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

Plasma Treatment Basics for Coatings

Posted by Josh Simon on Fri, May 25, 2012 @ 09:04

I would like to point out a great talk given by my friend Mikki Larner over at Plasma Blog which gives an easy-to-understand rundown of the basics of plasma treatment of surfaces.  For those new to this whole thing, not all hydrophilic coatings will stick to all surfaces.  In order to get a hydrophilic coating to adhere to a surface, some materials require that you treat them with energized plasma (i.e. the fourth state of matter), which functionalizes or at least charges the surface to provide the chemistry necessary to make the coating stick.

The paragraph above is greatly simplified, but this video describes the process in more detail.

 

Often, some sort of test will follow the coating process, such as pinch testing.

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Tags: surface preparation, plasma treatment, Plasma Treatment Systems, surface modification

MDM East Wrapup - Hydrophilic Coatings

Posted by Josh Simon on Thu, May 24, 2012 @ 03:23

This year is the first year that MDM East is in Philadelphia, which is essentially my own backyard.  I had a chance to spend two days at the show (and it is not over yet by the time of this writing.)

Many of the regular crowd members of the hydrophilic coating industry were present at the show.  I saw booths for Advansource, Hydromer, BioInteractions, DSM, Surmodics, Harland, and that company that owns Medi-Solv.  Absent were booths for AST, Coatings2Go, and my own employer, Biocoat. (Forgive me, please, if I forgot anyone.)

Not having to man a booth gave me a lot of time to wander and meet with people.  Interestingly, I had the impression from just about all of the hydrophilic coating companies that the show was "meh".  (That would be an onomontopeia for the sound you make when you are generally NOT impressed.)

Really that all boils down to number of leads obtained at the show.  The comment I heard most often, multiple times, was that the show was great for catching up with current customers and seeing people that you already know, but not so great for meeting new faces.  Comments went on to suggest that the MDM/BIOMED show circuit is saturated, i.e. there are too many of them in too many places that are not so far away from each other (like Chicago vs. Minneapolis, anyone?).  Coating companies are hungry for new blood, and frankly a little tired of fighting over the same customers time after time.

 

MDM East

Tags: medical device coating, Hydrophilic Coating, coatings companies, coatings vendor, medical device coatings, hydrophilic coatings, coatings customers, coatings manufacturer, MDM East

Hydrophilic Coatings Particulate

Posted by Josh Simon on Fri, May 11, 2012 @ 02:54

As promised to one reader, I am putting a little bit more information here on particulates and particulate testing with regards to hydrophilic coatings.

The first thing I want to do is point you to some great information on general theory and the regulatory status of particulates for medical devices.  There is an excellent article by Susan Reynolds and Ryan Lunceford on the basics of particulate testing.  It talks about the prevalent use of USP 788, as I have done in my previous article on medical device particulates here, including some specifics on the differences between laser counting versus microscopic counting of particles.

The article is a few years old, and at that time, the AAMI was not yet finished writing its report on setting medical device particulate limits.  However, now that report is out, and you can find it here.  Personally, I found it a little vague.  It does not give any sort of concrete limits to follow, and is not any sort of draft guidance.  It is good for figuring out how to think about this when going about your own particulate tests, however.

One item touched on by both the AAMI report and the article is composition.  Specifically for hydrophilic coatings and/or lubricious coatings, these particles have characteristic identities.  Like anything else, a major consituent of particulate could be clean room dust, which originates from human skin or clothing, or other particles tracked in from the outside.  However, after abrasion, it can also be due to coating wear particulate.  In fact, one method of testing durability for a hydrophilic coating is to run it through a tortuous path test and then measure the amount of particulate in the path after multiple cycles.  For increasing number of cycles, you can track the increase in particle count.

Again, this is just an idea and not a standard.  There are no suggested limits for a test like this right now.  Everything in this field is at this point "unregulated", and we are all concerned about what the FDA will eventually do to throw a wrench in the innovation in the name of hypersensitivity. 

 

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Tags: lubricious coating, Hydrophilic Coating, medical device coatings, hydrophilic coatings, lubricious coatings, particulate testing