https://medicaldevicecourses.com/members/smk45/activity/ Activity feed for smk45. Fri, 24 Apr 2026 18:41:04 -0400 https://buddypress.org/?v= en-US 30 hourly 2 b26d3ab99a9aa2eafcbe33451b088eeb https://medicaldevicecourses.com/activity/p/16046/ Wed, 15 May 2019 19:16:31 -0400 Maintaining a good relationship with vendors requires effort, like everything else that is good. On-time payment to vendors is definitely a priority because you are doing business with them and this is the best way to show that you are…   Read more»

]]> 3f79fc4f9482ba1b630f5a6ba9ee1222 https://medicaldevicecourses.com/activity/p/16045/ Wed, 15 May 2019 19:16:30 -0400 The results here don’t particularly surprise me! Everyone wants to have a purpose in life and a lot of times, we draw that from our work since we dedicate most of our time in a given day to doing that….   Read more»

]]> 03c011f256878672ff75f3de58481298 https://medicaldevicecourses.com/activity/p/16044/ Wed, 15 May 2019 19:16:30 -0400 Dr. Simon’s classes are always very practical and teaches the reality of how the medical device industry works. Taking this class has enlightened me on what kind of company I work for (matrix organization), which I didn’t think of before….   Read more»

]]> 18ef383091aaa148758cf9d159f7223c https://medicaldevicecourses.com/activity/p/15895/ Wed, 15 May 2019 19:15:03 -0400 I believe that Americans are overworking due to a combination of factors including motivation, peer pressure, and more work to complete overall. Motivating factors in this economy is to make as much money as possible to be able to live…   Read more»

]]> d051e109a244f836d808dc3627720623 https://medicaldevicecourses.com/activity/p/15893/ Wed, 15 May 2019 19:15:02 -0400 I would love to continue as an engineer until I become a principal engineer. Once I am a principal engineer for a few years, then I would consider looking into a management position so that I understand how to manage…   Read more»

]]> f0ed0a54e656d0fa8cb57a458cc10864 https://medicaldevicecourses.com/activity/p/15891/ Wed, 15 May 2019 19:15:01 -0400 One of my biggest motivation at work is to perform in such a way that my manager has minimal to no negative feedback. When I started off with CAD work, my manager came back with a lot of constructive criticism,…   Read more»

]]> 135fe7f2d01b12c81629929671d8b0b8 https://medicaldevicecourses.com/activity/p/15703/ Wed, 15 May 2019 19:13:01 -0400 Hi ks629, I think you make a valid point but I see why using a different coating from the same supplier may be beneficial. Since the contract is already signed with that specific supplier, it’s easier to change product selection…   Read more»

]]> aa003ea75c8884a6bed28b2f7d26ca81 https://medicaldevicecourses.com/activity/p/15701/ Wed, 15 May 2019 19:13:00 -0400 At work, we have multiple projects going on simultaneously in R&D to enhance some of our product lines. One of the projects involved mixing in a different material to reduce the overall weight of the implant. Another project involved aimed…   Read more»

]]> cde631f648869ab3b8f81f6d76d25daf https://medicaldevicecourses.com/activity/p/15699/ Wed, 15 May 2019 19:12:59 -0400 In my experience, the procurement process is very straight forward but can sometimes be expensive. There have been several occasions where I have found a given product for a relatively cheap price but because it’s not on the approved vendor…   Read more»

]]> 64efeae2cd46a057801b9483654a6216 https://medicaldevicecourses.com/activity/p/15635/ Wed, 15 May 2019 19:12:21 -0400 Agreeing on the project goals is crucial to get the project up and running. If the whole team is not on board, you can’t continue with the project without it failing or just not producing good quality results. Effective communication…   Read more»

]]> 2a8aeb3d52d21a097a6d2e892da47844 https://medicaldevicecourses.com/activity/p/15633/ Wed, 15 May 2019 19:12:20 -0400 Another way to keep track of a project’s progress is through team meetings in which the whole team gets filled in on each member’s status within the project. Typically, team meetings will go over what has been completed, what is…   Read more»

]]> d68ee8dbf728c280dda7e4ec3ab32727 https://medicaldevicecourses.com/activity/p/15483/ Wed, 15 May 2019 19:06:50 -0400 I have had to modify CAD drawings to accommodate new design changes. This involved changing the rev number, adding redlines, and adjusting the bill of materials (BOM). Once the redlines drawing was approved, I had to go back and remove…   Read more»

