I was able to find a kickback allegation that happened very recently, this past September 2017. It involves Galena Biopharma with a prescription opioid scheme. Galena Biopharma had to pay more than $7 million in the settlement. Two of the…   Read more»

As a person who has been working in the medical device field for multiple years, before I started this course I definitely was not sure what to expect as far as the class content / structure. I can honestly say…   Read more»

As others have said in this thread I think it is very crucial to ensure that everyone attending / participating in the risk management meetings have a thorough understanding of exactly how the product works. From there as a team…   Read more»

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

De Novo is a classification process which uses a risk based strategy for new novel devices whose types has not previously been classified. It can be used for devices that would have been classified into Class III to allow them…   Read more»