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 processes. Also, Verification can be done after Design Input of the Planning…[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 less isolated/lonely ensuring greater productivity. Also, I imagine projects would be better…[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 types of traits I would look for: The person is . . .

Responsive to change. Rather than reactive; someone who…[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 of top med-tech companies, this guidance is very relaxed and not strictly enforced.…[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 of top med-tech companies, this guidance is very relaxed and not strictly enforced.…[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 of top med-tech companies, this guidance is very relaxed and not strictly enforced.…[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 technical standards. For this, the workmanship of the product must also be scrutinized with inspections and design…[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 technical standards. For this, the workmanship of the product must also be scrutinized with inspections and design…[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 technical standards. For this, the workmanship of the product must also be scrutinized with inspections and design…[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 idea for a solution, deregulating the FDA/loosening the reins on their approval processes, is…[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 idea for a solution, deregulating the FDA/loosening the reins on their approval processes, is…[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 idea for a solution, deregulating the FDA/loosening the reins on their approval processes, is…[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, more creative, and/or fulfills an additional need that the original product lacked to provide. For the suture…[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, more creative, and/or fulfills an additional need that the original product lacked to provide. For the suture…[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 the finished drug. Basically, it justified the need for rigorous regulation policies and p…[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 cues, your application assumes the role of a physical therapist (or, in this case, an auditory therapist) a…[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 are asking themselves, which FDA center has responsibility over my…[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 are asking themselves, which FDA center has responsibility over my…[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 separate of the other. I would not want my unfamiliarity of marketing to slow…[Read more]