With all of these I think it depends on the severity of the deviation the failure causes to the original scope of the project. Sometimes losing a vendor or a new regulation might not have a available alternative or work around and the project cannot proceed or must make drastic or time and money consuming changes to continue. In cases where there…[Read more]

Unforeseen occurrences are should be factored in with task scheduling. If a schedule is too tight then any delay will cascade into other tasks which depend on the initial task. This will in turn cause those tasks to be delayed, and so forth. In order to help with this task duration should be established with considerations in place in case of any…[Read more]

Persistence is important with unresponsive team members or even sometimes with the PM themselves. In a capstone project I participated in, with the our advisor acting as PM, we found it difficult to contact them for input outside of our weekly progress meetings due to their other obligations. To help with this issue our group was diligent in…[Read more]

One possible way to save time and effort is to approach FactoSet in regards to validity testing. The company that developed the growth factor most likely has an established method to determine its level of activity or if it is functional. Even if their particular method is proprietary and not available to the project team, FactoSet may still be…[Read more]

Any unethical practices should be avoided from a design standpoint. However, if a project does find itself in a situation like you have outlined the reality is they may take some of the actions you have mentioned. In contemplating taking these actions, the decision makers would most likely weigh what they stand to lose by remaining ethical against…[Read more]

I don’t think this situation will occur in any meaningful frequency. Most hospitals or physicians will only have FDA approved products on hand and those which do not are most likely not very reputable and will use any device they seem fit. As the previous post mentioned there are stipulations for extremely rare cases as well as for diseases or…[Read more]

In response to the questionable services provided by acupuncturists in addition to their regular service, I feel this is acceptable provided that their primary service is FDA approved and they are properly licensed. The extra income from their secondary services, provided these services are not harmful, help keep the business open and financially…[Read more]

I believe there is more scrutiny in the pharmaceutical industry simply because it is a much larger industry. This means many more companies with many more products for the FDA to regulate. Since Pharmaceuticals affect many more people and also involve products that may have far more subtle complications compared to an implant or other biomedical…[Read more]

I agree with aij5. The novel portion of this particular product is the sensor and reporting aspect, the drug is already an approved product. If the device portion is approved it has the potential to be used with other drugs. However, if the device somehow controlled the dosage administered to the patient then there would be more hurdles to cross…[Read more]

Proper planing and deciding release schedules for different regions should be considered, but the major goal in developing a commercial product is to have it available in the primary market first and then expand into other regions. Having a simultaneous release of a product into every market would take too much time and resources. If an issue was…[Read more]

Currently, there is a major issue involving the overuse of opioid painkillers in pain management. So much so that the FDA has released guidelines for doctors to explore the use of chiropractic methods and acupuncture as alternative treatments:
https://www.fda.gov/downloads/Drugs/NewsEvents/UCM557071.pdf

The FDA has also approved an…[Read more]

I feel that, for adding more coatings to test, it becomes a balancing act between finding an ideal antibiotic and the increased time and resources of a larger study. In these situations I think it’s important to properly research beforehand on established coating and protocols to minimize the chance that any mishaps were due to factors that are n…[Read more]

During my undergraduate studies, the majority of the BME courses within the B.S. program focused on group work and projects instead of the testing and individual work that Chemistry, Physics, or even Mechanical Engineering courses focused on. I believe this was due to the Department’s recognition of the importance of developing social skills n…[Read more]

I currently work in the Forensic Toxicology department of a diagnostic laboratory, mostly handling GC/MS confirmation of positively screened drug samples. Within the company, most project management communication is done through emails or in person between lab directors and supervisors along with the technologists assigned to a current project.…[Read more]