Express Healthcare (Vol.14, No.11) December 2021

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A separate code for medical devices will better address the unique needs of the medtech sector Abby Pratt, Senior Vice President, Global Strategy & Analysis, AdvaMed in an interaction with Express Healthcare explains about code for medical devices sector and its crucial role Why is separate code is required for Medtech sector? A separate code for medical devices will better address the unique needs of the medtech sector. The AdvaMed code aims to bridge the gap and drive cognizance on the unique requirements of the medtech sector with respect to training and clinical research. Medical devices vastly are distinct from pharmaceuticals in terms of their design, manufacturing, innovation life cycle and deployment in a clinical setting. Given the knowledgebase, skills and training required of healthcare professionals to operate, deploy or utilise certain medical devices, manufacturers of medical devices will need to engage doctors differently as compared to their counterparts in the pharmaceutical industry. Therefore, a distinct code for medical device manufacturers around ethical conduct with healthcare providers and physicians is critical. How is the new code going to help the medtech industry in the interaction with the healthcare professionals? Medical device companies, globally and in India are dedicated to advancing medical science; developing high quality, innovative medical technology; and improving patient care. The

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healthcare professions during the course of their business but also help maintain a healthy medtech innovation ecosystem for the benefit of the industry as whole. Code adoption strengthens the industry’s relationships with physicians and other health care providers by focusing interactions on developing innovative and cutting-edge technology and patient care, thereby helping to ensure the independence of health care professionals’ medical and clinical judgment.

While the COVID-19 pandemic is far from over, the global disruption it has caused will drive many healthcare organisations to rethink their business model new code will act as an essential guide for all companies as they strive to achieve their business objectives while ensuring

patient safety and integrity in all their actions. We urge all med-tech companies – including small, medium, and large size firms and all the

representatives on the forefront of these businesses to proactively adopt the code. The code will not only standardise interactions with

How has AdvaMed conceptualised and developed the methodology for the code of ethics for India? AdvaMed stood up a task force in October 2019 to draft an India Code of Ethics based on the U.S. Code but tailored to business and market realities in India in response to the AdvaMed India Executive Committee’s recommendation to develop a code of ethics to promote greater consistency across the industry for ethical interactions with healthcare professionals in India. That task force, comprised of mainly India based ethics and compliance lawyers, completed the draft code in June 2020. Following successful completion of legal review by outside counsel from both India and the U.S., the Code underwent rigorous member committee review


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