Cost of hydrophilic coatings for medical devices

September 2, 2010

I would not call it a pet peeve, yet, but I do smile sardonically whenever I get an email or phone call like the following:

Dear Sir,

We understand you have hydrophilic coatings. We want to use your coating on our medical device. Please send us a quote for it.

Sincerely,

Mr. Not A Likely Customer

It is as if we have a magical machine that can coat anything and all one has to do is slap a few devices in one end and get coated items out of the other. For uniform objects, or mostly uniform objects, that is true in companies that specialize in producing them. However, usually customers like these neglect to mention that their device resembles an asteroid on a stick with a bad case of infected acne, and that they want only the white heads coated but not the black heads. Such a machine does not exist, and must be built after much development. (Though I sincerely hope it never will be.)

If you have written an email like this, or are about to write one, what you need to understand is that every medical device is unique. Even if you look at two catheters that do the same thing, from two different companies, you will notice devils in the details that will require process differences. Nobody has a ready-made process that can coat anything, especially a GMP-grade process that can coat anything. So when you write an email like that, it belies your ignorance of what you are doing, and it shows suppliers like us that you A) have a long way to go to get to a device or B) are likely to fail.

I think the reason for this misunderstanding of the hydrophilic coating industry for medical devices is that most of these kinds of inquiries come from non-medical people that are trying their hand at the medical industry. They are used to gigantic vapor deposition companies that coat with teflon or parylene where they DO have magic machines that can coat nearly anything, and like most other commodities, you slap down an order and they spit out a quote. Hydrophilic coatings, especially as used in the medical field, are not a commodity. They are an advanced, specialized, heavily regulated part of the overall GMP processes developed for making medical devices, and everything that goes along with that.

So what do they cost? It depends on your device. As Margaret Palmer stated in her interview, you really can’t know what they cost until you spec out a design and see. That makes it difficult and requires a commitment that some are not willing to put forth, but that is ok, because the remainder of customers need the coating since they do not have a product without it.

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Product vs. Process Feasibility for Hydrophilic Coatings

August 26, 2010

I just got back from an interesting business trip that touched on a central theme:  product vs process feasibility.

I frequently get the question “Is your hydrophilic coating good for X application?”  Where “X” is anything from bread and butter catheters to the bizarre non-medical application.  The answer to that question is never a yes or no.  It always depends on who’s asking.  The proper question is, “Is your hydrophilic coating good for MY X application, under MY circumstances and environments?”  This is what product feasibility is really about.

Let’s say you have a catheter and you are making over 100 passes with it into and out of the body in a single surgery.  I know that’s extreme, but stay with me here.  Now let’s say you ask me the question, “Can I sterilize this twice with ethylene oxide?”  For most hydrophilic coatings, in this case, I would answer, “I wouldn’t do that, but you can test it and see.”  Why?  Because every time you sterilize a polymeric coating, no matter whose coating it is, you lose a little bit of the coating.  Losing coating is a foregone conclusion, but it is ONLY a bad thing if you lose too much.  The object is to retain enough coating to be “good enough” to get through one of your procedures with lots of room to spare.

Now let’s say a different person comes to me with an identical catheter that only makes 1 pass in a single surgery.  It goes in and out and that’s it.  When asked the same question about sterilizing twice with ethylene oxide, I would answer, “Yeah, I bet you could!  But you should test it and see.”  See the difference?  From what I know about my company’s coating, I know it could easily handle something like that.  (However, I still always make sure to add in that the medical device company that uses it on their device is ultimately responsible for verifying.)

Great, so now we understand how to think about whether or not a coating SHOULD be used on a product.  The next question is CAN it?

That is a different question all together.  That is process feasibility.  If you give a sample to Biocoat and tell us to coat it, we will.  We will slap a coating on that thing any way we can, just so you can get a chance to see if it works or not in your application.  That does not mean, however, that what we did is reproducible or controlled.  It’s only research.  After or in parallel with your product feasibility testing, you need to think about process feasibility…. and you need to think about it early:

What is the general coating process?

What parameters control coating quality?

How robust is the process?  Is it forgiving, or a bear?

How far can I change things like temperatures, speeds, humidity readings, cure times, etc. without messing something up?

How does the geometry of my device affect the coating thickness, adhesion, and lubricity?

