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Engineering

Planning and execution of technology and product development.


Systems Engineering:

  • Product requirements and specifications

  • Configuration, testing, analysis, and maintenance strategy

Mechanical and Electronics Engineering:

  • Disposable and Instrument Development

Software Engineering:

  • System architecture

  • Life-cycle management

Platform Concept Development:

  • Microfabrication and microfluidics

    • DRIE and FIB for fabrication of micron sized features

    • CVD and ALD for thin layer films

    • Fluidic modeling and optimization of surface features

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Integration

Manufacturing design and integration of assay chemistry onto desired platforms, including disposables and instrumentation


Integration of Assay Chemistry:

  • Platform integration and comparisons

Reagent Stabilization:

  • Lyophilization

Automated Workflows:

  • Design and implementation of automated nucleic acid extraction and NGS library prep

Analytical Method Development:

  • Assessment of Ligation and PCR Efficiency

  • Mid-workflow QC methods

In-house Synthesis of Polymers and Solid Surface Attachment Chemistries

Design for Manufacturing

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Assay Chemistry Development

Design, optimization and supply of quality reagents for biomolecule detection


Molecular Diagnostics:

  • Design and testing of nucleic acid extraction and amplification

    • Solid phase and specific target capture

    • PCR, isothermal amplification, and surface phase

  • Next-gen library prep

Immunoassay:

  • Development and optimization

  • Molecule selection

Reagent Supply, QA and QC:

  • Direct supply and qualification of select reagents from low-cost centers

  • Independent supplier identification and qualification

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Consulting & Program Management

Establishing efficient project planning and systems, analyzing resource allocation, examining market assessments, and tracking growth.


Global Health:

  • Local Partners

  • Policy

  • User case and user experience

  • Clinical and regulatory affairs

Program and Quality Management:

  • Resource allocation

  • Project plans, tracking and recording

  • Product development documents

  • Risk management and regulatory compliance

  • Design control and procedures

  • Quality documents

Technology and Product Strategy:

  • Technology assessments against market needs

  • ROI calculations

  • Marketing and commercialization oversight and strategy