Medical Device Courses | PJL27 | Activity

PJL27 replied to the topic "Managing Early Market Interest Before Project Completion" -

Sat, 03 May 2025 04:07:06 -0400

I agree with everyone else. It is important to not rush the project process. Each and every step needs the proper amount of time to ensure proper documentation is covered, quality is ensured after appropriate testing, and other key factors…. Read more»

PJL27 replied to the topic "How small projects can grow out of control without warning" -

Sat, 03 May 2025 03:55:46 -0400

I think it is important to maintain proper communication and be transparent of the current issues. A project managemer should approach leadership with a plan on how the team will mitigate the challenge. A plan shows that the team is… Read more»

PJL27 replied to the topic "What factors should be considered during selection a vendor?" -

Sat, 03 May 2025 03:45:37 -0400

Some things to consider when choosing a vendor are quality, timeliness, compliance to regulatory standards, communication, prioritization for patient safety, cost, and more. A vendor needs to understand exactly what the company is requesting and be able to deliver on… Read more»

PJL27 replied to the topic "Engineer vs. Manager" -

Sat, 03 May 2025 03:26:04 -0400

I think this is a great point of discussion. I find myself asking this a lot. I think both roles require a different skillset. Engineers/scientists require more technical knowledge and working with different softwares. Project managers require more poeple skills,… Read more»

PJL27 replied to the topic "Motivation factors" -

Sat, 03 May 2025 03:19:47 -0400

This is a tough question to answer. To provide encouragement on professional growth, a goal is necessary. So without any scope of a promotion or development, it would be difficult to stay motivated. Moving up in a company is more… Read more»

PJL27 replied to the topic "The Manager’s Role in Sustaining Team Engagement During Trials" -

Sat, 03 May 2025 03:13:43 -0400

Something I’ve seen managers do a lot is have regular 1:1s with people and then recurring team meetings where people can bring up any concerns that they have. Something important is for the managers to create a welcoming environment where… Read more»

PJL27 replied to the topic "Vendor Decision" -

Sat, 03 May 2025 03:01:54 -0400

This mini-sim showed great importance of procurement management and risk management. I think it is better to have a backup plan and vendors so in case something goes wronge, you are prepared. I see in many cases where a supplier… Read more»

PJL27 replied to the topic "Procurement Management and environmental/social policies" -

Sat, 03 May 2025 02:56:11 -0400

I think it is fair for companies to encourage their suppliers to comply with more ethical standards. For example, using more ethically sourced materials. However, if the suppliers disagree, companies should have other suppliers in mind that they can use…. Read more»

PJL27 replied to the topic "Nine Knowledge Areas" -

Sat, 03 May 2025 02:29:38 -0400

In my opinion, I think the 3 knowledge areas that are most important are quality management, risk management, and integration management. Quality management is a very critical area and procurement doesn’t matter if they aren’t of high quality. Quality regulations… Read more»

PJL27 replied to the topic "Penalization for Going Over Budget and Time?" -

Mon, 14 Apr 2025 03:50:53 -0400

I agree with the previous posts that sometimes project delays and exceeding the budget is not always expected or at the fault of any team member. Rather, I would prefer delays and going over the budget over poor quality and… Read more»

PJL27 replied to the topic "Lessons from Medtronic’s 2015 Consent Decree – Why Robust Change Control is Critical" -

Mon, 14 Apr 2025 03:38:37 -0400

These cases highlight the importance of keeping up-to-date with newer regulations. As more research is done, certain things are found to be harmful or dangerous. The FDA is always updating their policies. Additionally, many small changes to a device after… Read more»

PJL27 replied to the topic "Why Capturing Lessons Learned Matters" -

Mon, 14 Apr 2025 03:33:28 -0400

I think this is a great point. For bigger projects that have a larger impact or cover something new (new line of medical devices for the company or international product), it is very important to document risks and lessons learned… Read more»

PJL27 replied to the topic "Importance of Lessons Learned in the Project Closing Phase" -

Mon, 31 Mar 2025 03:58:57 -0400

Usually projects that start off will consider similar projects that were executed beforehand and learn about what worked well and what didn’t. Otherwise something that could be implemented is a dashboard of projects that were completed with supporting documents and… Read more»

