• 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
    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends

    Power Trip: A Discussion of Custom Medical Electronics

    The MDR Transition: An Opportunity for Design Change?

    Preserve and Protect: Sustainability Initiatives for Medtech Manufacturing
    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
    Heather Danks Named Chief Technology Officer at LEX Diagnostics

    Vitalchat Awarded Patent for Patient Monitoring, Bandwidth Conservation Tech

    South Korean Regulators Authorize Expanded NeuroStar TMS Indications

    Ian T. Meredith Joins Avertix Medical’s Board

    Hologic, Bayer Team Up for Contrast-Enhanced Mammography
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends

    Power Trip: A Discussion of Custom Medical Electronics

    The MDR Transition: An Opportunity for Design Change?

    Preserve and Protect: Sustainability Initiatives for Medtech Manufacturing
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Medtech’s Most Powerful M&A Drivers

    The Link Between Medtech and Connected Medical Devices

    Is the FTC Partly Responsible for Muted M&A Activity?

    Holistic Risk Management: Navigating the Future’s Uncertainties

    Defining End of Life for Medical Devices
    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
    NDH Medical Inc.

    Providence Enterprise USA Inc.

    Johari Digital Healthcare Ltd.

    Medbio LLC

    Halkey-Roberts Corporation
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    A One-Stop-Shop, Turnkey Solution Is Paramount for Success

    How Additive and Subtractive Manufacturing Are Revolutionizing the Medical Device Industry

    Medical Device Commercialization: It’s What, Not When, to Transfer to Manufacturing

    How In Silico Simulations Can Slash Medical Device Development Risk

    The Top 7 AI Applications Transforming Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    NDH Medical Inc.

    Providence Enterprise USA Inc.

    Johari Digital Healthcare Ltd.

    Medbio LLC

    Halkey-Roberts Corporation
    • 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
    Editorial

    Thoughts on the NY Times Editorial Board Statement

    ...

    Thoughts on the NY Times Editorial Board Statement
    Sean Fenske, Editor-in-Chief06.13.19
    To say the image of the medical device industry is unfavorable with the general public recently is an enormous understatement. Regrettably, in 20 years of covering this industry, I can’t recall a time the view of medtech has been as low as it’s been in the last 12 months or so.

    One of the earliest notable instances in this wave of bad PR could be attributed to a 60 Minutes story that focused on transvaginal mesh from Boston Scientific. The news was limited to that program and didn’t really garner major attention, but it could be argued it was the first domino to fall.

    Soon thereafter, the documentary The Bleeding Edge premiered in April 2018 before quickly making its way to Netflix. As has been discussed within MPO as well as in the Mike on Medtech podcast, the film is a scathing examination of the flaws within the medical device industry and its pathway for getting products to market. While it only highlighted a handful of medical device horror stories, it certainly put the spotlight on the industry and called attention to several manufacturers’ troublesome practices and the FDA’s oversight of those practices.

    Then, about a month before the end of the year, the findings of an investigation led by the International Consortium of Investigative Journalists was released. Its reports detailed the analysis of approximately 10 years of data from the FDA and identified 1.7 million injuries and 83,000 deaths that could be linked to medical devices that had been cleared or approved for market release.

    At the start of May 2019, more fuel was added to the fire. This time, the attack wasn’t as much against the industry directly, but rather an indictment against the job the FDA was doing in its mission to protect patients. I’m referring to a published opinion issued by The Editorial Board of The New York Times.

    For those who haven’t read the actual statement (read it yourself at http://bit.ly/mpo190699), it presents highlights of some of the products that have caused issues for patients on a rather significant scale. Technologies such as vaginal mesh, breast implants, the Essure device, implantable defibrillators, artificial heart valves, and others are mentioned. The opinion piece then goes on to suggest potential ways the regulatory pathway to market could be improved.

    The first suggestion is the subject of my focus—tightening approval standards. This is primarily tied to the 510(k) pathway. The piece refers to the 510(k) as a “ regulatory loophole” that was not meant to be permanent. It mentions that the process allows for technologies to be compared to previously released devices that could be “decades old or were subsequently pulled from the market.” It also cites an Institute of Medicine recommendation to abolish the 510(k) pathway. Finally, the opinion piece insists any device intended for permanent residence inside a human body be subject to rigorous testing before hitting the market.

