© 2016 by Spiral Medical Development, LLC

October 31, 2016

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 wil...

October 7, 2016

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 qu...

October 5, 2016

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 a...

October 5, 2016

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:  d...

October 5, 2016

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...

October 5, 2016

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 l...

October 5, 2016

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...

October 5, 2016

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:...

October 5, 2016

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...

October 5, 2016

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...

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DISC Training Reloaded With Some Neuroscience

October 7, 2016

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