Expert Q&A: Navigating the road to approval for medical devices

Umaima Ahmad - CEO of 52North

Lorna Maclean - founder and CEO of Demetria

Dr Melis Eda Ekinci - founder and CEO of Woost

Can you provide an overview of the solution you are developing?

LM: In short, we are improving endometriosis diagnosis times from nine years to nine minutes, and moving the process from an invasive surgery under general anaesthetic to a simple AI-enhanced ultrasound scan.

ME: Woost is dedicated to creating a paradigm shift in the diagnosis of gynaecological conditions starting with polycystic ovary syndrome (PCOS) with the use of menstrual blood testing. We are developing home-centred care and testing solutions to track key biomarkers in menstrual blood to significantly reduce diagnosis time of PCOS and monitor disease progression. Our test devices will be easy-to-use, affordable and accessible to any woman anywhere to monitor their gynaecological wellbeing. Our patient-centric model will eliminate location-specific restrictions providing real-time, regular, point-of-care testing. Our digital platform will provide continuous access to health data for all women to use, be preventive and take actions towards a better health throughout their lifetime.