Projects / P-12
Medical devices
Bringing an AI recovery app to two markets
Planning how an AI-assisted app that guides patients after surgery could reach the market in the UK and the US.
P-122025
- Project
- A UK and US launch plan for a post-surgical recovery app
- Context
- MSc, University of Sheffield
2markets compared
~33%estimated cost saving from the chosen route
The question
What is the simplest, cheapest safe route to market for an AI app that influences clinical decisions?
What I did
- Defined what the app does: a personalised care plan, data from home devices, automatic alerts to clinicians, and AI-assisted guidance.
- Classified the product (Class IIa) and identified the software and usability standards it must meet.
- Compared the UK route (UKCA marking) with the US route (FDA 510(k) against an existing cleared app).
- Analysed launch costs and recommended launching in the UK first, with the intended use scoped to stay in Class IIa.
What I found
The recommended route was estimated to cut costs by about a third and make the launch simpler.