https://medicaldevicecourses.com/members/yg385/activity/ Activity feed for yg385. Sat, 25 Apr 2026 00:17:23 -0400 https://buddypress.org/?v= en-US 30 hourly 2 7079978d08a23e0143e4bdd7cbc2282e https://medicaldevicecourses.com/activity/p/47242/ Mon, 20 Apr 2026 03:44:28 -0400 There are several good posts here, many of which point out a combos with generally the same 3 knowledge areas, that being scope, risk, quality, or time, or some variation of that.  While I’ll say that I generally agree with…   Read more»

]]> c896c5fb6c585a03af4ed5471d6e5509 https://medicaldevicecourses.com/activity/p/47238/ Mon, 20 Apr 2026 03:38:08 -0400 @anthonynjit agreed that the bottom up would be the ideal. However, it unfortunately is often not the case in the real world. In my company, for example, the top-down approach is usually what’s done. My company is able to do…   Read more»

]]> 6943c68e0a381525a8d9dafa744428f1 https://medicaldevicecourses.com/activity/p/47237/ Mon, 20 Apr 2026 03:32:08 -0400 As many are saying, this depends on costs associated with the project, as well as timeline. However, regardless, ‘supplier diversity’ should be done no matter the costs during the project. It’s less ‘suppler diversity’ and moreso, looking for alternative vendors…   Read more»

]]> 87ca86ed97d1c7c25e0cd56ec2cf86c9 https://medicaldevicecourses.com/activity/p/45878/ Tue, 07 Apr 2026 01:09:42 -0400 @mmd55 agreed, I also don’t agree with rushing timelines. You make a good point on things taking longer preventing a patient from receiving that potentially lifesaving medical device, however, I would argue that taking a longer time to ensure things…   Read more»

]]> 9741caa4bdc1828223ef9cf512867c25 https://medicaldevicecourses.com/activity/p/45876/ Tue, 07 Apr 2026 00:58:38 -0400 Going through this post, several people bring up good suggestions! Creating a project plan, setting meetings, and creating a WBS are all good tools to use to ensure that your project stays on task. One tool I didn’t see touched…   Read more»

]]> 6f40c87d38ae7836c1eebcd415ead744 https://medicaldevicecourses.com/activity/p/45874/ Tue, 07 Apr 2026 00:41:18 -0400 An important note to consider is what position the manager is hiring for and whether that position is high level or not. Bringing in an outside hire to fill in a role that none at your current company are interested in…   Read more»

]]> 81be726504493439ecca3e75808cae44 https://medicaldevicecourses.com/activity/p/45032/ Sun, 29 Mar 2026 02:19:09 -0400 @sic23njit-edu agreed! To add to this, I think an important point to consider is to also look at what the company has done historically. Yes, we need to mitigate uncertainty and understand we can’t eliminate it completely, looking back at…   Read more»

]]> 0cc2094d51df4f1c8e568cecf1ef6886 https://medicaldevicecourses.com/activity/p/45031/ Sun, 29 Mar 2026 02:13:47 -0400 @kelsipetrillo this is an interesting suggestion! While on the surface, this may be a way to help broach the topic with the team and address the issue, I see potential issue with rolling this out in the real world. A…   Read more»

]]> e95e087c81560edf35bdb15b70272700 https://medicaldevicecourses.com/activity/p/45030/ Sun, 29 Mar 2026 02:07:30 -0400 The kind of problem that throws things out of schedule dictates the response. Before jumping to discussing the approach, one concept I feel is important to be aware of is the part of the PM’s role in a project. When…   Read more»

]]> 5be6faa0e2f386cfb390ad816fe1afe7 https://medicaldevicecourses.com/activity/p/43609/ Sat, 14 Mar 2026 02:02:22 -0400 As a couple of posters have mentioned, reporting lessons learned is a great tool to use for helping develop individuals so that the next projects run even more smoothly! To add onto this point I’d like to share a fun…   Read more»

]]> d5c576fe50b9544e7141bacec2fb1143 https://medicaldevicecourses.com/activity/p/43606/ Sat, 14 Mar 2026 01:53:33 -0400 Honestly, your best tools will always be communication first and foremost, then accountability, accountability, accountability! As a PM you can only do so much. To a certain level, a team member has to manage themselves. There will always be other…   Read more»

]]> 6b82008584d5cbf4e11cf8a16ff3f5a1 https://medicaldevicecourses.com/activity/p/43605/ Sat, 14 Mar 2026 01:44:55 -0400 This weeks videos on PM are really interesting. In my job (working as a process dev eng in a medical device manufacturing company) verification vs validation both in very loose terms mean ensuring that the customer spec is met–in other words…   Read more»

