https://medicaldevicecourses.com/members/jrc99/activity/ Activity feed for jrc99. Sat, 25 Apr 2026 02:14:09 -0400 https://buddypress.org/?v= en-US 30 hourly 2 94dae837c12f7a8c8a4711526ea22c5b https://medicaldevicecourses.com/activity/p/31457/ Mon, 28 Apr 2025 22:13:15 -0400 I totally agree that Failure Mode and Effects Analysis (FMEA) should have been incorporated. This seems like an immense oversight in product development. I think the project and the project team need stricter protocols since it seems too relaxed. The…   Read more»

]]> 906a665174c393e55504277fe6c385df https://medicaldevicecourses.com/activity/p/31456/ Mon, 28 Apr 2025 22:02:58 -0400 I think management needs to realize the importance of risk management and enacting contingency plans. Whatever can go wrong will go wrong. This is not to have a negative view on everything, but instead taking precaution in project development. Yes,…   Read more»

]]> 4a2951fe73d05d815b66b2bb5a8c7675 https://medicaldevicecourses.com/activity/p/31455/ Mon, 28 Apr 2025 21:44:47 -0400 To start, I think a project manager should reinforce and emphasis the original scope. Depending how long the project is, maybe some personnel forgot the details of the true scope. This is the first action to correct unforeseen problems. Address…   Read more»

]]> 1bc7c946d968cb1c8ad8cf3f95ce3a93 https://medicaldevicecourses.com/activity/p/31363/ Mon, 21 Apr 2025 21:02:04 -0400 I think incorporating Risk-Based Monitoring could be an effective way to maintain study qualities without sacrificing cost and timeline goals. The analytical data that RBM provides can identify points in clinical trials that pose the most risk. The risk at…   Read more»

]]> 15a49062b9010f58cc75249994f31501 https://medicaldevicecourses.com/activity/p/31362/ Mon, 21 Apr 2025 20:18:48 -0400 I have not come across a project where there was a lack of structured communication, but I think I have some thoughts on effective tools and strategies to remedy this. My first thought is to incorporate the RACI (Responsible, Accountable,…   Read more»

]]> 12a79bc0731a3312f56d8b8c4cb6c53e https://medicaldevicecourses.com/activity/p/31361/ Mon, 21 Apr 2025 19:53:48 -0400 I think keeping clear definitions of a deviation and a violation to all staff are necessary. Trained staff is better than untrained staff. Untrained staff that may not be able to classify something as a violation correctly increases the chances…   Read more»

]]> 0fabe818b8e51c502cf222d26c5e6f56 https://medicaldevicecourses.com/activity/p/31316/ Sat, 19 Apr 2025 16:42:53 -0400 I think using Failure Mode and Effects Analysis (FMEA) can be an effective approach to prevent errors, losses, or subsequent issues. It is a tool risk management would utilize to identify how the project may fail and assess the severity…   Read more»

]]> a88cded20f1c438ba7e8f95fa6677df2 https://medicaldevicecourses.com/activity/p/31298/ Wed, 16 Apr 2025 18:58:23 -0400 I think it is very important to bring up these past situations so the future generations can continue to learn to avoid such disasters. In medical device development, safety to the patients are of most importance and it is one…   Read more»

]]> be58d7c73e2034cec05d0fa06e29db4c https://medicaldevicecourses.com/activity/p/31295/ Tue, 15 Apr 2025 19:09:49 -0400 I definitely agree with the last post that using a hybrid method using both analogous and bottom-up estimation methods is an effective approach. I think to confront the uncertainty aspect in a project, integrating the risk management team with their…   Read more»

]]> bc8c8d769f6f3d45051da6cb082923df https://medicaldevicecourses.com/activity/p/31238/ Fri, 11 Apr 2025 03:36:36 -0400 I think that cases like these really highlight how project development errors can affect stakeholders so strongly. Many parties will suffer because of something like this. The stakeholders that suffer the most are the customers/patients that use these products. Errors…   Read more»

