Posted by: @abhitrivedi1211 What factors contribute to determining values for risk index numbers. Two examples are ‘how often the failure occurs’? and ‘what is the severity of the failure?’. Some factors that contribute to determining the values for the risk…   Read more»

Posted by: @lmathis When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting?  I do believe that once a device maker has weighed the risk-benefits profile extensively…   Read more»

Posted by: @fgk4 As we all have learned this week, a validation may not be required if:- There were no changes required to the product after verification.- A clinical trial is not required- Product changes did not affect the user…   Read more»

Posted by: @la82 As mentioned in other discussions, design control is an integral part of any medical device design, and its benefits are clear. However, what are some of the issues that arise of the process and if it is…   Read more»

Posted by: @hg93 “Design Controls” is a FDA term and defined in FDA 21 CFR 820.30. Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and…   Read more»

Posted by: @jr377 This year, the Right to Try act was signed into federal law. This law allows patients to request the use of investigational drugs (without FDA involvement or state law). There was a current “compassionate use” framework, but…   Read more»

Posted by: @alexandrabuga Background: Henrietta Lacks was a woman whose cancer cells were the source of the HeLa cell line, the first immortalized cell line and one of the most important cell lines in medical research.  Lacks was the unknowing…   Read more»

Posted by: @llefevre According to the National Institute of Health web site on clinical trials, there are over 225,506 studies currently being conducted throughout the United States and 192 countries. Less than 1% of the total number of studies being…   Read more»

Posted by: @amd29 Prof. Simon has made it simple; he seems to definei) Marketing: — as being able to have the customer believe that what you – the marketing agent – areoffering is what they truly need ii) Sales: —-…   Read more»

Posted by: @srg36 I have a question about family businesses. Say for example someone started a sole proprietorship, and down the road the business grows and is successful, and that person wants to pass the business on to his 2…   Read more»

Posted by: @amandaally1029 What is the difference between public and private companies? Based on their differences, what are some pros and cons of each? Give an example of a private and public company, and state the successes. The difference between…   Read more»

Posted by: @sahitya-sadineni Part of FDA’s mission statement is providing safety and protecting the public health in the use of drugs, medical devices, and etc.. The second part of the mission statement states that they are “advancing the public health…   Read more»

Posted by: @sahitya-sadineni Precision and accuracy are very important to the scientific field. Accuracy is how close the value is to a standard while precision refers to how close the values are. What roles do precision and accuracy play into…   Read more»

Posted by: @hruship101 Many departments such as Manufacturing or R&D tends to complaint that their quality department is so stringent in terms of documentation and the document control even if it means to delay product launch or to prevent the…   Read more»

Posted by: @tulikadasp When it comes to animal research there are various constraints we need to keep in mind. One of them is animal rights. A lot of animal rights group are against this. Recently there are few news about…   Read more»

Posted by: @hm243 In industry, research is done to make discoveries for products that can help people right away, while in academia, research create results for the long run. I feel that both types of research are important and necessary….   Read more»

Posted by: @mduru During the COVID19 pandemic we’ve seen significant shift of resources in many industries. The medical device industry was one of the industries that felt this shift the strongest. Some approvals were fast tracked by regulators while some…   Read more»

Posted by: @kak33 Hey everyone, One of the learning objectives for this week was to get an idea of the different jobs available to Biomedical Engineers. In this week’s lecture, Dr. Simon identified a few positions that are available in…   Read more»