hotspot -WSS

hotspot

author：fashion 2025-10-02 21:00:25 - browse：41

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： Medicare details structure of new drug price negotiation program
Next article： New lesbian bars spark hope amid disappearing LGBTQ+ spaces

hotspot

WSS

Smaller biotechs seek to piggyback on weight loss drug boom

GOP hopefuls to address prominent, controversial group questioning what's taught in schools

UnitedHealth wins $3.3 billion takeover of Amedisys

STAT Readout Newsletter: Biotech news today

Medical experts exlpore how to eliminate bias in clinical algorithms

The future of Biogen: Pragmatism, ‘moonshots,’ and no Twinkies

leisure time

hotspot

entertainment

After affirmative action ruling, medical educators look to 'holistic review'

Synthetic human embryos? Researchers say term is overblown

Walensky prepares to leave CDC — and Congress — behind

How AI can help patients find reliable information about doctors

FDA approval of Sarepta Duchenne genetic therapy gives me hope

Brazil's Jair Bolsonaro is barred from running for office until 2030

23andMe had bad news about my health. I wish a person had delivered it

Tuskegee Airman Raymond Cassagnol dies at 102

George Santos makes 1st court appearance after pleading not guilty to 13 counts

Merck, Daiichi strike cancer drug pact worth up to $22 billion

entertainment

Roche acquires Telavant from Roivant, adding experimental IBD treatment

Thousands protest in Iraq for a second day over burning of Quran in Sweden

Cassava Sciences’ Alzheimer’s clinical trials should be halted

STAT Summit: Ending the crisis of Black deaths in the U.S.

Lilly’s obesity pill cuts 15% of weight at highest dose in mid

Questions loom on AstraZeneca cancer drug as safety concerns ebb

knowledge

hotspot

focus

hotspot