    While I can’t help but see validity in several points being made, I do question if some of the suggestions aren’t more knee-jerk type reactions responding to the negative news flooding the industry. There are portions of the 510(k) process that should be questioned and perhaps revised, but to abolish a regulatory review pathway that has seen tens of thousands of products enter the market safely does not seem like a practical way to address the concerns. Perhaps implantable devices that will remain in the body for the patient’s lifetime shouldn’t be allowed to go through the 510(k). Then again, what if the product is simply a revision in a family of products that address similar conditions? Does it make sense to completely retest each product in the family under a PMA, for example? Again, the process certainly can be revisited, but knee-jerk reactions should not be the answer.

    There’s another aspect to this discussion—the bigger picture for medical device manufacturers and the direction in which healthcare is moving. This is a factor I’ve mentioned in previous Letters. As medicine moves to a value-based system, will medical devices that are “substantially equivalent” to another product already on the market gain any traction? If a new product offering doesn’t provide a significantly more efficient method for treating a patient by reducing the time required or improving the outcome, why would a physician or surgeon select it? Given that value-based healthcare still has not taken hold in a major way across healthcare, it remains to be seen how medical professionals will react to new “substantially equivalent” products that enter the marketplace.

    For financial reasons, it may be in manufacturers’ best interests to attempt to differentiate their products from similar technologies on the market; in that effort, they just may do so enough that they’re unable to use the 510(k) pathway anyway. Perhaps that’s how the true transformation regarding device approvals arrives. 

    Sean Fenske, Editor-in-Chief
    sfenske@rodmanmedia.com
    Related Searches
    • implantable
    • regulatory
    • medical device
    • boston scientific
    Suggested For You
    Sense of Touch with FUTEK at BIOMEDevice Boston Sense of Touch with FUTEK at BIOMEDevice Boston
    Precision Metal Components with Hobson & Motzer at BIOMEDevice Boston Precision Metal Components with Hobson & Motzer at BIOMEDevice Boston
    Keeping Tabs on Tissue Oxygen in Peripheral Artery Disease Patients Keeping Tabs on Tissue Oxygen in Peripheral Artery Disease Patients
    Micro Injection Molding with Accumold at BIOMEDevice Boston Micro Injection Molding with Accumold at BIOMEDevice Boston
    Stainless Steel Tubing with K-Tube at BIOMEDevice Boston Stainless Steel Tubing with K-Tube at BIOMEDevice Boston
    Late-Breaking Trial Data Shows Continued Success of Boston Scientific Late-Breaking Trial Data Shows Continued Success of Boston Scientific's EMBLEM S-ICD System
    Boston Scientific to Buy Vertiflex for $465M Boston Scientific to Buy Vertiflex for $465M
    FDA Approves Boston Scientific FDA Approves Boston Scientific's VICI Venous Stent System
    Boston Scientific Boston Scientific's Lotus Edge TAVR Wins FDA Nod
    Massachusetts Medical Device Development Center Names $200K Challenge Winners Massachusetts Medical Device Development Center Names $200K Challenge Winners
    FDA Halts Sale of Pelvic Mesh in U.S. FDA Halts Sale of Pelvic Mesh in U.S.
    Hand-in-Hand with Quality and (Regulatory) Changes Hand-in-Hand with Quality and (Regulatory) Changes
    FDA FDA's Material Evaluation—Mike on Medtech
    Going Beyond the Conversation in Addressing the Skills Gap Going Beyond the Conversation in Addressing the Skills Gap
    Discerning Medtech’s Path in 2019 Discerning Medtech’s Path in 2019

    Related Videos

    • Electronics | Surgical
      Sense of Touch with FUTEK at BIOMEDevice Boston

      Sense of Touch with FUTEK at BIOMEDevice Boston

      Ehsan Mokhberi of FUTEK explains how sensing technologies are enhancing the feel of medical devices for physicians and surgeons.
      Sean Fenske, Editor-in-Chief

    • Machining & Laser Processing
      Precision Metal Components with Hobson & Motzer at BIOMEDevice Boston

      Precision Metal Components with Hobson & Motzer at BIOMEDevice Boston

      Anthony Bracale of Hobson & Motzer speaks on the firm's manufacturing facility in Wallingford, Conn., while Peter Doolittle addresses the labor shortage.
      Sean Fenske, Editor-in-Chief

    • Patient Monitoring
      Keeping Tabs on Tissue Oxygen in Peripheral Artery Disease Patients

      Keeping Tabs on Tissue Oxygen in Peripheral Artery Disease Patients

      Insights from those who have helped develop and test the Lumee Oxygen Platform on its benefits over traditional monitoring methods.
      Sean Fenske, Editor-in-Chief 05.30.19


