Medical Device Courses | es364 | Activity

es364 replied to the topic "Job Satisfaction" -

Thu, 18 Apr 2024 00:56:29 -0400

Financial compensation is one of the important factors in employee motivation. Normally if an employee is paid well, he will have a good and serious performance. However, as mentioned in the lecture, money is a short-term motivator because by the… Read more»

es364 replied to the topic "Familiarity of eachothers work" -

Wed, 10 Apr 2024 17:01:26 -0400

I think it’s very important to make sure everyone understands each other’s roles because it can contribute to the long-term efficiency and success of the project. If each team member understands the roles and responsibilities of other team members, it… Read more»

es364 replied to the topic "Changining staff" -

Wed, 10 Apr 2024 16:46:32 -0400

In my opinion, if a critical task is left unresolved due to a change of position or departure of a team member, it is essential to manage the situation effectively to minimize the impact on the project timeline. The first… Read more»

es364 replied to the topic "Vendor Decision" -

Wed, 10 Apr 2024 16:35:49 -0400

In this simulation my decision was to go with more than one vendor. SOP in this simulation indicated that any vendor that makes a component that is essential to the product’s concept and function cannot be sole-sourced. The coating is… Read more»

es364 replied to the topic "Project Slack Time" -

Fri, 05 Apr 2024 20:34:09 -0400

I think the slack time is very important because it is the amount of time by which a task within a project can be delayed without causing an overall project delay. Slack time helps to mitigate project risks and uncertainties… Read more»

es364 replied to the topic "Most Important Phase" -

Fri, 05 Apr 2024 20:10:06 -0400

Firstly, it’s crucial to understand that the successful completion of every stage of the project from initiation to closure depends on each of them. However, in my opinion I think the most important phase in the project process is the… Read more»

es364 replied to the topic "Team members personal issues with eachother" -

Fri, 05 Apr 2024 19:58:47 -0400

One of the most important aspects of project management is the resolution of conflicts between team members. There are many strategies a project manager can use in these situations. For example, it is important to encourage open communication within the… Read more»

es364 replied to the topic "Email Communication" -

Sun, 24 Mar 2024 23:16:20 -0400

I would rather interact via Teams since these platforms are ideal for brief exchanges, group discussions, and project collaboration because they provide real-time communication and file sharing options.On the other hand, emails are better suited for detailed communication or documentation…. Read more»

es364 replied to the topic "Strategies to Counteract Negative Schedule Variance" -

Sun, 24 Mar 2024 23:04:33 -0400

I think the first thing to do is for the project manager to identify the root cause of the negative schedule variance (SV). After identifying the root cause, project managers can take a number of steps to mitigate the effects… Read more»

es364 replied to the topic "Success Rate of Projects" -

Sun, 24 Mar 2024 22:46:16 -0400

In my opinion a very successful project is one that fulfills every objective perfectly. Also, I think that a successful project is one that is completed within the time limit and within the allocated budget. However, I think a project… Read more»

es364 replied to the topic "Over budget project" -

Sun, 10 Mar 2024 22:57:36 -0400

There are several methods that can help to mitigate the situation and complete the project without going over budget, which may include re-estimating the scope of the project. It means determining whether features or products in the project’s scope can… Read more»

es364 replied to the topic "Underestimating Task Duration" -

Sun, 10 Mar 2024 22:37:32 -0400

There are several strategies that project managers can use to properly handle situations where workers underestimate the duration of tasks. Breaking down project tasks into smaller, more manageable chunks and setting an approximate time for each is one such strategy…. Read more»

es364 replied to the topic "Compromises in Conflict" -

Sun, 10 Mar 2024 22:27:00 -0400

In circumstances where there is an imbalance of power, stakeholders can try to create mutually beneficial compromises and find effective ways to solve problems by applying different compromise strategies. Some strategies might include focusing on the big picture. It means … Read more»

