https://medicaldevicecourses.com/members/jacobchabuel/activity/ Activity feed for JacobChabuel. Sat, 25 Apr 2026 03:48:56 -0400 https://buddypress.org/?v= en-US 30 hourly 2 9e9d4383338ee790ee8376b9a669701e https://medicaldevicecourses.com/activity/p/46984/ Fri, 17 Apr 2026 23:02:34 -0400 I definitely experienced scope creep during my capstone project as many others have also shared here. An initially simple project turned out to be a logistical nightmare as our troubleshooting and efforts to fix the issues in the project were…   Read more»

]]> 8092fc24b4e05bd6806ce714359ae0b9 https://medicaldevicecourses.com/activity/p/46981/ Fri, 17 Apr 2026 22:30:59 -0400 I think this is a very situational question as others before me have suggested. I think that it very much depends on who is on your teams and what each team member is capable of. I think in general it…   Read more»

]]> 956ef4bc8210570e98bea90a1a617ed5 https://medicaldevicecourses.com/activity/p/46979/ Fri, 17 Apr 2026 22:13:38 -0400 This weeks slides showed us that the medical device field hinges on regulatory and legal requirements. This including patient protections and design controls. In terms of integration management, the slides state that the responsibility of a PM is to determine…   Read more»

]]> 077cff2e1f09a19b34a31e40b5bf6943 https://medicaldevicecourses.com/activity/p/46388/ Sun, 12 Apr 2026 07:03:59 -0400 Conflict resolution is something I have to facilitate a lot in my current job. In general, I find that the best solution to conflict resolution is taking the role of a mediator who hears the concerns of both parties and…   Read more»

]]> 51331e68a67c66772dfde4af7f7321ab https://medicaldevicecourses.com/activity/p/46386/ Sun, 12 Apr 2026 06:31:28 -0400 I luckily have never had the experience of someone involved on my project signing off on a product that has yet have verification tests completed, however as others have said this is a very concerning situation. This is not only…   Read more»

]]> 3ba5559071ec2327059f8adc9c2a14a8 https://medicaldevicecourses.com/activity/p/46377/ Sun, 12 Apr 2026 05:25:38 -0400 I don’t know if I personally can comment on what the ratio of positive and negative aspects are in the instance that a project is successful but faces setbacks. I think at the end of the day, every project is…   Read more»

]]> c0d5d3a983f851e17b2c1dcf3f456d28 https://medicaldevicecourses.com/activity/p/45120/ Sun, 29 Mar 2026 22:18:28 -0400 The power of the board of directors in a project lifecycle is absolute, and they hold the ability to terminate or freeze projects for budgetary or scheduling concerns. As others have mentioned, the board essential acts as an oversight committee…   Read more»

]]> fae709e00affccf8bd9964fa5b5631dd https://medicaldevicecourses.com/activity/p/45118/ Sun, 29 Mar 2026 21:52:55 -0400 You can reduce the fatigue experienced by your project team by preventing the need for change to occur in the first place. Now, speaking objectively you can only do so much to prevent the need for change. As others have…   Read more»

]]> 09c5eefa513d3740e8180d3eace1f81c https://medicaldevicecourses.com/activity/p/45108/ Sun, 29 Mar 2026 20:35:01 -0400 I absolutely have encountered this issue during capstone and for my thesis project. In both cases, this involved a machine failure. These issues would have been catastrophic for the project as both a thesis and our capstone were time sensitive…   Read more»

]]> 0195e1b4cb696e474d1f935bc21be69a https://medicaldevicecourses.com/activity/p/43798/ Sun, 15 Mar 2026 20:09:36 -0400 Everyone has made very valid points regarding this topic. I am a very firm believer in proper communication to achieve goals and address any issues in the lifespan of a project. If a team member was producing lackluster work, I…   Read more»

]]> 5ffc370b6555d21a0d93012946d20b7a https://medicaldevicecourses.com/activity/p/43795/ Sun, 15 Mar 2026 19:39:34 -0400 In my experience, I think that review meetings are the most important for plan execution. It ensures that all members of the team are informed on project progress and are aware of deliverables that are expected of them. Status reviews…   Read more»

]]> 4a41ea9cc152d219f9ec79c3c6bbcb01 https://medicaldevicecourses.com/activity/p/43790/ Sun, 15 Mar 2026 19:17:18 -0400 @dev-doshi Hey Dev, I think this is a very insightful response! To answer your questions, starting with stakeholders risk tolerance I think the amount of uncertainty that stakeholders are willing to accept is dependent on the organization. Large corporations likely…   Read more»

