3 Trends That Can Improve Manufacturers’ Speed to Market

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.

#1: Industry 4.0 Technologies Take Hold

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:

• IoT enables continuous monitoring of critical equipment and can improve inventory practices. As more manufacturers explore IoT’s potential, they’re finding that it could have a major impact in greater asset utilization, higher uptime and improved customer service.
• Advanced analytics are being deployed in areas like product quality testing and predictive and prescriptive analytics. Automation in combination with advanced analytics is enabling personnel to make data-driven decisions to improve operations and product quality.
• In medical product development, manufacturers are assessing the business value of using AI and ML technologies to identify process problems, product defects and equipment maintenance issues before they result in costly delays.

These technologies are taking hold in every area of manufacturing, including product assembly, quality inspection, equipment maintenance and, of course, manufacturing documentation.

#2: FDA Technology Modernization Expedites Innovation

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:

• Issued in 2017, the FDA’s Digital Health Innovation Action Plan encourages innovation in digitally enabled devices through a pre-certification program, which allows pre-certified developers to market their lower-risk devices faster.
• In 2019, the agency released a suite of guidance documents to “continue to encourage innovative approaches to the development of digital health tools, and to ensure the agency’s approach to overseeing these technologies advances along with it.”
• To help prepare for the continued rise in data-rich applications, in 2019 the agency also unveiled its Technology Modernization Action Plan (TMAP), a three-pronged action plan aimed at modernizing the use of technology to advance the agency’s public health mission.
• Other recent updates by the FDA, motivated in part by advancing technology, offer guidance on Breakthrough Device designation, the De Novo pathway and Humanitarian Device Exemption (HDE), among others, to encourage innovation and enable modern regulatory oversight.

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.

#3: Digital-First Platforms Facilitate Critical Connections

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:

• Manufacturers can link standard operating procedures (SOPs) and work instructions in their digital quality management system (QMS) directly to digital production record phases.
• Manufacturers can launch quality forms from a production record, and automatically launch training and enforce training compliance on the production line.
• Operators on the shop floor can input data directly into tablets and pull information from their enterprise resource planning (ERP), manufacturing execution system (MES) and other systems.

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" 

References:

“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