es364 replied to the topic "Challenges PM face" -

Sat, 02 Mar 2024 20:28:51 -0500

Managing scope creep is an important issue that project managers encounter. The term scope creep means that the project’s scope gradually expands beyond its initial parameters, which might lead to higher expenses, longer schedules, and more resource constraints. In order… Read more»

es364 replied to the topic "Who is a Stakeholder?" -

Sat, 02 Mar 2024 20:14:40 -0500

Any person, entity, or organization with an interest or concern in a project is considered a stakeholder. Stakeholders may be found inside or outside of the project or organization, and their levels of involvement and influence may differ. They may… Read more»

es364 replied to the topic "Determining relationships between tasks" -

Sat, 02 Mar 2024 20:04:52 -0500

There are some strategies that can help project managers to effectively gain input from all team members in the project without spending an inordinate amount of time developing the Gantt chart. These strategies include holding collaborative planning meetings. Usually in… Read more»

es364 replied to the topic "FS and SF in Gantt Chart Relationships" -

Tue, 20 Feb 2024 17:52:35 -0500

In an FS dependency, the start of one task depends on the completion of another task. As you said, task B cannot start until task A is finished. For example, task A is “cutting wood” and task B is “shaping… Read more»

es364 replied to the topic "What is the difference between project management process and design control?" -

Tue, 20 Feb 2024 17:40:15 -0500

A complete structure for managing every task of a project, from project initiation to project closing, is provided by project management processes. The primary goal of project management processes is to guarantee that projects are finished on schedule, within budget,… Read more»

es364 replied to the topic "Project manager priority" -

Tue, 20 Feb 2024 17:26:10 -0500

The collaboration and alignment of the project team and stakeholders, in my opinion, is critically important to the project’s success. It is ideal for a project manager to find a balance between team and stakeholder satisfaction rather than giving one… Read more»

es364 replied to the topic "Hiring team members" -

Wed, 14 Feb 2024 18:58:18 -0500

The choice between hiring workers with specialized skills and those with a wide variety of skills, in my opinion, is based on a number of variables, such as the project’s particular requirements, the activities involved, the project’s schedule, and the… Read more»

es364 replied to the topic "How poor planning affects a project" -

Wed, 14 Feb 2024 18:46:55 -0500

Although I can’t speak from personal experience, I believe that poor planning during project initiation can affect the project negatively in different ways. For instance, if a project starts without clearly outlining the people, money, and materials needed, it… Read more»

es364 replied to the topic "Making connections between people and schools" -

Wed, 14 Feb 2024 18:25:36 -0500

Hi everyone , My name is Endri Shkjau and I’m a BME Masters student at NJIT. Here is my LinkedIn page: https://www.linkedin.com/in/endri-shkjau-670336191/ I look forward to connecting with you all! Thanks, Endri

es364 replied to the topic "Funding in Medical Devices Industry" -

Thu, 08 Feb 2024 17:47:50 -0500

A project’s decision to be pursued with the possibility of future patenting, even in the absence of funding, might be influenced by a variety of factors. It would be a smart idea to move on with the project if it… Read more»

es364 replied to the topic "How to ensure the project is on schedule to meet deadline" -

Thu, 08 Feb 2024 17:24:44 -0500

I agree with the majority of the comments above that fulfilling deadlines is one of the most crucial and challenging aspects of a project. There are a few essential components of project management that can improve the efficiency of meeting… Read more»

es364 replied to the topic "Project Manager Experience" -

Thu, 08 Feb 2024 17:06:52 -0500

The type of manager that is best for a certain project should rely on the assignment. An academically focused project manager may be preferable for projects in highly technical or research-intensive fields due to their analytical and research skills. Furthermore,… Read more»

es364 replied to the topic "Different Project Manger Approaches" -

Sun, 04 Feb 2024 20:10:21 -0500

The preference for a hands-off or micro-managerial leadership style often depends on the team members and project. The hands off leadership style requires highly skilled and motivated team members. Also in this style sometimes there might be a lack of… Read more»

