Medical Device Courses | cn249 | Activity

cn249 replied to the topic "Employee Engagement" -

Wed, 29 Apr 2026 21:32:04 -0400

In my work environment, we work 12 hour shifts within the same three rooms. We have different coworkers working in different sections based on the schedules made by our coordinator. Typically, in one room, there would be three to four… Read more»

cn249 replied to the topic "How to manage and train low performers in common companies?" -

Wed, 29 Apr 2026 20:50:32 -0400

Companies usually have a record for any mishaps or mistakes that employees make. In a biotechnology company for medical purposes, there will indeed be a record of any mistakes an employee makes, let it be a small mistake or a… Read more»

cn249 replied to the topic "Are you an X or Y?" -

Wed, 29 Apr 2026 20:37:29 -0400

To begin, as a team leader, I would say to be patient, understanding, and confident in your position. You are the team leader for a reason. Show management or your team members that you are capable and that there is… Read more»

cn249 replied to the topic "The Manager’s Role in Sustaining Team Engagement During Trials" -

Wed, 22 Apr 2026 19:51:24 -0400

There are different techniques managers use to keep teams motivated during long projects. There should be weekly standups or weekly meetings with their entire team to see where everyone is at and if there are any areas they need help… Read more»

cn249 replied to the topic "Motivation factors" -

Wed, 22 Apr 2026 19:24:58 -0400

I agree with everyone that has posted here. The only thing is that the job I am currently at does not align with my studies or passion. As an undergraduate coming out of college, that first real industry job is… Read more»

cn249 replied to the topic "Why Do People Leave?" -

Wed, 22 Apr 2026 19:11:48 -0400

Job satisfaction is the most important factor in employee retention and productivity, but compensation and a good work environment are the main drivers of job satisfaction. If those factors are missing, most people would not stay. With compensation, there are… Read more»

cn249 replied to the topic "Human Resource Management" -

Wed, 15 Apr 2026 23:35:14 -0400

Many users mentioned the Failure Mode and Effects Analysis (FMEA). This is a method that can be used to prevent errors, losses, or subsequent issues. FMEA is a method to analyze risk and looks at how something can fail, the… Read more»

cn249 replied to the topic "Familiarity of eachothers work" -

Wed, 15 Apr 2026 20:44:50 -0400

Precious time should be used to make sure that everyone has a working idea of what everyone does. It is important to share what others are doing. Based on personal experiences, it generally feels unprofessional and infuriating when team members… Read more»

cn249 replied to the topic "Nine Knowledge Areas" -

Wed, 15 Apr 2026 20:29:53 -0400

Every post here has a good combination of which three out of the nine knowledge areas are important. Personally, I would say that time management, scope management, and cost management are the most important and most prevalent in medical device… Read more»

cn249 replied to the topic "Personnel evaluation when succeeding project but delaying." -

Wed, 08 Apr 2026 21:47:35 -0400

In the industry, there is no such thing as a project being 100% successful with no failure, delays, or something going wrong. There also should not be a 100% failure rate on a project with careful planning, organization, and appropriate… Read more»

cn249 replied to the topic "Different results from each test companies." -

Wed, 08 Apr 2026 20:58:31 -0400

In the real industry, this tends to happen a lot as even though the verification and validation has passed within the company, it can fail with the contracted company’s methodology while prematurely signing a license agreement when the verification and… Read more»

cn249 replied to the topic "hiring policies for a project manager" -

Wed, 08 Apr 2026 20:40:36 -0400

As many user posts have mentioned, there are benefits to hiring within the company and from outside sources. Generally, it would be better to hire within the company because the employees would know how the company operates. They would know… Read more»

cn249 replied to the topic "Monitoring and Controlling in a Project" -

Wed, 25 Mar 2026 19:15:58 -0400

In addition to the listed items and what others have said, quality assurance/control, risk management, post-market surveillance, and customer satisfaction/user interaction would benefit from monitoring and controlling as well. These aspects should be paid close attention to in all types… Read more»

cn249 replied to the topic "monitoring phase of a project" -

Wed, 25 Mar 2026 18:45:00 -0400

It is generally agreed upon that too much monitoring would lead to micromanaging when it comes to project management. Too much monitoring can also lead to overhead. With unnecessary monitoring, the project management team is already wasting hours rather than… Read more»

cn249 replied to the topic "The power of the board of directors" -

Wed, 25 Mar 2026 18:31:35 -0400

The board of directors at any job, being a biotechnology group or a medical device company, are pretty powerful when it comes to running a project. The board has plenty of power because they have the ability to decide if… Read more»

cn249 replied to the topic "Significance of Scope Verification in Project Execution" -

