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January 11, 2022updated 26 Jan 2022 11:40am

Ensuring quality and supply chain visibility for medical device components

Due to a combination of medical devices becoming more complex and precise, along with manufacturers increasingly operating as global entities, outsourcing for individual components is an efficient way of ensuring that each part of your product is expertly tailored for its application.

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Medical Metals and Coatings

Medical-wire components are essential for therapeutic devices. They play the important role of transmitting, sensing or stimulating signals within the body, all the while needing to be biocompatible and offer various features (depending on the application) such as lubricity, conductivity or fatigue resistance. OEMs must choose an appropriate metal material and configuration (such as thickness or coiling), as well as a suitable coating to ensure that the medical device is as efficient and reliable as it can be. This whitepaper outlines the support you can receive from Sandvik experts for materials and coating selection, with an included example of how materials are selected for orthopedic applications, which marked the company’s entrance into the medical field.
by Sandvik
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Some components are more complex than others, and outsourcing can become complicated and lack transparency if they’re going through multiple subcontractors. For components such as medical wire, a lot of important decisions have to be made; what metal alloy is best suited for the application? What cutting method is being used to ensure precision? What kind of coating should be used, and what is the best method of application?

This poses a problem for OEMs not only because it can be time consuming having to negotiate and explain end-goals to multiple subcontractors, but if the final product is not up to scratch, it can be difficult to identify where the problem is in the design or manufacturing process. This approach can lack supply chain visibility and lead to inconsistent quality control.

The solution is to find a medical wire manufacturer than can act as a one-stop-shop for these components, from design to production, who are experts in each area of wire configuration.

Enter Sandvik, who can provide medical device manufacturers with everything from metal/alloy development to surface treatments, precise cutting and coiling. Starting from the initial consultation where OEMs can explain what properties they need the wire to feature, followed by designing, testing, and final development, customers can rely on Sandvik every step of the way.

According to Gary Davies, manager at Sandvik Materials Technology’s business unit for medical wire manufacturing: “A medical device OEM may have one wire producer, and another company is doing the coiling or stripping of the coating. If there’s a quality problem, the subcontractor that’s doing the coiling may blame the quality issue on the wire supplier and the wire supplier may blame it on the coiler. This situation doesn’t benefit the OEM because they just want a good quality product.

“A one-stop-shop is responsible for the product from beginning to end, including the quality, performance and precision. If you’re doing all of those processes under one roof, then this enables design time to be used more efficiently, so the time working with the OEM can be more focused on consistency and quality.”

Medical wire from Sandvik falls under its EXERA® brand, which was launched in 2016. The brand’s inception followed a partnership with a pacemaker manufacturer and the demand for support with difficult configurations became clear. From building machines designed specifically for complete precision for cutting ultra fine wire, to utilising expertise in metallurgy and process development, Sandvik was the perfect fit for a one-stop-shop approach.

Sandvik offers more than 200 metal alloys, metallurgy experience dating back to 1862, expert precision cutting, a range of polymer insulation, PTFE coatings and extruded coating. By acquiring Polyfil and Galvarex the electroplating and electropolishing capabilities, as well as customised coiling and coating stripping services have been added to the value-added service portfolio. EXERA® components have been used for a variety of applications, including vascular therapy, biosensing, and neurostimulation.

For more information about Sandvik’s medical materials, download the whitepaper below.

Free Whitepaper
img

Medical Metals and Coatings

Medical-wire components are essential for therapeutic devices. They play the important role of transmitting, sensing or stimulating signals within the body, all the while needing to be biocompatible and offer various features (depending on the application) such as lubricity, conductivity or fatigue resistance. OEMs must choose an appropriate metal material and configuration (such as thickness or coiling), as well as a suitable coating to ensure that the medical device is as efficient and reliable as it can be. This whitepaper outlines the support you can receive from Sandvik experts for materials and coating selection, with an included example of how materials are selected for orthopedic applications, which marked the company’s entrance into the medical field.
by Sandvik
Enter your details here to receive your free Whitepaper.

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