Absolutely! One of the aspects of my thesis project was to develop an in vitro blood-brain barrier; primary cortical neuronal cells would be attached to the bottom of a well while endothelial cells and astrocytes would be suspended on either…   Read more»

To answer how much information is needed to begin a formal project it is important to outline what information is needed. You sort of answered this in your question, enough preliminary details to plan or propose. These preliminary details (most…   Read more»

Verification tasks can be designed during the Planning process of project management. For example, if the project will need clinical trials for design verification then anticipating and formulating them in the Planning process would ease the remainder of the development…   Read more»

If I were to interact face-to-face I might take more initiative. For this simulation I mostly waited until a group member made a suggestion then either agreed or offered an alternative. Face-to-face interactions are, to me, much more motivating and…   Read more»

My dream team would be selected based on personal traits and drives under the notion that technical skills are less important because they can be learned while personal skills need time and nurturing to be developed. These would be the…   Read more»

The FDA is currently drafting a guidance to regulate certain “general wellness devices.” These include ones that help “log, track, or trend exercise activity” for the maintenance of a healthy lifestyle, exactly what the Fitbit does. Although, with the coercion…   Read more»

Most of the example above described some variation of testing as their chief form of design verification. But verification is more than this, it is making sure that the design of the device is right, i.e. it meets its required…   Read more»

This is a really great topic because it is relevant and controversial. My thoughts are these: Trump has the right intent, there are problems within the regulatory practices/policies of the FDA and we need a concrete, forthright solution. However, his…   Read more»

I disagree with the argument that some products do not seem to enter the Decline phase of their life cycle. Instead, the actual need does not decline while the product can get replaced with one that is more technologically advanced,…   Read more»

What the Thalidomide disaster did to the FDA was not only demonstrate the importance of drug trials, as Chris’s post pointed out, but, even more importantly, tightened surveillance on how these trials were conducted, their results, and the efficacy of…   Read more»

I disagree and feel your application is more than a simple mobile medical app, I would consider it a rehabilitation device (conveniently packaged as an app on your phone, ipad, etc.). (I am expanding on Hiren’s post). In retraining auditory…   Read more»

Combination product development alone is very tricky because of the FDA’s rudimentary policies on combination products. Manufacturers are often left scratching their heads as to which regulatory pathway to follow for their combination product even before it is complete; they…   Read more»

I think I might enjoy working in a classical functional organization. I like working in research/engineering and would prefer not to be bothered with the marketing, manufacturing, or accounting aspects of the project; in a functional organization each department works…   Read more»

For a Project Manager, the difficulty in hopping from fundamentally different projects would be in executing project planning. The inventory of necessary materials, equipment, and specialists, time management, and overall project execution for skyscraper construction are completely different from those…   Read more»

Design Validation means exactly that, verifying that the right device was designed. For example, if a user wanted an ointment to heal burn scars but the final product only caused hair to grow on the scar instead then this product…   Read more»