Wed, 11 Mar 2026 21:46:07 -0400

Scope verification is the acceptance of the project scope which is different from design controls verification. These are the objectives, deliverables, milestones, technical requirements, limits and exclusions, and reviews with customers. The biggest challenge is scope creep and this happens… Read more»

cn249 replied to the topic "Companies efforts in the executing step" -

Wed, 11 Mar 2026 21:20:56 -0400

Most companies use estimated deadlines and progress reports to look into whether the project is progressing properly or not. As per the lecture this week, status review meetings are done to review progress during the project execution. These regularly scheduled… Read more»

cn249 replied to the topic "Project Plan Execution" -

Wed, 11 Mar 2026 21:08:31 -0400

With my undergrad experience and at my current place of employment, team development is important especially for project plan execution. With undergrad, the senior project involves building a medical device prototype and I had the role of being the team… Read more»

cn249 replied to the topic "Managing Resources When Faced with Design Flaws" -

Wed, 04 Mar 2026 23:39:03 -0500

The preliminary tests should be dependent on the risk factors, the cause for failure, and implementing fast, yet low-cost methods. As seen with this simulation, time is of the essence due to the partnership and competitive nature of the medical… Read more»

cn249 replied to the topic "Why Capturing Lessons Learned Matters" -

Wed, 04 Mar 2026 23:05:56 -0500

The closing process group is generally responsible for concluding all activities to formally complete the project, phase, or contractual obligations. The lessons learned are also part of the organizational process assets. The earliest chance that companies should review the closing… Read more»

cn249 replied to the topic "Hiring team members" -

Wed, 04 Mar 2026 22:28:05 -0500

With what many users have posted and collectively agreed upon, having a group of hires that have broad skill sets that can be more versatile in their role would be the most ideal group and make a stronger team. It… Read more»

cn249 replied to the topic "Project Slack and Start and Finish Times" -

Wed, 25 Feb 2026 23:00:49 -0500

Project slack is the difference between the late finish and the early finish. As long as the project is finished within that range, the project is okay. During project slack, the schedule can be juggled where the team can account… Read more»

cn249 replied to the topic "In planning, the method to calculate each task duration." -

Wed, 25 Feb 2026 22:44:34 -0500

Scheduling tasks really depends on how difficult it is and how it affects the sequential events that come after that task or what needs to be done before or after that task. Most can be calculated with the Gantt chart… Read more»

cn249 replied to the topic "Pitfalls of estimate both costs and resources" -

Wed, 25 Feb 2026 22:18:34 -0500

For my senior project during undergrad, my team and I had experienced the pitfalls of costs and resources. The academic project served as a way to allow biomedical engineering students to understand what it takes to develop and design a… Read more»

cn249 replied to the topic "Risk Responses" -

Wed, 18 Feb 2026 23:07:12 -0500

In the lecture, the risk management process involves assessing, evaluating, managing, and measuring. You assess the situation with what can go wrong and make a list. Then, you evaluate the list to see how probable and if they can hurt… Read more»

cn249 replied to the topic "Initiating Process Group" -

Wed, 18 Feb 2026 22:29:31 -0500

During the lecture, Dr. Simon had explained and defined these three inputs that make up the initiating process group of PM. The Enterprise Environmental Factor is everything you know about the organization’s culture and how the organization behaves around projects…. Read more»

cn249 replied to the topic "Team members personal issues with eachother" -

Wed, 18 Feb 2026 22:21:55 -0500

A project manager chooses the people for a project team and that is part of the planning process group. They choose these people based on their skill sets, availability, knowledge, and sometimes compatibility. Everyone in the group would have the… Read more»

cn249 replied to the topic "Failed Verification Testing" -

Wed, 11 Feb 2026 23:36:28 -0500

The only industry example I have is in a biotechnology company, but with medical device development, I have an example for when I worked on creating a medical device prototype for my undergrad senior project with my group. With the… Read more»

cn249 replied to the topic "Design Change Requests" -

Wed, 11 Feb 2026 22:20:57 -0500

The best way to avoid this type of situation is communication. Communication plays the biggest role in project management to relay messages or any sort of changes in the project especially due to the time deadline, budget, and resources being… Read more»

cn249 replied to the topic "Business and customer satisfaction in project management" -

Wed, 11 Feb 2026 22:03:38 -0500

Business needs and customer satisfaction should both be markers in the goals they want to accomplish in project management. For example, with running a biotechnology business, the company’s needs are more than likely going to be getting clients, increasing production,… Read more»

cn249 replied to the topic "Critical Role of Design Controls in Medical Device Projects" -

Wed, 04 Feb 2026 22:30:52 -0500

Like what many users have mentioned, involving regulatory experts and validation early into the development process is a way for organizations to find that balance between regulatory compliance and innovation. The use of regulatory compliance is to make sure that… Read more»

cn249 replied to the topic "Should procedures or standards for verification and validation tests be approved by the FDA?" -

Wed, 04 Feb 2026 21:58:59 -0500

Verification checks that the inputs equals the output, meeting design specifications, while validation checks that the inputs equal the user needs or intended use, satisfying the acceptance criteria. All of these testings are done by the project manager and project… Read more»

cn249 replied to the topic "Project Managers utilization of PDCA and other structured processes" -

Wed, 04 Feb 2026 21:25:19 -0500

If there are resource pressures or the lack of resources, during the planning stage, the project manager can identify what they need, what manufacturers produce those resources, and how abundant they are with availability, material wise and team member wise…. Read more»

cn249 replied to the topic "What are challenges will we face if we missclassify a medical device ?" -

