Spiral Medical Development

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 wa

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 sta

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 need

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

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 fro

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 undergraduat

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

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

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 particl

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.