I really think that the 2 most important things to remember when contemplating if you will sign an NDA is the credibility of who you are dealing with and making sure you have completely read and understood the guidelines of…   Read more»

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: @orleron In this module we learned about organization types and how those can affect medical device projects. What type of organization do you work in or what kind would you like to work in and why? The laboratory…   Read more»

Risk must be identified during the planning stage of the project development process. This way the risks can be strategically observed and categorized. It also gives the team a chance to find methods to avoid risks that aren’t necessary for…   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 think the risk is worth the effort if the potential benefit of the…   Read more»

Posted by: @dparekh Creating a list of risk is a good starting point, however, it is not enough on itself. You also need an action plan for each risk in order to be able to manage them effectively.We learned about…   Read more»

Posted by: @savery115 Statistical sampling is required for design verification and validations. If you have worked for a company or written protocols in the past – how have you explained or ensured that the sampling plan and statistical approach you…   Read more»

Posted by: @rgp29 Hello everyone, I have noticed how Dr. Simon keeps pointing out to importance of taking minutes in all the meeting of the team. I never really thought of how important they are. Before this, when I was…   Read more»

Posted by: @tulikadasp Clinical trials for medical devices have many similarities to drug trials, there are some necessarydifferences in the way the trials are designed and carried out. And in some cases, for medical devices, clinical trials may not even…   Read more»

The ethical concerns related to the use of clinical trials that require human subjects are complicated. Primarily, these issues are hard to deal with because sometimes animal models and normal in vitro testing doesn’t give the most accurate picture of…   Read more»

Clinical studies are dangerous for some drugs but they are a necessary process of drug development. the benefits are that through the use of clinical studies drugs can be finely developed for a larger group of patients. However, this may…   Read more»

Posted by: @amd29 When a medical device is clinically tested it is to evaluate the safety of such a device on the human and whether or not the desired result will be obtained from doing the clinical testing of the…   Read more»

Posted by: @manolo Advertising is a component of marketing. The way a product is promoted/advertised is what most average people notice about a product. What was a really great promotion/advertisement that you remember? For me, a great one would be…   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. In my opinion…   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: @hzy2 Has anyone seen the documentary called The Bleeding Edge on Netflix? The documentary talks about a medical device (Essure) that was cleared by FDA and implanted into women for sterilization purposes. Following implantation, these women started to…   Read more»

I haven’t been fortunate enough to be a part of a QC team but I would imagine that organizational skills play a tremendously important role in the success of this team. There should be a couple areas that a QC…   Read more»

Posted by: @tulikadasp In this age, different emerging technologies are beginning to rapidly change the nature of work. Internet of things(IoT), Artificial intelligence (AI), Machine learning are just a few examples of the new, disruptive technologies that are impacting the…   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: @krp67 If anyone has taken Dr.Simon BME 682 class they know a little bit about Project management and in week 2 he discussed some aspects of PM. Where does PM fit into pre-clinical and/or clinical studies? Do we…   Read more»