Wed, 28 Jan 2026 21:32:24 -0500

According to the FDA, the classification of a medical device is based on finding the regulation number that is the classification regulation of the device. Project teams have to use a classification database or find the device panel. Device classification… Read more»

cn249 replied to the topic "The Role of Regulatory Strategy in Combination Product Development" -

Wed, 28 Jan 2026 21:06:47 -0500

As many users under this post have mentioned, a balance of both the medical device’s own regulatory experts and an outsource to consultants would be the best in both worlds. Both regulatory experts and consultants have their own skills and… Read more»

cn249 replied to the topic "Caution with Medical Devices that Require a PMA" -

Wed, 28 Jan 2026 20:57:32 -0500

To begin, PMA is one of the most rigorous applications out there for medical devices that can pose-high risk. This typically includes performing pre-clinical and clinical trials to ensure the safety and effectiveness of Class III medical devices. Many regulatory… Read more»

cn249 replied to the topic "Works of a project manager and a program manager?" -

Wed, 21 Jan 2026 23:42:22 -0500

There are slight differences between the works of a project manager and program manager in terms of scope, change, planning, management, success, and monitoring. Overall, they are kind of similar to each other in some aspects. To add onto gdecarvalho’s… Read more»

cn249 replied to the topic "Remote or In-Person PM" -

Wed, 21 Jan 2026 23:03:25 -0500

Honestly at first, communicating in-person was the go-to method for companies, but it can be difficult to work fully in-person with a group of people working on a project. Working under a project manager that primarily communicates online would be… Read more»

cn249 replied to the topic "How to communicate effectively between team mates in project team ?" -

Wed, 21 Jan 2026 22:44:05 -0500

From many experiences with working in a project team as a member and as a leader, a lot of problems form due to miscommunication, misunderstanding, or the lack of communication between team members. As a team member, it is crucial… Read more»

cn249 replied to the topic "Risk Management: Risk v.s. Reward" -

Thu, 13 Nov 2025 06:05:22 -0500

As many users of this post have said, biotechnology companies tend to look at the rewards more than the risks. I do think that there are some companies that actually do take into account the risks, but they only take… Read more»

cn249 replied to the topic "Risk Management Team =/= Project Team" -

Thu, 13 Nov 2025 05:41:46 -0500

There are some cases where the risk management team is the project team. From my experience from my undergraduate senior project, my project team was the risk management team because it was our project. We knew the project all the… Read more»

cn249 replied to the topic "Distinguishing Between Hazards and Hazardous Situations in Risk Evaluation" -

Thu, 13 Nov 2025 05:38:04 -0500

As we have learned from this week’s lecture, hazards are a potential problem posed to you. It is just there and it does not do anything to you. These can include biohazard, chemical, electrical, or mechanical hazards. A hazardous situation… Read more»

cn249 replied to the topic "Feeling Safer?" -

Thu, 06 Nov 2025 02:14:50 -0500

As most users have said here, yes, I do feel safer knowing that medical devices include verification and validation testing. That goes to show that these companies and those building the device have the people’s health and safety in their… Read more»

cn249 replied to the topic "Design Matrix Content" -

Thu, 06 Nov 2025 01:52:27 -0500

I do think that these 4 columns are enough information in a design matrix. Design inputs, design specifications, verification, and validation are the most important and basic information to include in a design matrix. They are all correlated to each… Read more»

cn249 replied to the topic "The Relationship Between Verification and Validation" -

Thu, 06 Nov 2025 01:48:25 -0500

I think that verification and validation can be conducted simultaneously, but that depends mostly on what design input it is for the device. Most of the time, verification testing is done first and validation testing is done later in the… Read more»

cn249 replied to the topic "Design control and risk management" -

Thu, 30 Oct 2025 00:58:01 -0400

Design inputs, control, or requirements are targeted for the intended use of the device in terms of the user and patient needs. Design control helps to indicate the user needs and the specifications associated with it to provide the correct… Read more»

cn249 replied to the topic "Details needed in a DHF for complex devices" -

Thu, 30 Oct 2025 00:48:42 -0400

The Design History File consists of many documentations, figures, protocols, appendices, and miscellaneous items. For any medical devices, simple or complex, they should be extremely detailed to note everything that was done from the initial design to the finished product…. Read more»

cn249 replied to the topic "Impact of customer feedback on design inputs" -

Thu, 30 Oct 2025 00:46:39 -0400

Design teams should incorporate customer feedback into the design process very early on. They should not wait until the last minute to look or ask for feedback when time is ticking away and the deadline for the finished product is… Read more»

cn249 replied to the topic "Ethical Challenges of AI in Clinical Trials" -

Thu, 23 Oct 2025 04:14:56 -0400

Artificial intelligence has been up on the rise as of recent years, but it seems to be slowly taking over this past year. I have not seen this much use of AI until this year. AI can be used to… Read more»

cn249 replied to the topic "Benefits for Patients in Clinical Research" -

Thu, 23 Oct 2025 03:38:02 -0400

Clinical experiments require human testing and this is usually done after preclinical trials have passed in animals and are deemed safe to perform on human testing. It is more involved than animal testing as it has more risks and precautions… Read more»