Enhancing Regulatory Compliance and Safety in Patient Self-Care : An Approach to Symptom Checkers, Connected Devices, Autoinjectors and AI-Powered Autoinjectors

Abstract

This research investigates the use of various medical devices in supporting patient self-care, with a focus on regulatory compliance in the US and EU. It explores how technologies like Software as a Medical Device (SaMD), connected devices such as infusion pumps, and autoinjectors are reshaping patient self-management. By examining the intersection of these innovations with medical device regulations in both regions, the study highlights the regulatory challenges and opportunities they bring. The emphasis on SaMD, infusion pumps, and autoinjectors is driven by their widespread adoption and their crucial role in enhancing self-care for managing various health conditions.

The objective of this research is to examine the role and risks of medical devices, with a particular focus on Software as a Medical Device (SaMD), connected devices, and autoinjectors, in enabling patient self-care. This includes an emphasis on their regulatory compliance within the US and EU, two of the most widely recognized and established medical device regulations globally. The objective also involves analyzing how these devices intersect with relevant regulations, identifying challenges and opportunities in areas such as cybersecurity and interoperability, and advocating for a patient-centered approach to self-care that enhances safety, effectiveness, and regulatory compliance. The research aims to improve regulatory compliance and industry practices for medical devices, supporting patient-centered self-care and advancing healthcare delivery. A substantial part of the research focuses on autoinjectors, driven by the increasing use of these devices for self-administering a variety of medications and the lack of sufficient tools to achieve regulatory compliance for autoinjectors. The study results aim to support the safety, effectiveness, and regulatory compliance of the autoinjectors, thereby speeding up their approval process.

The research concludes by emphasizing the critical importance of a patient-centered approach to self-care, the need for robust agile regulatory process, and the pivotal role of education and training in maximizing the benefits of medical devices. It advocates for future advancements in healthcare policy and practices to enhance patient-centered self-care and evolve regulatory standards to better support patient needs.