Top 5 Trends in Post-Market Surveillance 2023

At Smarteeva, we interact with numerous medical device industry insiders and pay attention to where their processes and investments are going. Most medical devices processed are mature. However, newer technologies facilitate possibilities for better process adherence, efficiency, and product safety. Here are the top 5 trends we witnessed:


  1. Partner & Customer Self-Services: Consumer-grade medical devices facilitate a patient to monitor and maintain their health by themselves, and the trend for these devices have risen in the past year. As these devices enable consumers with self-servicing ability, the desire to embed complaints management in mobile devices & applications grew vastly.  Also, we are seeing actual investments being made in consumer self-service for complaints reporting as well as partner/distributor portals being rolled out.
  2. Increased Data Collection & Reporting: Increased data collection & reporting is happening in the USA & Europe. FDA has sunset some of the summary reporting requirements, and following the experience with various implantable devices, FDA requires most adverse events to end up in the public MAUDE system. Also, the new MIR form released in the process of EUMDR went from 4 pages to 12, calling for more information mapping, collection and reporting.
  3. EU Data Protection: The GDPR, EU’s new data protection law is another focus point. The stringent EU Medical Device Regulation (EU MDR) has increased investment in data protection and stringent data sharing agreements.  We are noticing a trend of Medical Device companies wanting to keep EU Personal Data within EU borders.  This is affecting application hosting as well as support personnel to shift to the EU.
  4. Generative AI: Generative AI such as ChatGPT is another upward trending tool we noticed. While implementing Generative AI can help accommodate large work volumes along with other benefits, no real success projects have been recorded recently.  This is an area where companies want to invest and we believe that more software dollars will shift to AI in the near future.
  5. Increased importance of MAUDE Data: The MAUDE database contains information about the safety of medical devices and is gaining momentum as it is a powerful tool for manufacturers, regulatory authorities and even clinicians. The two reasons for the MAUDE database’s popularity can either be from a competitive lens or the sheer amount of data records that are now more meaningful.


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 Platform and utilizing the latest AI and Machine Learning innovations, Smarteeva Software is a true partner to its business users.

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