• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    MPO's Most Read Stories This Week—June 25

    Magnetic Insight Announces $17 Million in Series B Funding

    BreatheSuite Adds Brad Fluegel to its Board

    Labcorp Launches At-Home Collection Device for Diabetes Risk Testing

    Thirona, Free Flow Medical Partner on COPD Solutions
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Theranos Fraud Trial, Part II: The Blame Game Continues

    An Update on Surgical Robotics

    Letting the Light In: How Failure Analysis is the Cornerstone of Success

    Three Talent Strategies to Attract High-Demand Skills

    The Advantages of Bioburden Screening for Sterilization Validation
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    JBC Technologies

    Xact Wire EDM Corp.

    Cirtec Medical

    Fusion Biotec Inc.

    Concise Engineering
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    The Power of Leveraging Customer Relationships

    Cost Effective & Efficient Wire EDM Techniques

    How MedTech Professionals Can Help Combat Physician Burnout

    How to Optimize Manufacturing Lines and Choose Which Machines to Buy

    How Are Hypodermic Needles Made?
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    JBC Technologies

    Xact Wire EDM Corp.

    Cirtec Medical

    Fusion Biotec Inc.

    Concise Engineering
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Columns

    FDA Making Progress With Technology and Data Action Plans

    There is an urgent need to get advanced technologies into the healthcare ecosystem, but all products must first get regulatory approval.

    FDA Making Progress With Technology and Data Action Plans
    Related CONTENT
    • BMP Medical - Delivering Custom Plastics Manufactured Solutions
    • NTK Cutting Tools USA
    • Rootstock Software
    • Simbex
    • HS Design Inc.
    Alan Rencher, Vice President, Engineering, MasterControl03.04.21
    To continue its ongoing mission of advancing public health, the U.S. Food and Drug Administration (FDA) has always welcomed new discoveries and innovation. Yet in recent years, the rapid pace of progress has forged a sizeable gap between the industry’s progress and the technologies needed to translate them into useful therapies. There is an urgent need to get advanced technologies into the healthcare ecosystem, but all products must first get regulatory approval.

    In early 2019, the FDA experienced an influx of investigational new drug (IND) applications. Much of the growth was attributed to a surge in new cell and gene therapy products. Drug delivery system technology has also been on the rise, and nanotechnology is currently being explored as a drug delivery vehicle due to its ability to provide site-specific and target-oriented delivery of precision medicines.1

    Combination products using advanced software and interconnectivity are becoming increasingly popular in the point of care and the home healthcare markets. These products are designed to provide a high level of precision with treatment regimens. They also enable healthcare providers to receive and react to data in real time, which greatly enhances many aspects of patient care.

    The innovations moving through regulatory pathways are made possible through technologies enabling connectivity, interoperability, and the use of more data. Data is more abundant, more focus-area specific, and has a wide range of life sciences uses. For example, artificial intelligence (AI) and machine learning (ML) technologies are highly data-centric and are becoming more common in mainstream healthcare.

    AI is designed to simulate human intelligence processes. It acquires information, determines how to analyze and use the information, and self corrects upon receiving new data. An AI algorithm has a programmed ability to continue learning and adapting based on the information it receives, making it useful for processes that involve analyzing enormous amounts of data. ML is an artificial intelligence technique that can be used to design and train software algorithms to learn and act on data, which is often used for predictive analytics. According to the FDA’s action plan on artificial intelligence and machine learning, “the technologies have the potential to transform healthcare by deriving new and important insights from the vast amount of data generated during the delivery of health care every day.”2

    By nature, AI can continually acquire and analyze data and provide useful information for making decisions or solving problems. However, AI is designed to work through every possible route or option to present the best solution. This approach isn’t always practical because it can take a long time to reach a goal. Heuristic learning is a practical method for problem-solving, learning, or discovery. It may not always find the best solution, but it will always find a satisfactory solution in a reasonable amount of time. Used with AI, heuristic learning is a way to inform the algorithm about the direction to a goal, then it estimates the least costly route to a good solution to use in decision-making.

    FDA’s TMAP Program Fosters Innovation
    In an effort to stay abreast of scientific and technological advancements, the FDA implemented its Technology Modernization Action Plan (TMAP) in 2019. The modernization initiative has been a groundbreaking endeavor not only to facilitate innovation, but to overcome challenges within the regulatory paradigm. The FDA’s multifaceted responsibilities call for the agency to continuously monitor science, technology, and data trends. Oversight of complex, interconnected medical products requires cross-functional expertise from multiple offices within the FDA. That said, the agency’s modernization effort allows more transparency and collaboration across the organization, as well as the overall life sciences community.

