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Scott replied to the topic "Failure's of Pre-Clinical / Clinical Research" – 6 years, 2 months ago
Interesting. Did they go back and re-do the protocol and initiate the the trails again after realizing the diminished interleukin levels? If they conducted it again, what happened afterwards?
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Scott replied to the topic "Discussion Topic: Beyond experimental design issues" – 6 years, 2 months ago
The main motivating factor, in terms of animal studies, is conducting the study on these animals and seeing what the results are. The results will demonstrate if the research for the university is worth pursuing and these type of studies… Read more»
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Scott replied to the topic "Academia vs. Industry Research" – 6 years, 2 months ago
Generally speaking, research in industry is investigate and completed “faster” usually because they have the resources in terms of money and experienced people. It also depends what type of research that the company is conducting. In terms of medical device… Read more»
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Scott replied to the topic "Milestones Missed: Failure or Success?" – 6 years, 2 months ago
It depends. If you are missing milestones that need to be accomplished that are highly critical to compliance and basically keeping the customer/patient safe, then I would be able to accept missing it. These are the type of situations that… Read more»
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Scott replied to the topic "Multiple Project Managers for one project" – 6 years, 2 months ago
Most of the projects that I have worked on, which have had a big scope and long timelines, has followed a format in which one person is the Project Manager and underneath the project manager are a bunch of Project… Read more»
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Scott replied to the topic "Discussion Topic: Project Management in a medical device setting" – 6 years, 2 months ago
The regulatory aspect of project management for medical devices is a very obvious difference. I think another big difference between project management for medical devices vs building construction involves the tighter and stricter deadlines. For medical devices, meeting deadlines is… Read more»
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Scott replied to the topic "Project Life Cycle" – 6 years, 2 months ago
Planning phase and executing phase are by far the most important phases in product lifecycle management. During the planning phase it is imperative to get all stakeholders involved in developing a timeline, budget, resource allocation, and solidified sequence of steps… Read more»
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Scott replied to the topic "Professions in Academia and the Industry" – 6 years, 2 months ago
To answer your question regarding consulting: In order to be a “real” consultant, you need years of experience. Companies will usually reach out to you specifically for special projects that need to be done and will look for you to… Read more»
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Scott replied to the topic "Discussion Topic: Academia vs. Industry" – 6 years, 2 months ago
Outside of of the pros of industry salary and academia tenure, I would argue that there are certain pros and cons with the type of people and personalities you can expect to work with in industry and academia. I believe… Read more»
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Scott replied to the topic "Discussion Topic: Practical vs. Informational courses" – 6 years, 2 months ago
I don’t believe there is a right or wrong answer as to what the ratio should be that is offered. I believe that it is solely dependent on what ones overlying goal is upon completion of their degree. Sure, NJIT… Read more»
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Scott replied to the topic "Advice for Biomedical Engineering Students" – 6 years, 2 months ago
Everyone in this forum keeps stating “get an internship or co-op”. For a lot of people trying to break into the field, this is actually a lot more challenging then it seems. When companies are recruiting at schools, they have… Read more»
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Scott posted a new topic "Innovation and Discovery Hurdles" – 6 years, 2 months ago
We discussed during Innovation and Discovery some common mistakes that occur between operations and the dedicated team bringing about this change. Essentially the main takeaway of it was for companies to create an opportunity for people to think differently within… Read more»
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Scott posted a new topic "Severance and Release Agreement" – 6 years, 2 months ago
Has anyone ever been laid off of a job that required them to accept a severance and release agreement? Basically the company gives you some form of compensation in exchange for agreeing not to sue the employer. During this time… Read more»
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Scott posted a new topic "Ring Fenced" – 6 years, 2 months ago
Has anyone ever worked for a company in which that company was sold off and every employee became legally a ring-fenced employee? Essentially the employee has a certain time period where they cannot leave the position or company that was… Read more»
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Scott posted a new topic "Upper vs Middle Management." – 6 years, 2 months ago
A small part of the lecture reviewed Upper Management vs Middle Management. Upper Management people are strategic and tend to set the groundwork and vision for what the company could be. Middle Management people are tactical and make sure what… Read more»
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Scott posted a new topic "Deviations That Occurs During Verification" – 6 years, 2 months ago
For the Verification step, a test is generated to ensure the design outputs meet the design input requirements. If the test doesn’t pass, then a deviation essentially occurs. Has anyone encountered a Verification Test that didn’t pass? If it didn’t… Read more»
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Scott posted a new topic "Statistical Sampling" – 6 years, 2 months ago
Statistical sampling is required for design verification and validations. If you have worked for a company or written protocols in the past – how have you explained or ensured that the sampling plan and statistical approach you have taken has… Read more»
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Scott posted a new topic "Ethical Issues with Clinical Trials" – 6 years, 2 months ago
Clinical trials and research is designed to expose a limited sample of subjects to potential new treatments. Human tests of a medical intervention typically pose risk to subjects despite the amount of laboratory and pre-clinical trails conducted prior to the… Read more»
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Scott posted a new topic "How Quality Departments React to Audits" – 6 years, 2 months ago
Having a detailed and accurate Quality System is extremely important for a medical device company. The Quality Systems ensure that essentially everything within a medical device company is documented. This includes validations, risk assessments, design history files, etc. When an… Read more»
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Scott posted a new topic "Regulatory Projects Worked On" – 6 years, 2 months ago
Two years ago I was working on BSI from a Supply Chain perspective. It was interesting in the fact that we had to understand different countries regulations in the European Union. Some required regulatory approval to receive product whereas some… Read more»
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