Medical Device Courses | os97 | Activity

os97 replied to the topic "Skills Learned in this Class" -

Sat, 03 May 2025 05:11:14 -0400

I feel like the most important concept I learned in this course is how to address and solve problems within a project. One of the most enjoyable parts of this course has been completing the project simulations. A huge part… Read more»

os97 replied to the topic "What should the project team learn from the failure project" -

Sat, 03 May 2025 04:20:42 -0400

Something to point out about failure in projects is that failed projects can be incredibly demotivating for a team. Many individuals can feel disappointed by negative results after the time and effort they placed into attempting to succeed. Failure does… Read more»

os97 replied to the topic "Covid 19 Vaccines" -

Sat, 03 May 2025 04:11:46 -0400

To address the aspect of speed in relation to the COVID-19 vaccine program, a great topic to consider was Operation Warp Speed. This project had a goal of accelerating the COVID-19 vaccine development, and saw success primarily because clinical trial… Read more»

os97 replied to the topic "Let's Be Motivated!!!" -

Mon, 28 Apr 2025 04:03:49 -0400

From my co-op experience, I have noticed that one of the biggest motivators has been introducing employees to the people they are helping. The company I work at regularly has seminars with guest speakers who have received and used products… Read more»

os97 replied to the topic "What’s Your Motivator?" -

Mon, 28 Apr 2025 03:56:19 -0400

Being in Biomedical Engineering, my biggest motivator is the help I can give. I used to volunteer in the hospital, and through this I was able to see first-hand the amount of good technologies and innovations from the BME field… Read more»

os97 replied to the topic "Engineer vs. Manager" -

Mon, 28 Apr 2025 03:53:10 -0400

As someone who is currently starting in the industry, I prefer the role of the engineer. I have little work experience, and thus am unfamiliar with the work environment and its dynamics. Along with this, a majority of my skills… Read more»

os97 replied to the topic "Time Management in Medical Devices" -

Mon, 21 Apr 2025 03:51:01 -0400

Tackling the aspect of keeping up with fast-evolving technology in terms of biomedical device development, the best way to do so is via proactive action. Rather than keeping up with change, it is best to try and predict what changes… Read more»

os97 replied to the topic "Vendor Decision" -

Mon, 21 Apr 2025 03:42:48 -0400

Considering the mini-sim from this week, going for multiple vendors can be more beneficial for next steps in terms of finalizing alternate sources for the coating material. In considering vendors available for a product, fitting the requirements stated within the… Read more»

os97 replied to the topic "Human Resource Management" -

Mon, 21 Apr 2025 03:26:46 -0400

To touch upon the mention of scenario-based simulation training, within the company I am currently working in, we are mandated to complete certain virtual training sessions each quarter, keeping us up to date with new technologies brought to the company,… Read more»

os97 replied to the topic "Project managers' charactristic" -

Mon, 14 Apr 2025 03:50:28 -0400

When it comes to project management, communication skills are a must. This helps the project manager facilitate collaboration, prevent conflicts, define goals & expectations, and allows for decision-making in the project to occur. Communication within a project is what allows… Read more»

os97 replied to the topic "Unexpected Time Delays - miniSim" -

Mon, 14 Apr 2025 03:30:23 -0400

Budgets can be high with animal experiments. This has to do with how time and labor intensive the studies are, resources needed for animal care, long-term nature of the studies (if applicable), material and equipment costs, and compliance with regulations…. Read more»

os97 replied to the topic "Optimizing Information Distribution" -

Mon, 14 Apr 2025 03:13:28 -0400

I believe that finding a balance between these two alternatives is dependent on understanding the roles of different team members within a project and the complexity of the information being communicated. Different team members have different roles, and a way… Read more»

os97 replied to the topic "In planning, the method to calculate each task duration." -

