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at644
@at644
Eminent Member
Joined: Sep 1, 2025
Last seen: Oct 18, 2025
Topics: 1 / Replies: 22
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RE: Medical Device Marketing: Informative or Misleading?

Two companies, Kimberly-Clark and Halyard Health, were found guilty of fraud eight years ago for the medical gowns they sold. The gowns were marketed ...

5 days ago
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RE: Science and Strategy… or Just Storytelling?

Yes, storytelling can help people understand medical devices better. The importance of clear and clever communication is found in sales as well. Hospi...

5 days ago
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RE: Marketing Strategies to Differentiate from the Competition

A company with a motivating mission statement and a vision that encompasses a bigger or more inspiring goal can effectively distinguish itself from co...

6 days ago
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RE: Why Is Cash Flow More Important Than Profit for a Business?

My previous response was intended for your other discussion on public versus private companies, which I added there. However, I want to add to this di...

2 weeks ago
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RE: Public or Private: Which Path Builds a Stronger Company?

The medical device industry is diverse and compromises of both public and private companies. Privately owned companies benefit from reasons that you m...

2 weeks ago
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RE: Why Is Cash Flow More Important Than Profit for a Business?

The medical device industry is diverse and compromises of both public and private companies. Privately owned companies benefit from reasons that you m...

2 weeks ago
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RE: Evaluating Medical Device Projects (ROI, NPV, Value)

Evaluating financial ratios can determine if a company is capable of investing for returns that come later. A balance between short term financial goa...

2 weeks ago
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RE: Common challenges faced while auditing a Quality Management System (QMS) in the medical device industry & how can they be dealt with

Challenges during auditing can appear in the investigator’s audit report especially when they are QMS deficiencies. Negar and Natalie provided example...

3 weeks ago
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RE: Quality Management and How It Can Enhance QA/QC

I would enhance what is already in place rather than initiating a system that would take more time. A thorough review of the QMS would include revisin...

3 weeks ago
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RE: Quality Control and Assurance: Role in Post Market Surveillance

QA should conduct an investigation if an adverse event occurs or if post surveillance data detects an issue with the medical device. As per most quali...

3 weeks ago
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RE: Combination Product

Nasal spray is a combination product because a drug is prepackaged in a delivery system that enters the nose. The pump can be specialized to deliver a...

4 weeks ago
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RE: How to start career in regulatory area (no industry exp yet)

People in medical device regulations need to handle changes set by different regulatory bodies. Many companies also want to sell abroad or work with o...

4 weeks ago
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RE: FDA Classes: Reform needed or fine as is?

In terms of general reform or changes, what came to mind was the Medical Device Amendments of 1976. Similar medical devices already sold in the countr...

4 weeks ago
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RE: Stability testing importance

Medical containers and trays that are used to store surgical instruments benefit from stability testing. The regulatory requirements for these medical...

1 month ago
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