https://medicaldevicecourses.com/members/kbentleymsm-edu/activity/ Activity feed for kbentleymsm-edu. Fri, 24 Apr 2026 15:55:39 -0400 https://buddypress.org/?v= en-US 30 hourly 2 256a31f71b15dd3cd7be8bd8ce8f0151 https://medicaldevicecourses.com/activity/p/22726/ Wed, 23 Jun 2021 03:24:35 -0400 Posted by: @orleron Well, you did it! You made it to the end of Medical Device Development. The original intent of this course was to teach you what professionals in the medical device field do in the real world if…   Read more»

]]> 7e33083ab733be1d0c16152235882b8c https://medicaldevicecourses.com/activity/p/22725/ Wed, 23 Jun 2021 03:13:34 -0400 Posted by: @savery115 A small part of the lecture reviewed Upper Management vs Middle Management. Upper Management people are strategic and tend to set the groundwork and vision for what the company could be. Middle Management people are tactical and…   Read more»

]]> 7845d2ce12e2dc66e199bdea128df6c9 https://medicaldevicecourses.com/activity/p/22724/ Wed, 23 Jun 2021 03:07:12 -0400 I felt most drawn to the matrix organization. The reason I like that format is because it is more collaborative in nature than the functional and project-based methods. I am always inclined to believe that people are more apt to…   Read more»

]]> fd2589be1ae21581e3134c46afde55b7 https://medicaldevicecourses.com/activity/p/22688/ Wed, 16 Jun 2021 16:36:52 -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»

]]> 3e504cf742ab236658680fcde1b39de2 https://medicaldevicecourses.com/activity/p/22687/ Wed, 16 Jun 2021 16:24:46 -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?  Some risks must be accepted when considering what the device is, but I think…   Read more»

]]> 5999811a4ba143e56cad6d2e3c2d81b4 https://medicaldevicecourses.com/activity/p/22686/ Wed, 16 Jun 2021 16:19:56 -0400 Posted by: @hg93 Risk management is the process of analyzing, identifying and responding to risk factors throughout the course of the project. Managing risks early on in the project is the best way to avoid project catastrophes. Continuously applying the…   Read more»

]]> e8a1759172d7fba1ec6df38f340a1360 https://medicaldevicecourses.com/activity/p/22651/ Wed, 09 Jun 2021 01:44:29 -0400 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 important to the…   Read more»

]]> ca54e5bfe95805b361c4237d7ed00a8b https://medicaldevicecourses.com/activity/p/22650/ Wed, 09 Jun 2021 01:23:16 -0400 Posted by: @hg93 “Design Controls” is a FDA term and defined in FDA 21 CFR 820.30. Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and…   Read more»

]]> 721cb6cc15b23baa17c33a355ff6f4b2 https://medicaldevicecourses.com/activity/p/22649/ Wed, 09 Jun 2021 01:18:02 -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»

]]> a31870eeaf09b3b6e9619d26c00489ac https://medicaldevicecourses.com/activity/p/22589/ Wed, 02 Jun 2021 03:14:35 -0400 Posted by: @orleron As you interact with the CRA profession, you will notice a heavy preference for people with a “clinical background”. This means people who have been or are nurses, doctors, or other kinds of technical workers who interact…   Read more»

]]> 755b86ad0cab1a3754c2d1576ac471af https://medicaldevicecourses.com/activity/p/22588/ Wed, 02 Jun 2021 03:00:07 -0400 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»

]]> d7b6717925db50513b84d99c6733dfd2 https://medicaldevicecourses.com/activity/p/22587/ Wed, 02 Jun 2021 02:51:29 -0400 Posted by: @dh239 I feel that it is acceptable to take the risk of a clinical trial when the results of the trial are expected to either benefit or not affect those involved. This would be in the case of…   Read more»

]]> 774e8faccb90dab03feace39ae40b528 https://medicaldevicecourses.com/activity/p/22544/ Tue, 25 May 2021 02:03:20 -0400 Posted by: @llefevre It is estimated that globally, the market for Clinical Trials is in upwards of $44 Billion as of 2020 and is expected to grow by approx 6% over the next 7 years, mostly fueled by the need…   Read more»

]]> bec7d38835ec269fbec6949e799ae7be https://medicaldevicecourses.com/activity/p/22543/ Tue, 25 May 2021 01:53:37 -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. I decided to…   Read more»

]]> e574af9ea9038a401b2ed769958d7782 https://medicaldevicecourses.com/activity/p/22542/ Tue, 25 May 2021 01:41:43 -0400 Posted by: @sahitya-sadineni After watching the videos from this week’s lecture, we have learned about the various company types. While thinking about this, would you consider turning down a position based on the type of company it is? For me…   Read more»

]]> 613fb603a0f3f3127f001d96a48f34c1 https://medicaldevicecourses.com/activity/p/22519/ Sat, 22 May 2021 22:40:34 -0400 2ced60bacd2e189830f5c409e8e2b40a https://medicaldevicecourses.com/activity/p/22518/ Sat, 22 May 2021 22:40:25 -0400 18f4dc8c607773dc143f9ded8f8df1ae https://medicaldevicecourses.com/activity/p/22517/ Sat, 22 May 2021 22:28:01 -0400 Posted by: @christoph To a layman, a surperficial assessment of 510K process is that it is nonsensical.WHY are devices being compared to devices created 40 years ago.This makes no sense to me. Why arent the just assessed on their own…   Read more»

