Coating Process Development

Coating Method Development & Validation Services

With most low-friction hydrophilic coatings, the process employed to apply the coating is just as important as the raw coating solution employed in obtaining optimum coating performance and efficiency. Developing an effective and reliable coating process quickly and efficiently can be a major barrier to the development and launch of a coated medical device. As the industry’s only comprehensive source for everything coatings, we are uniquely positioned to provide you the detailed processes, standards and practices required to reliably deploy an advanced surface to your healthcare product. After understanding the unique needs of your company and the coating performance requirements of your device our expert team will work to rapidly develop a performance coating process that is effective and repeatable. The work is supported by a complete range of surface analysis capabilities. Once this process developed and validated, you have the option to utilize Harland coating services, conduct a bridge coating program for temporary production or immediately transfer the coating process to your facility with complete training and implementation support.

Features

    • Industry leading speed to market
    • ISO 13845 quality system
      • Robust process ready for production
      • Dedicated methods laboratory
      • FDA/CE regulatory support
      • Ability to handle small lots and quick turnaround times for development and market launches

Harland’s Coating Process Development Approach

Initialization

At the outset of each program, we quickly work to understand the performance requirements, economic targets and production volume goals of your particular medical device. With these product parameters in mind, we’re able to share best practices, possible approaches and the advantages and disadvantages of the various coating chemistries available to fulfill your needs.

Feasibility

Upon determining your requirements and preferences, we perform rapid proof-of-concept coating services on your samples. After thorough inspection, testing and evaluation, a comprehensive technical report is then completed.

Prototype Development

With data and experience gathered through the feasibility phase, we optimize the surface enhancement chemistries and manufacturing processes to efficiently achieve the highest quality device coating. Additionally, we provide coating services for any quantity of prototypes required for your development needs.

Validation (DOE/OQ/PQ)

Using statistical methods and designed experimentation, we find the process limits for your device coating, identifying the upper and lower limits of all pertinent production variables.

Small Runs

As your product advances through the development process, Harland’s proficient method development delivers fast-turnaround coating services to support pre-clinical studies, clinical trials and market launch quantities.

Launch

After development of your coating and application process, if you choose to transfer operations to your facility, we provide complete training and implementation support to your staff. In addition to initial start-up assistance, we’re also available for ongoing refresher training and validation support.

Process Development Lab
Inspecting coated devices
Packaged catheters

All of Your Coating Needs in One Place

Every medical device is unique and bringing it to market is a major challenge. That’s why Harland’s Coatings 360 approach tailors a complete answer to your distinct product coating needs and goals. We’re the industry’s only comprehensive source for high-performance coatings, equipment and production coating services—everything you need to coat your medical device on time and within budget. We provide it all in-house, so when you partner with us, you have one resource for everything coatings.

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White Paper: 10 Essentials for a Hydrophilic Coating Program

10 essential elements to consider when selecting a coating program for medical devices such as catheters, guidewires, introducers and other devices.