Medical Device Courses | Talha Chaudhry | Activity https://medicaldevicecourses.com/members/talha-chaudhry/activity/ Activity feed for Talha Chaudhry. Fri, 24 Apr 2026 14:14:11 -0400 https://buddypress.org/?v= en-US 30 hourly 2 0736bb60239f2773b2ba6bf4476d90ab Talha Chaudhry replied to the topic "Let's Be Motivated!!!" - https://medicaldevicecourses.com/activity/p/12530/ Wed, 15 May 2019 16:56:48 -0400 To build off what you said, the venture supervisor can be a surprising huge motivator. To know that someone believes in what you can do so much to put forth a lump sum to create a product greatly validates your…   Read more»

]]> 3c557c87d6832bf426386fe4c40d6323 Talha Chaudhry replied to the topic "What’s Your Motivator?" - https://medicaldevicecourses.com/activity/p/12503/ Wed, 15 May 2019 16:56:35 -0400 What motivates me is the fact that one day I know the work I put it in will have a meaningful impact on someone else. I may never meet that person, know that person, or perhaps even like that person,…   Read more»

]]> 7456b954ec0dd0af2716ac7ff9453de7 Talha Chaudhry replied to the topic "Integration PM" - https://medicaldevicecourses.com/activity/p/12415/ Wed, 15 May 2019 16:55:48 -0400 For my project, the smart-cast, integration was the toughest challenge to overcome! Simply put, our project had several components from both a hardware and software perspective. It’s very easy to get one sensor working to give an output signal on…   Read more»

]]> e0d4c3d3b3a3b6817cb466c7cf805508 Talha Chaudhry replied to the topic "Procurement Management" - https://medicaldevicecourses.com/activity/p/12414/ Wed, 15 May 2019 16:55:47 -0400 In order to see if a vendor will meet our requirements, we actually did significant research on the vendor itself and looked to see if they actually made products to ISO standards, ASTM standards, so on and so forth. We…   Read more»

]]> a20197b242c481f0befde3d40a306c02 Talha Chaudhry replied to the topic "Discussion Topic: Scope creep....when your project changes" - https://medicaldevicecourses.com/activity/p/12353/ Wed, 15 May 2019 16:55:14 -0400 During the initial design phase of our capstone project, we laid out what we wanted to accomplish in the limited amount of time we had. Our scope at the beginning was actually too large so we cut it down before…   Read more»

]]> f679d8651984522c3e0692b542196449 Talha Chaudhry replied to the topic "Combination Product" - https://medicaldevicecourses.com/activity/p/12264/ Wed, 15 May 2019 16:54:19 -0400 A combination device is a device with multiple components that serve different purposes. Typically for a combination device, it is reviewed by the department in the FDA based on its primary mode of action. Sometimes the primary mode of action…   Read more»

]]> 2b0e420d59aa4a922b42473c329aa689 Talha Chaudhry replied to the topic "Work Logs and FDA Audits" - https://medicaldevicecourses.com/activity/p/12200/ Wed, 15 May 2019 16:53:43 -0400 The FDA is a regulatory institution and therefore can do some serious damage to your company/employees if the audit uncovers irregularities that weren’t accounted for. I don’t have any examples personally, but the story the person above me sounds exactly…   Read more»

]]> 455ea80d1b864f60ec4461ca1302eae6 Talha Chaudhry replied to the topic "Importance of Logging Work" - https://medicaldevicecourses.com/activity/p/12156/ Wed, 15 May 2019 16:53:21 -0400 For our capstone project, we have to write code for sensor components in the design. It was my responsibility as well as another team member to take care of the code. At first, we would constantly talk to each other…   Read more»

]]> 5db647956c5d9e717f0d13dc4bba8d23 Talha Chaudhry replied to the topic "Underestimating Task Duration" - https://medicaldevicecourses.com/activity/p/12090/ Wed, 15 May 2019 16:52:42 -0400 I can relate to this quite a bit. Project estimations are very difficult when third-party vendors are involved. During my capstone project, we purchased a strain gauge that ended up being too small for our application. We didn’t know until…   Read more»

]]> e6e477d724f78450efb67c7b4bc33e00 Talha Chaudhry replied to the topic "In the Shoes of a Project Manager" - https://medicaldevicecourses.com/activity/p/12026/ Wed, 15 May 2019 16:52:06 -0400 1. Be prepared for issues regarding third party components: Suppliers have the potential to ship late, ship faulty components, or even not ship the components to you at all. You have to be prepared for all scenarios 2. Time management:…   Read more»

