Finding the optimum coating for a new medical device can significantly help to streamline the process of getting a product from concept to cash flow. However, this is easier said than done. Optimizing efficiencies in development timelines takes skill and experience with coatings.
A device may work as intended outside of the body during prototyping, but clinical trials can bring numerous issues to light that were possibly overlooked or not considered during development.
In addition, there is a common failure among manufacturers to understand the chemistry required for coatings and assess different options during the earlier stages of device development. This can cause problems further down the development timeline – particularly when it comes to beginning clinical trials and progressing to regulatory approval. If the coating is insufficient, regulatory approval will not be granted.
US-based company Formacoat is a specialist provider of medical device coatings and comprehensive R&D solutions. With hundreds of coatings in stock, there is a strong chance that the family-owned company will have the right solution – or may even develop one especially.
“We get people who come to us with certain ideas of what they want to use,” explains Brontë Gross, marketing engineer at Formacoat. “And it winds up being that the chemistry is completely incompatible in some circumstances. Or sometimes, they want to do things that their coating’s not the best choice for.
“It’s better to come in with an open mind because we have access to such a wide variety of solutions that it can help avoid those sorts of issues.”
Resolving misconceptions around medical device coatings
All too often, coatings are an afterthought for manufacturers. Many customers approach Formacoat towards the end of their design phase when access to their devices is more limited and their idea of the type of services and solutions that they want may not always be the best choices.
“They just want us to tack a coating on. So, that sets them and us up for failure in terms of meeting their timelines with little to no testbed,” says Brecon Gross, manufacturing engineer at Formacoat. “We’re waiting sometimes up to three months for a customer just to send us examples of their product. And they want us to be able to turn around something in one to two weeks after that to meet their clinical deadlines.
“Being able to work ahead of time, with more access to an initial substrate, or with ideas of even the basic choices that are available, allows us to reduce the risk towards the customers and parts.”
While there are often mechanical and design engineers in start-ups developing new devices, there can be a lack of chemical engineers within these companies. And this absence of chemical know-how can lead to issues with coatings at later stages in development and when entering clinical trials.
“We have seen where the coating chosen by a customer can physically degrade their device based on the application because chemistry can be aggressive,” adds Brecon Gross. “And getting chemistry to stick to new-age polymers can be very challenging. It’s chemically resistant, heat resistant, crack resistant – and that also means coating resistant, to a certain extent.”
There is also a misconception that a coating must be tested on the final device. But this can prove to be expensive, especially if destructive testing is needed. However, to test the coatings, the product does not have to be functional. In fact, Formacoat can take discarded or broken devices and test out coatings on materials that would otherwise have been disposed of. If destructive testing is required, it does not have to damage a finished device or necessary component.
Streamlining the process for medical device coatings selection
Formacoat’s vast experience in coatings and extensive range of solutions can dramatically speed up the progress toward regulatory approval for a medical device. The company often has a strong indication of the best solution when approached by a potential customer. This expert insight can mean a process that may ordinarily take up to five months for certain manufacturers is reduced to a few weeks.
“The most effective streamlining we have is we can home in on the right coating for a given device, an application, and customer market in one interaction. One experiment would take a catheter development company two to five months because they have to go through all the steps,” explains Mark Gross, CEO of Formacoat and father of Brecon and Brontë. “We have so many different coatings and so much experience. We can find the right coating for a device based on all our knowledge about the markets, the prices, the costs, the substrates, and the application. That can all be done in three weeks.”
Furthermore, Formacoat’s speed in providing the ideal coating can be even faster in certain applications. Such is the level of expertise within Formacoat that the optimum coating, in some cases, does not even require any testing.
“Within the last three months, we had a customer and were going to do four coatings. And after the initial engineering meeting with them, we only tested one because we knew what they needed,” says Brecon Gross.
“It met all their criteria, and it didn’t take us any extra time. We literally white-boarded the answer to their coating requirements, because we had already used all the options and we eliminated them without even doing any substantive testing.
“Now, that is only an effective answer for customers that need to go very, very fast. We would always prefer to test more cases and give people options. But if their use case is that they need to be on market ‘yesterday’, then that’s what we can do.”
Formacoat customers can rest assured that whatever coating is recommended by the company is the top choice for not only functionality but also longevity for the medical device. “We have the equipment, we have the chemists, we have the engineers, and we have almost all the coatings in-house. The only things we need are your use cases, your requirements, and your product. The rest of it is already in our building,” adds Brecon Gross.