Feature Article

By: Brian Buntz

Surface treatment of medical device components is a wide-ranging topic, encompassing techniques such as blast finishing, plasma treatment and an array of coating technologies that are vital to the production of many medical device components. But establishing an in-house surface treatment operation can be tough work. In the medical device sphere, the demands for surface treatment seem to be constantly changing, making it difficult for nonspecialised firms to keep up. Device manufactures that do establish in-house surface treatment facilities often face initial quality-control problems and frequently encounter high rejection rates—at least when starting out, explains Derrick Stanbrook, Process Development Manager, Rösler UK, (Prescot, UK; www.rosler.com), a surface-finishing subcontractor. Companies establishing in-house surface-treatment operations also must spend time dealing with costly learning curves each time a new team member, product or surface-treatment requirement is introduced, he adds. Installing necessary equipment can entail other problems, as well. For instance, surface blasting operations require establishing procedures to deal with the dust and any effluent resulting from mass finishing.

 

Outsourcing surface treatment frees medtech firms from the need to maintain the associated raw material inventory and dedicated production space. There are often financial and strategic benefits, as well. For instance, surface-treatment subcontractors often can achieve production efficiencies that enable them to minimise per-part surface-treatment costs. “In addition, many device firms have found surface-treatment subcontracting partnerships to be cost effective since potential problems are identified and eradicated before significant investment has been made in a design,” Stanbrook says. “By working with the medical device company every step of the way, small design changes can be made early in the process to prevent huge delays and overruns late in the game.” Stanbrook cites an example from the prosthetic implant industry, where Rösler worked with a variety of manufacturers to eliminate a number of finishing processes on femorals. “We were able to produce the required finish on a ground femoral casting straight from the grinding machine without any preparation processes being performed,” Stanbrook says. “This brought significant finishing cost savings, reduced lead times and eliminated rework and double handling.”

 

Outsourcing surface treatment of new medical components can be especially advantageous during the early stages of product release, says Gerhard Winter, President of Plasmatech Inc. (Erlanger, KY, USA; www.plasmatechnology.com), which specialises in plasma-enhanced chemical vapour deposition (PECVD) technology. “Once initial, small-batch processing parameters are established, upscaling can be challenging since it is not necessarily a linear process.” Device manufacturers can rely on a subcontractor’s expertise to take them from prototyping to full production ramp-up, Winter says. “Rather than risking under- or over-sizing capital equipment based on preliminary market demands, the medical device firm can defer this, along with associated personnel and overhead expenses, until production requirements are confirmed.” If volumes increase enough to make it economically viable, and the device manufacturer chooses to bring the treatment in-house, the outsourcer can recommend an appropriate system and then transfer the model-specific process parameters to the medical device company, he explains.

 

When establishing a subcontracting relationship, it is vital to clearly delineate your objectives at the outset. The surface treatment firm needs to have a comprehensive grasp of your expectations. Your company should make sure everything you plan to accomplish is in writing and that your goals are laid out as clearly as possible. “Ideally, thorough consideration will be given to establishing procedures for the medtech manufacturer’s component manufacture, handling and storage before the surface-treatment work actually begins,” Winter recommends. “Prior to going forward with production, the medical device firm and supplier typically work together to establish detailed processing, handling and quality-control procedures to be followed by the service provider,” he says.

 

To make sure you meet your deadlines and that the subcontracting work complies with your expectations and the requisite regulatory standards, it can be helpful to define intermediary milestones between the start and finish of the outsourcing project and to set up a timetable. This strategy enables your company to have a clear understanding of the status of a project as it progresses.

 

It’s also important to advise your subcontractor, as early as possible, of any planned changes in production. “Let the supplier know of any change in material, production, storage or assembly methods that pertain to pre- and post-treatment [stages],” Winter says. “Even subtle and seemingly inconsequential changes can impact surface treatment or coating results.”

 

Your subcontractor should have an idea of “how you want to position the business for the next two or three years, and how the provider can help you realign the relationship to support your goals,” Winter says. If your company needs to change its outsourcing strategy, it can be helpful to get input from the outsourcer, so the vendor can adapt to your company’s shifting needs. Stanbrook also recommends frequent communication regarding your firm’s current and future surface treatment requirements. “By sharing information on market requirements, product development and through face-to-face meetings with the end-user, we are able to ensure we are correctly investing in equipment, consumables and process facilities,” he says.

 

Unless you have enlisted your oustourcer to clean parts for you, make sure you verify the cleanliness of the components before shipping them to the outsourcer. “We obviously need to start with a clean product,” says Henrik Nittmar, PhD, CEO of Corline Systems AB (Uppsala, Sweden; www.corline.com), a company that offers heparin-based coating services to enhance biocompatibility of medical devices. “Normally we ask customers to provide products cleaned as for clinical use, but not sterilised,” he explains. “We also ask our customers to double-check with their material supplier to make sure that the production process does not involve materials such as lubricants that may come off the material after cleaning,” he adds. “This is not uncommon, and materials suppliers are not always upfront about such things.” Such seemingly small details can have very negative consequences if they are overlooked, Nittmar says.

 

Winter also stresses the importance of part cleanliness: “Residual cleaning agents or mould release can create weak boundary layers resulting in surface treatment or coating failures,” he explains. “Parts should be handled with gloves—before and after surface treatment,” he advises. “Both untreated and treated components should be stored appropriately and kept sealed until ready to use,” Winter adds. “To reduce risk of contamination, consider packaging in quantities no larger than what is required for a lot run, shift or day.”

 

The importance of understanding a product’s full life cycle, from processing and storage to its use by doctors, can’t be overstated, says Kurt Jansson, COO of Corline Systems. “By knowing all the details, we can use our broad experience to suggest a better solution for our customers. The best results are achieved through true partnerships.”