Decades of In-Vitro Diagnostic System Design Experience
With a forward-looking approach to adapt to where the diagnostics market is heading
Tensentric has been developing in-vitro diagnostic instruments since the beginning in 2009. We know that the industry has changed a lot over the last 10 years and will even more so in the next 10 years as diagnostics move from central labs to point of care and point of need, and evenually even to the patient’s home. Our team stays on top of the latest diagnostic technology and industry trends so we can design a system that meets our client’s needs, no matter their core technology.
We have experience with:
Cell Imaging & Flow Cytometry
Fluorescence Based Detection
Chemiluminescence Based Detection
Enzyme Linked Assays
Lateral Flow Assays and Readers
Remote Patient Monitoring
Sample Collection Kits
Cross-Disciplinary Team to Accelerate Your Development
Tensentric’s BSL-2 lab and biochemical literacy help us streamline your diagnostic system development
Most in vitro diagnostic systems have an assay which transforms the sample to produce a desirable signal. We’ve learned from decades of experience that early prototypes and development should be done with representative biological samples in order to mitigate development risks arising from unpredicted interaction between the actual biochemical assay and the consumable and instrument which can cause product development delays.
That’s why we built a fit-for-purpose biosafety level 2 molecular biology laboratory and a team of biochemical engineers to bring our client’s chemistry in-house. Our BSL-2 lab and biochemical engineers enable us to rapidly prototype and test assays with representative biological samples, minimizing development and integration risk and ensuring high-fidelity testing as early on as possible.
Human Factors for Diagnostics: From CLIA-Waived to High Complexity
Recognizing the spectrum of users for diagnostics systems and their typical pain points
Our user experience, human factors engineers, and industrial designers have a deep understanding of diagnostic system workflows, clinical lab use environments, and typical user groups.
With a depth of experience ranging from CLIA-Waived point-of-care systems all the way to devices used in a high-complexity CLIA certified laboratory, Tensentric is set up to design and execute rigorous human factors studies and formulate deliverables to support any diagnostics regulatory submission, for both US and OUS.
Interested in how we can help you?
Our Clients Include…
We serve a broad spectrum of clients from early-stage start-ups through large and well-established medical and life sciences OEMs.