]]> 85c2c38bd3e8bfed21b19adef3269762 https://medicaldevicecourses.com/activity/p/15472/ Wed, 15 May 2019 19:06:42 -0400 Like cdj24 mentioned, it’s hard to say which situation is better without knowing the context of the project and the company. Ideally, having a positive SV and CV is preferred but that’s not always possible. If the schedule is flexible…   Read more»

]]> d3ad27085dc42d2a80d85ae0c646fdd4 https://medicaldevicecourses.com/activity/p/15469/ Wed, 15 May 2019 19:06:41 -0400 In my experience, some factors that affect schedule variance negatively involves accounting for unplanned events. Recently we had to complete competitive testing on implants in comparison to our own implants. We had to complete implant characterization but the motors on…   Read more»

]]> d8faf00329492a99c2fbd6a89ce5148c https://medicaldevicecourses.com/activity/p/15406/ Wed, 15 May 2019 19:05:58 -0400 Depending on the need to outsource, there are a lot of factors a PM needs to consider when picking a third-party vendor. The PM must consider whether the task at hand is a primary service that the company offers. If…   Read more»

]]> 1ded76fbc5d5bf30e6ca8bfa0f813374 https://medicaldevicecourses.com/activity/p/15405/ Wed, 15 May 2019 19:05:58 -0400 Verification is mostly paper work. All the design inputs such as specifications, government and industry regulations, knowledge taken from previous designs, and any other information necessary for proper function are compared with the design outputs such as drawings, assembly instructions,…   Read more»

]]> 56ed6875ab0ad89054ce580db36542b0 https://medicaldevicecourses.com/activity/p/15404/ Wed, 15 May 2019 19:05:57 -0400 When having a stern project stakeholder like Patty in the simulation, it is the project manager’s duty to mediate any issues in concerns. Through clear communication and open-mindedness, the team should be able to tackle any issues that may arise…   Read more»

]]> f44226a4b7d2f719693c7808afa3975d https://medicaldevicecourses.com/activity/p/15264/ Wed, 15 May 2019 19:04:34 -0400 As many have mentioned above, most company SOPs will not allow for any unethical activity to get around the FDA. And if a company decides to go against the policy, they will have to pay for the consequences. This is…   Read more»

]]> 878cb38bec25419d42ae5bc50997a7f5 https://medicaldevicecourses.com/activity/p/15263/ Wed, 15 May 2019 19:04:33 -0400 This actually occurred in my team a few months ago. The previous PM got a new job with another J&J branch and one of the principle R&D engineers got promoted to becoming PM. So in our case, it wasn’t a…   Read more»

]]> f443a35d8460fe12b5797336784a62fd https://medicaldevicecourses.com/activity/p/15257/ Wed, 15 May 2019 19:04:30 -0400 Gantt charts are used to map out reasonable timelines including the initiation of a project and critical pathways, this way critical milestones can be monitored. The development of network diagrams and gantt charts allows smooth initiation, continuation, and completion of…   Read more»

]]> 0b43a9da1efcd66784c491df71a350fc https://medicaldevicecourses.com/activity/p/15228/ Wed, 15 May 2019 19:04:15 -0400 The planning phase is crucial in the project life as it sets the tone for the coming stages. You want to plan well so as to avoid any future complications. That is where risk management comes in to play so…   Read more»

]]> 94080ec90e30ec609f1b31bbbbb4ee33 https://medicaldevicecourses.com/activity/p/15227/ Wed, 15 May 2019 19:04:14 -0400 I think it’s important to build in a discovery period for projects. Usually at the project kickoff meetings, stakeholders will immediately want to know what the final delivery date will be. This may not always be attainable especially in the…   Read more»

]]> 55fcd5db79f7014a21ebbbfc36d25ea5 https://medicaldevicecourses.com/activity/p/15225/ Wed, 15 May 2019 19:04:08 -0400 At the company I work for, one of the tasks I had to complete was to finish building a lateral compression tester used in our lab to test the firmness of breast implants. This second fixture was to be shipped…   Read more»

]]> 7db9bb157a7d8baa7d66e6292b1b718d https://medicaldevicecourses.com/activity/p/15103/ Wed, 15 May 2019 19:03:04 -0400 As a PM running a risk management meeting, I’d focus on defining risks instead of identifying risks and make sure everyone in the meeting is clear on them. I would have a top-to-down breakdown of the risk sets with room…   Read more»

]]> f52dd2d26379009241908cb5a8685b3c https://medicaldevicecourses.com/activity/p/15099/ Wed, 15 May 2019 19:03:02 -0400 At my company, design reviews are not as restricting as the capstone design review session. No one is forced to be silent while their project is being evaluated. There’s more of a dialogue between the team and the one who…   Read more»