Mon, 31 Mar 2025 03:41:14 -0400

For determining the duration of each task, it’s good to have an understanding of the team members performing the task, and what resources they have access to. Resources team members have access to determine time spent on the procedure. More… Read more»

os97 replied to the topic "Project Plan Execution" -

Mon, 31 Mar 2025 03:18:30 -0400

Within my experience, a key aspect of project plan execution is checking the feasibility of the project plan before making an effort to follow through on it. Some of my work is incredibly time-sensitive and requires costly resources. Keeping this… Read more»

os97 replied to the topic "How Many Project Update Meetings Are Necessary to Keep them Productive" -

Mon, 31 Mar 2025 03:08:41 -0400

Project update meetings are a great way of getting an entire team onboard with the projects occurring, seeing who can help out for certain trouble spots, and making plans for future work based on everyone’s feedback. However, for long term… Read more»

os97 replied to the topic "How do the FDA manage" -

Mon, 17 Mar 2025 03:55:52 -0400

Within the medical device industry, the FDA device review is the process in which FDA review teams review submitted data to determine whether to approve the device or not. In this process, there might be a meeting of an advisory… Read more»

os97 replied to the topic "hiring policies for a project manager" -

Mon, 17 Mar 2025 03:39:31 -0400

While external hiring can diversify staff, bring new skills to the team, and create a larger talent pool, internal hiring has a large amount of benefits that make it more beneficial to project managers. A reduction in hiring costs is… Read more»

os97 replied to the topic "Pitfalls of estimate both costs and resources" -

Mon, 17 Mar 2025 03:16:13 -0400

While I have not managed projects myself within academics or medical device development, in terms of improper estimation of costs I have also seen an extension within the project time-line. If the budget for certain projects is not enough, the… Read more»

os97 replied to the topic "Planning Techniques" -

Mon, 10 Mar 2025 03:56:35 -0400

I do not have much industry experience either in addressing project planning, however in what projects I have seen and participated in there have been common factors. Before the initiation of any work such as data gathering, a key detail… Read more»

os97 replied to the topic "Project Initiation" -

Mon, 10 Mar 2025 03:44:52 -0400

This is an amazing definition of the concept of project initiation. Keeping in mind all the objectives of project initiation, I’m curious about what complications can arise within the medical device industry. A business case typically includes a summary of… Read more»

os97 replied to the topic "Making connections between people and schools" -

Mon, 10 Mar 2025 03:07:02 -0400

Hello everyone! My name is Olena and I am a BME Undergraduate student at NJIT. Here is my LinkedIn, looking forward to connecting with you all!
https://www.linkedin.com/in/olena-sen/

os97 replied to the topic "Task scheduling" -

Sun, 02 Mar 2025 23:42:07 -0500

This is a great definition of task scheduling! Another couple of details to include is that task scheduling can change throughout the project based on the schedule available, risks, technical specifications, etc. Observation and conversation with the individuals being scheduled… Read more»

os97 replied to the topic "Email Communication" -

Sun, 02 Mar 2025 21:48:46 -0500

Emails are best for more formal communications and messages that are meant to be sent to a large number of individuals. In case multiple emails build up, it is a good idea to re-evaluate what older emails are important to… Read more»

os97 replied to the topic "How people try to follow the changing trend." -

Sun, 02 Mar 2025 21:29:35 -0500

A great way to keep up with regulatory changes is via predicting what changes can occur. Some organizations undergo analysis of past regulatory changes in order to understand how regulation can develop in the future, thus allowing for earlier preparation… Read more»

os97 replied to the topic "Risk Management in Project Planning" -

Mon, 24 Feb 2025 04:52:04 -0500

@sarahqudah1 I believe that with medical device projects, market adoption is one of the more overlooked issues. Cost and accessibility of the product are important to consider in the creation of it. High development costs create high costs of product,… Read more»

os97 replied to the topic "Effective Scheduling in Medical Device Development" -

Mon, 24 Feb 2025 04:22:47 -0500

Especially in terms of medical device development, early start and finish dates allow for flexibility in schedule that can be incredibly helpful based on issues occurring with the project. Issues with ordered resources, delayed meetings, and problems with deliverables can… Read more»

os97 replied to the topic "Different Types of Risks in a Project" -

Mon, 24 Feb 2025 02:52:20 -0500

While all these risks are incredibly significant, one that is constantly present from the beginning of a project is financial risk. Questions on the presence of the finances needed for resources, work, and further development, are details that permeate every… Read more»

os97 replied to the topic "Verification Failures and Adjusting Test Conditions" -

