https://medicaldevicecourses.com/members/andres-86/activity/ Activity feed for Andy 86. Sat, 16 May 2026 10:34:20 -0400 https://buddypress.org/?v= en-US 30 hourly 2 9e902253e0a4ab4361110732d881e8ef https://medicaldevicecourses.com/activity/p/48690/ Mon, 04 May 2026 03:56:37 -0400 I believe the biggest way to avoid this situation is not necessarily to treat “meets dimensions” as the same thing as “meets specifications.” In the ouch simulation, the CamTech pouch physically fit the device, but the odor and toluene issue…   Read more»

]]> 0b07c4c9464fae6aa8449b27947e9c24 https://medicaldevicecourses.com/activity/p/48689/ Mon, 04 May 2026 03:52:00 -0400 For me, my biggest motivator is my family. I thrive on having a comfortable family home for her and I that we can be proud of, while also going to travel to other countries and experience what we can together….   Read more»

]]> 8c410d2286a336a1f19e489218c62c1b https://medicaldevicecourses.com/activity/p/48686/ Mon, 04 May 2026 03:45:55 -0400 From looking at the results listed, they don’t surprise me honestly. I think when someone thinks of their ideal or “dream” job, the reason is that it is both excited and challenging for them to do for most of their…   Read more»

]]> f2fd785ab0d2868e4cf5392105058c29 https://medicaldevicecourses.com/activity/p/47962/ Mon, 27 Apr 2026 03:58:24 -0400 I agree with your point, especially about how the outsourcing is not just about smaller companies lacking resources, but also about access to expertise and efficiency. Even if a company has the ability to run trials in house, I think…   Read more»

]]> 7d545ebb0417467a51987a466f09f6d3 https://medicaldevicecourses.com/activity/p/47960/ Mon, 27 Apr 2026 03:53:37 -0400 I think this is honestly a tough situation because at first you would be really motivated just from the excitement and passion of the project itself, but over time that lack of long term growth would start to catch up….   Read more»

]]> e140d89fa185ffdf78fc74322fa9be3f https://medicaldevicecourses.com/activity/p/47956/ Mon, 27 Apr 2026 03:45:33 -0400 I agree honestly that job satisfaction matters the most, but I don’t think it works entirely by itself. An employee could enjoy the actual work they do, but still leave if they feel underpaid, unsupported or even disrespected by their…   Read more»

]]> 3ed496176e42be145384b777642e207c https://medicaldevicecourses.com/activity/p/47248/ Mon, 20 Apr 2026 03:53:56 -0400 From a project management perspective, I think it is important to at least give teams a basic understanding of what everyone else is doing, even if deadlines are rather tight. It may seem like skipping that step saves time, but…   Read more»

]]> b12d535d25d01d6c3d0cb2dbe1cc6ae2 https://medicaldevicecourses.com/activity/p/47245/ Mon, 20 Apr 2026 03:46:51 -0400 An effective way to evaluate on how to develop a project team is to tie development directly to the project performance gaps. Instead of automatically trying to plan big team buildings events or expensive training sessions, one can look at…   Read more»

]]> 7c85ac4a2de6642981c49370aa5185ed https://medicaldevicecourses.com/activity/p/47240/ Mon, 20 Apr 2026 03:40:49 -0400 I think one of the first steps to this is to quickly analyze and identify whether the missing task is on the critical path, because that could determine how urgent the situation really is. If it is, then the priority…   Read more»

]]> a719d26b7d140e062dc9724f40109f14 https://medicaldevicecourses.com/activity/p/46506/ Mon, 13 Apr 2026 03:53:35 -0400 Some of the main reasons project cost increases are due to the following: scope creep, failed testing, supplier delays, and poor planning that can occur from the beginning of the project. In medical device development especially, one failed test in…   Read more»

]]> 90a0ac2973ec069629985fbbeb172677 https://medicaldevicecourses.com/activity/p/46504/ Mon, 13 Apr 2026 03:48:37 -0400 I agree that the budgeting and clinical studies are some of the hardest parts of a project, especially in medical device development where one failed study can have a delay on everything. Additionally, some of the most difficult parts is…   Read more»

]]> 4b5460671e4c32fa10bc61654ab6446e https://medicaldevicecourses.com/activity/p/46502/ Mon, 13 Apr 2026 03:38:23 -0400 A major factor that could affect schedule variance in a medical device project is the failure happening during verification, validation OR regulatory review. As an example: if a prototype fails biocompatibility testing or required documentation is incomplete, the team may…   Read more»