What kind of unique equipment will my device need for coating?  (Very rarely can two different devices use the same tooling and equipment for coating.)

How repeatable is this process?  How much do lubricity and durability vary normally?

What are my cycle times and throughput?

It is quite possible that you will get a beautiful coating on your test device, but later find out you can’t scale it up…. or that you can’t scale it up cheaply.  So, having a coating is not just dependent on the coating itself, but also the process involved with applying it.  Thus, both the concept of product feasibility and process feasibility need to be managed simultaneously, and you should always start EARLY.

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Poll: Sterilization methods for hydrophilic coatings

August 19, 2010

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Hydrophilic coatings in the supply chain

July 22, 2010

Business models for selling hydrophilic coatings generally seem to be converging: the coating company offers its technology to a medical device customer…. the medical device customer either licenses the technology from the coatings company and pays a license fee/royalty, or they opt to have a third party contract manufacturer put the coating on their device for them, in which case the contract manufacturer is actually the licensee of the coatings company and the license fee/royalty is baked into whatever the contractor charges the medical device customer. Sometimes, the coating company is also a contract manufacturer. Other times, the coating company may sell equipment of its own to the medical device customer to help them bring the process in house.

The key to everything, of course, is that it all needs to be profitable for everyone. From what I have seen, this means that final device manufacturers benefit the most from licensing/contracting the coatings, as opposed to component manufacturers.

More specifically, here is what I mean. Say you are a tubing manufacturer. You extrude tubing for various devices, i.e. catheters, etc., and you sell the tubing to the big companies like Medtronic, J&J, St. Jude, etc. Chances are you sell a piece of tubing for a few cents. Occasionally, a tubing manufacturer gets it in its head that it would like to offer a hydrophilic-coated line of tubing. This is not optimal for a couple of reasons. First, the cost of the coating in many cases will be several times the cost of the tubing. You cannot take a 50-cent piece of tubing and put a $1 to $5 coating on it and expect to be able to sell that. Now, there are cheap coatings out there, but you get what you pay for. A lubricious hydrophilic coating that claims it can keep under $1 per device at a production of 10,000 units per year, including the cost of labor and equipment is either a) lying or b) going to rub off/dissolve/abrade after several cycles or c) has a coefficient of friction higher than most leading hydrophilic coatings (0.0003 to 0.03). (Production volumes of over 1 million are a different story.) The “cadillac” coatings are better than that in terms of lubricity and durability, but they require more money in materials and indirect costs. Second, this is a bad deal for the hydrophilic coating company. When the Medtronics and St. Judes of the world approach coating companies directly, they are looking to coat devices that sell for $100 to $1000, sometimes more. The royalties involved in this can be in the double digit dollars per device. Royalties are what allow most hydrophilic coating companies to exist: they are 100% margin, and require little or no work. The other aspects of the business aren’t nearly as lucrative. Given that, why would a hydrophilic coating company want to sell to a tubing manufacturer, to continue with this example? At most, the coating company would get a few cents per tube, if that, and this money may be more from the margins on the coating solutions rather than an actual royalty because a tubing manufacturer is probably not willing to pay much royalty. It makes no sense for either side with this business model.

Of course, the mathematics can change with higher volumes, and this is also not to say that you can’t make a deal that some coating company might take. Either way, it is better to know what both parties are entering.

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Plasticizers and extrusion agents

June 24, 2010

Plasticizers and extrusion agents…. the scourge of hydrophilic coatings.

Every hydrophilic coating has a certain set of substrates that it coats well, and other substrates that are not so good. Exactly which substrates a given hydrophilic coating sticks to varies from company to company because it all really depends on the ingredients in the coating, including the solvent and other additives in there, not to mention the chemical makeup of the substrate. Since every company out there has a different formulation that interacts differently with various surfaces, results can be different. One company’s coating may coat polyurethanes really well, whereas another company’s hydrophilic coating might not stick so well to that particular polyurethane.

Ok, so be it. When searching for a coating, you should be aware of this fact. However, it can be more complicated.