]]> a5e81c4c8c022eccdaa7e78746bf3c7a Talha Chaudhry replied to the topic "Are Missed Milestones really Bad?" - https://medicaldevicecourses.com/activity/p/12025/ Wed, 15 May 2019 16:52:05 -0400 Missing milestones is not so bad if you either have the foresight to anticipate issues or if you have well-developed contingency plans. Missing milestones become an issue when something unexpected happens that you weren’t prepared for. For example, say you’re…   Read more»

]]> d266e545b2b428704029a7f7a41f0465 Talha Chaudhry replied to the topic "Benefits of this course" - https://medicaldevicecourses.com/activity/p/12024/ Wed, 15 May 2019 16:52:04 -0400 The biggest thing from this course that I’ve learned is knowledge about the regulations and the bureaucracy involved with creating a medical device. During my undergraduate coursework, I never really went into detail about such regulations and what it actually…   Read more»

]]> f8e2e8062d91843b8fb61f8e6bb8cce1 Talha Chaudhry replied to the topic "Missing a Milestone Experience" - https://medicaldevicecourses.com/activity/p/11958/ Wed, 15 May 2019 16:51:27 -0400 During my capstone project for the smart-cast, we’ve missed a couple milestones due to external factors. We also just a gantt chart to record our progress, and when we missed a milestone it would set us back considerably. Things like…   Read more»

]]> d4f77673aaf62b872f1739fe4e077230 Talha Chaudhry replied to the topic "Experience Breaking Down A Project" - https://medicaldevicecourses.com/activity/p/11957/ Wed, 15 May 2019 16:51:27 -0400 I’m also currently working on my capstone project, and we also broke down the project into categories. We split up the project into hardware and software. The project is developing a smart-cast, a cast that can measure the degree of…   Read more»

]]> 6a0c03eea0f3985bd911f354855e9ff2 Talha Chaudhry replied to the topic "Revising a Gantt Chart" - https://medicaldevicecourses.com/activity/p/11955/ Wed, 15 May 2019 16:51:26 -0400 Certain factors may include any of the following: Time, Budget, Contingency Plans, and any inspection dates. For time, the PM needs to readjust the gantt chart in order to make up for lost time because of missing a milestone. He…   Read more»

]]> 7502c0c9182eab43b93d7986a64b4b32 Talha Chaudhry replied to the topic "Discussion Topic: Integrating Six Sigma into Project Planning" - https://medicaldevicecourses.com/activity/p/11872/ Wed, 15 May 2019 16:50:34 -0400 You can begin the integration of six sigma with project planning with the development of a project life cycle. By doing this, you can add statistical knowledge of the problem, reduce the chance of an incorrect assessment of the issue…   Read more»

]]> 6bbd5b03c8d1a0d7fb782d21d8ab6b67 Talha Chaudhry replied to the topic "Discussion Topic: The critical path" - https://medicaldevicecourses.com/activity/p/11869/ Wed, 15 May 2019 16:50:32 -0400 Currently I’m working on my capstone project, and one of the tasks I thought to simple ended up becoming a part of the critical path. What I’m talking about is making components stay in place. For context, I’m designing a…   Read more»

]]> a354428e2e84b9fb321fa5a87285c789 Talha Chaudhry replied to the topic "how the PM handles budget cut?" - https://medicaldevicecourses.com/activity/p/11868/ Wed, 15 May 2019 16:50:31 -0400 A budget cut is something a pm and a whole project team should always be prepared for. It does affect the overall cost estimation of the project, but more than that, a budget cut can result from several issues outside…   Read more»

]]> 07d93ed1952f42509743f5447506faaf Talha Chaudhry replied to the topic "Potential FDA Changes under Trump" - https://medicaldevicecourses.com/activity/p/11740/ Wed, 15 May 2019 16:49:16 -0400 I share your concerns with the idea of Trump removing efficacy as a critical step in the approval process. It was because of the need for better efficacy that we avoided the Thalidomide disaster in the United States. The potential…   Read more»

]]> 0cb990a3d94a74920227dd1211d64cab Talha Chaudhry replied to the topic "Fitbit: A Medical-Grade Device?" - https://medicaldevicecourses.com/activity/p/11739/ Wed, 15 May 2019 16:49:16 -0400 I agree that this should not be classified by the FDA because it does not pose significant risk to the user. The fitbit is an extracorporeal device that is non-invasive and it a general wellness product, like the individual above…   Read more»

