Medical Device Courses | jjp93 | Activity

jjp93 replied to the topic "Clinical Project Team Roles" -

Mon, 27 Apr 2020 19:57:49 -0400

Out of all those options for a clinical project team, I would pick a lab to work in or Clinical Research Associate. It involves the actual research for the trials and analyzing the data. You are very involved in the… Read more»

jjp93 replied to the topic "Overworked Americans vs. Motivation" -

Mon, 27 Apr 2020 19:43:02 -0400

Many Americans put in more hours because they give into the peer pressure of working long hours but also because they have too much work to do. Each industry is different, but some companies do push their workers to continuously… Read more»

jjp93 replied to the topic "Why do people leave work?" -

Mon, 27 Apr 2020 19:34:43 -0400

I believe that limited recognition and praise is definitely a valid reason to leave work but I also believe if the work culture is toxic or unhealthy for the person, that’s another reason people leave. That or there isn’t growth… Read more»

jjp93 replied to the topic "Why do people work?" -

Sat, 25 Apr 2020 01:58:59 -0400

People have many different reasons for working and that too in combination of the ones that are listed. I am not surprised at all about the results. For me personally, I care about the exciting and challenging work, as well… Read more»

jjp93 replied to the topic "Engineer vs. Manager" -

Sat, 25 Apr 2020 01:51:16 -0400

I think if I were given a choice between a management role and an engineering/tech role, I would want to choose the engineering/tech role. I would want to work for many years in the engineering/tech role and learn as much… Read more»

jjp93 replied to the topic "What’s Your Motivator?" -

Sat, 25 Apr 2020 01:44:24 -0400

I think many factors motivate me to finish my work and goals. At work, deadlines motivate me to finish my work. Everything has to get done on time and I am someone who stresses if I do not meet deadlines… Read more»

jjp93 replied to the topic "Importance of Human Resource Management" -

Thu, 16 Apr 2020 00:36:05 -0400

Human resource management is important for the medical device field because when you hire someone for the right role, they should be able to time manage and live up to those responsibilities that were required for the position. HR also… Read more»

jjp93 replied to the topic "Procurement Management" -

Thu, 16 Apr 2020 00:14:33 -0400

I specifically have not had to encounter choosing vendors, but our company has had specific vendors and vendor changes. What I believe are some steps to choose a vendor is how long it takes for them to get the request… Read more»

jjp93 replied to the topic "Communication Management" -

Thu, 16 Apr 2020 00:07:30 -0400

I do agree that lack of communication can cause many issues in any aspect of life, especially at work and in teams. For a project, communication should be dependent on everyone in the project and organization. The organization has to… Read more»

jjp93 replied to the topic "planned value vs actual costs" -

Fri, 10 Apr 2020 21:35:02 -0400

Planned value and actual costs are very important when in the monitoring and controlling phase. When starting the project, you have to figure out how much money will be involved in the project and how much to estimate. When monitoring… Read more»

jjp93 replied to the topic "Importance of Metrics" -

Fri, 10 Apr 2020 21:27:10 -0400

Metrics definitely have an important to the team as a whole as well as the project manager. This gives everyone a clear view of where everyone is and what areas need work. Weekly metrics give people a clear understanding of… Read more»

jjp93 replied to the topic "PM: Handling Team Issues" -

Fri, 10 Apr 2020 21:21:44 -0400

Real world issues will always arise in any situation when it comes to team projects. Everyone gets sick or has to take a vacation, but these situations are to help those recover and clear their mind to think better when… Read more»

jjp93 replied to the topic "Underestimating Task Duration" -

Sun, 29 Mar 2020 20:10:26 -0400

Having a lack of knowledge in the new area of research or issues with international projects that become delayed because its not completed do have an effect on task duration. When working with international companies, their timeline and how they… Read more»

jjp93 replied to the topic "Risk Management impact" -

Sun, 29 Mar 2020 20:03:07 -0400

The word risk does give off negative thoughts, but I do not believe that risks are always negative. Having risk management is important in knowing the potential hazards that can affect the product and the consumers which will help the… Read more»

jjp93 replied to the topic "Meeting Deadlines with Research" -

Sun, 29 Mar 2020 19:56:39 -0400

There has been a lot of research and time put into developing the one carrier for FactoSet and deadlines are approaching but an effective method is to make sure to reference the Gantt Chart that was created when first starting… Read more»

jjp93 replied to the topic "Benefits of this course" -

Fri, 13 Mar 2020 18:00:19 -0400

My thoughts on this course are that it is filled with so much information and it is delivered well. I think the forums as well as the simulations help students to learn about the industry and make us thing more… Read more»

