Presenting clinical evidence to payers is the most efficient method of gaining coverage. But when this strategy is unsuccessful or hits a wall, a ground-up approach is required, relying on consistent and steady support from local physician champions that demonstrates broad acceptance of a technology.
As India’s cancer burden grows, the Indian cancer diagnostic and treatment market offers many opportunities for Western medical device companies that make such products. To succeed, Western companies need to develop their strategies in India carefully.
Ever since the advent of laparoscopic surgery some 25 years ago, payers have become wary of minimally invasive surgery. What should device manufacturers do?
No matter how tortuous the path to durable coverage and adequate payment for a new technology, the bedrock of the entire reimbursement process relies on the clinical evidence of safety and effectiveness. This inaugural blog post is the first in a series focused on the key reimbursement issues in this fluid health care environment.
As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Below are some updates of recent regulatory changes in the medical device and IVD industry from around the world, compiled by The Emergo Group.
Systems thinking is a disciplined way of thinking beyond the traditional boundaries of a product, and considers the complete flow of information or activities across a cooperating set of systems and human interventions to complete an intended job. For healthcare, this includes the span of activities for people, devices, information systems, and processes needed to meet various clinical and home healthcare scenarios.
Should you design your perfect product or begin with your minimum viable product?