Start Now Medical Coating Programs
Hydrophilic coated catheters, guidewires and other devices
Start Now is Harland’s proven process for bringing a new medical coating programs successfully to market with the coating being conducted either in a Harland Coating Services facility or in your own manufacturing location. The Start Now process consists of a series of stage-gated steps designed for rapid speed to market while including the necessary steps to produce a robust, production-ready coating method. Typical applications include hydrophilic coated catheters, guidewires and other devices typically used for minimally invasive procedures.
Speed to market matters.
With today’s hypercompetitive medical device market and shorter product life cycles, speed to market is more important to a product’s success than ever before. But with rapid product development timetables, they cannot come at the expense of high quality process development. Harland’s Start Now process has proven itself in achieving these development goals.
Our START NOW process looks like this. (at right)
Here’s a description of each step
Understand customer needs
At the onset of each program we work to thoroughly understand your performance requirements, device characteristics, 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.
Using the experience gained from the outcome of the feasibility phase, we optimize the surface enhancement chemistries and manufacturing process employed to coat your parts. At this stage we also provide coating services for any quantity of prototype parts required for your development needs.
Method Optimization / Operational Qualification
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.
At this step we conduct a formal transfer of the Coating Method and work instructions to your facility to a Harland Coating Services location. If the coating is to be done in your facility, the Method Transfer step includes on-site training of your personnel needed to implement the Coating Method.
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.
Additional 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!
Once the coated product is launched we remain available to provide ongoing refresher training and validation support.