]]> 213cc0919cc36248c0284c77b481b09d https://medicaldevicecourses.com/activity/p/45164/ Mon, 30 Mar 2026 03:46:33 -0400 Delays or increased costs do not automatically mean that a project was unsuccessful, as others have mentioned. Many projects could encounter challenges or delays like supply chain issues, testing complications or changes in requirements that are outside of a team’s…   Read more»

]]> 9dcf3b9c5557af99d571a36834d9364b https://medicaldevicecourses.com/activity/p/45162/ Mon, 30 Mar 2026 03:38:54 -0400 Identifying the root cause of discrepancy between both internal and contracted verification and validation testing is something I agree with as the most important FIRST step. Additionally, reviewing the testing protocols and equipment utilized by both parties, companies would most…   Read more»

]]> f47a2f583ba35d2943ce1e0209ad9c22 https://medicaldevicecourses.com/activity/p/45161/ Mon, 30 Mar 2026 03:32:42 -0400 I agree that communication between the design and manufacturing teams is truly important during the transfer of design, especially when production demands begin to INCREASE. Additionally, it is an important aspect to consider that ensuring all manufacturing documentation is complete…   Read more»

]]> 758bf0265b6403d68e8e09c306a71052 https://medicaldevicecourses.com/activity/p/43851/ Mon, 16 Mar 2026 03:57:20 -0400 I think another important aspect during design transfer is making sure the manufacturing team really understands the product and how it is supposed to be built. During development the engineers usually assemble the prototypes themselves and they know the device…   Read more»

]]> 58ae2cfb8074f5fca6bd154cd289b79a https://medicaldevicecourses.com/activity/p/43850/ Mon, 16 Mar 2026 03:54:14 -0400 If this were to happen in the middle of validation, I think the first step would be to immediately document and record the defects and contact the vendor in order to start a root cause investigation into the matter. Since…   Read more»

]]> 6fb173d51b366774a6c23108f060c4f9 https://medicaldevicecourses.com/activity/p/43849/ Mon, 16 Mar 2026 03:48:14 -0400 A lot of points listed here I agree with, especially with increasing project risk just to shorten the schedule could be a dangerous path, especially in medical device development. In the miniSim example, reducing the animal study timeline significantly from…   Read more»

]]> 4d98d4748424afd4910f08fefb1f046e https://medicaldevicecourses.com/activity/p/43122/ Mon, 09 Mar 2026 02:59:00 -0400 While I think transparency is important, one practical reason finances might not necessarily be fully disclosed to a PM is that the budgets are often tied to a larger portfolio of projects and upper management might want flexibility to shift…   Read more»

]]> a8a4f7dafcaf23427a59ea6c9fc6beb8 https://medicaldevicecourses.com/activity/p/43120/ Mon, 09 Mar 2026 02:46:36 -0400 I believe early stage risk assessments should be prioritized because they help identify major hazards before significant time and resources are invested into development. I hear my self mimicking this sort of idea frequently as it is important not only…   Read more»

]]> eb2d94f50cf09490d84f5a23af31b20c https://medicaldevicecourses.com/activity/p/43116/ Mon, 09 Mar 2026 02:35:21 -0400 In real world projects, I think these line of phase processes act more as a framework rather than a strict sequence of steps, but alternatively they should still be linear in some fashion. As several others have mentioned, teams often…   Read more»

]]> 43ed80b318d9be6c37f3a9cab93cbc58 https://medicaldevicecourses.com/activity/p/42416/ Mon, 02 Mar 2026 04:17:47 -0500 A lot of great points raised, especially between padding tasks and building structured buffers. Slack management should also be aligned with regulatory risk and verification cycles. As an example, tasks tied to design verification, validation or supplier lead times could…   Read more»

]]> 81e7b9db20b85846afd306e11844be3b https://medicaldevicecourses.com/activity/p/42414/ Mon, 02 Mar 2026 04:02:09 -0500 Budget cuts indeed cause an impact on cost estimation, but I would say they also expose weaknesses in the original estimating process. In medical device development, especially with regulated products, cost estimation should already be included with contingency reserves that…   Read more»

]]> 43c09aba611d7b1cda6ac64c8aedbf33 https://medicaldevicecourses.com/activity/p/42412/ Mon, 02 Mar 2026 03:50:36 -0500 I agree with the emphasis on the prioritization of safety and regulatory compliance, although I believe there are other important balancing tools for the PM to utilize such as regulatory strategy integration. Rather than treating the FDA requirements as something…   Read more»

]]> 1bd3c0aadabce1e706cc9aab0db81c36 https://medicaldevicecourses.com/activity/p/41573/ Mon, 23 Feb 2026 02:00:59 -0500 There are a lot of points I agree with, especially those regarding neutrality, early intervention and structured conversations. A good approach would also be starting with an address to the issue quickly before it affects deliverables. Personally, meeting each person…   Read more»

