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Vansh Amin
@vanshamin
Eminent Member
Joined: Aug 26, 2025
Last seen: Nov 9, 2025
Topics: 0 / Replies: 31
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RE: Process Validation for OEMs

I think you brought up a great point about validating alternative equipment, in case of equipment failure. I think that in addition to validating alte...

4 days ago
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RE: Updating documentation or information overload?

Alot of great points were already brought up in this thread. Trying to keep balance between maintaining up-to-date documentation and balancing ineffic...

4 days ago
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RE: When Design Controls Fail — The DePuy Hip Recall

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 desig...

5 days ago
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RE: Design Transfers to Contract Manufacturers

There are many issues and limitations involved with using contract manufacturers. Someone has already brought up ensuring good and consistent QC. Whet...

2 weeks ago
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RE: How Many Design Reviews Are Enough?

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...

2 weeks ago
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RE: Bridging the Gap Between Users Needs and Design Inputs

Others have already mentioned specifics of using documents like the DID, and DSD to turn broad user needs into specific device specifications. However...

2 weeks ago
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RE: Challenges faced in patient recruitment, how can CROs and CRAs address them?

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 trial...

3 weeks ago
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RE: Gold Standard or Paperwork Nightmare?

GCP is absolutely necessary because innovation is useless, if the methods used to essentially prove the device are not sound. While GCP does involve m...

3 weeks ago
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RE: The Secret Ingredient in Every Clinical Trial: Trust

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 patient...

3 weeks ago
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RE: Marketing Strategies to Differentiate from the Competition

I think marketing for medical devices should first and foremost focus on presenting positive patient outcomes. It should especially be emphasized for ...

4 weeks ago
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RE: Who Are You Selling To?

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 lar...

4 weeks ago
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RE: Science and Strategy… or Just Storytelling?

@shreya I think you bring up a really great point about how different audiences being important for narratives. I think that different narratives a...

4 weeks ago
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RE: LLC vs LLP

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 wo...

1 month ago
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RE: Public vs. Private

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, whe...

1 month ago
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RE: Public or Private: Which Path Builds a Stronger Company?

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 inves...

1 month ago
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