]]> dbe978dabd27b47a17baeb327385d47e https://medicaldevicecourses.com/activity/p/42569/ Tue, 03 Mar 2026 14:35:49 -0500 This is a fun one! Reading through the comments already posted, one thing I noticed that was missed is this: as the PM, you are often not in charge of hiring new members. You may not even have a say…   Read more»

]]> a32725675741771355677ee72cf64f2d https://medicaldevicecourses.com/activity/p/42568/ Tue, 03 Mar 2026 14:29:40 -0500 Many of these comments hit the nail on the head with providing a checklist, previous meetings, and team buy-in as the first steps for ensuring that all approvals will be met and the project will be able to continue forward…   Read more»

]]> 0a6de19a278b661be29f2e4bacba2753 https://medicaldevicecourses.com/activity/p/42565/ Tue, 03 Mar 2026 14:23:40 -0500 This is a really good question and post to make. When working in the medical device industry, whether that be in the R&D sector, manufacturing, etc. each one of us will run into this question. There are a few fundamentals…   Read more»

]]> b2ae69a773073041b3f7316973021564 https://medicaldevicecourses.com/activity/p/42353/ Sun, 01 Mar 2026 20:00:37 -0500 As many others have mentioned, this would be considered a major change. If a product failed to meet the regulations needed by the country in which the product would be sold in, this is something that would most likely be…   Read more»

]]> 67dc883cd4af1d3464f2d53d33757cf2 https://medicaldevicecourses.com/activity/p/42351/ Sun, 01 Mar 2026 19:50:10 -0500 @dev-doshi completely agree. I work in a medical device manufacturer. And for us, the name of the game isn’t pure avoidance, but risk mitigation. By the time we start planning out the manufacture of a device, we’re looking more at…   Read more»

]]> d47e11125b236f2d15366139be60dfbf https://medicaldevicecourses.com/activity/p/42345/ Sun, 01 Mar 2026 18:51:02 -0500 Similarly to what others have mentioned, in my job, the go-to is Microsoft Team’s messages and Outlook for sending emails and setting up emails. Teams allows for quick communication–messaging and even calls when its urgent. Outlook allows for setting up…   Read more»

]]> 56019855185d76b4c65967402f2123e7 https://medicaldevicecourses.com/activity/p/41604/ Mon, 23 Feb 2026 04:59:13 -0500 Absolutely agree with many of the viewpoints here, meet about it, meet about it, meet about it! The team should have a final Lessons Learned meeting at the conclusion of a project, and the biggest issues highlighted. Everyone should bring…   Read more»

]]> 63d8ff56617988e287c2fdb950be4ded https://medicaldevicecourses.com/activity/p/41603/ Mon, 23 Feb 2026 04:56:38 -0500 @dev-doshi Very valid input. However, to comment on one of your suggestions, in order to make the ‘nooks and crannies’ check easier, the team should be aligned and clear on what their roles and expectations are. The PM needs to…   Read more»

]]> 8e8eb0d81c62a33f0e6bd2e4c1d11110 https://medicaldevicecourses.com/activity/p/41602/ Mon, 23 Feb 2026 04:53:52 -0500 @vanshamin This is an interesting/insightful perspective. By mentioning that the metric itself shouldn’t become a target, might you mean essentially that the PM should ensure they shouldn’t put on ‘blinders’ over the situation so to say? Because agreed, however, the…   Read more»

]]> ad7274e76ecc574ca8b2e3ba3395dc8e https://medicaldevicecourses.com/activity/p/40353/ Fri, 13 Feb 2026 01:50:34 -0500 Several of the comments on here touched on good points including communication and research. However, the best path may be to source the document directly from an ERP system that has revisions of a doc. If there is a controlled…   Read more»

]]> 1cf9d19cdb190a67e45ce3b505c69e19 https://medicaldevicecourses.com/activity/p/40351/ Fri, 13 Feb 2026 01:45:02 -0500 This is a fun one! I work as a process dev engineer in manufacturing and my company heavily manufactures medical devices. Often there’s no way to really anticipate scrap turnout and issues. What helps is if we’ve manufactured similar devices…   Read more»

]]> 62624a70bc35993163a5d200031fcbea https://medicaldevicecourses.com/activity/p/40348/ Fri, 13 Feb 2026 01:35:14 -0500 I noticed several others have pointed out that changes typically shouldn’t be done all at once; agreed, this is true. Typically changes are made to a machine/tool or process in a controlled way. However, I feel I should point out…   Read more»

]]> cd3d58d978f074755ed91cf0cdfe8387 https://medicaldevicecourses.com/activity/p/39760/ Sun, 08 Feb 2026 02:54:34 -0500 @at644, while usually true, having documented procedures does not always guarantee compliance. Procedures can and will help avoid the pitfalls of treating design control and project management as two different entities but ensuring that staff follow the procedures would be…   Read more»

