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nk229 replied to the topic "Restrictions for physician's gifts" – 5 years, 12 months ago
I would have to agree with what others have said in that in the first place, it is inappropriate for the wife to have come to the dinner. When going to dinners or lunches there should be a professional or… Read more»
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nk229 replied to the topic "Consultants NDAs and CDAs" – 5 years, 12 months ago
While this consultant definitely seemed to be in violation of the NDA or CDA, however this topic can be tricky. Having worked with two companies that work on the same technology it is clear that sometimes the way things are… Read more»
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nk229 replied to the topic "NDA vs Patents" – 5 years, 12 months ago
One of the main advantages that I have seen with patents over NDAs is that a patent can offer a competitive advantage over other companies. For instance when talking about drugs and drug delivery systems, if you have found that… Read more»
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nk229 replied to the topic "Discussion Topic: Your organizational type" – 5 years, 12 months ago
I work for a matrix organization. I personally like this because it allows me as a researcher to have someone who can more heavily focus on the science of the projects and another to focus more on the business. Very… Read more»
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nk229 replied to the topic "Organizational Behavior Management" – 5 years, 12 months ago
I believe that there needs to be a certain balance when it comes to organizational behavior, it should be somewhere between structured and very comfortable. Companies have to have a certain degree of slack in there behavior, you should enjoy… Read more»
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nk229 replied to the topic "Organizational structure and Culture both leading to project success?" – 5 years, 12 months ago
I agree with what everyone has said about culture playing an important role in the success of an organization. For me it is crucial since my research heavily depends on cooperating with another group. The work requires planing, sharing information… Read more»
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nk229 replied to the topic "Usability Risk Analysis" – 5 years, 12 months ago
When in research and development it is easy to overlook usability as a concern because you may be very familiar with the technology. You understand how everything should be done and why. However most people wont understand the science behind… Read more»
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nk229 replied to the topic "Risk management and Labels" – 5 years, 12 months ago
Working with pharmaceutical risk and instructions are a major concern. When people take a medication there are usually instructions on how to take it, however the user may not understand why things need to be done a certain way. Even… Read more»
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nk229 replied to the topic "Risk Identification" – 5 years, 12 months ago
I would like to expand on the above mentioned checklist and previous similar projects. As a researcher that is my primary method of risk assessment. To me a new project means working with a new drug, thus the first thing… Read more»
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nk229 replied to the topic "Minutes for meetings" – 5 years, 12 months ago
This may be slightly off topic, but one important thing to consider in meeting minutes is clarity. When our project manager takes down meeting minutes she often writes what she hears and interprets, however that may not always be correct…. Read more»
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nk229 replied to the topic "Design Transfer" – 5 years, 12 months ago
I believe that it heavily depends on the size of the company and what the company is producing. The company I work for is fairly small however the technology we produce is relatively unique. Each project is unique and experience… Read more»
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nk229 replied to the topic "Factors to Consider While making Gantt Chart" – 5 years, 12 months ago
One thing that I have come to learn is that you no matter how much you plan, some things are out of your control. For instance in my field we have to do several pre-clinical trials, which have to be… Read more»
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nk229 replied to the topic "Consequences Of Insufficient Design Controls" – 5 years, 12 months ago
I would like to focus one particular aspect of design controls, specifically planning. Poor planning can be disastrous for a project. From my own experience, pre-clinical and clinical trial dates are planned well in advance, which means when the time… Read more»
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nk229 replied to the topic "Important Part of DDP" – 5 years, 12 months ago
I don’t think it is fair to assign one part of the DDP as the most important. One could argue that quality management(or any other part) is the most important, even if the most important part is done correctly, if… Read more»
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nk229 replied to the topic "Design input sources" – 5 years, 12 months ago
While my company primarily deals with drug delivery systems in film form, there has always been discussion of developing a device to distribute films to patients. While most of the requirements would be determine by management, market research, users, etc.,… Read more»
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nk229 replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics 8 years, 5 months ago
I would have to agree with what others have said in that in the first place, it is inappropriate for the wife to have come to the dinner. When going to dinners or lunches there should be a professional or business related aspect to the meal. As my father is a physician I would say these regulations are not too restrictive in the slightest.…[Read more]
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nk229 replied to the topic Consultants NDAs and CDAs in the forum Consultants and Legal Basics 8 years, 5 months ago
While this consultant definitely seemed to be in violation of the NDA or CDA, however this topic can be tricky. Having worked with two companies that work on the same technology it is clear that sometimes the way things are done are just the logical way. Especially in an environment that is as heavily regulated as the medical device and…[Read more]
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nk229 replied to the topic NDA vs Patents in the forum Consultants and Legal Basics 8 years, 5 months ago
One of the main advantages that I have seen with patents over NDAs is that a patent can offer a competitive
advantage over other companies. For instance when talking about drugs and drug delivery systems, if you have found that your product has worked best with certain processes or certain reagents patents can offer more protection. If other…[Read more] -
nk229 replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies 8 years, 5 months ago
I work for a matrix organization. I personally like this because it allows me as a researcher to have someone who can more heavily focus on the science of the projects and another to focus more on the business. Very often in R&D I encounter things I have never encounter and having a subject matter expert to go to if I need a second opinion or…[Read more]
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nk229 replied to the topic Organizational Behavior Management in the forum Organizational Development in Device Companies 8 years, 5 months ago
I believe that there needs to be a certain balance when it comes to organizational behavior, it should be somewhere between structured and very comfortable. Companies have to have a certain degree of slack in there behavior, you should enjoy working the other people and maintain a certain level of friendship. However there needs to be a a certain…[Read more]
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