Alejandro Escario, CTO of Madrija, spoke at the 2024 Meeting on Updates in Research with Medical Devices, organized by the EPIC Foundation in Madrid.
The event brought together different perspectives: regulatory agencies, the healthcare technology industry, research organizations, and data processors.
The EPIC Foundation’s main objectives are:
-To foster excellence in the treatment of cardiovascular diseases.
-To serve as a vehicle for education and innovation in the field of Interventional Cardiology.
-To provide a forum for meeting, generating, and exchanging knowledge.
-To build collaborative ties with other organizations, Scientific Societies, or Private Companies.
Armando Pérez del Prado, president of the EPIC Foundation, emphasizes that “the entry into force of the new European regulation requires manufacturers to provide clinical evidence of the efficacy and safety of products and devices through clinical follow-up studies, known as PMCF, to verify that the real-world efficacy in patients matches what was shown in the initial clinical trials. That is where researchers come in, whose interest in continuing to improve patient safety remains as strong as ever”.
Finally, on the collaboration between public administrations and the private sector, Pérez del Prado notes that “we must encourage the continued domestic manufacturing of medical devices that maintains very high quality standards, but it has to be the Administration that supports this, without losing sight of protecting the safety of the patient, the end user. There clearly needs to be a connection and prior support so that, on our end, we can see that we’re able to seek agreements, sit down, and talk more openly”.