]]> 8465e794ca46053910761df715a918af https://medicaldevicecourses.com/activity/p/15096/ Wed, 15 May 2019 19:03:00 -0400 The role of project stakeholders is very valuable since there is always potential for positive and negative influence of one stakeholder over another. The greater the potential influence, the greater the risk reach project goals. Knowing the weight of each…   Read more»

]]> ee34f0b73218d55e5a1c79c50079d08e https://medicaldevicecourses.com/activity/p/14912/ Wed, 15 May 2019 19:01:18 -0400 The initiation phase is the hardest but most crucial part that sets the tone of the remaining phases for the given project. When you are pitching a new idea, you have to make sure it is presented succinctly with minimal…   Read more»

]]> d50162635885d4b722c52679ba064eb7 https://medicaldevicecourses.com/activity/p/14897/ Wed, 15 May 2019 19:01:09 -0400 It is very important to pick team members wisely. Depending on the types of projects your team covers, it’s ideal to pick people who have qualities that your team may be lacking in and/or in need of. Also, having people…   Read more»

]]> d9816b91ed537dfa8a38972ccbe3f00c https://medicaldevicecourses.com/activity/p/14767/ Wed, 15 May 2019 18:59:53 -0400 I’ve practiced the most, if not all of the 9 design controls covered in this week’s lecture in both school and work. For my undergrad senior capstone class we had to practice design controls over the span of two semesters….   Read more»

]]> 6357b0919357ee8404573875d2e791b4 https://medicaldevicecourses.com/activity/p/14646/ Wed, 15 May 2019 18:58:50 -0400 You bring up a great point – medical device regulation standards do not translate uniformly on a global scale. What may be deemed as a “safe” medical device in Europe for example may not pass US FDA regulations. When working…   Read more»

]]> 491e15d4d524a66e29cec3dfd877ce03 https://medicaldevicecourses.com/activity/p/14584/ Wed, 15 May 2019 18:58:15 -0400 I think it’s important that all projects are clearly prioritized and that each team member understands the level of priority each project holds. Being able to prioritize projects well ultimately impacts the success of the project and the response from…   Read more»

]]> ced38ab3405cf92cbe98e4cf5329b16a https://medicaldevicecourses.com/activity/p/14582/ Wed, 15 May 2019 18:58:14 -0400 I believe the ratio of interpersonal skills to technical skills should be 50:50 in the medical device industry. There are instances where you can talk yourself up but you can only do it for so long until your lack of…   Read more»

]]> ee18160fdf568f27b915bef372654ed9 https://medicaldevicecourses.com/activity/p/14579/ Wed, 15 May 2019 18:58:12 -0400 I currently work at Ethicon as a R&D Engineer co-op. There are three industries that J&J spans which are consumer products, pharmaceutical products, and medical devices. Within these industries, there are many subsidiary companies. Ethicon falls under the medical device…   Read more»

]]> 2dc60693baed323c4083fcbec42631c6 https://medicaldevicecourses.com/activity/p/11437/ Wed, 15 May 2019 16:44:58 -0400 Hi Nicole, You bring up an interesting point in that companies should be questioned if they are not willing to have legal counsel. When legal disputes arise, it forces the contractor to think twice as to why they want to…   Read more»

]]> 9a93bf4532e18f0d25d6128274809e70 https://medicaldevicecourses.com/activity/p/11431/ Wed, 15 May 2019 16:44:54 -0400 This is all the more reason as to why being professional in business exchanges is important and should be reinforced. That is not to say table talk needs to be dry and fully factual. Various topics can be discussed but…   Read more»

]]> 327e84ce6ec415d671e8d4c8408fafa7 https://medicaldevicecourses.com/activity/p/11427/ Wed, 15 May 2019 16:44:52 -0400 Hi Fady, The consultant that was hired at your company is in violation of an NDA or CDA for sure. It is quiet irresponsible of him to just copy the document from another company and not edit out the embedded…   Read more»

]]> 5dbe9d1d23f670733c367816086d1dbf https://medicaldevicecourses.com/activity/p/11324/ Wed, 15 May 2019 16:43:55 -0400 There definitely needs to be a balance when it comes to organizational behavior and I think a lot of people find it hard to draw the line between what is professional and what is too friendly. If employees are too…   Read more»

]]> 6d8ed7bd60eb1af76d4c42ece46891fc https://medicaldevicecourses.com/activity/p/11323/ Wed, 15 May 2019 16:43:55 -0400 Interesting viewpoint here! Being part of an open and welcoming company culture motivates employees to perform better. Instead of fending for yourself, you are more inclined wanting to better your contribution to the overall company community. A good company culture…   Read more»