In a previous post about hydrophilic coatings on PVC, I also mentioned that plasticizers can be a problem. This is true of any other material, not just PVC. Pretty much all commercially available plastics out there contain plasticizers, especially if they have a prescribed durometer. Who knows what these plasticizers are? Many of them are proprietary, like the ones found in the various types of Dow’s Pellethane, which is usually a polyurethane-based material. Like the case with PVC, these plasticizers can bloom to the surface while your coating is curing or while your substrate is soaking in a solvent…. or they could just simply be present at the surface to begin with, without any prompting. Also, like the case with PVC, these plasticizers can knock the coating off the surface, i.e. drastically reduce adhesion.

Thus, Polyurethane A may be chemically identical to Polyurethane B, but the “B” polymer might contain disruptive plasticizers that cause problems for the coating, whereas “A” may not have any that interfere. Moreover, when you go from one hydrophilic coating vendor to another, you might find that “B” coats fine and “A” is the problem now.

Extrusion agents, which sometimes include certain waxes, are equally troublesome. They can cause the same problems as plasticizers. The processing of the plastic can drastically alter the distribution of extrusion agents and/or plasticizers in the material causing weird things to happen. The other day, I saw a piece of polyurethane tubing which was extruded in a metal mold, and then had a lumen created in the center with forced air. The outside of the tube coated beautifully! The inside of the tube was an absolute pain in the rear to coat consistently, even when controlling for un-related factors that occur with inner diameters! It was like night and day. The best explanation for that was that since the two surfaces were formed differently (OD vs. ID), they had different distributions of extrusion wax in them, and the ID side had too much for getting a good coating. I was amazed.

So, if you are developing a product and you run across this phenomena, you have two choices: 1) Seek another material for your device or 2) Seek another coating vendor that may not have that problem with that particular material. Taking the second option may be tough, however, because it is a general rule of thumb that these plasticizers will cause problems. Of course, changing your device material mid-stream is bad too, which is another reason why you should always select your coating vendor as early as possible in the design process.

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Coatings Research: Who does what?

June 2, 2010

Often, prospective clients will ask questions about our coatings regarding tissue interaction, degradation, and biocompatibility. There is definitely some information there, but what most people do not realize is much of that information is specific to certain devices. If your device is different, the research we have done may not apply.

Who does what for coatings?

Think about biocompatibility first. The coating material controls much of the aspects that make up this term, but so does the substrate. If your substrate leaches some toxic substance, it may not matter if a company’s coating is biocompatible or not. Moreover, what is biocompatibility? The definition varies with application. For someone using an implantable scaffold for bone, you want a long-term material that will degrade over time and integrate with tissue. For a joint surface you want the opposite. For a vascular catheter, you want something that will last an hour or two at most in the body. So calling up a coating company and asking, “Is your coating biocompatible?” is sort of an unqualified question.

Degradation is often related to biocompatibility. Asking “How long does it take for your coating to degrade?” is also sort of an unqualified question. Shape contributes to absolute degradation rate!! What kind of surface area are we talking about here? A thick block of coating material will degrade differently from a 1-micron coating over a 10-cm long cylinder, which will degrade differently than a half-micron coating over a 10-mm x 10-mm sheet. Sure, this data can probably be normalized, but few have done experiments like that. We may be able to tell you what the degradation rate is on a 10-cm polyesther rod, but that may not do you any good.

Shape controls more than you might think. As a tissue engineer, I can tell you that shape can mean the difference between “biocompatibility” and cancer. For instance, if you implant polyethylene rods under the skin of a rat, the rat will grow a fibrous capsule around the rods and wall them off. If you take that same polyethylene material and instead fashion it into a sheet and implant the sheet under the rat’s skin, cancer will result. So as far as tissue interactions are concerned, I can tell you the probable interaction with a coated surface, but the only way to get a definitive answer for YOUR device is to do the research.

This brings me to my final point. As a client, you will eventually need to answer all these questions about a coating yourself, especially if you are the manufacturer of a Class III medical device in the US. A given coatings company has probably done a lot of research on their coating, but the applicability of that research to YOUR application is always a question. Granted, there is often a chance for collaboration because more often than not the coatings company will be eager to know the results for its own purposes too. Thus, the best way to quiz a coatings company about these things is to qualify your questions with “On your test substrates, what kind of results do you get for _______?” Chances are, those answers will only serve to reduce major surprises about the coating and help you make a business decision…..before you run the tests all over again for yourself.

