As the data collection methods have extreme influence over the validity of the research outcomes, it is considered as the crucial aspect of the studies
May 2025 | Source: News-Medical
The statistical programming languages most utilized in biometrics for the medical device industry are Python, SAS, and R. These languages help support the necessary functions–from regulatory compliance to sophisticated analytics and automation–through rapid application of technologies and the increasing complexity of medical device data.[1]
Medical device studies yield vast and varied data sets that result in innovation and enhanced patient safety. Statistical programming languages help facilitate the analysis, validation, and preparation of this data for regulatory submission, ensuring compliance, reproducibility, and relevance in results.
SAS has been a lead resource in statistical programming for the medical device and clinical research space, providing sophisticated support for regulatory submissions while being consistent and compliant in data structuring for regulatory purposes.
Python has become the language of choice for artificial intelligence, machine learning, and automation in biometrics for medical devices.
Although R is not as dominant as SAS or Python, it is still an important choice for performing specialized statistical modeling and robust data visualization in biometrics.
Usage Rates of Statistical Programming Languages in Biometrics (Medical Device Industry, 2025)
| Language | Primary Role | Usage (%) | Key Features | Industry Examples |
|---|---|---|---|---|
| SAS | Regulatory, TFLs | 68% | Compliance, Structured Data | Adverse event reporting, FDA submissions |
| Python | AI, ML, Automation | 75% | Versatility, Data Science | Wearable analytics, NLP, automation |
| R | Statistical Modeling | 15% | Graphics, Advanced Stats | Survival analysis, biomarker studies |
The medical device space is heavily driven by the advances in software, connectivity, and analytics:
Choosing the right programming language is up to the clinical question, type of data, and regulatory requirements:
The accelerated development of automation, real-world data integration, and regulatory technology is changing the programming landscape of medical devices:
Statistical programming is core to the biometrics innovation in the medical device industry. The teams within the industry that are skilled in SAS, Python, and R can change complex device data into useful information which drive, compliance regulatory approval, and facilitate patient safety and clinical advancement to produce a new generation of medical devices. [1][2][3]
Statswork’s Approach in the Medical Device Industry:
Statswork provides an integrated analytics platform across the medical device lifecycle: from study to AI/ML model development; real-world evidence to regulatory reporting; and all the multimodal data in between (sensor outputs, hospital records). Statswork is the solution that builds interpretable AI solutions, designs actionable dashboards, and provides packages for statistical reporting submission in Python, SAS, or R. Statswork also provides all analytics with the highest standards of transparency and clinical significance.
Accelerate your medical device innovation:
Maximize Statswork and our advanced statistical programming, automated analytics, and regulatory expertise. Contact Statswork for your unique solution to take your project from data to impact.
