• 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
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    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
    BMP Medical Expands Sterling, Massachusetts Facility

    Abbott's Proclaim XR SCS OK'ed for Diabetic Neuropathy

    Environmental Sustainability Becoming Increasingly Important to Medtech Industry

    Duane DiFranco Joins Harvard MedTech’s Medical Advisory Board

    Lionel Bonte Named President of Mativ’s Healthcare and Wellness Business Unit
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Reflections on 2022 and What’s Ahead for Medtech: MPO Sounding Board

    3 Ways to Prepare for ISO 13485/Part 820 Harmonization

    A New Home for Theranos' Elizabeth Holmes?

    Health Cost Drivers for Large Employers

    Braving Change: Facing Fears in the Midst of Major Transitions
    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

    LEMO USA Inc.

    Arthur G. Russell Co. Inc., The

    JBC Technologies

    Paragon Medical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    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

    Telemedicine and Connectivity to Drive Material Innovation in the Near Future
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Forefront Medical Technology

    LEMO USA Inc.

    Arthur G. Russell Co. Inc., The

    JBC Technologies

    Paragon Medical
    • 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
    Columns

    Learn from My Mistakes: Why You Need a Quality System

    ...

    Learn from My Mistakes: Why You Need a Quality System
    Related CONTENT
    • MEDICAL & BIOTECH MANUFACTURING
    • Empirical Technologies Corp.
    • Breakthrough Device Designation Granted for New Neuromodulation Platform
    • First CellFX Procedure Performed in Canada
    • Turner Imaging Systems Announces International Expansion
    Dawn A. Lissy, President & Founder, Empirical04.03.18
    I’ve made my share of stupid mistakes. When I was younger, most of them stemmed from just not thinking things through. I still cringe to admit I had some really big hair in the 1980s, one of many reasons I’ll be forever grateful my younger years were not captured on a smartphone and shared on social media. I also wish I’d listened to that college advisor about which classes to take to finish my master’s degree. And there were more than a couple of lessons learned starting a test lab in a friend’s garage, which eventually laid the foundation for the Empirical family of companies I run today.

    I thought I had prepared thoroughly. But because I didn’t know what I didn’t know, I was missing key information that could have spared me misery and money.
    Even now, I armchair quarterback myself over the holes in my pre-game. If only I’d bothered to learn some rudimentary Chinese before my recent trip to Shanghai, I never would’ve ended up in that “massage parlor.”

    This perfect hindsight we all have in the wake of a bad decision is what drives a good quality system. Whether you’re a major company or a one-man band, taking the time to lay out the checks and balances for device development is a small investment of time and money up front that will more than pay for itself in the long run.

    Meredith May is vice president of Empirical Consulting, the branch of Empirical companies that focuses on guiding clients through the process of gaining and maintaining regulatory approval. She has helped to clean up a lot of mistakes that a quality system could have prevented.

    “Spending money up front to ensure your system is complete will save you money down the road,” May said. “The majority of what I call ‘bleeding of money’ is paying for something but not making money because it’s when you rework, recall, and have to redo things. If you have a quality system in place, that will reduce those non-value-added expenditures.”

    That may require a shift in thinking for smaller businesses and the solo entrepreneur. If your device is the make-or-break project for your company, it’s easy to get distracted by the almighty dollar. A good quality system will train your focus on the bigger picture, while still taking into account that you need to make a profit.

    “It’s really easy to focus on sales and revenue because that’s going to be the lifeline of your business,” May said. “It may be easy to ignore the things that aren’t necessarily what you want to do because you don’t see a direct cost benefit. But a good quality system can prevent a major financial disaster. How much will it cost if you end up with a recall, warning letters, and shutdown?”

    It also gives you a solid framework for dealing with employees and vendors.

    “If you are a one-man band and you’ve got three people reporting to you, you don’t have the time to make sure they’re doing what they’re supposed to be doing,” May said. “By having a quality system, you provide them with the structure to tell them what to do. That protects you from the FDA coming in and alerting you to issues you could’ve addressed ahead of time.”

    Once beyond your product’s feasibility stage, you need at least a partial system in place for design controls. As you add activities and stages, you need a quality system in place before progressing. If the plan is to sell your company or device, having a quality system is a mark of credibility and value.