    To effectively expedite innovative and breakthrough products, the FDA must be more agile and dynamic. Therefore, a top TMAP priority was the migration of the agency’s technology infrastructure to a cloud environment. This helped the organization become more modernized, thus delivering more value to the industry and public. Because data has taken a more central role in medical product development and use, the agency had to better focus on data management.

    FDA’s Data Modernization Strategy
    The digitization of processes, pervasive use of mobile technologies, and advancements in data gathering and analytics have created new types and more uses for data. A central part of the FDA’s TMAP blueprint is making better use of data, which led to the development of the Data Modernization Action Plan (DMAP). Specifically, this data strategy focuses on the stewardship, security, quality control, analysis, and use of data in developing state-of-the-art products and solutions. At a high level, the DMAP will enable the agency to align technology and innovation across multiple industries, enhance its data practices, and allow efficient collaboration across a growing, diverse workforce. Operating in a cloud environment is crucial to executing DMAP.3

    The Necessity of a Data Management Strategy
    Understanding the potential of what can be achieved through data is largely the impetus for the FDA’s DMAP strategy. Evolving technologies are ushering in next-generation solutions and more precision processes. Data is a highly integral component of these technologies. Capabilities to track and trace medical and food products can lead to more expedient responsiveness to unplanned events such as pandemics, natural disasters, and global supply chain disruptions.

    A significant component of TMAP is data governance, which is a collection of practices and processes that help ensure proper data asset management. For example, the number of projects in the

    Center for Drug Evaluation and Research’s data standards portfolio has substantially increased. Having a more structured approach to manage the center’s data initiatives has become imperative.

    TMAP/DMAP Progress Report
    One year into the TMAP initiative—before, and even during, the COVID-19 pandemic—the FDA has been making some notable progress with its action plans. In October 2020, the agency published a TMAP program update highlighting some of its achievements.

    While the FDA’s technology modernization efforts aimed to meet the rapid pace of scientific and technology innovation, they were also established to improve the user experience of its workforce as the agency’s workload increased. The Office of Information Management and Technology has been actively launching a mobile device management program to give staff the necessary tools to work remotely without slowing productivity.

    AI technology can rapidly analyze data and automatically identify connections and patterns in data that people or rules-based screening systems can easily overlook. The agency has been leveraging AI to expand its predictive analytics capabilities in a pilot program for screening imported foods as part of its food safety initiative. Noting the amount and diversity of foods—particularly seafood—the United States imports, safety is a top priority.4

    According to former FDA Commissioner Stephen Hahn, the pilot program has made a significant improvement in surveillance efforts. In addition to improved food product oversight, the FDA is using ML to gain insight from its stores of collected data to make more informed decisions about which facilities to inspect, what foods are most likely to cause health concerns, and other potential risks. “The results are exciting. This approach has real potential to be a tool that expedites the clearance of lower risk seafood shipments and identifies those that are higher risk,” said Hahn.5

    Technologies that were once siloed and independent are now becoming more interoperable. In August 2020, the FDA approved a novel automated insulin delivery and monitoring system. The interconnected, bluetooth-enabled device is a closed-loop system that works by measuring the body’s glucose levels every five minutes and automatically adjusting insulin delivery. The device functions on internet of things technology, which enables medical devices from different manufacturers to be interconnected and effectively communicate with one another.6

    Measuring the Progress
    Overall, the TMAP and DMAP action plans have enabled the FDA to take a more modernized, proactive approach to pursuing its regulatory mission. The modernization strategies are a work in progress, but the agency has identified specific metrics to measure the success of each strategy. These include a recognizable reduction in regulatory cycles, broader data sharing across the organization and the life sciences industry, and the creation of a culture of empowerment among its workforce. Going forward, the agency plans to continue engaging with industry stakeholders and providing public updates on its activities and accomplishments. 

    References
    1. bit.ly/3tWhTDd
    2. bit.ly/3b01TY1
    3. bit.ly/2ZcaUrp
    4. bit.ly/3agjADt
    5. bit.ly/3tUb2dh
    6. bit.ly/3d8bTRH


