• 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
    Study Confirms Safety, Accuracy of Vectorious' V-LAP In-Heart Sensor

    Norman Noble Achieves ISO 13485:2016 Certification

    Indian SMEs Gaining Access to Russian Medtech Market Amid Ukraine Conflict

    Quell Wearable Neuromodulation Device Wins De Novo Authorization

    JenaValve Releases First Commercial Trilogy Heart Valve Implant Results in Europe
    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

    Cirtec Medical

    BMP Medical

    Fusion Biotec Inc.

    Trademark Plastics Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    ‘Right to Repair’: Separating Fact from Fiction

    Taking a Holistic Approach to Decentralized Clinical Trials (DCTs)

    Investment in Health Startups Drops

    The Power of Leveraging Customer Relationships

    Cost Effective & Efficient Wire EDM Techniques
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    JBC Technologies

    Cirtec Medical

    BMP Medical

    Fusion Biotec Inc.

    Trademark Plastics Inc.
    • 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

    Using Digitization to Get Ahead in Medtech

    ...

    Using Digitization to Get Ahead in Medtech
    Image courtesy of MasterControl.
    Related CONTENT
    • MedWorld Advisors
    • FDA Approves Device to Help Increase Access to More Lungs for Transplant
    • A New, Tailored Review Framework for Artificial Intelligence-Based Devices
    • FDA to Modernize Mammography Services and Improve Their Quality
    • FDA Warns J&J and Sientra for Breast Implant Compliance Failure
    Bryant Headley, Customer Success Executive, MasterControl05.01.19
    Companies developing cutting-edge medical devices need cutting-edge technology for their business processes. Whether a company focuses on finding new device materials, designing non-invasive monitors, or tackling the regulatory process, medtech is advancing too fast for paper-based processes. In a digital age, companies continuing to use paper-based processes will be left behind. For medtech companies in particular, digitization is taking over, and rightfully so—it’s key to conducting clinical trials, navigating the regulatory gauntlet, getting products to market faster, and tracking adverse events post-market. Many companies have embraced this idea and updated their processes to include software solutions replacing paper-based quality management, manufacturing production records, and regulatory information management. A step in the right direction, but it isn’t enough.

    Companies that have taken a fragmented approach to digitization have likely wound up with various software solutions from different vendors to accommodate different departments. This may be a step up from using paper, but it’s far from ideal. A company can never reach full potential if it operates in silos. Keeping up with medtech industry trends requires a certain amount of interconnectivity that is hard, if not impossible, to achieve without automated solutions that enable communication between multiple departments.

    Top 4 Medtech Trends Where Digitization Gives You an Edge
    While some medtech companies have gone full speed ahead with digitization, others have clung to paper-based processes with the “if it ain’t broke, don’t fix it” adage. These processes may have previously been sufficient, but the industry is fast approaching a point where compliance will be impossible with paper. It’s ironic companies that develop products with cutting-edge technology are hesitant to embrace technology for business processes. Whatever the reasons companies have for not embracing automated solutions, the benefits will always outweigh the risks. And in a constantly changing industry, adopting software solutions becomes less about getting ahead and more about keeping up.

    1. Tracking and complying with new regulations. Companies dealing with healthcare products tend to have a long list of regulations that grow and evolve over time, and regulatory bodies expect companies to stay current and provide documentation to prove it. This is certainly the case with medtech, as shown by new regulations imposed by the U.S. Food and Drug Administration (FDA), the European Union’s Medical Device Regulation (MDR), and updates to ISO 13485. New regulations and standards frequently mean at least one product development aspect must be changed in some way. Keeping track of and complying with these new regulations is nearly impossible with paper-based processes for quality and manufacturing management—it’s a different story for companies that have digitized.

    An automated solution for device registration and submissions management helps keep track of regulatory changes and new requirements in various global markets. However, streamlining these processes is possible on a much greater scale using integrated solutions that enable seamless organizational collaboration. By digitizing quality and manufacturing management processes, companies have an easier time compiling, routing, revising, and publishing large amounts of required documentation and training. They can also view the entire registration or submission’s lifecycle to avoid bottlenecks and decrease turnaround time. Digitization facilitates mastering regulatory requirements in multiple countries and taking control of a global supply chain, which increases market access.

