BEYOND USABILITY: DESIGNING CLIA WAIVED DEVICES

As medical device consumables become more complex, so does manufacturing them. Sterilization is becoming an increasing concern in the industry. To ensure the proper

Medical devices and IVD systems are developed with the purpose of assisting health care providers diagnose and treat patients to overcome sickness or disease

Are you ready for the Clinical Laboratory Improvement Amendments waiver? With the large market for laboratory devices growing fast, the benefits of designing for

In NPD, a prototype is a representation of a product idea intended to learn something about it.

Every product development effort containing embedded software must answer the question early on “Which operating system should the device run?”

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.

There are many features that drive LCD and touchscreen selection for a device in any industry, but these decisions become more restricted in the

Tensentric offers in-house machining, 3D printing, and other prototyping options to accelerate the design and development cycle with rapid iteration.

The process of defining user stories, asking questions about the intended user group(s), and identifying the user’s needs helps define the “why” behind each