Medical devices
Developing the next generation of detection and diagnostic technology.
The tools for detecting disease and biological threats determine what is possible in medicine, public health, and biodefense. We bring laboratory science, engineering, molecular diagnostics, and regulatory expertise to the development of detection and diagnostic technologies.
What we provide
Diagnostic and detection technology development
From point-of-care molecular tests to high-throughput laboratory platforms and field-deployable systems, covering feasibility, analytical validation, clinical or operational evaluation, and regulatory submission preparation, with emphasis on rapid and multiplexed molecular diagnostics.
Biosensor and novel detection platforms
Exploration of biosensor approaches to pathogen detection, drawing on molecular recognition, signal transduction, assay chemistry, and the engineering needed to produce reliable, manufacturable devices.
Regulatory strategy and FDA pathway support
Regulatory framework analysis, pathway selection, study design, and preparation of documentation for FDA review.
Device commercialization and market entry
Market analysis, business model development, manufacturing partner identification, distribution strategy, and go-to-market planning.
Contracting officers and program managers
Tell us about your requirement. We respond by email and can provide a capability statement on request.