Statistical Analysis for Medical Devices

Why Do I Need a Statistician for my Medical Device?

Statisticians in the MedTech field identify what data to collect, what analysis methods to use, and how to present the results to smooth your product’s journey to the market. Their role is to help your team present data in such a way as to focus the FDA’s attention on the device’s performance, preventing lost time on any unnecessary distractions or deficiencies. With the right data, the first time, your device will have a greater success of receiving clearance from the regulatory body.  

Hiring an expert statistician early in the clinical and regulatory process can make a critical difference in getting your device approved by a regulatory body, such as the FDA.  These experts can help you identify what device features and indications are most easily validated versus which have a less certain journey to success in a clinical trial. Bringing in statisticians early can save your organization time and money.  

MCRA statisticians have the technical expertise, medical device domain knowledge, and regulatory experience to help clients get things right the first time. Our team includes former senior FDA statisticians who are well-versed in the requirements needed for FDA submissions, making the process as straightforward and manageable as possible. Our statisticians are integrated across our service and therapy areas, allowing them to work closely with your regulatory and clinical team and allowing you to incorporate the development of your statistical analysis plan with other services across all therapy areas.

MCRA’s statistical team offers the following across our integrated service portfolio:

• Development of Statistical Analysis Plans
• Sample Size Calculations
• Statistical Programming
• Data Analysis
• Interpretation and Response of FDA Statistical Feedback