As medical device consumables become more complex, so does manufacturing them. Sterilization is becoming an increasing concern in the industry. To ensure the proper sterilization is in place, there are four key considerations during development: Balance of device functionality and bioburden elimination: Different sterilization methods have different degradation effects on materials making it important to […]

Medical devices and IVD systems are developed with the purpose of assisting health care providers diagnose and treat patients to overcome sickness or disease to, in the end, improve their quality of life. Therefore, it is essential that medical devices and IVD systems be designed as safe and effective for the intended users, uses and […]

Are you ready for the Clinical Laboratory Improvement Amendments waiver? With the large market for laboratory devices growing fast, the benefits of designing for the waiver are even more important for better and faster patient care. For manufacturers, it vastly broadens the potential market to include non-lab and non-hospital clinics, urgent care centers, medical facilities […]

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 medical device space.

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 design input, resulting in a minimum viable product.

Connecting medical devices to the cloud provides tremendous advantages, and using Cellular IoT technology may be the only way to make the connection.

For complex consumables requiring assembly in a certified clean room, Tensentric’s experienced manufacturing team and FDA registered, ISO 13485 facility is here to help bring your product to market.

A thorough and robust Human Factors process is essential and required for medical device and in vitro diagnostic system design.

With some hands-on practice, tips and guidance, you can master this art and science of moderation and collect high-quality data.

When designing a new medical, diagnostic, or life science device, the safe and effective delivery of product is just as important as its safe and effective use. Often there are several levels of packaging, one for it to be shipped in bulk, like a crate, one for it to be shipped in small quantities, like […]

CLIA waived devices provide numerous benefits to the healthcare industry and patient care, including a broader market for manufacturers, rapid patient testing, diagnosis and treatment within an office visit, and reduced laboratory overhead and licensing costs. However, designing a CLIA waived device comes with its own challenges of ensuring the device is simple and accurate, with an insignificant […]

When designing of a battery-operated medical device, selecting the battery cannot be postponed.

When developing wireless communication solutions, three things matter – security, performance, and cost of implementation.

For many high volume medical devices, a pre-certified RFID module can be cost-prohibitive.

Choosing a fabrication method for medical products with plastic parts carry added complexity due to the materials, precision needed, and regulatory environment.

Implementing Secure Boot and Secure Firmware Updates in embedded devices ensures trusted code execution.

Designing a medical device to meet the IEC 60601-1-2 4th edition Electromagnetic Compatibility (EMC) standards is notoriously difficult. Making matters worse, the details of what goes on during EMC testing is cloaked in mystery to many engineers. Regardless of the difficulty, every electronic device must pass formal EMC testing before it can be sold commercially. […]

Wireless power is ideal for charging sealed, battery-operated, handheld medical devices, and the technology can be reduced in size to in the smallest of devices.