At Smarteeva, we work with a wide range of medical device industry experts, paying close attention to how their processes are evolving and where their investments are being directed.
Past Approaches to Post-Market Surveillance
Historically, post-market surveillance practices were primarily reactive, focusing on reporting adverse events after they occurred. Companies often relied on spontaneous reports from healthcare providers, which could lead to significant delays in addressing issues. This reactive approach often resulted in insufficient data for robust decision-making.
Moreover, the reliance on legacy systems made it challenging to analyze data effectively. Many organizations lacked the tools necessary to identify trends or assess the significance of reported issues, which hindered their ability to protect patients and improve product performance. The absence of a standardized reporting framework further complicated matters, as variations in how data was collected and shared meant that critical information could be overlooked or misinterpreted.
Current State of Post-Market Surveillance
Post-market surveillance has significantly evolved as manufacturers face tighter regulatory requirements. Companies are adopting integrated methods, using real-world data from electronic health records and patient registries to improve monitoring.
With this evolution, organizations are moving toward proactive surveillance, continuously collecting and analyzing data. Advanced analytics and visualization tools provide insights into product performance, allowing swift action on safety concerns. Machine learning algorithms further enhance this process by offering predictive analytics, helping companies forecast and prevent adverse events.
In 2024, the landscape of post-market surveillance has rapidly evolved. This article highlights five key trends that are shaping how companies monitor product safety and efficacy after the launch of medical devices, pharmaceuticals, and consumer products.
Trend #1 : Automated Complaint Intake & Initial Assessments
The complaint intake process, traditionally riddled with manual steps like data entry, initial assessments, issue coding, and follow-ups, is now undergoing a transformative shift. In 2024, medical device companies are investing in cutting-edge technologies such as AI-powered email readers, direct customer complaint submission systems, and AI-enhanced tools for coding and risk assessment. Automated follow-ups not only save time but also improve accuracy, setting a new standard for efficiency and compliance in complaint management.
Trend #2 : PMS Report Automation
Another critical trend reshaping post-market surveillance is the automation of PMS reports like PSUR, MDR, CER and PMCF. Companies often spend significant time and resources generating these complex reports which require precise data aggregation and formatting to meet regulatory standards. Automation has emerged as a key trend, with advanced platforms now reducing report generation time by up to 80%, integrating data from ERP, RIMS, and other systems. By automating report templates, data aggregation, and error checks, companies are improving compliance while cutting reporting cycles from months to weeks.
Trend #3: Proactive risk management
As AI technologies proliferate, MedTech companies are transforming risk management into a proactive process. AI-powered automation now enables MedTech companies to monitor risks in real time, processing complaints faster and with greater accuracy. This approach not only allows companies to identify potential risks immediately but also facilitates benchmarking against industry and competitor records. Reports show that MedTech firms implementing AI-driven tools have reduced response times by up to 40%, reflecting the growing need for technology-led solutions in post-market surveillance.
Trend #4: Leveraging Industry Data for Customer Insights
The post-market surveillance landscape of 2024 is transforming, driven by AI’s ability to integrate industry data with internal complaints and adverse events. This evolution enables marketing and product development teams to uncover nuanced patterns of product usage and customer feedback. This approach has unlocked a data-driven strategy that enhances product development cycles, improves user satisfaction, and ensures companies remain agile in meeting consumer needs.
Trend #5: AI Agents replacing RPA
Traditional RPA is being replaced by AI agents, which offer smarter, more scalable solutions for managing complaints and PMS workflows. Unlike RPA’s static, rule-based automation, AI agents leverage machine learning to adapt dynamically and automate up to 50% more processes. This transition empowers organizations to tackle complex PMS workflows, such as complaint classification, report generation, and regulatory submissions, with greater precision and minimal human input.
About Smarteeva
Based out of Santa Barbara, CA. Smarteeva Software provides cutting-edge and innovative Post Market Surveillance applications for the Medical Device industry. Smarteeva’s Complaint Handling, Adverse Event Reporting, Risk Management and Recall Management solutions prioritize compliance, organizational efficiencies and user-friendliness. Built on the Salesforce.com Platform utilizing the latest AI innovations and Machine Learning, Smarteeva Software provides a true partner to its business users.
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