Service : Mechanical Design
Engineered for an Enhanced Healthcare Experience
Based in Antwerp, Belgium, Minze Health is a medtech start-up that aims to help patients who suffer from urinary symptoms by creating an internet-connected uroflowmetry device. The founders of the company noticed that the process of a uroflow test in Europe and in the U.S. could be an unpleasant experience for many, especially those who have to constantly re-visit the hospital to get the test done.
As a result, “Homeflow” was invented together with a mobile APP to record the voiding diary and a platform for keeping the data and online diagnosis with the urologist. The complete service requires the combination of both software and hardware, which should be as user-friendly as possible to avoid the discomfort and clumsiness when using the product.
When Minze approached CRE8, they already had the design and a first working prototype ready, but the challenge was how to adopt the original design for mass production. CRE8’s mechanical engineers spent significant amount of time with Minze to really study the needs from them and embark on extensive research.
The product structure was then adjusted accordingly and the 3D files were modified to enable a cost-effective, smooth manufacturing solution. Considering different user scenarios for men, women, and toddlers, the device was designed in three versions, but all needed to meet certain criteria each creating its own challenges.
For hygienic reasons, the product must be waterproof, so it can be washed and disinfected frequently after usage. Our engineers chose ultra-sonic welding techniques to make it water-resistant, but due to the high-quality standard needed to pass medical testing, the process became very accuracy oriented.
Medical Grade Materials
The materials used for the product need to pass FDA Approval, obtain CE Marking, and must meet ISO 10993’s standards, therefore limiting the availability of choices. CRE8’s team made many trial shots to source the most suitable materials, of which the uniqueness required parameter calibration.
The hardness of the rubber pads has to be extremely precise, as the pads that cover the multi-sensor unit will affect the uroflowmetry results. CRE8’s engineers experimented many times with different hardness of the medical grade materials and used over-molding technology to find the perfect balance of softness and bounciness.
Last but not least, in order to get all the certifications required for a medical product, our engineers helped our client to prepare for the documentation needed, including the process validation report. Overall the project succeeded through extensive collaboration. The client has its own professional background in electronic engineering but also trusts our expertise. This created an environment of mutual learning with a result of a GREAT healthcare product.