explore -WSS

explore

author：explore 2025-09-06 06:00:06 - browse：7439

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： Moonlake's readout produced a cash windfall. Risks remain
Next article： PBM reforms clear House panel

hotspot

Wikipedia

WSS

Readout Newsletter: Bayer study halts, Carmot to IPO, and more

Eye stem cell transplant could help restore vision in injured people

Listen: Racing for gene therapy & a pioneering approval

Childhood cancer progress stalls for Black, Hispanic kids: Report

ActiGraph execs on goal of drug approvals with digital endpoints

Eye stem cell transplant could help restore vision in injured people

leisure time

explore

knowledge

Tori Bowie and the unacceptable rates of Black maternal death

Evacuations in place as 3 wildfires burn in eastern Washington state

Cancer drug shortages should be causing more outrage

ProMED sees offers of support, but its future remains unclear

Psychedelics group wrestles with new pharma identity

FDA's Woodcock to retire early next year

Drug repurposing or repositioning? The language matters

Liz Cheney makes 1st public comment since Trump's election interference indictments

Duchenne breakthrough therapy leaves behind pioneering families

New details revealed about Purdue's marketing of OxyContin

hotspot

Weight loss drug costs may need more research, senator suggests

Surge of respiratory disease in China has likely explanation

Childhood cancer progress stalls for Black, Hispanic kids: Report

Weight loss drug costs may need more research, senator suggests

World's first CRISPR

ActiGraph execs on goal of drug approvals with digital endpoints

hotspot

knowledge

Wikipedia

knowledge