hotspot -WSS

hotspot

author：focus 2025-09-28 21:56:33 - browse：6571

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： BioMarin wins approval for gene therapy to treat hemophilia A
Next article： Readout Newsletter: Biogen, Eisai, Aardvark Therapeutics, etc.

Wikipedia

hotspot

WSS

Bird flu in dairy cattle: New measures to control spread to humans

Scientific mystery highlights the blind spots in genomics databases

Depression: FDA OKs Otsuka Pharmaceuticals digital therapeutic

Medicare Advantage 2025 payments will dip, Biden administration says

Overprescribed: High cost isn't America's only drug problem

Rare Northern Lights show in US this week: Where and how to see it

Wikipedia

hotspot

focus

How one medical school became remarkably diverse

Insurer loopholes limit power of law against surprise medical bills

Drug repurposing or repositioning? The language matters

Titanic submersible victims' family mourns: 'Enormous tragedy and devastation'

Novavax promises a turnaround & Lilly roils the obesity market

How corporate America is slashing DEI workers amid backlash to diversity programs

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

Zelenskyy on how Russian invasion may end, gratitude for US aid and Putin's weakness

Walensky prepares to leave CDC — and Congress — behind

Pancreatic cancer is often deadly, but new discoveries are raising hope

explore

Trial using CRISPR to edit HIV out of cells disappoints

Masked men burn a market in a Mexican city plagued by gang violence, killing 9 people

Trial using CRISPR to edit HIV out of cells disappoints

Trump seeks lengthy delay of classified docs trial, citing upcoming election

Trial using CRISPR to edit HIV out of cells disappoints

Republican states more likely to report Covid vaccine side effects

Wikipedia

hotspot

knowledge

hotspot