es364 replied to the topic "More Influence or Less?" -

Sun, 04 Feb 2024 19:59:37 -0500

In my opinion , it is not necessary that all team members contribute equally to projects. However, it is very important that each team member accomplish their goal. Some strategies that can help ensure that all team members are contributing… Read more»

es364 replied to the topic "PDCA cycle in Biomedical Engineering" -

Sun, 04 Feb 2024 19:50:04 -0500

The Plan-Do-Check-Act (PDCA) cycle has four phases which are plan , do ,check and act. During these phases there are many specialities like biomedical engineers, clinicians, project managers, regulatory experts, and quality assurance specialists that work together to ensure the… Read more»

es364 replied to the topic "What are challenges will we face if we missclassify a medical device ?" -

Mon, 29 Jan 2024 06:49:06 -0500

Misclassifying a medical device can result in a number of issues and difficulties that could compromise regulatory compliance. Misclassifying a medical device might end up in submitting the wrong type of pre-market submission (e.g., 510(k) instead of PMA, or vice… Read more»

es364 replied to the topic "Regulatory Project Management" -

Mon, 29 Jan 2024 06:38:33 -0500

The regulatory role is crucial in the development of medical devices in order to meet all the requirements set by the FDA. As we can see from the lecture, the regulatory role breaks down in product development and post-market management…. Read more»

es364 replied to the topic "Sizes of Project Teams" -

Mon, 29 Jan 2024 03:02:46 -0500

I think that the success of working in large or small groups and with people from different backgrounds depends on the particular project, its objectives and the dynamics of the team. Some of the advantages of working in smaller project… Read more»

es364 replied to the topic "FDA classification for bme devices" -

Sun, 28 Jan 2024 23:32:23 -0500

It is very important to understand the differences between the three classes early on in a project because it can help save money and time. Typically, Class I devices are low-risk devices, which are known devices with a long history… Read more»

es364 replied to the topic "Difference between drug and medical device?" -

Sun, 28 Jan 2024 23:13:18 -0500

Drugs and medical equipment are very important for the safety of our health. Medicines and medical devices have many differences that may include their mechanism, their interaction with the human or animal body, their regulatory agencies that are within… Read more»

es364 replied to the topic "Pre-market Approval (PMA) vs. 510(k)" -

Sun, 28 Jan 2024 22:52:46 -0500

Both the PMA and the 510(k) are the most important documents required by the FDA for medical devices to receive market approval. PMA is technically required for all Class III devices. Typically, medical devices that are classified as Class III… Read more»

es364 replied to the topic "When is giving gifts like the "old days" too much?" -

Mon, 04 Dec 2023 02:46:01 -0500

Gift-giving to doctors is a delicate and complicated topic, with different national and local laws and standards applying. In my opinion, it’s fine to give a physician small gifts that are under $100, but not often. Also, it is ok… Read more»

es364 replied to the topic "Restrictions for physician's gifts" -

Mon, 04 Dec 2023 02:32:50 -0500

This is a very good question. In my opinion, if you invite a physician to a dinner to talk about the product you can promote and they bring their spouse to the dinner, it is very disrespectful to only pay… Read more»

es364 replied to the topic "Discussion Topic: Course conclusion and impressions" -

