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jr377 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics 6 years, 10 months ago
I noticed that no one talked about a recorded phone call/video call. I’m not sure which it would count under. Technically its not written, pushing my assumption of it being an verbal agreement. However, it is easily proven, especially in court, by playing the recording for whoever is arbitrating seeing as it is a physical recording. That is the…[Read more]
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jr377 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies 6 years, 10 months ago
As stated you don’t usually get to choose. That being said, I think you need to lean on the knowledge vs compatibility side. For the sake of giving percentages, let’s say 70/30. You can people who have great relationships but if they don’t know anything whats the point. You wouldn’t be able to get anything done, but you’d agree on it. On the flip…[Read more]
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jr377 replied to the topic Upper vs Middle Management. in the forum Organizational Development in Device Companies 6 years, 10 months ago
I don’t think that it matters if you want to be upper management if you’re bad at middle management. I may be wrong, but I’m pretty sure that upper management gets promoted from middle management. You have to be good at one to be able to become the other. If you are a good middle manager, then you have the option to work your way up the ladder,…[Read more]
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jr377 replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies 6 years, 10 months ago
Personally I believe I would rather be in a functional organization. I like clear cut positions and knowing how to advance. Interdepartmental coordination shouldn’t be as much of a problem compared to the other types. I wouldn’t want to be project-based because I don’t like bad company cultures, and I wouldn’t want to be in a matrix organization…[Read more]
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jr377 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 6 years, 10 months ago
I’m going to use a non-BME example to help clarify my thoughts. Whenever you get a coffee, the cup will usually have a label that warns that it is in fact, hot. Seems silly right? Well it’s a result of Liebeck v. McDonald’s Restaurants. A woman sued and won because she burned herself due to spilling hot coffee on herself. These labels aren’t…[Read more]
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jr377 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 6 years, 10 months ago
From best to worst option for each risk level-
High risk: Avoidance, Mitigation, Transference, Acceptance
Medium risk: Mitigation, Transference, Avoidance, Acceptance
Low risk: Acceptance, Transference, Mitigation, AvoidanceHigh risks need to be dealt with or else you may have major issues in the future including large lawsuits. The last thing…[Read more]
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jr377 replied to the topic Expense of Regulations in the forum Risk Analysis for Medical Devices 6 years, 10 months ago
I believe that “There is no such thing as a free lunch” is a really applicable quote for this situation. As stated previously stated, there are costs to hiring people to create and maintain this standard. All of the work put into the standard, including the test that the standards exemplify, require money. There are also basic costs that, for…[Read more]
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jr377 replied to the topic Deviations That Occurs During Verification in the forum Introduction to Design Controls 6 years, 10 months ago
I haven’t actually had the experience to comment with a story of my own, but I do have a few questions that tie into this subject. How often do failed verification tests occur? It seems like verification failures occur more often than failed validation tests. It also seems as if these failures are relatively simple fixes. Are there any you know of…[Read more]
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jr377 replied to the topic Customer Needs and Design Input in the forum Introduction to Design Controls 6 years, 10 months ago
sin3, I think you switched verification and validation a little in your mind. Verification determines, like you said, every input has an output. Those inputs would come from the DID. Validation however, is what is used to determine whether or not the product fits the customer needs, not verification. Other than that, I agree with the rest of your points.
