Applications | Design & Manufacturing | Clinical & Molecular Diagnostics
Preserve clinical chemistry & molecular diagnostics market performance
Ensure your assays perform consistently and your workflows are cost-effective, from prototype to production. Ascential helps you find submission-ready solutions for your innovation. Our experts provide medical device manufacturing solutions that support point-of-care testing and diagnostic applications such as
- PCR, qPCR, RT-PCR
- Isothermal Amplification
- Cartridge-Based Sample-to-Answer Systems
- Syndromic Infectious Disease Panels
- STI/STD Testing Platforms
- Oncology Diagnostics
- Clinical Chemistry and Immunoassay Systems
- Hematology and Coagulation Analyzers
- Microbiology
- ID/AST Automation
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Solutions
Comprehensive manufacturing solutions for clinical & diagnostic instruments
Our team partners with you to transform your breakthrough assays into production-ready systems, providing end-to-end services for cohesive manufacturing. With integrated automation, prototyping, early-access builds, and sustaining engineering, we establish sample-to-result workflows that preserve performance, regulatory compliance, and product design.
Diagnostic Instrument Development
Collaborate on end-to-end instrument design from systems engineering, sample handling and preparation, fluidic metering and reagent delivery, optical detection (fluorescence, absorbance, luminescence), thermal management for amplification and incubation, and instrument control software as per IEC 62304.
Diagnostic Consumable & Cartridge Development
Initiate a development plan that balances consumable geometry, material selection, and surface properties around assay sensitivity and contamination control requirements. We validate designs for microfluidic cartridges, reaction vessels, sample collection interfaces, and disposable fluidic paths.
Regulatory-Ready Design & Manufacturing Transfer
From the concept phase onward, we structure design controls, risk management (ISO 14971), and requirements traceability for submission success. Thorough DFM analysis, tolerance stackup, and process validation protocols inform supporting IQ/OQ/PQ documentation.
Verification Builds & Clinical Study Support
Confirm your instrument meets design, usability, and clinical performance expectations with functional prototypes and pilot-scale production runs. Test the accuracy, reproducibility, and manufacturability you need for full-scale production and real-world use.
Diagnostic System Manufacturing
Drive clinical accuracy with incoming inspection, in-process controls, and final test protocols designed around platform-specific fluidic, optical, and thermal performance parameters.
Sustaining Engineering & Cost Optimization
Resolve component obsolescence, improve your manufacturing yield, and reduce the cost-per-test through VAVE programs on fielded diagnostic platforms.
Capabilities
Design & build functional, tested diagnostic platforms
We architect systems that address the realities of diagnostic performance:
- Minimal carryover and contamination
- Reduced dead volume and precision liquid handling for reproducible results
- Thermal uniformity, optical sensitivity, and cross-talk mitigation to preserve assay fidelity
- Optimized signal-to-noise, accuracy, and repeatability
- Scalable throughput with reliable, serviceable instruments
Diagnostic Platform Design
Seamlessly integrate sample handling, reagent delivery, and detection function into your diagnostic system workflow design. By co-developing instruments and consumables across fluidics, optics, thermal management, automation, and software, we ensure the platform performs reliably and matches your chemistry intent.
Regulatory-Ready Design
Simplify your 501(k) submission efforts with robust design controls, risk management per ISO 14971, requirements traceability, and IEC 62304 software processes structured from feasibility. We ensure design history files, verification protocols, and manufacturing documentation are complete and defensible.
Sample-to-Result Workflow Engineering
Ensure your assay’s bench-level sensitivity and specificity translate directly to production instruments. By having all manufacturing components operate as a unified workflow, we can analyze pre-analytical variability (lysis efficiency, pipetting CVs, carryover, thermal exposure) so results are consistent even with untrained operators.
Manufacturing-Driven Development
Hit your cost and scale targets with designs built for real-world production. We integrate DFM analysis, tolerance studies, and supplier considerations into development so unit costs, yield, and scalability are validated rather than estimated from expensive prototypes.
Case Study
Enabling quicker, scalable AST without compromising accuracy
A precision diagnostics company looking to scale phenotypic antimicrobial susceptibility testing (AST) faced slow workflows, limited throughput, and tight spatial tolerances in existing lab environments. Ascential partnered to integrate microfluidics, thermal management, advanced robotics, and custom software into a single automated system.
The platform now performs AST directly from positive blood cultures, an achievement that was granted FDA Breakthrough Device Designation. Throughput increased by 70%, reagent dispensing became 4× faster, and overall patient testing capacity rose by 50% — without compromising accuracy. A balance that reduced risk, time-to-market, and cost.
Why Choose Ascential?
Diagnostic Domain Expertise
Our deep expertise in diagnostics helps you move seamlessly from concept to clinical and laboratory deployment.
Integrated Engineering
Resolve cross-subsystem trade-offs instead of discovering them at integration. Our mechanical, software, manufacturing, automation, and systems engineers collaborate in-house to design comprehensive, resilient solutions.
Manufacturing Power
Tap into a global network of FDA/ISO-certified facilities for cost-efficient support and manufacturing capabilities. We deliver strategic production support to enable smoother transfers and a faster ramp to volume.
Commitment to Quality
Meet the highest standards of performance, traceability, and regulatory compliance with rigorous design controls. We set your 510(k), De Novo, PMA, and EU IVDR submissions up for success.
Frequently Asked Questions
Get answers to common questions about our clinical and molecular diagnostics capabilities.
We work under NDA. Our role is to engineer the instrument and consumable platform around your assay. Your science team owns the chemistry; we ensure the fluidic handling, thermal profiles, optical detection, and consumable design preserve the assay performance your chemistry delivers.
FDA 21 CFR 820, ISO 13485, IEC 62304 for software, ISO 14971 for risk management. We have direct experience supporting 510(k), De Novo, PMA, and EU IVDR submissions. Design controls and traceability are part of Ascential’s standard development process, not an add-on.
Our manufacturing footprint spans the U.S. and Southeast Asia. We match program phases to the right site: early prototyping and pilot builds in the U.S. for speed and engineering proximity, volume manufacturing in Southeast Asia where the cost structure supports high-volume diagnostic consumable and instrument production.
Manufacturing engineering participates from early development to streamline decision-making. DFM, tolerance stackup analysis, process development, and supply chain qualification run in parallel with product design. By the time the design is locked, the manufacturing process has been developed and validated alongside it.
A diagnostic instrument program from concept through design verification typically runs 18-30 months, depending on system complexity and regulatory pathway. Point-of-care cartridge-based systems tend toward the shorter end; multi-module central lab analyzers toward the longer end.
Either. Ascential routinely qualifies and integrates client-specified suppliers, particularly for assay-specific reagents and specialty components. If you don’t have a preference, we use our qualified supply base. For components critical to clinical performance, we recommend dual-source qualification regardless of source.
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