Medical Device Courses | ag2265 | Activity

ag2265 replied to the topic "Covid 19 Vaccines" -

Sun, 30 Apr 2023 18:07:25 -0400

I agree with @DevDesai about how the FDA allowed multiple phases to occur as multiple researchers, scientists, and governments were internationally collaborating in order to develop and distribute an effective formulation of the COVID19 vaccine. The vaccines were developed rather… Read more»

ag2265 replied to the topic "How do most companies tend to solve the problem?" -

Sun, 30 Apr 2023 17:59:03 -0400

I wanted to expand on @srp98 response and how they mentioned that a legal team could get involved during a situation where the vendor delivers a subpar product to the company and are unsure how to proceed. The company can… Read more»

ag2265 replied to the topic "Change Requests During Clinical Trials" -

Sun, 30 Apr 2023 17:47:35 -0400

As @sah67 mentioned the DCR (Document Change Request) process occurring during the clinical trials stage can have many negative effects on the outcome of the study or even affect the patients partaking in the study. Furthermore, this may cause issues… Read more»

ag2265 replied to the topic "Job Satisfaction" -

Mon, 24 Apr 2023 03:33:46 -0400

I agree with @hmara sentiment regarding how money can only take you so far. As mentioned in the lecture as well that earning money is simply a short-term goal in the grand scheme of life. Money is simply a tool… Read more»

ag2265 replied to the topic "How to manage contracts with external clinical trial management teams?" -

Mon, 24 Apr 2023 03:21:08 -0400

Smaller companies bear the burden of not having connections to resources and services that larger companies may have access to due to their prominent reputation in the industry. In this case it is crucial that the smaller companies have a… Read more»

ag2265 replied to the topic "Methods to make a time and budget planning in the clinical trial" -

Mon, 24 Apr 2023 03:04:43 -0400

I agree with everything that @sah67 mentioned about how it is imperative for the PM to have a cohesive understanding of the project, its expectations, its desired outcomes, its limitations etc. I appreciate how you mentioned large tasks such as… Read more»

ag2265 replied to the topic "Verification & Validation NDAs" -

Mon, 10 Apr 2023 03:30:25 -0400

What happened during this week’s simulation was eye-opening to me as I did not expect that different parties involved with the same project could be on different pages and one slight oversight or lapse in communication could lead to last-minute… Read more»

ag2265 replied to the topic "Initiating Process Group" -

Sun, 09 Apr 2023 23:13:31 -0400

I agree with the previous commenters as to answering the question of which group to go to find out various information about the company procedures, guidelines, policies, etc. The Organizational Process Assets (OPAs) are any assets related to the project… Read more»

ag2265 replied to the topic "Project managment: Monitoring & Controlling Phase" -

Mon, 27 Mar 2023 03:49:01 -0400

The common theme amongst all the responses is that yes a change control process is an important practice to have for project management as it ensures that any changes made are done so in a structured and controlled manner. This… Read more»

ag2265 replied to the topic "project changes and stakeholders" -

Mon, 27 Mar 2023 03:15:21 -0400

I agree with how @dke2 outlined that specific documents need to be appropriately filed and presented to the stakeholders so that they understand all aspects of any changes that may be made to the project and what those changes may… Read more»

ag2265 replied to the topic "hiring policies for a project manager" -

Mon, 27 Mar 2023 03:03:40 -0400

As @kaf43 there are benefits to either side of whether one decides to hire project managers within the company or externally. I also agree with @vv48 and how it does not necessarily matter where the project manager is hired from,… Read more»

ag2265 replied to the topic "Hiring team members" -

Mon, 13 Mar 2023 02:11:40 -0400

I think that it is the job of the project manager to determine what type of role they are hiring for and which type of employee would be better suited for the job. I agree with @jj52 and how they… Read more»

ag2265 replied to the topic "Difficulty of a Project" -

Mon, 13 Mar 2023 02:06:08 -0400

@jj52 I understand where you are coming from when you claim that budgeting and providing productive results may be the most difficult when it comes to a project. I would say that the budgeting aspect needs to be done correctly… Read more»

ag2265 replied to the topic "Project managers' previous experiences" -

Mon, 13 Mar 2023 01:57:00 -0400

Ideally a company should hire a project manager that has experience managing a specific type of project as well as being able to adapt to different project types. It would be beneficial for the company to have a manager that… Read more»

ag2265 replied to the topic "Project managers' charactristic" -

Mon, 06 Mar 2023 04:15:44 -0500

I agree with @vv48 in saying that it is more important for the manager to be better at communicating than the technical skills because they are overseeing several different teams which require different approaches when managing them. Some teams can… Read more»

ag2265 replied to the topic "Project manager priority" -

Mon, 06 Mar 2023 04:01:55 -0500

I completely agree with everything @kaf43 mentioned about how it is important to keep BOTH the stakeholders and the project team happy in order for the project to run smoothly and be successful. As you said the stakeholders are the… Read more»

ag2265 replied to the topic "Project manager responsibilities" -

Mon, 06 Mar 2023 03:51:20 -0500

I agree with how @sb2538 emphasized the role of the project manager and how they are responsible with initiating the project and seeing it through. That being said it is important for the project manager to have a strong grasp… Read more»

