Rules & compliance
Software for an FDA-regulated lung-transplant company
Pratyank’s work at Traferox Technologies, before PlainSpoken.
Led a clinical logistics platform that cut manual processing 80% and data-entry errors 30%, and was responsible for the software on two lung devices that later received FDA clearance and approval.
- Manual clinical processing on the logistics platform
- −80%
- Data-entry errors
- −30%
- Core features that keep working without a network
- 100%
The situation
Transplant teams were coordinating donor-lung logistics with manual, paper-heavy processes, where a lost record or a dropped connection can cost an organ. Traferox makes regulated lung preservation and perfusion devices, so its software work had to meet medical-device standards.
What was hard
Clinicians work in hospitals and in transit, where connectivity drops. The data was sensitive and had to serve both clinical use and machine learning. And a small team had to ship web, mobile and backend at once.
What Pratyank did
The clinical logistics platform (led)
- Led the full-stack build: a Next.js/React web app on a Python backend, plus a cross-platform mobile app in C# .NET MAUI, handling clinical data under PHIPA and HIPAA.
- Designed offline-first sync so 100% of core features keep working without a network, then reconcile safely.
- Architected an Azure ML pipeline with structured data modelling for preprocessing medical data.
- Set up CI/CD with GitHub Actions, owned code review and architecture decisions, and mentored junior developers on API design.
Device software (responsible for)
- Owned the software for the X°Port Lung Preservation System and the TorEx Lung Perfusion System within an ISO 13485 quality system and IEC 62304 lifecycle: design reviews, change control, and traceability from requirements to code, tests and ISO 14971 risk controls in the Design History File.
- Audited the devices’ C code for correctness and safety against MISRA C.
- Supported IEC 62366-1 usability engineering with clinical users.
What changed
On the platform, manual clinical processing fell 80% and data-entry errors fell 30%, and medical teams use it in live clinical workflows.
On the device side, X°Port later received FDA 510(k) clearance (May 2025) and TorEx received FDA Premarket Approval (July 2026). Those approvals cover each device as a whole; Pratyank was responsible for its software.
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