https://medicaldevicecourses.com/members/cjm64/activity/ Activity feed for cjm64. Fri, 24 Apr 2026 17:08:51 -0400 https://buddypress.org/?v= en-US 30 hourly 2 37513422558c75eabd962b3f880fd532 https://medicaldevicecourses.com/activity/p/20028/ Mon, 04 May 2020 00:04:28 -0400 How to motivate someone will vary greatly based on the person they are and what drives them. If you are a manager in this situation it is on you to figure out what motivates that person and then use that…   Read more»

]]> 6c200db77d0f9e31579a8c3a9fa156b6 https://medicaldevicecourses.com/activity/p/20027/ Sun, 03 May 2020 23:59:05 -0400 I think that the two are unrelated. The reasons that you work and the reasons to leave a particular employer can be vastly different. People work because they want a challenge, which I believe is an inherent human trait. But…   Read more»

]]> 04938cf077a633b4c94898e68d8fbcaf https://medicaldevicecourses.com/activity/p/20026/ Sun, 03 May 2020 23:50:56 -0400 I think the biggest learning for me in this class came from the simulations. Working together with a group of people towards a “real world” goal is something that I do not have much experience with as much of my…   Read more»

]]> b345ada85d183f339b86e8229cec0846 https://medicaldevicecourses.com/activity/p/19962/ Mon, 27 Apr 2020 00:43:38 -0400 I think the biggest reason that people work themselves so hard is that they fear what will happen if they do not. Management has become so accustomed to attempting to cut costs wherever they can that manpower has become one…   Read more»

]]> 7a4cc220e16584e569b2b03d9a8b9a60 https://medicaldevicecourses.com/activity/p/19961/ Mon, 27 Apr 2020 00:34:03 -0400 Different from what many people here have said, I currently want to remain in an R&D/engineering role for as long as possible. To me the process of taking a problem and creating a solution is one of the most rewarding…   Read more»

]]> 1192a579471c9d90aed15560ada36236 https://medicaldevicecourses.com/activity/p/19960/ Mon, 27 Apr 2020 00:29:21 -0400 As you mentioned, retaining key employees is critical to project and company success. The amount of effort put into retaining an employee must match the value that they bring to the company. If you have a person who is critical…   Read more»

]]> a54195c6c2c7b7af7bfc3050c9e8bbcd https://medicaldevicecourses.com/activity/p/19898/ Sun, 19 Apr 2020 21:18:39 -0400 It is important to attempt to prevent a situation like this by ensuring that people on the team are not going to just leave without notice, and that management is not constantly shuffling people around. But such things are inevitable…   Read more»

]]> 5f8bd4c2cd4fb4dc988dfa6e8b7a6316 https://medicaldevicecourses.com/activity/p/19896/ Sun, 19 Apr 2020 21:13:10 -0400 I did a co-op at J&J, and the group that I was working with was looking at sourcing completed products that J&J could sell under one of their brand names. In this case it was facial cosmetics, and I was…   Read more»

]]> b1d4f8dd84d399fc8b6eb95b4ee9ca06 https://medicaldevicecourses.com/activity/p/19893/ Sun, 19 Apr 2020 20:57:08 -0400 Using different components from the same company does not completely solve the issue of dual sourcing, because those two components are not completely independent. Most likely the two chemicals are made in the same location. So if something happens to…   Read more»

]]> 7225768c0221132762be47839a20c492 https://medicaldevicecourses.com/activity/p/19848/ Sun, 12 Apr 2020 23:31:41 -0400 Like any relationship in the world, communication is key. It is important that you understand the obligations of each team member, but it is just as important for them to be open with you about their obligations, both to the…   Read more»

]]> 868d5332d04e1647c39d564845a02b2d https://medicaldevicecourses.com/activity/p/19845/ Sun, 12 Apr 2020 23:17:43 -0400 Metrics are an important way to measure how healthy a project is. High level metrics like cost and progress allow the company to track the work that has been done and make decisions about the future of a project. There…   Read more»

]]> 6702006c5c39a955413d2a7599904ca5 https://medicaldevicecourses.com/activity/p/19844/ Sun, 12 Apr 2020 23:13:59 -0400 Monitoring the difference between planned value and actual value/costs is critical in ensuring that the project will maintain its viability. In a more perfect world, these projects would happen because there are things people need to be healthy, but in…   Read more»

