• 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
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    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
    FundamentalVR Launches All-In-One Software Development Kit

    Meridian Medical Technologies Expanding Missouri Facility

    Attune Medical, Heart Rhythm Clinical Research Solutions Evaluating ensoETM Device

    Glooko, Hedia Teaming Up on Personalized Diabetes Care

    Establishment Labs' Mia Femtech Debuts in Japan
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Checking Up on Surgical Robotics

    Building a Network: How Synchron Is Developing a New Device—and a New Market

    Six Lessons Learned on Developing a Strong Company Culture

    As Hiring Slows, Companies Look Inward to Fulfill Talent Needs

    Artificial Intelligence: Medtech Opportunity or Health Danger?
    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
    Fusion Biotec Inc.

    NDH Medical Inc.

    Medbio LLC

    JBC Technologies

    Providence Enterprise USA Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    6 Considerations for Companies on the Cusp of Being Acquired

    3 Key Elements to Consider When Managing a Medtech Sales Force

    Tech-Enabled Virtual Speech Therapy Improves Speech & Communication Skills

    Practical Strategies for Digitization and Integration in Medtech Manufacturing

    Sensors: The Heart of Minimally Invasive Equipment Technology
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Fusion Biotec Inc.

    NDH Medical Inc.

    Medbio LLC

    JBC Technologies

    Providence Enterprise USA 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
    • 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
    Online Exclusives

    Process Validation: An OEM's Perspective

    Iapyx COO shares his experience from both sides of the coin.

    Ranica Arrowsmith, Associate Editor09.12.13
    Medical Product Outsourcing ran a feature on process validation in medical device manufacturing in its September issue. Here are some further insights from Tom Flannery, chief operating officer of Iapyx Medical, a San Diego, Calif.-based maker of infection prevention technology.

    Iapyx, which gets its name from the Greek god of healing, is a small medical device company that focuses on infection prevention from respiratory care devices in and around the hospital. According to Flannery, Iapyx deliberately does not have a large Internet presence because it prefers to fashion itself as a “virtual company.” The company has three primary partners: the inventor, the director of operations (Flannery) who manages supply chain and supply side, and the CEO, who negotiates private labeling deals.

    Flannery joined Iapyx from Nypro (now owned by Jabil), a precision injection molding and contract manufacturing company, where he was general manager of their Tijuana, Mexico, manufacturing facility for twelve years. It was there that he gained an intimate knowledge with process validation procedures.

    “A lot of people look at validation as a check-the-box type of activity, and then they move forward,” Flannery told MPO. “And I’m not just talking about small companies—I’m talking about large, global medical device entities. Really, validation paints a picture that must be maintained through the life of the device, and it can be adjusted. But the important thing to look at in validation is you do not want to look at it as the check-the-box activity that the U.S. Food and Drug Administration (FDA) says you should. Most companies lose the validated stage shortly after they’ve completed the validation because there’s no statistical tie-in to what they do after production. So they do all these tests, they’ll launch into production, and then their release criteria aren’t comprehensive to the validation. Therefore, they’re not able to prove to themselves or to their end-user that what they’re doing in production is maintaining that validated state. Every one of those critical quality criteria that you establish in validation needs to be verified going forward.”

    The FDA puts forth the following definition and criteria for retrospective validation:

    “Retrospective validation is the validation of a process based on accumulated historical production, testing, control, and other information for a product already in production and distribution. This type of validation makes use of historical data and information which may be found in batch records, production log books, lot records, control charts, test and inspection results, customer complaints or lack of complaints, field failure reports, service reports, and audit reports. Historical data must contain enough information to provide an in-depth picture of how the process has been operating and whether the product has consistently met its specifications. Retrospective validation may not be feasible if all the appropriate data was not collected, or appropriate data was not collected in a manner which allows adequate analysis.”

    “Retrospective validations are used when you’ve determined something is critical to quality that was not originally anticipated in the validation,” said Flannery. “You would then look backward and ask, based on what we know today, what are the operating ranges by which we can manufacture the product that we know its going to be good statistically speaking? Not qualitatively speaking, but quantitatively speaking. That’s the beauty of the end-user market: Ultimately, you’ll find out that people are going to use your devices in ways that you never intended them to be used.

