https://medicaldevicecourses.com/members/djwhitemsm-edu/activity/ Activity feed for djwhitemsm-edu. Fri, 24 Apr 2026 21:38:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 69782294cea3a4ee36339c7ff0ee2fbd https://medicaldevicecourses.com/activity/p/22717/ Tue, 22 Jun 2021 20:02:23 -0400 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»

]]> 577e357a333836623e0e626da4ac7276 https://medicaldevicecourses.com/activity/p/22716/ Tue, 22 Jun 2021 19:52:42 -0400 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»

]]> 212d8905072805bb29c328bea2211502 https://medicaldevicecourses.com/activity/p/22715/ Tue, 22 Jun 2021 19:43:14 -0400 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»

]]> c32c0b20394bcde561cced0841cff655 https://medicaldevicecourses.com/activity/p/22679/ Mon, 14 Jun 2021 22:04:59 -0400 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»

]]> 3865fdd3fe0e12f948b855207c4e6257 https://medicaldevicecourses.com/activity/p/22678/ Mon, 14 Jun 2021 21:53:06 -0400 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»

]]> 596961163986141b4fff4e75684cca40 https://medicaldevicecourses.com/activity/p/22677/ Mon, 14 Jun 2021 21:43:35 -0400 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»

]]> d6677f75df501cd3f17c80b073cabf6c https://medicaldevicecourses.com/activity/p/22645/ Tue, 08 Jun 2021 16:48:49 -0400 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»

]]> eb13be5332a204572ae30e34dd2bbaeb https://medicaldevicecourses.com/activity/p/22644/ Tue, 08 Jun 2021 16:36:19 -0400 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»

]]> bc84465153a895d854f74c21c9e3f5a0 https://medicaldevicecourses.com/activity/p/22643/ Tue, 08 Jun 2021 16:31:19 -0400 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»

]]> 88217dd8c5f88cff98a7cf66a1512e28 https://medicaldevicecourses.com/activity/p/22583/ Mon, 31 May 2021 23:59:49 -0400 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»

]]> c706e932f1b5ffdf778e1a163a5edab1 https://medicaldevicecourses.com/activity/p/22582/ Mon, 31 May 2021 23:55:05 -0400 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»

]]> c1e10fb5a3e1e830b4aa6822dea423df https://medicaldevicecourses.com/activity/p/22581/ Mon, 31 May 2021 23:50:38 -0400 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»

]]> a38cb0f1acabba745e37b00de794fb29 https://medicaldevicecourses.com/activity/p/22548/ Tue, 25 May 2021 20:19:07 -0400 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»

]]> 7aaaf8d5f997092709b8d167549452ed https://medicaldevicecourses.com/activity/p/22547/ Tue, 25 May 2021 19:35:06 -0400 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»

]]> 94ae1d8dd1f04f8b66c1c7adbab636e7 https://medicaldevicecourses.com/activity/p/22546/ Tue, 25 May 2021 16:38:43 -0400 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»

]]> 0f46ce17f682d8d2f3424b8975354df5 https://medicaldevicecourses.com/activity/p/22506/ Thu, 20 May 2021 21:23:56 -0400 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»

]]> 2de463d0f378f3bbbc7e86c7f40eb068 https://medicaldevicecourses.com/activity/p/22505/ Thu, 20 May 2021 21:04:19 -0400 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»

]]> 9881a1878974138f9720eef6f932a0cf https://medicaldevicecourses.com/activity/p/22504/ Thu, 20 May 2021 20:52:16 -0400 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»

]]> 64d5ed68f4bc56c4a7bd915409cb64bc https://medicaldevicecourses.com/activity/p/22452/ Mon, 10 May 2021 19:36:53 -0400 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»

]]> 11fb16fb17231613419c993ee341bc45 https://medicaldevicecourses.com/activity/p/22451/ Mon, 10 May 2021 19:18:00 -0400 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»

]]> d5dfbb4ccd113c4df97b72f50847bc55 https://medicaldevicecourses.com/activity/p/22450/ Mon, 10 May 2021 19:02:48 -0400 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»

]]> 078f11ed421c8a28e0c56299f33711eb https://medicaldevicecourses.com/activity/p/22402/ Tue, 04 May 2021 23:54:10 -0400 Posted by: @rv347 Hi -In this week’s lecture Dr. Simon mentioned how BME is a diverse degree, in which you learn a little bit of everything. While it can be an advantage to have a variety of skill sets, you…   Read more»

]]> ae4cd34aaeb7ba857ad26007874a2ffc https://medicaldevicecourses.com/activity/p/22401/ Tue, 04 May 2021 23:46:09 -0400 Posted by: @orleron We are meeting in an interesting time, to say the least.  As a disease, covid19 has many elements to its treatment and many of those elements use medical devices.  There are ventilators and syringes, which we all…   Read more»

