Lubricious Coatings in spec, on time, and on budget - Part 2

Posted by Josh Simon on Mon, Sep 24, 2012 @ 09:38

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 DipTech Systems 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.

 

 

 

 

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

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.

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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

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.

Tags: medical device, Regulatory, medical device development

Verification of Lubricious Coatings on Medical Devices

Posted by Josh Simon on Wed, Mar 21, 2012 @ 10:43

I have hinted much on this blog about ways to go about verifying hydrophilic coatings on medical devices.  When I speak of "verification", I am talking about the first "V" in "V&V", i.e. the Verification step in Design Controls that may or may not precede a Validation step, depending on the device.  As you may quickly realize, speaking about specific verification steps for any device is a huge task, because verification is nothing more and nothing less than confirming that design inputs = design outputs.  Does your device prototype meet specification?  Since every device in the world has different specifications, it is impossible to come up with ways that apply to all devices.

However, for lubricious coatings there are some general themes that pop up which are widely applicable, even though specific verification tests may vary per device. 

 

Adhesion

In all but rare cases, if you are coating a device, you want the coating to stick, at least for a while.  You may not care if the coating ultimately resorbs, or you might care.  However, in most cases, you would not be satisfied if the coating flaked off and left material behind in the body.  Thus, some sort of adhesion test is necessary.  For flat surfaces, ASTM D3359-78 may be appropriate.  This is known as the "tape test". Modifications to this test would be necessary for curved or irregular surfaces.  Adhesion can also be tested with a pinch test indirectly.

Lubricity

If using a lubricious coating, you obviously want it to be slipperier than a device without the coating.  Thus, your verification process will require some testing of lubricity against a control, and/or to your spec.  Pinch testing is also an option for this, and you can click on the button below to get an article that goes into details on that.  There are also other tests you can rig up, such as an anatomical model for sliding your coated article through it and measuring force or ease of insertion/withdrawal.  The pinch test paper mentions four major kinds of lubricity tests. However, the limitation of most lubricity tests is that they do no correlate to clinical use.   Despite this limitation, they can still be a good basis for making an engineering decision.

 

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Sterilization

Most sterilization testing involves bioburden analysis, i.e. making sure that you get a 4-log kill (or whatever your spec states).  The other thing to think about is how the sterilization method will affect your coating, so you will need to do coating performance tests after sterilization, as well as before (if that is still relevant to you).  Performance testing can be the same type of tests mentioned above for Adhesion and Lubricity.

Aging

Once you have a favored set of tests and output variables, such as lubricity via pinch testing, or adhesion via tape test, you can keep using those tests over and over for environmental effects, such as Aging.  Does your coating remain lubricious after aging?  This can be accelerated aging, but make sure the conditions of acceleration do not adversely affect the coating.  For example, if your coating is sensitive to water vapor, do not run an aging study at 100% Relative Humidity, because it will not correlate with real time.

Transportation and Handling

How will people treat your lubricious coating on the road, in the doc's office, during shipping, at the patients' houses?  The first step is to do a shipping study.  Send the coated article somewhere and test its performance.  Make sure it stands up.  From there, you can gradually get more nasty by subjecting it to harsher environments, mimicing the trunk of a sales rep's car on a hot day in Puerto Rico, for instance.  Again, you will be using your preferred performance output variables.

Differences in testing will be dictated by what your device actually is.  Is it an IOL Cartridge?  Is it a Jamshidi needle?  Is it a coronary guidewire? 

Also, this list is by far not exhaustive.  I have not even mentioned things like biocompatibility and particulate testing.  I wonder if I should make several parts to this post?

 

Tags: medical device, medical device coating, lubricity, medical device development, medical device coatings, hydrophilic coatings, lubricious coatings, lubricity testing

Pinch Testing White Paper Released

Posted by Josh Simon on Fri, Feb 24, 2012 @ 03:39

As promised, and not long after my last message, I present to you our newest white paper on Pinch Testing.  In its pages, you will come to understand what kinds of parameters govern the pinch test, with regard to hydrophilic coatings.

