PERSONALIZED MEDICAL DEVICES FROM CONCEPT TO CLINIC: A REVIEW OF REGULATORY PATHWAYS IN THE US, EU, AND INDIA

Abstract

Personalized medical devices (PMDs) signify a revolutionary change in the field of health care that corresponds with the worldwide trend of the patient-oriented approach. Contrary to conventionally manufactured, mass-use devices, PMDs are tuned to correspond with the anatomical, physiological, and even genetic characteristics of individual patients. With the aid of new technologies, such as 3D printing, artificial intelligence, wearable technology, and biomedical engineering, the innovations should be used to improve therapeutic accuracy, clinical results, and patient comfort. As discussed in the paper, the classification of PMDs, namely custom-made, patient-matched, and adaptable devices, the pathway of their development, the technologies they employ, and the regulatory issues involved, are outlined. It also provides a comparative study of the regulatory systems worldwide, such as the US FDA, the EU MDR, and the CDSCO of India. Although PMDs have huge potential, the mainstream inclusion of this technology into healthcare is complicated by regulatory inequities, standardization problems, post-market surveillance, and ethical issues. In the conclusion of the article, the author suggests the use of universal rules, fair access, and technology-based forms of control that would facilitate the safe, effective, and universal implementation of PMDs in clinical areas.