Medical Device Courses | ms2768 | Activity

ms2768 replied to the topic "Outsourcing Clinical Trials" -

Sat, 27 Apr 2024 21:46:43 -0400

I believe that if a company has the resources (employees, labs, schedule, timing, money) available to conduct the clinical trials in house, they would certainly do so. Outsourcing these clinical trials to third party companies that specialize in performing trials… Read more»

ms2768 replied to the topic "Job Satisfaction" -

Sat, 27 Apr 2024 21:41:35 -0400

Within my experience so far in the industry, all of the things you have mentioned (financial compensation, job satisfaction, recognition, and work life balance) play an equal part in motivating employees. However, individuals could have different motives for working in… Read more»

ms2768 replied to the topic "Clinical Trials" -

Sat, 27 Apr 2024 21:37:23 -0400

This is a great discussion because clinical trials are indeed extremely important to the release of many life saving medical devices on the market today and all that will be released in the future as well. As to how many… Read more»

ms2768 replied to the topic "Team Development at a Low Budget" -

Sun, 14 Apr 2024 03:28:59 -0400

In my opinion, the best way to strategize to upper management and stakeholders the value of the project is to have a meticulous planning stage where the most important detail of project scope is accurately described. This is done through… Read more»

ms2768 replied to the topic "Changining staff" -

Sun, 14 Apr 2024 02:56:40 -0400

This is a very interesting topic because I have seen a situation like this occur during one of the projects that I was a part of in the medical device industry. I believe that larger corporations have a plethora of… Read more»

ms2768 replied to the topic "Quality control in small projects." -

Sun, 14 Apr 2024 02:30:48 -0400

Based off the lecture on quality control this week, I don’t think that “its not done well” in smaller projects, I think it’s just not as common in smaller projects. Additionally, the larger and more developed organizations (such as JNJ,… Read more»

ms2768 replied to the topic "Success Rate of Projects" -

Tue, 09 Apr 2024 15:24:12 -0400

While its difficult to put a number to how many projects are successfully completed in the industry, I remember the lecture mentioning that many projects do not go to completion due to various reasons. Not enough resources, a drastic change… Read more»

ms2768 replied to the topic "Leaders of Change Control" -

Mon, 08 Apr 2024 03:27:03 -0400

This is an interesting topic because I believe it varies highly from company to company. Each organization has their own respective protocols and approval lists in place to ensure that change controls not only go smoothly but are approved by… Read more»

ms2768 replied to the topic "Project manager flexibility" -

Sun, 07 Apr 2024 23:57:43 -0400

From my experience in the workplace, I think the mini simulation was accurate in demonstrating how flexible a successful project manager would need to be. At some point after working on projects, there will be people on the project team… Read more»

ms2768 replied to the topic "Compromises in Conflict" -

Sun, 24 Mar 2024 18:56:56 -0400

The mini sim this week did a great job representing some of the ways to go about resolving time conflicts within the project timeline. From my experience within the industry and learning from the mini sim, I believe that being… Read more»

ms2768 replied to the topic "Changes to Products in Production" -

Sun, 24 Mar 2024 02:00:38 -0400

While all the documentation in the DHF and other company based paperwork is transferred at the end of a project’s lifecycle, the members of the project would still be contacted if there are any issues moving forward with the project… Read more»

ms2768 replied to the topic "Making connections between people and schools" -

Sun, 24 Mar 2024 01:55:19 -0400

Hello Everyone!
My name is Meet Sukhadia and I am currently a master’s student at NJIT studying Biomedical Engineering. I am also a Research and Development Engineer at Ethicon, here is my LinkedIn profile:
https://www.linkedin.com/in/meet-sukhadia-82153790/
I look forward to connecting with you all!

ms2768 replied to the topic "Over budget project" -

Fri, 08 Mar 2024 17:44:54 -0500

While many have said that the project being over budget is poor planning, the lectures did indicate that there are situations where the budget in the planning stage is not accurate because many differences such as additional clinical research or… Read more»

ms2768 replied to the topic "Planning and Executing in Project Management" -

Fri, 08 Mar 2024 17:31:39 -0500

This is a great discussion because it shines light on the importance of the planning stage and how important it is for this to be detailed enough so the execution stage can go smoothly. As discussed in the lecture, there… Read more»

ms2768 replied to the topic "Instances of Multiple PMs" -

Fri, 08 Mar 2024 16:46:44 -0500

This is an interesting conversation to me because from my experience so far within the industry, I have not worked on a project where there was multiple project managers. There could be multiple people assisting the project manager in decision… Read more»

ms2768 replied to the topic "Determining relationships between tasks" -

Sun, 03 Mar 2024 16:32:03 -0500

As the lecture detailed, Gantt charts greatly help the project timeline stay intact and connect the tasks to one another so the team can understand the order of operations. Determining the dependencies of tasks would require getting the entire team… Read more»

ms2768 replied to the topic "Who is a Stakeholder?" -

Sun, 03 Mar 2024 16:26:54 -0500

I believe that a stake holder would be anyone that would be affected by the success or failure of the project, whether is it financial or career wise. For example, a project I am currently working on in the medical… Read more»

ms2768 replied to the topic "Hiring team members" -

Sun, 03 Mar 2024 16:22:47 -0500

In my five years of experience within the medical device industry, I have worked with various project managers and I would say that the answer to your question in this situation would be both options. In my opinion, it depends… Read more»