jjp93 replied to the topic "Design Validation" -

Fri, 13 Mar 2020 17:54:33 -0400

I believe that the user needs and intended need are not as specific so that when design validation occurs, there is leeway for what is considered passing and failing. They do need to be well defined but not too detailed… Read more»

jjp93 replied to the topic "Team Development" -

Thu, 12 Mar 2020 16:43:48 -0400

I believe during the execution process, when an employee goes on vacation or is absent, those that can be foreseen should be incorporated in the timeline created earlier during the initiation and planning phase. There should be time overestimated for… Read more»

jjp93 replied to the topic "Challenges PM face" -

Mon, 02 Mar 2020 18:08:45 -0500

One challenge that project managers face with projects is making sure each task stays on track with the Gantt Chart. Each member of the group has to make sure to do their part in the project but sometimes problems arise,… Read more»

jjp93 replied to the topic "Communication and Responsiveness" -

Mon, 02 Mar 2020 18:08:16 -0500

Within groups, there are many different type of people, where some people do not communicate with the rest of the group or not often enough. When this happens, most likely people are always going to be bothering the unresponsive member… Read more»

jjp93 replied to the topic "Overlapping activities" -

Mon, 02 Mar 2020 18:07:22 -0500

I believe the planning phase is really important for a project to be successful. Like in the example, problems are unavoidable which may require members of the group or the project manager to go back and figure out other ways… Read more»

jjp93 replied to the topic "Importance of Logging Work" -

Mon, 24 Feb 2020 18:31:39 -0500

I agree that logging work is important especially when there are new employees at work as well as when there are audits going on. When I used to work at a research lab, there were different notebooks used for different… Read more»

jjp93 replied to the topic "Estimating Project Timeline" -

Mon, 24 Feb 2020 18:20:52 -0500

I agree that the entire team is needed to determine the duration of the project and each task because those who work on those tasks will know how long they will take and what will be involved in the task…. Read more»

jjp93 replied to the topic "Gantt chart" -

Mon, 24 Feb 2020 18:12:56 -0500

It’s important to have multiple overlapping tasks in different categories because in different departments, tasks can be completed early on and at the same time as other tasks which can speed up the timeline and give more time for validation… Read more»

jjp93 replied to the topic "Inputs for Design Input Document" -

Sun, 23 Feb 2020 20:55:03 -0500

I do agree that the marketing team is a good group of people to figure out the specifications of the device, but I also believe that engineering and regulatory should be involved in the specifications. The marketing team knows what… Read more»

jjp93 replied to the topic "Sucess Factors" -

Sun, 23 Feb 2020 20:48:50 -0500

For a project, there should be effective communication within everyone in the group. If people are working by themselves and don’t tell other people on their progress, there can be delays in the project timeline which would push back trials… Read more»

jjp93 replied to the topic "Planning Phase" -

Sun, 23 Feb 2020 20:42:48 -0500

During the planning phase of the project, I do agree that the user needs should be considered in a vague aspect. The customers are the ones who are going to be using the device/product so that should be one of… Read more»

jjp93 replied to the topic "Communication is the way" -

Mon, 10 Feb 2020 19:00:20 -0500

Communication is definitely a big factor in projects because without it, you aren’t able to talk to vendors, other team members, your manager, or the customers. I also believe you need to be a good listener and approachable because when… Read more»

jjp93 replied to the topic "Best timing for validation and verification" -

Mon, 10 Feb 2020 18:52:54 -0500

The best time for validation and verification is when all the deliverables and specifications of the project are figured out and then it’s time to manufacture and test out the actual product. You must make sure that the product looks… Read more»

jjp93 replied to the topic "Simulations" -

Mon, 10 Feb 2020 18:45:04 -0500

If this was a real industry project with a team, there would be more face to face interactions. There would be meetings and discussions with different people in the team to discuss how to go about the issue in the… Read more»

jjp93 replied to the topic "Product Life Cycle" -

Thu, 06 Feb 2020 01:34:08 -0500

I do agree that sutures do not seem to have decline in the different phases of the product life cycle but potentially in the future it might. Currently sutures are used in hospital settings as well as clinics to fix… Read more»

jjp93 replied to the topic "Initiating a Project Idea" -

Thu, 06 Feb 2020 01:27:32 -0500

The hardest part of the project development is initiating an idea because many devices and projects already exist. There are different testing that each project requires and if it does not make a revenue for the company, many of the… Read more»

jjp93 replied to the topic "Design Control Process" -

Thu, 06 Feb 2020 01:20:15 -0500

While currently working in the industry, I had a chance to be apart of the Design Changes and a little bit of the verification and validation part of the design controls steps. I would definitely like to be more involved… Read more»

jjp93 replied to the topic "Determining project priority" -

Sun, 02 Feb 2020 22:26:35 -0500

I do agree that many of the lower priority projects go on hold or get cancelled because of the lack of resources as well as the lack of interest and benefit of the project. Resources can impact a project timeline… Read more»

jjp93 replied to the topic "Possibility of Global Regulation of Medical Devices?" -

