In the previous article, I focussed on getting a lubricious hydrophilic coating to market in spec, and what goes into specifications. I gave references to other articles that can help with finding out more about coating selection. In this article I want to focus on time, as in, the time to market for a medical device with a hydrophilic coating.
The first thing to do here is point you to an article from this blog called Why You Won't Get Your Coated Medical Device to Market in 6 Months. This article explains exactly that.
Next I want to elaborate on some of the points I made in that article about time to market. The biggest killer of timelines is not taking into account the time it takes to set up and validate a coating process. I have experienced several cases where a customer has Biocoat do some test coatings for a client successfully, to then have the client say, "Ok, so let's just have you make another 10,000 and we'll be set." Hold the phone! That is not how it works, even if we were a contract manufacturer. "But why doesn't it work like that? You made some great samples, just make more!", says the customer.
Understandable question if you are not working for a hydrophilic coating company, so let me explain.
As I have said before, hydrophilic coatings are not trivial. They are a sophisticated component that forms a substantial piece of the manufacturing process. There is a big difference between whipping up 4 or 40 samples versus producing 10,000 GMP-grade medical devices suitable for use in vivo. If I am doing research samples, I can put a coating onto a device anyway I know how, and as long as it works on a small scale, that is all I care about in the initial stage because I just want the customer to successfully test it on an animal or mechanical tester. Once the device is to come into contact with human subjects, a whole new world of laws and regulations apply.
To make a GMP-grade medical device, a GMP-grade (Good Manufacturing Practice) process is needed. That requires that each device or lot of devices has a batch record and full set of SOP's for the creation of the device, and all of that made on a process that has itself been validated for its installation, operation, and performance (IQ, OQ, PQ). There is no magic validated process anywhere in the world for applying a hydrophilic coating to any device that it may come across, even "easy" devices. Every new device that comes along requires new SOP's and a new process. That requires time to set up. Contract Manufacturers make their living by doing this very thing, but even they need time.
Moreover, the scaleup from making 10 to 100 devices is not a one-to-one thing when making 10,000 devices or 100,000 devices. In each level of production there will be different degrees of automation. There will be different numbers of each piece of equipment, and different numbers of operators. This all has to be planned out.
Medical Device Engineers are so focussed on the processes for extruding their tubing and drawing their wires, and validating those processes, that they forget all about the fact that they need to do the same thing for their hydrophilic coatings. Except here it is worse, because there ARE magic machines and validated processes for making some kinds of tubing and wires, but that is not so for lubricious hydrophilic coatings.
So, again, if you want your coated device on time, make sure you factor in the process development time. You will need anywhere from 6 months to a year to do this properly.