The Medtech & Pharma Platform Association (MPP) is pleased to announce the publication of a paper entitled ‘Development and regulation of connected combined products – Reflections from the Medtech & Pharma Platform’ in of the journal Clinical Therapeutics. Reductions in wireless connectivity costs combined with the rapid adoption of smartphones and other mobile devices with connectivity to cloud-based services increasingly enable classical drug delivery devices to be connected to a digital ecosystem as “connected combined products” (CCPs).
The reflection paper aims to identify regulatory uncertainties and development challenges for CCPs, present best practices and stimulate the discussion to achieve a fit-for-purpose regulatory framework. It provides considerations on the clinical and regulatory framework, usability and human factor engineering, the development process and lifecycle management and cybersecurity and data management. The paper calls for joint discussions across the pharma, medtech and tech sectors, together with regulators and lawmakers in the EU to define pragmatic solutions and regulations to foster the development of CCPs and facilitate patients’ access. The paper is accessible via this link.