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:

Louisa 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.

Magda 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.

Program

8h30 – Coffee Mingle

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

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

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

10h15 – Q & A
Louisa Harvey and Magda Skowronek

10h30 – Coffee break

Applying Human Factors and Usability Engineering
10h40 – 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