    “Let’s say I’m looking to acquire a small company. If that little company doesn’t have a quality system, I have little to no confidence that I’m protected from their decisions,” May said. “If they haven’t developed their product with a quality system, I don’t know if they’ve done everything that is required to be done.”

    It can justifiably be a deal-breaker, she noted.

    “Without a quality system, there may be liabilities there you don’t know you have because you haven’t been tracking it,” she said. “If I were doing due diligence on a small company, I’d either walk away or cut my price in half.”

    That said, there’s no need to develop quality systems for aspects of your device your company doesn’t cover. If the goal is simply to create a device and sell your design, you don’t have to plan for issues such as how to handle complaints if you’re not selling directly to a hospital.

    “Think of your quality system as a blueprint to prove your bases are covered,” May said. “The purchasing company will have more confidence in what they’re buying and will be willing to pay more for it. It’s a way of justifying your asking price.”

    Regulations for your device are the starting point for devising your system. They don’t provide all the answers, however—they tell you what to do, but not how to do it.

    “Regulations were put into place because industries learned lessons from failures,” May said. “Experts like us have learned how to put the systems in place because we’ve learned from our failures. We want you to benefit from our mistakes.”

    That’s why we strongly recommend outside support to develop a quality system. This is really not something you should entrust solely to yourself. When you bring in someone who’s worked with numerous companies on an array of projects, you benefit from all the mistakes that expert has seen and had to clean up. It’s essentially compounding interest of “what-ifs”—your range of troubleshooting increases exponentially, as do your potential solutions.

    “You want someone who has experience in your specific area, someone who has been audited by FDA or other regulatory bodies. Someone who has sat across from an inspector, looked them in the eye, and had to defend their choices,” May said. “That person will understand the deep implications of all the decisions they have to make in developing your quality systems.”

    It’s an invaluable perspective often gained the hard way—one we’re happy to share with our clients. We’re here to prevent whatever slips we can, whether it’s flagging an incomplete design file or a heartfelt warning to not go through that door off a busy Chinese street. 


    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
    • sales
    • regulations
    • company
    Suggested For You
    MEDICAL & BIOTECH MANUFACTURING MEDICAL & BIOTECH MANUFACTURING
    Empirical Technologies Corp. Empirical Technologies Corp.
    Breakthrough Device Designation Granted for New Neuromodulation Platform Breakthrough Device Designation Granted for New Neuromodulation Platform
    First CellFX Procedure Performed in Canada First CellFX Procedure Performed in Canada
    Turner Imaging Systems Announces International Expansion Turner Imaging Systems Announces International Expansion
    CE Mark Granted to Predictive Software for Kidney Allograft Survival CE Mark Granted to Predictive Software for Kidney Allograft Survival
    OmniVision Debuts Industry’s First 8 Megapixel Medical-Grade Image Sensors OmniVision Debuts Industry’s First 8 Megapixel Medical-Grade Image Sensors
    Precision Coating Merges with N2 Biomedical Precision Coating Merges with N2 Biomedical
    Babson Diagnostics Raises $31 Million in Series B Funding Babson Diagnostics Raises $31 Million in Series B Funding
    Picarro Unveils EtO Gas Concentration Analyzer Picarro Unveils EtO Gas Concentration Analyzer
    FDA Approves Abbott FDA Approves Abbott's Portico with FlexNav TAVR System
    Medical Devices Market to Top $671.49 Billion by 2027 Medical Devices Market to Top $671.49 Billion by 2027
    Improved Outcomes Proven With Insulet’s Omnipod 5 System Improved Outcomes Proven With Insulet’s Omnipod 5 System
    Vicarious Surgical Business Combination with D8 Holdings Approved Vicarious Surgical Business Combination with D8 Holdings Approved
    Siemens Healthineers’ Somatom X.ceed Tomography Scanner Cleared by FDA Siemens Healthineers’ Somatom X.ceed Tomography Scanner Cleared by FDA

    Related Literature / Brochures

    • MEDICAL & BIOTECH MANUFACTURING

      ISO 13485:2016 • FDA Registered

    • Empirical Technologies Corp.

      Empirical Technologies Corp.

