2022 Technology Trends: Digital Health Marks the Future of Medical Development

Going into 2022, remote monitoring, wearables, sensors, and other "mHealth" products are taking center stage.

Medical Device Usability Requirements: Changes to IEC 62366

The updated standard allows the manufacturer to assess and mitigate risks that are associated with correct use and use errors.

The Ergonomics of Robotics: Part 2

In this two-part series on robotics and wearable devices, part 1 highlighted the wearable device product category. Part 2 moves the discussion from wearable devices to how robotic surgery is changing the...

The Ergonomics of Wearable Designs: Part 1

The wearable device product category is exploding in healthcare design. Wearing these sensory devices that continuously collect, measure and report the user's physiology, exercise behavior,...

Key Human Factors Drive Design for Disposables, Test Kits and IFUs

Bring to mind your last straight-out-of-the-box experience with a disposable medical device of any kind. Without a doubt, everyone has experienced the same frustrations:...

Ergonomics and Handheld Medical Devices: Five Vital Elements for Design Success

Dexterity, precision, control and comfort — without them, no handheld or hand intensive medical device is a success, for either the medical professional using...

Adapting Prototyping to Meet Rapid Advances in Medical Device Designs

Rapid prototyping has long played a vital role in the evolution of medical device technology. Effectively applied during a product's early design stages, it can generate...

Design Validation and Regulatory Requirements

Design validation is one of the most important aspects of the design and development process for medical devices. It is at this stage that the medical device manufacturer confirms that the device...

Validating IFUs for Reprocessed Medical Devices

Incidents of nosocomial or healthcare acquired infections (HAIs) and bacteria that have become resistant to antibiotics (“superbugs”) are a concern for U.S. FDA. These ongoing incidents...

Managing Cybersecurity Risks in Connected Medical Devices

The landscape of the medical device industry is changing, driven by emerging technologies and the influx of smart devices, telemedicine, and new patient care models. This new frontier...

Twice As Nice: Overmolded Devices Provide Strength, Aesthetics, and an Ergonomic Grip for Medical Applications

If you’ve picked up a power tool at the hardware store recently, or used a multimeter to check for power on a kitchen outlet,...

Vision Trainer Teaches Focusing Techniques at Home

Inventions often find unintended uses. The first mechanical clocks in Europe were intended to track the motions of celestial bodies and found their original market among monks who kept a...

Iron Man Special Effects Team and Progressive Device Designers: Superheroes with a Connection

Comparing the cool factor of medical device components to Robert Downey Jr.’s gleaming armor in the film Iron Man 2 is…well…tough. But...

Safety and Human Factors Engineering in Medical Device Design

Medical devices manufactured today require significant attention to safety and human factors engineering that has not always been exercised in medical device design. IEC safety...

Early Team Integration Leads to Market Success

Developing a medical device requires sensitivity to the delicate balance between usefulness, usability, desirability, and manufacturability. Every medical device must be useful (meet a need) and...

New Blood Pressure Connectors Prevent Misconnects

Healthcare professionals use medical devices in a variety of settings and situations from urgent to routine. In an emergency, any sort of confusion, hindrance, or hesitation concerning the...

For FDA Approval, It All Boils Down to the Validation

We’ve all purchased new technologies, trinkets, and toys that were so counterintuitive that it was surprising how the product ever made it to market. While a poor gadget may present...

Human Factors Engineering in the Design of Surgical Instruments

In July 2010, the FDA released a warning on a number of fibrin-based bleeding control products that were demonstrated to cause air embolisms in patients when used improperly...