Visualizing devices of the future: Human Factors Requirements and Market Insights

The primary objective of the workshop is to educate companies about regulatory requirements that may be overlooked and guide them on the necessary steps for compliance throughout the product development process. Human factors validation testing stands out as one of the more costly tests mandated by regulatory authorities. Surprisingly, despite this, approximately 90% of the usability testing submitted to the FDA is rejected the first time around, often due to a lack of understanding of the human factors process.

Harvey Medical will be facilitating the workshop, incorporating specific case studies from members involved in the development of medical devices or software categorized as medical devices.


About our guest speakers:

A person smiling at the camera Description automatically generatedLouisa has been in the medical device industry for 20 years. She founded Harvey Medical (a ClariMed company), a world-leading human factors and market insights company. Their research ensures products are developed to be safe, easy, and effective for use, evidence of which is required by regulators.




A person with blonde hair wearing a black v-neck shirt Description automatically generatedMagda is an accomplished Human Factors Researcher and Artificial Intelligence Specialist with a foundational background in psychology and social research. Her current focus lies in pioneering the integration of Human Factors and AI within the medical device industry, specifically targeting improvements in human-computer and human-robot interaction.



8h30 – Coffee Mingle

9h00 – Opening/Scene SetterNatale Rolim, EU Project Manager at NHT

09h15 – Human Factors (Usability) Requirements for Medical Devices, Software as a Medical Device, and AI as a Medical DeviceLouisa Harvey, Founder at Harvey Medical

10h00 – How AI is Shaping the Future of Medical Device DesignMagda Skowronek, Human Factors Researcher and AI Specialist at Harvey Medical

10h15 – Q & ALouisa Harvey and Magda Skowronek

10h30 – Coffee break

Applying Human Factors and Usability Engineering10h40 – Case Study on Class I Medical Device: Colic Button

11h00 – A Case Study on Class II Medical Device: Sensocure

11h30 – A Case Study on Class II Software as a Medical Device: Medicue

12h00 – Drink, Snacks & Networking

12h30 – 1:1 speed meetings with Harvey Medical