hotspot -WSS

hotspot

author：hotspot 2025-10-01 23:39:28 - browse：9

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： Wildfire smoke exposes gaps in outdoor worker protections
Next article： UnitedHealth’s Optum accused of antitrust violations in California

WSS

Listen: Covid's latest surge, Alnylam at the FDA, & the end of an era

Despite FDA concern, risk that CAR

ReNAgade cuts staff seven months after raising $300 million

How housing is health care on Long Island

FDA proposes changes to key medical devices approval pathway

UnitedHealth’s Optum accused of antitrust violations in California

focus

hotspot

explore

Heart attack and stroke risk calculators need revising

The EPA's new lead rule: How one expert crunched the numbers

Bright Health sells Medicare Advantage business to Molina

Takeda, Janssen join wearable maker to measure scratching

Malaria cases in Florida and Texas: Here’s what you need to know

What to make of Biden’s latest efforts on cancer research

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

Diverse clinical trials: Why aren’t we there yet?

Medical records are filled with copy

The EPA's new lead rule: How one expert crunched the numbers

Wikipedia

Will the market for weight loss drugs really reach $100 billion?

Walmart eyes Medicare Advantage provider ChenMed

Hospitals consider fixing cancer drug shortages on their own

Walmart eyes Medicare Advantage provider ChenMed

What don’t we know about an Alzheimer’s drug side effect?

With clinical trial data readouts, here's how to spot spin

Wikipedia

explore

focus

entertainment