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

Coating Medical Devices is a Two-Way Street

Posted by Josh Simon on Tue, May 29, 2012 @ 11:15

I have not mused about the business in several posts, so let me get back to that for a bit.

When it comes to coatings for customers, the focus is on the customer, and rightly so.  Naturally, for such a deal to occur the customer must be interested in the hydrophilic coating (or other coating) company, but what is on the other side of the coin? 

This is:  the coating company must be interested in you too.

We do not talk about this enough, and openly, but doing so will save a lot of people a lot of wasted time on both sides of the relationship.  Every slippery coating company wants to land the gigantic medical device suppliers of the world, and they also want to land a good many of the smaller players too! When speaking of catheters, guidewires, introducers and other "conventional" devices, those people have nothing to worry about.  A coating company will nearly always welcome you with open arms.

What about the less obvious devices that may or may not benefit from a coating?  I generally go by these criteria when thinking about taking on a customer:

1)  Application of the coating onto the device should be achievable, and with minimal manufacturing nightmares.

2) The volume produced should be significant, on a yearly basis.

3)  The customer should be an established, if not reputable, business, not a university, not a lone physian, not a retired consultant with no resources, not a grad student, etc..

4)  The application should be in the medical or diagnostic field, or at least if not in the medical field, the forces and environmental conditions where the coating is used should be along the same lines as medical forces/conditions.

5)  The customer must undestand that coatings are not free.  (Don't laugh!  I have been asked to give our services gratis!)

 

Achievable Coatings

Much of this is talked about in this paper on hydrophilic coatings.  If you have a medical device with an odd shape, the best thing to do is ask someone like me or another person working at a hydrophilic coating company.  Anyone with some coating experience will do.  I have seen great ideas and great devices foiled by the simple fact that getting the coating onto the darned thing is nigh impossible.

 

Production Volume

I have a large family.  One day I will probably go broke from the number of college educations I need to pay for.  In order to have any hope of staving off bankruptcy, I need to keep the high-value customers rolling in.  A high-value customer is quite simply a customer that brings in much more money than we spend on maintaining them.

If your company is in India (or another faraway land), and you want to buy $10,000 worth of material every year, and my company needs to spend $12,000 to visit you and provide customer service to you every year, guess what?  We are not interested.  That is not high-value.

If you are a lone-actor that wants to coat 5 pieces of stainless steel, once, ever, that prospect really holds no hope for a coating company.  It is wonderful that a century from now your device will be the greatest thing since sliced bread with a volume of millions per year, but our outlook is more toward the 2 to 8-year time scale.  Unless your device is already in a company an under initial stages of Design Control, it is probably not less than 8 years out.

 

Established Customers

Honestly, this is more related to the previous two points than anything else.  It takes a serious company to A)  know how to develop a medical device in today's world and B) be capable of producing the volumes necessary to make us both successful.

Physicians (and occasionally Professors) do provide great design ideas for medical devices, but they themselves have often dedicated little time to understanding how a device is designed and commercialized.  Going it alone is not an option.  If you come to me as a lone physician unattached to a company, I will thank you for your time and point you to Coatings2Go.

I will also say the same to graduate students, and consultants that just want to try something out, and for the same reasons.

Simply having a company to work from is not always a guarantee either.  It is necessary to demonstrate a knowledge of product development in the medical field, if this is a medical device.

 

Medical Devices and Non-Medical Uses

I do not want to make it seem like trying to coat non-medical devices with hydrophilic coatings is pointless.  It is not, IF you know what the characteristics of the coating are.  Nevertheless, I still get calls from people that want to coat valves for the crude oil industry and truck parts, etc.  They usually do not bother to read (and admittedly it may not be that easy to find) the material that talks about the impermanent nature of hydrophilic coatings, especially under high abrasion and repeated use.  High abrasion and repeated use are two phrases that sum up the vast majority of non-medical uses, and thereby eliminate most of those uses with medical grade hydrophilics.

If you are from a non-medical company, think long and hard before calling up a supplier of something that is impermanent and mostly geared for disposable single-use devices.

 

Coatings Cost $$

See the first paragraph under Production Volume.  The good news about this is that although coatings cost money, the goal here is to make the customer money as well.  Both parties must benefit.

This rules out charities that produce medical devices, unless of course they find a vendor willing to donate.  It is not so prevalent for people to ask for lifetime free coating supplies, but often they can be taken aback by the costs associated with coatings.  Often, hydrophilic coatings, drug delivery coatings, and antimicrobial coatings are more epxensive than non-stick PTFE coatings, and other sorts of barrier coatings.

