Quantitative v. Qualitative (ft. Bert Boquet)

Safe and Effective

In our third episode of Safe and Effective, we talk to Bert Boquet about the intricacies of the ever-present data debate of qualitative vs. quantitative 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.

• Guest: Albert Boquet
• Host: Heidi Mehrzad
• 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Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry | FDA