• 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
    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability

    Machining & Laser Processing Have Huge Parts to Play in Medtech Manufacturing

    Medtech R&D Teams Must Be Creative & Resilient to Survive

    Struggling Suppliers in Electronics Manufacturing Services (EMS)

    Deep (Brain) Thoughts with Medtronic's Neuromodulation President
    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
    PDC Unveils New Brand Identity

    MD&M West News: Teamvantage Launches New Parent Company

    BD Receives EUA from FDA for COVID-19, Influenza A/B, RSV Combination Test

    Qosina Names Lee Pochter as Executive Vice President

    FDA Okays Early Feasibility Study for Anteris' TAVR Product
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability

    Machining & Laser Processing Have Huge Parts to Play in Medtech Manufacturing

    Medtech R&D Teams Must Be Creative & Resilient to Survive

    Struggling Suppliers in Electronics Manufacturing Services (EMS)

    Deep (Brain) Thoughts with Medtronic's Neuromodulation President
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Deducing the Dual Reality of Elizabeth Holmes

    The Return of the AdvaMed MedTech Conference…Live!

    Material Matters: New Materials Call for New Thinking

    5 Ways to Maintain a Talent-Centric Mindset, Even During Economic Uncertainty

    The Changing Face of UK Medical Device Regulations: Most Recent Update
    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
    LEMO USA Inc.

    Forefront Medical Technology

    Paragon Medical

    Halkey-Roberts Corporation

    JBC Technologies
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Onshoring Medical Device Manufacturing Can Strengthen Supply Chains

    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
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    LEMO USA Inc.

    Forefront Medical Technology

    Paragon Medical

    Halkey-Roberts Corporation

    JBC Technologies
    • 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

    Staying Dry: Waterproofing a Heart Monitor

    Comar resolves market growth needs for the myPatch sl Holter recorder while enhancing design and addressing specific demands.

    Staying Dry: Waterproofing a Heart Monitor
    To achieve its IP 68 rating and prevent recorder failure, the myPatch sl design relies on a hermetic, ultrasonic seal between the injection molded recorder housing components and the button overmold to protect the recorder’s internal PC circuit board and battery.
    Staying Dry: Waterproofing a Heart Monitor
    Ben Lecomte wore the myPatch sl recorder on his historic 5,500-mile swim from Japan to San Francisco to measure the impact of the long-distance swim on his heart.
    Related Content
    • MedWorld Advisors
    • DDL Inc.
    • Steute Meditech Inc.
    • Comar Holds Groundbreaking Ceremony in Vineland, NJ
    • FDA Warns Against Use of Unauthorized Diabetes Management Devices
    Adrian Possumato, Principal Consultant, Medica Consulting05.21.19
    Unlike most scale-up efforts where the simple maintenance of quality is paramount, dms-service challenged Comar to make significant process improvements in an effort to increase their already high level of quality without disrupting supply. The principal focus of this effort was the recorder’s hermetic seal achieved via ultrasonic welding during assembly of the molded recorder components.
     
    Ambulatory ECG Monitor
    Lynda Cole knew she would need additional manufacturing capacity to support the successful 2017 launch of dms-service’s innovative myPatch sl Holter recorder.
     
    Cole, owner and manager of dms-service, first started in the Holter recorder industry in 1977 with her father’s business, Scole Engineering Co. Inc. Since that time, she has witnessed first-hand the technological advances in Holter monitoring that are represented in the revolutionary myPatch sl design.
     
    These technical advances have resulted in a recorder design that requires advanced molding and assembly capabilities.
     
    As an ambulatory electrocardiogram (ECG) monitor, the myPatch sl recorder is regulated by the United States Food and Drug Administration (FDA) as a Class II medical device under 21 CFR Part 820 and supported by a 510(k) regulatory clearance by FDA’s Center for Devices and Radiological Health.
     
    Waterproof Design
    dms-service released a truly innovative solution with the myPatch sl recorder. The myPatch sl features an IP rating of 68—waterproof up to two meters of water for one hour and two channels of continuous ECG recording for 14 days. It offers multiple electrode sizes for patient comfort and convenience, and is available in adult, pediatric, ladies, sports, and neonate electrodes.
     
    What does this IP rating mean? It means the patient does not need to worry about taking a shower while wearing the device or a quick swim with the sports electrode.
     
    To achieve this IP rating and prevent recorder failure, the myPatch sl design relies on a hermetic, ultrasonic seal between the injection molded recorder housing components and the button overmold to protect the recorder’s internal PC circuit board and battery.
     
    Choosing a Supplier
    “The advanced design of the myPatch sl recorder coupled with the quality systems and regulatory compliance requirements to support an FDA cleared medical device also limited dms-service's choices for an alternative molder/assembler,” cited Cole. “We needed a supplier that offered the full suite of services, as well as, the agility required to support the molding and assembly of our device."
     
