Development and Regulation of Connected Combined Products: Reflections From the Medtech & amp; Pharma Platform Association

Clin Ther. 2022 Apr 4:S0149-2918(22)00112-6. doi: 10.1016/j.clinthera.2022.03.009. Online ahead of print.ABSTRACTPURPOSE: Patients taking a medicinal product in a homecare setting typically use a medical device to facilitate the injection process. Reductions in wireless connectivity costs, combined with the rapid adoption of smartphones with connectivity to cloud-based services, are enabling these drug delivery devices to now be connected to a digital ecosystem as connected combined products (CCPs). The purposes of this article are to identify the challenges in developing and releasing these products when they straddle different regulatory frameworks and standards and to highlight gaps in the European Union regulations.METHODS: Industry subject matter experts from pharmaceutical, medical device, and consultancy companies, who are members of the Medtech & Pharma Platform Association, formed 4 working groups to address current best practice for developing and releasing CCPs and the different relevant regulatory frameworks. The 4 areas studied were clinical and regulatory, usability and human factors engineering, development and life cycle management, and cybersecurity.FINDINGS: Development teams require new skills to create innovative products that have a good safety profile and are simple to use, such as design thinking to understand user needs and systems engineering to manage complexity and ensure interoperability. Risk management process should integrate cybersecurity, ...
Source: Clinical Therapeutics - Category: Drugs & Pharmacology Authors: Source Type: research