A device to monitor and better understand a patient’s post-operative wound recovery.

FluidAI’s INLINE MONITOR is designed to be used with existing closed wound drainage systems to monitor the pH and electrical conductivity of wound drainage. The device is to be used with trained operators in tandem with a monitor application for easy input and access to vital patient information. FluidAI’s CTO, Abdallah El-Falou, recalled being drawn to Cortex for our portfolio, design-thinking prowess, and insight on DFM and manufacturing constraints – and that’s exactly what we set out to deliver.

FluidAI connected with Cortex to aid their team in improving the design of their post-operative recovery medical insight device, and to engineer a solution with a minimal part count that can be quickly and easily assembled to improve production time, all while staying within the constraints of several medical equipment regulations and guidelines.

In essence, this product allows post-operative wounds to be monitored closely and precisely by passing drainage from the wound through an electrical sensor that reads the pH Value and the conductivity of the drainage, providing key information in examining the proper healing of the wound. Cortex was entrusted with the responsibility of evolving the original prototype device design into a mass-manufacturable, cost-effective, easy-to-use, and aesthetically pleasing product, while retaining all intended intricacies in functionality.

In Production and Market Ready.

In pursuit of creating a product that could be cost-effectively brought to market, some hurdles had to be overcome. For instance, the main flow channel for the drainage in the prototype could not be manufactured in its original form factor. On top of this, because of this form factor, bubbles would get stuck in the channel and contaminate the data being processed. Cortex engineers devised and implemented a solution that not only solved the bubble issue, but also made it fully manufacturable.

The device was kept in line with its original design – the small handheld form factor was kept intact to retain portability, and its clean smooth surfaces were retained to prevent impurities from building up on the device.

Wrapping it up

While Cortex was mid-process in the design of the Origin system, FluidAI extended the project to include packaging design. Besides securely housing Origin and it’s supporting components, there were other user-centered objectives:

• Present Origin in a sophisticated and clean manner, with strong brand representation
• Guide the user in how to open the packaging and remove the contents in the proper sequence
• Include the device’s IFU in an easily accessible location for reference by caregiving staff

The cost and environmental footprint of producing the packaging were to be kept as low as possible, and the packaging was to have minimal assembly directions. These constraints further influenced the decisions made in creating this packaging, such as the material used and the number of glue tabs required in the final pattern.

Variations of graphics and layouts were also explored on the exterior to provide all required information as specified by not only FluidAI, but also in compliance with relevant regulatory guidelines.

Cortex Deliverables: 

• Concept development 
• Prototype development 
• Custom circuit board design
• Production design 
• Contract manufacturing
• Packaging design and graphics
• Ongoing support for packaging production