Old martial arts movies, including those of the sci-fi variety which have wise green aliens always have a scene where the student sits at the feet of the master and soaks up knowledge. Drinking in every word the teacher says, the intent is that one day the student will be able to "take the coin from the master's hand", which is a sure sign that the knowledge has passed down. The student then becomes the master and the circle is complete. For me, this is pretty much how I was trained to sell. None of my degrees are in selling and none of the two hundred or so university courses I have taken in my 25 years of school were on that subject. It was all taught from the master's lips. In my cas
If you are an HR Professional or just someone who has been in the corporate environment a while, you have probably gone through DISC training at some point. For those who have not, DISC is one of the major "personality tests" (aka behavioral style assessments) that quantifies how strong you are in four different behavioral areas. The four areas have names corresponding to the DISC acronym: Dominant, Interactive, Supportive, Conscientious, and that is where the problems starts. Each letter has qualities associated with it, but with names like those who is going to remember any of that? Dare I even write an article that explains these qualities when the information will just enter in throug
Medical device projects and life cycles follow the same general format from conception through development and sales. As anyone who has worked on medical device projects can attest, most device-related projects fail. The process of device development can get stuck at any point for seemingly different reasons depending on the life cycle stage, but in reality addressing each of these varying difficulties begins with a common thread: becoming aware of the natural styles and needs of fellow team members. The most crucial skills needed to function as a team member working on medical device projects are not taught at university. Few courses exist in Design Controls and Manufacturing Process Valida
Armed with a Google search engine, one does not need to look far to determine how utterly bad a patient’s prognosis could turn if whatever put that person in the hospital gets compounded with an infection. Heaping that problem onto an ailment always makes it worse: diabetes with infection, stroke with infection, bone fracture with infection. It is never good. If cancer does not get you, the drain circling initiated by an infected something added to your problem very well could. It is really quite common, and as an example orthopedic literature gives ranges of 30 to 60% of all open fractures becoming infected. For urinary catheters, the rate is 100% if the patient keeps it in long enoug
Let’s say you’ve been keeping track of the growing market for neurovascular and cardiovascular products out there, and let’s also say you’ve realized that most of these products require some way of being slippery in order to get into those tiny spaces in the brain and peripheral blood vessels. You’d be on the mark. The neurovascular market grows at 15 to 20% per year and the cardiovascular market grows at about half that range, depending on who you read. One could take it from there to assume that these products all need some kind of technology, probably a coating, to remain slippery, so why not make a go of it as a business? Making the right decision on that should involve a few considerati
For a lot of us, winding up on a medical device development team is an accident. How many people in our day sat there in high school and said, “I would like to develop intravenous catheters and neurovascular devices”? Not many. On the other hand by the time we hit late college or graduate school, some had the suspicion that this would be a cool thing to try. Today, the “kids” are more plugged in than we were, so it would not be surprising if a rising number of undergraduates and high school students indeed look to the future in medical device development. After all, it is a sound investment: the Healthcare industry (along with Education) tends to avoid most of the ups and downs in the la
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 med
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" de
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 thebasics 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
The first thing you need to do when looking into biocompatibility for a medical device, coated or not, is think about your application and categorize it on this chart: For most hydrophilic coatings, the application requires a Limited exposure (<24 hrs) in a Circulating Blood environment. Therefore the chart reveals that you will need to do cytotoxicity, sensitization, irritation, systemic toxicity, in some limited circumstances genotoxicity, and finally, haemocompatibility. If your application is different, look it up on the chart and see which tests you need. First, make sure that your devices are tested exactly as they are delivered clinically, i.e. coated and sterilized. You do not wan
I have hinted much on this blog about ways to go about verifying hydrophilic coatings on medical devices. When I speak of "verification", I am talking about the first "V" in "V&V", i.e. the Verification step in Design Controls that may or may not precede a Validation step, depending on the device. As you may quickly realize, speaking about specific verification steps for any device is a huge task, because verification is nothing more and nothing less than confirming that design inputs = design outputs. Does your device prototype meet specification? Since every device in the world has different specifications, it is impossible to come up with ways that apply to all devices. However, for l
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. 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
In a previous post 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
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 withBCC 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 Antimicr
I am not going to say this is a hopeless cause, because there could always be that device out there that could benefit from a slippery hydrophilic coating that I have not seen yet. However, if you think about dental and orthopedic applications in relation to hydrophilic coatings and/or lubricious coatings, I am generally not enthusiastic when approached by these companies. Mainly, what I am thinking about right now are bone screws and plates for bone repair, and dental implants for prosthetic dentistry. To analyze this, I want you to ask yourself what sorts of environmental conditions are these devices exposed to? Essentially, these are implantable medical devices, so everything I said in
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 questi
The Qmed blog has an insightful article on differentiating between leachables and extractables in medical devices. Though the article does not specifically mention lubricious hydrophilic coatings, it is still an important consideration. Something to know: All hydrophilic coatings contain multiple ingredients, some of which are not completely bound within. Even crosslinked coatings that purport to be chemically resistant still contain unreacted products from whatever reactions are used in the crosslinking. The article at Qmed makes us aware that these sorts of leftovers can either leach out or be extracted out, and there is a difference. The author notes that leaching occurs under "normal
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 th
Coatings exist in multiple industries, aside from medical device coatings. In fact, there is an index of all kinds of coating methods on Wikipedia that is enlightening. When it comes to medical device coatings, I tend to think that the industry is behind on its technology, when compared with circuit board coating technology, for instance. Most of the coating processes in that index are never used in medical device manufacturing, as near as I can tell. The main reason for this is demand. Not all of those coating methods are necessary for medical devices, even though they are required for circuit boards or electronics. So, what are the most-used methods for coating medical devices? Dip Coating
Here is another question that comes up sometimes: Do you have a coating that is lubricious when dry? More often than not, these questions come from non-medical professionals who want to use the coating for a piece of machinery, rather than a biomaterial which interacts with a living system. In other cases, the device is for a machine that is used as part of a medical device that has moving parts. The easiest answer to this question is "no", because hydrophilic coatings accomplish their mechanism through formation of hydrogels on a microscopic level, which closely associate electrostatically with water and lower friction. The more precise answer is actually a question: What do you mean by