This paper is an attempt on my part to educate engineers in the field about how to choose a coating based on pinch test data.  For a few years now, I have encountered pinch test data from various companies that portray hydrophilic coatings in a durable and lubricious light.  The problem I saw with some of that data is that it was misleading.  In some instances, it did not give the conditions of the test.  Heck, it sometimes seemed like the authors of the data did not even know there were any test conditions in some cases.  They merely touted it as if it were sliced bread, but better.

That makes it rather difficult to tell the good coatings from the bad.  They are all more or less lubricous, but whether or not they can stand up to abrasion is not honestly portrayed in all cases.  It is my hope that this article would shed some light on that.

 

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Tags: Hydrophilic Coating, pinch tester, white paper, medical device development, pinch testing

Coatings odds and ends - From pinch tests to trade shows

Posted by Josh Simon on Thu, Feb 23, 2012 @ 01:46

There has been a flurry of activity this year that I am working to keep up with. 

Quite soon, I will be releasing an entire white paper based on my earlier blog article here, 5 Critical Questions to Ask About Pinch Testing. Do not worry about missing the release because you will see an announcement here, plus a press release, most likely.  From either of those sources you will be able to download the article.

We also just got back this week from the MDM West show in Anaheim, CA. With regard to hydrophilic coatings and related subjects, there was a lot of activity there.  Although I must note that Bayer's hydrophilic coating was conspicuously absent from their booth.  Maybe they finally read my blog articles on Hydrophilic Coating Market Size? There were also a few nice talks on plasma treatment of surfaces before coating, and another talk on cardiovascular-based applications by Dr. Ron Sahatjian of Medi-Solve.  To be honest, I could not attend either talk due to the traffic at my booth, and the schedule of meetings I kept that week.  If anyone wants to remark on them, feel free.

This is a little shot of the "Biocoat crew" from the show.

Biocoat Hydrophilic Coatings

Left to Right:  Dhruv Patel, Peg Beavers, Keith Edwards, Josh Simon

Tags: pinch tester, medical device development, hydrophilic coatings, MDM West, hydrophilic coating market, hydrophilic coatings blog, pinch testing, plasma treatment

Lubricious Coating: Regulatory & Economic Landscape

Posted by Josh Simon on Thu, Oct 06, 2011 @ 03:54

The folks at MDDI have posted an article contributed by me on the Regulatory and Economic Landscape for Hydrophilic Coatings, in my opinion. Normally I post these musings here, but MDDI wanted to pick up the article from me, so enjoy!

If you are looking for coatings, and want to talk personally with the big players in that arena, do not hesitate to attend the MDM Minneapolis trade show coming up.

 

MDM Minn 4c resized 600

Tags: medical device coating, coatings companies, coatings vendor, coating company, business of hydrophilic coating, coating manufacturer, medical device development, medical device coatings, lubricious coatings, coatings customers, coatings manufacturer, FDA regulation of coatings, coatings supplier

Leachables vs. Extractables - Hydrophilic Coating Considerations

Posted by Josh Simon on Mon, Sep 26, 2011 @ 10:00

The Qmed blog has an insightful article on differentiating between leachables and extractables in medical devices.  Though the article does not specifically mention lubricious hydrophilic coatings, it is still an important consideration. 

Something to know:  All hydrophilic coatings contain multiple ingredients, some of which are not completely bound within.  Even crosslinked coatings that purport to be chemically resistant still contain unreacted products from whatever reactions are used in the crosslinking.  The article at Qmed makes us aware that these sorts of leftovers can either leach out or be extracted out, and there is a difference.

The author notes that leaching occurs under "normal" conditions of use, i.e. what will come out of your coating when you place it in the body at 37C for some length of time?  Extraction is what happens during exaggerated conditions, i.e. what will come out of the coating at 50C in an acidic water bath, or an oil bath?

Extractables can give clues to what the leachables might be.  They can also tell you how stable your material is, chemically.  The presence of an extractable is not necessarily a show-stopper.  Unwanted leachables might be harder to explain, however.  Either way, both of these things will make up part of the larger picture of biocompatibility for your material.

 

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Tags: lubricious coating, medical device coating, Hydrophilic Coating, biomaterials, medical device development, medical device coatings, hydrophilic coatings, lubricious coatings, FDA regulation of coatings, extractables, leachables