Development of a novel IVD platform

T2 Biosystems aim was to develop a custom IVD system with PCR sample preparation and Magnetic Resonance detection, in aggressive timescales.

Our client asked:

T2 Biosystems selected Sagentia Innovation to work with them on the development of its benchtop instrument for clinical trials and commercial release. They wanted to develop a flexible platform suitable for the analysis of pathogens, genomics, proteins, and small molecule immunochemistry.

The project story:

Sagentia Innovation’s multi-disciplinary team started with system architecture and concept generation that was built around the client’s proprietary technology.

We continued with Proof of Principle to de-risk the project and develop key system modules before completing the detailed design  of the entire system.

Parallel activities investigated user interface, consumable design,  and Industrial Design.

Our team ensured prototype delivery for verification testing and clinical trials.

Results: deliverables and outcomes

The outcome of this project was a fully integrated system and consumable development within the required timescale.

Sagentia Innovation delivered the required functionality that met the required footprint and BoM cost.

The instrument went on to achieve FDA clearance and following successful clinical trial and commercial release, has enabled numerous next generation models to be added to the client’s product portfolio.