Mon, 17 Feb 2025 04:54:11 -0500

One thing to consider with the testing of worst-case scenarios is the resources that get used within this verification process. Worst-case scenarios can involve a multitude of possibilities without specification, and in turn need a large amount of equipment and… Read more»

os97 replied to the topic "Managing Problem Solving on Diverse Teams" -

Mon, 17 Feb 2025 04:41:45 -0500

One of our largest issues for the project simulation involved having a clear line of communication. The presence of a discussion board in both the group canvas and main course assignment canvas was a confusing start. Thankfully, this problem was… Read more»

os97 replied to the topic "A Hypothetical Perspective about the First Simulation" -

Mon, 17 Feb 2025 03:24:12 -0500

Something that stood out in the process of designing the bottle labels was how it failed criteria at the 37C bath test. Likely what occurred was the adhesive degraded in some form with response to heat, especially considering the labels… Read more»

os97 replied to the topic "Project Management for Non-PM Positions" -

Mon, 10 Feb 2025 04:31:47 -0500

Outside of a project management role, project management skills can reflect well in leadership experiences and in management of personal goals.Project manager duties of creating goals, identifying what deliverables are needed, having a clear line of communication, and keeping note… Read more»

os97 replied to the topic "Pre-market Approval (PMA) vs. 510(k)" -

Mon, 10 Feb 2025 04:21:53 -0500

A great way to see the difference in PMA and 510(k) pathways is to answer if the product is life sustaining, and if there is a predicate to the device. Life sustaining devices tend to go through the PMA pathway… Read more»

os97 replied to the topic "Understanding your role..." -

Mon, 10 Feb 2025 02:59:00 -0500

I’m in favor of there being a leader acting as a main head with support. Having support allows for a leader to get quick feedback on goals and plans being implemented. Part of a leader’s duties in terms of project… Read more»

os97 replied to the topic "Ambiguity in Medical Device Classification" -

Mon, 03 Feb 2025 04:47:10 -0500

For medical device classification ambiguity, it is important to understand the intended use of the device and present indications for said use. With the example of the artificial pancreas within the simulation, its intended use was to control insulin regulation… Read more»

os97 replied to the topic "Different Project Manger Approaches" -

Mon, 03 Feb 2025 04:16:21 -0500

A huge factor that can play into preference can be the experience of the individual entering the team. For an individual who is new to the team and learning many skills, a more micromanaging technique can aid with the onboarding…. Read more»

os97 replied to the topic "Handling Conflicts Among Team Members Effectively" -

Mon, 03 Feb 2025 03:46:08 -0500

For a project manager, handling team conflicts will involve a good amount of proactive action. As mentioned, many conflicts can arise from miscommunication, disagreement in methods, and from a difficulty addressing situations before they escalate. One way to address this… Read more»

os97 replied to the topic "How to communicate effectively between team mates in project team ?" -

Mon, 27 Jan 2025 04:17:21 -0500

With communication breakdowns, it is important to identify potential areas of misunderstanding prior to conveying information. Many breakdowns come from the difficulty in including context, misrepresentations of tone, or assumptions of understanding information conveyed. It is important to understand that… Read more»

os97 replied to the topic "Transitioning to New Technologies During an Ongoing Project" -

Mon, 27 Jan 2025 03:46:23 -0500

It is incredibly important to predict what risks can come from including new technologies and adapting them within a project. New technologies are capable of coming with their own constraints, and with conflicts against existing work based on older technologies…. Read more»

os97 replied to the topic "Balancing Stakeholder and Customer Values" -

Mon, 27 Jan 2025 02:00:47 -0500

I agree that typically values depend on a case-by-case basis, however in terms of medical devices I believe stakeholder values might take priority. For customer values there is typically a necessity involved that ensures a permanent presence of the customer’s… Read more»