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 from a usability document, I guess! The biggest unknown was Fig. 5.10 User Interface of Unknown Providence (UOUP).

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simulated fluids

Author tends to cyro-preserved mammalian cell lines in our BSL2 facilities at the University of Victoria.

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 on the site of use, the constructed parts must be able to withstand extended exposure to high or low salt concentrations, acidic or basic conditions, a range of degradative enzymes and/or microbial interactions.

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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 into conceptualization, but at some point you’ll realize you need to expand the group of people who have used the device, or risk basing your entire program on a sample size made up of just a few people.

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DC Bias on capacitanceMulti-layer ceramic chip capacitors (MLCCs) are the most common capacitor found in modern electronics. MLCCs have many attractive features: low ESR, good capacitance-to-volume ratio, relatively low leakage, non-polarity, and low cost. It’s no wonder that when choosing a capacitor, an electrical engineer will usually specify a ceramic first before any other type.
However, there is one major drawback to high-capacitance ceramic capacitors that is poorly understood by even experienced engineers: the effect of DC bias on capacitance.

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medical device designComputer games and medical device design both begin conceptually in a somewhat similar space – a point where reality and science fiction meet. From there the directions they take are infinitely different but the processes are virtually identical. I recently spoke on a panel at our local Global Game Jam (the world’s largest game jam event) about User Experience and Human Factors. I went excited to tell all these budding game developers about UX from a different perspective. I didn’t expect to learn there are so many similarities between the two.

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Image: Bjarne Hansen

Three years ago I migrated from medical device design and development to the client side of Digital Health. I had the privilege of leading and managing components of transformational initiatives related to Electronic Health Record, also known (and preferred by users) as Clinical Information Systems. This experience changed my thinking about medical design excellence.

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Medical Device UX Design process

Image credit: Mariya Tereshkova

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 reasoning behind your design will help it pass through your team and regulatory submissions and approvals.

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Understanding the Basics of Adhesives

Figure 2 Types of Adhesives Image courtesy Pepin Manufacturing

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 of the skin, contours of the body, perspiration levels and how much hair the patient has at the fixation site.
But wait, there’s even more. Wear time and load requirements will have an affect as well. This is the final installment of a three-part blog series covering the dos and don’ts of developing a skin-worn wearable medical device and the science of sticking to skin.

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wearable medicaldevice

Claris Reflex is a wearable sensor that provides 24/7 continuous monitoring of patient movement.. Photo courtesy Claris Healthcare

There is no denial that the wearable medical device market is growing extremely fast and companies are rushing to get their device to this fast evolving market. Although timing is critical for technology based devices, what is more important is to review and address any high risk issues carefully during each step of development to ensure a successful design. It is much easier to make changes in the beginning rather than make costly fixes later in the development.
Over a three-part blog series I will go over the dos and don’ts when developing a skin-worn wearable medical device and the science of sticking to skin. This first blog explains the dos of skin-worn medical device design and development.

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