Ep.003 Safe and Effective Podcast: Quantitative vs. Qualitative Data (ft. Dr. Bert Boquet)
Episode 003: In this episode our host, Heidi Mehrzad, talked with Bert Boquet about the intricacies of the ever-present data debate of #QualitativeVsQuantitative in the sphere of medical human factors summative (validation) studies. In our discussion we shed light on the complexities of choosing the right data type and formulating an effective experiment design for validation studies, whilst also discussing the nuances of such between medical devices and combination products. Together, we tackle the myriad of challenges human factors researchers confront regarding not just formulating an effective experiment design, but also identifying a potential unified approach for validation data collection between medical device and combination product approaches to ensure cohesive measures and robust data sets for both.
Additionally, we provide a sneak preview of our next episode in which we address the integration of a collaborative approach between #Clinical and human factors teams, and it's necessity due to the evolution of the #MDR and its "new" usability requirements within.
Listen to the podcast here or on your favorite podcast platform.
Research Links for this episode:
Guest: Albert Boquet
Host: Heidi Mehrzad, ceo and founder, HFUX Research
Applying Human Factors and Usability Engineering to Medical Devices | FDA
Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development | FDA
Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry | FDA