Posted by: @fo3 As we know, forming a project team is partly making sure every member is working toward the same goal(s). Each member should be able to contribute something valuable to the project according to their expertise/role. How would…   Read more»

Posted by: @la82 The lectures introduce the three types of organizations. Project managers’ roles are specifically mentioned in both matrix and project-based organizations. While other posts discussed the preference of working under one or the other, no one mentions what…   Read more»

Posted by: @amd29 Quite recently Dr. Simon organized us into project teams. And strangely, I became a part of one before I knew it. The approach of forming the team was weird.Personally, after experiencing with the Functional Organizational type in…   Read more»

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?’. There are several factors that contribute to determining values for risk…   Read more»

Posted by: @fgk4 The ISO 14971:2012 “Risk management for medical devices” requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundrum for all medical device manufacturers. It is a gray area…   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?  When dealing with risks, according to the FDA it is okay to use medical…   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: @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: @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: @savery115 Clinical trials and research is designed to expose a limited sample of subjects to potential new treatments. Human tests of a medical intervention typically pose risk to subjects despite the amount of laboratory and pre-clinical trails conducted…   Read more»

Posted by: @smitshah I cant really think Why is it needed to use double blind study since I think single blind i.e. only patient blind must work.In double blind both Investigator and patient will not know about the drug and…   Read more»

Posted by: @sahitya-sadineni After reading through the article “Emotional Intelligence in Marketing Exchanges”, I found myself mostly agreeing with what the article was presenting. A high emotional intelligence can expand the business income inside an organization and can likewise reach…   Read more»

Posted by: @manolo Dr. Simon touched upon Branding when going over the Facets of Marketing. The coloring is an important component to think about when branding a product/company. What kind of coloring do you notice companies are using and why…   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: @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: @bb254 Based on your work experience in any company, what were some issues you found with the quality department and how would you fix them? For example:I work in the manufacturing department of a medical device company but…   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: @savery115 I’ve never had the opportunity to conduct or be a part of a team doing pre-clinical / clinical research. For those of you who have done it in the past or are currently working in this type…   Read more»