Should You Start A Hydrophilic Coatings Company?
Let’s say you’ve been keeping track of the growing market for neurovascular and cardiovascular products out there, and let’s also say you’ve realized that most of these products require some way of being slippery in order to get into those tiny spaces in the brain and peripheral blood vessels. You’d be on the mark. The neurovascular market grows at 15 to 20% per year and the cardiovascular market grows at about half that range, depending on who you read. One could take it from there to assume that these products all need some kind of technology, probably a coating, to remain slippery, so why not make a go of it as a business?
Making the right decision on that should involve a few considerations. Here are five of them to think about:
1) Changing a coating vendor is a huge pain.
If your dreams include landing the Johnson & Johnson’s, Medtronics, and St. Jude Medicals of the world, you need to have something really great up your sleeve, or you need to think again. When a company selects a vendor for a product, particularly for a hydrophilic coating, that selection is written into the regulatory submissions of the product. If it is in the US, that means the 510K (for a Class II) or the PMA (for a Class III) submission for the device mentions the coating by name. In order to put your new coating on their existing device, the company would have to re-submit their 510K or supplement their PMA…. a huge deal especially if that product is actually a product line with tens or even hundreds of SKU’s. The paperwork alone is staggering, not to mention revalidating production.