]]> 98eae6c5fc1c969779d548292607caa9 https://medicaldevicecourses.com/activity/p/19772/ Sun, 29 Mar 2020 19:03:02 -0400 For my master’s thesis there are three key people with input in the design, myself, my advisor, and our clinical collaborator. The clinical collaborator is the least involved in the day to day of the project, so during the planning…   Read more»

]]> 82b676b0330a801a14cbaaf0795200c8 https://medicaldevicecourses.com/activity/p/19770/ Sun, 29 Mar 2020 18:46:15 -0400 Design validation is critical to the life-cycle of a project as it is when you test to make sure that the product or deliverables meet the requirements specified by the client. In any company regardless of the industry it is…   Read more»

]]> 0521fd9843fdff41f53b7514225359b4 https://medicaldevicecourses.com/activity/p/19769/ Sun, 29 Mar 2020 18:15:11 -0400 I have run into these problems on a smaller and more personal scale. I am currently completing my master’s thesis, which revolves around the early design and development of a medical device. I am far enough along in the thesis…   Read more»

]]> 331db5f2bb66ec1349ad72832ecb077f https://medicaldevicecourses.com/activity/p/19722/ Mon, 16 Mar 2020 00:28:01 -0400 The planning phase of a project is one of the most critical stages in my opinion, because proper planning can make or break a project. If we take the example of time allotment like you have in your post, if…   Read more»

]]> 00a1cfb07a8ab11fdc85e5a7e9ad5997 https://medicaldevicecourses.com/activity/p/19721/ Mon, 16 Mar 2020 00:23:10 -0400 I would disagree that the portions you listed are the most important. I think some of them, like the managing of vendor relations, are key components to the whole process, but I think a disproportionate amount of value is placed…   Read more»

]]> 3a63098436c98276b78f3a0cb8c86c97 https://medicaldevicecourses.com/activity/p/19720/ Mon, 16 Mar 2020 00:19:06 -0400 I have found that both this class and Dr. Simon’s other class to be very insightful and useful. The knowledge gained from this class has helped me several times through my classes. I am currently completing a masters thesis revolving…   Read more»

]]> e28a40414caf13db707e5f2343700e3b https://medicaldevicecourses.com/activity/p/19683/ Mon, 09 Mar 2020 02:58:19 -0400 Risk is something that is very hard to quantify and accurately describe before the product goes out into the public because it is impossible to prepare for every single eventuality. The grey area is also something that is really hard…   Read more»

]]> b2da3424ca4320c1279048a83889dd58 https://medicaldevicecourses.com/activity/p/19682/ Mon, 09 Mar 2020 02:58:05 -0400 Scope management is used to ensure that a project does not just keep expanding and expanding until it becomes impossible to take to market because it is so massive. Scope management means that throughout the life of a project the…   Read more»

]]> 3a4e046fb47eded7a12e2b10119e4a2b https://medicaldevicecourses.com/activity/p/19681/ Mon, 09 Mar 2020 02:57:48 -0400 One of the biggest challenges a project manager will face will be differing personalities within the project team. Being able to manage the members of the team and keep them on schedule and working well will ensure the success of…   Read more»

]]> da8e50915ce442f91d95f084b926479c https://medicaldevicecourses.com/activity/p/19622/ Mon, 02 Mar 2020 01:08:35 -0500 In estimating project time I think having a team that has worked together before and a leader that has a good understanding of how the members of the teamwork will best remedy the issue of poor time estimations. If the…   Read more»

]]> 3c01580aacbd68125e7a78ee9e311fcf https://medicaldevicecourses.com/activity/p/19621/ Mon, 02 Mar 2020 01:03:24 -0500 Similarly to your example about your capstone project, I too have been extensively commenting code that I have written for my Master’s thesis. I am working on a prototype of a diagnostic device, and I have been building the different…   Read more»

]]> 00c525e52fc7849e68fc5cdf175e8ae5 https://medicaldevicecourses.com/activity/p/19620/ Mon, 02 Mar 2020 00:51:04 -0500 The Gantt chart is much more reflective of a “perfect” schedule than it is how the project will actually occur. Things overlap because those specific tasks are independant on one another. With tasks being independent it allows flexibility within the…   Read more»

]]> 98687b17bcf25991ebd5a6dac2ddfb69 https://medicaldevicecourses.com/activity/p/19547/ Sun, 23 Feb 2020 01:15:46 -0500 In the lecture this week, Dr. Simon spoke about the scope management plan. This is a good way to attempt to control scope creep by predicting areas where the scope may grow and having preset methods for handling these changes….   Read more»

