Case study: How strategic resource allocation and adaptive study design accelerated FDA submission for a home-use device while maintaining quality compliance.

A leading pharma manufacturer partnered with ClariMed to optimize the Instructions for Use for a new migraine inhaler before FDA submission. Through rigorous formative testing with 20 participants, we identified 18 critical improvements for the IFU and user interface. The study prevented potential post-market issues and ensured clear user guidance.

A medical device manufacturer sought to evaluate belt designs and GUI messaging for a rechargeable implanted battery system. Our rapid usability testing with heart condition patients delivered actionable insights in two weeks, improving interface clarity, belt comfort, and aligning instructions with user expectations.

When a large pharmaceutical company needed clinical usability data for FDA submission of biosimilar syringes, we delivered through daily stakeholder communication, multiple nationwide study teams, and rigorous quality protocols. Result: on-time reports, successful BLA submission, and reduced study duration without compromising data integrity.

In-depth interviews with people living with HIV revealed key insights about injection device preferences and treatment needs. Through careful research in a private setting, we delivered comprehensive findings that helped our client develop a more effective and user-centered solution.

We optimized a medical device manufacturer's document control process through custom automation and workflow solutions. By implementing a tailored electronic system and integrated design change management, we reduced document release times by 40% and increased team productivity by 30%.

Key transplant stakeholders shared insights on the complete kidney transplant journey, from organ retrieval through implantation. Through interviews with surgeons, perfusionists, and OPO managers, we mapped critical touchpoints and optimization needs to inform device development.

Online research with people experiencing urinary retention uncovered insights about daily challenges, treatment journeys, and device preferences. Our findings helped guide development of an implanted medical device that addresses user needs and improves quality of life.