Skip to main content
Sister Publication Links
  • Sustainable Plastics
  • Rubber News
Subscribe
  • Login
  • Register
  • Subscribe
  • News
    • Processor News
    • Suppliers
    • More News
    • Digital Edition
    • End Markets
    • Special Reports
    • Newsletters
    • Resin pricing news
    • Videos
    • Injection Molding
    • Blow Molding
    • Film & Sheet
    • Pipe/Profile/Tubing
    • Rotomolding
    • Thermoforming
    • Recycling
    • Machinery
    • Materials
    • Molds/Tooling
    • Product news
    • Design
    • Mergers & Acquisitions
    • Sustainability
    • Public Policy
    • Material Insights Videos
    • Numbers that Matter
    • Automotive
    • Packaging
    • Medical
    • Consumer Products
    • Construction
    • CEO Issue
    • Diversity
    • Best Places to Work
      • 2022 winners
    • Processor of the Year
    • Rising Stars
    • Women Breaking the Mold
  • Opinion
    • The Plastics Blog
    • Kickstart
    • One Good Resin
    • BRICS and Plastics
    • All Things Data
    • Viewpoint
    • From Pillar to Post
    • Perspective
    • Mailbag
    • Fake Plastic Trees
  • Shop Floor
    • Blending
    • Compounding
    • Drying
    • Injection Molding
    • Purging
    • Robotics
    • Size Reduction
    • Structural Foam
    • Tooling
    • Training
  • Events
    • K Show Livestream
    • Plastics News Events
    • Industry Events
    • Injection Molding & Design Expo
    • Livestreams/Webinars
    • Editorial Livestreams
    • Ask the Expert
    • Plastics News Events Library
    • Processor of the Year submissions
    • Plastics News Executive Forum
    • Injection Molding & Design Expo
    • Plastics News Caps & Closures
    • Women Breaking the Mold Networking Forum
    • Plastics in Automotive
    • Reuters Responsible Business Europe 2022
    • Reifenhäuser Technologies Livestreams
    • Polymer Points Live
    • Numbers that Matter Live
    • Plastics in Politics Live
    • Sustainable Plastics Live
    • Plastics Caps & Closures Library
    • Plastics in Healthcare Library
    • Women Breaking the Mold Networking Forum Library
  • Resin Prices
    • All Resins
    • Commodity TPs
    • High Temp TPs
    • ETPs
    • Thermosets
    • Recycled Plastics
    • Historic Commodity Thermoplastics
    • Historic High Temp Thermoplastics
    • Historic Engineering Thermoplastics
    • Historic Thermosets
    • Historic Recycled Plastics
  • Rankings & Data
    • Injection Molders
    • Blow Molders
    • Film Sheet
    • Thermoformers
    • Pipe Profile Tubing
    • Rotomolders
    • Mold/Toolmakers
    • LSR Processors
    • Recyclers
    • Compounders - List
    • Association - List
    • Plastic Lumber - List
    • All
  • Directory
  • Custom
    • Sponsored Content
    • LS Mtron Sponsored Content
    • Conair Sponsored Content
    • KraussMaffei Sponsored Content
    • ENGEL Sponsored Content
    • White Papers
    • Classifieds
    • Place an Ad
    • Sign up for Early Classified
MENU
Breadcrumb
  1. Home
  2. News
October 13, 2017 02:00 AM

Chinese medical market tough nut to crack for processors

Kent Miller
  • Tweet
  • Share
  • Share
  • Email
  • More
    Print
    Kent Miller
    Benjamin Bouchard, vice president and managing director-China for GW Plastics Inc.

    Shanghai — China's medical device market is booming, but regulatory walls and concerns about intellectual property are keeping foreign processors largely on the bottom tier of the supply chain.

    One complaint frequently heard among global plastics companies at the recent Medtec China trade show in Shanghai was that onerous standards — often stiffer than those in Europe and North America — effectively keep components makers out of the lucrative final-assembly and OEM business.

    "Some products that don't require a clean room to be made in America require a clean room in China," said J.Y. Goh, marketing manager at Singapore-based injection molder Univac Precision Products Co. Ltd.'s Suzhou plant.