PJL27 replied to the topic "Information Distribution For Project Success" -

Mon, 31 Mar 2025 03:04:44 -0400

I think that regular meetings should be set (either weekly or biweekly) where regular updates are discussed amongst a team. However, in the case mentioned above, there was a crucial piece of information that was found outside of the regular… Read more»

PJL27 replied to the topic "How Many Project Update Meetings Are Necessary to Keep them Productive" -

Mon, 31 Mar 2025 02:50:16 -0400

To add onto the previous posts, I agree with sending out an agenda prior to the meetings. It gives attendees an idea of what topics will be covered and if any preparation is required.A meeting format that I’ve seen work… Read more»

PJL27 replied to the topic "Optimizing Information Distribution" -

Mon, 17 Mar 2025 03:02:06 -0400

This is funny to me because I’ve discussed this exact topic where I work. Someone joked to me that in the summary emails following a meeting, they would include a very brief 2 sentence recap for one of the project… Read more»

PJL27 replied to the topic "Significance of Team Development in Project Execution" -

Mon, 17 Mar 2025 02:55:22 -0400

Team dynamics play a crucial role in the success of project execution. We can see that in the mini sim we were assigned this week. One team member who was the liason of all business management favored time schedules and… Read more»

PJL27 replied to the topic "Enhancing Quality Assurance: Lessons from the DePuy ASR Hip Recall" -

Mon, 17 Mar 2025 02:45:05 -0400

I agree with the statements the prvious posts mentioned. I think that patient-reported outcome measures (PROMs) are a great way to identify any issues in a medical device after it’s released. However, this is a more reactive approach and I… Read more»

PJL27 posted a new topic "Company collaboration" -

Mon, 10 Mar 2025 03:40:16 -0400

This week, we had our second simulation assignment. It focused on creating a viable injectable bone growth factor syringe. BoneFix, an orthopedic company, was looking to expand its biologics division but lacked a growth factor that would perform well against… Read more»

PJL27 replied to the topic "Email Communication" -

Mon, 10 Mar 2025 03:27:22 -0400

Emails are a much more formal mode of communication. I typically use it when sendging out formal requests, meeting minutes, or need to contact multiple people. I also use it when I am contacting people for the first time as… Read more»

PJL27 replied to the topic "PMI Talent triangle" -

Mon, 10 Mar 2025 03:13:44 -0400

I definitely agree. Having a good grasp on business and strategy can also allow project managers to know which areas to prioritize. For example, if they know a competitor medical device company will also be laucnhing a similar product, they… Read more»

PJL27 replied to the topic "Different Types of Risks in a Project" -

Mon, 03 Mar 2025 04:34:16 -0500

This is a really great topic, and I do think that the answer to which types of risks are more predominant and the most impactful depend on the industry. I think that finanical risk and reosurce risks are not as… Read more»

PJL27 replied to the topic "Task scheduling" -

Mon, 03 Mar 2025 04:00:03 -0500

Another very useful tool is the Work Breakdown Structure. It essentially helps define the project scope better and breaks it down into the larger functions and their tasks. This can help with making sure that no task is overlooked. Forgetting… Read more»

PJL27 replied to the topic "Identifying the Critical Path – Preventing Project Delays" -

Mon, 03 Mar 2025 03:50:48 -0500

I agree with the posts above. Indentifying the critical path will aid in a seamless execution of the project. Another tool I find to be helpful is a prioritization matrix. It will allow the stakeholders and project managers to break… Read more»

PJL27 replied to the topic "Benefits and Challenges of Gantt Charts in Medical Device Projects" -

Mon, 24 Feb 2025 00:00:06 -0500

Gantt charts are a great tool especially for sticking to the project timeline in a visual manner. However, sometimes these charts do not offer flexibility in terms of deadlines. There are many ways Gantt charts can be improved. For example,… Read more»

PJL27 replied to the topic "Avoiding Pitfalls in Project Initiation: The Importance of Clear Proposals and Feasibility Studies" -

Sun, 23 Feb 2025 23:51:45 -0500

Some other things to keep in mind are ensuring that you are up-to-date with all the regulations and standards/qualifications that must be met. The FDA is constantly updating so it is important to be informed of any changes that would… Read more»

