Medical device supply chains are continuing to experience delays amid the recovery from the disruption and shutdowns caused by Covid-19, with numerous bottlenecks occurring throughout.
Within the medical device industry, manufacturers are facing extended waiting times for vital components and raw materials, slowing down the development process and preventing new devices from entering the market.
A key factor in the delays amongst smaller medical device manufacturers is that they are often reliant on multiple vendors to supply everything required for production. However, being dependent on several suppliers is a disadvantage amid prolonged supply chain disruption.
In an industry where timelines are critical, one bottleneck can have severe knock-on effects elsewhere and can even bring development and production to a standstill when waiting for deliveries. Some medical device manufacturers are understood to be waiting more than a year in some instances, with delays lasting for up to 65 weeks for the materials required for vital medical devices such as catheters. Many industry veterans have never known such levels of uncertainty in the supply chain.
“You get one bottleneck at one particular process and everything behind it then also falls behind,” explains Todd Paulsen, vice president of Formacoat – a specialist provider of medical device coatings. “It just causes a horrible cascade effect that people are still struggling with.”
And during clinical trials, if schedules and deadlines are not kept to, it can result in a failure to gather sufficient data required to progress to the next stage towards regulatory approval. In fact, if delays occur over extended periods, then manufacturers may need to restart the regulatory application process from scratch.
While for smaller and newer businesses, the inability to get their device to market causes economic impacts and may mean that operations are not financially viable.
Obtaining coatings amid supply chain disruption
To avoid production delays, relying on fewer partners in the supply chain is a considerable advantage. The faster a device moves from concept to cash flow, the better for a business and patients – who may be in urgent need of such medical devices.
Many of Formacoat’s customers are reaping the rewards of the company’s extensive range of medical device coatings. If there are supply issues or delays with specific coating, Formacoat’s team of experts will likely have another option available. Alternatively, the company’s highly innovative R&D team could even develop a coating to meet the exact performance requirements.
“We are very much specialists in the application of coatings to get our customers to market,” adds Paulsen. “We have so many different coatings to choose from and can pivot quickly.”
Amid times of severe disruption in the supply chain, the family-run company’s long-term strategy of building up coatings stocks has been a notable benefit for customers who may be unable to get supplies elsewhere. The Minnesota-based business has almost 100 types of coatings available from 45 different suppliers.
“We’ve always been of a purchasing mindset and tried to have backups in our system that are not only available but are also qualified,” adds Paulsen.
“When it comes down to it, if I can’t get supply A) from this particular vendor, we’ll have another in place that we can sub it out for, and it’s already qualified and taken care of. Pre-planning was very beneficial to us in the long run. Because we have so many different coatings to choose from, that really did insulate us from any sort of major disruptions.
“We can almost always find something different that’s available. Providing our customers with those options keeps them going as well. I always tell people that we are the ones able to get you from concept to cash flow the quickest.”
To learn more about the range of coatings that Formacoat has available, download the document on this page.
