Medical device development takes several years to complete, and drug development can take over a decade to complete. The clinical trial process has become more complex and expensive, as mentioned. Cha...

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 Human Services. This regulation was also adopted b...

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 nocebo effects are helpful to understand chronic and me...

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 for disease protection and claimed they met AAMI l...

Yes, storytelling can help people understand medical devices better. The importance of clear and clever communication is found in sales as well. Hospitals depend on purchasing departments to acquire m...

A company with a motivating mission statement and a vision that encompasses a bigger or more inspiring goal can effectively distinguish itself from competitors. A unique or modern purpose can secure s...

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 discussion about cash flow versus profit. Understand...

The medical device industry is diverse and compromises of both public and private companies. Privately owned companies benefit from reasons that you mentioned such as faster and more flexible decision...

The medical device industry is diverse and compromises of both public and private companies. Privately owned companies benefit from reasons that you mentioned such as faster and more flexible decision...

Evaluating financial ratios can determine if a company is capable of investing for returns that come later. A balance between short term financial goals versus long term investment can depend on the p...

Challenges during auditing can appear in the investigator’s audit report especially when they are QMS deficiencies. Negar and Natalie provided examples of frequent problems that can arise. As a result...

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 revising sections that need to be improved on so that the...

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 quality management systems, a complaint should be opene...

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 precise dose consistently. The primary mode of ac...