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Checklist for seeking a Hydrophilic Coating

May 14, 2010

When calling up a vendor for hydrophilic coatings as a possible source for your device, it is useful to have certain information handy. This will help ensure smooth communication between you and the vendor and minimize time wasting on either side. The last thing you want is to start up a project that was a showstopper from the get-go. Here we go:

checklist

* Know what field your device is used. (Sounds stupid, but people do sometimes call for coatings not knowing this simple thing. Some coatings companies have exclusive licenses that shut them out of certain fields.)

* Have some projections for sales/manufacturing – How many widgets do you want to coat in a year? This influences price and lots of other things.

* What kind of device is this? A catheter? Tubing? An instrument? A diagnostic surface? Some other odd device?

* What surface do you want coated? Inner diameter? Outer diameter? One side? Both sides?

* What dimensions are the device and how far along the length/width do you want coated?

* What is a very rough selling price for your finished device? This may tell you if the device is worth coating at all. Cheap devices need cheap coatings. Expensive devices can have fancier/more advanced ones.

* In which stage of development is your device? Pre-feasibility/Research? Feasibility? Design Inputs? Verification? Clinical trials? The later you are, the worse off you are.

* What property of the coating interests you most? Lubricity? Durability? Hydrophilicity? Non-thrombogenicity? Anti-microbial agents? Other?

* How many devices do you wish to coat? One? More? Does your device have multiple parts or pieces that need to be coated separately?

* What is the substrate material you wish to coat?

* How long until you plan to launch the finished device? The closer you are to “D-Day”, the more difficult it could be to change up your process by adding a coating step to it.

* How long does the device dwell in the body? Minutes? Hours? Days? Weeks? Months? Forever?

* How may times will this device be sterilized, and how will it be sterilized?

* If this device is being passed in and out of the vasculature or some other tissue, how many times will it pass in and out in a single surgery?

There are other questions, but if you have a handle on these, both you and the coating vendor will definitely be off to a great start, or you will realize that the fit might be better with someone else after you’ve gotten this basic info out of the way.

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BIOMEDevice Boston 2010 Wrapup

April 29, 2010

BiomedDevice Boston 2010

Having just gotten back recently from the BIOMEDevice show in Boston, I wanted to share some of my impressions. As far as coatings companies go, there were a few of them there. A couple of them were industrial coaters that seemed eager to try their hand in medical devices, and then there were Biocoat and Advansource who have lots of experience already in the field. Compared to the bigger shows like MDM West, this was sort of dinky, about 5,000 attendees and exhibitor personnel. On the other hand, MDM West is actually a conglomerate of maybe 10 shows, most of which have little to do with healthcare. This show in Boston was all healthcare.

We did alright for leads too. The MDM show in Minneapolis yields about the same as this one. The take-away message from this is that companies are still seeking coatings. There are a lot of startups and big companies alike that have still not completely caught onto the utility of hydrophilic coatings. Granted, many more advanced companies are looking for more advanced coatings, but you would be surprised just how many companies out there could really use a basic hydrophilic and do not have one. It is almost like they never heard such a thing existed, sometimes, even though this technology’s roots stretch all the way back to the 1950′s and 60′s.

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Continued Interview on Hydrophilic Coatings

April 15, 2010

Josh: What are some of the greatest challenges with taking a device, putting a hydrophilic on coating it, and bringing it to market?

Margaret: Once clients become convinced that they need a hydrophilic, or other coating, some of the key issues are:

*Material- is it able to be coated with a hydrophilic coating that will stick adherent and durable? Surface pretreatment can often determine
success or failure. How do you know if one is needed without starting down the coating path?

*Cost- one of the first questions I get is how much does it cost. So many contributors to that answer are not within the initial control of
either customer or supplier. As one gets better at the process optimization there are economies that may not initially be apparent.
Material costs may depend on solids, composition, ambient temperature,shelf life or exposure to drying in process. Shelf life may
be a day and if there is not an efficient coating process, much material waste can occur. Process costs can also rack up (no pun intended) with make-up air in clean rooms for solvent systems, flammability or carcinogenicity concerns for some solvents can be prohibitive from worker safety, equipment design, ovens,insurance and
disposal costs. Cost is an incredibly relative thing. There are several costs- development, scale up and ongoing manufacturing. Each has its own set of issues and answers.