]]> a8babb8dadfcd502972e3417823944f4 https://medicaldevicecourses.com/activity/p/31224/ Tue, 08 Apr 2025 21:32:24 -0400 As the last post mentions, FMEA is a great and effective decision-making framework to use in such a scenario. It is extremely effective because it presents data to help calculate a risk priority number (RPN). This is an easy way…   Read more»

]]> 1054dfbadedc92ae019b9dcd5703385c https://medicaldevicecourses.com/activity/p/31216/ Mon, 07 Apr 2025 19:56:43 -0400 I think the aspect of sharing unfinished designs can be improved. Even though sharing a successful idea can boost the morale of the team, it can be just as devastating if one small thing goes wrong. Therefore, I think it…   Read more»

]]> f257854b97f65f5c8fc1b4cba31add1d https://medicaldevicecourses.com/activity/p/31162/ Sat, 29 Mar 2025 02:18:14 -0400 I think a way project teams ensure that they measure relevant metrics is to focus on measurements pertaining to regulatory demands, validation and verification milestones, and risk management. Also, making frequent measurements can help monitor performance in these areas of…   Read more»

]]> 0b763c7e19f9d4b62d0ac61d65e117c8 https://medicaldevicecourses.com/activity/p/31129/ Mon, 24 Mar 2025 21:28:38 -0400 Using the information about EV, PV, and AC, I think could pose a risk if it is not paired with any other form of analysis. EV, PV, and AC are surface level ways of telling you that the project is…   Read more»

]]> 2b37f02200ac071ec4c79c69848b24ad https://medicaldevicecourses.com/activity/p/31128/ Mon, 24 Mar 2025 21:01:52 -0400 Organizations can strike the right balance between maintaining control and allowing flexibility for creative problem-solving and adaptation by incorporating quick responses from the CCBs. Agile review on these potential changes helps expedite the process during project development. It would prove…   Read more»

]]> 1e0e54d2e9e65a2856aeff92733a9ff2 https://medicaldevicecourses.com/activity/p/31054/ Fri, 14 Mar 2025 19:56:26 -0400 I think a great approach to fix the potential problems from each extreme side is to incorporate two ways of communicating informational updates. For information that does not require questions and in depth talks, it can just be put into…   Read more»

]]> df32a7680d36bcbb28e41ca251e80600 https://medicaldevicecourses.com/activity/p/31031/ Tue, 11 Mar 2025 19:19:59 -0400 I think project managers can strike the right balance between providing enough information without overwhelming stakeholders through two methods. The first method would summarizing the updates effectively. Sometimes the parties involved in the project do not need every exact detail…   Read more»

]]> b6953ff50027648d2a168573b618dcd9 https://medicaldevicecourses.com/activity/p/31026/ Tue, 11 Mar 2025 02:43:09 -0400 I think the biggest challenges in achieving scope verification are managing the communications between all team members and stakeholders in the project. Scope creep is the result of missing or lack of communication between people involved in the project. A…   Read more»

]]> db2646ce08681c284b5b377e8abc6598 https://medicaldevicecourses.com/activity/p/30958/ Wed, 05 Mar 2025 01:58:12 -0500 Using an agile and stage gate hybrid approach would require checkpoints throughout the project timeline. This keeps all the personnel in the project in line with the project goals. Also, the team can pivot quickly to fix an issue with…   Read more»

]]> eb18fd3e2ba0a0f2b93f266bba4f5cc3 https://medicaldevicecourses.com/activity/p/30950/ Tue, 04 Mar 2025 04:09:44 -0500 A major strategy to ensure that all stakeholders stay aligned is by everyone acknowledging who is responsible for certain tasks in a project. Tools can be used in parallel like a Gantt chart and a RACI (Responsible, Accountable, Consulted, Informed)…   Read more»

]]> 325e83e55939ff4fb342c71252876d27 https://medicaldevicecourses.com/activity/p/30949/ Tue, 04 Mar 2025 02:17:24 -0500 I think the best answer definitely depends on the overall size of the project. In this case, I feel like a liaison assigned to FactoSet could work since the project is not as complex. This is just one person and…   Read more»

