Speed is of the essence for new medical devices entering the market – and the coating plays a vital role. Delays in the commercial launch of a medical device can have a serious impact on the bottom line and impede revenue generation.
For a smaller company, bringing in this revenue is what will ultimately secure its future and help establish its presence and the product on the market.
A crucial aspect of many medical devices is the coating. Selecting the optimum coating can save substantial time in not only enabling the product to enter the market sooner but also ensuring its long-term performance.
If a coating is just selected off-the-shelf out of convenience, there is a risk that it will be ineffective and could cause a variety of regulatory approval issues. This will send the manufacturer back several steps, requiring them to start the regulatory application process all over while they try to find a coating that meets their needs.
“There have been times when the manufacturing phase begins before the manufacturer has realised that the coating is necessary,” says Todd Paulsen, vice-president at coatings specialists, Formacoat. “The phrase ‘you don’t know what you don’t know’ comes to mind. This can come from a lack of testing, forethought, or quite simply: it just doesn’t work. It can be quite costly and lead to problems further down the line.”
In the unlikely scenario that a device receives regulatory approval and is launched on the market with an inadequate coating, any resulting defects will require devices to be recalled and returned to the manufacturer to rectify. This can lead to considerable costs and even fines for the manufacturer while diminishing revenue potential even further.
Ideally, the exact demands of a medical device must be established before the prototyping phase to make sure that the coating is sufficient, as an effective coating can boost the lifespan of a medical device and decrease the frequency of replacements required.
To avoid these negative consequences, manufacturers should consider working directly with a coating application specialist for their medical device in the earlier stages of development. But who do you turn to? “Most certainly you’d like the applicators with the most options and that have the most experience in applying all variety of coatings,” adds Paulsen. “You want someone that will be able to tell you whether or not your device even needs a coating. And can show you the data to back up that opinion.”
Getting medical devices to the market more quickly
Ensuring that medical device coating needs are met is what Formacoat specialises in. The Minnesota-based business cuts straight to the point with the Formacoat Formula, asking potential customers: “What do you want? And why?”
Formacoat has built an extensive range of coatings, meaning there is a strong likelihood that the company will be able to provide the optimum solution.
The company offers robust hydrophobic coatings that provide a protective barrier for medical devices against liquids, preventing contamination or damage from moisture. Formacoat also provides high-performance hydrophilic coatings to enhance the lubricity and biocompatibility of a medical device.
At Formacoat, there is a focus on functionality and thinking outside the box to deliver what an application requires. Their highly innovative R&D team stands at the ready-to-try solutions never before considered, borrowing from more than 20 years of coating experiences to mould, shape and modify coatings to perform in new and exciting ways.
What has added a new dimension to R&D at Formacoat is the 3D printing machines. This technology aids not only in the modelling of the products and devices but also in creating fixtures and coating apparatuses needed to coat every possible type of device. The technology helps to speed up development timelines and market launches.
The performance of coatings provided by the company is assured, with proof in the track record of Formacoat customers getting products to the market more quickly.
The success of Formacoat is reflected in its growth. With the family businesses effectively starting from one man in a garage, the company moved to a large purpose-built facility a few years ago that was expected to be big enough to last for several years. Yet due to the demand for its products, the company is now expanding to open a new facility in its home state, as well as looking further afield at a potential facility in Ireland to serve the European market.
To learn more about the extensive range of medical device coatings Formacoat provides, download the document below.