Sun, 02 Feb 2020 22:17:44 -0500

With the different regulatory systems including FDA and the Europe’s new system, there can be a globalization of regulatory procedures, but I don’t think it would be any time soon. There are many products that can be used in the… Read more»

jjp93 replied to the topic "FDA Regulations of Medical Device-Drug" -

Sun, 02 Feb 2020 22:07:32 -0500

With the different regulation requirements for medical devices and drugs individually, I do believe that when a combination of the two is at play, that both regulation requirements need to be done to have the product be approved by the… Read more»

jjp93 replied to the topic "Discussion Topic: Projects of all types" -

Tue, 21 Jan 2020 21:08:54 -0500

I do believe Project Management has its similarities and differences in different types of industries. It all pertains to the type of project people are working for. Each project manager will have to work with different types of team members… Read more»

jjp93 replied to the topic "Ideal project team" -

Tue, 21 Jan 2020 21:07:54 -0500

For a project team, it would be dependent on how many people are needed for the project and what kind of project it is. For a project that requires a lot of team work, I would want people who can… Read more»

jjp93 replied to the topic "Interpersonal Skills" -

Tue, 21 Jan 2020 21:06:59 -0500

Interpersonal Skills are important skills to have when working with coworkers and managers in a industry or academic setting. A Project manager must be able to communicate with their team and other managers to convey what is needed in the… Read more»

jjp93 replied to the topic "Written Agreement v/s Verbal Agreement" -

Wed, 15 May 2019 21:38:48 -0400

The difference between or verbal and written agreements is that written agreements definitely easier to find and use as proof if something goes wrong or to show the other person what’s in the fine print when there is a disagreement…. Read more»

jjp93 replied to the topic "Restrictions for physician's gifts" -

Wed, 15 May 2019 21:38:48 -0400

I do believe this is too restricted, but it is also for good reason. Getting gifts worth more, even if it is health based, can seem as a bribe and could be used against the doctor in the future. Or… Read more»

jjp93 replied to the topic "Discussion Topic: Course conclusion and impressions" -

Wed, 15 May 2019 21:38:47 -0400

I believe this course was beneficial for an overview of the medical device industry as well as academia. I learned a lot about which departments I would not be interested in but also realized some departments that could be of… Read more»

jjp93 replied to the topic "Forming a Project Team" -

Wed, 15 May 2019 21:37:38 -0400

I believe you need to have a good balance of someone who is knowledgeable in their role as well as a good relationship with them. Someone who you do not get along with might be more difficult to work with… Read more»

jjp93 replied to the topic "Organization Type vs. Effectiveness" -

Wed, 15 May 2019 21:37:38 -0400

I think that the best organizational structure would be a mix between functional organization and matrix. There aren’t silos and information is given to everyone in the department depending on the project. Even though you are reporting to more than… Read more»

jjp93 replied to the topic "Discussion Topic: Your organizational type" -

Wed, 15 May 2019 21:37:37 -0400

I find that at my job, we are a mixture of functional and project-based organization. We have different departments ranging from microbiology, HCM, different engineers, manufacturing, and marketing. All the teams work with each other within the department but some… Read more»

jjp93 replied to the topic "Risk Management Mistakes" -

Wed, 15 May 2019 21:36:51 -0400

I believe this article has a many valid points. Risk management and design control should be used together to make sure everything runs smoothly for the product that is being designed. If they are used separately, many simple mistakes can… Read more»

jjp93 replied to the topic "Expense of Regulations" -

Wed, 15 May 2019 21:36:48 -0400

I believe these regulations costs money is because of how useful it is which means there will be people who need it, making it a business. The company has to purchase them to make sure all the companies’ regulations are… Read more»

jjp93 replied to the topic "Manage Risk" -

Wed, 15 May 2019 21:36:48 -0400

For a low severity of a risk, I would either choose acceptance or mitigation depending on the situation. If the risk had options of making it less severe or less likely to occur through mitigation, I would say this is… Read more»

jjp93 replied to the topic "What FDA Looks For In A Design Control System ?" -

Wed, 15 May 2019 21:35:59 -0400

I believe for a complete design control system, they will look at the correct signatures for the documentations and see if everything is timed properly. If an instrument is being used and has the same time for two different things,… Read more»

jjp93 replied to the topic "Consequences Of Insufficient Design Controls" -

Wed, 15 May 2019 21:35:58 -0400

I believe that the design control portion can be used insufficiently if there aren’t proper design review meetings or if these meetings are not facilitated correctly. These meetings are used to help create the product without any faults or misunderstandings… Read more»