    2. Optimizing human factors engineering. Human factors engineering is the process of observing and gathering scientific data about human behavior, such as learning styles, abilities, and limitations to develop devices intended users can intuitively operate. Specifically, medical device developers must consider the device, its use environment, and its intended users to eliminate as many risks as possible. This is especially important when designing healthcare products, as user error can mean the difference between life and death. Certain regulations contain elements of human factors engineering, making it part of the medical device product development process. The FDA, for example, requires a Human Factors Engineering or Usability Engineering report in a premarket submission with its own specific set of requirements.

    One of these requirements is to control and eliminate risk as much as possible. The risks human factors engineering identifies must have corresponding risk mitigation strategies. Effective risk management is much easier with integrated technology solutions. Risk management functionality is usually included in a quality management system (QMS). If a company purchases a QMS from one vendor and a regulatory information management system (RIMS) from another, risk mitigation becomes complex. If the two systems cannot integrate, data and information sharing must be manual. This is time-consuming and prone to human error, whereas two systems on the same platform can communicate without requiring human interaction.

    3. Lowering the barriers to entry. Highly regulated industries operate in markets with many barriers to entry, which should be comforting to established medtech companies unwilling to lose market share. However, in other industries those barriers either don’t exist or are easily overcome by goliaths. Pharmaceutical and tech companies are venturing into the medtech space with the resources to overcome the obstacles of entering a new market. Pharmaceutical companies are accustomed to operating in a highly regulated environment and tech companies already have the resources for designing and manufacturing complex technology products. Either is in a good position to break into the medtech industry.

    This might not bode well for existing medtech companies, especially those on the smaller side or that manufacture relatively few products. For businesses concerned about increased competition, the best course of action is to digitize. This represents a substantial investment and helps products travel the development process faster while maintaining compliance. Digitizing automates critical processes commonly requiring significant time and manpower. Beyond automation, digitization allows companies to meet compliance regulations faster with fewer issues—especially if they’re already in the industry and know the regulations.

    4. Securing devices and data. The specialized knowledge tech companies possess is one reason they’re poised to break into medtech. Their technology expertise gives them a distinct advantage over incumbent medtech companies. However, the general tech industry doesn’t have the same strict requirements as healthcare companies or those that store and use protected health information. The Health Insurance Portability and Accountability Act (HIPAA) and Federal Food, Drug and Cosmetic Act (FD&C Act) apply to some medtech companies, depending on the information they handle. In some cases, a security breach can adversely impact patient health; this risk doesn’t generally exist in the tech industry. Medtech also has more regulations than the general tech industry. For example, last year the FDA released draft guidance indicating medical devices needed a cybersecurity bill of materials, which includes information about cybersecurity vulnerabilities and their exploitability.

    Digitizing processes can help with this increasing problem. As far as preventing breaches goes, it probably can’t, but it will provide more security controls upfront. Having effective procedures in place for handling cybersecurity can reduce the risk of security breaches. Drafting the correct standard operating procedures (SOPs) and keeping them up to date is much easier with digitization. When dealing with highly sensitive patient data, have policies in place to provide proper data security, and train employees on those policies. Of course, it’s entirely possible to have paper-based SOPs. Keeping them updated, being able to find the latest version, and getting approvals in a timely manner are also technically possible, albeit extremely difficult on a non-digitized system.

    Choosing a Solution
    Once a company decides to digitize it proceeds by looking at the entire organization’s needs and how each department interacts. Taking a piecemeal approach to digitization guarantees the problem will be revisited further down the road—which has happened with electronic health records (EHRs). When healthcare organizations first started digitizing their processes, everyone hoped it would lead to better patient care. In some ways, it has. There are less medication errors, the coding process is more streamlined, and costs have been reduced. However, EHRs have hardly lived up to their hype. The reason is simple—different EHRs aren’t on speaking terms with each other.

    If a patient’s primary care provider (PCP) has adopted an EHR and that patient has to visit the emergency room, in most cases, that hospital won’t have to access to the PCP’s records—which negates some of EHRs’ benefits. The same is true of companies that try to implement systems from different vendors across their organizations. The systems don’t interface with one another, severely limiting their effectiveness and keeping the organization from reaching its full potential.