 

 

 

 

Tags: coatings companies, coatings vendor, coating company, business of hydrophilic coating, coating manufacturer, Coatings2Go, antimicrobial coating, coatings customers, coatings manufacturer, coatings supplier

Bayer Boosts Coatings Presence in China

Posted by Josh Simon on Wed, Nov 23, 2011 @ 10:38

I found an interesting article talking about Bayer's coating business and its increased focus on the Chinese market.  Let me point out that the business of "coatings" is gigantic and comprises everything from paint, to industrial coatings, aerospace surfaces, and yes, even medical device coatings.  In this article, Bayer is talking about moving a multiple hundreds of million (perhaps over a billion?) dollar operation in a market just as large.

By contrast, hydrophilic coatings are an almost infintesimally small part of the overall business of "coatings".  Bayer does indeed have a hydrophilic coating it obtained when it bought the business from Lombard Medical. However, I am not sure that Bayer yet realizes that this market is infintesimally small compared to its other businesses. 

In my guestimation, the entire market for hydrophilic coatings, in the world, is not over $120 million.  (Although it is definitely growing fast.)  You have to remember, this is not medical device revenue.  This is revenue for hydrophilic coatings sold to the medical device companies that eventually put them on products.  Effectively, what a hydrophilic coating company sells is a "bottle of stuff", or a "bottle of goo", as Peg Palmer is often fond of saying.  How much money you can get for goo is limited to whatever license fees, royalties, or direct revenue you can get for it.  Unless you capture the entire market, your realistic expectations are likely to be smaller than the rounding error of one of Bayer's typical products.

 

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Tags: Hydrophilic Coating, coatings companies, coatings vendor, coating company, coating manufacturer, industrial coating, Coatings2Go, hydrophilic coating market, coatings manufacturer, coatings supplier, non-medical coating, industrial coatings, Bayer

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.

 

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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

Hydrophilic Coatings Webinar Available Online

Posted by Josh Simon on Fri, Sep 23, 2011 @ 02:11

med medicalcoatings bannerark resized 600

An archive of the webinar we recently announced on hydrophilic and hydrophobic coatings is now available to everyone for download.  Please stop by and grab the file and listen to it.

Click here to download the hydrophilic coatings webinar.

The webinar was sponsored by Biocoat and Specialty Coating Systems. Half of the presentation by Josh Simon is actually about hydrophilic coatings and the second half by Lonny Wolgemuth talks about hydrophobic coatings. Remember, hydrophilic means "water loving". Hydrophobic means "water fearing". The webinar sets the record straight on which is which and why you would want to use some in specific applications.

For both coatings, lubricity is discussed, i.e. how slippery they are respectively, as well as some basic mechanical properties and medical device applications. 

All in all, I am told this is a pretty good overview of coatings, and it is a nice place to start if you are just beginning your research on this area for possible future products or medical devices. 

 

Tags: advanced coating, lubricious coating, medical device coating, Hydrophilic Coating, hydrophobic coating, Biocoat, parylene, coatings companies, coating company, business of hydrophilic coating, coating manufacturer, biomaterials, basecoat, durability, durability testing, coating cost, coating costs, Specialty Coatings Systems, medical device coatings, hydrophilic coatings, lubricious coatings, coatings customers, coatings manufacturer, coatings supplier

Surmodics Announces Realignment of Business

Posted by Josh Simon on Thu, Aug 25, 2011 @ 09:36

Surmodics' latest news release tells of a realignment, which by my count is the second such one in the last couple of years.  I could be off.  Read the release here. 

My humble opinion is that they tried to spread themselves a little too thin by getting into the pharma business, and now they want out.  Maybe now they will focus on their hydrophilic coatings, drug releasing materials, and perhaps their in vitro business.

A kid once asked me, "if you are so smart, how come you aren't rich?"  He had a point.  My own personal wisdom and business sense have not made me rich yet, so take the following for what it is.

I think that the idea of creating a business out of making various drug delivery coatings for medical devices is not sustainable, on a contract basis, licensing basis, or otherwise.  Here's why:  in order to get ONE good drug releasing coating verified and onto the market on a product, you need a whole company.  Even then, your chances of failing are huge.

If you spread yourself out thinly and try to make numerous drug delivery coatings, you increase your chances of failure for each coating.  Surmodics got lucky by creating the coating for the Cypher stent (with Cordis' help), and Cordis represented over 30% of their revenue until just a few years ago.  Once they started to branch out and offer this for everyone, I think they got ahead of themselves.

In a previous article on poorly made hydrophilic coatings, I barely scratched the surface of what sort of development time and effort it takes to make a good hydrophilic coating.  If you want that coating to release a drug, multiply that by 10.  Then if you want to switch from drug A to drug B, throw away everything you know about releasing drug A from the coating, and do it all over again.  Each drug or agent in a coating will act differently as far as kinetics of release and chemical interaction with the matrix are concerned.  It takes a lot of work and people (scientists) who know what they are doing.  This is why the Medtronics, Boston Scientifics, and J&J's of the world spend millions per year to do this: an amount probably equal to most of Surmodics market capitalization.

 

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Tags: advanced coating, news, business of hydrophilic coating, Surmodics, drug delivery coating, reports, coatings supplier