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Navigating the Landscape for Over-the-Counter or Direct-to-Consumer IVD Tests

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Date/Time

Date(s) - December 8, 2022
10:00 AM - 11:00 AM CT

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Healthcare diagnostics has seen a significant increase in over-the-counter (OTC) or direct-to-consumer (DTC) testing. A trajectory that was already in the making prior to COVID-19, this area has increased at a faster pace as more consumers are comfortable performing OTC tests at home. This change in consumer expectation, as well as an evolution of global regulatory requirements, has led to increased considerations and requirements by IVD manufacturers to produce robust testing options.

Join NAMSA for this webinar as we evaluate those enhanced requirements specifically as they affect human factors and usability engineering to insure all IVDs are safe and effective for the intended users, uses and use environments. Early understanding of these requirements is crucial and can influence the device display, controls, functions, results interpretations, instructions and countless other design inputs impacting the consumer.

Participants of this webinar can expect to learn how to:

  • Define human factors and usability and how that definition may change based on country
  • Identify when in the product development lifecycle human factors and usability requirements should be considered
  • Apply ISO 14971 and IEC 62366 standards as part of a formal risk analysis in the development of a human factors/usability risk assessment
  • Translate risk assessment to a human factors and usability testing plan and where key activities can be leveraged for multiple markets

Time will be allotted for Q&A.

 

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Speaker

Wendy Schroeder

Principal Strategy Consultant, Clinical

Wendy Schroeder has been involved with research and clinical trials for more than 25 years, and has a deep understanding of medical devices including 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. She has supported medical device product development including device risk classification, pre-clinical testing and design controls and clinical strategy interactions with the FDA.

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.