]]> ead51d78c930b7be39629a65891df5c1 https://medicaldevicecourses.com/activity/p/30867/ Tue, 25 Feb 2025 05:07:57 -0500 Medical device projects definitely should utilize cost estimation effectively and efficiently. A way to do that is investigating a project that was highly similar to the current project you are working on. Medical device projects deal with FDA regulation procedures…   Read more»

]]> 35baa2903198cfa5a9b88487504d9319 https://medicaldevicecourses.com/activity/p/30863/ Tue, 25 Feb 2025 04:33:42 -0500 A Work Breakdown Structure (WBS) is definitely a useful tool in a project, especially when it comes to medical devices. Most of what I am about to say definitely depends on the size of the project since the complexities of…   Read more»

]]> f9244214f47890af5e8db2b3f677abfb https://medicaldevicecourses.com/activity/p/30858/ Tue, 25 Feb 2025 01:32:29 -0500 These certifications are definitely useful in building your resume and marketability. Employers will be more keen in hiring someone with more project management knowledge and experience. The Google PMP is a newer certificate available on a more broad scale to…   Read more»

]]> b18e79eeef894351e861a11f24e41941 https://medicaldevicecourses.com/activity/p/30828/ Mon, 24 Feb 2025 01:41:18 -0500 Risks are present in the project life cycle in different forms. It is up to the project managers and or the risk management team to assess, evaluate, manage, and measure the risks. If the probability of the risk becoming a…   Read more»

]]> 43fef0ca7db2f6960b99f12916a21e34 https://medicaldevicecourses.com/activity/p/30796/ Thu, 20 Feb 2025 01:34:08 -0500 Early start (ES) and early finish (EF) can be helpful in scheduling flexibility and resource planning. In terms of scheduling flexibility, ES helps the team know the earliest date the task can start and helps prepare for the task that…   Read more»

]]> f4b044f2cd9d8a54bd7ad6172b6a72b9 https://medicaldevicecourses.com/activity/p/30794/ Thu, 20 Feb 2025 00:10:12 -0500 Gantt charts can be a useful tool in all stages of designing a medical device. Pros of using Gantt charts is that they identify which tasks have slack and which tasks are on the critical path. Tasks that have slack…   Read more»

]]> 94b5f0bcfdc722fe69733b516b4147f6 https://medicaldevicecourses.com/activity/p/30722/ Fri, 14 Feb 2025 23:18:43 -0500 As the week comes to an end, the groups are wrapping up their proposals to Dr. Simon and starting the simulation report. This simulation gave groups a good feel on how to modify a verification tests for labels that were…   Read more»

]]> 0f952fdf0a7863711030fd38f03ffd1d https://medicaldevicecourses.com/activity/p/30717/ Fri, 14 Feb 2025 05:10:00 -0500 1eacefc676f3b4ee215eb41ddd06f538 https://medicaldevicecourses.com/activity/p/30716/ Fri, 14 Feb 2025 05:09:58 -0500 a83c578b99fa4e356e6f09a6a68b73a0 https://medicaldevicecourses.com/activity/p/30715/ Fri, 14 Feb 2025 05:09:57 -0500 58e54e0a16968f713a3bedd921025733 https://medicaldevicecourses.com/activity/p/30714/ Fri, 14 Feb 2025 05:09:33 -0500 Keeping all these details in mind, I think a balance of both perspectives can be valid depending on the product and the function of that product. Mimicking worst case scenarios helps combat Murphy’s law as much as possible. It is…   Read more»

]]> b1c7b997400a3c15ac1e7e3cb41890e2 https://medicaldevicecourses.com/activity/p/30703/ Wed, 12 Feb 2025 21:06:06 -0500 The Design Input Document (DID) and Design Specification Document (DSD) are procured during the PDCA cycle of a project. The first document being a more brief overview of the inputs and basic details what they want the product to have….   Read more»

