Adaptive Design Excellence for Orthopaedic Implant Evaluation

A small medical equipment manufacturer needed robust statistical support for their post-market trial of an orthopaedic implant in the US market. They required expertise in adaptive trial design to efficiently evaluate real-world performance while meeting FDA post-market surveillance requirements.

• Complete comprehensive Statistical Action Plan for post-market surveillance

• Conduct thorough 3-month and 6-month interim analyses

• Implement adaptive design elements to optimise trial resources

• Develop time-to-event modelling for implant performance

• Create systematic adverse event reporting framework

• Visualise recruitment flow and results for stakeholders

1. Statistical Framework Development

• ·Adaptive trial methodology implementation

• Power calculations and sample size determination

• Interim analysis thresholds establishment

• Bayesian approach for longitudinal data analysis

2. Technical Implementation

• Time-to-event modelling for implant longevity

• Adverse event classification and reporting systems

• Interactive data visualisation dashboard

• Statistical analysis automation pipeline

3. Regulatory Alignment

• FDA post-market surveillance compliance

• Quality control protocols

• Data integrity assurance

• Documentation for regulatory submissions

Quantitative Outcomes

• 30% reduction in required sample size through adaptive design

• Comprehensive analysis of 3-month and 6-month data points

• Identification of key performance indicators for long-term success

• Early detection of potential safety signals

Qualitative Benefits

• Enhanced clarity for decision-making through visual analytics

• Streamlined adverse event monitoring and reporting

• Robust foundation for FDA compliance

• Data-driven insights for product refinement

• Clear communication of results to clinicians and stakeholders

"Umbizo's statistical expertise transformed our post-market surveillance capabilities. Their implementation of adaptive design elements and sophisticated time-to-event modelling provided invaluable insights at our critical 3-month and 6-month review points. The visualisation tools made complex data accessible to our entire team, from engineers to clinical advisors."

Director of Clinical Affairs

• Statistical Action Plan: 3 weeks

• 3-Month Interim Analysis: 2 weeks

• 6-Month Interim Analysis: 2 weeks

• Ongoing support and refinement

Extending the adaptive design framework for additional orthopaedic products and developing predictive models for long-term implant performance based on early clinical indicators.