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Biocoat Home Lubricious Coatings in spec, on time, and on budget - Part 2 Posted by Josh Simon on Mon, Sep 24, 2012 @ 09:38 Tweet 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. 1 Comment Click here to read/write comments Tags: lubricious coating , Hydrophilic Coating , coatings vendor , coating company , coating manufacturer , medical device development , hydrophilic coatings , lubricious coatings , coatings manufacturer , coatings supplier Lubricious Coatings in spec, on time, and on budget Posted by Josh Simon on Mon, Aug 13, 2012 @ 12:02 Tweet Ultimately on this blog, I try to keep the marketing of my own products to a minimum because what I am trying to do here is provide an educational resource. The title is deceptive, therefore, because I am actually thinking broadly and more literally about how any lubricious coating can be applied in spec, on time, and on budget. I do this because I was recently presented with a marketing piece from a medical device development company that broke their services down into precisely those three categories. So, what is involved with getting a hydrophilic coating onto a commercial device in spec, on time, and on budget, and how much of that is dependent on the vendor versus just plain old reality? Let me focus on specs in this article. Maybe later I will cover the others. A couple of years ago, I posted a checklist for hydrophilic coatings . That post explained many of the questions a potential client should answer before contacting a vendor. Like the coatings white paper I wrote on the same basic subject, it explains that you need to at least know what the device will be used for, i.e. what industry, what procedure, as well as what the materials used in the device are, among other things. Once those things are known, there is another layer below that. For example, lubricity is a broad term to mean slipperiness, but just how slippery should the medical device surface be? What coefficient of friction do you want? 0.1? 0.01? Teflon is a great hydrophobic coating that can go as low as 0.1, but true hydrophilic coatings are needed to get to 0.01. After understanding the friction (or lack thereof) at the surface, what sort of use will the device experience? Is it going to be quickly inserted in vivo and then removed after a few seconds, or is it going to abrade against the inner lumen of a blood vessel, or maybe even another hard plastic catheter? Being able to tell your coating vendor what you want is important, and that is independent of the coating vendor. In some ways, most hydrophilic coatings on the market are the same, but they do differ in other important ways as far as processing, composition, and business models. They also can influence the other two pieces of this puzzle: time and budget. 1 Comment Click here to read/write comments Tags: medical device , advanced coating , lubricious coating , medical device coating , Hydrophilic Coating , medical device development , medical device coatings , hydrophilic coatings , lubricious coatings Medical Device Industry - An Informal Survey Posted by Josh Simon on Tue, Jul 31, 2012 @ 09:04 Tweet Over at the Medical Design Perpectives blog, I have a guest article there about a trip I took to visit almost 50 medical device companies over the last three months. The trip was ultimately for the purpose of selling our hydrophilic coatings, but what wound up happening is I got a great set of answers to some questions about where the medical device industry is heading. Medical device companies are heading outside the US , to put it simply. 0 Comments Click here to read/write comments Tags: medical device , Regulatory , medical device development Lubricity Testing - Manipulation of Data for a Smoother Outcome Posted by Josh Simon on Thu, Jul 05, 2012 @ 04:27 Tweet I've been locked in my office all day today working on the slides for this upcoming webinar. You can registor for it by clicking this link: Depending on how you test a hydrophilic coating, you will get different outcomes, for the same coating, and some may be "good" and others not. Moreover, companies that sell hydrophilic coating frequently "massage" the data, usually by leaving out some particulars, to make their coatings seem more lubricious or durable than they really are. What I aim to do here is not directly attack printed data, but rather educate the public on the proper questions to ask about data, so they can think critically about it themselves. I will go over several different types of lubricit...