Airgo™ is a respiratory device for ventilation and breath dynamics monitoring. This non-invasive wearable marks a step forward in continuous spirometry, sleep disorder screening and ICU respiratory pattern detection, allowing 24/7 real-time minute ventilation monitoring and providing reports useful for caregivers.
MyAir, an innovative Med-Tech startup, was engaged in the battle against COVID-19: Airgo™ is being employed in the prediction of respiratory distress in Coronavirus patients both at hospital and at home.The device consists in a holter (worn over the floating ribs) and a recorder unit. The unit collects the signals from the holter and, through proprietary algorithms, produces automated reports and dashboards for doctors.
Creanova’s team collaborated with this medical startup in development, engineering, prototyping, production and assembly of the recorder unit, an essential part of this innovative wearable.
Creanova’s product engineers were asked to make the project feasible and manufacturable according to medical regulations and with the goal to realize the product as in the client’s mind. We supported the client through the product development in respecting the medical regulations and requirements.
The engineering refinement led to the optimization of the recorder unit’s details:
The engineering refinement resulted in a 3D model with very strict tolerances and small thicknesses, slightly different from the starting project also in design.
Much attention was paid to the material, as intended to make up a wearable. The recorder unit can stay in contact with the skin for more days and ISO 10993 indications had to be followed to respect the criteria of cytotoxicity, sensitivity and irritation.
As part of the wearable engineering process, Creanova’s product engineers took care of Airgo™ prototypes, leveraging our experienced supply chain, which allowed us to refine functional details in very tight spaces by vacuum casting technology.
Our prototypes of this respiratory device satisfied cytotoxicity requirements for a skin contact lasting for more than 48 hours. The relative test was certified by one of our partner laboratories and was the first step towards a prototype fully suitable for prolonged wearable use.
The wearable prototypes were used to perform clinical trials and medical device Class IIa certification.
Creanova supported MyAir up to the end product through its contract manufacturing services, smoothly driving the client through mold making, shells and electronic boards production and final assembly.
The Airgo™ assembly was performed in the Creanova’s production site, certified with ISO 13845.