80% less paperwork, 90% faster reviews: Transforming BCI Operations
About Paradromics
- Location: United States
- Industry: Neurotechnology
- Employees: 51-200
At the junction of medicine and technology, Paradromics is pioneering a Brain-Computer Interface (BCI) that can decode brain activity at unprecedented scale, translating thought directly into action. For patients with ALS or paralysis, this isn’t an abstract vision, it’s a chance to communicate again. But pushing into an uncharted regulatory landscape demands a system as advanced as the technology itself - every process must be traceable, compliant, and fast.
Use cases implemented
Key metrics
- Reduction in operator paperwork:-80%
- Reduction in traveler review time for engineers:-90%
- Reduction in process innovation time:-15%
Testimonials
Challenge
The complexity of Paradromics’ processes meant that traditional systems were not capable of the speed and adaptability needed to support the company’s objectives:
- Weighty documentation burden Operators spent 30–60 minutes per process on manual paperwork, whilst senior engineers devoted a combined 3–4 hours daily to reviewing paper travelers - an administrative load that disrupted focus, stifled innovation, and slowed throughput.
- Regulatory complexity in uncharted territory As a BCI developer pushing the regulatory envelope, Paradromics needs airtight traceability and compliance during a time when FDA pathways are still evolving. This compliance extends across physical device manufacturing, quality management, and the implementation of their software.
- Fragmented data systems Process data lived across multiple platforms - paper, digital forms, legacy systems - hindering visibility across processes. It was difficult to drill into the information and analyse the root cause of reworks, discover process bottlenecks, or discover where traceability had collapsed.
Solution
Paradromics implemented Seal as their operational backbone - a single, validated digital platform across manufacturing execution, quality systems, and software compliance.
- Seamless operator workflows Paper-based steps replaced with guided digital workflows, reducing the possibility of operator error and minimising execution time.
- Unified data ecosystem All operational data, from nonconformance reports to calibration records, now live in one platform, enabling traceability and real-time access by engineers.
- Automated compliance guardrails Built‑in version control and digital audit trails substantially reduce oversight risk and boost regulatory confidence.
- Foundations for faster procedure development With entire process histories and contextual data at their fingertips, engineers will be able to build and update processes more efficiently.
- Validated, trusted foundation Seal’s pre‑validated architecture gives Paradromics a robust compliance framework without building one from scratch, vital in their emerging‑regulatory environment.
Outcomes
The implementation of Seal on Paradromics’ operations has delivered transformative, measurable impact across the business:
- 80% reduction in Operator paperwork Operator time spent on paperwork dropped by 80%+, freeing up focus for core process execution.
- 90% reduction in traveler review time for engineers Senior engineers reduced manufacturing traveler review time by over 90%, significantly increasing capacity for innovation.
- 15% faster process innovation Build‑outs of new workflows are now 15% quicker, enabling faster iteration and responsiveness.
- Foundation for future insights With data centralised, the team is now beginning to extract analytics for process flow optimisation and predictive improvements.