Is Your Medical Device Software FDA Design Control Compliant? It Better Be

Medica

 

Simple-to-use, highly reliable blood testing analyzer and chemistry analyzer products for clinical laboratories.

 

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Mission
Medica Corporation manufactures simple-to-use, highly reliable diagnostic blood testing analyzers. Actively engaged in developing new technology, Medica specifically designs products to enhance productivity and the quality of care in small to medium-size in vitro diagnostic laboratories.

 

deliverables

A custom built touchscreen interface for the blood gas analysis hardware. 

Enhancing a precision tool with an appealing and easy-to-use design 

The Business Case

Medica's flagship blood gas analyzer, the EasyStat, was approaching 15 years in the marketplace. During those 15 years, Medica's competitors continued to advance their systems with the addition of new technology, analytics, connectivity options, and user experience. Medica found themselves in a situation where they were losing various opportunities because their product was lacking features that many customers now required. 

 

"I would have to say, however, even more important than the actual coding that AndPlus provided was their assistance in setting up a much-needed software development process at Medica. Medica had typically followed the traditional waterfall approach to software development, however, we wanted to move toward the Agile development approach. They were able to leverage their extensive knowledge and experience with the Agile development process to set up, configure, and train us in the ways of Agile through the use of the Jira and Confluence cloud-based tools."

- Seth Avis, Program Manager, Medica

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The Challenge

Even though the blood gas analyzers were reliable, the user-interface was outdated, which caused confusion among users who were used to more modern control interfaces. The EasyStat’s original control panel forced lab technicians to use push-button controls on a small LCD screen in order to operate the highly technical piece of equipment. Not only did the control system create a poor user-experience for people who were familiar with the device, it also made training and troubleshooting a time consuming process.

 Small LED screen and push buttons didn’t create an engaging experience. Users were only presented with a few lines of text per screen which made for an inefficient process of hopping from screen to screen for even the simplest tasks. In order to take action on any prompts given by the screen, a user was limited to a 0-9 keypad and a “Yes” button and a “No” button. 

 

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The Solution

One of the strategic objectives with the new product was to significantly overhaul the user interface. The legacy systems utilized an outdated LCD display and membrane keypad, which was being replaced with a 7" color touchscreen in the new analyzer. We decided to leverage Android for the development of our user interface in order to provide the richest UI/UX experience to users and to most effectively take advantage of the new touchscreen hardware that was at our disposal.

An additional objective for the EasyStat upgrade was to increase the configurability, ease of maintenance and longevity of the product. AndPlus collaborated with Medica’s hardware team to define an abstract communications protocol for their firmware. This allowed us to emulate firmware responses without talking to actual hardware so that we could test various scenarios that are difficult to reproduce in real world situations.  This allowed the team to test features within seconds what would normally take several minutes to complete in the real world.

The application manages various interactions that occur between a user and the machine. There are both manual operations and also automated operations that happen in the background. Some automated operations can also be triggered manually, such as a calibration. Manual operations can be triggered through the UI, but there are also physical interactions with the moveable parts of the analyzer itself. Such physical interactions include lifting the sampler to reveal the syringe or capillary, and replacing consumables components, such as the reagent module and sensor cartridges.

Today the EasyStat is Medica’s flagship product. It is used to precisely measure pH, PCO2, PO2, Na+, K+, Ca++, Cl, and Hct and calculate additional parameters.

 

How we architect FDA approved Medical Software
 
Innovation is in our DNA and design is part of who we are. At AndPlus, function and form are intertwined from day one until product launch. Whether it's complex medical instruments or a straight-to-consumer healthcare device, we understand the critical importance of 100% reliable performance and a great user experience.
 
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