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.
The healthcare giant reported worldwide medical devices sales of $27.5 billion for the full-year 2014, a decrease of 3.4 percent versus the prior year.
According to a regulatory filing dated January 12, Medtronic and Covidien could complete their $43 billion mega-merger by the end of the month.
The deal will help Roche develop combination therapies and identify cancer patients more accurately.
Olivier Bohuon says he is not a fan of the concept of big is beautiful, and adds that there’s not much innovation occurring in hip implants.
One of the best ways for small and mid sized Western device firms to take advantage of these growing markets is to conclude agreements with reputable, trustworthy, and well connected medical device distributors located there.
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?
While getting rid of the medical device tax is a key issue for many Western device manufacturers, perhaps a more important issue is global competition.
Will the device tax be repealed? What are its implications under the 114th Congress? This primer provides some answers.
Comprehensive and unwieldy payer policies for wound care, the tiered system of FDA regulation of human cells, tissues, and cellular and tissue-based products, and the use of brand specific names in HCPCS coding have created a challenging reimbursement environment.