The design input essentially details what is expected of your finished product. Sources of design input can be taken from market research to see what consumers want and how to make improvements on your product that they were initially not expecting but they might need later on. Another design input would be the regulations that the product must…[Read more]

In my opinion, the team member list and management part is the most important aspect of the DDP because this will lead to many negative consequences. It’s very important for everybody involved to be aware of not only his/her responsibilities but the responsibilities of others as well because they have a deep understanding as to how the project is…[Read more]

The purpose behind pre-clinical and clinical trials is to determine how a product or service performs on a group of test subjects. Without clinical trials, there will be no way to determine the efficacy of the product or if the desired result is reproducible and causes arm to some patients. Products and services that do not cause harm to patients(…[Read more]

Both documents are necessary because they are used to describe the product in the two major ways you can describe anything: qualitatively and quantitatively. The DID is the document in which the writer can briefly describe the essential features of the product so that the reader can have a more intuitive way of understanding the device. In this…[Read more]

A good way to think about Design Controls is that it is a systematic approach that is used for one main purpose: to ensure that a developed complies with the imposed regulations. It describes the entire process in which a concept or idea is brought into fruition by developing a tangible product that complies with certain rules and limitations. The…[Read more]

One significant challenge to Design transfer is that the design transfer may be understood well by all parties, but there may be a lack of planning how to transfer the product design into a controlled manufacturing environment. This can be a significant problem as there may be multiple delays in the process. Another notable challenge is that the…[Read more]

There are a lot of ethical issues that arise in clinical trials. One approach that is taken to address these issues is to do a risk-benefit analysis to see if the outcome is worth the input. Medical research often requires patients or subjects to endure pain, discomfort, or even injury during procedures. Such things can lead to momentary or…[Read more]

I have a very positive opinion on the Right to Try Law. I think that terminal patients should be allowed to try an experimental treatment despite the possible risk of death. It makes sense because cancer patients will die regardless of whether or not they get treatment. The Right to Try Act allows them one last chance to get cured. Even if it…[Read more]

One of the obvious advantages of a Placebo-Controlled Trial (PCT) is that it doesn’t require a large sample size, which also implies lower costs. This can also help the clinician determine the relevance of the clinical trials to the objective. The trade-off to working with a small sample size is that if the results of the study are valid, the…[Read more]

I don’t think that emotional intelligence is used to manipulate consumers to buy products. Manipulation implies that you have control over the consumer if you have emotional intelligence. You never have control over the customer because they can voluntary say no for any reason. It’s kind of like the analogy about the horse and water. You can guide…[Read more]

Johnson&Johnson:

Vision: “Caring for the world, one person at a time”

Mission: “To help people everywhere live longer, healthier, happier lives.”

A vision statement conveys the ultimate goal/purpose behind the company. In other words, it states what the company expects to see in the future as a result of their efforts. The mission…[Read more]

I think that the key to increase customer participation and interest in a product is to offer something that would entice them. One way to do that would be to state in the advertisement that they will get a discount on the price if they immediately answer the advertisement or commerical. One thing you can do is to raise the initial price to a…[Read more]

I would consider working in a partnership if I were to open such a business because even though you profits will be shared, your losses will be shared as well. The business is most likely going to survive if the losses were socialize because one owner may not be able to continue his/her business if the losses are too great. The key is finding the…[Read more]

I would definitely turn down a job offer based on the company’s financial standing because it’s important and good to know what you are getting yourself into. You want to keep your personal goals in mind and you are selling your skills and labor to your employer so you are in his/her hands. It’s important to know about the company’s size to see if…[Read more]

If I had to choose, I would pick a General Partnership simply because ownership is shared between at least 2 or more people. This is particularly useful because work and management would be easier if it was divided. There is a lot of risk in having to do all of the work alone and it can become overwhelming. Some of the major advantages of a GP are…[Read more]

For this, it’s important to do a Cost-Benefit Analysis to see how much “bang you get for your buck.” Paying for quality is important in order to avoid legal liability for any mistakes that produce very negative results. However, one important that should be considered is that the gap between cost and benefit needs to be high, which needs to happen…[Read more]

The issue behind Quality is that there is an assumption that the procedures that have too be followed will optimize results. Compliance and quality assurance are important but it’s important to acknowledge that having procedures and strict standards can curb innovation and creativity. In other words, R&D cannot pursue new techniques or develop new…[Read more]

The FDA can unintentionally cause quality to be lowered through its regulations because companies may be forced to work around them. There may be loopholes associated with certain regulations and companies can use that to either raise prices for products and lower quality because of the legal liability. Many big companies(e.g. Johnson&Johnson)…[Read more]

Accuracy is a measure how closely your product meets a specified standard or criteria. Precision is a measure how reproducible your results are, whether your product performs consistently across a group of customers. The FDA tries to optimize quality of medical devices by focusing on these two aspects of a product. If a product performs…[Read more]

Alipogene tiparvovec (Glybera) is a drug synthesized to counter Lipoprotein lipase deficiency (LPLD), a genetic disorder that is known to cause pancreatitis. It was meant to be a means of gene therapy for individuals with LPLD. This drug was approved to be used in Europe in 2012 but it was not approved for use in US. There were plans to make it…[Read more]