Medical Device Courses | kelsipetrillo | Activity

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

Thu, 01 May 2025 03:28:10 -0400

My biggest personal motivator is personal growth. I’m inspired by the fact that there are lots of things that I don’t yet know. When starting something new, I am excited to find out what I will learn from it. I… Read more»

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

Thu, 01 May 2025 03:20:53 -0400

There are many ways to keep long projects engaging while also preserving consistency. One great idea was already suggested, which was to celebrate the small wins. These celebrations can help invigorate morale without distracting from the project. Some examples of… Read more»

kelsipetrillo replied to the topic "Employee Engagement" -

Mon, 21 Apr 2025 13:37:50 -0400

I agree with the previous response that regular evaluations are helpful for improving employee engagement. One topic that I see being heavily discussed often on professional platforms such as LinkedIn is the ability of companies to treat their employees as… Read more»

kelsipetrillo posted a new topic "Creating Realistic Schedules in Clinical Trials" -

Mon, 21 Apr 2025 13:32:12 -0400

A critical component of clinical trial planning is to create a detailed timeline, which can be enhanced with tools such as Gantt charts. However, clinical trials can pose a unique set of challenges compared to other types of projects because… Read more»

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

Mon, 21 Apr 2025 13:24:45 -0400

As has been discussed throughout this thread, there are a variety of factors that influence retention. When considering how authority affects whether employees want to stay or leave, it is necessary to understand the authoritative model used at the company…. Read more»

kelsipetrillo replied to the topic "Nine Knowledge Areas" -

Fri, 18 Apr 2025 17:07:58 -0400

I agree with what has been previously mentioned: all 9 knowledge areas are critical for effective projects. However, if I had to chose the three most important, I would pick integration management, scope management, and risk management. Integration management is… Read more»

kelsipetrillo posted a new topic "Maximizing Quality Management" -

Thu, 17 Apr 2025 23:40:45 -0400

The process of quality management is highly dependent on regulatory considerations and company standards. However, the purpose of quality management is truly to provide an exceptional product that functions at its maximal potential. Further, the main aspects of quality management… Read more»

kelsipetrillo posted a new topic "Navigating Compressed Schedules" -

Thu, 17 Apr 2025 22:49:48 -0400

To shorten the length of a project, duration compression can be used, such as crashing and fast tracking. On one hand, crashing can result in higher costs, while fast tracking can cause increased work and possibly increased risk. A project… Read more»

kelsipetrillo replied to the topic "Lessons from Medtronic’s 2015 Consent Decree – Why Robust Change Control is Critical" -

Fri, 11 Apr 2025 20:10:03 -0400

The Medtronic SynchroMed II example demonstrates an important principle: the lifecycle of a device does not end once it enters the market. Instead, it enters a phase where rigorous change control, robust quality systems, and continuous post-market surveillance become critical…. Read more»

kelsipetrillo replied to the topic "Impact of Testing Variability on Product Risk" -

Tue, 08 Apr 2025 22:36:38 -0400

In medical device development, it’s critical to make sure your results are generalizable and repeatable. One way to do this may be to implement standards that all labs should use when conducting their experiments. A good demonstration of how this… Read more»

kelsipetrillo replied to the topic "Managing Early Market Interest Before Project Completion" -

Tue, 08 Apr 2025 22:29:38 -0400

This is a topic I was interested in discussing as well, especially after getting started on this week’s simulation. In the context of the simulation, it seems as though there were some disclosure issues: the client fully implemented the product… Read more»

kelsipetrillo replied to the topic "Change Control in Project Management" -

Mon, 24 Mar 2025 20:30:20 -0400

I agree that this is a very important topic for project managers to consider. On one hand, you should want to design the best product possible. On the other hand, as you discussed, you have to avoid scope creep, cost… Read more»

kelsipetrillo replied to the topic "Role of Monitoring & Controlling in Project Success" -

Mon, 24 Mar 2025 20:21:19 -0400

This is an interesting question. While conventionally quantitative outcomes are important to consider, there are lots of other key considerations as well (such as team morale and stakeholder expectations, as you mentioned). In any project, there will have to be prioritization…. Read more»

kelsipetrillo replied to the topic "Importance of Lessons Learned in the Project Closing Phase" -

Mon, 24 Mar 2025 20:12:34 -0400

One of the key strategies to ensure “lessons learned” are actually learned is effective collaboration and communication. As you touched on in your post, the first step to this is adequate documentation throughout the project. This way, no key details… Read more»

kelsipetrillo replied to the topic "Significance of Team Development in Project Execution" -

Tue, 11 Mar 2025 23:54:21 -0400

As mentioned in this week’s lecture, teams should be designed such that each team member has different skill sets that will contribute uniquely to the project tasks. For this reason, team design is probably one of the most critical components… Read more»

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

Tue, 11 Mar 2025 23:41:07 -0400

As mentioned previously, an effective method to mitigate scope creep is to have solid relationships with stakeholders. A big part of this is consistent communication, so that stakeholders are involved every step of the way. One way to make this… Read more»

kelsipetrillo posted a new topic "Optimizing Information Distribution" -

Tue, 11 Mar 2025 23:16:39 -0400

A key executing process in project management is information distribution. This entails different forms of communication, such as emails and meetings. A common joke in the workforce is “this could have been an email”. Although it’s a joke, it does… Read more»

kelsipetrillo replied to the topic "Email Communication" -

Sun, 09 Mar 2025 15:49:15 -0400

In my opinion, communicating via email is much better than Teams in a project management context. In my own work, there are some projects I have been involved in for years now. Often, communications can seem mundane in the moment,… Read more»

kelsipetrillo posted a new topic "Considerations of Verification Protocols" -

Sun, 09 Mar 2025 15:43:37 -0400

Designing a good verification protocol is a key aspect of project development. An effective verification protocol will ensure that the project scope is fulfilled and stakeholder expectations are met. It will test all design specifications. One critical aspect of these… Read more»

kelsipetrillo replied to the topic "Initiating Medical Device Projects" -

Sun, 09 Mar 2025 15:32:43 -0400

As briefly previously mentioned here, one big obstacle that can occur during the project initiation phase is lack of regulatory understanding. Medical devices are subjected to strict regulatory considerations. Regulatory parameters are nuanced depending on features of the device, such… Read more»

kelsipetrillo replied to the topic "Significance of Scheduling in the Planning Phase" -