    Catheter maker Optinova AB must deal with extremely high tolerances demanded by Chinese regulators.

    "They are higher than in Europe. Sometimes they aren't really relevant," said Asa Mattson, director of consumer care at the Aland Islands, Finland-based company.

    Vaguely worded and rapidly implemented regulations were a bugbear cited by Michael Lou, sales and marketing director at the Suzhou factory of Wayne, Pa.-based Tekni-Plex.

    Noting the particularly strict standards on phthalates, Lou observed dryly: "If everyone complied with this regulation, every factory must be shut down."

    While U.S. regulations typically distinguish between a medical device's design and its manufacture, Chinese law leaves manufacturers legally exposed for a poorly designed product.

    For foreign-owned processors, the usual tactic is to ship individual components to a manufacturer, typically a major multinational. This customer then assembles the final product and submits to the Chinese Food and Drug Administration for approval or exports it.

    Kent Miller

    Bill Pan of MedPlast Inc.

    "Due to regulatory limitations, we cannot provide fully assembled products," said Bill Pan, the Suzhou-based Asia sales director of MedPlast Inc., a Tempe, Ariz.-based medical molder and contract manufacturer.

    "We can only supply components," he said. "We can provide fully assembled products in the United States and Europe. The [CFDA] medical regulator in China is more critical than those in the U.S. and Europe."

    Some processors perform basic assembly. For example, Bethel, Vt.-based GW Plastics Inc. puts together a disposable breathing apparatus that will be used with a nebulizer.

    The complaints are backed up by the European Chamber of Commerce in China.

    "Many devices that do not need clinical trials in Europe or other main markets need to undergo very expensive and time-consuming trials in China," the chamber wrote in its annual China position paper released in mid-September.

    The chamber advocates for harmonizing Chinese regulations on risk classification and clinical reports with international regulations.

    Still, despite its challenges, the long-term boom in the Chinese medical market is drawing foreign companies in.

    The market rose from 120 billion yuan ($18.1 billion) in 2010 to 308 billion yuan ($46.4 billion) in 2015 and is estimated to reach 600 billion yuan ($90.4 billion) in 2019, according to Medtec show organizers. The show was held Sept. 20-22 in Shanghai.

    "It used to be that no Chinese manufacturer would pay Western prices for products because there was always a Chinese molder who would do it cheaper," said Benjamin Bouchard, vice president and managing director-China for GW Plastics.

    "But now the Chinese medical OEMs realize that they have to have a quality product and a good reputation, and that comes from companies like us," he said. "We're seeing the Chinese medical devices market as a big opportunity."

    Nothing sets off alarm bells in some companies more than a potential customer asking for help to reverse engineer an existing product.

    "In the early years of this show, people would come up to us with a product and say, 'Just build that for me.' We'd say, 'No, no, no, no!'" Bouchard said. "We absolutely cannot allow the knowledge we learned from working on one product to migrate to another product."

    One processing executive, who asked not to be identified, bluntly blamed would-be intellectual property thieves for limiting his company's China medical business: "There's an awful lot of copying of existing products. We'll no-quote on a lot of things. We're very careful about that."

    The company is so cautious that it keeps mold fabrication stateside.

    "We have some technology and ways that we make the tools that we don't share," the executive said. "[Our medical business] isn't growing as fast a pace as we'd like to see, but it's growing."

    RECOMMENDED FOR YOU
    Hillenbrand cites recycling as 'strategic growth' area with Herbold acquisition
    Letter
    to the
    Editor

    Do you have an opinion about this story? Do you have some thoughts you'd like to share with our readers? Plastics News would love to hear from you. Email your letter to Editor at [email protected]

    Most Popular
    1
    IRS provides guidance for how excise taxes will impact resin pricing
    2
    California passes strictest plastics law in US, with EPR and recycling targets
    3
    Industry veterans plan nationwide network of PET recycling plants
    4
    Newell closing Coleman plastics plant in Texas
    5
    PS prices jump in June, more increases on horizon
    SIGN UP FOR TO RECEIVE THESE EMAILS AND ENEWSLETTERS
    EMAIL ADDRESS

    Please enter a valid email address.

    Please enter your email address.

    Please verify captcha.

