• 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
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    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
    Cretex Companies CEO Steps Down

    Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread

    Endoscopic Hemostasis Devices Market Valued at $730 Million

    Henry Schein Buys Majority Interest in Prism Medical Products

    Boston Scientific's Vercise Genus DBS Earns FDA Approval
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    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
    K-Tube Technologies

    Medicoil

    Element

    FUTEK Advanced Sensor Technology Inc.

    Concise Engineering
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Spectrum Plastics Group

    PTI Engineered Plastics Inc.

    Qosina Corp.

    Element

    Medicoil
    • 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

    MPO Summit: The View from the Top

    ...

    MPO Summit: The View from the Top
    Related CONTENT
    • Foregoing the Rainbow for the Pot of Gold
    • Biocompatibility Pulse Check: How FDA’s New Requirements Affect Our Industry
    • A Different Class of Engineer: How to Connect with Rising Medtech Talent
    • Coming Clean: Developing Standards for Cleaning Reusable Devices and Instruments
    • Empirical Celebrates 20 Years of Service in the Medical Device Industry
    Dawn A. Lissy, President & Founder, Empirical11.26.18
    It started with a wintry dusting of snow and ended in a blaze of autumnal glory. On top of a mini tour of Colorado’s best seasons, the two-day MPO Summit in Broomfield on Oct. 11-12 offered forecasts and insights into what it takes to weather changes in the medical device industry and how we can better serve our clients.

    The point of the conference was to compare best practices among medical device outsourcing professionals to support a healthy client base. It featured a multi-session spotlight on innovations, challenges, trends, concerns, and education for those of us in this segment of the industry.

    I was pleased to hear that rather than previous messages of “cut costs for clients at all costs,” the focus was on how to provide top-notch service through critical and value-added strategic partnerships between clients and vendors. I’ve never aspired to be the cheapest source of mechanical testing, regulatory consulting, or small-batch manufacturing. For 20 years, I’ve worked to develop a family of companies that may not be the lowest cost but are the highest value, so I eagerly embraced this change of focus from bottom line savings to top-level service.

    I’m partial to this conference not just because the wonderful team at MPO gives me a byline, but also because this conference’s discussions don’t shy away from uncomfortable topics. The “elephant in the room” is always at the top of the agenda, and attendees respectfully tackle issues that are more often relegated to barstools than panel discussions.

    But this was the conference for “real talk.” Previous years have included gloves-off discussions about the medical device tax, what to do about a dwindling labor pool of skilled workers who can manufacture devices, and some brutal truths about being a woman in a predominantly male industry.

    I appreciate that respectful and open approach to topics that cause too many professionals to cringe. This year was no exception. From the regulatory implications of the EU Medical Device Regulation (MDR) compliance and how Brexit will impact operations to project breaking points, sessions focused on the often ugly truths behind successes and failures.

    This has been a year full of mergers and acquisitions, which can be unsettling. As companies buy, reposition, and rebrand, there are layoffs, project delays, leadership changes, and other shifts that cause uncertainty. My experience both as an employee at an acquired company and as an observer from the small business space is that 1+1 does not equal 2 in these transactions. Unless an in-process project is critical, most forward movement pauses while the new owner decides the priority order of integration of systems. 

    As an outside service provider, my standing with the new entity is in question in the wake of a deal. This is not a comfortable spot. As new leadership evaluates contracts, projects can be cancelled without any notice and business relationships that spanned decades can disappear overnight. On the upside, these M&A activities also breed innovation—our industry has seen more leaps in technology advancements from new stakeholders pushing companies out of previously established comfort zones. 

    There was also a sobering update on the international regulatory climate and how that affects device development in the United States. It’s been common practice for device developers of new technologies (Class III devices) to first seek regulatory clearance abroad and work their way back to the U.S. Food and Drug Administration (FDA). Because FDA is generally considered the strictest, most demanding regulatory body in the world, device developers often pursue approvals in the European Union before the United States. But the pool of regulatory agencies abroad has shrunk from more than 90 to fewer than 70. Add to that a rush to meet the May 2020 MDR deadline, and we now have an audit queue that’s backed up past the 2020 implementation date. So new devices that could be improving patient outcomes are standing in line rather than making their way to the marketplace.

