• Login
    • Join
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Manufacturing
    • Markets
    • Top 10 Orthopedic Device Firms
    • Buyers' Guide
    • Events
    • More
  • Magazine
  • News
  • Exclusives
  • Manufacturing
  • Markets
  • Top 10 Orthopedic Device Firms
  • Buyers' Guide
  • Events
  • Current & Past Issues
    Features
    Departments
    Columns
    Editorial
    Digital Edition
    Subscribe Now
    Advertise Now
    Editorial Guidelines
    eNewsletter Archive
    Top Features
    From Nitinol to Nanotubes: A Materials Science Roundtable

    In Good Repair: Trauma Technologies Under Review

    Anxious Undertones: A Review of 2019

    Automated Analysis Advantages for Part Validation

    Tried and True Metalworking
    Breaking News
    Certifications
    Clinical Trials
    Device Approvals & Patents
    Financial & Deals
    International
    Market Data & Trends
    OEM News
    People
    Product & Service Releases
    Products
    Quality, Recalls & Risk
    Regulatory & Legal
    Supplier & Contract Mfg.
    Live From Shows
    Top News & Features
    Orthofix Appoints New Spine Business Leader

    Viant to Halt EtO Sterilization at Michigan Plant by End of Year

    Synaptive Medical's Modus V Expands Into Spine Market

    3D-Printed Graftless Bone Transplants Go to Clinical Trials

    CrossRoads Extremity Systems Acquires Implant Systems from Surgical Frontiers
    3-D Printing/Additive Mfg.
    Assembly & Automation
    Biocompatibility & Testing
    Clean Room
    Coatings/Surface Modification
    Contract Manufacturing
    Design
    Extrusion
    Finishing
    Forging & Casting
    Instruments, Cases & Trays
    International/Offshoring
    Laser Processing
    Materials
    Machining & Tooling
    Molding
    Packaging & Sterilization
    Prototyping
    Research & Developement
    Software & Quality
    Staffing, Training & Prof. Dev.
    Supply Chain

    3D-Printed Graftless Bone Transplants Go to Clinical Trials

    CrossRoads Extremity Systems Acquires Implant Systems from Surgical Frontiers

    Micro Spine Implant Could Restore Standing and Walking

    RTI Surgical Appoints New Division Leaders

    From Nitinol to Nanotubes: A Materials Science Roundtable
    Biologics
    Bracing/Prosthetics
    Extremities
    Imaging
    Instruments
    Large Joint
    MIS/Robotics
    Spine/Neurology
    Trauma/Sports
    Top Markets
    Molybdenum-Rhenium Biomaterial: Something ‘MoRe’?

    New Exoskeleton Shoulders Rehab Burden for Stroke Patients

    Repairing Knee Cartilage Defects with the Patient's Own Cells

    Compamed 2019 Preview Report

    Straightening Out a Spinal Device’s De Novo Pathway
    Companies
    Categories
    Company Capabilities
    White Papers
    Add New Company
    International Buyers Guide Companies
    Edge International/Supra Alloys

    Orchid Orthopedic Solutions

    Nelson Laboratories LLC

    Huron Tool & Cutter Grinding Co. Inc.

    Five Star Manufacturing Inc.
    Industry Events
    Webinars
    • Magazine
      • Current & Past Issues
      • Features
      • Editorial
      • Departments
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
    • Breaking News
    • Buyers' Guide
      • Companies
      • Categories
      • Company Capabilities
      • White Papers
      • Add Your Company
    • Manufacturing
      • 3-D Printing/Additive Mfg.
      • Assembly & Automation
      • Biocompatibility & Testing
      • Clean Room
      • Coatings/Surface Modification
      • Contract Manufacturing
      • Design
      • Extrusion
      • Finishing
      • Forging & Casting
      • Instruments, Cases & Trays
      • International/Offshoring
      • Laser Processing
      • Materials
      • Machining & Tooling
      • Molding
      • Packaging & Sterilization
      • Prototyping
      • Research & Developement
      • Software & Quality
      • Staffing, Training & Prof. Dev.
      • Supply Chain
    • Markets
      • Biologics
      • Bracing/Prosthetics
      • Extremities
      • Imaging
      • Instruments
      • Large Joint
      • MIS/Robotics
      • Spine/Neurology
      • Trauma/Sports
    • Top 10 Orthopedic Device Firms
    • Online Exclusives
    • Slideshows
    • Videos
    • Webinars
    • Events
      • Industry Events
    • Live from Show Event
    • About Us
      • About Us
      • Contact Us
      • Privacy Policy
      • Terms of Use
      • Advertise With Us
    Columns

