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Methods

A Method is the detailed description of every critical element for your coating program. It includes the detailed processes, standards and practices required to reliably deploy an advanced surface on your healthcare product.

Method Development Services

Speed to Market Matters

Methods represent the second “M” in The 4M Framework.  A Method is the detailed description of every critical element for your coating program.   It includes the detailed processes, standards, and practices required to reliably deploy an advanced surface on your healthcare product.   The process we use to prepare the Method we call START NOW!  It starts with a detailed understanding of your device and the coating performance your product requires.  Capabilities include lubricity and durability testing, coating thickness measurement, coating coverage, FTIR spectroscopy, high-pressure liquid chromatograph, and more.

With today’s shorter product life cycles, improved speed-to-market has become essential.  By some estimates, up to 80% of a medical device company’s profit comes from products introduced in the last 5 years. Get to market faster with Harland Medical’s exclusive START NOW! Process and Method Development services.  

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Method Development Services

In addition to Method Development for functional coatings like hydrophilic coatings, Harland has a dedicated team to prepare Methods for combination device programs. These devices have specialized testing and analysis requirements that Harland has in-house. Details can be provided upon request.

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Development & Validation

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Initialization

At the outset of each program we quickly work to understand your performance requirements, economic targets and production volume goals. With this understanding, we are able to share best practices and clearly explain options and benefits of different approaches and discuss the chemistry products available to fulfill your specific needs.

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Feasibility

With your requirements in mind, we perform rapid proof of concept coating services on your samples, inspect and test them and return them with a comprehensive technical report.

Prototype Development

Using the experience gained from the outcome of the feasibility phase, we optimize the surface enhancement chemistries and manufacturing process used to produce your parts. We also provide coating services for any quantity of prototype parts required for your development needs.

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Validation

With your requirements in mind, we perform rapid proof of concept coating services on your samples, inspect and test them and return them with a comprehensive technical report.

Small Runs

As your product advances through the development process, Harland’s method development services are there to deliver fast turnaround coating services to support pre-clinical studies, clinical trials and market launch quantities of coated devices.

Launch

We provide complete training and implementation support if you choose to transfer the process to your facility. In addition to the initial start-up support we are available to provide ongoing refresher training and validation support.

Total Solution

Single Supplier for All of Your Medical Device Coatings
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