]]> 4a8c6f4c4975a63cc2c012e2e4558bc6 https://medicaldevicecourses.com/activity/p/22400/ Tue, 04 May 2021 19:29:11 -0400 Posted by: @karen-immanuel Hello all, I was just curious as to what level of education is best before getting into industry. My thoughts are that BS is good enough to employ you with basic skills and knowledge. Later, you can…   Read more»

]]> 22deb7e8f069aa5f89b9f2bfe0ddac94 https://medicaldevicecourses.com/activity/p/22207/ Mon, 19 Apr 2021 19:23:42 -0400 Posted by: @krp67 Communication Management seems like a trivial knowledge area however, its seems as though it needs to be implemented in a PM. This topic of communication is critical. Lack of communication is why we have so many issues…   Read more»

]]> 9c6c2504db1d99962b7295e9290de0f5 https://medicaldevicecourses.com/activity/p/22206/ Mon, 19 Apr 2021 19:10:51 -0400 Posted by: @smitshah When you have to supplier both having good reputation for the things they manufacture and supply but only thing that can distinguish them is the contract they presented. So which factors would you consider to look for…   Read more»

]]> 64bf801c6820d48ba8a9f37cd4f0dfa1 https://medicaldevicecourses.com/activity/p/22205/ Mon, 19 Apr 2021 18:33:51 -0400 Posted by: @nakimw Say that someone on your project team changes positions to a different job so that you no longer have said person to perform a critical task for the project. His or her assigned task not being done…   Read more»

]]> 6ba8f68286ba533daac0ce8d33af799d https://medicaldevicecourses.com/activity/p/22128/ Thu, 15 Apr 2021 22:18:30 -0400 Project failure is a preventable in some cases however in some cases it is inevitable. This can occur for many reasons. There could be time restraints, circumstances that push the project behind schedule, lapses in judgement as it pertains to…   Read more»

]]> 3bbff03b718b24df398db77e2c375cd0 https://medicaldevicecourses.com/activity/p/22127/ Thu, 15 Apr 2021 22:08:49 -0400 Posted by: @asg49njit-edu So after a lot of thought I just realized that there was recently an example of a high risk high reward scenario. Not to long ago there was a group of people on reddit that decided to…   Read more»

]]> 71cd6a167c7fc140b2b695385e17a26a https://medicaldevicecourses.com/activity/p/22125/ Thu, 15 Apr 2021 21:58:26 -0400 For any team project or team building exercise communication and responsiveness to what is being communicated are completely crucial for any real progress to be made. Communication involved being able to express a personal perspective of a subject to another…   Read more»

]]> 46766b9411a7f46a1a8e50c5e30358b4 https://medicaldevicecourses.com/activity/p/22008/ Tue, 06 Apr 2021 02:48:36 -0400 I think that the proper time for a project to be initiated is if and when a team can agree on an idea that they think they have the resources to explore. If this  is the case then the next…   Read more»

]]> bc4f5d84c6ce4766199fa2457cbeff3c https://medicaldevicecourses.com/activity/p/22007/ Tue, 06 Apr 2021 02:39:49 -0400 Posted by: @devarshi-joshi After the development of team how do the execution process works or what does it do during the absence or vacation of an employee or with an personal problem? I think that after a team is fully…   Read more»

]]> b475f34ff3873bebaac6cb93e3abd0ce https://medicaldevicecourses.com/activity/p/22006/ Tue, 06 Apr 2021 02:24:58 -0400 Posted by: @devarshi-joshi According to me the most important 5 success factors are:1)Agreeing on the project goals2)Effective Communication3)Develop clearly defined plans with assigned responsibilities.4)Managing project scope effectively.5)Making sure of management support. So how are these factors individually important for a…   Read more»

]]> 16003450b746b019480faf18c241cdb3 https://medicaldevicecourses.com/activity/p/21942/ Tue, 30 Mar 2021 18:05:55 -0400 Posted by: @sallirab When we say the word “Risk” it always come in mind a Negative thoughts, but does the Risk are always negative ? As we know Risk results can be positive or negative, can you please give an…   Read more»

]]> 645cef56d71f0a032bab7f036dcaf4f2 https://medicaldevicecourses.com/activity/p/21941/ Tue, 30 Mar 2021 17:53:04 -0400 Posted by: @ial4 Hello everyone, Suppose you’re leading a project aimed at updating the packaging for a product line. You begin the planning phase by estimating your project budget and completion date.when you enter the buildup phase ,you get much…   Read more»