    Besides the administrative benefits of only dealing with one vendor, using solutions supported on the same platform allow the interoperability EHRs severely lack. Medtech companies need this connectivity to stay ahead of the curve in a constantly changing industry and keep up with new regulations and standards. One such perk is found in the quality/manufacturing relationship. These two departments certainly require unique solutions; however, when those solutions are connected, management has a better idea of what’s going on within the plant and the company.

    A prime example of this is the FDA’s requirement for a written program for routine calibration of manufacturing equipment. This affects manufacturing because of the calibration aspect, and affects quality because of the written requirement. Because this requirement overlaps both departments, separate systems would almost certainly result in the same work being done multiple times. This is a common result of the left hand not knowing what the right hand is doing, which results in inefficiencies and noncompliance.

    To maintain market share and meet regulatory requirements, medtech companies can no longer afford to procrastinate digitizing. The connectivity of the modern world requires software solutions be used, and common sense requires these solutions communicate with each other. Existing and future trends for medtech only reemphasize this point, as remaining competitive means using solutions that help meet regulatory requirements, design better products, secure those products, and stay one step ahead of competitors. 


    Bryant Headley has two decades of experience in regulatory compliance, technology, program management, and automating software systems in federal government agencies, including the FDA’s Office of Regulatory Affairs and the Office of Compliance and Business Integrity at the U.S. Department of Veteran Affairs (VA). He currently works with the sales, customer, and product development teams at MasterControl to facilitate success with governmental entities such as the FDA, VA, Department of Defense, and Department of Treasury.
    Related Searches
    • technology
    • system
    • guidance
    • supply chain
    Related Knowledge Center
    • Software & IT
    Suggested For You
    MedWorld Advisors MedWorld Advisors
    FDA Approves Device to Help Increase Access to More Lungs for Transplant FDA Approves Device to Help Increase Access to More Lungs for Transplant
    A New, Tailored Review Framework for Artificial Intelligence-Based Devices A New, Tailored Review Framework for Artificial Intelligence-Based Devices
    FDA to Modernize Mammography Services and Improve Their Quality FDA to Modernize Mammography Services and Improve Their Quality
    FDA Warns J&J and Sientra for Breast Implant Compliance Failure FDA Warns J&J and Sientra for Breast Implant Compliance Failure
    FDA to Closely Examine Surgical Stapler Risks FDA to Closely Examine Surgical Stapler Risks
    FDA Commissioner Scott Gottlieb to Step Down FDA Commissioner Scott Gottlieb to Step Down
    ICU Medical Recalls ChemoLock Vial Spike (20mm) Due to Risk of Detached Plastic Particles ICU Medical Recalls ChemoLock Vial Spike (20mm) Due to Risk of Detached Plastic Particles
    FDA Orders Doctor to Cease Marketing Unapproved Breast Augmentation Device FDA Orders Doctor to Cease Marketing Unapproved Breast Augmentation Device
    Small Steps Small Steps
    Research & Development Feature Trailer 2019 Research & Development Feature Trailer 2019
    Latest Steps to Strengthen FDA’s 510(k) Program for Premarket Review Latest Steps to Strengthen FDA’s 510(k) Program for Premarket Review
    Strategies for Maximizing Your Supply Chain Strategies for Maximizing Your Supply Chain
    CES 2019: 7 More Health Tech Highlights CES 2019: 7 More Health Tech Highlights
    CES 2019: 10 Health Tech Highlights CES 2019: 10 Health Tech Highlights

    Related Buyers Guide Companies

    • MedWorld Advisors

      MedWorld Advisors

      ...
      Florence Joffroy-Black, CEO/President 11.22.21

    • Surgical
      FDA Approves Device to Help Increase Access to More Lungs for Transplant

      FDA Approves Device to Help Increase Access to More Lungs for Transplant

      The Xvivo Perfusion System allows the transplant team to perform a more careful assessment of lung function.
      PR Newswire 04.30.19

    • Digital Health | Software & IT
      A New, Tailored Review Framework for Artificial Intelligence-Based Devices

