IVD System Development: Don’t Forget the Assay
Iterating product design while keeping biochemical system interfaces at the forefront de-risks key technical challenges earlier and accelerates device development.
When you're choosing a partner to design and manufacture your medical device or in-vitro diagnostics system, you can’t afford to have any doubts.
Turn-key System Design from Initial Concept through Volume Manufacturing
Tensentric’s team averages over 20 years of engineering experience and are highly skilled in all aspects of complex system design. From early concept development and ideation, through detailed design and prototyping, developing and manufacturing saleable medical devices and in-vitro diagnostics is Tensentric’s core competency. We’re ISO13485-2016 certified for both design development and manufacturing and have successfully completed over 125 development projects since the company’s inception in 2009.
Many of our clients and investors have leveraged our many decades of medical device and in-vitro diagnostics system design experience to perform technical assessments of potential acquisitions and for independent third-party evaluations. We’re happy to share our expertise and offer this as a dedicated service.
Our best in class Human Factors Engineering (HFE) services help you optimize the usability and use-safety of your products. Our services include user research, risk analysis, user interface design and rapid prototyping, usability testing with full COVID-19 precautions as well as human factors studies requiring BSL-1 or BSL-2 laboratory facilities.
Tensentric has recently extended our service offering to carry our designs into volume manufacturing of finished products. Focused primarily on high level assembly of highly complex systems during the initial NPI phase or ramp-to-volume, we have a dedicated manufacturing facility of 12,000 square feet with all necessary equipment and fixtures including an ISO certified clean room.
Iterating product design while keeping biochemical system interfaces at the forefront de-risks key technical challenges earlier and accelerates device development.
Imagine a medical device development team has done preliminary analyses on who will be using the device.
Every product development effort containing embedded software must answer the question early on “Which operating system should the device run?”
February 28, 2020
King Cake, Gumbo, Beads and an Authentic Louisiana Crawfish Boil!
Jeff Gentry, COO
jeff.gentry@tensentric.com
+1.720.204.0071
2900 Center Green Court
Boulder, Colorado 80301
corporate@tensentric.com
+1.303.402.0477
474 South Taylor Ave.
Louisville, CO 80027
mfg@tensentric.com