“Bringing Innovative Devices From Concept to Successful Commercialization: Regulatory Considerations and Standards Matter”

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The medical device industry is one of the fastest growing sectors that aim to improve patient care and deliver an efficient global healthcare system. New discoveries in medicine, biomedical engineering technologies, digital health and connected health are driving innovation.  With advances in wireless communication, sensors, biomaterials and others, medical technology companies are focusing on products that are cheaper, “smarter,” wearable, more efficient -- accelerating the speed to market. Governments regulate medical devices to promote and protect public health and safety. Across the world, the regulation of medical devices varies from highly regulated to no regulation.  Countries such as the United States, the European Union, Japan, Canada, United Kingdom and Australia have developed comprehensive systems with established regulatory frameworks.  Other regulatory bodies in other regions like Asia, Latin America, Middle East and North Africa are in various stages of developing their systems and enacting them into laws.  

This presentation will discuss the importance of the design control process, a critical milestone for regulators, in the product development lifecycle process. As a case study, a general understanding of the medical devices regulatory framework and requirements for bringing devices into market into the U.S. will be discussed. In addition, how the use of voluntary standards has become essential in establishing medical device regulations will be explained, as well as introduce the IEEE standards development lifecycle. 

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