Medical Device Courses | Vansh Amin | Activity

Vansh Amin replied to the topic "Specifications: A double edged sword?" -

Sun, 19 Apr 2026 18:29:25 -0400

While having a broader specification range seems better at first it does come with multiple problems. As others have said, having a wider specification range than necessary will create problems in the consistency of your product. Additionally, having a wider… Read more»

Vansh Amin replied to the topic "Single Source/Dual Source" -

Sun, 19 Apr 2026 17:53:03 -0400

I also think it would be best to go with an entirely different supplier, both for the reasons you mentioned as well as others. Quality issues or a disaster at the manufacturing site would result in using the same supplier… Read more»

Vansh Amin replied to the topic "Nine Knowledge Areas" -

Sun, 19 Apr 2026 14:39:23 -0400

I would say the three that are the most important are time management, cost management, and risk management. I think these three are all interconnected and effects on one tend to cascade negatively onto the others as well. Time management… Read more»

Vansh Amin replied to the topic "Factors affect schedule variance (SV)" -

Sun, 12 Apr 2026 22:21:44 -0400

Essentially, all reasons that were given that could affect the schedule variance are just different types of risks. Others have already brough up risk management as a tool to mitigate these risks therefore reducing the impact of those risks on… Read more»

Vansh Amin replied to the topic "Instances of Multiple PMs" -

Sun, 12 Apr 2026 21:43:53 -0400

The way work is split between multiple PMs can be difficult to figure out and the best way to do it definitely depends on the specific project. The cleanest way to do it in my opinion is to split the… Read more»

Vansh Amin replied to the topic "PM Leadership Styles" -

Sun, 12 Apr 2026 21:35:29 -0400

I also think that in the context of medical device development projects transformational leadership is the most effective. Transformational leadership allows for not only innovation but also encourages individuals to contribute to the project to their own strengths. However, I… Read more»

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

Mon, 30 Mar 2026 01:01:07 -0400

Ideally teams should rely on both historical data and expertise when estimating tasks but in practice this may be difficult, especially when historical data is sparse or somehow biased by other factors that may not be applicable to the current… Read more»

Vansh Amin replied to the topic "Difficulty of Changes" -

Sun, 29 Mar 2026 23:31:45 -0400

While I do agree that while generally SOPs would be the easiest document to change, it is certainly not always the easiest. It heavily depends on the scope of not only the SOP but also the impact of the changes…. Read more»

Vansh Amin replied to the topic "Unexpected Time Delays - miniSim" -

Wed, 25 Mar 2026 19:12:23 -0400

While it may be beneficial to take a risk to shorten the projects time frame, this decision depends heavily on the magnitude of the benefit, and the size and impact of the risk being incurred. In the example displayed by… Read more»

Vansh Amin replied to the topic "Challenges PM face" -

Sun, 15 Mar 2026 02:32:20 -0400

I have seen a lot of great responses in this thread especially about the challenged PMs face especially about information. One challenge I think PMs will face when working on projects is simply failing. It is very likely that as… Read more»

Vansh Amin replied to the topic "PM Personnel Management" -

Sat, 14 Mar 2026 18:14:33 -0400

I agree that communication is the primary tool that you should use to handle these types of issues. To keep people on schedule you may have to have regular check ins on project progress so that you can first identify… Read more»

Vansh Amin replied to the topic "Companies efforts in the executing step" -

Wed, 04 Mar 2026 20:35:22 -0500

In addition to all the earlier points, in a regulated industry such medical devices rigorous documentation is required at many of the project stages. Falsifying progress would mean lying on official documentation at some point, which would be a far… Read more»

Vansh Amin replied to the topic "monitoring phase of a project" -

Wed, 04 Mar 2026 20:00:46 -0500

I pretty much agree with the majority opinion here on project monitoring. I also think the biweekly meeting is great idea that suits the majority of the monitoring needs without being overbearing. For updating the project plan, while theoretically there… Read more»

Vansh Amin replied to the topic "Keeping Finances a Secret from the PM" -

Wed, 04 Mar 2026 19:37:43 -0500

I agree with your point that withholding project financial information from a PM seems extremely detrimental. Reading this thread I did see some seemingly reasonable answers as to why this practice would be implemented but it seems like ultimately the… Read more»

Vansh Amin replied to the topic "Preplanning for Risk" -

Sat, 28 Feb 2026 21:58:43 -0500

I agree with many of the posts in this thread about creating buffer in the schedule being one of the most effective and definitely one of the simplest ways to reduce the risk to the task being late. Jb678 brought… Read more»

Vansh Amin replied to the topic "Information Distribution For Project Success" -

Sat, 28 Feb 2026 21:16:32 -0500

One solution to the information problem is to have short (about 15 minute) daily huddles to provide critical updates. This when paired with some project dashboard software that allows for tracking of progress, general schedule, critical and noncritical actions, and… Read more»

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

Sat, 28 Feb 2026 20:34:39 -0500

A key way to reduce slack days used when considering team members schedules it to maximize redundancy within the team such that people can always be shuffled in the event of team members being out, or having an emergency. For… Read more»