]]> 8445b2b4c33766126f648e9b46ed8739 https://medicaldevicecourses.com/activity/p/39757/ Sun, 08 Feb 2026 02:44:59 -0500 When you mention the product life cycle, that can apply to a variety of things as there are several different components that make up the product life cycle. There is the development phase, introduction phase, growth phase, maturity phase, and…   Read more»

]]> 839cb3e38d06cea28aa96e1d804c930a https://medicaldevicecourses.com/activity/p/39754/ Sun, 08 Feb 2026 02:08:03 -0500 To ensure that the DHF is done properly and completely a PM would need to be cognizant and responsible for all nine steps involved throughout the entirety of the project. While they wouldn’t be responsible for actually generating every individual…   Read more»

]]> 69629748bd4ea9f264fc3eeac4bb35e4 https://medicaldevicecourses.com/activity/p/38796/ Sun, 01 Feb 2026 20:51:26 -0500 Various people agree with the concept that roles should not only be clearly defined, but defined early in a project, or even before the project commences. This is essential to promote a sense of ownership and responsibility amongst team members….   Read more»

]]> beea46c32cb97ec7f2f268d494774133 https://medicaldevicecourses.com/activity/p/38792/ Sun, 01 Feb 2026 20:43:02 -0500 Reading through the responses, I agree with many of what was proposed; there are several good options for how to control expectations including consistent communication with shareholders, clearly defining project scope early on, and using a tiered control system. However,…   Read more»

]]> 04c069af282fcb3d30304c084bd8bafc https://medicaldevicecourses.com/activity/p/38786/ Sun, 01 Feb 2026 20:24:47 -0500 Reading through the responses, I noticed that many suggested having team meetings as a whole as well as additional individual meetings with those involved to try and resolve the conflicts. While this is a solid approach that can work, I…   Read more»

]]> aaa858546828ba19c2e8f6e7d86d7ba3 https://medicaldevicecourses.com/activity/p/36877/ Sun, 25 Jan 2026 20:04:39 -0500 The neat (and maybe painful part) of being a project manager is, that dependent on the industry, you can be expected to be a jack of all trades. In my job for example (working in a medical device manufacturer), the…   Read more»

]]> f85ae5f95d9c1f20f60c6da7587ae719 https://medicaldevicecourses.com/activity/p/36876/ Sun, 25 Jan 2026 19:58:53 -0500 @njq3 , this is exactly the point I want to touch upon. You mentioned how you sort of came into the leadership role in your current company and grew into it. The original posts asks about what makes a leader,…   Read more»

]]> 1df0b267955fc12d2cc01e309478a0e4 https://medicaldevicecourses.com/activity/p/36875/ Sun, 25 Jan 2026 19:52:18 -0500 Reading through the posts, I’ve noticed many have highlighted the importance of listening, defining roles, and respect. All very valid points in ensuring proper communication in a team. To take it one step further though, I’d like to specify a…   Read more»

]]> 3bc1c3226f657fbe5068c328a14bf545 https://medicaldevicecourses.com/activity/p/30361/ Mon, 02 Dec 2024 04:37:03 -0500 @an83 Exactly. To add onto this, from the outside, it seems it may be difficult to even grasp a consulting position in the first place as a new graduate with-assuming-little to no experience. Consulting should be chosen if it is…   Read more»

]]> 56e5d5a423f7c7548ada6228bbfb95c5 https://medicaldevicecourses.com/activity/p/30359/ Mon, 02 Dec 2024 04:30:32 -0500 @hc255 agree; I also firmly align with how you pointed out that this doesn’t necessarily have to be a scary thing.  It is indeed important to ask and well understand what’s considered confidential, what are the penalties associated with breach…   Read more»

]]> 64c0e6b579efe1d409b177dabb4b4d8a https://medicaldevicecourses.com/activity/p/30358/ Mon, 02 Dec 2024 04:21:07 -0500 @rm829 , very true and I wanted to especially highlight one of the points that you brought up. Something important consider is location as it relates to the physicians specialty. Simply considering somewhere tropical or somewhere that’s a popular vacation spot…   Read more»

]]> b5706a02cb2b258f28711d5379bb4994 https://medicaldevicecourses.com/activity/p/30249/ Sun, 24 Nov 2024 21:20:37 -0500 @ag2357 , to play the devils advocate to you and @kaf43‘s suggestions to increase communication-what if increasing this communication within the organization leads to issues? How would increasing that communication look like? For example, would the CEO ask the operators…   Read more»

