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 timely medical device-related research and regulatory topics.
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 basic regulatory overview specific to medical device and is a fundamental precursor to the Main Program. Topics include:

  • Overview of medical device through terminology
  • Device specific regulations and classification
  • Good Clinical Practice
  • Roles, Responsibilities and Study Monitoring
  • Premarket Submissions

Main Program

Day 1 Presentations:

  • Devices, Decentralized, and Quality by Design, 3 Pillars to Success

  • FDA Breakthrough Devices and Safer Technologies Programs

  • Career Planning: Acquiring Competencies & Champions

  • GDPR and Other Regulatory Frameworks

  • FDA’s Digital Health Centers of Excellence Program (DHCoE) – Overview of Resources

  • Speaker Panel 

Day 2 Presentations:

  • The Ethics and Regulation of Medical Device Innovation
  • Increasing Female Enrollment in Clinical Studies
  • Imagining Failures to Identify Blind Spots in Device Research
  • What to Know About the Proposed Rule to Harmonize the FDA Regulations on Human Subjects Research with the Common Rule
  • Updates to FDA Inspectional Guidances
  • CRA Study Startup and Closeout
  • Speaker Panel

 Learning Objectives: Pre-Conference Workshop

The participant will be able to:

  • Discuss FDA medical device terminology as an introduction to the workshop.
  • Describe regulations, including risk categorization and device classifications.
  • Understand the types of premarket submissions submitted to CDRH as well as best practices and strategies for submissions.
  • Examine Good Clinical Practice for medical device as well as the roles and responsibilities key partners in clinical research.
  • Review and share medical device study monitoring processes.
  • Interactive Q&A

Learning Objectives: Main Conference

The participant will:

  • Discern how applying quality by design principles increases participant safety and data quality while supporting trial efficiency.
  • Examine the goals of the FDA Breakthrough Devices and Safer Technologies Programs to provide patients and providers with timely access to medical devices.
  • Discuss resources for professional development and provide insights for leveraging support in career growth.
  • Understand the impact of GDPR and other regulatory frameworks on business as well as the pitfalls that companies should be award of that increase risk.
  • 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.
  • Examine and discuss the rigorous compliance environment in consideration of the blurred lines between care and research in medical device that present ethical and regulatory considerations.
  • Determine ethical and regulatory consideration to ensure ethical decision making and compliance through case scenarios.
  • Discuss the new FDA draft guidance to improve enrollment in underrepresented racial and ethnic populations.
  • Understand techniques to increase female enrollment in clinical trials.
  • Investigate improving the quality of outcomes and preventing mishaps by using prospective hindsight to spot potential blind spots in research.
  • Comprehend the Notice of Proposed Rulemaking to harmonize FDA’s regulations on human subject research with those of the Common Rule
  • Discuss recruitment and retention strategies.
  • Identify the updates to the FDA compliance program manuals for Sponsors/CROs and Sites.
  • Recognize CRA responsibilities from study start up to close out from the sponsor perspective and the helpful tools to assist process.
  • Participate in speaker panel discussions held at the end of each day.