Medical device clinical trials must align clinical questions, operational realities, and FDA expectations from the start. Iterative engineering, operator influence, software behavior, and real-world data all affect outcomes and credibility. HIC’s senior clinicians, former FDA and CDRH reviewers, and experienced device biostatisticians work together to define the clinical strategy, then translate it into protocols across early feasibility, first-in-human, pivotal, and post-market studies, using traditional, adaptive, or Bayesian designs where they add value. Endpoints are selected to demonstrate intended clinical benefit, models are built to support interpretability, sample size is designed to support statistical reliability, and study conduct is planned to protect data integrity. Each plan aligns with ISO 14155 and current FDA clinical trial guidance and is built for inspection readiness.
HIC clinical trial designs are crafted by seasoned professionals who have extensive experience in designing, running, and reviewing device studies in the real world. Our teams integrate human factors into clinical flow, manage device design changes under the IDE through documented impact assessment and FDA engagement where required, and coordinate investigator training and monitoring to limit operational drift. Data flows are structured so that listings, analyses, and narratives tell a coherent story from protocol through clinical study report and submission. The goal is a trial that stands up to scrutiny, answers the questions FDA is most likely to ask, and that your team can execute on time and on budget.
Device trials engineered for decisive evidence
- We bring former FDA and CDRH judgment to endpoint definitions, visit schedules, and analysis strategies so study designs reflect how adequacy of evidence is judged in practice
- Our device biostatisticians construct operating characteristics and simulations that justify adaptive features, interim looks, and sample size, giving reviewers a transparent basis for confidence in the design
- We embed human factors specialists and experienced trial operators into planning, so site training, monitoring, and deviation management protect data quality and preserve the analysis set
- We coordinate protocol language, case report forms, and analytic outputs so the clinical module reads as one story from protocol through clinical study report and submission