]]> 3fb86b6799573f68e623bd901a1e2e0d https://medicaldevicecourses.com/activity/p/21940/ Tue, 30 Mar 2021 17:42:58 -0400 With any project management process cost analysis need to be a major component of the planning portion. Without knowing how much your project may cost can detrimentally affect the chances of success. It is also important information to know because…   Read more»

]]> 7b0a1f7d3a8c3e56d861beb48ce2ad97 https://medicaldevicecourses.com/activity/p/21886/ Sun, 28 Mar 2021 04:32:52 -0400 Unexpected time delays are a factor that is uncontrollable for any group. However, I do think that in the planning stages of a project the amount of time allotted for project development should include inevitable delays and there should be…   Read more»

]]> c87c49cb1b9cff52bc6dc9e02eb97b6e https://medicaldevicecourses.com/activity/p/21885/ Sun, 28 Mar 2021 04:28:00 -0400 Posted by: @naglaa-hemida From the point of initiating an idea to be a project to the point we get this project to the manufacturing stage, project passes by many stages, millstones and research that can lead to failure. Poor choice…   Read more»

]]> 3bd2b8471d9cf8ee291276a569606180 https://medicaldevicecourses.com/activity/p/21884/ Sun, 28 Mar 2021 04:13:44 -0400 Posted by: @ap962 The end of the Monitoring and Controlling Phase is marked by the Closing Phase. What are steps that need to be followed to ensure that phase is carried out effectively? To ensure that the closing phase of…   Read more»

]]> 3d0bf264378ff3717b373257b2b5feb3 https://medicaldevicecourses.com/activity/p/21809/ Sat, 20 Mar 2021 02:04:53 -0400 Emotional intelligence is more than necessary in a professional setting because it affects all interpersonal interactions with coworkers, subordinates and superiors. It is a crucial trait to have in a project management team because without regard to peoples emotions it…   Read more»

]]> 2544726be6756bb1e00e49b49d78bfee https://medicaldevicecourses.com/activity/p/21802/ Thu, 18 Mar 2021 03:18:58 -0400 The best way to avoid repeated mistakes in a project management team is to have constant evaluation and feedback about things that can be done more successfully. The PDCA cycle: plan, do, check, act is a very helpful tool for…   Read more»

]]> f781df861efc451aa7077f366a5722d4 https://medicaldevicecourses.com/activity/p/21801/ Thu, 18 Mar 2021 03:08:58 -0400 Posted by: @naglaa-hemida We all start as team members to be a project manager, and it takes time, effort, passion and determination to be a good project manager. However, what are the skills that we should be looking for in…   Read more»

]]> 9003938a433bfce240df9e4040635919 https://medicaldevicecourses.com/activity/p/21734/ Sun, 14 Mar 2021 18:59:22 -0400 Posted by: @rjs84 Part of the executing process involves information distribution, solicitation, source selection, and managing vendor relations. Most of the time and money of the project go into its execution. I would argue that the parts of the executing…   Read more»

]]> 9c321d87102dc4d83ffa638be9e2b897 https://medicaldevicecourses.com/activity/p/21731/ Sun, 14 Mar 2021 18:44:01 -0400 Posted by: @limalo What do you think is one skill a project manager needs to succeed? Personally I think one skill that is necessary for a good project manager is the ability to organize. This skill is actually more of…   Read more»

]]> 532bfcfa7a6c72f132c771f388778c6e https://medicaldevicecourses.com/activity/p/21640/ Fri, 12 Mar 2021 04:11:47 -0500 The HiMirror is a smart mirror that can analyze your face and give information about how your skincare is doing. This includes changes in the pigmentation and hydration of your skin. This is such a great gadget to detect wrinkles,…   Read more»

]]> d59538c3b56af05206a2705d3bcb237f https://medicaldevicecourses.com/activity/p/21596/ Mon, 08 Mar 2021 04:32:57 -0500 Posted by: @sallirab Post-market surveillance is important because it reveals more about product safety and effectiveness that could not be learned during clinical trials. It also monitor products’ performance in the field, detecting product faults, and help initiating necessary measures…   Read more»

]]> 8d5a59a2090b15f9ee423477998c1d25 https://medicaldevicecourses.com/activity/p/21593/ Mon, 08 Mar 2021 04:21:54 -0500 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»

]]> 9752bad576166c578a395dc37ad2ed39 https://medicaldevicecourses.com/activity/p/21586/ Mon, 08 Mar 2021 04:15:49 -0500 Posted by: @nr473 Being a project manager in the medical device industry requires being able to cope with ambiguity and the ability to be able to handle constraints in budget, scope, and time. Most of the projects will require cross-functional…   Read more»

]]> 4bf97bec71ac3cee0018e6bc9d1cbeb4 https://medicaldevicecourses.com/activity/p/21496/ Tue, 02 Mar 2021 15:46:17 -0500 0