Posted by: @rgp29 Hello everyone, As I was listening to this week’s lecture, it called my attention the fact that companies can only give gifts of 100$ to the physicians and those gifts have to be related to health. Additionally,…   Read more»

@jafangnibo Hi! I think that for many traditional businesses the company usually works as a functional organization. I can agree that coming from education, we were definitely working within a functional organization. Personally, I don’t think that this is an…   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? I would…   Read more»

Posted by: @rajamharrison Do you believe risk management is an important part of the planning phase?  Is it necessary or it is just a waste of money and time? Why? Crucial. To not include risk management during the planning phase…   Read more»

@salston I couldn’t agree more! I often think about the devices that we currently have in the medical field. At some point a risk assessment team thought about the “what ifs” and took a chance on a device because of…   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 there are many medical devices that are used whose benefits outweigh…   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»

@ayomide-o Hi Ayomide! I do agree that there is importance in each of the 9 steps of the design process. I do think that while each part has its own value, what would be one that without it, a device…   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: @efields30 This week we learned multiple types of clinical study, Retrospective, Blinded, Randomized, etc. Research a clinical study you are interested in and describe which type of clinical study it is. I am interested in retrospective studies. Retrospective…   Read more»

@alexbryant-harden Greetings! I think that your response has prompted me to think a bit further about my response to this question. There are risks involved and in some cases those risks involve the loss of life or other medical complications….   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»

@prentism Hi Prentis! This is such a great example of customer participation! This also reminds me of the lays potato chip flavor contest. This contest, as well as the Starbucks contest, involves consumers and gives them the excitement of possibly…   Read more»

Posted by: @orleron Remember “The Four Ps of Marketing”: product, price, promotion, and placement. Product:What are you selling & why?Price:How much does the product cost? When does the price change?Promotion:How will you promote the product? Viral marketing? Internet Advertising?Placement:Who sells…   Read more»

Posted by: @bb254 If you were to have ownership of a corporation, which type of corporation would you want to be an owner of?a. Sole Proprietorshipb. Partnershipc. Limited Liability Partnershipd. Limited Liability Companye. Running Corporationf. Corporation (S Corp. or C…   Read more»

@shavondraleak I think the networking aspect that you mentioned in your response is spot on! While there are many technical aspects of starting a medical device company, have a good network could be beneficial for the physician. One of the…   Read more»

Posted by: @orleron Perhaps in your career you will meet (or be) a physician who works in a hospital or private practice and wishes to create his or her own medical device.  Though this is a noble goal, what challenges…   Read more»

Posted by: @orleron This is a phrase you will encounter sometimes. “The Cost of Quality” is a concept. Let’s say you have a product, and you do no QA/QC on it. For a while, you might do fine. The product…   Read more»

@shavondraleak HI Shavondra! I thought your post posed great suggestions as to what a project manager should consider when choosing a biomaterial. I didn’t think about the aspect of costs as it pertained to choosing a biomaterial. As a project…   Read more»