From my experience and in my opinion I do not think the risk associated with a specific product performance (or lack thereof), should have a major impact on the sample size that you use for testing. Sample size is usually driven by the confidence and reliability associated with a specific product requirement in conjunction with the test evaluation…[Read more]

I currently work as an R&D engineer for a medical device company, and have had some experience with working with the QA (quality) department on risk analysis. As our professor has mentioned in this week’s lecture the identification (assessment) of risks usually occurs in a brain storming team meeting. Generally the philosophy I have seen taken i…[Read more]

If any requirement in the Design Verification (DV) Protocol is not met during testing you will be unable to complete DV until this situation is rectified. I have been in this situation before and there are a few common options you have to choose from depending on specific requirement that was not met. Like it has already been mentioned one…[Read more]

It seems everyone in this thread agrees that the determination for the appropriate sample size for statistical analysis stems from what your desired confidence and reliability levels. At the company I work for we use our confidence and reliability to determine how we evaluate specific product requirements based on whether or not the test we are…[Read more]

I actually have experience working as a test method development engineer for a medical device company (Becton Dickinson), working as this role your main job objectives are to develop and validate test methods that are used for design verification testing. Another part of this job role also includes identification and validation of the equipment…[Read more]

Based on my experiences working within relatively big medical device project teams the two biggest things that I think are very important with regards to creating /managing gantt charts are the “critical path” and amount of “slack”. Whoever the project manager is for a project, aside from making sure that all milestones are being achieved the nex…[Read more]

I do have experience attending a few design reviews and also leading one. From my experiences design reviews are exactly as everyone has been describing. They are important milestones within the medical device development cycle, and are a part of the required design control process. Design Reviews do require a lot of preparation, and the way in…[Read more]

If I was involved in clinical research trials I would like to be a monitor. I would enjoy being able to monitor the clinical trial participants heath throughout the study, and see what the effects are of taking or not taking the medication (treatment, etc,). I am very analytical in nature and being able to gather all of the patient’s health data w…[Read more]

Yes, I do think that Placebo-controlled trials are both ethical and necessary. When performing any scientific study, I think it is very important to have a control to be able to compare the effects of whatever it is you are studying (medication, treatments, etc.) to someone that has not received these medications or treatments. Having a control…[Read more]

I would start out by saying the obvious, which is that since companies are willing to people as a CRA without having any clinical background would mean that it is not a complete necessity. On the other hand I do think that the specific role you are performing in the clinical research field could demand more or less of a clinical background. For…[Read more]

In the time period we are currently living in, as many others have mentioned, I believe the most effective ways of getting customers to get engagement with marketing information that they are interested in is definitely via all the types that the internet and social media has to offer. One of the most interesting forms of internet…[Read more]

Becton Dickinson (BD)
Mission Statement:
“To help all people live healthy lives”
Vision Statement:
“Become the organization most known for eliminating unnecessary suffering and death from disease, and in doing so, the best performing companies in the world.”
Quality Policy:
“We will consistently provide superior products and services in pursuit o…[Read more]

The major difference between public and private companies, is that public companies have shares that can be publicly traded on the stock market. A private company might become a public company by conducting an initial public offering, which is when shares of the company are offered to the public. Becoming a public company entails a number of…[Read more]

For a mid-sized medical device company like you have described (50 people & approx. 10 million in revenue), there are a few benefits that a company like this could get from becoming an “Inc.” versus an “LLC”. First would be the ease associate with getting loans or credits, which get then be used to acquire more assets or even buy another company…[Read more]

I think there could be many ways to overcome the bad relations that the quality department often has with other departments such as R&D. One way could be to ensure that the quality representative or team that is involved in an R&D project is included from the beginning of the project and is kept up to date with any project changes that are being…[Read more]

Hello Professor, as someone who works as an R&D engineer and has a lot of experience working with the quality department I can relate to the notion of quality as “burden”. After spending so much time working with quality on the day to day tasks, I think it is sometimes easy to forget about the big picture that the quality department represents (as…[Read more]