• 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
    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability

    Machining & Laser Processing Have Huge Parts to Play in Medtech Manufacturing

    Medtech R&D Teams Must Be Creative & Resilient to Survive

    Struggling Suppliers in Electronics Manufacturing Services (EMS)

    Deep (Brain) Thoughts with Medtronic's Neuromodulation President
    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
    PDC Unveils New Brand Identity

    MD&M West News: Teamvantage Launches New Parent Company

    BD Receives EUA from FDA for COVID-19, Influenza A/B, RSV Combination Test

    Qosina Names Lee Pochter as Executive Vice President

    FDA Okays Early Feasibility Study for Anteris' TAVR Product
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability

    Machining & Laser Processing Have Huge Parts to Play in Medtech Manufacturing

    Medtech R&D Teams Must Be Creative & Resilient to Survive

    Struggling Suppliers in Electronics Manufacturing Services (EMS)

    Deep (Brain) Thoughts with Medtronic's Neuromodulation President
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Deducing the Dual Reality of Elizabeth Holmes

    The Return of the AdvaMed MedTech Conference…Live!

    Material Matters: New Materials Call for New Thinking

    5 Ways to Maintain a Talent-Centric Mindset, Even During Economic Uncertainty

    The Changing Face of UK Medical Device Regulations: Most Recent Update
    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
    Forefront Medical Technology

    Providence Enterprise USA Inc.

    Paragon Medical

    LEMO USA Inc.

    Arthur G. Russell Co. Inc., The
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Onshoring Medical Device Manufacturing Can Strengthen Supply Chains

    How Artificial Intelligence Can Combat Key Issues Impacting Healthcare

    Why Advanced Sensors Are Crucial Within Medical Pumps

    How Artificial Intelligence Could Help Prevent 80% of Chronic Diseases

    4 Ways to Use Injection Molding in Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Forefront Medical Technology

    Providence Enterprise USA Inc.

    Paragon Medical

    LEMO USA Inc.

    Arthur G. Russell Co. Inc., The
    • 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
    Related Content
    • Sense of Touch with FUTEK at BIOMEDevice Boston
    • Precision Metal Components with Hobson & Motzer at BIOMEDevice Boston
    • Keeping Tabs on Tissue Oxygen in Peripheral Artery Disease Patients
    • Micro Injection Molding with Accumold at BIOMEDevice Boston
    • Stainless Steel Tubing with K-Tube at BIOMEDevice Boston
    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
    • transvaginal
    • essure
    • technologies
    • data
    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
    • MO SCI Acquires Assets Of 3M’s Advanced Materials Business
    • Positive Long-Term Prospects For Japanese Diabetes Care Market
    • CGM Devices Could Become Main Glucose Monitoring Solution In U.S.
    • The Future Of Biomedical Engineering Advancements
    • Endologix Shares Positive 12-Month Results Of DETOUR-2 Trial
    Breaking News
    • PDC Unveils New Brand Identity
    • MD&M West News: Teamvantage Launches New Parent Company
    • BD Receives EUA from FDA for COVID-19, Influenza A/B, RSV Combination Test
    • Qosina Names Lee Pochter as Executive Vice President
    • FDA Okays Early Feasibility Study for Anteris' TAVR Product
    View Breaking News >
    CURRENT ISSUE

    January/February 2023

    • Struggling Suppliers in Electronics Manufacturing Services (EMS)
    • Machining & Laser Processing Have Huge Parts to Play
    • Medtech R&D Teams Must Be Creative & Resilient to Survive
    • Medtronic Neuromodulation President, Nnamdi Njoku, Interview
    • 6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability
    • 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

    Tocotrienols May Have Protective Effect on Liver in NAFLD Patients
    Indian Gooseberry Extract Shown to Offer Blood Sugar Management Benefits
    ADM Expands Production to Meet Demand for Probiotics
    Coatings World

    Latest Breaking News From Coatings World

    AkzoNobel Reports Revenue Growth in 2022
    Orion Engineered Carbons Announces New Distribution Partnerships
    Personnel Changes at BASF
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    PDC Unveils New Brand Identity
    MD&M West News: Teamvantage Launches New Parent Company
    BD Receives EUA from FDA for COVID-19, Influenza A/B, RSV Combination Test
    Contract Pharma

    Latest Breaking News From Contract Pharma

    KORSCH Acquires MEDELPHARM to Strengthen R&D Product Line
    SRI Names Kathlynn Brown Biosciences Division President
    Battelle, AmplifyBio, Andelyn Biosciences Win Research Contract
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Kiss Colors & Care Taps Rapper JT as Brand Partner
    Revolution Beauty Expands into Walmart in the U.S.
    Macro-Environmental Factors Impacting the Packaging Industry
    Happi

    Latest Breaking News From Happi

    Perfect Corp. Receives MLPS 2.0-Compliant Status to Help Beauty and Fashion Brands Meet China's National Cybersecurity Standards
    Ocean Conservation Managers Convene for Fifth International Marine Protected Area Congress, Receives Private Sector Support From Mary Kay Inc.
    Mintel Reveals Macro-Environmental Factors Impacting Household and Personal Care Packaging
    Ink World

    Latest Breaking News From Ink World

    Orion Carbons Announces New Distribution Partnerships
    DuPont Reports 4Q, Full Year 2022 Results
    Graphic Packaging Reports Strong 4Q, Full Year 2022 Results
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    'Build Back the Wisconsin Paper Industry' event announced
    Magic Johnson to keynote Dscoop Edge St. Louis World Expo
    Norway's Digital Etikett grows with HP Indigo
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Edgewell’s Sales Increase
    Mitsui Chemicals, Asahi Kasei Combine Nonwovens Businesses
    Hospeco Offers TaskBrand Prep-Paint-Finish Wiping System
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    OssDsign Launches New Product for Additional Surgical Procedures
    OSSIO Introduces Non-Permanent Compression Staple
    Dennis Jones Joins Intelivation Technologies as Manufacturing VP
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Identiv Expands NFC and HF Solutions Portfolio
    HID Acquires GuardRFID to Expand Healthcare Offering
    DuPont Reports Fourth Quarter, Full Year 2022 Results

    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