This course has been extremely helpful in teaching me the background knowledge and divisions of medical device development. I learned about what division I would enjoy the most working in and what divisions such as Regulatory I would not enjoy working on in the future. By learning the basic steps of how a product gets developed I have a better…[Read more]

I work in a functional based organization where I work with only other quality engineers. We coordinate with each other on our own projects and will only reach out to other organizational groups when our projects overlap our when we need a favor and have to coordinate how we can help each other out. I think Functional organization is the best…[Read more]

I think it would be more challenging for a project manager to work in a matrix based organizational project. In the matrix based project you must coordinate with other functional departments more and must structure your project around other department groups. This will require the project manager to coordinate with all the other departments to see…[Read more]

For me personally I think I would be better suited for Middle management based on my experience in the medical device industry. I think to be in upper management you need a lot of experience that will better prepare you to make decisions on the direction of the company and it will allow you to make more informed decisions. The experience will help…[Read more]

In order to run a risk management meeting I think the risk manager must first take time to assess all possible rise, give them a severity ranking and point out areas where risk are more likely to occur. Then once you get to your weekly meeting, I would bring up these risk and my assessment of them, and talk to my members about my assessments, and…[Read more]

I think that these regulations cost money because they provide a platform that companies can use, where if they follow these guidelines, they will be recognized as a company who abides by these set out standards and who provides safe and exceptional products. For start up companies I think they should pay to use these regulations because it helps…[Read more]

Based on the options for Risk Management, choosing mitigation would be my selection for a low severity risk. If the risk is not severe there can be a way to mitigate the risk to reduce the severity level to a point where the risk may not affect your product. I do not think that you should just accept the risk, and if the risk can not cause severe…[Read more]

From my experience working in the medical device field I have had to sit on design review meetings that dealt with going over the validation process of multiple documents. The meetings are run by the project leader who will open up the discussion, review what had to get done for the week, what needs to be done by the next meeting, and will check…[Read more]

I believe verification is important because it makes sure that the device you are creating is exactly as you intended it to be, so that there are no unanticipated problems that may occur later on. By verifying that the device works and is safe, it ensures that it will later be successful on the market. This also keeps the patient safe from…[Read more]

The advantages of having each document is that it gives the team time to plan out their design study and to get a general idea of what they need their product to be. With the DID the team is able to first submit a document in the earlier stages of the process where it gives them a general idea of what items and specs they need for their model. The…[Read more]

Some potential problems from not following the design controls process and using the process wrong is to have major delays or changes in your device. By being too specific in documents such as the DID and DSD you may run into a problem where you need to make a very small modification to your device, but now you can not because of what you put in…[Read more]

In terms of determining whether to perform validation or not, validation should still be conducted in order to keep better understanding the product, and that human factors evaluation should be completed as well. Even if there were no changes to the product after verification, you still need to make sure that the majority of the population will be…[Read more]

Design Controls are a critical component of every project and provide the necessary checks to ensure that all devices are safe for use and meet their intended use. Design Controls will monitor the steps that you take in designing and creating your device to ensure that no necessary steps are skipped, that enough time is taken on each step to…[Read more]

Placebo controlled trials are ethical if the individual who is not receiving the correct treatment, is not in serious danger regarding their health. They are also ethical because all individuals have to sign an informed consent form beforehand, agreeing that they know about the chance of a placebo, but that the medicine may have significant…[Read more]

I believe obtaining informed consent in any medical setting or research setting is very important and necessary. Doctors and hospitals are meant to help and assist patients not secretly be using these regular patients who come to them for their own research. Informed consent is important because it allows an individual to have control over their…[Read more]

When it comes to handling clinical research I think it is a necessity to have some sort of clinical background or to have undergone a period of clinical training and observation before you can be in a clinical setting. As discussed in the lectures there are a number of adverse events and effects that can happen to the patients in the study. The…[Read more]

Some ways that company’s are engaging in Participation is through surveys, questionnaires, and special deals for customers. For instance, after you visit a company’s website, buy a certain product online or fill out a form on a company site, they will send you follow up emails. This will allow the company to engage with their customer and gain…[Read more]

I believe that when it comes to marketing, manipulation is the key component to success. Most customers at the time do not know that a product exist, do not know why they should buy the product, or do not know if this is the best product for them. In order to sell something you need to convince the customer that this is the product for them. Even…[Read more]

Emotional Intelligence (EI) is an individuals ability to interact and understand other individuals mood, behavior, wants and needs. EI will affect selling because it can allow a sales person to choose and say the right things to a customer. By observing who you are selling to you can understand what type of person they are, what type of tone and…[Read more]

As a midsized company with 10 million in revenue I would say that they company become a Inc instead of a LLC. As a company that wants to grow they need to start giving investors stock options so that they have the ability to expand. With a company that is growing they also need to strongly consider the risk with more employees and locations. As a…[Read more]