A diagnostics company sought to replace labor-intensive, error-prone manual sample preparation with a fully automated instrument capable of handling multiple patient tube types at high speed — all within a compact form factor suitable for clinical lab environments. Ascential delivered end-to-end engineering and development services, from initial concept through post-production support, producing a system that improved throughput, minimized human error, and achieved full regulatory compliance.
Pre-analytical sample preparation is a foundational step in diagnostic workflows — and one of the most persistent sources of error, inefficiency, and operator injury. Manual handling of patient sample tubes is slow, variable, and physically repetitive, creating risk at every stage: contamination, mislabeling, inconsistent pipetting, and musculoskeletal strain on lab personnel.
The client needed an instrument capable of managing the full pre-analytical workflow in an automated, reliable, and compliant manner — across a diverse range of sample tube types and diagnostic applications. Critically, the system had to be engineered within a compact form factor to fit within existing lab infrastructure and developed under strict regulatory controls to meet the requirements of Class II IVD classification and IEC 61010 safety standards.
Their goals were clear:
Eliminate Manual Sample Handling
Develop a fully automated instrument capable of processing and handling patient samples across diverse diagnostic applications, reducing manual labor and the risk of repetitive strain injuries to operators.
Manage Multiple Tube Types at High Speed
Design a system capable of handling multiple sample tube types at high throughput speeds while maintaining precision in liquid handling, all within a compact form factor.
Reduce Error and Meet Regulatory Standards
Minimize human error in diagnostic workflows, improve operator safety, and develop the system under the quality management controls required for Class II IVD and IEC 61010 certification.
Concept Through Post-Production Support
Engage a single engineering and manufacturing partner capable of owning the entire development lifecycle, from concept through new product introduction and ongoing after-market services.
Ascential engaged as the client’s full-service technical development partner, owning the program from initial concept through production and post-market support. Our cross-functional engineering team — spanning mechanical, robotics, fluidic, software, firmware, and systems engineering — designed and built a fully automated instrument for pre-analytical sample preparation that integrated advanced robotics and precise fluid handling into a compact, clinically suitable platform.
By engaging early and maintaining ownership across every engineering discipline, Ascential was able to design for regulatory compliance from the outset — reducing the risk of late-stage redesigns and keeping the program on schedule and on budget.
The instrument at the center of the solution features dual XYZ gantry robots nested together within a compact form factor — a design that delivers high-throughput performance without exceeding the spatial constraints of clinical laboratory environments. Key system capabilities included:
All master controller software, modular motor firmware, and system embedded controller firmware were developed under ISO 13485 quality management controls. The instrument was designed using the client’s design procedures to achieve Class II IVD compliance and IEC 61010 safety certification.
The instrument integrates a sophisticated combination of engineering disciplines, all designed, validated, and documented in-house by Ascential’s team across the full product development lifecycle:
| Capability | What Ascential Built |
|---|---|
| Robotics | Dual XYZ gantry robots nested in a compact form factor; pick-and-place robot operating at 50 ips over 30u2033 of travel; high-speed, high-precision coordinated motion. |
| Fluidic Handling | Automated pipettor robot for precise aspiration and dispense between reagent, patient sample, and output vials. |
| Sample Processing Modules | Integrated compact vortexing module and automated de/capping unit embedded within the instrument workflow. |
| Electronics & Controls | Custom control board hardware with distributed motion control topology via CAN bus interface; integrated sensors and safety interlocks. |
| Software & Firmware | Master controller software, modular motor firmware, and system embedded controller firmware u2014 all developed under ISO 13485 controls. |
| Barcode & Traceability | Tube barcode printing module integrated directly into the patient sample workflow for end-to-end sample traceability. |
| Regulatory Compliance | Full development executed under the clientu2019s design procedures to achieve Class II IVD compliance and IEC 61010 safety certification. |
| Full Lifecycle Services | Concept development, hardware and software design, UI, prototyping, supply chain development, verification testing, value engineering, NPI, safety certification, manufacturing, and after-market services. |
From concept development through manufacturing and after-market services, Ascential served as the client’s sole engineering and development partner. The completed instrument achieved its performance and compliance targets across every key dimension:
Pre-analytical errors account for a significant proportion of diagnostic mistakes — and the majority of those errors originate in manual sample handling. An instrument that automates this phase of the workflow doesn’t just improve throughput; it improves the integrity of every downstream diagnostic result it enables.
For the client, this platform represents a commercially ready, regulatory-compliant instrument that addresses a genuine gap in clinical laboratory automation. For the patients whose samples move through it, the result is faster, more reliable diagnostic decisions — with fewer errors introduced at the source.
Ascential’s role extended across the full product lifecycle — from early concept development and hardware design through new product introduction, safety certification, manufacturing, and ongoing after-market support. By maintaining end-to-end ownership of the program, we gave our client a single accountable partner capable of moving from idea to scalable production without the coordination risk of fragmented development.
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