explore -WSS

explore

author：focus 2025-09-29 21:20:56 - browse：6

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： 23andMe had bad news about my health. I wish a person had delivered it
Next article： A solution to the after

hotspot

focus

WSS

6 phony surgeries that take placebo to the extreme

The dental labor crisis is a moment of opportunity

Biden report: The neurospychology of memory and aging

Medicare inequities exacerbate Puerto Rico’s health disparities

PBM reform efforts get punted in Congress

Doctors' information doesn't help them choose wisely when sick

leisure time

explore

leisure time

Over 800 arrested across France in 3rd night of riots after fatal police shooting of teen

In utero gene editing: an explainer

Over 800 arrested across France in 3rd night of riots after fatal police shooting of teen

Key House Republican on health care plans exit from Congress

Hepatitis C has a cure — but many Americans still lack access to it

Gilead acquiring CymaBay and its liver disease drug for $4.3 billion

Hollywood unions extend contract negotiations for actors

In utero gene editing: an explainer

As demand for Covid shots wanes, Moderna seeks its next success

Biogen Alzheimer’s drug launch off to slow start

explore

PhRMA lawsuit over Medicare drug price negotiation tossed

Key House Republican on health care plans exit from Congress

6 phony surgeries that take placebo to the extreme

BioAge raises $170M for combination therapy with Zepbound

Vaccine advisory panel ACIP left half staffed by HHS

Gilead acquiring CymaBay and its liver disease drug for $4.3 billion

hotspot

hotspot

focus

hotspot