    Comar was selected as it offered ISO 13485:2016 and ISO 9001:2015 facilities, Class 8 cleanrooms, and established FDA registration for medical devices. The manufacturer’s capabilities included design-for-manufacturing services, in-house mold making and prototyping, and diverse molding technologies with a strict QA/RA umbrella.
     
    “We recognize the benefit that agility plays in delivering a quality product to market quickly,” stated Scott Conklin, Comar’s executive vice president of sales & marketing. “Comar has provided medical device and diagnostic manufacturers this benefit for a number of years now. The market rewards the first to arrive and it is incumbent on Comar to serve as a partner to our customers.”
     
    Improving Quality During Scale-Up
    “Improving on an already high IP score against water ingress was a challenge during scale-up operations,” explained Scott Taylor, medical device market director for Comar. “We have very strong resources and capabilities in design, manufacturing, and final testing whereby we were able to easily modify the recorder joint design and introduce an improved ultrasonic welding horn, improving output and quality simultaneously.”
     
    Losses/scrap during the ultrasonic welding operation were reduced from 22 percent to less than 2 percent and further improvements continue.
     
    Similarly, design-for-manufacturing improvements were made to the insert molding of the electrical contacts on the underside of the recorder and overmolding of the button on its topside. Specifically, positioning and retention of the contacts and snaps placed in the mold prior to the injection were improved, thus making it easier for the machine operator. Since it was made easier to do it the same every time, the overall product consistency improved dramatically.
     
    “It was critical that supply chain not be adversely affected during the implementation of these improvements.” said Cole. “Our market growth plans could not tolerate any delay. I was very impressed with Comar’s capabilities as all of the design and manufacturing improvements made not only kept our commercial plans on track, they were successfully and concurrently implemented. Comar has helped us considerably.”
     
    Moving Forward
    “We are very pleased to be entrusted by dms-service to assist with the growth of their business. We remain committed to meeting the needs of our medical device and pharmaceutical customers and are strategically positioned to support these industries,” explained Mike Ruggieri, CEO of Comar.
     
    Ben Lecomte Takes the Plunge
    What can happen to the human heart after months of swimming? Ben Lecomte’s historic 5,500-mile swim from Japan to San Francisco is a feat that can’t be missed. Watch the video below to learn about how the myPatch sl recorder is being used to measure the impact of the long-distance swim on his heart.

     

    Adrian Possumato is a principal consultant at Medica Consulting, a boutique pharmaceutical and medical device industry consultant.
    Related Searches
    • diagnostic
    • heart
    • Manufacturing
    • Molding
    Related Knowledge Center
    • Molding
    • Contract Manufacturing
    • Patient Monitoring
    • Electronics
    • Cardiovascular
    Suggested For You
    MedWorld Advisors MedWorld Advisors
    DDL Inc. DDL Inc.
    Steute Meditech Inc. Steute Meditech Inc.
    Comar Holds Groundbreaking Ceremony in Vineland, NJ Comar Holds Groundbreaking Ceremony in Vineland, NJ
    FDA Warns Against Use of Unauthorized Diabetes Management Devices FDA Warns Against Use of Unauthorized Diabetes Management Devices
    Sterilization Facility Shutdown Sparks Device Shortage Sterilization Facility Shutdown Sparks Device Shortage
    InDevR InDevR's FluChip-8G Influenza A+B Assay Wins FDA Nod
    FDA Green Lights First Device to Treat ADHD FDA Green Lights First Device to Treat ADHD
    FDA Warns Genomics Lab About Illegally Marketing Genetic Test FDA Warns Genomics Lab About Illegally Marketing Genetic Test
    FDA to Modernize Mammography Services and Improve Their Quality FDA to Modernize Mammography Services and Improve Their Quality
    FDA Approves New Device to Treat Moderate to Severe Chronic Heart Failure FDA Approves New Device to Treat Moderate to Severe Chronic Heart Failure
    A Trusted Partner A Trusted Partner
    FDA to Closely Examine Surgical Stapler Risks FDA to Closely Examine Surgical Stapler Risks
    FDA FDA's Update on Efforts to Educate Patients on Known Breast Implant Lymphoma Risk
    FDA Clears iCAD FDA Clears iCAD's ProFound AI for Digital Breast Tomosynthesis

    Related Buyers Guide Companies

    • MedWorld Advisors

      MedWorld Advisors

      ...
      Florence Joffroy-Black, CEO/President 11.29.22

    • DDL Inc.

      DDL Inc.

