5 Common Questions Answered About Medical Contract Manufacturing

923302_262233967253943_91942266_n1. What are the benefits of using a medical contract manufacturer?

Some benefits of using a medical contract manufacturer are companies do not have to expend capital on facilities and systems, time can be saved on training or hiring of extra employees, and contract manufacturers utilize professionals experienced in design and development of all manufacturing processes.

2. How do I choose a medical device contract manufacturer?

Look for a manufacturer who can keep costs down and offers rapid product development. Your medical device manufacturer should also follow strict quality assurance standards, such as ISO 13485.

3. For a medical device company, what is the most important consideration for selecting a contract manufacturing partner?

The most important consideration is compliance. The medical device company is responsible for ensuring the partner they select is compliant with the FDA Quality System Regulation. Yearly audits should be required and quality system evaluations need to be performed.

4. What medical contract manufacturing services and processes does Wilson-Hurd offer?

We provide the best in-class Medical Device Contract Manufacturing services including PCB Board assembly, box build, testing, and fulfillment services. We also have a number of processes that we use ranging from graphics printing, welding, heat staking, laser etching to traceability systems, material planning and procurement, and incoming inspection of materials.

5. What certifications does Wilson-Hurd have regarding your medical contract manufacturing division?

We maintain a FDA compliant quality record system and specialize in Class II medical devices. This division has also obtained certification to the ISO 13485 Standard in June of 2014.

You can find more information about our medical contract manufacturing on our website at wilsonhurd.com where you can request a quote or sample, as well as download a free brochure detailing more information about Wilson-Hurd’s capabilities.


Wilson-Hurd, founded in 1904, offers custom printing, fabricating, and electronic manufacturing services specializing in Electronic Control Products, Printed Electronics, POP Displays, Medical Contract Manufacturing, and Nameplates & Dials, Overlays, Panels.

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ISO 13485: What You Need To Know

Clean Room 2.2ISO 13485 is valued by many medical device manufacturers throughout the world. This method was developed to create a management system on which to build compliance to various regulatory requirements. The requirements are not specific enough to contradict any country’s particular requirements, but to allow a company to demonstrate the ability to meet them.

Based on the ISO 9001 process approach to quality management, ISO 13485 focuses on the management of risk in lieu of focusing on continual improvement. In order to achieve ISO 13485 certification, you must develop written policies for:

  • Document and record controls
  • Internal auditing procedures
  • Corrective and preventative actions
  • Process controls and validations
  • Traceability

ISO 13485 can help reduce surprises and failures that might damage a manufacturer’s reputation. It can be used as a tool to ensure the effectiveness of the quality management system. ISO 13485 also provides the manufacturer a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements.

Hydrogel 2Some other benefits that manufacturers hope to gain from having an ISO 13485 certification are:

  • Gain more business and access to markets around the world
  • Increase customer satisfaction by delivering quality products and consistently meeting customer’s requirements
  • Guarantee the manufacturer meets all production standards and regulations for producing medical devices
  • Establish a manufacturer’s credibility and commitment to quality

Wilson-Hurd’s Advanced Technology Facility is proud to be ISO 13485 certified. We take great pride in the quality of your products and strive to be the most respected provider in the markets served. If you would like to learn more about what Wilson-Hurd can do for your medical device, click here.


About Wilson-Hurd:  Wilson-Hurd Manufacturing specializes in the production of custom electronic control products, point-of-purchase displays, medical contract manufacturing, printed electronics, as well as nameplates & dials, overlays, and panels. Wilson-Hurd was founded in 1904, and is headquartered in Wausau, WI, with additional locations in Berlin, WI.

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Featured Project: Respiratory Motion Inc. ExSpiron PadSet

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Wilson-Hurd had the pleasure to work with Respiratory Motion Inc. on a medical device used in patient ventilation. The medical device known as the ExSpiron PadSet connects to a monitor to provide real-time monitoring of ventilation and respiratory rate. Wilson-Hurd’s Advanced Technology Facility (ATF) division used hydrogel technology to develop the PadSet and ran testing to ensure that the product functioned properly.

The ExSpiron PadSet went on to be used in Ebola research according to an article from the Boston Globe. The article states that researchers used the ExSpiron system to remotely perform diagnostics and therapies to a faux patient without having to come into direct contact. To read the full article about the research click here.

Some features and benefits that Respiratory Motion Inc. has mentioned about the PadSet include:

  • Five sensor array helps capture, recognize and discard artifacts
  • ExSpiron Hydrogel technology ensures good skin contact and optimal signal quality
  • Length adjustable Sensor provides for a flexible design which easily adjusts to different body sizes
  • Sensor presents a low profile comfortable Sensor Array
  • Connector provides secure connection
  • Latex-free
  • One size fits most

For more information on Respiratory Motion Inc, please visit their website at www.respiratorymotion.com.

To learn more about Wilson-Hurd’s capabilities, click here.


Are you a current customer of Wilson-Hurd? If you would like your company’s project to be featured on the homepage of our website in our “Featured Projects” section, please e-mail us at marketing@wilsonhurd.com.

Four Benefits in Selecting a Contract Manufacturer For Your Medical Device

Hydrogel 2The decision between hiring a contract manufacturer or leaving the production up to your company may seem daunting. There are many factors to consider. Do you have the resources? The skills? The tools? Do you have a compliant manufacturing quality system? Leaving these tasks up to your company may be too much to handle. That’s why choosing a contract manufacturer may be the best decision for developing your medical devices. Here are some reasons why.

The Benefits

Cost Savings

  • Companies do not have to expend capital on facilities and systems.
  • Money can be saved on labor costs such as wages, training and benefits
  • Contract manufacturers may offer cost advantages such as in acquiring raw materials

Experience

  • Contract manufacturers utilize professionals experienced in design and development of all manufacturing processes
  • Experts use their knowledge to assist companies in selecting the right materials and tools for the product
  • Products are manufactured at a much faster rate

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Business Focus

  • Companies will focus on their core competencies once they hand the manufacturing of the device over to an outside source
  • Time can be saved on training or hiring of extra employees
  • Responsibility of project production can be placed on the professionals with years of experience

FDA Compliance

  • Guarantees the manufacturer meets all production standards and regulations for producing medical devices
  • ISO 13485 certification establishes a manufacturer’s credibility and commitment to quality
  • Emphasizes the cleanliness and safeness in the production area

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Still wondering if contract manufacturing is right for you? Contact us and we can further discuss how Wilson-Hurd can help with your medical device!


About Wilson-Hurd:  Wilson-Hurd Manufacturing specializes in the production of custom electronic control products, medical contract manufacturing, printed electronics, as well as nameplates & dials, overlays, and panels. Wilson-Hurd was founded in 1904, and is headquartered in Wausau, WI, with additional locations in Berlin, WI.

For more information on Wilson-Hurd and our capabilities, visit our website at www.wilsonhurd.com, and contact us at 1.800.950.5013 or at sales@wilsonhurd.com