In the medical device industry, success requires bringing innovative products to market faster than the competition. But to accomplish this feat, medical device companies must put in place proactive strategies to ensure timely compliance with the regulatory requirements in global markets. Since the Food and Drug Administration (FDA) and other regulatory bodies have embraced the concept of total product life cycle (TPLC) management, medical device companies would be well served to follow it to shepherd a product from concept to completion.
TPLC enables device companies to manage the process from the concept and design of a product’s lifecycle through commercialization and ongoing safety monitoring, as it encourages collaboration and facilitates cooperation. But achieving both a successful design and regulatory compliance with TPLC is virtually impossible using traditional manual processes—such as spreadsheets—because static, manual processes do not provide an environment that enables the timely interaction essential to TPLC.