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 […]

Importance of Prototypes in New Product Development

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

Microsoft Blazor: Finally, a Cross-Platform GUI Solution for Medical Devices

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

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.

Formative Usability Testing in Medical Device Development

Imagine a medical device development team has done preliminary analyses on who will be using the device.

Choosing Touchscreen LCDs for your Medical Device Design

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.

In-House Rapid Prototype Fabrication Capabilities

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

Translating User Stories into Design Inputs

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.

Designing Medical Devices with Cellular IoT

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

Clean Room Assembly of Complex Consumables

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.

Human Factors for Medical Devices & IVD Systems

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

The Art of Usability Test Moderation

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

Medical Packaging Design: Thinking Outside the Box

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 […]

Designing Medical Devices with Cellular IoT

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 […]

Battery Selection Analysis for Medical Device Design

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

Designing Connected Devices with Bluetooth Low Energy

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

Low-Cost RFID Reader Design for Embedded Medical Devices

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

Plastic Part Tooling Strategies for Medical Device Development

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

Securing Firmware in Embedded Devices

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

Design for EMC Test: An Interdisciplinary Approach

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: How Small Can We Go?

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.