https://medicaldevicecourses.com/members/dev-doshi/activity/ Activity feed for Dev Doshi. Sat, 16 May 2026 08:55:09 -0400 https://buddypress.org/?v= en-US 30 hourly 2 32fec910daab2fe4d713b4b8fc04d57b https://medicaldevicecourses.com/activity/p/48687/ Mon, 04 May 2026 03:47:18 -0400 On April 24, 2026, the Trump administration fired all 22 members of the National Science Board, which is one of the governing bodies of the U.S. National Science Foundation (NSF). The National Science Board helps set the major funding for…   Read more»

]]> 76bd9556b8d3df0a2a9e2c7297927c2a https://medicaldevicecourses.com/activity/p/48683/ Mon, 04 May 2026 03:30:38 -0400 I think celebrating short-term victories and using small rewards helps keep the team motivated as well, as having rewards helps the team feel good about the work they have put in if it’s over a long period of time, since…   Read more»

]]> 273957e4c24d681b67ef68663b600a9c https://medicaldevicecourses.com/activity/p/48675/ Mon, 04 May 2026 03:08:44 -0400 I agree with what everyone has said so far about how to get a more diverse group to participate in clinical trials. However, I think more factors need to be considered. A major issue with “diverse recruitment” is that it…   Read more»

]]> e2b38f0de7f5ef531ad80a64302c334d https://medicaldevicecourses.com/activity/p/47811/ Sun, 26 Apr 2026 03:47:20 -0400 The PM definitely does have a large role in fully understanding the project and then applying this understanding to planning the clinical trials so it goes smoothly. However, I want to bring up other unpredictable aspects of clinical trials that…   Read more»

]]> d74da16ab40c1e72fd077ef621ff989d https://medicaldevicecourses.com/activity/p/47806/ Sun, 26 Apr 2026 03:25:46 -0400 I agree with what has been said so far in the thread, as taking legal action is a good last resort due to how long it takes and how many delays it can cause, and the vendor and other team…   Read more»

]]> c1d305fa0191b77e9cdc848a66cd9d2d https://medicaldevicecourses.com/activity/p/47805/ Sun, 26 Apr 2026 02:55:42 -0400 I agree with what everyone else has said so far, especially the information regarding the classes of recalls. I wanted to touch more on the deeper implications of a recall, as a recall shows deeper problems in the project itself….   Read more»

]]> 88d81a250c34f6367834466697aaa147 https://medicaldevicecourses.com/activity/p/47162/ Sun, 19 Apr 2026 19:03:58 -0400 I agree with what everyone has said so far, where the bottom-up budget is ideal, but certain situations require top-down budgeting. I wanted to open the floor to more nuanced conversations regarding budgets themselves, since the way the budget is…   Read more»

]]> 6109ef81d4b62b70ef320c66f25553d8 https://medicaldevicecourses.com/activity/p/46892/ Fri, 17 Apr 2026 00:54:16 -0400 I would like to bring in some nuanced perspectives from what has been said so far. I agree that there are certain things that should be completely disclosed to the public; however, I think the timing of the transparency matters…   Read more»

]]> cff4e4bbeebcab50d7ddaa30c6c2bfa5 https://medicaldevicecourses.com/activity/p/46889/ Thu, 16 Apr 2026 23:04:04 -0400 I agree with what njq3 has said about planning and surprises, as unexpected events can throw the trajectory of a project completely off course. Additionally, for planning, things like troubleshooting, the time it takes to coordinate, or back-and-forth in regulation…   Read more»

]]> d8d451c76fb818cbe536476028c8847c https://medicaldevicecourses.com/activity/p/46441/ Sun, 12 Apr 2026 19:34:40 -0400 I agree with what the previous posts are saying, as it truly depends on the situation and project context for what project management style will be the best fit. However, I have a more unique angle to bring. I think…   Read more»

]]> 3597aad87ae9d6cfea9effaa431613cb https://medicaldevicecourses.com/activity/p/46431/ Sun, 12 Apr 2026 18:40:35 -0400 I loved reading about the experiences that everyone has had with their work. I haven’t worked in a medical device company, but I have a different perspective from the people who actually use the medical devices from the big companies….   Read more»

]]> 53eb782e11fdf924e73be8b612adecd7 https://medicaldevicecourses.com/activity/p/45908/ Tue, 07 Apr 2026 07:03:10 -0400 I agree with all the responses so far. Verification checks whether the device meets the specifications that were outlined. This happens during development. Validation checks whether the device meets the user’s needs and happens closer to the end of the…   Read more»

