SYNCHRONIZING CLINICAL DEVELOPMENT STRATEGY WITH TECHNOLOGY INNOVATIONS IN MEDICAL DEVICESAbstract
The earliest anecdotes of ‘medical device’ dates back thousands of years. In 7000 BC, Neolithics used flint-tipped drills and bowstrings for dentistry. However, regulation of medical devices has only happened recently. Modern medical devices are used for the diagnosis, cure, mitigation, treatment, or prevention of disease. This industry is one of the most dynamic, disruptive, and fastest-growing among all segments in healthcare. However, there are challenges. The transition from innovation to patient care and eventually financial success has proven to be the Achilles hill for most organizations attempting to create a niche within the industry. There has been a multitude of problems to deal with. Financial, operational, technological, and regulatory issues have been plaguing the industry for years. Thankfully, with the advent of new-age technologies like artificial intelligence and machine learning, we are witnessing a paradigm shift in this space. In this review article, we delve deep into the history, evolution, and challenges in the medical devices space. We also look at the emerging technologies that are shaping the future. Clinical development strategies for medical device development have to be fully integrated into the initial stages of technology innovation. We provide a detailed roadmap to this effect. We elucidate the synchronization of innovation and clinical development across all stages of product development and commercialization. Lastly, we recommend critical facets of the post-marketing plan that need to be implemented for the financial viability of devices that leaves behind a lasting legacy for its clinical application.
Manish Narang *, Ramanpreet Walia, Upendra Kaul and Krishnakutty Sudhir
Medical Affairs-Asia Pacific & Japan, Department of Medical Affairs, Abbott Vascular, New Delhi, India.
12 September 2021
09 November 2021
17 November 2021
01 December 2021