    • Molding
      Micro Injection Molding with Accumold at BIOMEDevice Boston

      Micro Injection Molding with Accumold at BIOMEDevice Boston

      Aaron Johnson of Accumold expands on how shrinking medical devices is driving the need for smaller molded components.
      Sean Fenske, Editor-in-Chief

    • Tubing & Extrusion
      Stainless Steel Tubing with K-Tube at BIOMEDevice Boston

      Stainless Steel Tubing with K-Tube at BIOMEDevice Boston

      Gary Piazza of K-Tube Technologies shares the benefits of metal tubing for medical devices and addresses common challenges manufacturers face.
      Sean Fenske, Editor-in-Chief

    Loading, Please Wait..

    Trending
    • RJG Names Winners Of 2023 RJG Mold Smart Award
    • Diabetes Innovation: MIT Engineers Unveil Implantable Device With Oxygen Factory
    • A New Approach To Post-Market Surveillance
    • Danaher Names New Environmental And Applied Solutions Company Veralto
    • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
    Breaking News
    • Heather Danks Named Chief Technology Officer at LEX Diagnostics
    • Vitalchat Awarded Patent for Patient Monitoring, Bandwidth Conservation Tech
    • South Korean Regulators Authorize Expanded NeuroStar TMS Indications
    • Ian T. Meredith Joins Avertix Medical’s Board
    • Hologic, Bayer Team Up for Contrast-Enhanced Mammography
    View Breaking News >
    CURRENT ISSUE

    September 2023

    • Superior Subtractive Solutions for Machining Medtech
    • Medical Device Industry Experts' Thought on Assembly & Automation
    • Power Trip: A Discussion of Custom Medical Electronics
    • The MDR Transition: An Opportunity for Design Change?
    • 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

    Curcumin May Be As Effective as PPI for Indigestion
    Adding Human Milk Component to Formula Linked to Long-term Cognitive Benefits for Babies
    Women in Nutraceuticals Launches Pilot Mentorship Program
    Coatings World

    Latest Breaking News From Coatings World

    EMPA Develops Flame Resistant Epoxy Resin
    Becker’s Global Mental Health Program Shows Positive Impact
    Pacific Coatings Show Invites Industry to Top-Class Programs
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Vitalchat Awarded Patent for Patient Monitoring, Bandwidth Conservation Tech
    South Korean Regulators Authorize Expanded NeuroStar TMS Indications
    Ian T. Meredith Joins Avertix Medical’s Board
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Nexcella Completes 2nd NXC-201 Engineering Batch
    Almirall Upgrades Werum PAS-X MES
    Rentschler Names Industry Veterans to Leadership Posts
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    GK Hair Expands Color Range to 125 Hues
    WPO and AIPIA Sign MoU to Collaborate on Smart Packaging
    SuperstarBots & Skin Match Redefine Personalized Beauty Recommendations with Social Media Chatbot
    Happi

    Latest Breaking News From Happi

    Daniel C. Liebler Wins 2023 RIFM Board of Directors Excellence in Science Award
    NAD Refers SBLA Beauty To Federal Trade Commission
    Altuzza Fashion Show Features Hairstyles by Jawara Using Fekkai Haircare Products
    Ink World

    Latest Breaking News From Ink World

    HYBRID Software’s PrintFusion for Koenig & Bauer
    Fujifilm Announced European Release of the Acuity Prime Hybrid
    Pacific Coatings Show Invites Industry to Top-Class Programs
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Vibrant Labelexpo Europe 2023 concludes in Brussels
    Kenco Label & Tag adds sheeting system from Daco Solutions
    Bastille Parfums strengthens traceability with Avery Dennison RFID technology
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Lenzing Earns EU Ecolabel at Indonesian Plant
    Albis Starts Up Extra Wide Carding, Blending LIne
    Ahlstrom Launches Nonwoven Laundry Care Product
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    AOFAS, Arthritis Foundation Award Grants to Fuel Ankle Arthritis Research
    Lincotek Marks its 50th Anniversary
    FDA OKs Standalone Indication for ChoiceSpine's Blackhawk Ti Cervical Spacer
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Le Biscuit Boosts Omnichannel Operations with Zebra Technologies
    German Government, Bavaria Commit Support to ams OSRAM
    ASSA ABLOY Acquires Evolis

    Copyright © 2023 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