hotspot -WSS

hotspot

author：Wikipedia 2025-09-28 03:36:38 - browse：975

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： What does generative AI mean for health care? We asked experts
Next article： Criminal prosecution for violating HIPAA: an emerging threat

WSS

Military medical care influenced by rank and race, new study finds

Medicare to cover more brain scans related to Alzheimer’s drugs

A revolution in caring for preterm infants

Cancer cells are shown to suck energy source from immune cells

Readout Newsletter: Nvidia, Biogen, Ionis, AstraZeneca, ChatGPT

The Readout: Lisata, Eisai x Biogen, and the Met Gala (!)

hotspot

hotspot

focus

Indiana Supreme Court upholds abortion ban, says state constitution gives only limited protections

HIV vaccine remains elusive. Immunologists keep trying new ideas

Tori Bowie and the unacceptable rates of Black maternal death

Eight reasons why you should get an updated Covid vaccine

Heart attack and stroke risk calculators need revising

Readout Newsletter: Nvidia, Biogen, Ionis, AstraZeneca, ChatGPT

Apple is now the first public company to be valued at $3 trillion

NVIDIA and Google execs on the future of AI and drug discovery

Indiana Supreme Court upholds abortion ban, says state constitution gives only limited protections

Readout LOUD podcast: Merger Mondays, Ozempic panic

leisure time

Better Therapeutics data on benefit with GLP

Wearables generate powerful data but its not useful to doctors, yet

It's time to retire 'poor historian' from clinicians' vocabularies

How a billionaire couple greased the skids for Pelosi’s drug pricing bill

Wellcome Trust names Røttingen as its new CEO

Readers respond to H5N1 and livestock movements, and more

focus

hotspot

explore

hotspot