    On a more positive note, more companies are taking advantage of the relatively new, under-used programs such as First in Human and early feasibility options for Class III devices. That’s paving the way for a faster pipeline through FDA for regulatory approval in the United States.

    Professionals also shared war stories. I appreciated the candor and openness of Natasha Bond of Sana Health, Ben Walker of Innosphere, and Craig Weinberg of BDC Laboratories. I moderated their panel discussion, which laid out how to recognize when your brilliant plans aren’t working and how to course-correct.

    My favorite quotes from participants in this session:

    “The only thing more dangerous than an engineer who has never spoken to a customer is a marketer who has only spoken to one,” said Dave Nevrla, a cardiovascular medical device innovator and product marketing consultant who attended the summit.

    “Knowledge comes from books, but wisdom comes from doing things wrong,” said Craig Weinberg, speaking from his experience as CEO of BDC Laboratories.

    And words we should all live by from John McCloy, an engineer and entrepreneur: “If it’s not written down, it didn’t happen.”

    The panel I moderated and every other session came back to the same question in some way: How do we develop connections that strengthen the industry?

    The short answer: Check your ego at the door.

    The longer answer: Develop deeper, more productive partnerships with clients through frequent, honest communication that leads to a team approach for problem-solving and innovative solutions. This requires a shared corporate culture that doesn’t shy away from difficult questions, owning up to mistakes, and forward focus. It’s about open dialogue that examines vulnerabilities, fears, and challenges. It’s developing trust, setting realistic expectations, and staying on the same page as you work toward mutual success. 


    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
    • testing
    • manufacture
    • technologies
    • compliance
    Suggested For You
    Foregoing the Rainbow for the Pot of Gold Foregoing the Rainbow for the Pot of Gold
    Biocompatibility Pulse Check: How FDA’s New Requirements Affect Our Industry Biocompatibility Pulse Check: How FDA’s New Requirements Affect Our Industry
    A Different Class of Engineer: How to Connect with Rising Medtech Talent A Different Class of Engineer: How to Connect with Rising Medtech Talent
    Coming Clean: Developing Standards for Cleaning Reusable Devices and Instruments Coming Clean: Developing Standards for Cleaning Reusable Devices and Instruments
    Empirical Celebrates 20 Years of Service in the Medical Device Industry Empirical Celebrates 20 Years of Service in the Medical Device Industry
    Empirical Machine Earns FDA Contract Manufacturer Designation Empirical Machine Earns FDA Contract Manufacturer Designation
    Top 5 of the Past 15: Moments that Shifted, Shaped, or Shook the Medical Device Industry Top 5 of the Past 15: Moments that Shifted, Shaped, or Shook the Medical Device Industry

    Related Columns

    • 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

    • COVID 19: Supply Chain Professionals’ Ultimate Reality Challenge

      COVID 19: Supply Chain Professionals’ Ultimate Reality Challenge

      Having been a part of the medtech supply chain for 40 years, I can say there has never been a more difficult time for supply chain professionals.
      Chris Oleksy, Founder and CEO, Oleksy Enterprises and Next Life Medical; CEO, Emergent Respiratory 11.04.20

    • Congress Examines Additional COVID-19 Relief and Recent Regulatory Changes

      Congress Examines Additional COVID-19 Relief and Recent Regulatory Changes

      The legislative year is nearly coming to a close as Washington survives yet another tumultuous election cycle.
      Jeffrey J. Kimbell, Eric P. Juhl, JD and David C. Rudloff, Jeffrey J. Kimbell & Associates Inc. 11.04.20


    • 3D/Additive Manufacturing
      Additive Manufacturing: Debinding Fluids Must-Haves

      Additive Manufacturing: Debinding Fluids Must-Haves

      As the pressure to produce more complex biomedical parts increases, medical device manufacturing using 3D printing is gaining widespread acceptance.
      Venesia Hurtubise, Technical Chemist, MicroCare Medical 11.04.20

    • Diagnostics
       How COVID-19 is Reshaping the Diagnostics Testing Sector

      How COVID-19 is Reshaping the Diagnostics Testing Sector

      The short-term impact on the diagnostics sector is readily apparent as the pandemic has fueled overwhelming demand for effective SARS-CoV-2 testing solutions.
      Eric Williams, Managing Director, Capstone Headwaters 11.04.20

    • Will Industry’s COVID-19 Recovery End Prematurely?