ms2768 replied to the topic "Power of Stakeholders" -

Sun, 25 Feb 2024 02:43:39 -0500

Sponsors and/or stakeholders generally have a high amount of power and impact towards a successful project. They of course can influence a project at the highest level, to the point where the project would need to shift all directions in… Read more»

ms2768 posted a new topic "Pitfalls of estimate both costs and resources" -

Fri, 23 Feb 2024 03:36:45 -0500

One topic of this weeks lecture that I found really interesting was the estimation of costs and resources and the possible setbacks/pitfalls that can be associated with this. It made me think of my time in the medical device industry… Read more»

ms2768 replied to the topic "EF and LF in Medical Device Development" -

Fri, 23 Feb 2024 03:28:41 -0500

While there are various types (and hundreds of thousands) of medical device projects that are ongoing every year in med device companies, something common between them is the tasks in the project management process. As detailed in the lecture, the… Read more»

ms2768 replied to the topic "Transference of Risk in Medical Device Companies" -

Sun, 18 Feb 2024 18:54:54 -0500

Risk transference is one of the ways of risk mitigation in the medical device industry that highly relates to risk transfer in real life. As Dr. Simon states in the lecture, in real life there is risk transfer for everything… Read more»

ms2768 replied to the topic "PM Leadership Styles" -

Sun, 18 Feb 2024 18:43:08 -0500

Project leadership style is one of the most vital parts of a project’s outcome in my opinion, I think it is almost undervalued by most companies because they are focused more so on the project succession. There are other parts… Read more»

ms2768 replied to the topic "Estimates When Making the Project Plan" -

Sun, 18 Feb 2024 18:27:34 -0500

While companies that have a broad history of projects could use historical data to provide these estimates, its important for experts in market research and project management to come up with estimates, especially because they will be provided to the… Read more»

ms2768 replied to the topic "Strategies for Conducting Effective Design Review Meetings" -

Sat, 10 Feb 2024 06:17:25 -0500

Design reviews need to be some of the most organized parts of the project. All documents that need to be signed and approved prior to the meeting should be approved. Everyone that is required to attend the Design change review… Read more»

ms2768 replied to the topic "Project Management for Non-PM Positions" -

Sat, 10 Feb 2024 03:00:31 -0500

While most may believe that only people with the title of project manager are leading projects, there are many functions in the medical device industry that need the ability and knowledge to do so. Upon reading the post, I immediately… Read more»

ms2768 replied to the topic "Remote or In-Person PM" -

Sat, 10 Feb 2024 02:52:02 -0500

I was working during the pandemic and had to go in everyday because I was in a lab setting, we were providing certificates that allowed us to commute to work when that was banned as well. Now, I am in… Read more»

ms2768 replied to the topic "Functional Organization vs. Weak Matrix Organization" -

Sat, 03 Feb 2024 05:14:23 -0500

The different organizations mentioned in the lecture were also interesting to me because I tried to compare them to the teams i have worked on in the industry and feel like my company has had situations of all organizations. Currently,… Read more»

ms2768 replied to the topic "Combination Product Project Management" -

Sat, 03 Feb 2024 03:14:55 -0500

Combination products in the industry have additional forms and process steps that come with them as well. These of course vary from company to company how the overall project management process and documentation does. From the lectures, it was my… Read more»

ms2768 replied to the topic "Unique Product Lifecycles in Medical Devices" -

Sat, 03 Feb 2024 01:46:04 -0500

This part of lecture was very interesting to me because my current background in the medical devices industry is within the wound closure sector where I have worked with various wound closure devices such as sutures (for stitching), medical staplers,… Read more»

ms2768 replied to the topic "FDA classification for bme devices" -

Thu, 25 Jan 2024 21:30:00 -0500

It is always important to know the distinction between the three classes, as stated multiple times in the lecture and the mini simulation because it can lead to many avoidable expenses and loss of time. In the medical device industry,… Read more»

ms2768 replied to the topic "Project Management Information Systems" -

Thu, 25 Jan 2024 21:23:53 -0500

It is extremely vital to ensure that project progress is met for the project timeline to not be delayed or impacted at all. While ensuring that project responsibilities have been distributed accordingly to the members or groups, its important that… Read more»

ms2768 replied to the topic "Reclassifying Medical Devices" -

Thu, 25 Jan 2024 20:44:38 -0500

This is a very interesting topic because how possible it is in the “real world” for industries to experience something like this during projects. Based off the lectures and mini simulation this week, this is definitely a thought that popped… Read more»

ms2768 replied to the topic "Funding in Medical Devices Industry" -

Sat, 20 Jan 2024 00:37:07 -0500

While many have stated that the company should fund the project and go for the patent, the initial post only says that the project idea has a potential to be patented in the future. In the medical device industry, there… Read more»

ms2768 replied to the topic "How to increase emotional intelligence" -

Sat, 20 Jan 2024 00:26:17 -0500

The part of the lecture that focused on emotional intelligence and social skills really stood out to me and made me want to start reading the novel that was mentioned in the lecture. Similar to what others have mentioned above… Read more»

ms2768 replied to the topic "Sizes of Project Teams" -

Sat, 20 Jan 2024 00:19:39 -0500

I found it very interesting reading the different opinions and experiences of others that have been part of project management teams. From my personal experience at a medical device company and being parts of projects that had large teams, smaller… Read more»