Transforming conceptual medical protocols into certified, patient ready devices. This project demanded simultaneous hardware and software development, regulatory navigation, and deep user research to enable autonomous medical care at home.
We started with a medical concept and a rough functional outline. The mission was ambitious: transform non standardized, manual medical processes into a precise software algorithm, then build a physical, medical grade measuring device that patients could use independently at home.
The device needed to be portable, affordable, and intuitive enough for use without professional supervision. Most critically, it had to meet the stringent requirements for Class IIa and IIb medical device certification in the European market.
How do you take a complex clinical procedure that typically requires specialist oversight and translate it into something a patient can safely perform alone at home, while meeting every regulatory requirement along the way?
I managed the end to end development, bridging the gap between clinical requirements and technical execution. This meant orchestrating parallel workstreams across hardware prototyping, mobile app development, and regulatory compliance while keeping everything aligned.
Translated complex, non standardized medical protocols into structured software logic, ensuring clinical validity while maintaining a seamless digital flow.
Oversaw simultaneous development of medical hardware and mobile software, including Bluetooth connectivity and real time data synchronization.
Led deep user research to develop educational materials and interfaces that allow patients to perform complex medical exercises correctly at home.
Directed the development process to meet Class IIa and IIb certification requirements, focusing on safety, reliability, and data integrity.
We delivered a complete ecosystem: a small, lightweight, cost effective medical device paired with intuitive mobile software that successfully passed all regulatory hurdles.
Developed a device that successfully passed Class IIa and IIb regulatory requirements for the EU market.
Created a scalable solution that successfully digitized previously fragmented medical procedures.
Launched a product enabling high quality medical rehabilitation outside clinical settings.