    Alan Rencher is a results-driven software engineering executive and technology leader with more than 20 years’ experience and expertise in solutions and product development with leading tech firms and multi-billion-dollar companies in various industries. As vice president of engineering at MasterControl, he mentors the software delivery teams to plan and build enterprise-class solutions for the life sciences and works hand-in-hand with product and architecture leadership to set the company’s strategic vision. Alan leads with a development operations mindset to assist software engineers and teams to solve real-world problems that offer customers the most in-demand solutions. Prior to MasterControl, Alan spent time in leadership and architectural roles with companies such as Target, Melaleuca, COPB, Deseret Book, Defense Support Services, and Ameritrade. He holds various engineering and computer science degrees.
    Suggested For You
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    NTK Cutting Tools USA NTK Cutting Tools USA
    Rootstock Software Rootstock Software
    Simbex Simbex
    HS Design Inc. HS Design Inc.
    High Tech Turning Co. Inc. High Tech Turning Co. Inc.
    Nissha Medical Technologies Nissha Medical Technologies
    Beaumont Beaumont
    Northeast Biomedical, Inc. Northeast Biomedical, Inc.
    sfm medical devices GmbH sfm medical devices GmbH
    Anjon Medical Technologies Anjon Medical Technologies
    Breakthrough Device Designation Granted for New Neuromodulation Platform Breakthrough Device Designation Granted for New Neuromodulation Platform
    Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    Accu-Tube Appoints Matthew Haddle as CEO Accu-Tube Appoints Matthew Haddle as CEO
    First CellFX Procedure Performed in Canada First CellFX Procedure Performed in Canada

    Related Videos

    • BMP Medical - Delivering Custom Plastics Manufactured Solutions

      BMP Medical - Delivering Custom Plastics Manufactured Solutions

      Medical Contract Manufacturing, Design, Assembly & Packaging

    • NTK Cutting Tools USA

      ...
      Melissa Singher, Senior Product Coordinator 11.22.21

    • Rootstock Software

      ...
      Chuck Stevenson, Director of Marketing 11.16.21


    • Simbex

      ...
      Greg Lange, Chief Business Development Officer 11.15.21

    • HS Design Inc.

      ...
      Tor Alden, President 11.15.21


    Trending
    • The Power Of Leveraging Customer Relationships
    • Intermountain Healthcare & Siemens Healthineers Open 3 Tellica Outpatient Imaging Centers
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Magnetic Insight Announces $17 Million In Series B Funding
    • NHS England Selects Spectra Optia Apheresis System To Treat Sickle Cell Disease
    Breaking News
    • MPO's Most Read Stories This Week—June 25
    • Magnetic Insight Announces $17 Million in Series B Funding
    • BreatheSuite Adds Brad Fluegel to its Board
    • Labcorp Launches At-Home Collection Device for Diabetes Risk Testing
    • Thirona, Free Flow Medical Partner on COPD Solutions
    View Breaking News >
    CURRENT ISSUE

    June 2022

    • OEMs Seek Molders Offering Timely Techniques
    • Robotic Surgery: Cutting Through to the Latest
    • Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Florida Food Products Acquires Javo
    Roquette Launches Nutralys Rice Protein
    New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy
    Coatings World

    Latest Breaking News From Coatings World

    The Southern Society for Coatings Technology's 84th Annual Technical Conference A Success
    PPG to Showcase Specialty Automotive, Aerospace Adhesives, Sealants at Adhesives & Bonding Expo
    PPG’s New Paint for a New Start Initiative to Transform 25-plus Schools Worldwide
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most Read Stories This Week—June 25
    Magnetic Insight Announces $17 Million in Series B Funding
    BreatheSuite Adds Brad Fluegel to its Board
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Pierre Fabre and Lonza Enter Manufacturing Agreement
    MasterControl and Elemental Machines Form Biomanufacturing Partnership
    Qosina Strengthens Aseptic Capabilities
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Benefit Exec Joins Madison Reed's Board
    Peroni & Ellis Brooklyn Launch Fragrance Collection Inspired by Italian Spritz Cocktails
    Rhode Is Trending for June, Trendalytics Says
    Happi

    Latest Breaking News From Happi

    Wonder Curl Wins GlossWire's GlossPitch Competition
    Anti-aging Skincare Brand Vitabrid C12 Launches Bestsellers on Amazon
    Botanical Embedded Candles Can Be Fire Hazard, Says National Candle Association
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: INX’s VC Fund, Screen Industry and Ball Top This Week’s News
    British Coatings Federation Posts Online History
    Orion Announces Price Increases, Reduced Payment Terms
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    PCMC teams with IGT, Fujifilm makes big announcement and more
    Loftware recognized as 'AIDC Company of the Year'
    Schreiner MediPharm highlights sustainability of Needle-Trap technology
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Tranzonic Names VP of Supply Chain
    Ontex Climate Action Targets Approved by Science-Based Targets Initiative
    Suominen Test Center Assesses Biodegradability of Nonwovens
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—June 25
    3Spine Inc. Receives IDE Approval for U.S. Pivotal Clinical Trial
    Volume-Based Procurement to Reduce Chinese Orthopedic Market Value
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: eMagin, Applied Materials, and Schott Top This Week’s Stories
    NREL Names Jennifer Logan to Leadership Team as CFO
    National Grid Renewables Orders 2 GW of First Solar Modules

    Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login