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Mattie718 replied to the topic The Expert in the forum Marketing and Sales 6 years, 11 months ago
This was a very creative form of satire which highlights sometimes the disconnect between management and engineering. Obviously there were some requirements which were laid out in this video and the leader of the company wanted to do everything in his power to accomplish this and satisfy the customer. He started by employing a project manager…[Read more]
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Mattie718 replied to the topic Manipulation or no? in the forum Marketing and Sales 6 years, 11 months ago
I do agree to a certain extent that marketing has a manipulative aspect to it, but it depends on the product. Manipulation implies there is deceit behind the veil of the advertisement. If a company is hiding unfavorable side effects or going off of a platform preaching certain advantages which in reality do not exist, then it is manipulation. On…[Read more]
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Mattie718 replied to the topic Marketing Strategy in the forum Marketing and Sales 6 years, 11 months ago
One popular trend in the social media era of today is marketing products through popular influencers on various sites. This is probably most prevalent on Instagram where people can seamlessly integrate certain products into their everyday photo posts. Many times it is clothing brands, skin care and teeth whitening lines, jewelry companies, and…[Read more]
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Mattie718 replied to the topic Partnership characteristics in the forum Business 101 6 years, 11 months ago
Partnerships are sometimes a good idea, but you need a strong foundation to build off of. All throughout college you are apart of different class projects in which you must rely on people to make certain decisions and complete certain tasks. With those experiences in mind, there are very few people in which I would pursue this type of business…[Read more]
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Mattie718 replied to the topic Public vs. Private Companies in the forum Business 101 6 years, 11 months ago
There are several key differences between public and private companies. Public companies can be owned by an almost unlimited amount of shareholders and stocks are traded publicly on the stock market. Owners of this stock may receive dividends for each individual stock they own after quarterly or yearly profits are calculated. They are responsible…[Read more]
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Mattie718 replied to the topic Accepting job based on company. in the forum Business 101 6 years, 11 months ago
I think it all comes down to the type of person you inherently are: risk-averse tolerant. This is usually applied when talking about investing in money, but can also be applied here when undertaking a business venture. Like you said, if you do a little bit of research you can determine the companies track record and get an idea of the direction…[Read more]
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Mattie718 replied to the topic What are some ways Document Control can improve? in the forum Quality Control and Quality Assurance 6 years, 12 months ago
I think the best way to ensure Document Control requirements are fulfilled is to train the engineers to those high standards as soon as they start working. I know when i first started working I had to thoroughly read a Standard Operating Procedure which stringently detailed every sort of Documentation Practice from the way you write your dates to…[Read more]
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Mattie718 replied to the topic How Quality Departments React to Audits in the forum Quality Control and Quality Assurance 6 years, 12 months ago
I work for a company that was audited for several months and it was a very stressful time for not only Quality and Regulatory, but for basically every department. It is a complete effort to comply with the demands of auditors and takes a lot of coordination with representatives of all business functions. From my understanding one of the lead…[Read more]
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Mattie718 replied to the topic Good Quality Control or Quality Assurance Department in the forum Quality Control and Quality Assurance 6 years, 12 months ago
I currently work for a mid-size medical device company and while I do not think there is technically bad blood between Quality and the other departments, tensions sometimes escalate. I am in the manufacturing department and often times there are serious production issues which need to be solved immediately to avoid lengthy delays or failures in…[Read more]
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Mattie718 replied to the topic FDA on Recalled Items in the forum Regulatory Basics for Medical Devices 7 years ago
As stated before there are many reasons for a recall to occur. From personal experience I do not think it is the FDAs fault most of the time. The only reason it would be is a lack of auditing a certain company. Every couple years or so the FDA usually performs audits of medical device manufacturers and ensures they are following all the important…[Read more]
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Mattie718 replied to the topic Discussion Topic: Antibiotic-Releasing Hip Stem in the forum Regulatory Basics for Medical Devices 7 years ago
Device: Antibiotic-Releasing Hip Stem
Type: Combination of a device (hip stem component) and a drug (antibiotic component) but the primary mode of action is as the hip implant. This product will then need a Request For Designation (RFD) to allocate it to whichever department the FDA deems appropriate. This will most likely be the Center for…[Read more] -
Mattie718 replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 7 years ago
I do agree that the FDA is strict to an almost oppressive extent, but given the types of products they are dealing with, it makes sense. The rigorous and lengthy process of releasing a new product to the public ensures that it is for the right reasons and not just to fool people and make a quick buck. People can’t just give you something they…[Read more]
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Mattie718 replied to the topic PM in Pre-Clinical/Clinical Studies in the forum Pre-clinical Device Development 7 years ago
As mentioned in Dr.Simon’s lecture on managing a research project, there are several key steps to follow if you are going to complete it successfully. The Initiating Phase would consist of a lot of the literature searches and background knowledge compiled once a project has been decided on. In many cases there may have already been similar…[Read more]
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Mattie718 replied to the topic Research for the Fututre or Now? in the forum Pre-clinical Device Development 7 years ago
Obviously, a lot of people are saying they would prefer to conduct research which they will see implemented in their lifetime, if not within a decade or so. This is known as instant gratification and is the enemy to long-term innovation. Industry will only really engage in projects which impose a certain need or problem for a business and require…[Read more]
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Mattie718 replied to the topic This vs That in the forum Pre-clinical Device Development 7 years ago
I work in Industry currently so I’ll talk a little about the pros and cons of research on that side of the spectrum. There are definitely some pros such as working on more feasible and short-term projects which may be able to go from an idea to the hands of the customer in 5-10 years after all the design flaws have been handled and all…[Read more]
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Mattie718 replied to the topic PM in Pre-Clinical/Clinical Studies in the forum Pre-clinical Device Development 7 years ago
As mentioned in Dr.Simon’s lecture on managing a research project, there are several key steps to follow if you are going to complete it successfully. The Initiating Phase would consist of a lot of the literature searches and background knowledge compiled once a project has been decided on. In many cases there may have already been similar…[Read more]
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Mattie718 replied to the topic Manager Vs Engineering in the forum Intro to Project Management 7 years ago
I have seen many case studies on Engineering Ethics in which managers have not heeded the device of their underlying engineers, such as the Challenger disaster. I think in order for a manager to really perform their duties well, they need to have performed the same tasks they are asking the people they are managing. It is hard to respect someone…[Read more]
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Mattie718 replied to the topic Work Breakdown Structure(WBS) in the forum Intro to Project Management 7 years ago
The Work Breakdown Structure (WBS) is probably the first thing you should do when working on the Planning Phase. This is a very broad outline but it still lays the framework for the entire project. It is also versatile in that you can organize it in several different ways (by department, by product subsystem) so you can get the information across…[Read more]
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Mattie718 replied to the topic Milestones Missed: Failure or Success? in the forum Intro to Project Management 7 years ago
I do not think that missing milestones is necessarily a failure. To me, milestones are sort of like soft checkpoints in a project. You should do everything in your power to make sure that the certain set of tasks is completed at that certain planned date for that milestone, but if it is delayed there is still a large potential for the project to…[Read more]
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Mattie718 replied to the topic Advice for Biomedical Engineering Students in the forum Introduction to Medical Device Development 7 years ago
It all depends what you define as “Engineering Student” because that could mean Undergraduate or Graduate studies. In terms of the early years studying as an undergrad, I would probably advise to pursue some type of job within the department such as an office assistant or lab researcher. This could be the earliest chance you have to get a foot in…[Read more]
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