Posts categorized as“Product Development”

From a regulatory standpoint the differences between IEC 62366:2007 and IEC 62366 -1:2015 are minimal, with all the same boxes needing to be ticked. However, it is clear from reading the documentation that the whole process has been streamlined, using more familiar language and on the whole a more usable standard. Probably a good thing […]

Designing equipment (medical or otherwise) is a complicated process. This complexity is increased when the equipment of choice must either come in contact with biological material, or function within a biological environment. In order for a device to operate as intended, it must be able to withstand the unique conditions that biological fluids impose. Depending […]

Build an Input Pyramid to support your medical device development As a medical device designer, I see clients balancing cost and feedback in a daily struggle to decide when to get clinical feedback, from whom, and how much weight to give that input. KOLs (Key Opinion Leaders) and individual designer experience can take a product well […]

A good User Interface (UI) improves usability for any medical device UX Design. Even if your device has all the needed functions and features and your workflow is proven based upon research and testing, the UI that users interact with is where they really gauge the experience of the device. For medical devices, documenting the […]

Understanding the Basics of Adhesives Selecting wearable medical device adhesives requires a solid understanding of the basics of adhesive. Sticking a medical device to skin is not as simple as it sounds. Numerous variables come into play such as the patient’s age, gender, race, diet, activity, skin condition, and climate. Other variables include the stretchability […]