    “One example: We had an angiography device. During the validation, it was subjected to 1,000 pounds of pressure. The device was comprised of a syringe, a manifold and a hand controller pit that saw extreme amounts of pressure under operation, not on the patient side, but on the side of injecting the contrast through the device. What we learned was that initially, when the product was launched in the market, the introducer catheter, when used in the femoral artery, was rather large. Large holes in the femoral artery bleed, and they take a long time to heal. So, that entire market had gone smaller. We had been in the market for years with this device with no issues, and all of a sudden we started getting these complaints from very specific hospitals. They had started using smaller catheters, which raised the pressure enough to cause the product to fail. So we had to go back and re-design. In validation, you give yourself the widest possible window for success, because you don’t want to be verifying your process more than necessary—in other words, more than what is required by user needs. The re-design of our product cost hundred of thousands—if not millions—of dollars, and that was all because of the way in which the market used the device. Probably the most common need to go back and revalidate something looking backward is when the market uses your product in a way that the engineers didn’t anticipate.”

    The importance of collaboration in process validation

    Flannery says the idea of collaboration is “really missed” in the whole process of validation.

    “You get 10 engineers in a room talking about what’s important about the device, and they‘re going to talk about what’s important about that device from an engineering perspective,” he explained. “Very seldom do you see a clinician or someone who really understands the patient participate in that process. I cannot tell you how many times we’ve invested countless engineering hours reducing variation—because that’s what’s it’s all about, variation is the enemy, that’s what causes defects. But defects are defined by the user—and that’s my point. We’ll spend thousands of dollars and hours developing a process to eliminate variation that’s not important to the end user. On the other side of that coin is something very simple that is a problem to the end-user, and you get your product out there on market, and then you’ll be doing retrospective validations to figure out what your capabilities are around a particular process so you can go back and improve it.

    “The world-class companies really understand that validation is not just check-the-box. You’re creating a state, and if you can prove that you’re maintaining that state, design controls and all of the things that flow out of design controls such as change control and process development become crystal clear. And I would say—and I’ve only seldom seen this happen because it’s expensive—in many cases before you even make part number one, you should be able to tell even in a manual process that you’re maintaining a validated state through a few simple sates like a line clearance (where quality will release a process after verifying the machine settings, the material revision levels, operator training, etc.).”

    What does an OEM like Iapyx expect from contract manufacturing organization (CMO) partners?

    “I need a little more support on the engineering side because we don’t have a staff of engineers at Iapyx, but aside from that, in general, what Iapyx looks for is relatively unique because of our size and the fact that we try to stay ‘virtual,’ keeping our overhead low,” Flannery said. “I look for a full-service manufacturer who is on the same page as me philosophically—first, because trying to change someone’s mindset takes years, and once they’ve realized that there’s value in it, its too late. You have to make sure that your CMO is on the same page as you are. I have a company I’ve worked with for a year that is on the same page as me philosophically, but their challenge is implementing the systems necessary to be effective. That’s really the next thing. Once you recognize that your CMO philosophically understands what it is you’re talking about when you say ‘process validation’—that it’s not just an activity that they have to complete in order to be in compliance—then it’s whether they have the tools to accomplish the mission. This isn’t a difficult task.

    “When I was at Nypro, we developed a relatively standard system that accomplished 80 percent of the objectives and the other 20 percent was left up to the engineers to develop. We had standard procedures and a firm understanding of the need to be able to prove with each lot released that the validated state was maintained. Our system was really good at change control. If changes are made and the device master record1 is not maintained—and I’m not just talking about the component dimensional level, I’m talking about work constructions, environmental controls, change controls to the entire fishbone (Figure 1) of all the inputs all the way down to when you do preventative maintenance on a piece of equipment. The preventative maintenance should go into the device history record for the lots that were being produced before and after that repair occurred, so that in the event of a subsequent defect, the whole picture of the lot is present.