]]> bcd6522773420107c421020d329d382b https://medicaldevicecourses.com/activity/p/19546/ Sun, 23 Feb 2020 01:08:28 -0500 Design validation is an important part of the process of completing a project. Shipping a device without properly testing it can cause a number of issues. Without testing, there is no way to determine if the device is safe enough…   Read more»

]]> 447f52dabc31438f2e56677c3269a4b7 https://medicaldevicecourses.com/activity/p/19545/ Sat, 22 Feb 2020 22:37:24 -0500 In the initial phases of my Senior Design project during my undergraduate degree, it was determined that Infra-Red LEDs (IREDs) were needed to illuminate the eyes of a subject for the device we were working on. They had been used…   Read more»

]]> ecb24a1d9ec28adc2474d60af35a5a7c https://medicaldevicecourses.com/activity/p/19507/ Mon, 17 Feb 2020 01:37:12 -0500 To define one method to cover every experimental failure is quite tough. Each experiment will have its own unique needs and plans for evaluation. But as a sort of outline of the steps would need to be, isolate the problem,…   Read more»

]]> 6931f43331f239960cc41cc51469deaa https://medicaldevicecourses.com/activity/p/19506/ Mon, 17 Feb 2020 01:27:00 -0500 Face to face meetings are definitely the best method for getting the work defined and delegated, but as Dr. Simon said, they can definitely lead to a situation where the meetings can take up time that would be better spent…   Read more»

]]> 0d456945879f9770bbe040dbebc1b615 https://medicaldevicecourses.com/activity/p/19503/ Mon, 17 Feb 2020 00:53:39 -0500 Obviously this type of catastrophe will have massive ramifications in a world where the majority of manufacturing is conducted in China. A loss of supply of any key raw materials of finished goods can dramatically affect the way a business…   Read more»

]]> f90e4d3a939d12a89f71f273f5eec80a https://medicaldevicecourses.com/activity/p/19442/ Mon, 10 Feb 2020 01:29:41 -0500 Initiating a project is the hardest step because it is the time where the answer to the questions is the vaguest and nebulous. It is here that the very non-specific question of why must be asked. Why should we do…   Read more»

]]> f88c8ce7f89e9bc662122fd8bf19768c https://medicaldevicecourses.com/activity/p/19441/ Mon, 10 Feb 2020 01:02:51 -0500 It’s less of a specific product, but programming languages for large systems. If we take a device like an automated insulin pump, which has been on the market for more than 6 years now. If the code was written in…   Read more»

]]> baca21d2047ea5db22c709c5ff195b8a https://medicaldevicecourses.com/activity/p/19439/ Mon, 10 Feb 2020 00:49:37 -0500 Having worked under a project manager I would say that one major key is understanding the work habits of the people that you are managing. I know that for me being micromanaged or constantly reminded of what I have to…   Read more»

]]> af6e6f2bc625ba97923a74f7effca1f0 https://medicaldevicecourses.com/activity/p/19353/ Sun, 02 Feb 2020 01:02:48 -0500 I think the model needs, as Shurah said, a more holistic approach. This needs to start all the way in the beginning of the discussions surrounding the project. When it is first started, the goals need to be laid out,…   Read more»

]]> ec52786b19f6823c4627308f3a4b4698 https://medicaldevicecourses.com/activity/p/19352/ Sun, 02 Feb 2020 00:44:41 -0500 This is a rather nuanced situation. The easiest way to understand it, in my opinion, is to understand that cash is always king. Projects are always run by companies, and whilst they may start out as well-intentioned, once the company…   Read more»

]]> 093793f3bd442986623520cfb56e12cd https://medicaldevicecourses.com/activity/p/19351/ Sun, 02 Feb 2020 00:31:27 -0500 Lumbar support devices for lower back pain is something that comes to mind for this scenario. They would definitely be placed in category 2. They are often advertised as being a treatment for a number of symptoms ranging from discomfort…   Read more»

]]> b91882c6253f87127bf92ccb4e62d1f5 https://medicaldevicecourses.com/activity/p/19306/ Sun, 26 Jan 2020 22:10:55 -0500 These new regulations, combined with the now almost certainty of Brexit, put medical device companies, and especially project managers into a unique and challenging scenario. EU MDR has introduced a whole array of changes to the existing laws, with the…   Read more»

