While it is a terrible practice to define something with itself Project scope management is the management of the scope of the project.
This is important at several phases within a project from its genesis all the way to its completion. Initially, it is mainly to process of filling in all the steps needed to get
to a desired outcome. For device…[Read more]

i don’t think using the pharmaceutical industry as a comparison is a good idea since drugs like thalidomide were allowed on the market and cigarettes caused “no health issues” for such a long time. I believe that the government should have strict design of experiment guidelines, require companies to submit all raw data results and analysis…[Read more]

To address this question, quite a few factors have to be considered and I believe the answer is not as simple as a yes or no. Among the factors to consider are the location and availability of supplies that can treat the illness that are approved. In the field, during natural disasters, or in the event proper medical care will not arrive in time,…[Read more]

While it is easy to say make regulations elastic to do everything they intended to do without hindering innovation, practically insuring that everything is done to prevent a critical failure once on the market and deregulating as a means of sanctioning progress is almost impossible with a regulation that affects such a broad range of things from…[Read more]

Since I don’t want to echo too much of what everyone said I’ll add what I think is not said. While leadership is a key role it is vague, and charisma is not really needed while it can help with team moral. Being an effective PM doesn’t mean that everyone likes you. Since PMs must PDCA, foresight and being able to seamlessly shift their focus from…[Read more]

Any major changes, in this case material composition changes, needs to be reported to the FDA. In the event that it is a novel material or a novel use of the material, in vivo studies will have to be done to verify and validate its performance because the material plays a huge role in the performance, safety, and function of a device. By changing…[Read more]

For clarification purposes.
The scamming that I was referring to is with regards to the fact that many of the treatment options available with acupuncture and electroacupuncture are not proven to be statistically significantly different than placebo acupuncture or sham acupuncture. Also, while EA and acupuncture are approved for certain patients…[Read more]

While I am not well versed in understanding the rationale of the FDA for determining the PMOA of a device, in this particular case i believe that it is a device. The rationale being that the drug component of the device has already been tested and approved by the FDA and is currently being used to treat patients. The innovative aspect of the…[Read more]

Due to an error and not being able to make a new forum I am posting here. While the topic is related to Fitbit, the question is not the same.

Should how we use a device define it?

When determining whether a device requires FDA approval, should the common use/assumed use of the device by consumers be put into consideration? If not, should the…[Read more]

I think the biggest issue here is what we determine as “Success”. If by success we mean climbing the ladder to eventually becoming a high-ranking official in a company versus landing a good paying job and being able to convince management to create a new project to develop a new product or service you thought of. The skill sets, both technical and…[Read more]