PJL27 replied to the topic "Making connections between people and schools" -

Sun, 23 Feb 2025 23:02:00 -0500

Hi everyone! My name is Priyanshi Luhar and I’m a student at NJIT in the BS/MS program studying biomedical engineering. Looking forward to connecting with everyone. I’ve included my linked in below:https://www.linkedin.com/in/priyanshiluhar/

PJL27 replied to the topic "A Hypothetical Perspective about the First Simulation" -

Mon, 17 Feb 2025 04:23:30 -0500

I agree with the points above. Changing the DSD is a more difficult process compared to the test veriffication plan. However, my decision on whether or not it would be appropriate to change the DSD would depend on if it… Read more»

PJL27 replied to the topic "Managing Problem Solving on Diverse Teams" -

Mon, 17 Feb 2025 03:45:21 -0500

My group performed similarly. We took a more collaborative approach. We first did a root cause analysis and identified the areas of error that could have contributed to the testing failure. From that, we listed ideas on which methods we… Read more»

PJL27 replied to the topic "Verification Failures and Adjusting Test Conditions" -

Mon, 17 Feb 2025 03:36:14 -0500

You bring up a really good point that I think is highly debated in this high stakes industry. Medical device developers will try to increase the scope and range the devices are usable to maximize usability and profitability. For example,… Read more»

PJL27 replied to the topic "Design Verification Failures" -

Mon, 10 Feb 2025 02:27:38 -0500

From my experience in the med tech field, I’ve learned that companies take measures so that devices don’t have to be redesigned. The device is made taking everything in consideration. It is very rare that the entire device needs to… Read more»

PJL27 replied to the topic "Managing Design Change Requests Effectively Without Disrupting Development" -

Sun, 09 Feb 2025 22:18:48 -0500

Design changes can occur due to wanteding to improve the medical device or wanting to fix any issues it may have. In wach case, it is good to have a list of risks to be proactive on as mentioned in… Read more»

PJL27 replied to the topic "How Frequent Design Reviews Can Improve Medical Device Quality and Reduce Failures" -

Sun, 09 Feb 2025 20:42:47 -0500

Having design reviews regularly shows the progression of the project and ensures that it is on the right track. Something that I think would be beneficial in a design review is to meet and review it with all the stakeholders… Read more»

PJL27 replied to the topic "Caution with Medical Devices that Require a PMA" -

Mon, 03 Feb 2025 04:52:32 -0500

While the long and challenging process for a PMA make it so that companies are discouraged at innovating new medical devices, it is necessary for a PMA to be rigourous so that the effectiveness is determined to comply with pateint… Read more»

PJL27 posted a new topic "Humanitarian Device Exemption" -

Mon, 03 Feb 2025 04:26:19 -0500

The FDA created the Human Device Exemption (HDE) in 1990 to help streamline medical device approval for devices intended to help treat or diagnose rare diseases. There are more than 7,000 rare diseases, but only a few have treatments. A… Read more»

PJL27 replied to the topic "Misclassification of a Device?" -

Mon, 03 Feb 2025 03:46:45 -0500

I agree that sometimes it is difficult to classify a medical device, especially if it is a combination product. Having a combination product brings in the additional challenge of determining the primary mode of action to see if the CDRH,… Read more»

PJL27 replied to the topic "Balancing Stakeholder and Customer Values" -

Mon, 27 Jan 2025 04:54:40 -0500

A project’s scope is based on customer needs and stakeholder values. Stakeholders are most invested in the financial situation with the project, while customer values focus on what is needed by the customers (surgeons, patients, researchers, etc). Often, project members… Read more»

PJL27 replied to the topic "Handling Conflicts Among Team Members Effectively" -

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

Something that is told very frequently at medical device (or anything healthcare or biotech related) companies is to focus on the “why”. Before jumping onto a project, it is important to understand what the aim of project is and exactly… Read more»

PJL27 replied to the topic "How to communicate effectively between team mates in project team ?" -

Mon, 27 Jan 2025 03:40:37 -0500

I think the previous posts bring up great points in having transparency to maintain a clear line of communication. I agree that messages may become unclear through email chains so having a 1:1 talk can clear up any miscommunication. I… Read more»