5 Critical Questions to Ask About Pinch Testing Data

Posted by Josh Simon on Thu, Jan 26, 2012 @ 04:54

Pinch testing data can be used to make or break a lubricious hydrophilic coating.  It can also be used to lie.  When you see any graph depicting lubricity and durability for a coating, it is time to stop and take a breath before absorbing the data.  Ask yourself about the nature of the test used to get the information. 

pinch tester

Some hydrophilic coatings can be painted as amazingly slick and durable, but when put to a rigorous test, not so much.  Others shine and duke it out among the top.  I will soon be publishing a white paper demonstrating how differences in testing methods can make big variations in friction outcomes.  Below is a preview table of the 5 questions to ask yourself whenever you view friction data for a lubricious coating.

Question

Issue

For what Load does the current data display?

Tests using lower loads can give the appearance of a durable coating.

What is the pinch pad material used in the test?

Soft pinch pad materials are easier on the coating, and can portray favorable results.

What is the substrate material used in the test?

Soft substrates are easier on the coating, and can portray favorable results.

Was the test conducted under saline, pure water, or dry?

For medical devices, performance in saline is most clinically relevant, but dry or pure water performance can be used to artificially portray a coating in a positive or negative light, compared to actual in vivo performance.

How many cycles are displayed in the test data?

Low cycle numbers may not show a difference between two coatings, or be used to sidestep durability issues.

Tags: lubricious coating, medical device coating, pinch tester, medical device coatings, lubricious coatings, pinch testing, lubricity testing

Hydrophilic Coatings Market Misinformation - Part 2

Posted by Josh Simon on Wed, Jan 11, 2012 @ 10:06

Last week I discussed why some of the estimates that the professional market research organizations make on the size of the medical device coatings market are a bit off.  I did not want to throw everything at you at once, so this week I will continue with the topic.

There is one other area where errors are made in estimating market size.  Let us take the example of a company that has developed its own antimicrobial coating for its own use.  In fact, currently there are several such examples of companies that do this:  Edwards Lifesciences, Cook Medical, B. Braun, and Medtronic. 

These companies employ their antimicrobial coatings on their own devices and gain revenue from sales.  For any one of the examples above, the sales on a given antimicrobial device are in the millions.  The mistake made by the market researchers is adding the revenue of these devices into their market size calculation.  If Cook Medical's minocycline/rifampin line of catheters sells $100 million per year (a number which I just made up off the top of my head), the market reports will add that $100 million to the market size.

This is incorrect.  When a company produces its own antimicrobial coating only for its own devices, it is not licensing out that coating or supplying it to others in any way.  However, what if they were?  Or, what if instead of using their own coating, they licensed an antimicrobial coating from a coating vendor and paid a royalty on it?  The revenue from the licensing and royalties to the coating vendor would be the number added into Market Size for medical device coatings. 

So, my proposal is that instead of simply adding the $100 million to the market size, what the researchers should do is pretend that those coatings were licensed from a coating company and then calculate the revenue gained by the theoretical coating vendor for those coatings.  This isolates the coatings revenue from the device revenue.

Afterall, we are looking at a coatings market, not a device market, so the revenues should be separated out.  Reports that talk about coated device markets might help coated device vendors, but they require all sorts of mental rejiggering to become useful for coating companies.

When you sell house paint, do you look at the selling price of all the houses you are going to paint, or do you look at how many gallons of house paint you are going to use to paint them?

 

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Tags: medical device, medical device coating, Hydrophilic Coating, medical device coatings, hydrophilic coatings, antimicrobial coating, hydrophilic coating market

Hydrophilic Coatings Market Misinformation

Posted by Josh Simon on Wed, Jan 04, 2012 @ 01:46

Happy New Year!  As we start another year at the Hydrophilic Coatings Blog, I want to wish everyone a prosperous and successful year.

Lately I have noticed several firms trying to estimate the size of the hydrophilic coatings market, which is a subset of the medical coatings market.  Previous articles as well as ongoing updates to the data exist on the subject by big names like JP Morgan, Frost & Sullivan, the BBC, and others.  Most of these reports agree with BCC Research (HLC049B) which puts the market for medical coatings at US$5.3 billion in 2010, growing at 10% annually.

I am here to tell you that number is probably wrong, and off by perhaps an order of magnitude or more.

First let's break the medical coatings market down into segments.  Here's how I would do it:

Lubricious Hydrophilic Coatings

Drug Delivery Coatings 

Antimicrobial Coatings

Hydrophobic and other barrier coatings

Of course this is simplified because there is some overlap between these areas.  For example, you can have a lubricious drug releasting hydrophobic coating too.  Nevertheless, follow my logic here.

 

Let's take a look at publically available information on Surmodics and its deal with Cordis to provide a drug delivery coating for the now-defunct Cypher stent.  The quarterly minimum royalty paid by Cordis to Surmodics is $1,000,000.  (This is from Surmodics' latest 10-K form.)  In its heyday, Surmodic's received roughly 30% of its roughly $70 Million/year revenue from Cordis, which means about $21 Million.  So, I will stress again, the revenue to Surmodics on that was $21 Million/year, while Cordis' revenue for Cypher at its peak was way more than that.  For argument's sake, let's say it was $1 Billion.

Researchers that write these marketing reports do not seem to understand that there is a difference between $21 Million and $1 Billion.  The stent market contribution from Cordis at that time was perhaps $1 Billion, but that $1 Billion does not count towards the drug delivery coating market.  Instead, you should use the $21 Million, which is the revenue to Surmodics.

Now think about this.  If every single stent company licensed a swanky new drug delivery coating from a coating company like Surmodics, what would the total revenue be for that?  If there were 10 such stent companies, and they were twice as successful as Cordis ever was, you would have a $420 Million market for drug delivery coatings.  That's probably a generous estimation.

Now add in all the other coating types to that.  Hydrophilic coatings are not drug delivery coatings.  They do not bring in as much revenue.  Trust me if I say that a "really decent" customer can potentially bring in $1 Million/year in hydrophilic coating revenue at an industry standard 2% royalty rate.  Granted, few customers are that decent, but let's pretend they are.  Surmodics claims to have 100+ licensees, so let's pretend that all of them are hydrophilic customers that are "decent", and now let's pretend that there's 5 major players in that market:  Surmodics, Biocoat, DSM, AST, and Harland.  If each one of those companies is bringing in $100 million per year, that's another $500 million for the hydrophilic coatings market.  Since we all know what Surmodics' revenue is, and it's not $100 Million (and it's not all from hydrophilic coating sales), you know that this is wishful thinking.  From the math, you can also see that we haven't even reached $1 Billion yet for market size ($420 Million + $500 Million = $920 Million).

Suffice to say, if you calculate out hydrophobic and antimicrobial coating markets, you will not come up with the other $4.3 Billion put forth by BBC, and again I think this is because they do not differentiate between revenue to the coating company versus revenue that a completed device on the market fetches an OEM.

 

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Tags: hydrophilic coating market