]]> 9f7a3c953f75d8f7d56d5431796bfb26 https://medicaldevicecourses.com/activity/p/42908/ Sat, 07 Mar 2026 03:32:26 -0500 General sentiment shared amongst the responses is that there is a threshold where monitoring becomes micromanagement of the team and I would agree. I think a good way to contextualize when this line is crossed is when typical quality assurance…   Read more»

]]> 6c539fd3f20c4b3125dc3de3c324a87c https://medicaldevicecourses.com/activity/p/42892/ Fri, 06 Mar 2026 23:40:33 -0500 I think one of the things I would consider as a PM in this instance is to consult the members of my team who would have more specialization in testing and validation. As a PM its good to have knowledge…   Read more»

]]> 37512ff8ba150c73250f2c00ce672a08 https://medicaldevicecourses.com/activity/p/42890/ Fri, 06 Mar 2026 23:05:43 -0500 @bryan-xavier I one hundred percent agree that peer mentorship and knowledge sharing is beneficial to fostering a successful project. Apart from our advisor on our capstone project, we also collectively shared a peer mentor who guided us through certain aspects…   Read more»

]]> 4a486b3e5b17823e2a13ffd228af417a https://medicaldevicecourses.com/activity/p/42385/ Sun, 01 Mar 2026 23:22:47 -0500 PMs as you stated should definitely prioritize safety not only to protect the brands reputation, but to also ensure the safety of the products for the consumers. Shareholders may express concerns or frustrations over delays especially if the investments were…   Read more»

]]> b7aabddff7165e99fc9bb17eaabbfaa1 https://medicaldevicecourses.com/activity/p/42372/ Sun, 01 Mar 2026 22:17:21 -0500 Cost and resource estimation can be an challenging aspect of project planning for any industry. As the lecture this week pointed out, the planning phase involves going through individual tasks within the WBS structure to determine where to allocate costs…   Read more»

]]> 5917701c73e49c539c3ea653fd58e36f https://medicaldevicecourses.com/activity/p/42369/ Sun, 01 Mar 2026 21:38:03 -0500 It can be argued that the work breakdown structure or WBS is one of the most fundamental tools in project management. In the case of medical device development, the WBS is unique as it not only has to account for…   Read more»

]]> 6b2f50ed496712ecc3b0c5b6f2bf161f https://medicaldevicecourses.com/activity/p/41027/ Wed, 18 Feb 2026 18:08:09 -0500 Medical device development is more complex than typical project management in the sense that the PM must manage the Design History File which includes non negotiable aspects of the project. As we learned from lecture this week, the PM processes…   Read more»

]]> 4e2621a42f1fca3b47d04c62aa9eac8d https://medicaldevicecourses.com/activity/p/41019/ Wed, 18 Feb 2026 17:14:05 -0500 I recently had a discussion with a supervisor where we both weighed the importance of certifications and degrees. Higher education degrees often offer broad strategic lens where as certifications (especially industry recognized certifications) are valued for the immediate technical proficiency…   Read more»

]]> 38a8b772b7a02232e8ff72e1f368fd97 https://medicaldevicecourses.com/activity/p/41014/ Wed, 18 Feb 2026 16:08:15 -0500 Hey everyone my name Jacob Chabuel and I am a thesis option Biomedical engineering student at NJIT. My undergraduate degree was also in BME with concentration in biomaterials. Here’s my LinkedIn profile: http://www.linkedin.com/in/jacob-chabuel-0950a1299Looking forward to connecting with others in and out…   Read more»

]]> d64846316790c299d663c6cf038b7d27 https://medicaldevicecourses.com/activity/p/40533/ Sat, 14 Feb 2026 16:25:38 -0500 One thing that I think is worth mentioning and I haven’t really seen brought up yet is the fact that product life cycles can really be influenced by technical debt. For example, companies may have invested so much money and…   Read more»

]]> d93c8d610adc5cedec35f7c6cd48c019 https://medicaldevicecourses.com/activity/p/40421/ Fri, 13 Feb 2026 16:18:47 -0500 Suppose you are the project manager for a class III device, a bio-absorbable vascular stent. The current strategy is to introduce this device to market that dissolves quicker than the industry standard. During pre-clinical trials, the results demonstrate that the…   Read more»

]]> 1c84db334b424e092b89363bef0e9049 https://medicaldevicecourses.com/activity/p/40417/ Fri, 13 Feb 2026 15:50:05 -0500 I was a bit confused on the wording of this post but I’m assuming you meant making modifications to a previously existing medical device. From my understanding, the FDA does not require a total re-evaluation of a device in that…   Read more»