    Mayday: How the Upcoming MDR Implementation Forecasts Disaster for Our Industry

    Mayday: How the Upcoming MDR Implementation Forecasts Disaster for Our Industry
    Related CONTENT
    • FDA Issues Guidance on Brain-Computer Interfaces for Paralysis or Amputee Patients
    • FDA Commissioner Scott Gottlieb to Step Down
    • A Return to Memphis: An ODT Forum Preview
    • ISO 14971 Update: What Changes Can Medical Device Manufacturers Expect?
    • Why Big Companies With Internal Labs Should Outsource Testing
    Dawn A. Lissy, President & Founder, Empirical08.14.19
    I’m generally an optimistic person. My outgoing voicemail greeting encourages every caller to “keep smiling!” My wardrobe is about 40 percent “Life is Good” apparel and I keep a daily gratitude journal.

    Despite this stockpile of good vibes and hopeful expectations, I have yet to find a ray of sunshine amid the brewing storm of regulatory change for medical devices in the European market. We’re less than a year away from the May 2020 implementation of the European Medical Device Regulation (MDR)—literally “mayday” for just about any company not already established with a CE mark or any firm large enough to have the resources to navigate the impending storm of reform.

    The MDR’s changes are complex and sweeping. The increased level of scrutiny, layers of oversight, and additional regulatory requirements are so deep and daunting, we’ve heard from several clients that they’re not even attempting to maintain CE marks, much less obtain new ones, until the dust settles three to five years from mayday. Startups have basically zero chance of breaking into the European market under the MDR. Christine Scifert and Ann Dunahoo, respectively executive vice president and principal consultant of MRC/X LLC, share my concerns that the changes will squeeze out potential breakthroughs by solo entrepreneurs and small businesses.

    “Small companies that have limited resources to gather the needed technical and clinical data are being negatively impacted by the MDR,” Dunahoo said.

    “The upfront cost for quality system inspections, including unannounced inspections and the cost of technical documentation submission is significant, so the small businesses have to weigh the cost against the expected EU market growth to determine if this is a market they pursue,” Scifert added.

    At Empirical, we’re seeing a shift in how our clients work to get their medical devices to market. It used to be common for smaller companies to first seek a CE mark and use it as a launching point for U.S. Food and Drug Administration (FDA) clearance and approval. But MDR is changing that. “I have more clients coming to me to get FDA clearance now because they can’t get into the European market. It used to be the other way around,” said Meredith May, vice president of Empirical Consulting. “Small companies with innovative plans aren’t going to even attempt to get into the EU. Now we see clients coming to the U.S. to get a 510(k) because they don’t want to keep up [with MDR]. They’re going to let their CE mark lapse and focus all their sales in the U.S.”

    We’re also seeing extreme backlogs as companies work to beat deadlines to maintain their CE marks. It’s like a traffic jam in Houston as residents attempt a mass exodus from a Category 5 hurricane. May said she began advising clients to renew CE marks in 2016 to get ahead of the looming regulatory bottleneck. At that point, it was reasonable to expect it to take nine to 12 months to obtain a new CE mark. But due to the rush of companies trying to get ahead of the changes, the backlog for just renewing an existing mark has stretched to at least 18 months.

    Also affecting regulatory flow: Of the 58 notified bodies in the EU, only two are currently certified to MDR. That means no other notified body can start processing applications for devices to be sold under MDR. Notified bodies are also not processing any new applications for CE marks under the existing Medical Device Directive (MDD) because of that backlog.

    Back to that traffic jam: Once MDR takes effect, it’s going to get considerably larger. Backlog aside, the MDR requires new levels of documentation not just for new technology, but for devices that were historically granted CE marks.

