It is not uncommon for organizations to have different IT systems for regulatory, product, and organizational information. Segregating the data, such as the QMS gate reviews, complaints, and adverse event reporting, from the product sales quota and organizational growth projections and actuals keeps regulatory auditors to the task at hand – inspecting the Quality Management System.
Yet as the Information Age evolves, the regulatory paradigm is shifting to “beyond compliance” for Total Product Lifecycle and organizational excellence. What does that mean to the IT systems and their data?
Post-market data has the potential to be a broader set of data to shed light on Total Product Lifecycle and integrate organizational data for continuous process improvement.
Have you considered the data available on social media platforms, online markets, and clinical registries? OTC products within these real-world data sets are redefining the scope of data governance. What does it mean when an online store has a blood-pressure cuff at 4.5 stars with over 10k reviews, compared to a competitor’s product at 5 stars with only 500 reviews? Of the 10k reviews, over 400 complain about inaccurate readings, almost as many stars as the total number of reviews for the competitor’s product – for the whole world to see and read! How should this be interpreted? How can platforms be linked to gain deeper insight into customers’ experience with product performance?
Other device and drug product information resides in hospitals’ Electronic Health Records (EHRs), which are sold back to companies to shed light on product performance. What was once the selection of data to be utilized by Enterprise Resource Planning (ERP) systems from primarily internal processes is now expanding to assemble the totality of information. ERP systems were built to connect the financial and product data and to monitor resources (both product inventory and human) to support the product inventory. However, ERP implementations, without focus on product quality and with a primarily focus on fiscal regulatory requirements, can drive poor ERP system implementation and lose sight of medical device quality. All too often ERP systems are viewed to be compliant with fiscal regulation and just need each site to load the product inventory, status flags, and labels.
Post-market data sources for monitoring can allow organizations to be smarter regarding product quality and continuous improvement. This means that ERP system implementations must address both fiscal integrity and drive Total Product Lifecycle by ensuring that implementation is not just a top-down approach to align with fiscal requirements but also a bottom-up approach to consider all device data needs. This will result in having better aligned data throughout the organization and with the ever-growing post‑market data. Data governance that periodically conducts checks and assessments of work activities on a day-in-day-out basis can identify activities that have been acquired over time and are no longer required. Data that brings no value and utilizes resources for collection and analysis is data to consider retiring. From my experience, data governance which aligns both top-to-bottom and bottom-to-top approaches is the foundation for both high-quality data and organizational efficiencies, and also leads to better products with higher ROIs.
Lachman Consultants is prepared to support its clients in evaluating data governance for Total Product Lifecycle and identifying the most effective way to utilize data. Contact us today to discuss how we can help your organization.
