Accuracy in rapid sepsis probability assessment
95%
0
Faster than prior diagnostic methods
99%
0
Reduction in time to market through streamlined production
20%
0
Case Study
Engineering a Rapid Sepsis Diagnostic Platform to Commercial Scale
From Concept to Commercially Ready: Results in Under 10 Minutes, Time to Market Reduced by 20%
A precision diagnostics company developed a cytometry-based sepsis probability platform using advanced machine learning analysis of white blood cells. To bring it to market, they needed an engineering and manufacturing partner capable of delivering the precision automation required for clinical reliability and the production infrastructure to scale commercially. Ascential provided comprehensive development, automation, and contract manufacturing support, enabling the platform to reach market 20% faster than projected.
The Challenge
Sepsis is the leading cause of in-hospital mortality in the United States, responsible for approximately 270,000 deaths annually, more than opioid overdoses, prostate cancer, and breast cancer combined. Despite the severity of the condition, conventional diagnostic methods require 24 to 72 hours to return results, creating critical delays in a clinical environment where timely treatment is directly tied to patient survival.
The client’s vision was a platform capable of rapidly assessing sepsis probability to give physicians actionable information at the point of triage. Realizing that vision required solving two interconnected engineering challenges: achieving the diagnostic speed and accuracy demanded by clinical use, and building manufacturing processes capable of supporting reliable, scalable commercial production.
Compress Time-to-Result
Deliver sepsis probability assessments within minutes, replacing methods that required 24 to 72 hours and could not support urgent clinical triage decisions.
Engineer for High-Throughput Reliability
Develop highly precise automation and manufacturing processes capable of supporting commercial-scale production without compromising diagnostic accuracy.
Ascential's Solution
Ascential engaged across the full development and production lifecycle, applying a design for manufacturability approach from the outset to ensure the platform could be produced at commercial scale without compromising performance. Machine learning algorithms and cytometry hardware were optimized in parallel to support high-throughput processing and improve diagnostic reliability across patient populations.
By integrating engineering, development, automation, and manufacturing under a unified program, Ascential ensured that design decisions made during development translated directly into a scalable, production-ready platform.
Streamlined production processes were implemented throughout the program, compressing the path from development to commercial launch and reducing time to market by 20%. The result is a platform capable of assessing sepsis probability in under 10 minutes with greater than 95% accuracy, replacing a diagnostic process that previously required up to three days.
Technical Capabilities Delivered
| Capability | What Ascential Built |
|---|---|
| Engineering and Development | Comprehensive engineering and development support spanning system design, algorithm optimization, and hardware integration |
| Design for Manufacturability | Applied DFM principles throughout development to ensure the system could be produced at commercial scale with consistent quality |
| Algorithm and Hardware Optimization | Optimized machine learning algorithms and cytometry hardware for high-throughput processing and improved diagnostic reliability |
| Automation | Delivered precision automation enabling sepsis probability assessment in under 10 minutes with greater than 95% accuracy |
| Contract Manufacturing | Provided scalable contract manufacturing expertise to support commercial production of the diagnostic platform |
| Production Process Streamlining | Implemented streamlined production processes that reduced time to market by 20% |
Key Results
- Sepsis probability assessed in under 10 minutes, replacing conventional methods that required 24 to 72 hours.
- Greater than 95% diagnostic accuracy achieved through optimized machine learning algorithms and cytometry hardware integration.
- Time to market reduced by 20% through streamlined production processes implemented across the development lifecycle.
- Commercial-scale manufacturing established via a design for manufacturability approach that embedded production considerations from the earliest stages of development.
Why It Matters
Sepsis demands rapid clinical response. Every hour between onset and effective treatment narrows a patient’s odds of survival, yet conventional diagnostics have historically been unable to provide actionable results within a clinically relevant window. A platform that delivers reliable sepsis probability assessment in under 10 minutes gives clinicians a fundamentally different tool at the point of triage.
For the client, Ascential’s role as a full-lifecycle engineering and manufacturing partner meant that clinical performance and production scalability were developed together rather than sequentially. The platform reached the market faster, built on a manufacturing foundation designed to grow with commercial demand. For hospitals deploying it, that means a reliable, scalable diagnostic that directly supports better patient outcomes in one of medicine’s most time-critical conditions.
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