]]> dd24525be328845dfb7cb4ab2501c312 https://medicaldevicecourses.com/activity/p/45054/ Sun, 29 Mar 2026 06:38:08 -0400 I think monitoring should not be treated as checkpoints, but instead be a system where you can stay up to date on how the project is going and predict roadblocks from the start. Dr. Simon always talks about feedback loops…   Read more»

]]> 7aecab9c472835a094f560c916c0ea27 https://medicaldevicecourses.com/activity/p/45053/ Sun, 29 Mar 2026 06:15:51 -0400 I like the questions that mmk68 poses, as this is a real issue that I have seen and encountered before. The first step to preventing major damage from a delay that is out of your control is for the PM…   Read more»

]]> d413cdb2ede1aab71b0ca4645fedbc4e https://medicaldevicecourses.com/activity/p/44582/ Tue, 24 Mar 2026 04:29:22 -0400   Most of the discussion so far has been about how the board of directors usually steps in at a high level. However, I think their real influence comes from how change is handled during a project. I agree that…   Read more»

]]> ecb5ae920be864fe75db30cab3a9e1dd https://medicaldevicecourses.com/activity/p/43725/ Sun, 15 Mar 2026 04:18:51 -0400 I think an extremely important aspect of project initiation is how uncertainty is communicated to the team. Analyzing which aspects of the project are uncertain is important, but communicating these uncertainties to the team and company is just as, if…   Read more»

]]> f83fb194b8de9dc7eb610c6a8bca4448 https://medicaldevicecourses.com/activity/p/43719/ Sun, 15 Mar 2026 03:41:52 -0400 One factor that has not been discussed is how learning curves can affect the cost and resource estimates. Many tasks in medical device development can involve processes that the team will be doing for the first time. This would require…   Read more»

]]> 0a473692b03d7ca4ad0b96b7ca04ea6e https://medicaldevicecourses.com/activity/p/43693/ Sat, 14 Mar 2026 23:06:24 -0400   I agree with the points regarding communication that have been mentioned so far. Something else I would like to add is that the PM has to make sure the technical work is being completed, along with maintaining a structure…   Read more»

]]> 3011c5422974b57966c5de0408a7a781 https://medicaldevicecourses.com/activity/p/42842/ Fri, 06 Mar 2026 08:51:00 -0500 The decision to go back to a previous phase is not based on a simple threshold of error. In real life, the discussion is about the cost of fixing the issue now versus the cost of allowing the issue to…   Read more»

]]> 3929178758716d8a83dd15d6635e6c77 https://medicaldevicecourses.com/activity/p/42841/ Fri, 06 Mar 2026 08:32:17 -0500 The way I think about the difference between the two is accountability versus coordination. Design controls are what establish the accountability for the device. Everything needs to be documented to prove that the device was developed responsibly. This includes the…   Read more»

]]> 2ac4e8b225f75ce6ed8f3924cc40dc82 https://medicaldevicecourses.com/activity/p/42839/ Fri, 06 Mar 2026 08:12:23 -0500 I agree with the points everyone has made so far. However, one thing I noticed is that everyone is assuming that falsification is happening intentionally. In a real-life situation, with capable leaders and team members, falsification may happen quietly and…   Read more»

]]> db84b08020e05f9f78c937dba1fe4456 https://medicaldevicecourses.com/activity/p/42288/ Sun, 01 Mar 2026 06:12:20 -0500 Most of the discussion so far has been about avoidance, but I want to bring into question whether avoidance is actually the dominant strategy in medical device development. Avoiding risk sounds ideal in theory, but in reality, many medical devices…   Read more»

]]> dda6dc76a395f2edbc417f5d44847f3e https://medicaldevicecourses.com/activity/p/42285/ Sun, 01 Mar 2026 05:28:03 -0500 I also agree that this qualifies as a major change in the device. If the EMA is questioning whether the current method to sterilize is safe and whether it changes the surface of the product, which you claimed is very…   Read more»

]]> 83a12097b2c72d9cf8a01e1723e93e02 https://medicaldevicecourses.com/activity/p/42264/ Sun, 01 Mar 2026 01:23:30 -0500 What I deduced from this week’s lecture is that slack is calculated flexibility that comes from understanding ES, EF, LS, and LF. Slack will be strategic if the PM understands how early and late times are derived from the network…   Read more»

]]> 8ce8ef5e942d41af7439bddb0b92ba33 https://medicaldevicecourses.com/activity/p/41419/ Sun, 22 Feb 2026 00:17:57 -0500 I love the examples that everyone has given so far! I want to build on this by directly connecting to project management tasks and seeing the FS and SF relations in play. I think your confusion comes from how both…   Read more»