*End use requirements: Implant? Short indwelling? What is the regulatory requirement? Each of the end uses require different performance criteria. How do you determine and maintain them, and determine appropriate regulatory paths?

*Plant facility issues: insurance, equipment, process, clean room issues in handling and venting, disposal, worker training/exposure, forgiveness of the process, disposal. Are your staff and facility ready for the process or do you need to look at a contract coater? And a contract coater presents other supervision and development issues which may be as difficult to control.

*Development -Are there resources in house to do this or should it be out-sourced? Does the coating material have a Master File with the FDA? FDA Always says that
a coating, even with Master File, must be tested on device, in configuration to be used due to potential interactions.

IP- Can you use what you want to? Do you need to protect yours? Is yours patentable? Is the coating product licensed from a reputable patent-holding company? Just go to USPTO.gov and look for hydrophilic coatings to understand the issues. The IP for hydrophilic and other coatings is a true “minefield”.

The good news? A sound project engineer with sufficient support from a responsive, reputable coatings company will succeed well.

Josh: Is there anything you wish prospective customers would do to be more informed or prepared during their investigation of hydrophilic coatings?

Margaret: Actually my experience is that most prospective customers are quite well-educated in the spectrum of available technologies. Since the
hydrophilics have been around since the 80′s, there has been alot of historical and anecdotal experience gleaned and passed down to the younger engineering generations. There usually remains some processing education to be done, including testing and methods of application. The solid project engineers who are tenacious in their handling and questioning their detailed observations will develop great products and successor products with accentuated features.

Josh: There are a few different types of hydrophilic coatings out there, i.e. acrylic, urethane, PVP, etc. How does a company go about choosing
the right coating for its application?

Margaret: In a nutshell? With the help of someone trustworthy. For the larger company, the advantage is depth of staff, budget ,and
internally existing engineering support will dictate if you can “toss the project over the fence” to someone who will develop the product then you have your (albeit expensive) answer. If you are a start up in a garage with a shoe string budget, there are concerns including cost, support, ease of use, and potential hazards in
handling and disposal. There is quite a spectrum of needs, experience, products, and materials.

Most of the companies in the supply field routinely handle the issues, but the “fit” with your own corporate culture and personality may also be worth considering. For example many companies feel they need the corporate size/validation of a large NYSE company. These larger coating companies do a wonderful job on many fronts, but do not often fit well with a start up, fast -moving or commodity product mentality.

The folks that I have seen succeed best, have really beat the bushes to evaluate their product and any and all coatings for it. They have very clearly defined their design, performance and corporate goals, and usually make an effort to visit and become aware of their supplier and the way they operate. Often these successful clients have hired consultants to help in screening potential coatings and vendors.

Josh: Anything else you’d like to add?

Margaret: Hydrophilic and other biocompatible coatings are a very interesting and complex field. It takes someone with experience to negotiate the
technology and patent minefields and to understand products and applications. Over my 35+ years coatings and medical devices, I have seen many new companies come and go. Companies looking to coat their device who have a good engineering, manufacturing and regulatory approach to evaluating suppliers should be well rewarded.

Josh: Peg, thanks so much for taking the time to give your thoughts!

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An Interview with Hydrophilic Coatings Expert Margaret Palmer

April 13, 2010

I am pleased to present over the next few posts an interview with Margaret “Peg” Palmer, President of Surface Solutions Labs and Coatings2Go. This is to get some perspective on the industry, where Peg has much experience.

Josh: Peg, I’ve known you for a while now, but please introduce yourself and tell us what your company, Coatings2Go, does.

Margaret: Coatings2go was launched in 2005 as a new business model for coatings for medical devices. Until this time, a royalty based business model was used by suppliers to the industry. In actuality this made alot of sense since intellectual property acquisition costs, high liability exposure, and small volumes of material would otherwise make supplying coatings to these markets cost prohibitive for a supplier.

As an inhouse coatings expert for CR Bard in the 80′s and 90′s, and inventor of technologies licensed through affilitate, Surface Solutions
Labs, Inc since 1995, I have seen alot of opportunity for a larger volume business for those that are using alot of coating material- especially on the commodity devices- and/or are start-ups without the budget for the up-front fees charged by most coating suppliers. The expiration of much of the IP in the industry has also contributed to a model that does not justify the high prices of royalties.

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