MedCity Influencers

Which should come first: FDA approval or CE Mark? (Best of MedCitizens)

Every week, MedCity News highlights the best of its MedCitizens: syndication partners and MedCity News readers who discuss life science current events on MedCityNews.com. Now here’s the best of what YOU had to say.

Every week, MedCity News highlights the best of its MedCitizens: syndication partners and MedCity News readers who discuss life science current events on MedCityNews.com.

Now here’s the best of what YOU had to say:

CE Mark or FDA approval? Medical device professionals weigh in. “With the ever-increasing stringency, time, and expense associated with FDA approval for medical devices, debate is sharpening in the medical devices industry over whether it is actually better business strategy to prioritize getting a CE mark for your product.”

Do doctors tell the truth? “Honesty in medicine is a fundamental pillar of our profession. However, physicians and scientific investigators have the same moral failings as the rest of our species. While we have moved beyond the atrocities of the Tuskegee syphilis “research,” we are actively combating plagiarism, fraud, corporate misconduct and ethical erosion.”

Raising the Medicare age is cost shifting, not saving.Every health care economist knows that health insurance premiums paid by employers are a form of compensation. So Romney’s plan is essentially a massive increase in the wage bill for employers who hire or employ older workers. I wonder if the corporate types who are pouring money into his campaign have carefully considered the economic implications of this proposal.”

Developing a monitoring mindset for a medical device trial. “The art of effective monitoring requires more than just an individual title, more than just a comprehensive procedure or checklist — it requires a mindset on the part of everyone who touches the clinical trial.”

Post-market studies would rebalance the the risk v. reward calculation. “Clearly, post-market studies will not prevent an ineffective product from being used in a large number of patients. But, one has to view the approach as a step between research and formal approval, where early users are enrolled in continued surveillance. And, the FDA could limit marketing claims until after post-market data provides sufficient evidence of efficacy.”

[Photo from digitalart]

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