    “Devices that were previously not covered by the MDD such as cleaning, disinfection, and sterilization are now covered by the MDR,” Dunahoo explained. “Companies that have not previously documented technical documentation will now need to put together technical documentation compliant to the MDR. In some cases, these companies will have to contract with a notified body and obtain the appropriate quality certifications.”

    We have yet to get clear guidance on what those quality certifications will be, May added.

    “Generally speaking, every medical device has to have clinical evidence [under MDR],” May said. “They’re just starting out with the implants. Keep in mind—tongue depressors are medical devices. How do you establish clinical evidence for a tongue depressor?”

    Dunahoo and Scifert cite that need for clinical data as the single most significant change stemming from this new regulation. The current MDD allows historical equivalence even for Class III devices. But under MDR, a company needs full technical documentation, which only occurs when the company owns the equivalent device. 

    Post-market clinical follow-up studies to gather clinical data on the actual devices are going to be required, Dunahoo said, and that data will have to be more in-depth and continuously gathered.

    “The manufacturer will also have to document Periodic Safety Update Reports (PSUR), which will be posted on EUDAMED Class IIa—updated every two years—and Class IIb/III—updated annually,” Dunahoo said. “Additionally, a Summary of Safety and Clinical Performance (SSCP) for Class III and implantable devices will be required to be updated annually.”

    It’s a considerable burden, even for larger companies. May predicts the trend she’s seeing of companies eschewing the EU for the U.S. will grow exponentially. Two particularly concerning possible outcomes: The U.S. market is glutted with competition, which will drive down prices and profit margins, and the potential dearth of devices for European patients.

    “This is a legitimate crisis,” she said. “Imagine I need to get a knee replacement, and they can’t get artificial knees into the hospital where I live in Europe. We are facing an immediate shortage of medical devices.”

    It’s a crisis stemming from a long overdue revamp of processes and procedures to better protect patient health, which is the silver lining I find in this wall of storm clouds. As is too often the case, a knee-jerk reaction to course correct immediately threatens to capsize the ship. I appreciate that the FDA solicits feedback from the industry before implementing major revisions, and strongly disagree with the European Commissioner for Health and Food Safety’s June 14 announcement that next May’s deadline is “realistic and achievable.” If the EU had negotiated these changes with the industry, we could’ve achieved a much more reasonable set of regulations that protect both patients and the market.

    And that’s my humble opinion as a determined optimist. I will cling to the hope that reason will somehow prevail, and our industry will weather this storm because it is anchored by the innovation and ingenuity that fuels it. 


    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
    • manufacturing
    • implants
    • clearance
    • knee
    Suggested For You
    Connecting the Dots in Medical Device Outsourcing Connecting the Dots in Medical Device Outsourcing
    Loci Orthopaedics Awarded $2.8 Million Grant Loci Orthopaedics Awarded $2.8 Million Grant
    FDA OKs OrthoPediatrics FDA OKs OrthoPediatrics' Next-Gen Cannulated Screw System
    PAVmed Announces First Human CarpX Procedures PAVmed Announces First Human CarpX Procedures
    What’s ‘In’ for Manufacturing? (Hint: It’s Not Neon) What’s ‘In’ for Manufacturing? (Hint: It’s Not Neon)
    Developing Market Access Strategies Developing Market Access Strategies
    Dominating the Competition with Digitization Dominating the Competition with Digitization
    ODT Forum Program Notebook ODT Forum Program Notebook
    Why Big Companies With Internal Labs Should Outsource Testing Why Big Companies With Internal Labs Should Outsource Testing
    ISO 14971 Update: What Changes Can Medical Device Manufacturers Expect? ISO 14971 Update: What Changes Can Medical Device Manufacturers Expect?
    A Return to Memphis: An ODT Forum Preview A Return to Memphis: An ODT Forum Preview
    FDA Commissioner Scott Gottlieb to Step Down FDA Commissioner Scott Gottlieb to Step Down
    FDA Issues Guidance on Brain-Computer Interfaces for Paralysis or Amputee Patients FDA Issues Guidance on Brain-Computer Interfaces for Paralysis or Amputee Patients

    Related Columns

    • Extremities
      Toe Fusion Alternatives Gaining a Firm Market Foothold

      Toe Fusion Alternatives Gaining a Firm Market Foothold

      Dr. Carl Hasselman, co-designer of the Arthrosurface ToeMotion Arthroplasty System, speaks about non-fusion alternatives for MTPJ osteoarthritis.
      Michael Barbella, Managing Editor 12.02.19

    • The Cluster Effect in Orthopedics: Is It Sustainable?

