Hi Dr. Simon, At the start of the semester, in one of your very first lectures you said that this course will get you a job. At the time, I didn’t think that could be true. As the class continued…   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: @cef3 So there may be more than just the 3 main organization types that Dr. Simon presented in the lecture: http://blog.hubspot.com/marketing/team-structure-diagrams. Say you were to start up a medical device company that will function worldwide. What type of…   Read more»

Personally, I have only worked in a Matrix-based organization and really enjoy this organization structure. Out of the three options, I think the Matrix-based would be my preference because of the sharing of departmental knowledge between colleagues. I think this…   Read more»

Posted by: @jaf22 In the world of medical devices, there is no such thing as a waste of money for risk assessment. When a device deals with aiding in human function with direct contact to user, then there is a…   Read more»

Posted by: @tulikadasp To make sure medical devices remain safe and effective once it’s on the market – medical post-market surveillance (PMS) is done. It a system that provides continuous feedback about a device on the market in order to…   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 that risk in medical device development is incredibly different than many other…   Read more»

Posted by: @jtl27 This week’s discussion reminds me a lot of what we had to learn in our capstone design class senior year. The three biggest deliverables for that class other than our powerpoint presentations were the two documents that…   Read more»

Posted by: @rv347 In design controls, there is the DID and DSD documents. DID is design input and gives a broad description of the product (ex, “red knob”), whereas the DSD is design specification and gives a very specific description(ex,…   Read more»

Posted by: @kbentleymsm-edu Consider the Design Controls lecture that Dr. Simon has made available.   Yes, we know that all parts work together to support the goal of medical device development. What aspect of Design Controls do YOU feel is most…   Read more»

Posted by: @merzkrashed According to ‘Bonezone Article – Design Verification – Validation File’, and FDA definition for Verification ‘ Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled’ So, Why do you think…   Read more»

In my line of work, one type of validation that is done is Test Method Validation. This is done to identify any variation that may be present within a test method and if a method is validated, it is considered…   Read more»

Posted by: @amandaally1029 With clinical studies comes lots of risks, especially where human participants are concerned. However, in order to figure out if a medical product, device, or drug is essential, these studies are necessary. What do you think are…   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: @merzkrashed As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill. Or a fake…   Read more»

Posted by: @smitshah Especially in medical device companies when product are in developing stages how can a company like verb or ethicon which are working on new technology or are about to launch a new surgical robot how would the…   Read more»

Medical device companies typically tend to market products to their primary consumers, doctors and hospitals. In the case of dental tools, oral surgeons, dentists, and hospitals would be the primary customers in the market. The sales department should reach out…   Read more»

@hodafattel I think you raise valid points about how the internet has changed traditional retail businesses, however, I think that there are some differences with how the internet has effected the medical device industry. To start, I think the target…   Read more»