]]> 6c04352ad2545905f89758927f4d06f9 https://medicaldevicecourses.com/activity/p/39276/ Tue, 03 Feb 2026 15:43:51 -0500 In the lecture this week we discussed both aspects of design controls and project management in the life cycle of a project. It is emphasized that the design controls of the project and project management should overlap with shared documents,…   Read more»

]]> 257159cd9b6dee7786adedf4d3f5d311 https://medicaldevicecourses.com/activity/p/39227/ Tue, 03 Feb 2026 05:09:43 -0500 I think the best project management software ideally would integrate scheduling tools, have some form of traceability, or be able to reference deliverables such as important documents or design files. That being said, I do not think there is one…   Read more»

]]> cbf6796526d0f68ff1597d0a0ec16fa7 https://medicaldevicecourses.com/activity/p/39217/ Tue, 03 Feb 2026 02:40:44 -0500 Medical device development is reliant on organization and structure in order to produce a successful product. These structured processes can include design reviews, design changes, and the PDCA cycle. In addition to this, project managers throughout the course of a…   Read more»

]]> bd0069c2d05c345e2b7ffa1dfc3f293f https://medicaldevicecourses.com/activity/p/37733/ Wed, 28 Jan 2026 23:23:45 -0500 Pulling from my experience as a Resident assistant, a big part of our job as a leader is to deal with conflict resolution or handling certain situations. A big thing that I try to do in these scenarios where conflict…   Read more»

]]> df57db6b0a66aae7f4c29285382c1469 https://medicaldevicecourses.com/activity/p/37709/ Wed, 28 Jan 2026 22:10:54 -0500 In this weeks lecture, we discuss in depth the role of the regulatory department after a project has been completed and is now an available medical device on the market. The regulatory department is responsible for maintaining documentation, maintaining readiness…   Read more»

]]> 4d2d59778fb15a0312540e7ef5013963 https://medicaldevicecourses.com/activity/p/37698/ Wed, 28 Jan 2026 21:10:55 -0500 I agree with Vansh to some extent in that the Regulatory Affairs Specialist is the team member that more closely works with the FDA and creates the legal strategy when dealing with them. That said, it is still the PMs…   Read more»

]]> 82c771be9d05eb386d43e76076629dfb https://medicaldevicecourses.com/activity/p/36293/ Fri, 23 Jan 2026 15:51:26 -0500 I think the thing that makes the project management role so interesting is that you do not necessarily need to have a deep level of understanding in one particular field or discipline. I find that the best project managers are…   Read more»

]]> 08d9f2ad86fb2b6808e3069c2ebc41b7 https://medicaldevicecourses.com/activity/p/35827/ Wed, 21 Jan 2026 22:55:05 -0500 As we are aware, Biomedical projects are often faced with tight deadlines, regulatory requirements from the FDA, and collaboration amongst different teams with varying backgrounds. In this sense, the project manager taking on a Biomedical project has to manage all…   Read more»

]]> 1c4b9c4f5fe0f2838a4e9f5f395a3640 https://medicaldevicecourses.com/activity/p/35811/ Wed, 21 Jan 2026 21:55:30 -0500 Taking away from my personal experience, I think there are several different ways to ensure that communication is properly established amongst a team. Drawing from my experience as an RA, the best communication occurred within our teams when we were…   Read more»

]]> e06cf1dc243faef77fd0b3d13eb528ec https://medicaldevicecourses.com/activity/p/33677/ Sat, 15 Nov 2025 04:54:09 -0500 Going based on of the question proposed in the title of this post, Risk assessments are absolutely necessary for medical devices. Risk analysis or assessments are required not only in the US by the FDA, but also in the EU…   Read more»

]]> 728cadf90462a5f0b9bed23108ff1328 https://medicaldevicecourses.com/activity/p/33675/ Fri, 14 Nov 2025 22:50:18 -0500 As was already said before me, I think it is virtually impossible to completely eliminate risk. Even using a medical device in perfect conditions and following intended use protocols to a tee, there is still a possibility for risk to…   Read more»

]]> 0abfb385a31aebd80db82b528f7dbf14 https://medicaldevicecourses.com/activity/p/33651/ Fri, 14 Nov 2025 18:48:05 -0500 I believe that in most scenarios it is ideal for the risk management team to be made up with members of the project team and those that belong to the risk management department. The individuals that are on the project…   Read more»

]]> 0d30af98e671d139ec9362559dcd6114 https://medicaldevicecourses.com/activity/p/33551/ Sat, 08 Nov 2025 22:39:51 -0500 To answer your question, I do not believe it possible to entirely predict all real world failures of medical devices. The core problem of design controls is that they are created with what the designers or creators anticipate to occur…   Read more»

