At IDEA Design Strategic Hub, we addressed the project through a Compliance by Design approach aligned with ISO 13485 medical device development principles, integrating signal integrity, thermal management and regulatory requirements from the earliest design stages. The result is a Class IIa medical device that combines technical precision, patient comfort and clinical robustness in a wearable form factor. Validated in real clinical settings and internationally awarded (iF Design, Red Dot), THEIA transforms complex biomedical technology into a market-ready product trusted by clinicians, regulators and investors.