Wed, 26 Feb 2025 01:25:49 -0500

I have worked on a project before that faced some major scheduling complications. In my case, we noticed very late in the project that a manufacturing device we had used early in the project had been malfunctioning. Consequently, we had… Read more»

kelsipetrillo replied to the topic "Identifying the Critical Path – Preventing Project Delays" -

Wed, 26 Feb 2025 01:15:05 -0500

I totally agree with the points you made in your post. It is crucial to develop both an effective and realistic schedule. As you briefly mentioned, a great way to do this is by using Gantt charts. While I have… Read more»

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

Wed, 26 Feb 2025 01:10:06 -0500

Hi everyone. My name is Kelsi, and I am a BME PhD student at Rutgers. I would love to connect with you all on LinkedIn:
http://www.linkedin.com/in/kelsi-petrillo
Thanks!

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

Sun, 23 Feb 2025 18:44:39 -0500

A very useful tool for managing scheduling in project management and medical device development is the Gantt Chart. Gantt charts can be used to visualize the timeline of a project. They give valuable information about which tasks must be finished… Read more»

kelsipetrillo replied to the topic "Avoiding Pitfalls in Project Initiation: The Importance of Clear Proposals and Feasibility Studies" -

Sun, 23 Feb 2025 18:32:04 -0500

As previously mentioned above, there are many negative consequences of having a poorly designed project proposal: misused resources, shareholder disappointment, projects delays, etc. I have never been apart of a project with this challenge, although I have some ideas of… Read more»

kelsipetrillo replied to the topic "Benefits and Challenges of Gantt Charts in Medical Device Projects" -

Sun, 23 Feb 2025 18:21:56 -0500

I have worked with Gantt charts previously on medical device projects and believe they have more benefits than limitations. In my experience, one of the biggest cons of Gantt charts is that they can be tedious/ time consuming, especially early… Read more»

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

Sun, 16 Feb 2025 21:49:27 -0500

DSDs include the key features of the device and outline in which conditions a device can not fail. Therefore, changing the DSD would almost certainly have implications of requiring changes within the verification testing as well. As mentioned in the… Read more»

kelsipetrillo posted a new topic "Managing Problem Solving on Diverse Teams" -

Fri, 14 Feb 2025 19:19:23 -0500

This week in class, we had our first project simulation. The goal of the simulation was to determine how to modify a testing protocol to identify what was causing a failure in the label adhesive. One thing I noticed in my… Read more»

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

Fri, 14 Feb 2025 19:10:01 -0500

As has already been discussed, I agree that it’s important to test a variety of conditions. This way, you can mimic more common/ “real world” settings and also test the limits of the product. With that being said, in the context… Read more»

kelsipetrillo replied to the topic "Functional vs Project-Based vs Matrix Organizations – Which Works Best?" -

Thu, 06 Feb 2025 16:19:56 -0500

As mentioned, matrix structures can lead to power struggles/ conflicting priorities, however, there are many ways an organization can mitigate conflicts without compromising efficiency and compliance. 1. Create clear roles and guidelines for all projects. “Power struggles” will most likely… Read more»

kelsipetrillo replied to the topic "Managing Design Change Requests Effectively Without Disrupting Development" -

Thu, 06 Feb 2025 16:09:10 -0500

I completely agree with the information you have included here about efficiently managing design change requests. I would expect that design changes are quite common in medical device development, so it is critical for companies to consider how they will… Read more»

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

Sat, 01 Feb 2025 16:38:06 -0500

An important consideration when deciding to use in house or external consultants is the longevity and size of the company. If the company has prior experience with similar devices, developing in house consulting will probably be more efficient since they… Read more»

kelsipetrillo replied to the topic "Balancing time, cost and scope in project management" -

Sat, 01 Feb 2025 16:24:48 -0500

In my experience, time is the most difficult aspect of a project to control. I had a personal experience with this when I was working on designing a medical catheter, which was designed to burst at a certain pressure to… Read more»

kelsipetrillo replied to the topic "Importance of Regulatory Strategy in Medical Device Project Management" -

Sat, 01 Feb 2025 16:14:50 -0500

As mentioned throughout this thread, it is critical to consider regulatory restraints early in the design process to have effective project management. However, I believe there may also be some advantages in waiting until later in the process, even though that… Read more»

kelsipetrillo replied to the topic "Leaders: Nature or Nurture?" -

Wed, 22 Jan 2025 19:11:30 -0500

I don’t believe anyone is born ready to be a leader without actively working towards that goal. As many people have mentioned in this thread, there is a lot of practice and experiences that must occur first to shape a… Read more»

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

Wed, 22 Jan 2025 19:11:29 -0500

I would like to expand on an idea that has been briefly mentioned in this thread, which is the idea that “toxic workplace culture” may be a largely subjective term. One example of this that I often see debated is remote… Read more»

kelsipetrillo replied to the topic "How would you handle team conflict as a Project manager?" -

Wed, 22 Jan 2025 19:11:29 -0500

One of the commonly mentioned strategies in this thread is to meet with all involved parties and work together to find a solution that will appease everyone. While I believe that’s a great idea, my own experiences have taught me that… Read more»