Supporting Your Diagnostic System, Cartridge Design and Reagents Integration Project.

Design Conceptionalization for consumable cartridge based Point-of-Care Diagnostic Systems.

We support you in your Strategy to Product: Translating your PCR or Isothermal Amplification & Detection applications to an integrated diagnostic cartridge based system.

One of our key skills is the integration of Real-time Multiplex PCR assay workflow and applications in diagnostic cartridges or consumables.

You can build on more than 20 years experience & expertise in commercialization any type of PCR and Real-time PCR reagents & applications and development of a diagnostic Point-of-Care System (STAT-Dx, Exit to QIAGEN). We can support you at all stages from Strategy, Design Conceptualization, towards selection of suitable development partners, a project infrastructure fitting to your company, towards a cost-effective to manufacture and scalable product, compliant with the regulatory & quality needs of your target markets.

In detail this includes the following areas:

• Target Markets & Target Applications / Diagnostic Needs
• Defining appropriate Design Requirements & Specifications
• Selection of Development Partners & Suppliers (Instrument, Cartridge, Manufacturing, Reagents, Software, other)
• Balancing technical, cost, risk, quality and marketing needs
• System Design Support
• Cartridge Design Support
• Development Planning
• Contractual Considerations
• Cost Analysis & Simulation of future Cost-Reduction Models
• Consulting for effective design-to-manufacture
• Translation of laboratory assay workflows to an fully integrated cartridge
• Integration & Stabilization of Sample Prep & assay Reagents,
• Support in design & implementation of reliable, scalable, validatable (typically ISO13485) and cost effective manufacturing processes
• Support in developing specifications & specifying customized materials and manufacturing equipment
• Management of Suppliers, outsourced activities
• Due Dilligence Support for Investors (Venture Capaital, Private Equity, Corporates)
• Contract R&D for Assay Development & Optimization