]]> 48a0c01a68b462de34aa3262ab91541e https://medicaldevicecourses.com/activity/p/22516/ Sat, 22 May 2021 22:21:36 -0400 Posted by: @amd29 In the field we will be dealing with people of different backgrounds, accents, looks and drives. What do these human differences mean to you as it relates to your function in directing their operation in the creation…   Read more»

]]> 5b8ce4d3485fd650c3c9fa88ba4a4529 https://medicaldevicecourses.com/activity/p/22515/ Sat, 22 May 2021 22:14:46 -0400 Posted by: @dipanpatel Ethics and Quality are very related; moral attitudes and conscious awareness of standards and guidelines have to be separate from intellectual/company’s agenda. As NJIT student studying ethics and/or professionals in the industry, have you come across ethical…   Read more»

]]> 9b3dee2c3681de9a1def7d1ea21ed7f8 https://medicaldevicecourses.com/activity/p/22466/ Sun, 16 May 2021 00:19:28 -0400 Posted by: @mduru I think it would be appropriate to say this topic is like a double edge sword. Just as with any controversy or disagreement, I think dialogue is the best way to go about it. Both side need…   Read more»

]]> 88d1d7ddde9e92823f019d8318102b76 https://medicaldevicecourses.com/activity/p/22465/ Sun, 16 May 2021 00:13:47 -0400 Posted by: @llefevre 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…   Read more»

]]> edf7b4d1d8674abb6b72d9bd63e32f96 https://medicaldevicecourses.com/activity/p/22463/ Sun, 16 May 2021 00:09:13 -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»

]]> 57f93bfa94cbe38b2b45ef841fa3cefc https://medicaldevicecourses.com/activity/p/22426/ Sun, 09 May 2021 17:14:39 -0400 Posted by: @maniakberk So a Project Manager(PM) position is something I wanted to have over the years but I was never accepted to any of my applications as an employee. So my question is that what a person can do…   Read more»

]]> 09f9218c6efae7d8d953d8b79ebc2f28 https://medicaldevicecourses.com/activity/p/22405/ Wed, 05 May 2021 03:01:34 -0400 I am looking to switch careers from a secondary educator.  I am earning my second masters and have been considering jobs in clinical research.  Specifically I considered clinical research associate.  Is this appropriate for such a transition when experience is…   Read more»

]]> 28cca5c57847b4b40717e2cbe18b4753 https://medicaldevicecourses.com/activity/p/22404/ Wed, 05 May 2021 02:52:31 -0400 Posted by: @orleron This week is an overall introduction to the field of medical device development. We take some time to pay attention to the differences between Academia and Industry (Commercial) because students in this course may come from one…   Read more»

]]> a0e5e05f49378be877f4459f2fa14daa https://medicaldevicecourses.com/activity/p/22403/ Wed, 05 May 2021 02:10:56 -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»

]]> 9d5afd2e75f84bf8ce252f6696c52079 https://medicaldevicecourses.com/activity/p/22238/ Wed, 21 Apr 2021 23:51:44 -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»

]]> 725ee88c6e594de5e441251afeb32b64 https://medicaldevicecourses.com/activity/p/22237/ Wed, 21 Apr 2021 23:40:04 -0400 Posted by: @devarshi-joshi The main functions of Human Resource Management department are : 1) Reduce turnover 2)Hire for fit 3)Focus on retention of top performers 5)Improve employee engagement. So my question is how this will help in medical field improving…   Read more»

]]> d41abcee57b8efff5fb842dd4debbedc https://medicaldevicecourses.com/activity/p/22234/ Wed, 21 Apr 2021 23:25:27 -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»

]]> 8aa2609088be5cddce42b805ae3393a9 https://medicaldevicecourses.com/activity/p/22115/ Wed, 14 Apr 2021 02:54:26 -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»

]]> 4a2e02b3762cee8f55d3d8b2430c58f2 https://medicaldevicecourses.com/activity/p/22114/ Wed, 14 Apr 2021 02:50:30 -0400 Posted by: @amin-sadig From as early as the mini sim we were told to consider outside factors such as vacation times for inspectors when planning a schedule so we don’t get delayed unnecessarily. Because the job of a PA is…   Read more»

]]> d60a44fae86aa91d0439cc014e833f7c https://medicaldevicecourses.com/activity/p/22113/ Wed, 14 Apr 2021 02:40:04 -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»

]]> 98adcfed84280d345c2d597ab99daee4 https://medicaldevicecourses.com/activity/p/22016/ Wed, 07 Apr 2021 04:16:19 -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»