]]> 5e6eb23cb4e56cf0ea699406a32dbfcd https://medicaldevicecourses.com/activity/p/19305/ Sun, 26 Jan 2020 21:43:06 -0500 Picking the proper team for a project is critical to the success of that project. It is important that each member of the team will be able to contribute to the team in an equally valuable manner, and is able…   Read more»

]]> 73038d6ad3dd3594a056a17e416479f0 https://medicaldevicecourses.com/activity/p/19304/ Sun, 26 Jan 2020 21:29:17 -0500 Project management absolutely differs between industries. The underlying concepts related to organizing and delegating the work will be similar but each industry requires such a knowledge base that switching industries is not realistic without a lot of education on the…   Read more»

]]> 0e7c1e1f333ccbea7b9d9c7f5b7deaea https://medicaldevicecourses.com/activity/p/17413/ Wed, 15 May 2019 21:39:15 -0400 Non-compete clauses are a tricky legal situation. A number of states have made them illegal on the grounds of restricting personal freedoms. That being said most people who work in the United States will have to sign one. When you…   Read more»

]]> 0f916c1cb587fa72731ffd01ecddbe1d https://medicaldevicecourses.com/activity/p/17409/ Wed, 15 May 2019 21:39:13 -0400 first of all Dr. Simon is right, never sign an indefinite NDA. Always make sure there is a way for the NDA to end. This applies to any contract you sing, make sure there is a way for it to…   Read more»

]]> 6341d926fe88c98143d19471c2f091c2 https://medicaldevicecourses.com/activity/p/17407/ Wed, 15 May 2019 21:39:12 -0400 An NDA is most certainly not a patent. An NDA is basically two parties agreeing that they will not tell anyone about the information in questions. It is more akin to a trade secret than a patent. A patent is…   Read more»

]]> fce1df97f864d10347fcbecb0c78a208 https://medicaldevicecourses.com/activity/p/17308/ Wed, 15 May 2019 21:38:25 -0400 I think that I am better suited for upper management. I have held high level leadership roles before, and whilst they were not in a company, they still suited my personality and how I like to work quite well. Being…   Read more»

]]> ac6f6fd3db3543ae26847ffbdbc3fd4b https://medicaldevicecourses.com/activity/p/17304/ Wed, 15 May 2019 21:38:23 -0400 I currently work in a matrix style organization. I think it fits me the best, and if I founded a company that is the way I would run it. The biggest benefit in my eyes is the ease of access…   Read more»

]]> f607c04f9faab46bc8f9bff385ce1a01 https://medicaldevicecourses.com/activity/p/17302/ Wed, 15 May 2019 21:38:22 -0400 Organizational structure and workplace culture are definitely correlated. If a company wants to use a matrix structure it is important that there be a relaxed environment where everyone feels they can express their ideas freely and without consequence. If a…   Read more»

]]> 3239165a7b4a915d2d40bd9591a6854c https://medicaldevicecourses.com/activity/p/17197/ Wed, 15 May 2019 21:37:27 -0400 My research into Task Analysis and Use Error Analysis seems that it is a good way to attempt to mitigate risk that stems from the actual handling and use of the products. IT involves breaking down the function into as…   Read more»

]]> 5cb70c0a8f821d3bd530fc01c1091c17 https://medicaldevicecourses.com/activity/p/17193/ Wed, 15 May 2019 21:37:25 -0400 Risk management once the product is in the hands of the end user is as you say, the largest part of risk management. Either through the use case, timing, or general negligence. As Dr. Simon pointed out, a surgeon in…   Read more»

]]> ea7347c59be82e87e8ea14cc43466bc1 https://medicaldevicecourses.com/activity/p/17190/ Wed, 15 May 2019 21:37:24 -0400 Sadly I think access to these regulations costs because they can. They know companies will need access and that they will be willing to pay as they will see it as a cost of doing business. Is it shady? Yes….   Read more»

]]> 7e7d0a20f3597c8f5316d2805c363678 https://medicaldevicecourses.com/activity/p/17079/ Wed, 15 May 2019 21:36:28 -0400 I have encountered this on a small scale. For my capstone project we are using InfraRed LEDs to illuminate the eyes with IR light. When we designed the circuit that will power the LEDs we needed to make sure that…   Read more»

]]> 70efee65e59a5604fc7045fbf0f0176d https://medicaldevicecourses.com/activity/p/17078/ Wed, 15 May 2019 21:36:28 -0400 Design verification is an essential step in the medical device development process. It gives quantitative data on whether or not the prototype of the device is working to specification. This allows for the understanding of problems that do not arise…   Read more»

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