]]> c3c82d15482e3c2cef4257a7f834114a Talha Chaudhry replied to the topic "General Wellness Product" - https://medicaldevicecourses.com/activity/p/11738/ Wed, 15 May 2019 16:49:15 -0400 I’m actually using this biomedical device for my capstone project. It’s called the comfortprene wrist and thumb-wrap. It’s a general wellness product that would fall into the second category of the FDA’s definition of said general wellness products. The reason…   Read more»

]]> 57fa40f17474deea5292c2ed0a0dca96 Talha Chaudhry replied to the topic "Toxic Medicine" - https://medicaldevicecourses.com/activity/p/11663/ Wed, 15 May 2019 16:48:32 -0400 The design controls that could potentially be visited do include DID, DDP, DSD, verification/validation protocols, risk analysis, and risk management. However, since this is a homeopathic product, the FDA has less oversight on it than say a injectable vaccine. A…   Read more»

]]> 5074a708ade2023dea3b5c1499d050dd Talha Chaudhry replied to the topic "How to initiate project successfully" - https://medicaldevicecourses.com/activity/p/11662/ Wed, 15 May 2019 16:48:32 -0400 From my experience, the initiation process can be divided into 4 phases for project management: Objectives: The first phase involves creating an objective(s). This is where you determine what information you need about from the project so that they can…   Read more»

]]> 6b913ac588452a7075ff9f1d789e9d14 Talha Chaudhry replied to the topic "Validation vs. Verification" - https://medicaldevicecourses.com/activity/p/11660/ Wed, 15 May 2019 16:48:31 -0400 I have an example I can share based on the definition you give. Take a smartphone for example, focusing mainly on the touch-screen interface. Validation processes would involve making sure that the pressure exerted on the display would translate from…   Read more»

]]> d2691d2ed52e3df0745738dc8d6f48e4 Talha Chaudhry replied to the topic "Difference" - https://medicaldevicecourses.com/activity/p/11602/ Wed, 15 May 2019 16:48:00 -0400 I believe the two positions are quite similar in a lot of ways. I see the clinical pm as a subset of project managers as a whole. According to progenics pharmaceuticals, these are the primary responsibilities of a CPM: -Leads…   Read more»

]]> ef7d9ee68ff02f9983f74ce2e2e33a49 Talha Chaudhry replied to the topic "Significant or non-significant risk" - https://medicaldevicecourses.com/activity/p/11601/ Wed, 15 May 2019 16:48:00 -0400 Going of la82’s post, I think the way the FDA defines the line between a device of significant and non-significant risk is blurry. I think this guideline especially raises a few concerns: • Otherwise presents a potential for serious risk…   Read more»

]]> 8808263b315b315119d50c21e172ca8f Talha Chaudhry replied to the topic "Discussion Topic: State of your Organization" - https://medicaldevicecourses.com/activity/p/11524/ Wed, 15 May 2019 16:45:40 -0400 I have not worked in industry before, nor do I have experience in any type of the organizations listed. If I were to go into industry, I would feel more gravitated towards a project-based organization. The structure of working in…   Read more»

]]> f098286596c7b4a48df9591dc2a08eda Talha Chaudhry replied to the topic "Project Manager Skills" - https://medicaldevicecourses.com/activity/p/11523/ Wed, 15 May 2019 16:45:40 -0400 I agree with the all the skills that Dr. Simon mentioned in the lecture, and I would like to add another important skill a project manager to possess. This skill can fall under awareness, but I believe it deserves great…   Read more»

]]> 7588f86ab0040c0523088ebb7364add2 Talha Chaudhry replied to the topic "Discussion Topic: To trial or not to trial" - https://medicaldevicecourses.com/activity/p/11522/ Wed, 15 May 2019 16:45:39 -0400 Design Validation is the assurance that the product is able to meet the needs of the customer and is in accordance with expectations set by the engineers responsible for creating the product. It involves acceptance and approval from third parties…   Read more»

]]> ba41d2b4025e116a3218463d4c3bfe2f Talha Chaudhry posted a new topic "Disconnect in rewarding motivation" - https://medicaldevicecourses.com/activity/p/10528/ Wed, 15 May 2019 16:34:16 -0400 In Dr. Simon’s Lecture from last week, he points out the disconnect in how the industry rewards motivation as compared to our own perspective. As employees, we hope for ‘teamwork’, ‘achieving challenging stretch goals’, and overall ‘candor’ to motivate us….   Read more»

