• 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
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    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
    Top News
    Axonics Buys Contura to Expand to Stress Urinary Incontinence

    Nurx Appoints Chief Medical Officer

    Median Technologies, UC San Diego to Partner on AI-Based Medical Imaging Technology

    Novel Heart Failure Treatment Technology Scores Positive Trial Results

    New COVID-19 Saliva Test Also Can Detect Variants and Flu Viruses
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Rethink Your Medtech ASC Strategy, Part 1

    Pandemic-Level Playing Field: How COVID-19 Made Space for Progress

    Tips for Reigniting Your MDR/IVDR Preparation

    Three Major Innovation Opportunities for Biomedical Textiles

    Use Vertical Integration to Increase Productivity, Drive Innovation
    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
    PTI Engineered Plastics Inc.

    FUTEK Advanced Sensor Technology Inc.

    K-Tube Technologies

    Medbio LLC

    Qosina Corp.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Grant Funding Works and How It Can Help

    Refurbished Medical Equipment Testing and Certification Under the NEC

    Taking the First Step with Metal Components

    4 Trends Driving Medical Manufacturing in 2021

    Pioneering AI Solutions to Reinforce Healthcare Services
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Forefront Medical Technology

    Concise Engineering

    Medbio LLC

    Medicoil

    FUTEK Advanced Sensor Technology 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
    • Podcasts
    • Resources
    • eBook
    • 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

    U.S. May Offer a Safe Harbor from the Impending MDR Storm

    U.S. may represent the preferred route to market with regulatory changes elsewhere in the world, like the EU's MDR.

    U.S. May Offer a Safe Harbor from the Impending MDR Storm
    Dawn A. Lissy, President & Founder, Empirical09.06.19
    My last column was a bit of a downer. I wrote about all the concerns I have with the changes coming from the European Medical Device Regulation (MDR) set to take effect in May 2020. (Spoiler alert—there were many.) While I still hold the opinion that the effects of MDR will leave our industry FUBAR across the pond, I’m now focusing on the bright side here in the United States, where the forecast for medical device developers is considerably brighter.

    Political winds have shifted. In 2013, the medical device tax sent some major players running to Europe to avoid the 2.3 percent up-front revenue tax. That tax has been repeatedly suspended by U.S. Congress, and the current bill to repeal it has rare bipartisan support.

    There are other factors that make for a more inviting environment for the medical device industry in the United States. The U.S. Food and Drug Administration (FDA) seems to recognize America is in line to receive the overflow from companies that won’t receive CE marks under MDR.

    My colleague Meredith May, vice president of Empirical Consulting, is my go-to source on all things regulatory. Based on what we’re seeing in the industry, we predict a significant shift in how devices are developing on the global stage. Clients that would typically work to obtain a CE mark before a 510(k) are now taking the opposite approach.

    “MDR is disrupting the EU market and much of the world,” she said. “Pre-MDR, it was faster to get a device into the EU market because the review process was controlled by [the developer]. All you had to prove was safety. In the U.S., we have to prove safety, efficacy, and substantial equivalent.”

    “It used to be really easy—you might have to have clinical trials in the U.S., but it was almost guaranteed you didn’t need it in the EU. Now it’s more likely you’ll need clinical investigation in Europe than in the U.S.”

    That means higher costs and more time, perhaps two to three times longer, to meet MDR requirements than a 510(k).

    “Your Class II device likely will not require clinical trials and investigation, which can cost anywhere from about $300,000 to about $2 million and take an extra nine months to five years depending on your end points,” May said. “No startups that I know of could manage that. That’s a huge financial and resource burden for startups.”

    That’s assuming you can find a notified body certified under MDR. Currently, only three of 58 European notified bodies are certified, and they’ve stopped taking new applications for CE marks due to the backlog of companies trying to renew their CE marks before May 2020. But FDA is up to date and moving forward with new 510(k)s. They’re also consistently releasing guidance documents, something MDR has yet to begin.

    “Even if you are trying to stick it out in Europe, you won’t know how to do that,” May said.

    Another FDA effort to speed the path to market: the Payor Communication Task Force. The program to facilitate early conversations with insurance companies and others is not a new resource—it launched in 2014. But it’s now generating more momentum and buy-in from developers wanting to be better positioned for having a device not just cleared for use in the patient, but also blessed for coverage by insurance companies.

    It seems like a no-brainer: If the FDA says a device is safe, it should be a viable treatment option. But the bar is different. FDA wants proof that a device is safe and effective. Payors want to know a device improves health outcomes and is reasonable and necessary for their beneficiaries. These different payor standards may require different data from what the FDA reviewed, which can result in limited or no coverage after a company or innovator has spent substantial time and money to earn FDA approval or clearance.

