Wake Up, Western Medical Device Makers!
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.
5 Questions About the Medical Device Tax, and Its Potential for Repeal
Will the device tax be repealed? What are its implications under the 114th Congress? This primer provides some answers.
HCT/P Regulation and Third-Party Reimbursement
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.
China’s Rapidly Expanding Cancer Market
Here are 5 strategies that Western medical device companies need to adopt to tap into the growing Chinese market for devices and diagnostics.
“Med-tech Innovation Happening at Speed of Technology, not Healthcare”
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.
3 Tips for Building Strong Business Relationships in Asia
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.
It’s Not About Faster Approvals, but About Better Availability, says FDA Commissioner Hamburg
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.
PMA Approval and Third-Party Reimbursement
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?
7 Reasons Your Medical Device Company Should Be “Ameing” for Asia
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.
FDA 510(k) Clearance and Third-Party Reimbursement
Reimbursement strategy can no longer be overlooked when planning the regulatory and clinical strategy for a product, particularly if it is a 510(k) product.