]]> fdfa7f7a74d45270d75649d2ad7ffb75 Talha Chaudhry posted a new topic "Why do people leave work?" - https://medicaldevicecourses.com/activity/p/10527/ Wed, 15 May 2019 16:34:15 -0400 So, this is essentially a follow-up to my previous post of ‘Why do people work?’. On one of the lectures Dr. Simon posted, there was a survey that said “‘limited recognition and praise’ was cited as the most common reason…   Read more»

]]> 4f386659ead32f22f970a66d640f1f23 Talha Chaudhry posted a new topic "Why do people work?" - https://medicaldevicecourses.com/activity/p/10520/ Wed, 15 May 2019 16:34:13 -0400 For the lecture this week, I was fascinated by the results of the study Dr. Simon referenced. The study asked employees why they stayed and worked at the company they are employed at. What motivates them kind of surprised me….   Read more»

]]> e04b12629d08a2cad9042b77305b87b6 Talha Chaudhry posted a new topic "Change Requests During Clinical Trials" - https://medicaldevicecourses.com/activity/p/10519/ Wed, 15 May 2019 16:34:12 -0400 When a project reaches clinical trials, I can imagine the morale of the project team being very high as they have created a working device that was proven to work and sent off for “testing”. Sometimes, as Dr. Simon mentioned,…   Read more»

]]> 072fb323afe6e444a946992e357a7c36 Talha Chaudhry posted a new topic "Design Review Meeting Culture" - https://medicaldevicecourses.com/activity/p/10499/ Wed, 15 May 2019 16:34:01 -0400 During a design review meeting, the project team meets to approve documents and decide on whether to move on to the next stage. Documents are reviewed beforehand, and any changes are brought up during the meeting. Now what is interesting…   Read more»

]]> aa3c851aaac73985aa3676105b4b7fa3 Talha Chaudhry posted a new topic "Device Class Confusion" - https://medicaldevicecourses.com/activity/p/10498/ Wed, 15 May 2019 16:34:01 -0400 I’m about to finish up a senior project and about to demo it very soon. One of the assignments I needed to complete was to classify the device based on what the FDA would think of my device. At first…   Read more»

]]> 10df50d60a91ead4dbdda8a915173693 Talha Chaudhry posted a new topic "Variance During M&C" - https://medicaldevicecourses.com/activity/p/10494/ Wed, 15 May 2019 16:33:59 -0400 During the monitoring & controlling phase, you can perform variance analysis to determine the worth of your project at certain points of the schedule. Schedule variance is the difference between earned value and planned value. If your schedule variance is…   Read more»

]]> 639ea9f1adfd74b77a26e393ae4edf58 Talha Chaudhry posted a new topic "PM: Quality Assurance Process" - https://medicaldevicecourses.com/activity/p/10479/ Wed, 15 May 2019 16:33:52 -0400 As a PM, quality assurance is a huge responsibility. What are some tasks that you would need to perform to obtain accurate assessment of quality assurance of your project? Once you have the results, how would you proceed from there?…   Read more»

]]> 924e017f3213631fedf2bb55ad43e931 Talha Chaudhry posted a new topic "PM: Handling Team Issues" - https://medicaldevicecourses.com/activity/p/10478/ Wed, 15 May 2019 16:33:52 -0400 One of the interesting things that Dr. Simon mentioned in this weeks lecture was the concept of team development. When you are a project manager, your project team is not composed of robotic entities. They are human beings who can…   Read more»

]]> ee93f6f6e25ef6e9d5737971373d90cd Talha Chaudhry posted a new topic "Thalidomide's Impact on Regulation and the FDA" - https://medicaldevicecourses.com/activity/p/10435/ Wed, 15 May 2019 16:33:33 -0400 As Dr. Simon pointed out in his first video, it is important to understand the history of the FDA when learning about regulation. One event I would like to highlight is the thalidomide scandal of 1962. Thalidomide was a sedative…   Read more»

]]> 78dd5f3c52ef1b4c84306c3f3c245c1a Talha Chaudhry replied to the topic Let's Be Motivated!!! in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2437/ Mon, 24 Apr 2017 23:16:13 -0400 To build off what you said, the venture supervisor can be a surprising huge motivator. To know that someone believes in what you can do so much to put forth a lump sum to create a product greatly validates your own abilities as an engineer even further and pushes you to perform at a high level. Those high expectations eventually become more of a…[Read more]

]]> 0 9c5239f1e469c67fcbbe820feb44d309 Talha Chaudhry started the topic Disconnect in rewarding motivation in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2436/ Mon, 24 Apr 2017 23:04:24 -0400 In Dr. Simon’s Lecture from last week, he points out the disconnect in how the industry rewards motivation as compared to our own perspective. As employees, we hope for ‘teamwork’, ‘achieving challenging stretch goals’, and overall ‘candor’ to motivate us. Employers often reward ‘individual effort’, ‘making the numbers’, and ‘agreeing with the…[Read more]

