The European Medical Device Regulation has radically affected the MedTech Industry. The Challenges for MedTech manufacturers especially SMEs are increasing which require a total reshape of their framework model for medical devices, one of which is the emphasized regulatory focus on clinical evidence and post-market surveillance.
Problems caused with devoid of Post Market Surveillance
A global scare a few years ago meant many women had to remove breast implants due to a non-medical grade breast implant which affected women so severely that in some cases it even resulted in death. An Investigation found that around 1.7 million injuries had been caused by unsafe medical devices and potentially as many as 83'000 deaths in the past decade. This clearly shows the critical importance and value of post market surveillance.
Post Market Surveillance (PMS)
PMS is the practice of keeping a check on quality, performance, and long-term safety of a medical device after its deployment in the healthcare industry.
With (EU) MDR being in full effect as of May 2021, a more standardized ruleset is set to be followed and the post market surveillance has been promoted from just a directive (as in former MDD) to a mandatory requirement for any medical device, be it new or existing, to be approved before usage in the market. This puts a significant burden on medical device manufacturers to update their current framework, and also to apply MDR to market-available devices and ensure compliance.
Post Market Success
Since device users are located all around the World and are hard to track and train, digital hybrid training is the perfect solution to increase post-market success for medical devices. It can reduce the time and cultural challenges for MedTech developers and can ensure both device and user success.
Another approach towards increasing and ensuring post-market success is to improve the quality of the devices themselves. This can be done by monitoring devices' performance, by measuring users' experience of the device and by having a robust ticketing and reporting system to meet user requirements and making innovative device developments accordingly.
Need of Digitalization in MedTech
How can MedTech companies turn their investments in digital tools and capabilities into a competitive advantage? The answer lies in the proposition that medical device companies will need to develop a clear understanding of the capabilities of their digital tools and how to use them most effectively. Rekonnect is the first-ever digitized solution for medical device manufacturers in their journey of post-market success. The platform supports all those features which are necessary to ensure medical device success.
Post-market Success Platform for MedTech
The eco-system for stakeholders involved with a medical device in the post-marketWhy choose Rekonnect
Conclusion: Adopting Digitalization can Restructure the Process of Post-Market Surveillance
The adoption of digitalized processes is crucial for MedTech companies in achieving post-market success. The EU Medical Device Regulation has increased the focus on clinical evidence and post-market surveillance, making PMS a mandatory requirement for medical device approval. By utilizing digital hybrid training and improving device quality through performance monitoring and user feedback, MedTech companies can increase post-market success. A robust and reliable post market surveillance system, Rekonnect, is the perfect solution for MedTech companies for increased post-market success and ensured compliance with EU MDR.