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
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.
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
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: GCP / ISO Risk overview
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: 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. Additional, 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: Impact of the European Union General Data Protection Regulation and Other Privacy Laws on Clinical Research
Blake Wilson, Partner, Hogan Lovells
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.
7:30 - 8:00: Continental Breakfast
8:00 - 9:00: Privacy & Confidentiality in the Age of Mobile Apps and Connected Devices
Leslie Thornton, JD, Ropes & Gray LLP
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.
11:20 - 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, Senior Clinical Research Associate, ICON
2:10 - 3:10: IVD Studies
Narvelle Delabruere, Sr. Clinical Program Manager, Hologic, Inc.
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.