StarFish Medical

StarFish Medical is a medical device design and development consulting firm with 25+ years of experience and 200+ professionals serving the MedTech industry. The company provides end-to-end product development services including product design and development, new product introduction with commercialization focus, quality assurance, and regulatory affairs consulting. StarFish Medical helps medical device companies navigate complex regulatory landscapes and achieve market clearance. The firm serves startups through global enterprises across diagnostics, drug delivery, and therapy device sectors. Key capabilities include multidisciplinary in-house teams for concept-to-commercial-product transformation, clinical trial support, and tech transfer facilitation. The company has completed over 1,000 programs. Recently, StarFish Medical launched ELLA, an AI-powered regulatory compliance navigation tool designed specifically for medical device companies. The firm publishes extensive technical resources covering medical device topics including accelerated aging testing, remote device reliability, connected device architecture, GUI development efficiency, and regulatory classification. StarFish Medical is positioned as a regulatory and engineering consulting partner rather than a device manufacturer, supporting clients across diagnostics, drug delivery systems, and therapeutic devices intended for clinical and home-based use.