBD

Blake Wilson, Partner, Hogan Lovells

Digital Health Technologies and devices that incorporate artificial intelligence/machine learning  continue to proliferate. We’ll review FDA’s current regulatory framework for medical devices and how these products fit in, as well as FDA’s expectations for development of devices that use artificial intelligence/machine learning.  We’ll also discuss current guidance that companies should consider when planning their regulatory strategy, and developments that may be on the horizon.    

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: Regulatory and Compliance Considerations for Human Subjects Research: Recent Developments Affecting Informed Consent, Data Privacy, and Consumer Protection, including as Related to Digital Health Technologies Used in Research

Leslie A. Thornton, Ph.D., J.D., Counsel, Ropes & Gray LLP

The federal government recently has enacted numerous statutory and regulatory changes that impact the conduct of human subjects research, including ever-evolving FDA guidance on topics affecting clinical research such as updated guidance on informed consent for clinical investigations and draft guidance on diversity action plans, as well as the NIH’s recommendations for informed consent for research using digital health technologies. Further, data privacy laws, including enhanced enforcement of the Health Breach Notification Rule and Section 5 of the Federal Trade Commission (FTC) Act and an increasing number of U.S. state laws have imposed heightened requirements for the collection and sharing of personal data, which can encompass personal data collected in clinical trials or other research, including via online tracking technologies. These laws can present difficulties, particularly where obligations may vary across jurisdictions. This talk will examine these developments and offer best practices for their implementation within an ever-evolving legal landscape.

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: Clinical Trial Budget Negotiation & Billing

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

11:20 - 12:20: Statistics in Medical Device Research

Austin Collins, MS, Senior Biostatistician, Biomedical Statistical Consulting, LLC

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

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

1:10 - 2:10: Monitoring Collaboration for Effective Monitoring Visits

Larissa Mitchell, CCRP, MS, BBA, Senior Clinical Research Associate, Boston Scientific

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

2:10 - 3:10: Demystification of In Vitro Diagnostic Clinical Studies

Narvelle Delabruere, Sr. Clinical Program Manager, Hologic, Inc.

The presentation will cover several key aspects pertinent to IVD clinical trials, including the regulatory requirements outlined in section 812.2(c). It will also delve into important considerations for study design, the Institutional Review Board (IRB) requirements for reviewing non-significant risk devices, the protocols for informed consent and the use of leftover samples, and the procedures for submitting data to the FDA.

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.