Product Design & Engineering

Controlling Risk

Iterative Prototyping and Data Collection

We are unrivaled when it comes to creating rapid prototype instruments for diagnostics. What sets us apart in our proprietary pre-built technology that includes both hardware and firmware the seamlessly integrates into our prototyping process.

With our pre-built technology, we can quick iterate on prototypes, collect data, and de-risk the product development process.

Making the Right Product

Human-Centered Innovation

Veranex was awarded a contract by the NIH Rapid Acceleration of Diagnostics (RADx) Program to establish best practices for the design of diagnostic technologies. Design is in our DNA.

Our design, engineering, and usability teams understand your product and its users. We strive to cultivate an understanding of the stakeholders who will use the product, and ultimately integrate the knowledge into the design and product development process.

The results are intuitive, safe, reliable, and highly desirable products that are intuitive to use.

Manufacturing Solutions

Design for Manufacturing at Scale

We are ISO13485-certified and FDA-registered manufacturers.

We understand the importance of tailored manufacturing capabilities that align with your specific needs in terms of scale and timing. There is no build too small for us. We scale alongside our clients as they move toward commercial volumes.

Our facilities include controlled inventory, dedicated diagnostics production lines, ISO Class 7 and 8 Clean Rooms, and three shifts specializing in complex electrical mechanical assembly.

Detailed Expertise & Services

Technical Expertise

  • Fluidics
  • Thermal Applification PCR / Isothermal
  • Fabrication
  • Simulation for Analysis and Testing
  • Optics / Other Detection Modalities
  • Microfluidics Design

Integrated Supply Chain, Procurement and Planning

  • Supplier selection and auditing
  • Supplier relationship management
  • Contract and price negotiation
  • Strategic procurement and inventory control
  • Establishing and maintaining traceable material plans
  • High volume planning
  • Systems integration
  • Facility site tech transfers
  • Client proposal costing
  • Cost reduction assessments, “should cost” analyses
  • BOM analyses
  • M+A due diligence support
  • Facilitating partnerships with clients and OEMs
  • NetSuite ERP management

Complex Consumables

  • Molecular Diagnostics
  • Microfluidics Cartridges
  • POC Disposables
  • Immunoassay Disposables
  • Disposable Cartridges with Integrated Electronics
  • In-cartridge Reagent Storage
  • Sequencing Disposables
  • PCR Disposables
  • Nucleic Acid Purification
  • Laboratory Automation Disposables
  • Circulating Tumor Cell Cartridges
  • Clinical Chemistries – Wet and Dry Disposables
  • Lateral Flow Immunoassay (LFA)
  • Instrument-less solutions
  • Dipstick tests
  • Colorimetric
  • Gravity-Driven Microfluidic
  • Microfluidic Paper-Based Analytical Devices (μPADs)
  • Biosensor-Based tests
  • Nucleic Acid Amplification Tests (NAATs)
  • LAMP
  • RPA

Production and Engineering

  • Commercial product launches
  • Design transfer into production
  • Facility site transfers
  • Technical document creation
  • Design for manufacturing
  • Notified body audit support
  • Fixture design and validation
  • M+A due diligence support
  • Lean event execution
  • Test method development
  • Process development and qualification
  • Execution of building EV, DV, V+V units
  • Specification assessment
  • Launch strategy analysis
  • CAPEX selection, installation, and qualification

Diagnostics and Life Sciences Systems

  • Point of Care Testing (POCT)
  • Point of Care (POC) Instruments
  • Molecular Diagnostics
  • PCR Instruments
  • Real-Time PCR Systems
  • Digital PCR Instruments
  • Precision Medicine
  • Sequencing Systems
  • Next Generation Sequencing (NGS) Platforms
  • Flow Cytometry
  • Immunoassay Systems
  • Chemiluminescence
  • Fluorescence
  • Blood Gas Analyzers
  • Electrolyte Analyzers
  • Fully Automated Analyzers
  • Clinical Chemistry
  • Hematology
  • Coagulation
  • Immunology
  • Microarray Scanners
  • Mass Spectrometry
  • Slide Staining and Scanning Pathology Systems
  • Chromatography and Electrophoresis
  • Digital Diagnostics
  • Mobile apps
  • Wearables
  • AI & Machine Learning
  • Gel/Blot Imaging Systems
  • Microplate Automation
  • CBC Systems
  • Microbiology Culture Systems
  • Life Science Systems
  • CLIA-Waived Systems
  • Liquid Biopsies
  • Circulating Tumor Cell Systems
  • Centrifuges
  • Laboratory Automation Robotics