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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If you’re reading this, chances are you have a great idea for a medical device and you’re starting your design.   You probably have an electrical element to your design. As tempting as it is to start ordering parts and tinkering, there are a few preliminary documents you can create to help you choose the right parts.  Eventually you’ll need a design that must pass the requirements of IEC 60601-1.

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FDA Regulation of E-cigarettesThe FDA Regulation of E-cigarettes aims to fill a technology regulation gap. Whether it’s the FAA and recreational drones or the USDA and the latest strain of genetically modified corn, widespread use of new technology is often followed by new regulation. And regulators have long struggled to keep pace with the seemingly endless stream of innovation that enters society. It’s not necessarily new technology itself that instigates regulation but rather the refinements that allow it to become widely available to the general public.
The past decade has seen vaporizers and e-cigarettes become widely available and while these products are capable of delivering nicotine in the form of smoke-like vapor, they technically have not met the definition of a “tobacco product” and therefore have been unregulated. Until now that is.

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Medical Device Generated DataIs Device Generated Data part of your medical device plans?

We live in a digital era, and if you are in the medical device design and development business, it may be wise to think digital health. There is an undeniable shift from stand-alone technology to integrated systems even for devices with specialized functionality. Granted, devices with unique diagnostic or therapeutic functionality still have a place in the market place, but those capable of uploading data into a server, the cloud, or even directly into an electronic health record are more attractive to hospital and tertiary care buyers.

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PMO (640x376)The point of  a PMO (Project Management Officer) is to have somebody responsible for all of the actions a company does in project management. The PMO makes sure Project Manager (PM) practices are consistent and there is the right balance of relationship management and technical management. Are we cutting to the chase at the right times, digging deeper at the right times and having a consistent approach to client focus while getting the product right throughout the organization?

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