Method Development

Method Development Services for Coating Medical Devices

Speed to market matters.
With the speed of product innovation in healthcare there is no assurance that medical devices used for a particular condition won’t fall out of favor with doctors, come under significant price pressure, or become obsolete after a relatively short time.

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 method development services.

At the onset 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.

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.

Validation (DOE/OQ / PQ)
Using statistical methods and design of experiments, we find the process limits for coating your device, identifying the high and low limits of the variables that influence the production of a good part.

With the confidence obtained with a successful Operational Qualification (OQ) we will design and perform a statistically driven Process Qualification study to ensure the target process produces coated parts that meet the specification.

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 Your Device!
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.