Clinical Investigations: Collecting Proof That Your Device is Safe and Effective

Clinical investigations play a crucial role in supporting regulatory submissions and must encompass the intended user and intended use environment. The U.S. Food and Drug Administration (FDA) refers to these pivotal studies as the definitive means of generating data that demonstrates the safety and effectiveness of a device for its intended use.

Join our hosts for the eighth installment of the NAMSA RAQA Café Podcast, where they sit down with Wendy Schroeder (NAMSA Principal Product Development Strategist–IVD, Clinical) to discuss valuable insights into clinical investigations and clinical evaluations, and examine the advantages and risks associated with participating in a clinical trial.

“When you are looking at an investigational product, investigational device you typically have to put that device into a clinical investigation where you use the device on human subjects and you demonstrate that it is safe and that it’s effective ” – Wendy Schroeder (Principal Product Development Strategist–IVD, Clinical)

Discussion topics include:

• Clinical evaluation
• Intricacies of clinical trials
• Benefits/risks of participating in a clinical study
• Respiratory season for clinical trials (flu and cold research season)

Helpful Links:

• NAMSA Webinar “Infectious Disease Diagnostic Devices: The Big Move”
• NAMSA/AdvaMed Webinar “Clinical Trial Site Budgeting – Risk Mitigation or Budget Control?”
• NAMSA Blog  “Clinical Trial Cost Analysis with Site Budget Estimates”

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

Meet the Speakers

Wendy Schroeder, RN, BSN, CCRC/PM, CRCP; Principal Strategy Consultant-Clinical, NAMSA

Wendy Schroeder has been involved with research and clinical trials for more than 20 years, and has a deep understanding of in vitro diagnostics (IVDs) and companion diagnostics (CDx). She has served as a key company stakeholder in the implementation of an in-house contract research organization (CRO) infrastructure for a commercial laboratory moving bench IVD science into clinical validation studies and launching a biorepository of blood samples with annotated clinical data. Wendy has provided research operations oversight for commercial laboratories (Caris Life Sciences, Ashion Analytics) and IVD manufacturers (VisionGate, Inc.) as well as at hospital and clinical sites.

Wendy holds a Bachelor of Science in nursing degree from Arizona State University (Tempe, AZ). She is a certified Research Coordinator and Project Manager (ACRP) and a certified Research Contracts Professional (MAGI). She has been an invited speaker and author of peer-reviewed journal publications on molecular diagnostics (MDx), clinical trial billing and IVD/Laboratory Developed Test (LDT) regulatory matters.

Linford Leitch; Former Regulatory Consultant, NAMSA

In 2021, Linford joined NAMSA as a Regulatory Consultant. He has 9 years of experience in the medical device industry with direct regulatory experience with Spine, Transcatheter Heart Valves and Hemodialysis devices. He specializes in developing global regulatory strategies for entry to market and maintain strategies throughout product lifecycle.

Richard Granquist; Senior Quality System Consultant, NAMSA

Rich Granquist has 17 years of experience in the medical device industry and has spent extensive time working with both start-up manufacturers and larger, global device manufacturers. He specializes in quality system development and risk management.

Rich started in the medical device industry as a Microbiologist focusing on preclinical testing including, packaging validation, biocompatibility testing and reprocessing instruction validation for urology and women’s health devices. He spent several years as a Quality Engineer performing complaint investigations, root cause investigation and product development focusing on aortic intervention vascular devices. In 2014, Rich joined NAMSA as a Quality Systems Consultant. Over his 16 years in the medical device industry, he has participated in numerous AAMI ISO standards committees and currently sits on the AAMI working groups for AAMI ISO 14971, AAMI ISO/TR24971, AAMI ISO 13485 and AAMI ISO 15223.