    Fig. 1: The cause and effect diagram, or fishbone diagram, is commonly used in process validation to keep track of every input to a device. It provides a simply way to determine where a problem, if one emerges, could have originated.


    “So I would say the top three [areas we look for in CMOs] beyond philosophy is effective change control; effective engineering tools for implementing and maintaining validated state, and really solid communication. The OEM needs to participate in this process. You cannot expect a CMO to understand the patient needs. And that’s really where the OEM really falls short—understanding what is going to impact the patient. Most of the time, the OEM has the same kind of manufacturing engineers working with the CMO—that’s exactly the wrong thing, because if you pick the right CMO, they should have the capabilities to do that. They need to have the marketing personnel working with the people who are touching the patient, who understand how the device is used and what it needs to do and what’s going to improve patient care.

    “When we did our validation on our closed section catheter, we were fortunate enough to work with a doctor who has more than 30 years having used a similar device. He worked with us on the little idiosyncrasies of the device and what the clinician/respiratory therapist would benefit from being able to use. I felt it was probably the most comprehensive validation from the patient perspective that I’ve ever conducted in my entire career, and I’ve conducted validations on hydro surgery devices and angiogram devices where we’re talking real patient safety concerns. This was an airway suction catheter, which granted has similar patient concerns, but it’s a device that has 40-plus years of effective use on the market. The patient has got to come first in this process, and most of the time it’s too much about process and not enough about patient.”

    1. The device master record is a comprehensive collection of every single process and input that has affected a device during manufacture.

    For the full feature on process validation, see the September issue of MPO.
    Related Searches
    • mpo-mag
    • Process Validation
    • medical product
    • mpo-mag.com
    Related Knowledge Center
    • R&D & Design
    • Contract Manufacturing
    • Testing
    • Molding
    • Tubing & Extrusion
    Suggested For You
    Jabil Jabil
    PTI Engineered Plastics Wins a 2021 Macomb Business Award PTI Engineered Plastics Wins a 2021 Macomb Business Award
    Abiomed Abiomed's Impella ECP Heart Pump Granted Breakthrough Status
    Trelleborg Launches Rapid Development Center in Minnesota Trelleborg Launches Rapid Development Center in Minnesota
    A Quality Validation Program for Extrusion—MPO Videobites A Quality Validation Program for Extrusion—MPO Videobites
    LifeSignals Inc. Receives FDA Approval for Remote Monitoring Platform LifeSignals Inc. Receives FDA Approval for Remote Monitoring Platform
    FDA OKs LifeSignals FDA OKs LifeSignals' LX1550 Multiparameter Remote Monitoring Platform
    Data Confirm the Accuracy of HeartFlow Planner in Modeling Post-PCI Outcomes Data Confirm the Accuracy of HeartFlow Planner in Modeling Post-PCI Outcomes
    Xenter Appoints Four Healthcare Industry Leaders to its Board Xenter Appoints Four Healthcare Industry Leaders to its Board
    Xandar Kardian’s Health Monitoring Radar Gains Clearance Xandar Kardian’s Health Monitoring Radar Gains Clearance
    CeQur Raises $115 Million Series C5 Financing CeQur Raises $115 Million Series C5 Financing
    Philips, Ibex Medical Analytics Partner to Accelerate Adoption of AI-Powered Digital Pathology Philips, Ibex Medical Analytics Partner to Accelerate Adoption of AI-Powered Digital Pathology
    Validation - What Validation - What's Your Level?
    FDA Grants Breakthrough Device Status to Epilepsy Treatment System FDA Grants Breakthrough Device Status to Epilepsy Treatment System
    FDA Approves Helius Medical FDA Approves Helius Medical's Stimulator Device for Gait Improvement

    Related Buyers Guide Companies

    • Jabil

      Jabil

      ...
      Mary Edwards, Marketing Manager 11.16.22

    • PTI Engineered Plastics Wins a 2021 Macomb Business Award

      PTI Engineered Plastics Wins a 2021 Macomb Business Award

      Organization Receives Top Honors in Hometown Hero Category

    • Cardiovascular
      Abiomed

      Abiomed's Impella ECP Heart Pump Granted Breakthrough Status

      The world’s smallest heart pump, according to the company.
      Business Wire 08.19.21


