Program Description

Device Research & Regulatory Conference: The Premier Conference for Device Professionals

Goal: This annual medical device conference provides attendees with a main program preceded by a half-day device basics workshop. The entire program features experts presenting topics regarding medical device design and development, clinical trials activities, data analysis, quality and regulatory process and post market management.
Attendees include the following roles and responsibilities:

  • Clinical Research Professionals (e.g., Principle Investigators, Clinical Research Associates, Clinical Research Coordinators)
  • Government, University, Industry and Support Organization Representatives
  • Quality, Regulatory, Research and Development, Engineering, Human Factors
  • Medical Device Designers/Developers
  • Medical Device Startup Companies
  • Medical Device Vendors, Service Providers
  • Clinical Research Organizations
  • Anyone interested in learning more about medical device research and regulatory process
Preconference Workshop

The preconference half-day workshop is designed to provide a comprehensive medical device regulatory overview and is a fundamental precursor to the Main Program. Topics include:

  • Introduction to the Medical Device Regulatory Framework
  • Navigating the 510(k) Pathway
  • Building Quality into Clinical Studies - Roles and Responsibilities of Sponsor-Investigators

Main Program

Day 1 Presentations:

  • Keynote: Direct Sponsor Involvement in Clinical Trial Recruitment and Other Trial Activities
  • The Ethics and Regulations of Medical Device Research: Treating a Patient or Experimenting on a Research Subject?
  • Medical Device Event Reporting
  • Lessons Learned: De Novo Classification Pathway
  • FDA’s Digital Health Centers of Excellence Program (DHCoE) – Overview of Resources
  • Speaker Panel

Day 2 Presentations:

  • Keynote: Improving Regulatory Processes through Collaboration
  • Utilization of Real World Evidence in Cardiac Lead Post-Approval Studies
  • Product Development Process Informs Clinical Trial Design
  • Medical Device Industry Trends – 2022 and Beyond
  • Cultural Considerations in Global Clinical Trials Management
  • Speaker Panel

 Learning Objectives: Pre-Conference Workshop

The participant will be able to:

  • Discuss FDA medical device regulations, including risk categorization and device classifications.
  • Understand risk categories of IDE studies
  • Examine roles and responsibilities of Sponsor-Investigators
  • Review FDA marketing applications for medical device

Learning Objectives: Main Conference

The participant will:

  • Distinguish between allowable and unallowable sponsor activities that put sponsor staff in direct contact with clinical trial participants.
  • Identify and address ethical and regulatory considerations in medical device research.
  • Understand medical device event reporting regulations and guidelines.
  • Discuss regulations for medical device export/import.
  • Examine the FDA De Novo Classification Pathway for novel medical devices.
  • Describe the Digital Health Centers of Excellence (DHCoE) Program, identify resources available locate Digital Health Software Precertification Information in support of digital health evolution and adoption.
  • Discuss ways to break down barriers to innovation and find pathways to FDA approval.
  • Examine the application of real world data to fulfill regulatory post-approval requirements.
  • Determine the logistical and regulatory considerations for utilizing real world data compared to prospective clinical studies.
  • Discuss the FDA’s investigational device exemption process.
  • Understand design controls and design history files and how the design & development process can be used to enhance clinical trials execution.
  • Investigate the critical trends driving future strategies, commercial models, operations, and technologies of the medical device industry.
  • Comprehend clinical study cultural aspects and recommendations for implementation.
  • Discuss the impact on patient access and comparing standard of care versus clinical trial options for cost savings to patients and hospitals.
  • Participate in speaker panel discussions.