      The Cluster Effect in Orthopedics: Is It Sustainable?

      For a long time, we all assumed Minnesota dominated the medical device industry worldwide, but is this true for the orthopedic surgical tools industry?
      Maria Shepherd, President and Founder, Medi-Vantage 12.02.19

    • ‘If You’re Reading This, You Need to Be at This Meeting’

      ‘If You’re Reading This, You Need to Be at This Meeting’

      The AAOS/FDA/Industry Townhall is taking place March 24, 2020, at the AAOS annual meeting in Orlando.
      Dawn A. Lissy, President & Founder, Empirical 12.02.19


    • Turning the New EU MDR Into a Competitive Advantage

      Turning the New EU MDR Into a Competitive Advantage

      This column examines three new elements of the EU MDR that medical device manufacturers can leverage.
      Dan Goldstein, Associate Director, Quality Assurance, MCRA LLC 12.02.19

    • Design | Large Joint | Spine/Neurology
      Five Reasons for the Small World of Orthopedic Product Development

      Five Reasons for the Small World of Orthopedic Product Development

      Why do product development people tend to stay within the orthopedic and spine industry and not cross over into other medtech sectors?
      Victoria Trafka, BSME, MSME, President and Lead Engineer, Engineering & Quality Solutions Inc. 12.02.19

    • Impeachment, Executive Orders, and Must-Pass Congressional Legislation: A Fall Update

      Impeachment, Executive Orders, and Must-Pass Congressional Legislation: A Fall Update

      The final quarter of 2019 has begun, which means Congress and the Trump Administration are hard at work finalizing healthcare initiatives before year's end.
      Jeffrey J. Kimbell, David C. Rudloff, and Caroline P. Tucker, Jeffrey J. Kimbell & Associates Inc. 12.02.19


    • Spine/Neurology
      Pediatric Orthopedics Taken Off the Back Burner

      Pediatric Orthopedics Taken Off the Back Burner

      There are several different types of scoliosis, a condition that causes a sideways spinal curve, that affect children and adolescents.
      Sam Brusco, Associate Editor 09.17.19

    • What Are Orthopedic Surgeon Salary and Employment Statistics?

      What Are Orthopedic Surgeon Salary and Employment Statistics?

      The percent of employed physicians is greater than self-employed physicians.
      Maria Shepherd, President and Founder, Medi-Vantage 09.17.19

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

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

      There are factors that make for a more inviting environment for the medical device industry in the United States.
      Dawn A. Lissy, President & Founder, Empirical 09.17.19


    • How Identifying Gaps in Clinical Data Can Ease the Transition to New Regulations

      How Identifying Gaps in Clinical Data Can Ease the Transition to New Regulations

      As of 2017, the European medical device market was estimated  at $126 billion, the second largest worldwide, comprising 27 percent of the global market. The European market trails only the United States, which accounts for roughly 43 percent of…
      Mike Goodson, Associate Director, Regulatory Affairs, MCRA LLC 09.17.19

    • Software & Quality
      Benefiting from Paperless Production Records: A Case Study

      Benefiting from Paperless Production Records: A Case Study

      EpiBone discovered how eliminating paper with digital production records can help ensure data integrity, reduce errors, and increase efficiency.
      Terrance Holbrook, Director of Product, MasterControl 09.17.19

    • Connecting the Dots in Medical Device Outsourcing

      Connecting the Dots in Medical Device Outsourcing

      San Francisco is globally renowned for many things: The Golden Gate Bridge (its color, international orange, was actually a primer used to protect the steel during transit), Ghirardelli chocolate, the TransAmerica pyramid building, and the “Pai…
      ODT Staff 08.14.19

    • What Keeps Hospital CEOs Awake at Night and How Can Medtech Help?

