Statisticians and The Role of Data in the MedTech Lifecycle
The process of getting medical devices approved and to market starts with obtaining data from clinical trials. This data is crucial to providing key evidence of your innovation’s impact on patients. But what happens if your data analysis doesn’t tell the right story?
Hiring an expert statistician early in the clinical and regulatory process can be the critical difference between getting your device approved by a regulatory body, such as the FDA. These experts can help you identify what device features are most easily validated versus which have a less certain journey to success in a clinical trial. By bringing in statisticians early, it can save your organization time and money.
Statisticians in the MedTech field identify what data to collect, how to analyze it, and how to present the results. 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.
MCRA’s Expert Statisticians
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 that 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 device, allowing you to incorporate the development of your statistical analysis plan with other services across all therapy areas.
Learn more about MCRA's Statistical Analysis Offerings here.