]]> d4ceaaf9a761da9140455c30bdc33d19 https://medicaldevicecourses.com/activity/p/22015/ Wed, 07 Apr 2021 04:04:57 -0400 @llefevre Wow!  That certainly sounds like a mess.  Although I am certain you knew the way things should have been handled, for anyone who may not have known, the example set at the company served as a good teacher.  I…   Read more»

]]> 1a73da5eb5857e9e7d5befdd6797f2de https://medicaldevicecourses.com/activity/p/22014/ Wed, 07 Apr 2021 04:00:02 -0400 Posted by: @ks629 In the lecture, Professor Simon mentions scope creep. Scope creep is when there is project work being done or considered that is outside the original agreed upon scope of the project. An example might be that the…   Read more»

]]> 130e90d9dbdc8344fb26f7bad709051f https://medicaldevicecourses.com/activity/p/21945/ Wed, 31 Mar 2021 00:52:59 -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»

]]> 97bcee225f2931818910fdba7b950652 https://medicaldevicecourses.com/activity/p/21944/ Wed, 31 Mar 2021 00:41:31 -0400 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»

]]> 627659a9aee8eb5425a6240b82f34908 https://medicaldevicecourses.com/activity/p/21943/ Wed, 31 Mar 2021 00:29:52 -0400 Posted by: @djr32 In this week’s lecture, we learned about planned value and actual cost. Planned value is the value of the work you are supposed to have on a certain date. While the actual cost is the cost of…   Read more»

]]> dbe8eb2ed936d461b76658bb17e7c7ab https://medicaldevicecourses.com/activity/p/21851/ Wed, 24 Mar 2021 03:52:43 -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»

]]> 57d98d85fd694a136bb0d997f8c79bd9 https://medicaldevicecourses.com/activity/p/21850/ Wed, 24 Mar 2021 03:39:53 -0400 Posted by: @devarshi-joshi The main functions of Human Resource Management department are : 1) Reduce turnover 2)Hire for fit 3)Focus on retention of top performers 5)Improve employee engagement. So my question is how this will help in medical field improving…   Read more»

]]> 782463ad0d9a485f3cf61c686111d247 https://medicaldevicecourses.com/activity/p/21849/ Wed, 24 Mar 2021 03:30:25 -0400 @llefevre You gave a great example of an organizational schematic.  The fluidity of the processes that took place under the matrix model and the positive outcomes that resulted were nice to hear.  I especially like that you mentioned the morale…   Read more»

]]> 406d69187dd9cf2b3e86e52adcca5585 https://medicaldevicecourses.com/activity/p/21753/ Mon, 15 Mar 2021 01:43:07 -0400 @k-faulk Thank you for your response.  You gave a nice example.  I am a teacher too.  The only reference I really have is in the education field.  I am more interested in seeing how a project would look in industry. …   Read more»

]]> 769b80de41feac268bf8ded6f4f67b29 https://medicaldevicecourses.com/activity/p/21752/ Mon, 15 Mar 2021 01:38:27 -0400 I think it would be best to hire someone to replace her.  Of course this person should be a very strong candidate and one who has the characteristics of someone who can work under such pressures.  If the project is…   Read more»

]]> aef8d96ad90880cbe1d1d9a48539b4f5 https://medicaldevicecourses.com/activity/p/21750/ Mon, 15 Mar 2021 01:08:25 -0400 To answer my own writing prompt, I felt most drawn to the matrix organization.  The reason I like that format is because it is more collaborative in nature than the functional and project-based methods.  I am always inclined to believe…   Read more»

]]> a3404796f5b3be00ff2409a7f686327a https://medicaldevicecourses.com/activity/p/21748/ Mon, 15 Mar 2021 00:57:57 -0400 Consider the three types of organizations in project management: functional, project-based, and matrix.  Which of those formats do you think you would most like to work under?  Explain.
 

]]> 60f7173326c82ce10d6a6fbd68283e30 https://medicaldevicecourses.com/activity/p/21624/ Wed, 10 Mar 2021 02:44:12 -0500 I think this is a great post. I am not in industry.  I suppose you can say I am in the industry of education.  I am a classroom teacher with a masters degree and working on my second masters.  I…   Read more»

]]> 600e83d4b089528a6d005c4f04feb91e https://medicaldevicecourses.com/activity/p/21623/ Wed, 10 Mar 2021 02:38:05 -0500 I do not yet know a lot about all of the restrictions that the FDA has put forth, but based on the initial post, it does not seem that the restrictions are too stringent.  As stated in the first post,…   Read more»

]]> 7052a9a7261d47e1d7deb71a8a4e0868 https://medicaldevicecourses.com/activity/p/21622/ Wed, 10 Mar 2021 02:26:29 -0500 This is only my second week in project management.  I still feel like I “just don’t know” how a project looks. I guess a practical, simple example would be nice to see.  Admittedly, I feel a little lost in the…   Read more»

]]> a2253817b48bc694c584f23fe594eb91 https://medicaldevicecourses.com/activity/p/21540/ Sun, 07 Mar 2021 19:26:43 -0500 I am currently engaged in my first week of project management. I ventured to this forum because I thought it could be helpful to check out skills students have learned after matriculating through the course.  I think it was nice…   Read more»

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