A NDA is a non-disclosure agreement. While a patent is something that is filed to protect a developing property. In a NDA, the people who have signed it must keep the information confidential and secret. The NDA is seen as…   Read more»

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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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….   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….   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…   Read more»