      DDL has been in medical device package, product and material testing industry for almost 20 years. We strive to offer the most effective business practices while employing a staff of technical experts.
      Chris Murphy, Marketing Manager 11.11.22

    • Steute Meditech Inc.

      Steute Meditech Inc.

      STEUTE recognizes that, due to patient vulnerability, a product manufactured for the medical market is fundamentally different from industrial and other types of products.
      Maurizio Lauria, Brand Manager 10.06.21


    • Comar Holds Groundbreaking Ceremony in Vineland, NJ

      Comar Holds Groundbreaking Ceremony in Vineland, NJ

      Celebrates the start of a new manufacturing facility.
      Comar 11.16.20

    • Patient Monitoring
      FDA Warns Against Use of Unauthorized Diabetes Management Devices

      FDA Warns Against Use of Unauthorized Diabetes Management Devices

      FDA is aware patients may choose to create these systems or purchase unauthorized or unapproved components or systems because of personal preference or cost.
      U.S. Food and Drug Administration 05.20.19

    Loading, Please Wait..

    Trending
    • MO SCI Acquires Assets Of 3M’s Advanced Materials Business
    • Positive Long-Term Prospects For Japanese Diabetes Care Market
    • CGM Devices Could Become Main Glucose Monitoring Solution In U.S.
    • The Future Of Biomedical Engineering Advancements
    • Endologix Shares Positive 12-Month Results Of DETOUR-2 Trial
    Breaking News
    • PDC Unveils New Brand Identity
    • MD&M West News: Teamvantage Launches New Parent Company
    • BD Receives EUA from FDA for COVID-19, Influenza A/B, RSV Combination Test
    • Qosina Names Lee Pochter as Executive Vice President
    • FDA Okays Early Feasibility Study for Anteris' TAVR Product
    View Breaking News >
    CURRENT ISSUE

    January/February 2023

    • Struggling Suppliers in Electronics Manufacturing Services (EMS)
    • Machining & Laser Processing Have Huge Parts to Play
    • Medtech R&D Teams Must Be Creative & Resilient to Survive
    • Medtronic Neuromodulation President, Nnamdi Njoku, Interview
    • 6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability
    • 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

    Tocotrienols May Have Protective Effect on Liver in NAFLD Patients
    Indian Gooseberry Extract Shown to Offer Blood Sugar Management Benefits
    ADM Expands Production to Meet Demand for Probiotics
    Coatings World

    Latest Breaking News From Coatings World

    AkzoNobel Reports Revenue Growth in 2022
    Orion Engineered Carbons Announces New Distribution Partnerships
    Personnel Changes at BASF
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    PDC Unveils New Brand Identity
    MD&M West News: Teamvantage Launches New Parent Company
    BD Receives EUA from FDA for COVID-19, Influenza A/B, RSV Combination Test
    Contract Pharma

    Latest Breaking News From Contract Pharma

    KORSCH Acquires MEDELPHARM to Strengthen R&D Product Line
    SRI Names Kathlynn Brown Biosciences Division President
    Battelle, AmplifyBio, Andelyn Biosciences Win Research Contract
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Kiss Colors & Care Taps Rapper JT as Brand Partner
    Revolution Beauty Expands into Walmart in the U.S.
    Macro-Environmental Factors Impacting the Packaging Industry
    Happi

    Latest Breaking News From Happi

    Perfect Corp. Receives MLPS 2.0-Compliant Status to Help Beauty and Fashion Brands Meet China's National Cybersecurity Standards
    Ocean Conservation Managers Convene for Fifth International Marine Protected Area Congress, Receives Private Sector Support From Mary Kay Inc.
    Mintel Reveals Macro-Environmental Factors Impacting Household and Personal Care Packaging
    Ink World

    Latest Breaking News From Ink World

    Orion Carbons Announces New Distribution Partnerships
    DuPont Reports 4Q, Full Year 2022 Results
    Graphic Packaging Reports Strong 4Q, Full Year 2022 Results
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    'Build Back the Wisconsin Paper Industry' event announced
    Magic Johnson to keynote Dscoop Edge St. Louis World Expo
    Norway's Digital Etikett grows with HP Indigo
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Edgewell’s Sales Increase
    Mitsui Chemicals, Asahi Kasei Combine Nonwovens Businesses
    Hospeco Offers TaskBrand Prep-Paint-Finish Wiping System
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    OssDsign Launches New Product for Additional Surgical Procedures
    OSSIO Introduces Non-Permanent Compression Staple
    Dennis Jones Joins Intelivation Technologies as Manufacturing VP
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Identiv Expands NFC and HF Solutions Portfolio
    HID Acquires GuardRFID to Expand Healthcare Offering
    DuPont Reports Fourth Quarter, Full Year 2022 Results

    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