The risks of starting a new project on just a Verbal Agreement is that there is tremendous room for genuine misunderstandings. The other team may not fully understand the nuances of the contract and because it was orally made there is nothing to look back on to fully understand it. However, if the contract was a written contract it would be easier…[Read more]

Throughout my undergraduate experience, there has never been a class that helped relate what I learned in the classroom to real life. I did not have first hand knowledge of the various opportunities engineers have coming out of college. This was one of the main reasons why I took this course as I wanted to understand what happens after college. I…[Read more]

When building a team many people make the mistake of just picking people they know really well. While yes this brings some form of comfortability to the team, the end results might be poor. When working with friends, one tends to be complacent and it is hard to work cohesively, without getting distracted. Because you are working with your friends,…[Read more]

When dealing with a medical device company, the best way to form the company would be through the marriage of a matrix organization and a geographical organizational structure. Because this company is providing products throughout the world, there must be several divisional heads set up. Additionally, medical device companies have several branches…[Read more]

The organization I would like to work in should be Project based organization. Something I value is the ability to work as a team on a specific job. And being part of a project based organization, I would have the opportunity to work with a team and have a clear end goal in mind. This provides clarity as well as room for exploring and expanding…[Read more]

When looking at risk-benefit analysis, one is basically answering the question “is the risk worth it?” To answer this question a thorough analysis needs to be done on the trade-offs of the product. Statistical measures need to be taken in order to fully understand and implement the risks versus reward of the product. When dealing with medical…[Read more]

When dealing with low severity risks it can be deemed worthy to accept the risk. By using the strategy of risk acceptance you can anticipate or adjust for greater profit margins and this should cover for the risks. Because the risks taken in this case are minor, the adjustments needed will also be non-consequential. However, if the severity of the…[Read more]

There are several ways of managing risk. Being part of a medical device company, it is integral to understand and predict certain risks and dangers the product might face. One form of risk management is risk mitigation. Risk Mitigation is when the consequences of certain actions can be reduced or limited. This is used in cases where risk is…[Read more]

Design inputs are critical to medical device development. The design requirements can be a document that can prove if the product will have issues or not. Usually, products that result in failure is due to faulty design inputs. The design input acts as the foundation of the product. The manufacturer needs to establish design requirements that take…[Read more]

Whenever production of a product needs to be exported, there are several production issues to look out for. When exporting the production design, it is integral to have strict, concise, and clear instructions for the other company. Also there needs to be a channel of clear communication between both companies for rapid communication in case of…[Read more]

The DHF is an integral part of the project design and development aspect. The DHF must be a set of documents that clearly states the intricacies of the product. The DHF must be continually updated in order to have the most optimal product. There should be a team or a specific person in charge of ensuring the DHF is regularly updated. People need…[Read more]

Design controls are parameters that are vital to the completion of a medical device. These controls are given out in conjunction with the customer needs. In fact, the design controls are put together in response to the customer needs and each design control will correspond to a particular need. Working on a capstone project right now has made me…[Read more]

I have had to make a Gantt chart twice through my academic career. The first time I made a Gantt chart was in high school as a senior. We had a capstone project and in order to keep the team on track we had to come up with a Gantt Chart. In high school it felt more like a tedious task where we would put due dates for certain things. We never…[Read more]

Being part of the BME capstone class this semester, many of the criteria and aspects detailed above are something I have encountered and worked on. For my particular project we are working with an outside company, not just a professor at NJIT. This adds to the challenges we face because our advisor is not always readily available to speak to.…[Read more]

When looking at the benefits of clinical studies, it is hard not to look at the potential risks of such studies. In clinical trials where the patient’s life is at risk there are always measures taken to warn the patient and provide him/her with ample information. Also most patients that participate in such trials are facing some form of imminent d…[Read more]

Placebo controlled trials are a staple of medical trials. Placebo trials allow for researchers to understand the efficacy of a novel drug or procedure. There is always concern for ethical issues when providing placebo therapy because certain patients will not be receiving potential treatment. However, these patients are told that there is a chance…[Read more]

I can understand your hesitation on working with a double blind study. However, a double blind study at times is necessary to obtain clear unbiased results. There have been times where studies have been manipulated by doctors or principal investigators. This can occur due to immense pressures on researchers to provide positive and conclusive…[Read more]

Creating fuss for a medical device is hard because many times a product is for a specific population, and this would usually be a small percentage of people. Therefore, it is difficult to get a large group of people excited. Also when a new Iphone comes out it can generate a large audience because there is visible changes in the phone. People get…[Read more]

Advertising manipulation versus persuasion is an interesting topic to look into in terms of product marketing. Advertisements surround us everywhere we go, ranging from social media to televisions. In fact, advertising has become geared towards becoming personal and intimate. Companies like Facebook and Google track their users moves and then…[Read more]

A SWOT Analysis of Biomet.

Strengths:
– Strenght of expertise in orthopedic implants
– Strong reputation as a lot of surgeons prefer Biomet over other companies
– Biomet has been a top company for years and has tremendous profits
– Biomet has a large R&D branch

Weaknesses:
– Biomet has not expanded its products to other medical device…[Read more]