]]> 0 1bdbd17ad1b2666dab602c6714d11cc1 Talha Chaudhry started the topic Why do people leave work? in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2435/ Mon, 24 Apr 2017 22:58:00 -0400 So, this is essentially a follow-up to my previous post of ‘Why do people work?’. On one of the lectures Dr. Simon posted, there was a survey that said “‘limited recognition and praise’ was cited as the most common reason for why employees left the company”. In the survey mentioned in the previous survey, almost half of the responses as to why…[Read more]

]]> 0 2c873fd867370e3dad9f11039e347f0d Talha Chaudhry replied to the topic What’s Your Motivator? in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2403/ Sun, 23 Apr 2017 23:34:29 -0400 What motivates me is the fact that one day I know the work I put it in will have a meaningful impact on someone else. I may never meet that person, know that person, or perhaps even like that person, but it gives me solace in the fact that I can make a difference with my own two hands and my one brain. The more I work and the more I learn, the…[Read more]

]]> 0 1ad3c0b35cd9ba2b9506986fb4b2fd2f Talha Chaudhry started the topic Why do people work? in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2337/ Wed, 19 Apr 2017 23:58:47 -0400 For the lecture this week, I was fascinated by the results of the study Dr. Simon referenced. The study asked employees why they stayed and worked at the company they are employed at. What motivates them kind of surprised me. I’ll list the results here:

Exciting and Challenging Work: 48%
Career growth and development: 43%
Working with…[Read more]

]]> 0 d6531787dfe21974f926b9b2ca293871 Talha Chaudhry started the topic Change Requests During Clinical Trials in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2336/ Wed, 19 Apr 2017 23:47:24 -0400 When a project reaches clinical trials, I can imagine the morale of the project team being very high as they have created a working device that was proven to work and sent off for “testing”. Sometimes, as Dr. Simon mentioned, even when a device is in clinical trials, change requests must be issued.

How would the project team approach a DCR…[Read more]

]]> 0 bc8bd2cb4a86957a99a3477b56d32fdb Talha Chaudhry replied to the topic Integration PM in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/2283/ Sun, 16 Apr 2017 23:03:36 -0400 For my project, the smart-cast, integration was the toughest challenge to overcome! Simply put, our project had several components from both a hardware and software perspective. It’s very easy to get one sensor working to give an output signal on a serial monitor, but taking that sensor data and displaying whilst datalogging it whilst checking to…[Read more]

]]> 0 8440bf336a9c2ddeb66d3f6765c7105f Talha Chaudhry replied to the topic Procurement Management in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/2282/ Sun, 16 Apr 2017 22:54:51 -0400 In order to see if a vendor will meet our requirements, we actually did significant research on the vendor itself and looked to see if they actually made products to ISO standards, ASTM standards, so on and so forth. We were lucky enough to get in contact from the vendor’s previous customers, and some of our team members were even previous…[Read more]

]]> 0 2b6b633b493f8c79753b20dbe4b8518e Talha Chaudhry replied to the topic Discussion Topic: Scope creep....when your project changes in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/2206/ Tue, 11 Apr 2017 14:42:01 -0400 During the initial design phase of our capstone project, we laid out what we wanted to accomplish in the limited amount of time we had. Our scope at the beginning was actually too large so we cut it down before we began development to only the essential customer needs. For example, our project was a smart cast that was designed to monitor the…[Read more]

]]> 0 a8b1bcc1b864aa76eebd940c1d23a084 Talha Chaudhry replied to the topic Combination Product in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/2094/ Mon, 03 Apr 2017 17:42:43 -0400 A combination device is a device with multiple components that serve different purposes. Typically for a combination device, it is reviewed by the department in the FDA based on its primary mode of action. Sometimes the primary mode of action is unclear. In that scenario, you would file an RFD, request for designation, to the FDA. It would only be…[Read more]

]]> 0 f789ccd707ccb198cb8fef166d856e25 Talha Chaudhry started the topic Design Review Meeting Culture in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/2091/ Mon, 03 Apr 2017 14:31:55 -0400 During a design review meeting, the project team meets to approve documents and decide on whether to move on to the next stage. Documents are reviewed beforehand, and any changes are brought up during the meeting. Now what is interesting is the culture. In my design review meetings, we had multiple project teams discussing the documents. There was…[Read more]

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