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

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

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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