      ...
      Brian Buck, Empirical Technologies Corp 11.11.22

    • Breakthrough Device Designation Granted for New Neuromodulation Platform

      Breakthrough Device Designation Granted for New Neuromodulation Platform

      In a pilot study treating refractory epilepsy with Neuroelectrics’ Starstim platform, patients experienced a 44 percent median reduction in seizure frequency.
      Business Wire 09.22.21


    • First CellFX Procedure Performed in Canada

      First CellFX Procedure Performed in Canada

      Pulse Biosciences expands its controlled launch of the CellFX System into the country.
      Business Wire 09.22.21

    • Turner Imaging Systems Announces International Expansion

      Turner Imaging Systems Announces International Expansion

      Company forges marketing agreement in the U.K. and Ireland.
      Business Wire 09.22.21

    Loading, Please Wait..

    Trending
    • Study: Catheter Ablation Significantly Lowers Dementia Risk In AFib Patients
    • Tandem Diabetes Completes Deal For AMF Medical
    • BMP Medical Expands Sterling, Massachusetts Facility
    • The Future Of Biomedical Engineering Advancements
    • Abbott's Proclaim XR SCS OK'ed For Diabetic Neuropathy
    Breaking News
    • BMP Medical Expands Sterling, Massachusetts Facility
    • Abbott's Proclaim XR SCS OK'ed for Diabetic Neuropathy
    • Environmental Sustainability Becoming Increasingly Important to Medtech Industry
    • Duane DiFranco Joins Harvard MedTech’s Medical Advisory Board
    • Lionel Bonte Named President of Mativ’s Healthcare and Wellness Business Unit
    View Breaking News >
    CURRENT ISSUE

    November 2022

    • MPO's 2022 Year in Review
    • Fine Print: A Discourse on Additive Manufacturing
    • Grab and Go: Examining the Thrombectomy Device Market
    • 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

    Vitamin D Supplementation Reduces Risk of Dynapenia
    Sustained-Release Caffeine Ingredient Offers Mood, Performance Benefits
    Multi-Strain Probiotic Improves Self-Reported Mood, Sleep, Serotonin Levels
    Coatings World

    Latest Breaking News From Coatings World

    Epoxytec Announces New Website Launch
    Paints and Coatings Market Worth $212B by 2026: MarketsandMarkets
    Axalta Releases Fourth Quarter and Full Year 2022 Results
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    BMP Medical Expands Sterling, Massachusetts Facility
    Abbott's Proclaim XR SCS OK'ed for Diabetic Neuropathy
    Environmental Sustainability Becoming Increasingly Important to Medtech Industry
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Pasithea Signs CMC Development and Manufacturing Agreement
    Experic Expands Analytical Capabilities and Facilities
    List Labs Expands Manufacturing Capacity
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Haircare Brand Uncle Funky’s Daughter Announces Retail Expansion
    TRESemmé Introduces New Pro Infusion Collection
    Walgreens Boots Alliance Shares 2022 ESG Report
    Happi

    Latest Breaking News From Happi

    KimChi Beauty Launches Spinning Hearts Love 02 Ahead of Valentine’s Day
    Dark & Lovely Names Actress Meagan Good Brand Ambassador
    Natural Household Care Company Tru Earth Adds Dishwasher Detergent Tablets
    Ink World

    Latest Breaking News From Ink World

    Xerox Releases 4Q, Full-Year 2022 Results
    Electronics For Imaging Names Frank Pennisi as CEO
    Fiery to Separate from EFI, Remain Wholly-Owned by Siris
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    EFI appoints Frank Pennisi CEO, Fiery now an independent business
    Bobst boosts senior sales team with Keith Nagle
    Penmar Industries adds Screen Truepress Jet L350UV SAI digital press
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Essity’s Sales Grow
    Thinx to Pay up to $5 million to Settle Class Action Suit
    Typar Highlighting New Building Innovations
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Orthofix Launches the Mariner Deformity System
    Tyber Medical Hires 2 New Execs
    Miach Ortho Raises $40M in Series B Funding
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Smart Devices with Privacy Focus Have More Consumer Appeal
    Siman Group Partners with SML to Unlock Full Retail Potential with RFID
    Brewer Science Presents Optics Integration Solutions at SPIE Photonics West

    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