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Choosing a Medical Device Manufacturer to fit your needs is no simple task.The thread that ties together all the technical and operational aspects of a customer and supplier relationship is the ability to ensure customer service of the highest quality. The manufacturer must be able to build a close working relationship and in-depth understanding of both the product that the OEM customer requires, and also how they operate so that it can provide support throughout the process. The closer that bond between the two becomes, the better prepared the supplier is to respond to changes in design or to identify and overcome any challenges that might arise.

Having started out over 20 years ago as a company to service the need for OEMs to be able to outsource high-quality components, CWT has ensured that both the relationships with OEMs, as well as the products produced, continue to achieve uncompromising standards. “When this company was started, the slogan was ‘a new day has dawned on customer service’. We still believe that today,” says Bob Boldig, president at CWT.

 

The Key to Success – The Right Fit

Selecting a medical device component supplier is a critical stage of the medical device manufacturing process. The components they manufacture may only play a small part in the overall design, but they play a big part in its overall success. As a result, it is vital that those who are chosen can deliver a high-quality product in sufficient supply and on time.

When choosing which supplier to contract, there is a long list of requirements that must be met, much of which is conducted through the procurement process with Pre-Qualification Questionnaires and Invitations to Tender documents.

But before those formal procedures, there are some key factors that can be focused on to identify whether a potential supplier is likely to meet your needs. Primarily, these can be condensed into the categories of manufacturing scope, expertise & experience, and ability to meet tight deadlines.

 

Manufacturing Scope

In many cases, this will mean that the supplier must carry out its manufacturing within a compliant cleanroom with the highest levels of hygiene to minimize the risk of any air pollutants or bacteria impacting the process.

In 2021, CWT expanded its operations with an expansion that doubled its manufacturing footprint and allowed for the construction of a brand new Class 7 cleanroom. Additionally, the expansion includes a Class 8 ultrasonic wash and passivation cell that enables it to carry out all the processes of manufacturing 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. “With the recent expansion, we are now in a much better position to support our rapidly increasing customer base.”

In addition to health and quality considerations, another key differentiator when assessing potential suppliers is how much of the production process they can carry out in-house. Will they need to outsource part of the manufacturing or can they both construct and carry out the finishing processes such as coiling and grinding. As a specialist manufacturer of medical grade wire components, CWT has established a full-service production facility that operates to all applicable industry and international standards.

 

Expertise & Experience

Beyond having the capacity and equipment to produce the components needed for a medical device, another key characteristic that sets ideal suppliers apart is the experience and specific areas of expertise that they have developed. Issues will always arise over the course of the product development process, so having a supplier that is experienced in working with their customers to minimize any such disruptions can be key in lowering costs and quickly getting back on track.

Equally, in the long term it is likely that a product will evolve or be updated, so the more experienced a supplier is in their specialist area, the more support and guidance they can provide that can help any such changes to be made safely, efficiently, and effectively.

 

The Ability to Meet Tight Deadlines

While the short-term priority in selecting a supplier will typically be to ensure that they can provide the components to meet the specifications of a medical device, the key to a successful long-term partnership will be dictated by their ability to respond to changing demand.

As levels of demand fluctuate, the ability of a chosen supplier to ramp up production rapidly to respond to any sudden spike can be critical in ensuring an OEM is able to capitalize. When assessing a potential supplier’s ability to do this, their relationship with material suppliers, the amount of additional manufacturing capacity they have and any ability to shorten lead times are all helpful indicators.

Having identified a clear demand for rapid turnaround in the long term, CWT has now launched the QwikCoil program that offers customers the chance to be guaranteed delivery of their coil components within just a week. Boldig assures, “People know that they can come to us and we’re going to respond very quickly compared to some of the bigger players that do this work and may have larger backlogs.”

 

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To learn more about how Custom Wire technologies can serve you and your business, be sure to reach out!  We look forward to hearing from you and learning how we can be of service.