    To further complicate the issue, a device may earn national and/or local coverage, meaning your hometown hospital may not cover the same devices as the Mayo Clinic. Again, this comes back to different data sets and expectations that can add time and cost to the development timeline if they’re not addressed early on.

    The Payor Communication Task Force facilitates conversations about data development, and the innovator may choose to incorporate payor suggestions into a device’s development plan. Rather than adding time and cost after marketing approval is obtained from FDA, device developers who work with the task force get suggested parameters and recommendations from payors to better position their device for reimbursement once it’s cleared or approved by FDA.

    It’s yet another example of how FDA is working to support patient access to innovative medical devices and for device developers, which we’re just not seeing in Europe right now.

    “If you take all of those things and look at them, the FDA is trying to have a more transparent and consistent process, whereas the MDR is creating a more muddled and confusing process in addition to adding time and cost,” May said. “In a sense, the FDA is trying to make it easier, not harder. The EU is trying to make it harder, not easier.”

    I remain hopeful the EU will come up with solutions for the current backlog and better processes for the future. Until then, we’re working to keep up with the market shift and do our part to support our industry. I trust that bright minds and commitment to best patient outcomes will eventually prevail, but hope that happens before May 2020. 


    Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting LLC, and Empirical Machine, LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio. 
    Related Searches
    • president
    • clinical trials
    • market
    • Manufacturing

    Related Columns

    • Surgical
      Rethink Your Medtech ASC Strategy, Part 1

      Rethink Your Medtech ASC Strategy, Part 1

      ASCs have adopted a strategy to focus on predictable, low-risk procedures with lower complication rates in an out-of-hospital setting.
      Maria Shepherd, President and Founder, Medi-Vantage 02.03.21

    • R&D & Design
      Pandemic-Level Playing Field: How COVID-19 Made Space for Progress

      Pandemic-Level Playing Field: How COVID-19 Made Space for Progress

      Pandemic restrictions may have diminished certain advantages large companies hold over small and mid-sized competitors.
      Dawn A. Lissy, President & Founder, Empirical 02.03.21

    • Tips for Reigniting Your MDR/IVDR Preparation

      Tips for Reigniting Your MDR/IVDR Preparation

      To get the MDR/IVDR preparation ball rolling again, here are four processes to help refocus on achieving compliance with the updated regulations.
      Nicolle Cannon, Founder and CEO, Cannon Quality Group LLC 02.03.21


    • Materials
      Three Major Innovation Opportunities for Biomedical Textiles

      Three Major Innovation Opportunities for Biomedical Textiles

      Biomedical textiles are gaining significant momentum for use in medical devices to facilitate less invasive surgical procedures.
      John Greco, Vice President of Sales, Cortland Biomedical 02.03.21

    • Contract Manufacturing
      Use Vertical Integration to Increase Productivity, Drive Innovation

      Use Vertical Integration to Increase Productivity, Drive Innovation

      The concept of vertical integration is simple: a company combining two or more stages of production that would normally be operated by separate companies.
      Ryan Lipe, Senior Vice President of Sales & Marketing, MGS 02.03.21

    • How to Better Prepare for Regulatory Requests and Minimize Impact

      How to Better Prepare for Regulatory Requests and Minimize Impact

      Pressure to increase efficiency in medical device development has been prevalent over the past year, especially with the intensified regulatory expectations.
      Sandi Schaible, Sherry Parker and Kim Ehman, WuXi AppTec Medical Device Testing 02.03.21


    • C-Suite Challenges in Medtech’s New Normal

      C-Suite Challenges in Medtech’s New Normal

      Many of the usual C-Suite management topics that are key to organizational success will remain the same this year.
      Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 02.03.21

    • COVID-19: Accelerator of a Modern, Data-Driven Supplier Strategy

      COVID-19: Accelerator of a Modern, Data-Driven Supplier Strategy

      By the time COVID-19 arrived in the United States, global supply chains were already buckling under a historic level of demand.
      Denise Odenkirk, Vice President, Supplier Sales, Global Healthcare Exchange LLC 02.03.21

    • Fixing Face Mask Form and Function

      Fixing Face Mask Form and Function

      Masks for the general public are varied in both style and effectiveness.
      Sam Brusco, Associate Editor 11.04.20


    • Cardiovascular
      The Heart of the Matter: Trends in Cardiology

      The Heart of the Matter: Trends in Cardiology

      Of the three major segments of coronary stents, bioabsorbable stents are expected to have the highest growth between now and 2022.
      Maria Shepherd, President and Founder, Medi-Vantage 11.04.20