]]> 095205565ed83ba8ca7b0f84fff3fbc5 https://medicaldevicecourses.com/activity/p/11322/ Wed, 15 May 2019 16:43:54 -0400 I think matrix organization structure is most ideal for collaboration projects. To break down what a matrix is, it is an organizational structure that distributes responsibilities among two or more dimensions. A matrix organization structure takes multiple perspectives into account…   Read more»

]]> 743985a5272f1961d8b059810779223a https://medicaldevicecourses.com/activity/p/11120/ Wed, 15 May 2019 16:40:04 -0400 Hi Fady, I agree that it is not clear as to what exactly “as far as possible” means and what standard it is being compared to. This statement definitely implies that all risks cannot be reduced completely, but should be…   Read more»

]]> 1d380927f1bdacca44b6df7b072e98cf https://medicaldevicecourses.com/activity/p/11118/ Wed, 15 May 2019 16:40:03 -0400 Hi Abhishek, After doing some research, I found that conducting a hypothesis test of effects/relationships (power analysis) would be ideal in determining sample size. Studies that attempt to determine an effect such as differences between two treatments or the presence/absence…   Read more»

]]> e5320e6320777c8c9b260a8300877390 https://medicaldevicecourses.com/activity/p/10987/ Wed, 15 May 2019 16:38:35 -0400 Hello, I have yet to gain industry experience, but I do have experience in creating Gantt charts for my Capstone class. A good practice is to start off by documenting what the purpose of the Gantt chart is and then…   Read more»

]]> db12df7b79661629e6a49b7cfc372f58 https://medicaldevicecourses.com/activity/p/10986/ Wed, 15 May 2019 16:38:34 -0400 The responses on this post do a great job at illustrating why meeting minutes are important. Meeting minutes are there to represent what initiatives a company takes and serves as legal protection. The IRS, courts, and auditors will only look…   Read more»

]]> 29246b62a215250053e6896396e201ad https://medicaldevicecourses.com/activity/p/10984/ Wed, 15 May 2019 16:38:33 -0400 Like Hetal mentioned above, it is a good idea to conduct a human factor study even if no changes were required after verification. For medical devices, it is crucial to run the human factors/usability engineering process in order to reduce…   Read more»

]]> bdc88a91ec9dccf228804359c6ccfdf6 https://medicaldevicecourses.com/activity/p/10826/ Wed, 15 May 2019 16:36:57 -0400 Hi Lamiaa, thanks for bringing this topic up. From what others have mentioned, it can be seen that the problems that arise from insufficient design control are significant. I wanted to give a couple of examples of medical device failures…   Read more»

]]> 5f0be46dac2d225b052f61c28beac5e1 https://medicaldevicecourses.com/activity/p/10825/ Wed, 15 May 2019 16:36:56 -0400 You make an interesting point Lamiaa. It definitely becomes a problem when a company strays away from adhering to their design controls. I am not quite sure what you mean when you say that “when the process becomes heavy, they…   Read more»

]]> f18505c43d0566d43f5f1d732fb37bcd https://medicaldevicecourses.com/activity/p/10641/ Wed, 15 May 2019 16:35:12 -0400 This week is simulation week and our project is on Bottle Label Development for a Hydrophilic Coating Product. This got me thinking about package development for products and the types of test they must pass. Any testing done on the…   Read more»

]]> 4be52fb292887604924502d515810463 https://medicaldevicecourses.com/activity/p/10636/ Wed, 15 May 2019 16:35:09 -0400 Once you get a new medical device project, the first two things you should do is find out what the user needs are and establish a design plan. When going about user needs, what kind of questions do you ask…   Read more»

]]> 03793016bfe2e8208aa1f50da51cd0d2 https://medicaldevicecourses.com/activity/p/10631/ Wed, 15 May 2019 16:35:07 -0400 This week’s lecture describes that there are 3 different organizational structures: functional, projectized, and matrix organizations. Each organizational structure greatly impacts the way the company manages projects and how employees work. What do you think are some pros and cons…   Read more»

]]> e76ab250b9d7accc090461b0827750e7 https://medicaldevicecourses.com/activity/p/10623/ Wed, 15 May 2019 16:35:03 -0400 I came across an article that discusses whether or not Fitbits should be classified as a medical device as per new FDA guidelines. Since it is not 100% clear as to what the FDA will regulate, it hinders big tech…   Read more»

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