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

Hydrophilic and Hydrophobic Coatings for Medical Applications

Posted by Josh Simon on Wed, Aug 24, 2011 @ 03:04

Along with a colleague of mine from Specialty Coating Systems, I will be hosting a webinar discussing both hydrophilic and hydrophobic coatings.  It would be my pleasure for all interested readers to register and come hear the talk.  There will be an opportunity to ask questions afterward.

The webinar will cover:

  • Hydrophobic vs. hydrophilic coatings, and examples of applications that may benefit from one of these coatings.

  • HYDAK┬« hydrophilic coatings for medical devices are lubricious, abrasion resistant, non-thombogenic, and biocompatible. Suitable for coating vascular catheters, guide wires and other medical devices, they can be applied to a wide range of polymeric and metallic substrates.  Learn which applications are most suitable for hydrophilic coatings.

  • Parylene conformal coatings are ultra-thin and biocompatible, and offer excellent moisture, chemical and dielectric barrier protection to a wide range of medical devices and components. Parylene coatings also improve the lubricity of components and reduce surface tack.

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Tags: Hydrophilic Coating, hydrophobic coating, penton webinar, Webinar

Lubricious Coatings: Pinch Test Primer

Posted by Josh Simon on Tue, Aug 16, 2011 @ 02:30

Lubricious coatings for medical devices come from various companies, chemistries, and calibres.  Differentiating the "men from the boys" can be difficult when it comes to coatings, however.  I do go into some detail in this in my white paper on hydrophilic coatings, but here I would like to expand on one method for determining lubricity and durability: pinch testing.

Conceptually, pinch testing is exactly what it sounds like.  A coated rod, wire, or tube is literally pinched between two surfaces inside a gripper, and then a motorized unit pulls and pushes the coated item through the gripper.  The motorized unit could be a type of mechanical tester, such as an Instron, which keeps track of the force and displacement during the test.  A few cycles will yield results on coefficient of friction for the lubricious coating, and a few more cycles will determine durability.

Sounds simple, right?

Determining if a coating is durable and lubricious, in favor of, or despite all claims about the coating, requires testing on a machine such as this, yet results from different machines are almost incomparable to one another.  Here are the factors that come into play:

  • Pinch Force - What force is the gripper applying to the coated object?  Many competitors in this field will put an almost non-existent pinch force on their coatings and then show that the coatings remain lubricious over many cycles of testing.  It makes pretty graphs, but the coating is still not durable, per se.
  • Pad Material - The gripper pads are made from some material.  What material is that?  Material matters.  A soft material like silicone gives a much easier test, than say, a hard plastic.  A common trick in this industry is to run a pinch test with a silicone pad and show durability out to tens of cycles,when in actuality, if that pad was switched for something harder, like polyethylene, the coating would fail within a few cycles.
  • Pad Shape - Pad shape determines contact area.  If the gripper pads are rectangular, a large area will be contacted on the surface of the test object.  The pinch force is therefore spread out over a wider area. Again, this makes for an easier test, compared with a shape that gives a line contact area.

Granted, not all hydrophilic coatings would need to withstand forces like this.  It depends on the application.  Moreover, pinch testing (and other methods of characterizing lubricity and durability) has not been correlated to clinical function.  Rather, it is a basis for making an engineering decision on a coating. No one really knows how many cycles on a pinch tester equates to how many passes in and out of the vasculature during a surgery, for example.  Something still needs to be the basis of a decision during the design phase. Plus, which coating do you want on that neurovascular catheter?  The one that fails in 20 cycles or the one that fails in 100?

However, understanding this data is still important.  A lot of marketing material from lubricious coating companies purports great things, when in reality, the tests are customized to make the coating look good.  The best thing to do is to get a bunch of samples of coatings from a bunch of coating companies and put them ALL through the same test.  A head-to-head comparison is the way to go.

 

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Tags: lubricious coating, pinch tester, lubricious coatings, pinch testing

Hydrophilic Coatings on PTFE

Posted by Josh Simon on Mon, Aug 08, 2011 @ 10:39

I have posted an entry as a Guest Blogger on Medical Design Magazine's Perspectives blog.  To understand more about why you would not want to coat a hydrophilic coating with Teflon┬«, see my article on coating PTFE.

 

Teflon structure

Tags: lubricious coating, hydrophilic coatings, lubricious coatings, Teflon, hydrophilic coating on PTFE, hydrophilic coating on teflon, hydrophilic coatings blog