      Will Industry’s COVID-19 Recovery End Prematurely?

      Finally, a light at the end of the tunnel, but will it remain lit?
      Michael Barbella, Managing Editor 10.01.20


    • Surgical
      Hype or Hope? The Future of Surgical Robotics

      Hype or Hope? The Future of Surgical Robotics

      Recent publications suggest the U.S. performs more robotic surgery than every other country in the world.
      Maria Shepherd, President and Founder, Medi-Vantage 10.01.20

    • COVID Community: How the Pandemic Is Bringing Out the Best in Us

      COVID Community: How the Pandemic Is Bringing Out the Best in Us

      Given the brain power and generosity of our industry, I knew I could follow the wisdom of Fred Rogers’ mother and “look for the helpers.”
      Dawn A. Lissy, Founder & President, Empirical 10.01.20

    • Electronics
      Why Applying Cleanliness Standards to Outsourced Medical Electronics Is Important

      Why Applying Cleanliness Standards to Outsourced Medical Electronics Is Important

      When looking to outsource the manufacture of electronic medical devices, cleanliness standards and processes should be a top consideration.
      Jay Tourigny, Senior Vice President, MicroCare Medical 10.01.20


    Trending
    • Telemedicine, Regulatory Changes To Characterize Medtech Industry In 2021
    • Masimo Earns CE Mark For New Fingertip Pulse Oximeter
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Philips Buys Capsule Technologies In $635M Deal
    • Understanding Food-Grade Vs. Biocompatibility For Medical Device Materials
    Breaking News
    • Cretex Companies CEO Steps Down
    • Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread
    • Endoscopic Hemostasis Devices Market Valued at $730 Million
    • Henry Schein Buys Majority Interest in Prism Medical Products
    • Boston Scientific's Vercise Genus DBS Earns FDA Approval
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • 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

    NIH Study Compares Low-Fat, Plant-based to Low-Carb, Animal-Based Diet
    Gadot Positions Mineral Line for Vegan Market
    Nutritfy India to Launch Global Broadcast Channel Covering Nutrition
    Coatings World

    Latest Breaking News From Coatings World

    LINE-X Launches Dealer Program with International Truck
    PPG Reports Q4, Full-year 2020 Financial Results
    BASF Begins Implementing Ralignment of Global Business Services Unit
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Cretex Companies CEO Steps Down
    Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread
    Endoscopic Hemostasis Devices Market Valued at $730 Million
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Pfizer, BioNTech Enter Vax Pact with COVAX
    FDA Approves Janssen’s CABENUVA
    AGC Biologics Appoints Boulder Site GM
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Coty Appoints Chief Procurement Officer
    Lageen Tubes Launches Mono-Material PE Tube Solutions
    Jason Jones Loses Battle with Covid-19
    Happi

    Latest Breaking News From Happi

    Carol’s Daughter Adds New Hair Products
    Moroccan Gold Series Launches NuDo Shampoo
    Youbody Debuts Waterless Body Wash
    Ink World

    Latest Breaking News From Ink World

    BOBST Demonstrates Future of Flexible Packaging Production at Virtual Open House
    Morancé Soudure France Adds Comexi F2 MC 10-color Flexo Press
    AR Packaging Acquiring Firstan Holdings Ltd
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Gallus planning virtual event for March
    Lemu Group engineers mask-making machine
    Niagara Label upgrades with Nilpeter flexo press
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Freudenberg to Establish Apparel Interlining Competence Centers
    Minet Adds Spunlace Line in Romania
    Lemu Group Engineers Mask-Making Machine
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Cretex Companies CEO Steps Down
    Conformis Enters Development & Supply Agreement with SITES Medical
    Sectra, RSA Biomedical Sign Distribution Agreement for Implant Stability Tool
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    UDC Subsidiary Adesis' Website Wins 2020 MarCom Platinum Award
    Ambiq Wins IoT Semiconductor Company of the Year Award
    Ynvisible Names Michael Robinson CEO, Jani-Mikael Kuusisto SVP Ventures

    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