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cs22 replied to the topic "Inadequate Testing" – 5 years, 11 months ago
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… Read more»
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cs22 replied to the topic "FDA Approves First Digital Pill in USA" – 5 years, 11 months ago
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…. Read more»
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cs22 replied to the topic "Challenges in the Global Regulatory Environment" – 5 years, 11 months ago
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… Read more»
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cs22 replied to the topic "Thoughts and Questions Related to Untested Medicine" – 5 years, 11 months ago
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… Read more»
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cs22 replied to the topic "Decision Making: To do or Not to Do?" – 5 years, 11 months ago
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… Read more»
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cs22 replied to the topic "Interpersonal skills vs technical knowledge" – 5 years, 11 months ago
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… Read more»
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cs22 replied to the topic "Discussion Topic: Share your project management experience" – 5 years, 11 months ago
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… Read more»
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cs22 replied to the topic Priorities for Projects in the forum Project Management Application: Clinical Trial 6 years, 11 months ago
Priorities and the scope of a project need to be managed like any other aspect. I think in the case of most projects the priorities differ between the upper and middle management and the research individuals and also the production team. With all the different stakeholders weighing priorities, and some having more say as to which priorities are…[Read more]
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cs22 replied to the topic Skills Learned in this Class in the forum Project Management Application: Clinical Trial 6 years, 11 months ago
For me, this course reinforced the importance of good management of a project regardless of its size. I have noticed how a lot of the topics covered could have improved many projects at my own workplace and how they can be used to improve future projects. Communication seems to be an important aspect of project management, and something as simple…[Read more]
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cs22 replied to the topic How to make good relation with vendors in the forum Project Management Application: Clinical Trial 6 years, 11 months ago
Some orders from vendors are also made to order to certain specifications. This means there is usually some delay between ordering and receiving from a vendor as they need time to fabricate the order. In cases such as this communication and managing orders to the vendor is even more important as the production of your product may depend on that…[Read more]
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cs22 replied to the topic Different PM techniques based on size in the forum Project Management Application: Clinical Trial 6 years, 11 months ago
Smaller companies have much less people to manage making it simpler in a way but in other ways more crucial as individuals in smaller companies are more than likely in charge of a larger portion of the work required to complete a project compared to a larger company where an individual’s specific contribution is a smaller fraction of the total w…[Read more]
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cs22 replied to the topic What’s Your Motivator? in the forum Project Management Application: Clinical Trial 6 years, 11 months ago
The main motivator for me is the opportunity to create something new. I also enjoy finding solutions to the various problems that occur during the course of a project. Seeing the end result of months of work is also a major motivating factor and gives me the desire to start new projects.
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cs22 replied to the topic Specifications: A double edged sword? in the forum Project Management Knowledge Areas 6 years, 12 months ago
A metric for a specific feature should always fall within the defined specifications; otherwise the documentation is meaningless and must be changed accordingly. Certain metrics can most likely have only a lower or upper limit if the design calls for it, such as a coating having a curing time of at least 2 hours where any time spent curing after 2…[Read more]
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cs22 replied to the topic Communication Management in the forum Project Management Knowledge Areas 6 years, 12 months ago
The method of communication management should be tailored to each specific company as various factors such as hierarchies, communication infrastructure, security protocols all differ between companies. Multiple methods of communication should be implemented to prevent issues where one is not available. Regular meetings can allow for communication…[Read more]
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cs22 replied to the topic Six Sigma and Project Management in the forum Project Management Knowledge Areas 6 years, 12 months ago
Six Sigma actually contains a specific project methodology when working with projects that will produce a new product as opposed to improving business practices:
DMADV System:
Define design goals that are consistent with customer demands and the enterprise strategy.
Measure and identify characteristics that are Critical To Quality, product…[Read more] -
cs22 replied to the topic Closing Phase in the forum Project Management Process and Medical Device Development 7 years ago
As the lecture also mentioned, a very important component of the closing phase is to properly record everything so that information can be used for future projects. This can help in not repeating the same mistakes in similar projects in the future.
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cs22 replied to the topic planned value vs actual costs in the forum Project Management Process and Medical Device Development 7 years ago
I think its important to remember that the monitoring and control phase occurs throughout the entire lifespan of the project and is always a factor in decision making. With that in mind, the various metrics help greatly since they give quantitative and easy to understand values at any stage that the project is on. The process of calculating these…[Read more]
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cs22 replied to the topic Post-project lessons learned in the forum Project Management Process and Medical Device Development 7 years ago
With a capstone project I was involved in, a major lesson we learned was adjusting the project scope due to limitations found in the design. With this project, one of the parts of the device required a much higher manufacturing precision that we were capable of producing given our budget and time frame. This caused us to select our second choice…[Read more]
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cs22 replied to the topic Unexpected Time Delays – miniSim in the forum Project Management Process and Medical Device Development 7 years, 1 month ago
I think the consequences of risking the project with poor experimental data are much greater than any time delays. If poor experimentation fails to uncover a particular design issue or if it is not accepted by appropriate regulatory agencies, then the delay to the project would be much greater than the alternative.
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cs22 replied to the topic Points to look for while out sourcing in the forum Project Management Process and Medical Device Development 7 years, 1 month ago
If the outsourced part is critical to the devices specific function, extra communication and scrutiny is required between the project team and the outsourcing company. Not only will the product need to meet all standards set, it will also need to be delivered reliably and on time for production to work. This should probably include a thorough…[Read more]
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