    • Virtually the Same? The Challenges of Online Conferences

      Virtually the Same? The Challenges of Online Conferences

      Like everyone else on the planet, I’m turning increasingly to virtual solutions to our physical challenges in the midst of a pandemic.
      Dawn A. Lissy, Founder & President, Empirical 11.04.20

    • Digital Health
      Digital Health Delivers During a Year for the Ages

      Digital Health Delivers During a Year for the Ages

      Internet of Medical Things technologies have emerged as the key enabler of a much more holistic and complete disease-state management toolbox.
      Brad Womble, Senior Director of Strategy, Marketing, and Mergers & Acquisitions, Jabil Healthcare 11.04.20


    • Advanced Technology for Staking and Swaging Medical Plastics

      Advanced Technology for Staking and Swaging Medical Plastics

      It reliably assembles heat- and vibration-sensitive components, and works with a wide range of plastic materials.
      Priyank Kishor, Global Product Manager—PulseStaking, Branson at Emerson 11.04.20

    • Quality Assurance When Supply Chain Disruptions Arise

      Quality Assurance When Supply Chain Disruptions Arise

      From supply chain disruptions to impromptu manufacturing modifications, the medical device industry has faced a whirlwind of complications in 2020.
      Sandi Schaible and Peter Steen, WuXi AppTec Medical Device Testing 11.04.20

    • The Top 30 and M&A in 2021: What’s Next?

      The Top 30 and M&A in 2021: What’s Next?

      With three of the top five companies appointing new CEOs in the last year and the global pandemic eroding earnings, M&A strategies could look a lot different.
      Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 11.04.20


    Trending
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • How Grant Funding Works And How It Can Help
    • 7 Considerations For Designing Medical Device Mechanisms
    Breaking News
    • Axonics Buys Contura to Expand to Stress Urinary Incontinence
    • Nurx Appoints Chief Medical Officer
    • Median Technologies, UC San Diego to Partner on AI-Based Medical Imaging Technology
    • Novel Heart Failure Treatment Technology Scores Positive Trial Results
    • New COVID-19 Saliva Test Also Can Detect Variants and Flu Viruses
    View Breaking News >
    CURRENT ISSUE

    January/February 2021

    • Seeking a Revolution in Clinical Care Through AI
    • Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit
    • Addition by Subtraction: The Latest of Machining for Medtech
    • Innovation Incubators: An R&D Roundtable
    • Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    • 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

    Martin Bauer Group Acquires Majority Stake in Beverage Company Power Brands
    Gencor Announces Positive Results in VeriSperse Bioavailability Study
    PanTheryx Inc. Acquires TruBiotics Brand from Bayer HealthCare LLC
    Coatings World

    Latest Breaking News From Coatings World

    Gelest CEO Elected to National Academy of Engineering
    PPG Appoints Tony Wu as VP, Automotive Refinish, Asia
    PPG Appoints John Bruno as VP, Investor Relations
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Axonics Buys Contura to Expand to Stress Urinary Incontinence
    Nurx Appoints Chief Medical Officer
    Median Technologies, UC San Diego to Partner on AI-Based Medical Imaging Technology
    Contract Pharma

    Latest Breaking News From Contract Pharma

    J&J’s Single-Dose COVID-19 Vax Issued EUA
    Icon to Acquire PRA Health Sciences
    Phlow Corp. and USP Form Alliance
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Universal Engraving Announces New President
    Raw Sugar Living Expands to Target with New Collection
    Supporting Female Beauty Brand Founders on International Women's Day
    Happi

    Latest Breaking News From Happi

    ACI and CBC Launch Webpage About ‘Quats’
    L’Occitane Launches Hand Cream Inspired by Women
    Kiehl’s Partners with Gyrl Wonder
    Ink World

    Latest Breaking News From Ink World

    Access Direct Mail Doubles Revenue with SCREEN's Truepress Jet520HD
    Etiflex Enters New Markets with Nilpeter FA-22 Installation
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    TLMI analyzes pandemic's effect on label industry in new report
    UEI names Ross Hutchison president
    Schreiner MediPharm and AARDEX partner for clinical trials
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    U.S. Nonwovens Rebrands as Radienz Living
    What You’re Reading on Nonwovens-Industry.com
    Texas Medical Technology Partners with My Protect Kit
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Pandemic Pain: NuVasive's 2020 Sales Fall 10 Percent
    Fusion Robotics Receives FDA Clearance for Spinal Navigation and Robotics System
    Kaia Health Unveils Next-Gen Complete MSK Care Solutions
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View Research

    Copyright © 2021 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