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Medical device companies are required to conduct postmarket surveillance (PMS) on their devices to maintain high product quality and safety. However, few companies realise the true value of the digital feedback they receive. In this post, we will explore current best practices for collecting and interpreting postmarket intelligence.
Most device manufacturers associate postmarket intelligence with medical device reporting (MDR), a surveillance tool intended to collect reports of device-related adverse events, use errors, product quality issues and device failures. However, Mickey Garcia, segment manager in the Medical Devices Product Management Group at MasterControl, encourages you to look beyond MDR.
Garcia recommends that you take advantage of the “treasure trove” of postmarket surveillance (PMS) data at your disposal to improve decision making, product design and time to market.
He’s not alone. The FDA is conducting and supporting a range of initiatives to enhance the nation’s PMS capabilities for medical devices, most notably its National Medical Device Postmarket Surveillance System, also known as MDS.
Postmarket surveillance encompasses three phases: data collection, data analysis and data distribution, i.e., how to get the results of the information you have gathered to the people in your organisation who can use it to improve processes and products.
Phase one: data collection
Most of us are familiar with the data collection phase since we are obligated by regulators to provide customer complaint information. However, complaints are only one source of postmarket feedback. Other valuable collection and monitoring sources include post-clinical studies, information from the health care system itself (e.g., electronic health records or EHR), smart devices and internal quality data (e.g., nonconformances). Many of these source categories have subcategories. Customer complaints, for example, can encompass everything from a highly structured FDA MedWatch Form 3500A to a casually worded social media comment.
Customer complaints are the ultimate indicators of product quality, which is why every complaint must be properly evaluated, investigated and, when necessary, corrected. Customers use MasterControl Customer Complaints module to automate and streamline the complaints process and facilitate MDR. MasterControl’s product management team is working on a new and improved version of the module, which will offer better MDR capabilities, a more flexible workflow and enhanced integration with other processes within the MasterControl software suite.
Phase two: data analysis
After data has been collected, it must be summarised and analysed. Corrective and preventive action (CAPA) and risk analysis are key components of phase two. If a complaint or nonconformance is determined to be a systemic issue, we must delve into the CAPA process and conduct a root cause investigation. Next, we must perform a risk analysis. Finally, all of the data gleaned from the CAPA and risk processes must be summarised, categorised and coded so that it can be trended. This is typically done manually. Someone must categorise and code incident records, which can be a tedious and time-consuming process. MasterControl is working on automated tools that will summarise and analyse chunks of big data, such as data coming from smart devices and EHR, based on keywords and natural language processing (NLP).
In the meantime, customers are using MasterControl CAPA and MasterControl Risk to track and trend important quality event and risk-related information. Both solutions can be seamlessly integrated with the customer complaints module. MasterControl Event Analyzer is another useful tool for automating the task of tracking and trending. The Event Analyzer Agent allows users to monitor and automatically flag issues that meet predefined criteria. These criteria can be directed at a specific quality channel or broadly at all quality channels at once.
Also in the works is a new analytics engine that will link data from any part of MasterControl, specifically data from complaints and nonconformances, to facilitate the internal reporting process.
Phase three: Data Distribution
During phase three, you must act on the results uncovered during the first two phases. The key to acting on the results is to bring the data to the “points of use” where it can be utilised to create knowledge bases, in addition to conducting the baseline MDR required by regulators.
Garcia advocates using the results to establish a product-realization knowledge base, a resource process engineers and manufacturing engineers can access for product and manufacturing information compiled from all postmarket data sources. He also advocates establishing a product-design knowledge base and using it to improve the design of products currently on the market, as well as your next-generation products in development.
“Despite having access to unprecedented data and technologies, few companies are truly exploring how to use big data to improve product safety and drive better health outcomes,” said Garcia. “That’s unfortunate because the business and operational benefits to be gained are substantial.”
For more information about postmarket surveillance, view Mickey Garcia’s webinar titled “Best Practices in Post-Market Intelligence.”
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