    • R&D & Design
      Trelleborg Launches Rapid Development Center in Minnesota

      Trelleborg Launches Rapid Development Center in Minnesota

      Provides Trelleborg’s healthcare and medical customers a single partner for design, rapid prototyping, development and serial production.
      Trelleborg 08.16.21

    • Tubing & Extrusion
      A Quality Validation Program for Extrusion—MPO Videobites

      A Quality Validation Program for Extrusion—MPO Videobites

      Tim Steele of Microspec Corporation offers insights on the importance of a validation program for extrusion for medical device makers.

    Loading, Please Wait..

    Trending
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    • A New Approach To Post-Market Surveillance
    • Philips Names New Supervisory Board Chairman
    • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    Breaking News
    • FundamentalVR Launches All-In-One Software Development Kit
    • Meridian Medical Technologies Expanding Missouri Facility
    • Attune Medical, Heart Rhythm Clinical Research Solutions Evaluating ensoETM Device
    • Glooko, Hedia Teaming Up on Personalized Diabetes Care
    • Establishment Labs' Mia Femtech Debuts in Japan
    View Breaking News >
    CURRENT ISSUE

    May 2023

    • Computer Concepts for Medical Device Design
    • IVD Manufacturers Are Being Put to the Test
    • The New State of Medtech Outsourcing
    • 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

    Stefan Pasiakos, PhD, Selected to Lead NIH Office of Dietary Supplements
    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing
    BGG Receives Patent for Saw Palmetto ID Method
    Coatings World

    Latest Breaking News From Coatings World

    PPG Opens $30-Million Battery Pack Application Center in China
    Fact.MR: Steel Pipe Coatings Market To Hit $14.0 Billion By 2033
    Omya Extends Lightweight Fillers Portfolio with the Acquisition of Bublon
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FundamentalVR Launches All-In-One Software Development Kit
    Meridian Medical Technologies Expanding Missouri Facility
    Attune Medical, Heart Rhythm Clinical Research Solutions Evaluating ensoETM Device
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Element Creates New Lab Solutions Division
    Paraza Names Edward Marple Executive Vice President, Development
    Avacta Achieves Second Milestone in AffyXell Joint Venture
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    L'Oréal Leads Funding Round for Biotech Company, Debut
    Chamberlain Coffee and IGK Launch Matcha Dry Shampoo
    Weekly Recap: Beautycounter Searches for CEO, Le Domaine Expands Availability & More
    Happi

    Latest Breaking News From Happi

    Skylar’s ‘Boardwalk Delight’ Eau de Parfum Launches to Record Success at Sephora
    Register for the IBA Cocktail Reception in Las Vegas During Cosmoprof North America
    Amyris Announces Transformation Program
    Ink World

    Latest Breaking News From Ink World

    DuPont Artistri Inks Expands Pigment Inks Portfolio at ITMA 2023
    Toyochem Constructs New Pilot Facility for High-Performance Polymers
    UFlex Reports Unaudited 4Q, Full Year 2023 Results
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Vetaphone demos ‘M’ corona treater at Mark Andy showroom
    Constantia Flexibles leads joint venture, Beontag rebrands and more
    Schreiner's Pharma-Comb IL Label supports clinical trial cancer medication
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Maxcess International Opens New Facility in Mumbai
    emtec Showcases Groundbreaking Achievement in Haptic Measurement
    Hollingworth & Vose Joins United Nations Global Compact initiative
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Former BD, J&J Executives Join Acuitive Technologies Board
    ODT's Most-Read Stories This Week—June 3
    Augmedics Debuts New Features, Indications for xvision Platform
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Schreiner Group Receives Three FINAT Awards
    MClimate Releases Maintenance-Free CO2 Display
    Blackstone Completes Acquisition of Majority Stake of Copeland

    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