Analytica Consulting has partnered with Becton Dickinson’s Quality Systems Team to enhance post-market surveillance through the implementation of a comprehensive Microsoft Power BI ecosystem. By leveraging robust capabilities in data connectivity, modeling, report distribution, and management, Analytica streamlined the analysis of complaints data from over 14,000 products spanning more than five years. This transformation has enabled BD to prioritize and address product failures more effectively on a global scale, improving efficiency and decision-making.
Background
Post-market surveillance is a critical regulatory and operational requirement for medical device companies, ensuring that products remain safe, effective, and compliant aftermarket release. It is also a mandatory process to meet the standards set by global regulatory bodies such as the FDA (U.S.) and MDR (EU).
The rapid global expansion of Becton Dickinson’s product line, combined with siloed processes and disparate data collection methods across multiple manufacturing sites, created significant challenges in establishing unified and certified data sources. Over time, this led to an over-reliance on manual efforts, as teams struggled to manage overlapping, unvetted data sources across various technologies to meet recurring reporting deadlines.
With continued company growth, the need for a standardized and unified solution became paramount to streamline reporting processes, improve data accuracy, and enhance operational efficiency across the business.
Accomplishments
Over a multi-year engagement, this project has successfully delivered a robust data-driven resource, providing executives, site managers, and engineering teams with insights into product performance across the world.
Key accomplishments include:
- Integrating and blending of data from multiple sources, enabling the identification of trends related to MDRs, Vigilances, Complaints, and Sales for proactive issue management.
- Eliminating redundancies and inaccuracies by transforming and consolidating disparate data sources into certified dataflows & datasets, ensuring consistency, reliability, and accuracy across the organization.
- Automating and optimizing reporting processes using Power Query M Language, DAX, and R to significantly reducing manual effort and enhancing efficiency in data analysis and reporting.
Looking Ahead
Analytica Consulting continues to collaborate closely with the Quality Systems team to navigate the ever-evolving audit requirements set by regulatory agencies while continuously exploring cutting-edge technologies to maintain a modern and adaptable solution.
Additionally, the highly successful rollout of the Post-Market Surveillance process has garnered widespread recognition, sparking interest from other divisions within Becton Dickinson seeking similar enhancements to their respective reporting processes.