Vansh Amin replied to the topic "Managing Challenges in Metrics" -

Sun, 22 Feb 2026 14:20:36 -0500

I think everyone has brough up great points so far in this discussion on how to measure relevant and useful metrics. One key point that I think no one has brough up yet is how you need to ensure that… Read more»

Vansh Amin replied to the topic "Monitoring Time and Budget" -

Fri, 20 Feb 2026 19:11:25 -0500

While it might be technically possible to recover from being behind schedule and over budget, I think that recovering from both of those conditions is incredibly unlikely. As someone else had said, being a little over budget and a little… Read more»

Vansh Amin replied to the topic "Email Communication" -

Thu, 19 Feb 2026 15:04:12 -0500

As an employee I prefer most important or simple communications to occur through teams. However, teams itself is not really built for a high volume of communication unless it is direct conversation, especially when multiple topics are involved as it… Read more»

Vansh Amin replied to the topic "Several modifications of verification at the same time" -

Thu, 12 Feb 2026 19:28:05 -0500

While changing multiple steps in the verification process does seem more efficient a key aspect of regulated industries in general is finding the root cause of issues. Executing multiple changes to the verification test at once will make it difficult… Read more»

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

Thu, 12 Feb 2026 19:11:24 -0500

Hypothetically, if I could change the DSD I would alter the part of the DSD that required that the label pass a submersion test. In the instructions for the simulation the simulation mentioned two products both the hydrophobic and hydrophilic… Read more»

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

Thu, 12 Feb 2026 18:58:12 -0500

As said a change control process is essential in managing design changes in a project. A change control system will allow for a thorough analysis of a design change and its potential impacts. This is critical for ensuring that changes… Read more»

Vansh Amin replied to the topic "Role of risk management in medical device projects" -

Thu, 05 Feb 2026 20:13:30 -0500

When considering risks for in medical device project management, technical and regulatory risks usually also have financial implications to them. An issue with a regulatory filing, will almost definitely set the project behind schedule which will cost the company money…. Read more»

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

Wed, 04 Feb 2026 18:57:18 -0500

I think that while Design reviews and Design change requests are important to do during the check and act phases, I think it is just as important to do these during the “Do” phase. While doing a final review as… Read more»

Vansh Amin replied to the topic "Sizes of Project Teams" -

Sun, 01 Feb 2026 19:29:17 -0500

Personally, I find that when it comes to making final decisions, differing backgrounds does not have as much impact when there is minimal overlap in roles or responsibilities regarding the project. Of course, as teams get larger overlapping responsibilities becomes… Read more»

Vansh Amin replied to the topic "Relationship between the FDA and Project Managers" -

Wed, 28 Jan 2026 14:42:53 -0500

While I do think that the PM should be ensuring that the team is keeping regulatory concerns in mind at all stages of the project, I am not sure if dealing with the FDA directly is the primary role of… Read more»

Vansh Amin replied to the topic "Remote or In-Person PM" -

Mon, 26 Jan 2026 04:27:08 -0500

While I believe that an online PM is possible, I think that usually an in person PM is generally better though it may depend on the specifics of the project. While obviously for entirely online teams an online PM would… Read more»

Vansh Amin replied to the topic "How can a project manager excel in the Biomedical field?" -

Sun, 25 Jan 2026 23:01:47 -0500

I also believe that interpersonal skills are far more important to a PM than technical skills. Like someone else said, the exact technical skills needed will vary from project to project, while the interpersonal skills can easily transfer and most… Read more»

Vansh Amin replied to the topic "Implementing a risk management plan" -

Sun, 16 Nov 2025 00:57:58 -0500

There were a lot of good suggestions in this thread about methods and tools you can implement in a risk management plan. I saw FMEA, and the bowtie method already mentioned in this thread, which are both great options for… Read more»

Vansh Amin replied to the topic "Are We Over-Relying on FMEAs?" -

Sun, 16 Nov 2025 00:19:53 -0500

I agree that a more dynamic approach to each device would be the best way to handle risk management on any individual project. I do think that you are correct, that maybe there may not be enough emphasis on scenario… Read more»

Vansh Amin replied to the topic "Can Risk Really Be Eliminated — or Only Managed?" -

Fri, 14 Nov 2025 20:34:22 -0500

I do not think it is really possible to design a zero-risk device. While certain kinds of risks can be eliminated, some risk will always exist in some form. Unfortunately, I think that means that striving for zero-risk designs, while… Read more»

Vansh Amin replied to the topic "Process Validation for OEMs" -

Sun, 09 Nov 2025 23:01:39 -0500

I think you brought up a great point about validating alternative equipment, in case of equipment failure. I think that in addition to validating alternative equipment, alternative materials should also be validated. Otherwise, disruptions in the supply chains can result… Read more»

Vansh Amin replied to the topic "Updating documentation or information overload?" -

Sun, 09 Nov 2025 22:24:33 -0500

Alot of great points were already brought up in this thread. Trying to keep balance between maintaining up-to-date documentation and balancing inefficiencies, has some challenges. I agree with the approach of using controlled versions and schedules updates rather than real-time… Read more»

Vansh Amin replied to the topic "When Design Controls Fail — The DePuy Hip Recall" -

