Company insight
Choosing the right medical device
electing a medical device component supplier is a critical stage of the medical device manufacturing process. The components they will manufacture may only play a small part in the overall design, but they play big part in its overall success. As a result, it is vital that those chosen can deliver a high-quality product in sufficient supply and on time.
S Finding the right fit
When choosing a supplier to contract, there is a long list of requirements that must be met. Most of this will be conducted through the procurement process, using pre-qualification questionnaires and invitations to tender documents. But before undertaking formal procedures, there are some key factors to focus on in order to identify whether a potential supplier is likely to meet your needs. Primarily, these can be condensed into the categories of; manufacturing scope, expertise and experience, ability to meet tight deadlines, quality of customer service and value-add services.
Manufacturing scope
Of fundamental importance in any medical device component manufacturer is that they possess the scale, technical skills and equipment to supply the number of components in sufficient quality for the medical device. In an area as tightly regulated as healthcare, this means they must have the relevant international standards, such as ISO 13485. In many cases, this will mean the supplier must carry out manufacturing in a
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component manufacturer
One of the most significant decisions during the process of manufacturing a medical device component is finding the right manufacturer for your product. Whether you are looking for industry experience, quick turn-around times or exceptional customer service, the relationship between the supplier and manufacturer is critical to its success. Medical Device Developments speaks with Mike Boldig, director of operations at Custom Wire Technologies, to understand why finding the right partnership is crucial to manufacture a successful product.
Top OEMs trust CWT’s precision grinding capabilities.
compliant clean room, meeting the highest levels of hygiene in order to minimise the risk of any air pollutants or bacteria impacting the process. In addition to health and quality considerations, another key differentiator when assessing potential suppliers is how much of the production process can they carry out in-house. Will they need to outsource part of the manufacturing, or can they construct and carry out the finishing processes, such as coiling and grinding.
Now in its 22nd year in business, US-based Custom Wire Technologies (CWT) is a leading medical device original equipment manufacturer (OEM) with experience in the design and development of medical wire components. Offering products and services in the areas of coiling, grinding and wire forming, the company is well equipped to
customise wire products for a variety of applications, such as guidewire coils and assemblies, Kirschner wires, mandrels and profile ground custom tips. In 2021, the company undertook an expansion in its operations in Port Washington, Wisconsin, that doubled its manufacturing footprint and allowed for the construction of a brand-new class seven cleanroom. Additionally, the expansion also includes a class eight ultrasonic wash and passivation cell that enables it to carry out all the processes of manufacture in house. “With the growth CWT has experienced in the past few years, we were no longer able to purchase equipment due to space constraints. This would have affected our ability for future growth,” explains Mike Boldig, director of operations at CWT. “We are now in a much better position to support our rapidly increasing customer base.”
Medical Device Developments /
www.nsmedicaldevices.com
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