]]> 72e6e3845ea8b038790bfd5d40457d3d https://medicaldevicecourses.com/activity/p/41417/ Sat, 21 Feb 2026 23:58:56 -0500 I think this question highlights how uncomfortable the reality is that if a project is technically feasible and can actually help the market in a specific clinical area, it does not immediately seem that the project has commercial viability. If…   Read more»

]]> 4e6c8676d7b4bf29797c6325512642c9 https://medicaldevicecourses.com/activity/p/41328/ Sat, 21 Feb 2026 06:49:02 -0500 What stood out to me from this week’s lecture slides is how different project management phases are from design control phases. In project management, the lecture discussed how phases can overlap and blend together, so there is no concrete, clear…   Read more»

]]> 608b509512713e024b16044e5b4a9a4a https://medicaldevicecourses.com/activity/p/40663/ Sun, 15 Feb 2026 20:57:55 -0500 I think one issue that has not been discussed enough is how developmental life cycles influence team behavior and risk tolerance, along with the timelines and documentation. The life cycles affect the humans who are bound by them. Teams often…   Read more»

]]> f0d2ffbc0b321eb036f0af6f1936f034 https://medicaldevicecourses.com/activity/p/40657/ Sun, 15 Feb 2026 20:02:40 -0500   I agree with how business needs and customer satisfaction are treated as separate priorities and should be intertwined when creating a plan. I think they should be embedded in the project proposal from the beginning. When customer needs are…   Read more»

]]> fcb1fe9cbfab1be74c7081d6085304fc https://medicaldevicecourses.com/activity/p/40646/ Sun, 15 Feb 2026 18:41:55 -0500 If I were the PM in this situation, I would take the results from the pre-clinical trials and definitely change the plan to address the situation. Continuing without making adjustments to the plan would be irresponsible. The first step I…   Read more»

]]> 7dbeeebd6b7f08c27fb5e9c6a49e1a3c https://medicaldevicecourses.com/activity/p/39330/ Wed, 04 Feb 2026 03:56:32 -0500 I think the optimal project management software should have intelligent automation and predictive analytics that all members of the team can use to see where the project is going, and also not have to waste time and energy on tasks…   Read more»

]]> 19526916ccc67123fe7df33b93db1b7c https://medicaldevicecourses.com/activity/p/39328/ Wed, 04 Feb 2026 03:32:00 -0500 I agree with how separating design controls and management can lead to issues with verification and validation. I think rushing these processes takes away the main point of verification, which is to make sure that the product itself works with…   Read more»

]]> aa9aaa1b65cb488433e0d2a860a2049f https://medicaldevicecourses.com/activity/p/39324/ Wed, 04 Feb 2026 01:49:57 -0500   I think design reviews and design changes are most important during the Check and Act phases of the PDCA cycle. The Check phase is important because it connects all the other phases of the design process together. With Check,…   Read more»

]]> 02b82c5de326308500710437cc15aed2 https://medicaldevicecourses.com/activity/p/38927/ Mon, 02 Feb 2026 04:35:05 -0500 One way to reduce “project myopia” is to connect the project lifecycle to the higher-ups at multiple points in the timeline. This ensures that the project is aligned with company goals and policies. In the lecture, it was discussed that…   Read more»

]]> 8faf6529ceb38ab5841ec0c2ccfcbd8f https://medicaldevicecourses.com/activity/p/38921/ Mon, 02 Feb 2026 04:20:20 -0500 You bring up good points about the submersion and drying times of the bottle label, since the timing is important for adhesion and how strong the adhesion is. With more time, more bonds can be made, allowing for a stronger…   Read more»

]]> 7196e97ec8a1e544c8b18c7c77ef0bb6 https://medicaldevicecourses.com/activity/p/38915/ Mon, 02 Feb 2026 04:08:41 -0500 The key theme across all these responses is that challenges in the regulatory section of project management must be addressed pre-emptively. Any issues must be predicted and prevented as opposed to reacting to the problems as they come up in…   Read more»

]]> f6b77adf6c3db7fa11b2a78e93a849aa https://medicaldevicecourses.com/activity/p/38869/ Mon, 02 Feb 2026 01:28:34 -0500 I think you make a good point about planning for uncertainty, since it is almost never possible for a best-case timeline for sure. This is especially applicable for Class II and III devices. One thing I would add is the…   Read more»

]]> 78afccd58001684b05b55d1af9fbaa3f https://medicaldevicecourses.com/activity/p/37002/ Mon, 26 Jan 2026 04:14:20 -0500   I currently work in a neuroscience lab that deals with the Protecadherin gene in the brain. This gene codes for the “molecular barcode” of each neuron, and this barcode is used to ensure that neurons make proper connections between…   Read more»