    Please select at least one newsletter to subscribe.

    Get our newsletters

    Staying current is easy with Plastics News delivered straight to your inbox, free of charge.

    Subscribe today

    Subscribe to Plastics News

    Subscribe now
    Connect with Us
    • LinkedIn
    • Facebook
    • Twitter
    • Instagram

    Plastics News covers the business of the global plastics industry. We report news, gather data and deliver timely information that provides our readers with a competitive advantage.

    Contact Us

    1155 Gratiot Avenue
    Detroit MI 48207-2997

    Customer Service:
    877-320-1723

    Resources
    • About
    • Staff
    • Editorial Calendar
    • Media Kit
    • Data Store
    • Digital Edition
    • Custom Content
    • People
    • Contact
    • Careers
    • Sitemap
    Related Crain Publications
    • Sustainable Plastics
    • Rubber News
    • Urethanes Technology
    • European Rubber Journal
    • Tire Business
    Legal
    • Terms and Conditions
    • Privacy Policy
    • Privacy Request
    Copyright © 1996-2022. Crain Communications, Inc. All Rights Reserved.
    • News
      • Processor News
        • Injection Molding
        • Blow Molding
        • Film & Sheet
        • Pipe/Profile/Tubing
        • Rotomolding
        • Thermoforming
        • Recycling
      • Suppliers
        • Machinery
        • Materials
        • Molds/Tooling
        • Product news
        • Design
      • More News
        • Mergers & Acquisitions
        • Sustainability
        • Public Policy
        • Material Insights Videos
        • Numbers that Matter
      • Digital Edition
      • End Markets
        • Automotive
        • Packaging
        • Medical
        • Consumer Products
        • Construction
      • Special Reports
        • CEO Issue
        • Diversity
        • Best Places to Work
          • 2022 winners
        • Processor of the Year
        • Rising Stars
        • Women Breaking the Mold
      • Newsletters
      • Resin pricing news
      • Videos
    • Opinion
      • The Plastics Blog
      • Kickstart
      • One Good Resin
      • BRICS and Plastics
      • All Things Data
      • Viewpoint
      • From Pillar to Post
      • Perspective
      • Mailbag
      • Fake Plastic Trees
    • Shop Floor
      • Blending
      • Compounding
      • Drying
      • Injection Molding
      • Purging
      • Robotics
      • Size Reduction
      • Structural Foam
      • Tooling
      • Training
    • Events
      • K Show Livestream
      • Plastics News Events
        • Plastics News Executive Forum
        • Injection Molding & Design Expo
        • Plastics News Caps & Closures
        • Women Breaking the Mold Networking Forum
        • Plastics in Automotive
      • Industry Events
      • Injection Molding & Design Expo
      • Livestreams/Webinars
        • Reuters Responsible Business Europe 2022
        • Reifenhäuser Technologies Livestreams
      • Editorial Livestreams
        • Polymer Points Live
        • Numbers that Matter Live
        • Plastics in Politics Live
        • Sustainable Plastics Live
      • Ask the Expert
      • Plastics News Events Library
        • Plastics Caps & Closures Library
        • Plastics in Healthcare Library
        • Women Breaking the Mold Networking Forum Library
      • Processor of the Year submissions
    • Resin Prices
      • All Resins
      • Commodity TPs
        • Historic Commodity Thermoplastics
      • High Temp TPs
        • Historic High Temp Thermoplastics
      • ETPs
        • Historic Engineering Thermoplastics
      • Thermosets
        • Historic Thermosets
      • Recycled Plastics
        • Historic Recycled Plastics
    • Rankings & Data
      • Injection Molders
      • Blow Molders
      • Film Sheet
      • Thermoformers
      • Pipe Profile Tubing
      • Rotomolders
      • Mold/Toolmakers
      • LSR Processors
      • Recyclers
      • Compounders - List
      • Association - List
      • Plastic Lumber - List
      • All
    • Directory
    • Custom
      • Sponsored Content
      • LS Mtron Sponsored Content
      • Conair Sponsored Content
      • KraussMaffei Sponsored Content
      • ENGEL Sponsored Content
      • White Papers
      • Classifieds
        • Place an Ad
        • Sign up for Early Classified