About this writeup
This handbook comes out of my graduate research on a large-volume infusion pump, done under the supervision of Prof. Kevin Fu and Axel Wirth. The pump is still in clinical use, so this document deliberately contains no reproduction details: no credentials, no interface paths, no firmware procedures. Those details live in the coordinated disclosure package held with the manufacturer.
What it does contain is the part that carries over to other devices: how to think about a clinical device, how to model its threats, how to score a finding, and how to decide what to publish.
It covers:
- The clinical context: why a medical device is not an IT asset
- Threat modelling: STRIDE, data flow diagrams, and trust boundaries when patient harm is the impact axis
- Risk analysis: why CVSS mis-ranks medical findings, and how to score so the number means something
- The regulatory frame: what the manufacturer is obliged to do
- Coordinated disclosure: the process, who to contact, CVE assignment, and the legal and ethical footing
- Research conduct: lab safety, device sourcing, and keeping a research record that holds up
- Templates: threat model, disclosure report, and risk register
- The decision register: every judgement call in one place
Read it below, or download the PDF. The project overview is on the case study page.
