Emerging developments in both manufacturing technology and the regulatory landscape are allowing manufacturers to realize dramatic efficiencies in product discovery and development, regulatory compliance and, ultimately, time to market.
A new MasterControl trend brief explores three emerging trends that are likely to help medical technology manufacturers more quickly deliver their life-changing products to market.
Game-changing tools around big data and advanced analytics, cloud computing, artificial intelligence (AI)/machine learning (ML) and advanced robotics, combined with the connective power of the internet of things (IoT), are enabling manufacturers to gather an unprecedented amount of insights, streamline processes and accelerate time to market.
Digital technologies create enormous opportunities for manufacturers’ ability to improve processes and procedures. For example:
These technologies are taking hold in every area of manufacturing, including product assembly, quality inspection, equipment maintenance and, of course, manufacturing documentation.
The 21st Century Cures Act, signed into law in December 2016, gave the U.S. Food and Drug Administration (FDA) the tools to begin modernizing regulatory programs. Since the Cures Act passed, the FDA has made several updates to help expedite the development, assessment, review and surveillance of medical devices. For example:
As the FDA takes steps to modernize, medtech manufacturers that embrace regulatory change and evolve technologically will be able to reduce the time and cost required to develop, manufacture and market safe and effective new devices.
To achieve the benefits of digital transformation, manufacturing organizations must capitalize on platform dynamics for more connected operations and a more holistic view of data across the entire product life cycle. Digital platforms can accelerate connections and information exchanges between systems, processes and data across the value chain. This way, a manufacturer’s quality and regulatory teams can better integrate and automate data and workflows throughout the entire product life cycle. For example:
Digital platforms connect multiple data sources, gather, share and synthesize data to create meaning from it, and enable more fluid cross-departmental collaboration, data management and shared insights to transform their operations and accelerate speed to market.
Technologies are evolving and maturing, and regulatory bodies are reacting to remove unnecessary roadblocks for device companies while protecting consumer safety. Manufacturing organizations that embrace these opportunities will be better positioned to achieve significant efficiencies in product discovery and development, regulatory compliance and, ultimately, speed to market.
To read more about these developments, download the "3 Tech Trends That Will Accelerate Manufacturers' Time to Market"
“Digital Health Innovation Action Plan,” U.S. Food and Drug Administration, July 2017. https://www.fda.gov/media/106331/download
“Statement on New Steps to Advance Digital Health Policies that Encourage Innovation and Enable Efficient and Modern Regulatory Oversight,” U.S. Food and Drug Administration, September 2019. https://www.fda.gov/news-events/press-announcements/statement-new-steps-advance-digital-health-policies-encourage-innovation-and-enable-efficient-and
“FDA’s Technology Modernization Action Plan,” U.S. Food and Drug Administration, September 2019. https://www.fda.gov/about-fda/reports/fdas-technology-modernization-action-plan
“Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration Staff,” U.S. Food and Drug Administration, December 2018. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program
“De Novo Classification Request,” U.S. Food and Drug Administration, December 2018. https://www.fda.gov/medical-devices/premarket-submissions/de-novo-classification-request
“Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff,” U.S. Food and Drug Administration, September 2019. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/humanitarian-device-exemption-hde-program
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