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 ...
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Author: Josh
Antimicrobial Medical Devices: Where are they?
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 ...
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Basic Bone Healing
Maybe you have broken a bone before and are curious about what happened inside the body while it was healing, or maybe you are studying for a test that covers bone healing in medical school or high school. For anyone in this situation, this course is quick review that covers the structure and function of bones and how they heal.
We all know what bone is, but not everyone...
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Get ready for a better synthetic bone regeneration material: P-15
If you were in the orthopedics business from the late 1990's through just recently, you saw the rise and fall of Bone Morphogenetic Proteins (BMP's) on the commercial market. Their story differs somewhat depending on the specific products: those based on BMP-2 and those based on BMP-7 (aka OP-1). BMP-2 fared better than its close relative, but like any commercial product it'...
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Should you start a hydrophilic coatings company?
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 ca...
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Three essentials to get started in Medical Device Development
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...
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Clinical Research for Medical Devices
This course takes the painfully dry regulations and methods used for clinical trials on medical devices and distills them nicely into a clean overview over the course of an hour. Students will learn about Good Clinical Practices (GCP's) and the regulations that govern clinical trials in the USA and rest of world, such as 21 CFR Parts 50, 56, and 812 and the ICH gu...
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European Medical Device Regulatory Basics
This is a basic online course for beginners that want to start learning about European Medical Device Regulatory Basics. The material breaks down the essential governmental structure of the EU and how this relates to the three different directives for medical devices: Medical Device Directive 93/42/EEC, In Vitro Device Directive 98/79/EC, and Active Implantable Medical De...
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Project Management for Medical Devices
This is a basic online course about how to manage medical device projects for new professionals or those just entering the field. Courses in Project Management (PM) abound both in the classroom and online. However, nearly all currently available courses focus either on generic PM or specific industries such as construction and software development. There is a decided lack...
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