Lubricious Coatings in spec, on time, and on budget

Posted by Josh Simon on Mon, Aug 13, 2012 @ 12:02

Ultimately on this blog, I try to keep the marketing of my own products to a minimum because what I am trying to do here is provide an educational resource.  The title is deceptive, therefore, because I am actually thinking broadly and more literally about how any lubricious coating can be applied in spec, on time, and on budget.  I do this because I was recently presented with a marketing piece from a medical device development company that broke their services down into precisely those three categories.

So, what is involved with getting a hydrophilic coating onto a commercial device in spec, on time, and on budget, and how much of that is dependent on the vendor versus just plain old reality?

Let me focus on specs in this article.  Maybe later I will cover the others.

A couple of years ago, I posted a checklist for hydrophilic coatings.  That post explained many of the questions a potential client should answer before contacting a vendor.  Like the coatings white paper I wrote on the same basic subject, it explains that you need to at least know what the device will be used for, i.e. what industry, what procedure, as well as what the materials used in the device are, among other things.

Once those things are known, there is another layer below that.  For example, lubricity is a broad term to mean slipperiness, but just how slippery should the medical device surface be?  What coefficient of friction do you want?  0.1?  0.01?  Teflon is a great hydrophobic coating that can go as low as 0.1, but true hydrophilic coatings are needed to get to 0.01. 

After understanding the friction (or lack thereof) at the surface, what sort of use will the device experience?  Is it going to be quickly inserted in vivo and then removed after a few seconds, or is it going to abrade against the inner lumen of a blood vessel, or maybe even another hard plastic catheter?

Being able to tell your coating vendor what you want is important, and that is independent of the coating vendor.  In some ways, most hydrophilic coatings on the market are the same, but they do differ in other important ways as far as processing, composition, and business models.  They also can influence the other two pieces of this puzzle:  time and budget.

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Tags: medical device, advanced coating, lubricious coating, medical device coating, Hydrophilic Coating, medical device development, medical device coatings, hydrophilic coatings, lubricious coatings

Why you won't get your coated medical device to market in 6 months

Posted by Josh Simon on Wed, Jun 13, 2012 @ 04:23

If anyone has ever been starry-eyed, it's me.  "I am going to get my PhD in only three years!"  "I will have all this extra money with this new job!"  "I will probably retire at 55!"  Of course, at that point reality rudely awakens me.  Shucks.

I am not old yet, but I am old enough to try and catch myself now when I start convincing myself about things like this.  I smile it away and shake my head.  Back to reality.

So it goes for other people, too.  In my job, the one I hear most often is, "I will get my medical device with a hydrophilic coating through clinical trials and to market in six months!" 

Well, if today is the first day you have talked to me about a hydrophilic coating on your medical device, no you won't.  Sorry!  Maybe six months from now, if all goes well, you can say that, but certainly not in our first conversation.

I have written similar articles on this blog before, and I still need to get the word out:  Hydrophilic coatings are not trivial.  They are sophisticated and advanced additions that add real value to some medical devices, and they require an entire level of attention to detail, all their own.

If you are coming to me with a six-month deadline to market, you are TOO LATE.  My next line to you will be, "Can you extend your timeline?"  By the way, this does not only occur with inexperienced startups developing their first medical devices.  This sometimes happens with veteran engineers too.

So, why then?

It breaks down into a few reasons:

  • Coating equipment always needs customization
  • The coatings themselves often need customization
  • Ordering machinery has a lead time
  • IQ, OQ, PQ take time
  • Devices with coatings must go through Verification and Validation, as per Design Controls, at least in the US
  • Clinical trials, at least in the US, require an IDE if they are significant risk, which takes time to get
  • FDA Clearance or Approval always takes at least 60 days

So, just do the math.  A proper aging study on a hydrophilic coating takes 4 months if you want a three-year shelf life.  You can do other things in parallel with that, certainly.  The lead time on the equipment alone can be four to six months, so even if you get the equipment in just three months, you still need to do IQ, OQ, PQ on it.  Also, this is if the type of equipment is exactly known from day one.  That never happens because every catheter shaft has holes at different spots, or different diameters, or shapes, etc, or maybe it is not even a catheter so it needs a different kind of machine invented entirely.  However, will that be possible if you still do not have your coating formulation nailed down yet?  If you are assuming that you will get a perfect coating on your first sample run and simply scale things up from there, you are mistaken most times.

These things take time.  Believe me, I would also love it if you could get to market in six months.  It makes the money come in a lot faster.  Reality is different.  Usually all of these things take the better part of a year, if everything goes smoothly, and in many cases they take the better part of two or three years.

I do not want to discourage anyone from trying a coating.  It can add real value to your device, and some devices may not be able to exist without one.  I do want to educate people about how long this stuff can take, however.

Tags: advanced coating, lubricious coating, medical device coating, Hydrophilic Coating, process development, medical device coatings, hydrophilic coatings, lubricious coatings

Implantable Hydrophilic Coatings

Posted by Josh Simon on Mon, Nov 21, 2011 @ 03:59

In a previous blog post on permanent hydrophilic coatings, I noted that really all hydrophilic coatings have some sort of bioerosion, degradation, and/or resorption rates in vivo.  For most coatings of this nature, those rates are high, which means they are not always suitable for implantation.

Honestly, that's a rather broad and general statement about the utility of implantable hydrophilic coatings.  In reality it goes back to a question I like to ask a lot on this blog:  What is your application?

Let me break that out into some more specific thought questions:

What kind of device do you want to coat?

WHY do you want to coat it?

Do you want it to be slippery?  Non-thrombogenic?  Closely associated with water to prevent fogging or misting?

Given your answer to the question above, exactly WHEN do you want the coating to possess those properties during the life of the device?  Pre-implantation? During implantation?  During explantation?  The whole time?

Given that last answer, how long is that time period?  Minutes?  Hours?  Days?  Weeks?  Forever?

In many cases, for example in the case of an implantable cardiac pacemaker, surgeons may be complaining that it is difficult to squish the leads into place during the procedure.  A lubricious coating might help with that.  However, once the device is implanted, who cares about what happens to the coating as long as it is biocompatible?  Or maybe I should ask:  do you care what happens?

If you do care, then you need to ask yourself why.  Is there some other function a slippery, non-thrombogenic, water-loving coating will serve a purpose after implanting that pacemaker?

Most of the time, when clients come to me asking for permanent hydrophilic coatings, it actually turns out that they do not need them to be permanent.  They just need them to fulfil a temporary role, which the coating can do easily, and then when it goes away it is of no consequence.

 

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Tags: advanced coating, lubricious coating, medical device coating, Hydrophilic Coating, biomaterials, hydrophilic coatings, lubricious coatings, non-thrombogenic coating

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