hotspot -WSS

hotspot

author：focus 2025-10-02 20:48:41 - browse：9

Tortoise and hare — Medical devices have historically been seen as having faster paths to market than their pharmacological counterparts. The growing requirement for cost-effectiveness trials may be slowing them down. Jonathan Elderfield/AP

When a colleague and I started our medical device company in 2009, we were in our second year at Harvard Medical School. Some classmates joked that they would still be in residency by the time we had moved on to our next big idea. We knew better — we expected it to be a long haul. Eight years into our journey, thousands of individuals have used our product in countries where it has been approved. But we have yet to gain approval in the U.S. — a long and expensive process.

In 2016, the United States Food and Drug Administration approved 22 new drugs, down from 45 approvals in 2015. The decline in drug discovery has been attributed to a variety of factors that include ballooning research and development expenses (the cost to develop a new drug is now estimated to be more than $2.5 billion), high rates of failure (a whopping 90 percent of Phase 1 candidates never make it to launch), and the complexity of human biology, which can thwart even the most promising candidates.

Medical devices have historically been viewed as having faster and lower-cost paths to market than their pharmacological counterparts: the average cost to develop high-risk, novel medical devices is estimated to be $94 million. After all, device engineers can leverage lower-cost animal models further into development than their pharmaceutical colleagues, the human clinical trials necessary for FDA approval are often smaller in scale, and, in some cases, expenses can be defrayed by revenue generated outside the United States in markets with faster regulatory pathways.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!

GET STARTED Log In

Previous article： Apple is now the first public company to be valued at $3 trillion
Next article： Alkermes shareholders re

leisure time

explore

WSS

Affirmative action in medical school literally saved lives

Parkland mass shooting to be reenacted for lawsuit

Eat, drink, but be wary — 4 foods that interact with medications

Virginia high school admissions case could be legal follow

In age of alternative facts, a scholarly course on calling out crap

At least 13 dead in Texas as scorching temps continue

leisure time

hotspot

Wikipedia

Bright Health sells Medicare Advantage business to Molina

California Joshua trees severely burned in massive wildfire

Supreme Court strikes down use of affirmative action

Judge in Trump's Jan. 6 case gives attorneys 2 weeks to propose trial date

The cancer drug shortage isn’t new — and neither are the solutions

New company forms to vet health AI models, root out weaknesses

In age of alternative facts, a scholarly course on calling out crap

New company forms to vet health AI models, root out weaknesses

Dobbs anniversary: the lost opportunity of abortion as health care

Malaria cases in Florida and Texas: Here’s what you need to know

explore

California Joshua trees severely burned in massive wildfire

Medicare details structure of new drug price negotiation program

Teen charged with murder as hate crime in killing of NYC dancer O'Shae Sibley: Sources

Tori Bowie and the unacceptable rates of Black maternal death

Eat, drink, but be wary — 4 foods that interact with medications

New air purifier tech could be key to improving indoor air quality

leisure time

leisure time

explore

hotspot