Sun, 09 Nov 2025 04:00:49 -0500

While it might be possible that not every real-world failure can be predicted or fixed with design controls, however in this case highlights how design controls are not effective unless there is a workplace culture willing to enforce integrity and… Read more»

Vansh Amin replied to the topic "Design Transfers to Contract Manufacturers" -

Sun, 02 Nov 2025 13:43:54 -0500

There are many issues and limitations involved with using contract manufacturers. Someone has already brought up ensuring good and consistent QC. Whether you rely on their internal QC or your QC to ensure product quality is also a very important… Read more»

Vansh Amin replied to the topic "How Many Design Reviews Are Enough?" -

Sun, 02 Nov 2025 13:36:27 -0500

I generally do agree with the others that one design review is probably not likely to be enough, and while technically following the law is likely not the best idea. Not only will this raise uncomfortable regulatory questions, but also… Read more»

Vansh Amin replied to the topic "Bridging the Gap Between Users Needs and Design Inputs" -

Sun, 02 Nov 2025 02:40:21 -0500

Others have already mentioned specifics of using documents like the DID, and DSD to turn broad user needs into specific device specifications. However, I believe that more generally speaking, anything that ensures the robustness of the feedback loop is the… Read more»

Vansh Amin replied to the topic "Challenges faced in patient recruitment, how can CROs and CRAs address them?" -

Mon, 27 Oct 2025 02:18:30 -0400

While virtual trials can help with reaching as many patients as possible, this approach has drawbacks to it as well. The main benefit of virtual trials is of course, the ability to reach the maximum number of possible participants across… Read more»

Vansh Amin replied to the topic "Gold Standard or Paperwork Nightmare?" -

Sun, 26 Oct 2025 23:17:08 -0400

GCP is absolutely necessary because innovation is useless, if the methods used to essentially prove the device are not sound. While GCP does involve much more extra paperwork, that causes things to take much longer and also cost more money,… Read more»

Vansh Amin replied to the topic "The Secret Ingredient in Every Clinical Trial: Trust" -

Sun, 26 Oct 2025 22:40:34 -0400

I agree with you, that trust is absolutely vital in a clinical study, not only to attract and retain participants, but to also ensure that the patients report honestly. I believe that the best way to build to maintain trust… Read more»

Vansh Amin replied to the topic "Marketing Strategies to Differentiate from the Competition" -

Sun, 19 Oct 2025 00:09:28 -0400

I think marketing for medical devices should first and foremost focus on presenting positive patient outcomes. It should especially be emphasized for outcomes that beat out competitors to highlight the benefits. For new devices you will probably be restricted to… Read more»

Vansh Amin replied to the topic "Who Are You Selling To?" -

Sat, 18 Oct 2025 22:13:00 -0400

For dental tools, as someone else has already mentioned, dentists tend to be in small practices that they may own and run themselves as opposed to larger hospitals. This makes marketing to them more difficult compared to patients themselves and… Read more»

Vansh Amin replied to the topic "Science and Strategy… or Just Storytelling?" -

Sat, 18 Oct 2025 21:59:39 -0400

@shreya I think you bring up a really great point about how different audiences being important for narratives. I think that different narratives and storytelling styles should be used for different target audiences. For the examples you use, investors, healthcare… Read more»

Vansh Amin replied to the topic "LLC vs LLP" -

Mon, 13 Oct 2025 03:07:36 -0400

As many others have said, LLP is not the best choice to start a business, and definitely not a good choice at all for a medical device company. You would need full trust in your partners for a LLP for… Read more»

Vansh Amin replied to the topic "Public vs. Private" -

Mon, 13 Oct 2025 02:18:27 -0400

I believe that being a private company does generally allow for far more freedom for the company as others have said. However, as you pointed out, when transitioning from public to private, the buyers will finance that buy with debt… Read more»

Vansh Amin replied to the topic "Public or Private: Which Path Builds a Stronger Company?" -

Mon, 13 Oct 2025 01:57:25 -0400

For the Biomedical Industry and Medical devices especially, I feel like in a vacuum keeping the company private is the best thing. Being able to invest money from the company into long term projects, as well as provide the best… Read more»

Vansh Amin replied to the topic "What’s the Real Difference Between Quality Control and Quality Assurance?" -

Sat, 04 Oct 2025 01:27:35 -0400

I think that directly comparing QA, and QC like this doesn’t really work well. As you said these groups have totally different roles. Like other have said, QC is testing batches to ensure that products aren’t defective, and ensure that… Read more»

Vansh Amin replied to the topic "Quality Management and How It Can Enhance QA/QC" -

Sat, 04 Oct 2025 00:36:02 -0400

I would definitely focus on initiating a quality management system. I think that a good quality management system not only enhances the quality of the operations of whatever company you may be in, but it will also hopefully ensure that… Read more»

Vansh Amin replied to the topic "Quality Control and Assurance: Role in Post Market Surveillance" -

Fri, 03 Oct 2025 23:57:42 -0400

If enough complaints or report of a single issue arise then that would mean there was either a deficiency in the inspection and testing process, or there was an issue with the shipping or storage of the device if that… Read more»