Case Study: Clairways advances wearable lung monitoring commercialization with SimBex

Clairways accelerates FDA-ready lung monitoring device with SimBex and $150,000 in funding

Clairways, a developer of a wearable smart lung monitoring device, faced the challenge of moving their functional lab prototype to a customer-ready, FDA-cleared product for commercialization. Their goal was to identify manufacturing partners and improve their evidence through respiratory trials to better position themselves for market entry. They engaged vendor SimBex for assistance in this process.

Simbex implemented a quality management system (QMS) to meet FDA regulations and assisted with fundraising procedures, including pitch deck development. They also partnered with Clairways to guide customer interviews, develop financial forecasts, and evaluate business strategies. As a result, Clairways further developed their regulatory strategy, gained a better understanding of their market, and used provided funds to accelerate prototyping, greatly advancing them toward a minimum viable product suitable for customer exploration and pre-clinical studies.

Clairways