ag2265 replied to the topic "Project manager flexibility" -

Mon, 27 Feb 2023 04:14:17 -0500

@Wk46 as I do agree that the expectations from the team members and the project manager should be defined prior to the project starting, however, it is extremely difficult to predict personal life events that may impact a team member… Read more»

ag2265 replied to the topic "Planning Techniques" -

Mon, 27 Feb 2023 04:06:49 -0500

While I personally cannot provide any industry insight I can provide academic laboratory insight and Capstone experiences that I went through when planning a project with several components and steps. In terms of academic laboratory experience I have worked on… Read more»

ag2265 replied to the topic "Team members personal issues with eachother" -

Mon, 27 Feb 2023 00:27:13 -0500

I agree with what previous commenters have mentioned in their responses especially how @jh597 emphasized that any problem occurring between two workers in the same company/team needs to be addressed immediately. As they mentioned, if the issue is not addressed… Read more»

ag2265 replied to the topic "Verification Protocols vs. Reports" -

Mon, 20 Feb 2023 04:40:17 -0500

A common trend that can be seen throughout the responses is that the verification protocol comes first and then the verification report follows. This is similar to how in our BME Capstone class during undergrad at NJIT we had to… Read more»

ag2265 replied to the topic "How to find outside project support" -

Mon, 20 Feb 2023 04:26:38 -0500

This is an interesting question as most people would not be open to seeking for help as they think that they can figure it out themselves. Several responses above have spoken about anecdotal experiences in industry, but personally I have… Read more»

ag2265 replied to the topic "Risk Responses" -

Mon, 20 Feb 2023 02:52:58 -0500

@kellyepcarter You bring upon a good point about how risk responses should be addressed given cost-effectiveness, rationality, and effective execution – if the risk response is not appropriate for the given situation it could cause further damage than what was… Read more»

ag2265 replied to the topic "Examples of budget changes due to DSD testing" -

Mon, 13 Feb 2023 00:27:35 -0500

As @pv223 mentioned I would say that it is extremely probable for a budget change to occur to accommodate for additional testing. In my own personal capstone project we had an initial design which we wanted to use and following… Read more»

ag2265 replied to the topic "How to increase emotional intelligence" -

Mon, 13 Feb 2023 00:18:27 -0500

From an objective perspective from someone who has never worked in the industry before I would think that the way to increase emotional intelligence of a work force could be attributed to two different facets: interviewing and managing. In regards… Read more»

ag2265 replied to the topic "Several modifications of verification at the same time" -

Mon, 13 Feb 2023 00:04:35 -0500

@ej851996 this is a great question to ask, personally in our own group we addressed this issue in our Lessons Learned section. After the simulation we learned that implementing multiple changes in one design change proposal could cause other problems… Read more»

ag2265 replied to the topic "Medical Device Project Start-up" -

Mon, 06 Feb 2023 04:42:50 -0500

I currently work in a research lab on NJIT campus where we conduct research on blast induced traumatic brain injuries (bTBI) using rodent animal models. This research can be linked with similar injuries that soldiers face when they are in… Read more»

ag2265 replied to the topic "Design Controls" -

Mon, 06 Feb 2023 04:20:10 -0500

As many people have mentioned throughout this discussion, I do believe that there is not one essential design control that trumps the others. As @ama224 mentioned, each design control feeds into one another and every design control is based off… Read more»

ag2265 replied to the topic "Organization type preference" -

Mon, 06 Feb 2023 03:36:13 -0500

Although I have no industry experience I can relate this question to the research lab that I work in where there are several research projects being conducted in the lab simultaneously, however, each project is being headed by one specific… Read more»

ag2265 replied to the topic "How do you set up a project organization?" -

Mon, 30 Jan 2023 04:47:12 -0500

@lei-hao You are certainly correct that each of these types of organizations for a project are dependent on different circumstances. I would say that a project manager should choose an organization type based upon the resources the team has, the… Read more»

ag2265 replied to the topic "Importance of Culture in Project Management" -

Mon, 30 Jan 2023 04:10:48 -0500

A company that I have heard of being difficult on its employees is Stryker and after reading @dani post I figured that I might as well look into this claim myself. After doing extensive research on multiple job sites such… Read more»

ag2265 replied to the topic "More Influence or Less?" -

Mon, 30 Jan 2023 04:00:44 -0500

I have worked in projects in the past where my contributions towards the project had varied depending on the role that I played within the group and what the responsibilities were for that particular role. For example, I have noticed… Read more»

ag2265 replied to the topic "Should procedures or standards for verification and validation tests be approved by the FDA?" -

Mon, 23 Jan 2023 03:16:04 -0500

Hi @wonbum-sohn I recall from taking Professor Simon’s other course BME 684 where he mentioned standards of verification and validation which are essentially protocols that must be followed when creating a medical device. These two standards are different where verification… Read more»

ag2265 replied to the topic "Project Management Skills for Engineers" -

Mon, 23 Jan 2023 03:02:45 -0500

I like this post @jj52 as it encompasses what is expected of a project manager and how they need to operate when working on projects. I also like how @kaf43 added to the discussion that a successful project manager needs… Read more»

ag2265 replied to the topic "Understanding your role..." -

Mon, 23 Jan 2023 02:56:58 -0500

I must agree with the common notion that roles are imperative in a group when working on a project so that each member understands their role and responsibilities to the group. I think that the group should first meet and… Read more»