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JacobChabuel replied to the topic "Significance of Team Development in Project Execution" – 2 months, 1 week ago
@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»
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JacobChabuel replied to the topic "Balancing time and money expectations in project planning" – 2 months, 2 weeks ago
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»
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JacobChabuel posted a new topic "Cost and Resource Allocation in Project Planning" – 2 months, 2 weeks ago
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»
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JacobChabuel posted a new topic "The Work breakdown Structure In Medical Device Project Planning" – 2 months, 2 weeks ago
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»
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JacobChabuel posted a new topic "Navigating Design History and Project Delivery" – 2 months, 3 weeks ago
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»
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JacobChabuel posted a new topic "Certifications vs Degrees for Project Management" – 2 months, 3 weeks ago
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»
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JacobChabuel replied to the topic "Making connections between people and schools" – 2 months, 3 weeks ago
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»
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JacobChabuel replied to the topic "Product Life Cycle – Impacts & Management" – 3 months ago
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»
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JacobChabuel posted a new topic "PM Problem Involving Pre-clinical Trial Results and Market Entry Deadlines" – 3 months ago
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»
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JacobChabuel replied to the topic "FDA about upgraded device" – 3 months ago
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»
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JacobChabuel posted a new topic "Project Management and Design Controls" – 3 months, 1 week ago
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»
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JacobChabuel replied to the topic "Project Management Software" – 3 months, 1 week ago
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»
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JacobChabuel posted a new topic "Project Managers utilization of PDCA and other structured processes" – 3 months, 1 week ago
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»
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JacobChabuel replied to the topic "Team Conflict with Project Manager" – 3 months, 2 weeks ago
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»
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JacobChabuel posted a new topic "Project Manager role in Post Market Surveillance" – 3 months, 2 weeks ago
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»
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JacobChabuel replied to the topic "Relationship between the FDA and Project Managers" – 3 months, 2 weeks ago
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»
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JacobChabuel replied to the topic "The Cross Disciplinary Skills Needed in a Project Manager" – 3 months, 3 weeks ago
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»
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JacobChabuel posted a new topic "How can a project manager excel in the Biomedical field?" – 3 months, 3 weeks ago
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»
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JacobChabuel replied to the topic "How to communicate effectively between team mates in project team ?" – 3 months, 3 weeks ago
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»
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JacobChabuel replied to the topic "Risk Assessments are necessary or not for medical devices?" – 6 months ago
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»
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