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at644
@at644
Trusted Member
Joined: Sep 1, 2025
Last seen: Nov 30, 2025
Topics: 2 / Replies: 39
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RE: Why Is Clinical Research So Complex?

Medical device development takes several years to complete, and drug development can take over a decade to complete. The clinical trial process has be...

1 month ago
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RE: Patient safety and data integrity during clinical trials

For the protection of human research subjects, regardless of the type of research, there is 45 CFR 46, which pertains to the Department of Health and ...

1 month ago
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RE: The Placebo vs. The Nocebo Effect in Blind Clinical Studies

Including as many factors as possible into a clinical study to support or even improve a treatment is beneficial for the study. Both placebo and noceb...

1 month ago
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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 ...

2 months 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...

2 months 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...

2 months 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 months 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 months 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 months 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 months 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...

2 months 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...

2 months 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...

2 months 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...

2 months ago
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