Program Description

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

Goal: This annual medical device conference, now in its 14th year, provides attendees with a main program preceded by a half-day device basics workshop. The entire program features over 13 experts presenting topics to assist those in roles specific to medical device design, development, testing, analysis, and post market management.

Attendees include the following roles and responsibilities:

  • Quality, Research and Development, Regulatory
  • Principle Investigators, Clinical Research Associates, Clinical Research Coordinators
  • Government, University, Industry Representatives
  • Engineering, Human Factors
  • Medical Device Designers/Developers
  • Medical Device Startups
  • Medical Device Vendors, Service Providers
  • Clinical Research Organizations
  • Anyone interested in learning more about medical device research and regulatory process and hot topics
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 and includes:

  • Introduction to the Medical Device Regulatory Framework
  • Sponsor-Investigator Trials: Developing and Managing an IDE
  • Sponsor-Investigator Trials: Coordinating Multisite IDEs
Main Program

Day 1 Presentations Include:

  • Host City Keynote: The Promise and Complications of “Broad Consent”
  • The 510(k) Program
  • Lessons Learned: De Novo Classification Pathway
  • The Types of Device Trials, Billing and Reimbursement
  • Expanding Access to Medical Device for Patients: Expanded Access Program, Early Feasibility Study Program and the Breakthrough Devices Program

Day 2 Presentations Include:

  • Clinical Evidence for Regulatory Purposes: IDEs and Real World Evidence
  • Utilization of Real World Evidence in Cardiac Lead Post-Approval Studies
  • Medical Device Industry Trends – 2020 and Beyond
  • A Former FDA Manager Spills the Beans on Making Quality Compliance Easier
  • Navigating a Clinical Trial Through the United Kingdom: It’s a Little More Than Tea and Crumpets
Learning Objectives: Pre-Conference Workshop

The participant will be able to:

  • Discuss FDA regulations including risk categorization and device classifications.
  • Discuss the IDE application process for sponsor-Investigator research
  • Discuss sponsor-investigator requirements and responsibilities in IDE trial
  • Discuss the coordination or multisite IDEs
  • Explain the investigator-initiated clinical study process.
Learning Objectives: Main Conference

The participant will be able to:

  • Discuss the meaning and use of Broad Consent.
  • Discuss the 510(k) determination and submission process.
  • Describe the FDA De Novo process including classification and submission.
  • Discuss the HUD and HDE application and approval process.
  • Discuss types of device trials including Category A and B IDEs.
  • Discuss the research reimbursement process.
  • Describe how to help patients in research trials avoid financial liabilities
  • Discuss Expanded Access Program, the Early Feasibility Study Program, and the Breakthrough Devices Program
  • Discuss the use of clinical evidence in the IDE process.
  • Discuss how new technologies and capabilities are impacting the medical device industry.
  • Discuss the Medical Device Single Audit Program (MDSAP)
  • Discuss cultural aspects to consider when implementing and conducting clinical research studies internationally.
  • Discuss the challenges of integrating generationally-diversity populations.
  • Discuss the unique differences of conducting research in the United Kingdom.