cs22

Forum Replies Created

RE: Communication and Responsiveness

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 c...

In forum Project Management Process and Medical Device Development

8 years ago
RE: Meeting Deadlines with Research

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 lev...

In forum Project Management Process and Medical Device Development

8 years ago
RE: Project Scope: When the timeline you have doesn't work

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 ha...

In forum Project Management Process and Medical Device Development

8 years ago
RE: Unapproved Device

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...

In forum Introduction to Project Management

8 years ago
RE: Thoughts and Questions Related to Untested Medicine

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 pro...

In forum Introduction to Project Management

8 years ago
RE: Inadequate Testing

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 Phar...

In forum Introduction to Project Management

8 years ago
RE: FDA Approves First Digital Pill in USA

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 b...

In forum Introduction to Project Management

8 years ago
RE: Challenges in the Global Regulatory Environment

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 ...

In forum Introduction to Project Management

8 years ago
RE: Thoughts and Questions Related to Untested Medicine

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...

In forum Introduction to Project Management

8 years ago
RE: Decision Making: To do or Not to Do?

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 i...

In forum Introduction to Project Management

8 years ago
RE: Interpersonal skills vs technical knowledge

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 ...

In forum Introduction to Project Management

8 years ago
RE: Discussion Topic: Share your project management experience

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 ...

In forum Introduction to Project Management

8 years ago
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