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pv223 replied to the topic Medical Device Project in the forum Organizational Development in Device Companies 6 years, 4 months ago
In my team, we started off by having the PM send out the DDP, a form to help him fill form a gantt chart, as well as all documents related to his project that he already had prepared. We then decided to have weekly meetings every Friday at 7 pm via call-in to discuss the progress on the project. Just recently, I sent out the DID based off some of…[Read more]
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pv223 replied to the topic Your Organizational prference; but why? in the forum Organizational Development in Device Companies 6 years, 4 months ago
Based off my past experience on how group projects tend to go for classes here, I would say that I am used to the Matrix form that Dr. Simon used and would probably prefer it over the others. For one thing, the smaller group of people in the same “division” (students in this case), make it easier to get in touch with each other since most of us…[Read more]
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pv223 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 6 years, 4 months ago
The reason labels are the least effective tool for risk management is that they are quite obviously not read. People often use common sense when opening up a product and more often than not figure out the way to use it after a few minutes of trial and error, if not right away. However, companies can not bank on everyone having enough common sense…[Read more]
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pv223 replied to the topic Factors Contributing to Risk Values in the forum Risk Analysis for Medical Devices 6 years, 4 months ago
How I remember it from the lecture, the three risk factors are Severity (S), occurrence (O), and noticeability (N) or S.O.N. The product of the numerical values for these three factors is how the Risk Priority Number (RPN) is assigned. For my analogy, you would want to minimize the amount of risks you would both want to take with your son and want…[Read more]
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pv223 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 6 years, 4 months ago
For high level risks, I would do my best to mitigate the risk in an attempt to decrease the severity of the risk and then would try to employ transference to see if anyone else can do something to circumvent the risk. If not, I would employ avoidance to circumvent the risk as best I can. For low level risks, I would either try to mitigate the risk…[Read more]
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pv223 replied to the topic Factors to Consider While making Gantt Chart in the forum Introduction to Design Controls 6 years, 4 months ago
Throughout this year in my Capstone class, the use of a Gantt chart has helped my group and I tremendously in keeping track of our progress. It is easy for us to know which aspects of the project are dependent on which other aspects, what milestones we need to hit, where we are in terms of progress (whether we’re on track, ahead of schedule, or…[Read more]
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pv223 replied to the topic Important Part of DDP in the forum Introduction to Design Controls 6 years, 4 months ago
I personally feel like a project’s quality is completely dependent on communication, especially if there is a team working together on a project. Without communication, the odds of having every aspect of the project working phenomenally as well as have them integrate with each other seamlessly is microscopic. If you were part of a team working on…[Read more]
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pv223 replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls 6 years, 4 months ago
As many have mentioned above, the more insufficient the design controls are, the more likely it is for the product to fail. There are a few examples of this scenario, such as when vehicle manufacturers have to recall a certain model due to some structural issues. Ethically, this can be related to the Ford Pinto fiasco. The bending iPhone 6 and 6…[Read more]
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pv223 replied to the topic Design Review Meetings in the forum Introduction to Design Controls 6 years, 5 months ago
While I myself have never been a part of a design review meeting, i still feel that such meetings are very important in the production process of a product. As a new idea is being developed, it goes through many changes in order to comply with any and all new restrictions that appear after the initial approval. Having such a meeting after all the…[Read more]
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pv223 replied to the topic Minutes for meetings in the forum Introduction to Design Controls 6 years, 5 months ago
As a previous secretary, there is a difference between a good set of minutes and a sub-par set of minutes. You know a set of minutes is good when someone who was not present at the time of the meeting but knows the general workings of the organization/company (be it a co-worker, a supervisor, etc.) can read through them and be caught up and not…[Read more]
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pv223 replied to the topic Customer Needs and Design Input in the forum Introduction to Design Controls 6 years, 5 months ago
The DID document is a very rough sketch. When anyone looks at it, they should be able to tell what it is even though there aren’t many details. This sort of document is great for customers who don’t really understand the specifics of everything that can goes on. The DSD is the Mona Lisa of the document. You add in all the details and those that…[Read more]
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pv223 replied to the topic WHAT IS THE OBJECTIVE OF CLINICAL TESTING ON PHARMACEUTICA DRUGS? in the forum Clinical Research Basics 6 years, 5 months ago
The purpose of clinical testing on pharmaceutical drugs is to see how well the drug accomplishes its intended purpose as well as identify any and all side effects that the drug can cause so that they can be listed for the patients that do take the medication. Without this testing, there is no way to see if the drug that is being produced is even…[Read more]
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pv223 replied to the topic Informed consent: What if Henrietta Lacks checked No for research use? in the forum Clinical Research Basics 6 years, 5 months ago
With the way society has progressed over the last few years, consent is more important than ever. If a research hospital would like to use a patient’s data/samples in a research study, then the hospital should definitely get permission from the patient first. For one thing, if a research hospital took data from a patient, used it without the…[Read more]
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pv223 replied to the topic Double Blind Vs Single blind Study in the forum Clinical Research Basics 6 years, 5 months ago
While I see what you mean when you say that having the investigator know what he is giving the subject has no harm, in actuality the exact opposite can actually be the case. If the investigator knows he is giving the subject the actual product, they may end up unconsciously dropping hints through facial movements, verbal emphasis, etc. and that…[Read more]
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pv223 replied to the topic WHAT IS MARKETING TO YOU? in the forum Marketing and Sales 6 years, 5 months ago
Marketing is about selling the product. That can be through promotion, EI manipulation, truthfulness, communication, from a marketing standpoint that is not as important as making sure the product sells. Personally, I’m not going to market a product that I have to make up facts for in order to make it appealing. If I want to sell a product to…[Read more]
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pv223 replied to the topic Brand Coloring in the forum Marketing and Sales 6 years, 5 months ago
When it comes to branding, color is a minor detail that can have a major impact due to the emotional messages it sends. For example, yellow is generally one of the happiest colors on the spectrum. It portrays optimism, warmth, an all around good feeling which is why locations such as Denny’s, ShopRite, and SubWay use it in order to seem more…[Read more]
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pv223 replied to the topic Partnership characteristics in the forum Business 101 6 years, 5 months ago
While partnerships sound all well and good on paper and may run low risk, they are still not easy to manage unless your partner is the definition of a perfect partner. While you and your partner may share similar goals and ideologies, the execution you may feel is best could be drastically different than what your partner sees as best and that can…[Read more]
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pv223 replied to the topic Family Businesses in the forum Business 101 6 years, 5 months ago
A sole proprietorship cannot be passed down from one person to another, however there are ways around it. One way is for the father’s company to be bought out by the son(s) and then have them change the business into one that can be passed down, such as an LLC or a corporation. Another way is to just have the father do take those steps himself…[Read more]
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pv223 replied to the topic R&D vs Quality in the forum Quality Control and Quality Assurance 6 years, 6 months ago
While R&D and Quality both want as many products to be shipped out as possible, Quality has the added responsibility of making sure that all the products meet all of the regulations. While their overall goal is the same, it is the added responsibility that causes R&D and QA to constantly butt heads. R&D wants to ship out as many products as they…[Read more]
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pv223 replied to the topic Discussion Topic: The cost of Quality in the forum Quality Control and Quality Assurance 6 years, 6 months ago
QA/QC is seen as a burden because of how stringent the engineer’s need to be to make sure no bad lots get approved and shipped out. From an R&D standpoint, QC Engineers are the thorn in the side that can’t be removed but in actuality these QC Engineers are more than likely saving the company. There are definitely ways to streamline the QC process…[Read more]
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