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 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 will be conducted through the procurement process with Pre-Qualification Questionnaires and Invitation 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 and experience, ability to meet tight deadlines and quality of customer service.
Of fundamental importance in any medical device component manufacturer is that they possess both the scale and technical skills and equipment to supply the number of components of sufficient quality for the medical device. In an area as tightly regulated as healthcare, this means that they must have the relevant international standards such as ISO 13485.
In many cases this will mean that the supplier must carry out its manufacturing within a compliant clean room with the highest levels of hygiene to minimise the risk of any air pollutants or bacteria impacting on the process.
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, Custom Wire Technologies (CWT) has established a cutting edge production facility that operates to all applicable industry and international standards.
In 2021, the company expanded its operations in Port Washington, Wisconsin 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 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 affect 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.”
Expertise and 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 product development process so having a supplier that is experienced in working with their customers to minimise 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.
Having manufactured medical device components such as medical coils for over two decades, CWT has expanded its customer base to include some of the largest original equipment manufacturers (OEMs) within the sector, producing a wide range of components for catheters and guidewires.
“We have been making coils for over 20 years and have seen a multitude of applications using numerous sizes of materials, making thousands of sized and shaped coils,” explains Boldig. “Our manufacturing experience give us the upfront knowledge as to what works and what doesn’t.”
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 respond to changing demand.
As levels of demand fluctuate, the ability of a chosen supplier ramp up production rapidly to respond to any sudden spike can be critical in ensuring an OEM is able to capitalise. When assessing a potential supplier’s ability to do this, their relationship with their material suppliers, the amount of additional manufacturing capacity they have and any ability to shorten lead times are all helpful indicators.
Having had to contend with a growth in demand from multiple customers because of Covid-19 – at the same time as the pandemic disrupted the supply of raw materials – CWT responded rapidly by implementing shift patterns around the clock to expand its capacity.
Based on the success of overcoming this challenge and having identified a clear demand for rapid turnaround in the long-term, the company has now launched the QwikCoil programme that offers customers the chance to be guaranteed delivery of their coil components within just a week.
“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,” says Boldig.
High quality customer service
Last but by no means least, 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. They must be able to build a close working relationship and in-depth understanding of both the product that the customer is manufacturing but also how they operate so that they 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 as a company to service the need for OEMs to be able to outsource a lot of the work that was not core to their capabilities, CWT has ensured that as much as it has grown has not led to it losing that focus of customer-centricity.
“When this company was started, the slogan was ‘a new day has dawned on customer service’. We still believe that today,” says Boldig.