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rgallo
@rgallo
Eminent Member
Joined: Sep 8, 2025
Last seen: Dec 11, 2025
Topics: 0 / Replies: 28
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RE: Bridging the Gap Between Users Needs and Design Inputs

Criteria definition with consultation of the target user is the best way to transform the user needs into operable specifications. This can be done wi...

4 weeks ago
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RE: Updating documentation or information overload?

I think balance comes with a clearly defined purpose for updating the living documentation. This would look more like making moderate to significant c...

4 weeks ago
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RE: Efficiency or Compliance?

I believe companies do treat design controls as a checkbox however they recognize that this can often lead to an increase in efficiency in product des...

4 weeks ago
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RE: When Mitigation Becomes Its Own Risk!

The addition of new risk controls will almost always add a level of complexity, but the moment a risk control creates additional risks is when it has ...

4 weeks ago
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RE: Are We Over-Relying on FMEAs?

FMEAs are critical in understanding the predictable flaws in a product and because of such, is a vital form to complete. However as mentioned, actual ...

4 weeks ago
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RE: Can Risk Really Be Eliminated — or Only Managed?

In the ideal world, I think absolute 0 risk would be maintainable and the gold standard for innovation, however no amount of testing or mitigation in ...

4 weeks ago
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RE: When and How Should Engineers Speak Up to Leadership?

I think the optimal way to speak up about an issue or a flaw in a project is to push for a team meeting to address the issue while focusing solely on ...

4 weeks ago
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RE: Design Controls vs Project Management — Why Do We Keep Mixing Them Up?

I think the main gap between design controls and project management is the amount of paperwork involved. In my experience, teams found any work that t...

4 weeks ago
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RE: Leadership or Management — What Drives Better Teams?

I believe the determining factor to this discussion is the size of the company and how many projects are going on at once. In my experience, I have be...

4 weeks ago
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RE: How “Modest” Should Gifts to Physicians Really Be?

I find the $100 dollar a gift limitation to be extremely futile, considering there is no period in which a gift cannot be provided. Even if there was ...

4 weeks ago
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RE: Are NDAs Overused in the Medical Device Industry?

NDAs have been used heavily in many many industries and I believe in most they have their purpose. Companies should have a right to protect the secret...

4 weeks ago
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RE: Verbal Contracts — Useful or Dangerous?

I think verbal contracts can be highly dangerous if taken as is even if recorded. As mentioned earlier in the discussion, I agree that they should be ...

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

I completely agree that significant impacts to the medical community are completely trivialized by a catchy phrase or a memorable nick name, with all ...

4 weeks ago
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RE: Should We Trust AI With the Future of Medical Device Marketing?

I think you bring up a good point when considering this newer technology in advertising strategies. There are many advantages to AI, as you suggested ...

4 weeks ago
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RE: Medical Device Marketing: Informative or Misleading?

As you suggested, marketing is vital for a product to thrive in the current product environment. Theres an extremely diverse market when it comes to t...

4 weeks ago
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