      What Keeps Hospital CEOs Awake at Night and How Can Medtech Help?

      With the continued surge of mergers and acquisitions, vertical integrations, and no clear U.S. policy or reform direction for our $3.6 trillion annual healthcare spend,1 the healthcare ecosystem remains in a phase of dramatic disruption. What Is K…
      Maria Shepherd, President and Founder, Medi-Vantage 08.14.19

    • Successful Strategies for Health Plan Medical Policy Outreach

      Successful Strategies for Health Plan Medical Policy Outreach

      Getting approval from the FDA can be a significant achievement for a company but a bigger challenge awaits for novel technologies: health payor acceptance and coverage. Adopting a novel technology does not occur easily due to complex commercial insur…
      Chelsey Jaworski and Anabel Tapia, MCRA 08.14.19

    • Design
      Why and How Good Design Matters to the Bottom Line

      Why and How Good Design Matters to the Bottom Line

      There should be no confusion: good design pays dividends. Literally. Many highly successful medical products that substantively improve the delivery of healthcare also significantly increase market share and revenue. But just what is the elusive good…
      Bryce G. Rutter, Ph.D., Founder and CEO, Metaphase Design Group Inc. 08.14.19


    Breaking News
    • Orthofix Appoints New Spine Business Leader
    • Viant to Halt EtO Sterilization at Michigan Plant by End of Year
    • Synaptive Medical's Modus V Expands Into Spine Market
    • 3D-Printed Graftless Bone Transplants Go to Clinical Trials
    • CrossRoads Extremity Systems Acquires Implant Systems from Surgical Frontiers
    View Breaking News >
    CURRENT ISSUE

    November/December 2019

    • From Nitinol to Nanotubes: A Materials Science Roundtable
    • In Good Repair: Trauma Technologies Under Review
    • Anxious Undertones: A Review of 2019
    • View More >
    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    International Scientific Society Calls for Omega-3 Blood Testing in Future Research
    Pharmactive Affron Saffron May Help Relieve Depression Symptoms
    Warmer Temperatures Could Lead to Concerning Levels of Arsenic in Rice
    Coatings World

    Latest Breaking News From Coatings World

    BCF: Coatings Industry Reports Record Improvement in Waste, Recycling, Accident Rates
    BASF Doubling Automotive Refinish Coatings Production Capacity at Jiangmen, China Site
    AkzoNobel’s Wanda Vehicle Refinishes Brand Celebrates 85th Anniversary
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Philips & Paige to Deliver Clinical-Grade AI Applications to Pathology Labs
    Eye Test for Parkinson's Gains Breakthrough Designation
    Biomerics Forms New Business Unit
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Stevanato Group Begins Construction on TEC
    Bayer, CHOP Partner to Develop Oral NRT
    Novasep Launches oXYgene for Boosting Viral Vector Production
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Pantone Names Classic Blue the 2020 Color of the Year
    Burst Launches Black Expanding Dental Floss
    Glossier Enters Nordstrom for the Holidays
    Happi

    Latest Breaking News From Happi

    Raining Rose Expands Exec Team
    Sozio Builds a New Facility
    Laverne Cox Is Matrix Ambassador
    Ink World

    Latest Breaking News From Ink World

    Geoff Loftus Joins EFI
    Berlin Packaging Wins 2 WorldStar Awards
    Graphic Village Expands Offerings with Canon Solutions America
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Converters Expo schedules return to Green Bay, WI
    Schreiner MediPharm and PragmatIC form strategic partnership
    Herma's labelstocks receive new certification
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Thrace to Relocate U.S. Capacity
    FiltXPO Speaker Line-Up Announced
    Nölken Incorporates Sustainable Wipes Packaging
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Orthofix Appoints New Spine Business Leader
    Viant to Halt EtO Sterilization at Michigan Plant by End of Year
    Synaptive Medical's Modus V Expands Into Spine Market
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Avancis, Smit Thermal, HZB, CNRS, Solliace Team for Higher Efficiencies in CIGS
    CES 2020: 'Where Tech Changes Business'
    Global Flexible Display Market Size to Increase at a CAGR of 28.1% Through 2025: GVR

    Copyright © 2019 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.