I agree with this article. Most devices do not have issues to get regulatory approval but they face numerous challenges when it comes to gaining reimbursement. Reimbursement policy has not kept up with the technological progress.

Aaron Liang I think this is a great point. In numerous therapeutic areas, adoption of technology has closely tracked reimbursement policies which incentives technological changes for some therapies but not others. For example in the field of computer assisted surgery, many government and private insurance payers will reimburse the cost of computer assisted navigation systems to improve outcomes in neurosurgery which has led to significant adoption of such systems. However in other forms of stereotactic surgery such as orthopedic surgery no such payer incentive exists and as a result, adoption of similar technology has been much poorer.

Of course, this could also prove to be beneficial as it presents an opportunity for innovators who can develop an alternative business model or technology that improves outcomes yet is able to deliver cost effective improvements in outcomes that allow them to fit into existing payment models without requiring payment adjustments.