One particular project I had worked on at a drug discovery & development laboratory ran into the issue of missing a milestone. In this situation, the Gantt chart had planned for 4 researchers to work on a complete the initial R&D along with half of the synthesis in 3 weeks. However, 1.5 weeks in, one of the student researchers working in the team…[Read more]

One particular project I had worked on at a drug discovery & development laboratory ran into the issue of missing a milestone. In this situation, the Gantt chart had planned for 4 researchers to work on a complete the initial R&D along with half of the synthesis in 3 weeks. However, 1.5 weeks in, one of the student researchers caught contracted…[Read more]

In my time as a research assistant at a drug discovery & development laboratory, I ran into a particular issue that I believe had the potential to affect the critical path of the project I was working on. The drug I was charged with synthesizing had two parts: a ‘backbone’ (which was a standard base molecule that different substituent groups wer…[Read more]

In regards to the original question of “does a budget cut affect the cost estimation of a project”, I believe it does. However, I would like to add to the conversation that the timing of the budget cut within the development process has a lot to do with the final cost estimation of a project. If the project experiences severe budget cuts early on,…[Read more]

There are several severe negative results that can occur within a company that results from an underestimation of cost of a project or a unforeseen budget cut. As mentioned above, layoffs, wasted time and resources, and overall employee moral are some of the biggest casualties as an event like this unfolds. Relationships with clients and suppliers…[Read more]

In my work experience at Bristol-Myers Squibb, I noticed key environmental factors that influenced how the company functioned. Their organizational culture/ structure were very well defined into specialized departments (silos) that preformed primarily project based tasks. In addition, the Symyx electronic notebook was heavily utilized to record…[Read more]

If I was a project manager and putting together a successful project team, I would be mainly concerned with 3 key skills: area of expertise, teamwork compatibility, and their ability to successfully communicate their ideas to the rest of the team/ outside agencies.

As jvv6 mentioned, my team would have a much diversified background when it came…[Read more]

I tend to agree with bb254 and Chaudhry that as marketed by its company, Fitbit PurePulse tracker is pitched as a “general wellness use and present a low risk to the safety of the user.” As long as the Fitbit company didn’t make any medical claims and the FDA had the chance to (but didn’t) regulate the device, the Fitbit company holds no legal l…[Read more]

I also agree with bb252 and Shachi in the respect that this LifeVest Wearable Cardioverter Defibrillator is in fact a Class III medical device. In regards to potential challenges faced while trying to get this device approved, I believe that proving its reliability to be able to successfully detect heart arrhythmias along with not misfiring when…[Read more]

A tend to agree with Roberto in my thinking that all products, regardless of need, undergo their respective life cycles. Most products will go through their cycles at a pretty ‘normal’ rate compared to niche and staple products. Highly specialized ‘fad’ products will rise and fall relatively quickly (silly bands) vs a cultural staple (corn).…[Read more]

Similar the Roberto’s example above, I have experience with method validation and verifications in my past work experience. At the pharmaceutical company I was working at one summer, I was tasked to optimize a method my company used to separate monoclonal antibodies from unreacted starting product. About halfway through the summer, I had come up w…[Read more]

I agree with the two above posts which state that he process and design verifications are done towards the end of the specified project.A successful validation program depends upon information and knowledge from product and process development. I would like to further emphasize that process validation encompasses a series of activities taking…[Read more]

I tend to agree with kpr76 and Roberto Pineda here when they conclude that they are different in function yet noticeably similar in their overall end goals. The occupation “project manager” is a broad term that is used across the scientific and construction community to name somebody who is in charge of the overall result of the project. This pro…[Read more]

When regarding all the different areas of interest that go into a Human Factor study including HF formation and HF validation, it is especially important to also consider the evaluation of Use-Related risk. The goal of use-related risk analysis will help identify critical tasks that should be further evaluated in a HF study. Two use-risk…[Read more]

In regards to the FDA guidelines posted by la82, I tend to personally agree with their overall classification of devices into SR and NSR classes. In addition, I would like to highlight that the decision boards pay special attention to HOW the device is proposed to be used in addition to the actual device. The intended use of a device could change…[Read more]

As touched upon by the 5 areas of Emotional Intelligence, (Awareness, Empathy, Regulation, Motivation, Social Skills) as explained by Daniel Goleman, I believe the single most important quality a project manager possesses is a superior ability to communicate. Communication in all forms, while often underrated, is critical to this roe perhaps more…[Read more]

My experience while working in industry centers around my time at Bristol-Myers Squibb where the entire department worked in primarily a project based environment. There was a common goal for the entire method and analytical development (MAD) department worked towards and each employee answered to their respective project leaders. These project…[Read more]

Design Validation is the testing of a product to ensure that it meets the user’s needs along with its expected intended uses by the engineers. Specified operation conditions must also be followed.

1) Slide- This product would benefit clinical trials because it is susceptible to user error. If the slide is not prepared the way it was engineered…[Read more]