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Will the device tax be repealed?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.
Here are 5 strategies that Western medical device companies need to adopt to tap into the growing Chinese market for devices and diagnostics.
In this interview Brian Williams, Director, Healthcare Strategy and Innovation at PwC, talks about the impact of med-tech trends such as outcomes based reimbursement, lessons learned in emerging markets, and impact of the device tax.
A good understanding of and appreciation for Asian cultural traits is essential to building strong relationships with Asian executives. Business in Asia will be more likely to thrive if a Western medical device executive is able to overcome these challenges.
Speaking to Advamed 2014 audience, the Commissioner tries to reassure device industry executives that the agency is working hard to ensure that U.S. is the leader for medical device innovation and manufacturing.
The reality is that often data cannot speak for itself. Even a high-quality randomized study may need the additional support of providers, key opinion leaders and most importantly specialty societies. So what can manufacturers do to address the payers’ stiff evidence requirements?
Welcome to the newest Medical Device Summit blog, “ Ameing for Asia .” This week’s inaugural blog lists 7 key reasons for Western medical device companies to enter and/or increase their presence in the Asian markets.