]]> 7f411536aec69ffccba292985bb084e2 https://medicaldevicecourses.com/activity/p/30619/ Fri, 07 Feb 2025 02:24:54 -0500 Design change requests in medical device development are definitely a challenge I agree. An idea on how a company can handle these change requests is finding primary and back up options for the parts/materials they will be using for the…   Read more»

]]> d506061df795abf715b0a963798e52ac https://medicaldevicecourses.com/activity/p/30604/ Tue, 04 Feb 2025 21:37:19 -0500 I think the previous post has made some excellent posts and definitely highlights the potential problems with this exemption program from the FDA. However, even with all of these points stated, I feel this is still a program that can…   Read more»

]]> 7acdd99d35ba54d22996c6b210e25d87 https://medicaldevicecourses.com/activity/p/30601/ Tue, 04 Feb 2025 20:24:02 -0500 I agree that companies can utilize techniques to create a DDP that is both structured but flexible such as a Gantt chart. Gantt charts are great at keeping your team informed about the development progress. It also helps identify which…   Read more»

]]> 5c4a7703bce4c48eb603fd996c5737c9 https://medicaldevicecourses.com/activity/p/30563/ Mon, 03 Feb 2025 01:10:52 -0500 @bryan-xavier Your information about the Breakthrough Devices Program definitely changed my own view about this topic I created. When I found out about this certain predicament from Dr. Simons lecture, my thoughts were pretty set on that medical device innovation…   Read more»

]]> 19fc52c12b0d175c5571e67778e700c3 https://medicaldevicecourses.com/activity/p/30561/ Mon, 03 Feb 2025 00:52:08 -0500 17a4711bb09179d7f19dce9961e51ef5 https://medicaldevicecourses.com/activity/p/30560/ Mon, 03 Feb 2025 00:52:06 -0500 6ffebe4ab2ce01c35e4d74e49a1074ac https://medicaldevicecourses.com/activity/p/30559/ Mon, 03 Feb 2025 00:52:05 -0500 287e77e87ad2b9224547ccb03ade8f07 https://medicaldevicecourses.com/activity/p/30520/ Wed, 29 Jan 2025 20:43:37 -0500 In Dr. Simon’s Week 2 Lecture, there are mentions of caution and avoidance of creating new devices that require a PMA. A PMA (Premarket Approval Application) does not allow a new device to use the substantially equivalent claim and clinical…   Read more»

]]> 0ba3379f3a613c413755ce9543e48c49 https://medicaldevicecourses.com/activity/p/30515/ Tue, 28 Jan 2025 22:56:27 -0500 I agree with the previous claims of underestimating regulatory requirements from the start. To add to that, picking the wrong classification of your medical creation will certainly create problems. Your potential product will fall under a single or a combination…   Read more»

]]> 94421a5d9d871300377fbedced5c64d0 https://medicaldevicecourses.com/activity/p/30455/ Mon, 27 Jan 2025 01:20:44 -0500 I think the biggest challenge out of the triple constraint is scope. Scope has to be almost perfectly planned out before the medical device development, especially before FDA approval. The scope needs to be definitive. If it turns out the…   Read more»

]]> 55612a4c347f4b45f5d8ed9329673eac https://medicaldevicecourses.com/activity/p/30454/ Mon, 27 Jan 2025 01:20:44 -0500 I think the biggest challenge in managing medical device projects is regulatory hurdles. Regulatory hurdles can put a heavy impact on your medical device development cycle. For one, it costs a lot of money to submit these regulatory applications. Depending…   Read more»

]]> 8d11b7b8de25acd6a73fd097aeda2da8 https://medicaldevicecourses.com/activity/p/30453/ Mon, 27 Jan 2025 01:20:43 -0500 I agree for the most part that regulatory process may be a big risk in the medical device project management. However my opinion is more that the technical, financial, and regulatory risks are more equally present and intertwined with each…   Read more»

]]> a2730e40967d3e835c3ae9a3eda7cf6d https://medicaldevicecourses.com/activity/p/30449/ Mon, 27 Jan 2025 00:27:20 -0500