]]> f106945a42df77757ce74cf1f695bda0 https://medicaldevicecourses.com/activity/p/41571/ Mon, 23 Feb 2026 01:52:09 -0500 The PM’s role does not fully shift from taskmanagement to compliance, but in medical device development, the two could become inseparable. Every task should generate objective evidence that feeds into the DHF, so managing activities and ensuring compliance occur in…   Read more»

]]> 5c0a1693c6e36fa35bd02fed8b8412aa https://medicaldevicecourses.com/activity/p/41570/ Mon, 23 Feb 2026 01:42:42 -0500 There is an appreciation to what is being said about having an emphasis on humility, documentation and risk management. I agree in regards that emotional intelligence is important when a phase needs to be reopened as well. In medical device…   Read more»

]]> ca12534b92920a24f0f6397d510bc453 https://medicaldevicecourses.com/activity/p/40746/ Mon, 16 Feb 2026 04:59:08 -0500 Understanding hiow the work is divided in a group project is crucial to ensuring both the efficiency and cohesion in the final version of the product. While assigning each individual person a separate section may promote accountability and speed, there…   Read more»

]]> 89f71cd7746c9d51bfb2e589091344b1 https://medicaldevicecourses.com/activity/p/40744/ Mon, 16 Feb 2026 04:56:06 -0500 I agree that in the real world, with a regulated environment in medical device development, there has to be a clear separation between roles while still maintain collaboration. The PM should not influence the verification outcomes, but they would absolutely…   Read more»

]]> 9d557e1e0c9194990877baefd213a372 https://medicaldevicecourses.com/activity/p/40742/ Mon, 16 Feb 2026 04:50:42 -0500 I personally lean towards the matrix organization, but with an emphasis on a balanced matrix. In biomedical and medical device structures, projects would require input from the regulatory, quality, R&D, manufactoring and marketing at the same time. The matrix structure…   Read more»

]]> d15c1633b8d952a4251d41f0c6907472 https://medicaldevicecourses.com/activity/p/39912/ Mon, 09 Feb 2026 04:56:29 -0500 I think overall in any project or mission, it is important to have a balance of the group size and the AMOUNT of groups as well. With that said, I like working in smaller groups due to the communication being…   Read more»

]]> fd4325ab0247ba1bb8bff688e00bea5d https://medicaldevicecourses.com/activity/p/39900/ Mon, 09 Feb 2026 03:22:24 -0500 I think the most important responsibility of the FDA is risk based protection for public health across the ENTIRE product lifecycle and not just the initial approval. While the safety and efficacy review before market entry is vital, their ability…   Read more»

]]> 3ecabe6c210945dc1864ee588b0237ab https://medicaldevicecourses.com/activity/p/39898/ Mon, 09 Feb 2026 03:11:04 -0500 In addition to verification/validation and post market surveillance, configuration and changes of management could help in the influence of a medical device’s product life cycle. As time goes on and there is maturation in the device, especially with devices that…   Read more»

]]> d890445318f0fdd805d86428a1b00d4d https://medicaldevicecourses.com/activity/p/38920/ Mon, 02 Feb 2026 04:19:44 -0500 For most projects, I prefer a smaller sized team (to me that would be around 4 to 6 people). Communication at this size is faster, the roles are clear and concise, and it is an easier task keeping everyone aligned…   Read more»

]]> 0b19e1db455b3b2e18ba4a3e9f72c5d6 https://medicaldevicecourses.com/activity/p/38910/ Mon, 02 Feb 2026 03:57:06 -0500 To me, it is crucial understanding ones own role because if a team is to work cohesively, everyone needs to play their part from the top down. It can be frustrating having to pick up the slack for someone who…   Read more»

]]> bed4367c302a70c3dea10f2b8af7d6f8 https://medicaldevicecourses.com/activity/p/38908/ Mon, 02 Feb 2026 03:49:57 -0500 There a lot of points already mentioned in this thread that I agree with, especially the shift of the project manager role once a device enters that post market phase. I think an aspect that has not yet been emphasized…   Read more»

]]> bd8fa3961973e3246b32524eaeafbcb7 https://medicaldevicecourses.com/activity/p/36979/ Mon, 26 Jan 2026 03:18:02 -0500 When a conflict between a project manager and a highly skilled member of the team arise, it’s important to understand there isn’t always a one size fits all. In one aspect, it depends on the competence of either member, but…   Read more»

