Post by arfanho7 on Feb 27, 2024 11:23:33 GMT
The high risk devices Stern studied included devices to treat patients with severe cardiac diseases including pacemakers coronary stents that prop open blocked arteries and implantable cardioverter defibrillators that submit pulses to regulate heartbeat.all other categories of high risk products such as tracheal and bronchial tubes to treat patients with emphysema and other lung ailments many prosthetic limbs joints and digits intraocular implants to correct seeing impairments and breast implants for reconstructive surgery for patients after undergoing mastectomy procedures.
A Previous research on drugs had found that on average the first entrant in a particular product category was the fastest to be approved with each follow on drug in the same category taking Hungary Phone Number percent longer. “THAT SUGGESTS THERE IS SOMETHING MORE ADMINISTRATIVE IN THE DELAYS SOMETHING IN THE CLASSIFICATION PROCESS THAT MATTERS” For medical devices on the other hand Stern found the opposite trend—and dramatically so. The first device in any given category—say a coronary stent—took on average percent longer to be approved than the next device in that category leading to an average delay of months.
There is a huge delay associated with being the first product to enter a new device market concludes Stern. As you can imagine that results in a big cost for folks trying to bring new products to market. In fact Stern conservatively estimates that delay costs firms an average of . million on top of the million average price to bring a new high risk medical device to market. That extra cost can dampen the ability of companies to pursue new innovations.
A Previous research on drugs had found that on average the first entrant in a particular product category was the fastest to be approved with each follow on drug in the same category taking Hungary Phone Number percent longer. “THAT SUGGESTS THERE IS SOMETHING MORE ADMINISTRATIVE IN THE DELAYS SOMETHING IN THE CLASSIFICATION PROCESS THAT MATTERS” For medical devices on the other hand Stern found the opposite trend—and dramatically so. The first device in any given category—say a coronary stent—took on average percent longer to be approved than the next device in that category leading to an average delay of months.
There is a huge delay associated with being the first product to enter a new device market concludes Stern. As you can imagine that results in a big cost for folks trying to bring new products to market. In fact Stern conservatively estimates that delay costs firms an average of . million on top of the million average price to bring a new high risk medical device to market. That extra cost can dampen the ability of companies to pursue new innovations.