Based in Antwerp, Belgium, Minze Health is a medtech start-up that aims to help patients who suffer from urinary symptoms. 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, so they came up with an internet-connected uroflowmetry device – Homeflow – together with a mobile APP to record the voiding diary.
When Minze approached CRE8, they already had the design and a first working prototype ready, but the biggest challenge was to adapt the original design for mass production, structure-wise and materials-wise. Especially the device was designed in three versions for men, women, and toddlers, each needed to meet its individual criteria in order to get all the certifications required for a medical product, making the project even more complex.
For hygienic reasons, the product must be waterproof, so it can be washed and disinfected frequently after usage. Our engineers selected 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 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.