]]> daf38123c4045cc8b375cb95841d2e16 https://medicaldevicecourses.com/activity/p/36976/ Mon, 26 Jan 2026 03:09:08 -0500 In regards to project management in medical devices, singling out one field as the best fit would be hard. It would be beneficial if some engineer (be it biomedical or other) would be a good fit, but the experience that…   Read more»

]]> 51dcd9d477e3adce5f603e557b05970d https://medicaldevicecourses.com/activity/p/36971/ Mon, 26 Jan 2026 02:37:12 -0500 When it comes to project managers on medical devices, it is important for them to have good analysis on systems coupled with a strong awareness for risks in the field. Biomedical projects and devices are not necessarily linear and certain…   Read more»

]]> b72e6efb3bece5f3400b866a3606395e https://medicaldevicecourses.com/activity/p/33724/ Mon, 17 Nov 2025 04:00:53 -0500 When answering this question, I am tempted to say that the risk should strive for a zero-chance, but that is impossible. Devices and products will always carry some risk, although they will be put to an acceptable level of risk…   Read more»

]]> 12ec29050a2c15c4c9c4569f8f2f03dd https://medicaldevicecourses.com/activity/p/33723/ Mon, 17 Nov 2025 03:47:41 -0500 There are a few conflicts that could arise when it comes risk management and the project team being involved in the same tasks. One is the distribution workload for the project. Having the same group work on two different sectors…   Read more»

]]> 28687e00ca35331503ca7e8b4031c904 https://medicaldevicecourses.com/activity/p/33722/ Mon, 17 Nov 2025 03:36:21 -0500 When discussing mitigation going “too far”, I think it is important to analyze whether a control is actually improving the device in an impactful or meaningful way, rather than just being work to place on a table for risk. Devices…   Read more»

]]> 3159aaf3189d00f2c02ce11f75494573 https://medicaldevicecourses.com/activity/p/33591/ Mon, 10 Nov 2025 02:30:22 -0500 Whether or not a company utilizes design controls as a tool or a checkbox ultimately comes down to their internal culture and the overall attitude within. Companies, whether big or small, that value accountability, learning, and growth will naturally treat…   Read more»

]]> cfae382f0025f5982642d985143ca234 https://medicaldevicecourses.com/activity/p/33588/ Mon, 10 Nov 2025 01:52:41 -0500 I think balance really can come down to defining the purpose for each document tier. Perhaps removing informal working logs or notebooks that are not officially updated changes in the DDP (such as design changes that affect verification, validation or…   Read more»

]]> 9ff62a42256355c21cd4799b6751515f https://medicaldevicecourses.com/activity/p/33579/ Mon, 10 Nov 2025 01:03:53 -0500 Similarly, as everyone has mentioned, I also believe that this incident (Therac-25) caused a fundamental rethinking and reshaping of how the industry approaches both software safety and design. With that said, it isn’t only just verification that is changing, but…   Read more»

]]> 4e0705998e1cad416062d2ab57534610 https://medicaldevicecourses.com/activity/p/33466/ Mon, 03 Nov 2025 03:57:20 -0500 Yes, I, along with a lot of others I am hoping, do feel safer knowing medical devices go through the verification and validation process not just now, but for the future as well. Off the top of my head, I…   Read more»

]]> 16e0155c1b3d20ffb977ec6ef0747cc3 https://medicaldevicecourses.com/activity/p/33463/ Mon, 03 Nov 2025 03:46:22 -0500 To me, balancing the user needs alongside business goals seems like a hard challenge to accomplish, although also an important part of the development process. From any viewpoint, the ideal position is that the device proposed not only is specified…   Read more»

]]> 625f77207ac260a6351f55447fc34d03 https://medicaldevicecourses.com/activity/p/33462/ Mon, 03 Nov 2025 03:37:31 -0500 While I don’t currently work in the medical device industry, the understanding and learning of the difference between verification and validation are essential and closely related cogs in the design control process. Verification is the involvement of checking that the…   Read more»

]]> b13e3655cd950d245fbf8d467959ede8 https://medicaldevicecourses.com/activity/p/33334/ Mon, 27 Oct 2025 01:36:33 -0400 The placebo effect is a great example of how phycological and physiological systems in our bodies are so deeply intertwined with each other. This makes it both a challenge and a learning opportunity in clinical research and study. Viewing it…   Read more»

]]> 946a2e4ae2fb72b0d0947a048afa1aaf https://medicaldevicecourses.com/activity/p/33329/ Mon, 27 Oct 2025 01:09:36 -0400 Biomedical engineers I believe play a significant role in clinical research and can be the bridge to piece a lot of aspects together. The background in the field has big focuses on design controls, systems thinking and even data analytics;…   Read more»

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