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 ac...

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 discusse...

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 experi...

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 a...

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 Conundr...

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...

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 c...

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...

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...

During the current pandemic, there are over 100 vaccines being tested on humans worldwide. The average human today is a subject for a vaccine. Do you think that different vaccines may work on differen...

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 subject...

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...

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 i...

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 colorin...

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 pa...