]]> 69721804d7fa83c4fe3d63e054f3c7b2 https://medicaldevicecourses.com/activity/p/30248/ Sun, 24 Nov 2024 20:59:16 -0500 @benjaminrofail , I agree. However there’s another important point that should be made here. A good project manager will make their choice based off of what they know and what makes sense. By that I mean that they may have…   Read more»

]]> 37dd7058becbb67d0d8884fd2be5db2b https://medicaldevicecourses.com/activity/p/30247/ Sun, 24 Nov 2024 20:48:47 -0500 As having worked in a Functional Organization and a Matrix Organization, I can say that my preference between the two has been the Matrix Organization. Within the Functional Organization, the pro was that all tasks were spear headed by the…   Read more»

]]> 6053ac44af7ab512452a205a0f975130 https://medicaldevicecourses.com/activity/p/30177/ Sun, 17 Nov 2024 20:08:47 -0500 My company has used the FMEA document to analyze risks. Although we also do have the the Ishikawa Diagram (Fishbone Diagram) to analyze risk-the general preference for my company are the FMEA docs. I feel the FMEA docs are most…   Read more»

]]> ac8248a1d464b97157634f38662253c2 https://medicaldevicecourses.com/activity/p/30176/ Sun, 17 Nov 2024 19:59:04 -0500 @dbonanno1 exactly, agreed with what you stated here! I think its also important to note that the question of “What could go wrong with this product” should be applied to the SME’s. The SME’s are the subject matter experts of…   Read more»

]]> dd575760f53962c58a20ff83ac388c00 https://medicaldevicecourses.com/activity/p/30175/ Sun, 17 Nov 2024 19:48:40 -0500 Several others have made very valid points already in that using an Acceptance approach doesn’t necessarily increase risk. However, I think its very important to distinguish that using the Acceptance method generally implies there is very low risk to begin with…   Read more»

]]> 022c8c80e516cfb05cf1b966f6473b91 https://medicaldevicecourses.com/activity/p/30082/ Sun, 10 Nov 2024 14:56:43 -0500 As many others have said, it is important to conduct the human factor study if the device is to be used in the human body. Although the guidelines may be general regarding what’d needed for these studies, conducting these would…   Read more»

]]> e0e984e393ac4dc36d80f85be169905f https://medicaldevicecourses.com/activity/p/30081/ Sun, 10 Nov 2024 14:48:04 -0500 As others have mentioned here, meeting minutes are useful for keeping the team in the loop as to what was discussed in every meeting. This is true, however, typically the project manager would send out tasks and dates associated with…   Read more»

]]> 81501dfb8c720252353c152146e5b5cf https://medicaldevicecourses.com/activity/p/30080/ Sun, 10 Nov 2024 14:17:50 -0500 Verification vs validation can be tricky to understand sometimes. Sometimes its helpful to view it as a ‘what makes sense’ in that moment when it comes up to verifying or validating a device. One example I can think of that…   Read more»

]]> ae477533567076ec292241dbd0fa5730 https://medicaldevicecourses.com/activity/p/29947/ Sun, 27 Oct 2024 20:18:02 -0400 @krp67 To add onto this and emphasize you’re point; yes these drugs do need to go through animal trials first, but they then must be confirmed with human trials. As you mentioned, the human body is not exactly one to one…   Read more»

]]> 8a214496b0bc0de7edbdb10f2b145309 https://medicaldevicecourses.com/activity/p/29946/ Sun, 27 Oct 2024 20:10:26 -0400 A double blind study greatly improves the authenticity of the study results and removes bias from both and patient and Investigator involved. To give an example, if you provide a swatch of color to a person and ask what color…   Read more»

]]> 6f820eb7fd8fa7362c1b4b2a4d1297bd https://medicaldevicecourses.com/activity/p/29945/ Sun, 27 Oct 2024 19:57:10 -0400 Having a clinical background seems to be used as a filter by many companies to recruit talent with a certain background and make it so those who do apply without that experience and get in-are exemplary. From that perspective, I…   Read more»

]]> 7369a803728d5d5f98576318f30cda09 https://medicaldevicecourses.com/activity/p/29889/ Sun, 20 Oct 2024 20:38:26 -0400 As mentioned, several companies use different methods for advertising rather than traditional ‘tv’ or simple video advertising. Many companies used word-of-mouth, targeted mail-in offers, or offer discounts and benefits to their members when referring others to join.  Some companies like…   Read more»

]]> e1634dc7a9b940e622059de2e923d9b6 https://medicaldevicecourses.com/activity/p/29888/ Sun, 20 Oct 2024 20:21:30 -0400 Reading through the replies, there are several good points brought up like: the internet has changed to allow a higher range of products to be advertised, the easier expansion of your consumer base, the cutting of overhead costs as some…   Read more»

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