Product Development

Where science meets strategy — building assays and core technologies that set the stage for everything that follows.

• De Novo Assay Development – Designing new molecular, immuno, or biochemical assays from scratch.
• Assay Optimization – Tuning sensitivity, specificity, and reproducibility across sample types.
• Reagent Formulation – Developing lyophilized or spray-dried reagents for robust storage and transport.
• Surface & Extraction Chemistry – Expertise in nucleic acid prep, solid-phase binding, and amplification workflows.
• Feasibility & Proof-of-Concept – Early-stage validation of scientific or technical concepts to reduce development risk.

Transforming ideas into robust, testable systems through smart mechanical, fluidic, and electrical design.

• Consumable & Hardware Design – Custom cartridges, housings, and swabs designed for usability and scale.
• Mechanical & Electromechanical Engineering – Subassemblies, actuators, and moving parts designed with DFM in mind.
• Electronics & Sensor Integration – PCB layout, circuit design, and embedded sensing for system feedback.
• Thermal & Fluidic Architecture – Microfluidics, heating elements, and pump/valve systems for precise control.
• Optical Modules – Fluorescence, absorbance, or imaging-based detection options (when applicable).
• Assay Integration – Translating workflows into compatible mechanical and fluidic operations.
• Rapid Subsystem Prototyping – Fast-track testing of optical, mechanical, or electronic subsystems.
• Design for Manufacturing – Optimizing material selection and part geometry for scalable production.

Aligning all components — hardware, software, and workflow — into a cohesive and intuitive product experience.

• Platform Integration – Merging mechanical, electrical, and software elements into a unified system.
• Embedded Software & Firmware – Device control, automation, and user interface integration.
• System Architecture – Defining modular interfaces between consumables, instruments, and user workflows.
• Design Traceability – Full documentation for design history files, V&V plans, and regulatory compliance.
• Risk Management – Performing FMEA, hazard analysis, and risk mitigation across system functions.

Supporting you through production scale-up, regulatory milestones, and long-term sustainability.

• Pilot Production – Low-volume runs to validate yield, reliability, and QC workflows.
• QMS Development – ISO 13485 and 21 CFR Part 820-compliant systems for growing teams.
• Clinical & Regulatory Support – Site selection, IRB planning, and clinical trial execution.
• Manufacturing Transfer – CM onboarding, BOMs, documentation, and process mapping.
• Supply Chain Planning – Vendor selection, logistics support, and COGS reduction strategies.
• Post-Market Engineering – Version control, field support, and sustaining engineering.