]]> f50d7c71323517de4d6d85d202118605 https://medicaldevicecourses.com/activity/p/36995/ Mon, 26 Jan 2026 03:56:46 -0500 I myself have not worked in industry yet, but I asked some family members who do about your question. PERT and CPM are used more implicitly in practice than their textbook form that you have mentioned above. A lot of…   Read more»

]]> 3b816376ae677cfc48b8ea09ac9e9537 https://medicaldevicecourses.com/activity/p/36986/ Mon, 26 Jan 2026 03:36:42 -0500 I like how it is very clear that continuous compliance is the main point regarding FDA “licensure.” From the standpoint of project management, this moves the focus from one approval milestone to continuous coordination across the company. Regulatory and project…   Read more»

]]> f668c41adae7a389376f6b7a20fd4995 https://medicaldevicecourses.com/activity/p/33632/ Wed, 12 Nov 2025 23:29:03 -0500 I think everyone here did a good job at breaking down the conceptual difference between hazards and hazardous situations. Something new I have to add is how time and device evolution should not blur the line between the two as…   Read more»

]]> 2fd0992d57df7778947a91ec1bc6f49c https://medicaldevicecourses.com/activity/p/33630/ Wed, 12 Nov 2025 21:15:07 -0500 I like how everyone emphasized how important structure, preparation, and inclusion is in risk management meetings. I want to talk more about the format of a meeting itself that can influence risk visibility. Dr. Simon talked about how risk management…   Read more»

]]> 32a550f052f66a0ca8bc84a75fbe86c6 https://medicaldevicecourses.com/activity/p/33628/ Wed, 12 Nov 2025 20:33:46 -0500 Everyone has brought up excellent points about Poka-Yoke and how it reduces errors on the production floor. However, something that no one has touched on yet is how Poka-Yoke can bridge the gap between manufacturing and compliance. Dr. Simon talks…   Read more»

]]> 765d9dd26cb1502b094e7ea62061b1e4 https://medicaldevicecourses.com/activity/p/33576/ Sun, 09 Nov 2025 22:32:28 -0500 I agree that design controls are more than a regulatory requirement in the sense that they are frameworks for quality and long-term communication. To answer Krish’s question, I think that smaller startups can gain a strategic advantage if they integrate…   Read more»

]]> ba06ef8f3726cdde82dd15dde388261e https://medicaldevicecourses.com/activity/p/33573/ Sun, 09 Nov 2025 22:10:38 -0500 I think everyone made great points regarding documentation, calibration, and clear communication between the Original Equipment Manufacturers and the Contract Manufacturer. Something that hasn’t been discussed yet, however, is ownership of data and traceability in validation. Modern validation is about…   Read more»

]]> 2ed5061f7298c3a201d9ec5cac2736f4 https://medicaldevicecourses.com/activity/p/33567/ Sun, 09 Nov 2025 20:42:15 -0500 I agree that the Therac-25 incident changed how we think about design controls; however, I think that the next “Therac moment” might come from overconfidence in verification rather than poor verification. ISO 13485 and IEC 62304 have made verification extremely…   Read more»

]]> b8d5f8be4516cd625e17b54749bf43b7 https://medicaldevicecourses.com/activity/p/33459/ Mon, 03 Nov 2025 03:20:03 -0500 I am in agreement with what everyone has said so far, especially regarding the points about how collaboration and regulatory boundaries are imperative. I also like the emphasis on how pre-planning can help avoid most conflicts before projects even begin….   Read more»

]]> a444eddd5fb00c5a6623b859a117e6db https://medicaldevicecourses.com/activity/p/33452/ Sun, 02 Nov 2025 23:17:10 -0500 I agree that verification and validation have distinct purposes that keep the design controls objective and therefore reliable. Verification makes sure the device gets the technical specifications down, and validation makes sure that those specifications are actually solving the user’s…   Read more»

]]> 159c4715eee81ca2ea3b04f6c6a630cd https://medicaldevicecourses.com/activity/p/33448/ Sun, 02 Nov 2025 22:15:20 -0500 I liked the point regarding maintaining consistent QC and QA in transferring design control. I also agree that there is great importance in maintaining traceability and documentation. Something that no one else has mentioned, however, is how the intent of…   Read more»

]]> 364ba7b8f89e46f5bc9b0ba7193f9f28 https://medicaldevicecourses.com/activity/p/33315/ Sun, 26 Oct 2025 06:49:59 -0400 I think biomedical engineers play a role in the entire feedback system that determines whether a clinical trial can evolve efficiently. In Dr. Simon’s materials, we can see how each subsystem of a process is reliant on controlled inputs and…   Read more»

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