I see and feel the passion you have towards a very strong argument towards the relationship of physician and pharmaceutical companies. I believe what you are posing is indeed happening in the world we live today. It is the result of the human nature to be greedy and selfish. With that being said I as Biomedical Engineer will not fed into this…[Read more]

The company I intern for has a NADCAP (National Aerospace and Defense Contractors Accreditation Program) certification for some of their tanks. This certification is an industry-managed approach to conformity assessment of special processes that brings together technical experts from prime contractors, suppliers and establish requirements for…[Read more]

In the last month or so at my Internship at Paramount Metal Finishings I have learned some about Quality Control. The company I intern for is not a medical device company however applications can be applied. The company takes military equipment and coats them with various solvents to make them rust resistant. So let say we do get rust on the parts…[Read more]

It seems like from an article I read the 510 K process is towards the CDRH center. CDRH employees have expressed concerns to the current 510 (K) program because some of the devices being evaluated are rather complex. The reviewers ability to make a well-informed decision was undermined by the poor quality of the 510 K submissions. There are three…[Read more]

A medical device that I can’t speak to much on because of IP is considered a combination product. It’s a diagnostic device which can accurately read small concentrations in the pico-scale. The device can use blood and or urine to detect let’s say tuberculosis. First the primary mode of action is to test concentration of blood of whatever agent…[Read more]

From doing some reading on the FDA website a ‘recall’ is when a manufacturer takes a correction or removal to address a problem with a medical device that violates FDA law. The first action called “correction” address a problem with a medical device in the place where it used or sold. This could be applicable to the type of action the actual…[Read more]

I have done research in academia but not for industry. Based on what Dr.Simon has stated about academia in terms of research is 100% true for the most part. The timeline for doing experiments and in general research is not stressful. The time associated with doing research is at a relaxed pace. The quality of results versus pumping out “stuff” is…[Read more]

As a pet owner, my view on this matter is will have a hint of bias towards how I respond. For me animals that are considered to be pets in the house I tend to cringe when I think of animals being put to death when it is for science sake. From reading an article it stated how people and myself believe that animals do have a mortality associated…[Read more]

Out of the three listed objectives, achievable is the critical objective. This objective has to be based on a plethora of other sub-factors. The amount of time it will take, the number of employees a company has, do we have enough money in the budget to do so. The trivial solution is if we have everything then yes this project is achievable. In…[Read more]

In theory, the WBS is an ideal template to follow when working on a project. I agree that the WBS is pertinent to the success of a project. In reality, people do not always follow the WBS due to people either being ignorant, lazy and or arrogant like Bob in Dr. Simons pretend scenario. In situations like Bob, that’s when projects fall apart due t…[Read more]

I agree with you manolo in terms of asking questions that are critical when initiating the start of a project. The important question to ask is the following: Whatever the project we are doing is there a market for the end product being made? Are there needs for it. Will this product create revenue for a company? This brings to point rv347 point…[Read more]

Undeniably we can say that industry has a demand that is sometimes unreasonable wither it be time given for a project, the quantity of something to be mass produced. With industry “cut corners” tends to be at the expense of quality. The demand placed on academia is not unreasonable but rather the opposite. In academia, the demand placed on som…[Read more]

People have been saying co-ops and internships however I found it most difficult to acquire these because I did not use my academic advisor to help me. Always speaks to your academic advisor they have the contacts to help you get an internship or co-op. With that being said it’s about who you know that gets you the opportunities it’s not based on…[Read more]

When I finally decided to take BME as a degree it came to the fact it had many different engineering disciplines associated with it. With many disciplines such as mechanical, chemical and electrical I knew this degree would give me knowledge in all these areas. Being able to partake in each discipline allowed me to appreciate the need for a…[Read more]

For this week’s simulation, an NCMR report would definitely have to be filled out for CamTech. CamTech would hear complaints rapidly once they heard about the volatile smell from there pouches. The PM and associates would have to have a meeting and understand why these pouches made it past the quality control department. The chemical hazards could…[Read more]

I would pick the broad category of being an investigator. More than likely be a medical device engineer of whatever the specified area of expertise, which the clinical trial is being done. I like solving problems, therefore, being an investigator allows me to have a challenge set before me. The challenge of figuring out what the problem is and…[Read more]

From a website it stated, “Market Competition increased, with supply market seeing continuous mergers and acquisitions, resulting in consolidations and CROs”( clinical leader website). I think the reason for the outsourcing is because it may be to much work for one company to simply do. They may not have enough specialized employees to do the wor…[Read more]

When I think of retention I think of elementary school days as to when students were retained because their grades were not adequate to advance the next grade or class. This is the negative connotation of the word. The positive side is knowing that something is producing well or effectively working well. An example is an employee you have had for…[Read more]