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jr377 replied to the topic Statistical Sampling in the forum Introduction to Design Controls 6 years, 10 months ago
I haven’t done statistical tests in industry but I can speak to academic tests I have done. In addition to paired t-tests and one way ANOVAs, mixed ANOVAs and repeated measures ANOVAs are good tests to determine significance between factors. These can take into account within-subject and between-subject factors. 95% is usually what is used in…[Read more]
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jr377 replied to the topic Factors to Consider While making Gantt Chart in the forum Introduction to Design Controls 6 years, 11 months ago
Although I haven’t started working in industry yet, I want to add a little to the Gantt chart “margin of error”. You need to have concrete goals for end dates for aspects of the project. You also need to do your best to get stuff done by those deadlines. You can’t allow too much time to be built in as a margin. Let’s say something ships late.…[Read more]
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jr377 replied to the topic Design Documents in Academia in the forum Introduction to Design Controls 6 years, 11 months ago
I will elaborate a little on IRB, because that documentation is the most important aspect of research in academia. The IRB reviews any ethical concerns of a research experiment. If they approve the study, that documentation then has to be posted in easily view-able location where the study will be taking place. The IRB would contain aspects of…[Read more]
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jr377 replied to the topic Customer Needs and Design Input in the forum Introduction to Design Controls 6 years, 11 months ago
Well one is necessary for the other. I don’t know if I would talk about them in terms of pros and cons. One document is necessary for the other. Let’s stick with the door knob example. You need a basic understanding of what is wanted. That’s what the DID document is for. An understanding of what is needed is formulated in this document. If you get…[Read more]
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jr377 replied to the topic Clinical Studies in the forum Clinical Research Basics 6 years, 11 months ago
One popular quotes that comes to mind is “nothing ventured, nothing gained”. This is exactly what clinical trials are for. Of course there is risk, but clinical trials are designed to minimize the risk of patient injury/death. The patients are told of the risks, and the effects that were seen in previous trials on animals and in vitro.…[Read more]
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jr377 replied to the topic Double Blind Vs Single blind Study in the forum Clinical Research Basics 6 years, 11 months ago
Double blinds are good, but triple blinds are better. The patient may have the placebo effect, the researcher may unwittingly indicate the type of treatment on way or the other, and the analyst may select data based on what they expect to see. The placebo effect is a well-documented phenomenon. The researcher may have bias, but one issue that I…[Read more]
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jr377 started the topic Right to Try Law in the forum Clinical Research Basics 6 years, 11 months ago
This year, the Right to Try act was signed into federal law. This law allows patients to request the use of investigational drugs (without FDA involvement or state law). There was a current “compassionate use” framework, but no actual law. This law allows for drugs as early as Phase I to be used. Patients may be charged the direct cost of…[Read more]
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jr377 replied to the topic Medical Device SWOT Analysis in the forum Marketing and Sales 6 years, 11 months ago
I chose to do an analysis of Merck
Strengths:
-Huge product portfolio
-Brand Name trust
-international presence
-large size company
-public faith because of not increasing drug prices and donating drugs to poor countries
-continuous growthWeaknesses:
-counterfeiting of products hurt the brand trust
-product safety controversies (ex.…[Read more] -
jr377 replied to the topic Discussion Topic: The Fifth "P" of Marketing in the forum Marketing and Sales 6 years, 11 months ago
One thing I’ve noticed that’s becoming more popular among companies are giveaways. These giveaways always interest people, because of course, who doesn’t like free stuff? The caveat is that the person has to interact with the company in some way. Either buy buying a product or advertising for them on social media. Online, they may have to like or…[Read more]
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jr377 replied to the topic Brand Coloring in the forum Marketing and Sales 6 years, 11 months ago
One color that is mainly used is blue. If you take a look at your phone it’s safe to say that at least a third of your apps have the color blue in it. There’s a few reasons for this. Blue is the favorite color of most people. That’s because there is a lot of positive associations with it, without many negative ones. For example, the sky and water…[Read more]
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jr377 replied to the topic Discussion Topic: Exercise your research skills in the forum Business 101 6 years, 11 months ago
Duplicate due to upload issues, sorry!
I chose to research Tesla Inc.
ROA: -7.64
ROE: -43.63
ROI: -14.25
Gross Margin: 19.15, Net Margin: -16.68
Liquidity Current Ratio: .86
Revenue: about $4 billion
Based off of dh239’s numbers the stats are worse than last year. However there was a significant growth in revenue. Tesla has been having issues…[Read more] - Load More