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Antibiotic susceptibility testing is one of the most time-sensitive processes in clinical microbiology. When a patient presents with a serious infection, every hour spent waiting for results can affect outcomes. Traditional phenotypic AST methods are slow, labor-intensive, and difficult to scale. Turnarounds can take up to 24–72 hours.
Our client needed to develop a next-generation AST platform capable of running directly from a positive blood culture. And to accelerate the clinical deployment timeline, they needed functional, risk-free production systems that could withstand FDA review. Their goals were clear:
Compress Time-to-Result
Reduce the AST turnaround time to support faster clinical decisions and better patient outcomes.
Fit Within Pre-Existing Infrastructure
Accommodate tight spatial limitations within hospital and clinical lab environments without major facility modifications.
Ensure Broad Bug/Drug Coverage
Improve throughput across a comprehensive menu of bacteria and antibiotics.
Streamline the Path to FDA Clearance
Build a system with the accuracy, traceability, and design controls necessary to achieve FDA Class II IVD approval and shorten time-to-market.
Rather than handing off work between siloed engineering teams, our cross-functional group — spanning mechanical, fluidic, optical, software, and systems engineering — worked in parallel with design, prototyping, and manufacturing process development. As a result, we were able to design custom instruments and integrate off-the-shelf (OTS) solutions where appropriate.
By engaging early and owning the full development lifecycle, Ascential was able to design for regulatory approval from the start, reducing costly late-stage redesigns and keeping the program on track.
The system Ascential designed and built consists of three integrated instruments — a Class II In Vitro Diagnostics device for use in labs, clinics, and hospitals — each purpose-built for a distinct phase of the AST workflow:
Together, the three instruments run AST diagnostics straight from a positive blood culture in under 8 hours.
The system integrates a sophisticated combination of subsystems, all designed, validated, and documented in-house by Ascential’s engineering team:
| Capability | What Ascential Built |
|---|---|
| Fluidic Handling | High-precision micro and macro fluidic systems for accurate reagent dispensing |
| Robotics | High-throughput robotic processing of microplates with precision XYZ gantries that have grip and rotate modules |
| Hazardous Material Handling | Contamination management systems designed for safe processing of infectious specimens |
| Thermal Management | Incubators with high-accuracy temperature control |
| Optics | Customized optical readers and centrifuge |
| Electronics & Controls | Custom control system electronics with integrated sensors and safety interlocks |
| Software & Firmware | Complex workflow scheduler, firmware, software, and UI |
From initial design through FDA approval, Ascential was a full-service technical program manager (TPM) partner. The completed system exceeded performance targets across every key dimension:
FDA Breakthrough Device Designation granted — a designation reserved for diagnostics that provide more effective treatment or diagnosis of life-threatening conditions — validating both the clinical significance and technical performance of the platform.
Antibiotic resistance is one of the most urgent challenges in global healthcare. Faster, more accurate AST means clinicians can prescribe the right antibiotic sooner, improving patient outcomes, reducing unnecessary broad-spectrum antibiotic use, and supporting infection control across hospital systems.
For our client, this system is a commercially ready, scalable platform that brings a clinically meaningful capability to market. For their patients, it means faster answers when time is most critical.
Ascential’s role didn’t end at engineering. We managed design controls, documentation, and regulatory strategy from the beginning to help our client align their innovation with regulatory requirements on a timeline that would have been difficult to achieve with fragmented insights from different production, engineering, development, and supply chain experts.
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