      A New, Tailored Review Framework for Artificial Intelligence-Based Devices

      The FDA is exploring a framework that would allow for modifications to algorithms to be made from real-world learning and adaptation.
      Scott Gottlieb, M.D. , Commissioner, U.S. Food and Drug Administration 04.03.19


    • Diagnostics
      FDA to Modernize Mammography Services and Improve Their Quality

      FDA to Modernize Mammography Services and Improve Their Quality

      Proposed rule would require breast density reporting, enhance the FDA’s ability to enforce mammography facilities’ compliance with standards.
      U.S. Food and Drug Administration 03.27.19

    • Surgical
      FDA Warns J&J and Sientra for Breast Implant Compliance Failure

      FDA Warns J&J and Sientra for Breast Implant Compliance Failure

      The two breast implant manufacturers failed to comply with post-approval study requirements.
      U.S. Food and Drug Administration 03.20.19

    Loading, Please Wait..

    Trending
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • FDA OKs J&J Vision's AcuVue Oasys Max 1-Day Contact Lenses
    • How To Overcome The Top 6 Medical Device Manufacturing Challenges
    • Cepheid, BioGX Partner To Create GeneXpert Monkeypox Test
    • Intermountain Healthcare & Siemens Healthineers Open 3 Tellica Outpatient Imaging Centers
    Breaking News
    • Enhatch Partners with Holo-Light to Deliver New Extended Reality Streaming Platform
    • Study Confirms Safety, Accuracy of Vectorious' V-LAP In-Heart Sensor
    • Norman Noble Achieves ISO 13485:2016 Certification
    • Indian SMEs Gaining Access to Russian Medtech Market Amid Ukraine Conflict
    • Quell Wearable Neuromodulation Device Wins De Novo Authorization
    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

    Kensing Acquires Vitae Naturals
    CoQ10 and Royal Jelly Supplementation May Improve High Intensity Exercise
    Shiitake Mushroom Extract Appears Helpful in HPV Infections
    Coatings World

    Latest Breaking News From Coatings World

    PPG to Increase U.S. Aerospace Products Manufacturing Output to Meet Rising Demand
    Solvay to Discontinue Use of Fluorosurfactants for Production of Fluoropolymers
    AkzoNobel Names New CEO
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Study Confirms Safety, Accuracy of Vectorious' V-LAP In-Heart Sensor
    Norman Noble Achieves ISO 13485:2016 Certification
    Indian SMEs Gaining Access to Russian Medtech Market Amid Ukraine Conflict
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Shimadzu Scientific Instruments Extends HQ Campus
    Vetter’s Newest Clinical Manufacturing Site Completes First Customer Fills
    Batavia Enters Commercial Manufacturing Business
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Naples Soap Company to Open New Store in Venice, Florida
    Nectar Recruits 8-Year-Old YouTube Star to Launch Her Own Bath & Body Line
    L'Oreal Exec Joins Function of Beauty
    Happi

    Latest Breaking News From Happi

    Rhode Island’s Department of Health, Raw Elements and Partners Expand Touch-Free Mineral Sunscreen
    Julee Wilson Named Executive Director of BeautyUnited
    Arey Launches Unisex Leave-In Conditioner
    Ink World

    Latest Breaking News From Ink World

    Amcor Lift-Off Initiative Shortlists Start-ups for Seed Funding
    Barentz Highlights Lincoln MFG’s New ISO 9001:2015 Certification
    Ingevity Appoints Christine Stunyo as Chief Human Resources Officer
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Eaglewood introduces Sitexco Label L10 anilox cleaning system
    Germark makes double press investment in Bobst
    UPM Raflatac to enhance service capabilities at Mills River factory
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Rockline's Springdale Campus Achieves 15 Million Safe Work Hours
    Emmanuelle Picard to Join Ahlstrom-Munksjö's Executive Management Team
    Alkegen Completes Luyang Acquisition
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Researchers Develop Microfluidic Sensors to Improve Implant Survival Rates
    Lawrence Yellin Appointed as Fuse Medical CFO
    Researchers Discover Novel Patching Material for Bone Defects
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Avery Dennison Highlights New Approach to Apparel with ADX Lab
    trinamiX Face Authentication Protects Users from Fraud Attacks During Mobile Payments
    Hugo Boss Partners with Nedap for Global RFID Roll-out

    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