Ameing for Asia

Understanding Asian Cultural Issues is Essential to Success in Asia

By Ames Gross
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While a better understanding of Asian cultural issues is crucial, it is also important to realize that in the end, people are people, and everyone around the world shares common goals and desires such as job promotions, higher salaries, and a happy family life. If Western executives keep this point in mind, and have a good grasp of Asian cultural issues, their businesses in Asia will be much more likely to succeed.

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Reimbursement Report

Humanitarian Use Devices and Third-Party Reimbursement

By Elizabeth Brown, MD
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Payers often apply the same evidence standards to Humanitarian Use Devices as other devices and demand high quality clinical trials, following an approach similar to the PMA or 510(k) regulatory pathways, where payers frequently impose a higher evidence standard than FDA. But how flexible are payers in setting their evidence requirements? Will they consider HUDs as investigational?

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