Mon, 04 Dec 2023 02:20:25 -0500

When I first started this class I thought it would be more of a medical device prescription class. However, I was surprised and at the same time happy to learn about the different jobs Biomedical Engineers can do and the… Read more»

es364 replied to the topic "Upper vs Middle Management." -

Sun, 26 Nov 2023 21:08:06 -0500

Depending on personal preferences, professional aspirations, and strengths, one may choose between Upper and Middle Management. Some people are ideally suited for upper management because they have a natural gift for imaginative thinking and like leading an organization. Others work… Read more»

es364 replied to the topic "Forming a Project Team" -

Sun, 26 Nov 2023 20:58:38 -0500

Establishing a project team is an essential first step in making sure a project is successful. Creating a project team that works requires a deliberate approach that considers each member’s unique capabilities as well as the group’s combined abilities. Working… Read more»

es364 replied to the topic "Organization Type vs. Effectiveness" -

Sun, 26 Nov 2023 20:43:49 -0500

In my opinion, the best organizational structure is the matrix organization. I think this way because the resources in this type of organization are very well managed. The same resources can be used for several projects like a marketing manager… Read more»

es364 replied to the topic "Discussion Topic: Risk Management, Risk Analysis" -

Sun, 19 Nov 2023 15:09:07 -0500

ISO 14971 is the primary ISO rule that regulates risk management for medical equipment. ISO 14971 is a worldwide standard that offers a framework for controlling the risks connected to medical devices at every stage of their life cycle, from… Read more»

es364 replied to the topic "Ways to deal with risks" -

Sun, 19 Nov 2023 14:52:28 -0500

An example of avoiding risk is when a specific substance used in the urinary catheter was found to have the potential to cause allergic reactions in certain patients . The company chooses to modify the urinary catheter using a different… Read more»

es364 replied to the topic "Risk Assessments are necessary or not for medical devices?" -

Sun, 19 Nov 2023 14:20:13 -0500

Risk assessments are required for medical devices. The regulatory framework for medical devices must include risk assessment as a fundamental element in order to guarantee the long term efficacy and safety of these devices. Risk identification, which begins with the… Read more»

es364 replied to the topic "Corporate Responsibility?" -

Sun, 12 Nov 2023 01:11:38 -0500

Like most of the comments, I believe that companies are taking their corporate responsibility very seriously. Companies are now expected to conduct business ethically, addressing matters like honesty, integrity, and transparency in their dealings with patients and healthcare providers. Furthermore,… Read more»

es364 replied to the topic "Gantt Chart Thought Process and Considerations" -

Sun, 12 Nov 2023 00:58:11 -0500

To guarantee an efficient project management procedure, a number of elements should be taken into account when arranging tasks and generating a Gantt chart. As most have indicated, timeliness is a key consideration. Another crucial piece of information that has… Read more»

es364 replied to the topic "Design Review Meetings: Attendance & Causes for Scheduling" -

Sun, 12 Nov 2023 00:43:22 -0500

Interim design review meetings are frequently brought about by the requirement to be flexible and adaptable to changing conditions as the product is being developed. An interim design review meeting may be scheduled for a variety of reasons by a… Read more»

es364 replied to the topic "Design Control Job Roles" -

Sat, 04 Nov 2023 16:23:45 -0400

I believe that staff skill levels, project complexity, and company size have the biggest effects on design control roles. More specialized positions may exist in larger organizations, enabling engineers to concentrate on particular facets of design controls. Employees can have… Read more»

es364 replied to the topic "Designing Verification Tests" -

Sat, 04 Nov 2023 16:13:08 -0400

When developing test procedures and protocols, some important things to take into account could be Standards and Regulations Compliance aspects, which mean making sure our testing procedures adhere to relevant legal requirements.Additionally, the tests that are required should be determined… Read more»

es364 replied to the topic "Design Input Requirement Categories" -

Sat, 04 Nov 2023 15:53:59 -0400

One of the functional requirements for an artificial cervical disc is that it should permit the cervical spine to move in a manner that is comparable to that of a healthy natural disc, including flexion, extension, lateral bending, and rotation.A… Read more»

es364 replied to the topic "What role would best fit your experience/skillset in clinical research?" -

Sun, 29 Oct 2023 23:33:14 -0400

I think investigator and study coordinator are two roles within clinical research that suit me best. I have experience working with doctors and patients. I have been working in my family’s private medical clinic for several years. My responsibility was… Read more»