]]> 22bea56eea685e972eeed900aff1937a https://medicaldevicecourses.com/activity/p/33520/ Thu, 06 Nov 2025 01:18:53 -0500 In reference to the title of the question, I do not think that there should necessarily a winner in regards to whether user needs or engineering viability are more important. The teams should instead come together and collaborate discussing what…   Read more»

]]> 4d7e29bb42746904ab2b74938e0b88bc https://medicaldevicecourses.com/activity/p/33518/ Wed, 05 Nov 2025 18:30:23 -0500 I believe that you make a great point that the constant updating of the documents contents can become very confusing or lead to an overload of information as you say. The most important thing to do in this instance to…   Read more»

]]> 29d605d53bcd117e701a5ba0a55aafab https://medicaldevicecourses.com/activity/p/33400/ Sat, 01 Nov 2025 04:01:45 -0400 User needs are often qualitative, for example the customer may want the device to be a specific dimension, or may want the device to be easy to clean. Regulatory compliance however demands that Design Inputs have to be quantitative, objective,…   Read more»

]]> c31b1a621ac4bc55827758da5edfcec0 https://medicaldevicecourses.com/activity/p/33395/ Sat, 01 Nov 2025 01:25:56 -0400 Teams can establish when they have done enough reviews by following the framework they initially created at the beginning of their design process. To ensure success, teams should plan to have a design review at each major milestone during the…   Read more»

]]> dda7001761606e5407e7d7bc286d9b75 https://medicaldevicecourses.com/activity/p/33393/ Sat, 01 Nov 2025 00:38:35 -0400 I think that design controls ultimately help innovation because they make the design process more sustainable and efficient in the long run. Checkpoints such as design reviews allows the creator to ensure that the device is working as intended and…   Read more»

]]> aafa4516c9403a6a27bbe54ad34b8d04 https://medicaldevicecourses.com/activity/p/33255/ Wed, 22 Oct 2025 22:39:55 -0400 Clinical research is a a complex multidisciplinary process that takes collaboration amongst clinicians, researchers, regulatory experts, and engineers. As biomedical engineers, we apply design principles, data analysis, and systems thinking to medical device intervention. Engineers can perform data interpretation, patient…   Read more»

]]> 3d301411fd6992b991758b7e9528d959 https://medicaldevicecourses.com/activity/p/33254/ Wed, 22 Oct 2025 21:46:39 -0400 I think one the most obvious reasons for participants to volunteer or willing join a clinical study is the financial compensation (or equivalent) they may receive for their time in the study. Not all studies, but some do provide participants…   Read more»

]]> 0ba2ca0c4746d8c8cd4014eb630dcaeb https://medicaldevicecourses.com/activity/p/33253/ Wed, 22 Oct 2025 20:52:03 -0400 I think whether or not you need a clinical background in this specific field is highly dependent on the role you are taking. For example principle investigators certainly should have clinical experience or come from a clinical background. These individuals…   Read more»

]]> 7817bf38a6c64d59f582599b6e7e5391 https://medicaldevicecourses.com/activity/p/33174/ Thu, 16 Oct 2025 22:04:44 -0400 As mentioned by others before me, there is certainly a psychological element when companies design their branding whether that be their logos, colors, or websites. This is no different in the medical device industry, colors are not simply chosen at…   Read more»

]]> a87822c5a3efdc29522a6b8cba2235ab https://medicaldevicecourses.com/activity/p/33173/ Thu, 16 Oct 2025 21:36:38 -0400 Marketing and design are different disciplines within industry, but have commonality in the sense that they both strive to understand the people using their product. Design has to take into account human factors like ease of use and clinical applications,…   Read more»

]]> d33b5d745b46fc8687e357e7e0718366 https://medicaldevicecourses.com/activity/p/33169/ Thu, 16 Oct 2025 21:06:01 -0400 In present times, device innovation no longer guarantees product success, and more often than not, it is the marketing or pitching of products that determines whether or not the device makes it to market. You could have an amazing product,…   Read more»

]]> be29fc0dcbfc86ad9562c38f194d0b6d https://medicaldevicecourses.com/activity/p/32922/ Wed, 08 Oct 2025 18:46:57 -0400 I think for medical device companies the decision to go in the route of an S Corporation or C corporations depends on what the company values and their plans for growth or development. In the early stages of the company,…   Read more»

]]> f5a70a85cd8addbf31180d640556ab0e https://medicaldevicecourses.com/activity/p/32921/ Wed, 08 Oct 2025 17:53:51 -0400 Having some exposure to the corporate veil from an engineering law class, I think the corporate veil is very important for owners of a company to be able to separate the liabilities of a company from their own personal assets….   Read more»

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