explore -WSS

explore

author：focus 2025-09-30 00:51:02 - browse：715

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： Indiana Supreme Court upholds abortion ban, says state constitution gives only limited protections
Next article： Scrutiny of post

WSS

Medicare Advantage overpayments discussion gets experts fired up

JPM 2024 Review: Hope for the XBI, deals from J&J, Merck, GSK

Fentanyl is making it harder to start addiction treatment

Readout Newsletter: Cytokinetics and Novartis' starcrossed tale

In shift, Texas to cover initial consult for Afghan baby's gene therapy

Cytokinetics sells Royalty Pharma a share of its heart drug for up to $575M

entertainment

explore

focus

The Supreme Court will review a ruling striking down a domestic violence federal gun ban

Life science postdocs should get big pay hike, NIH panel says

Medicare details structure of new drug price negotiation program

Does Paxlovid work in people vaccinated against Covid

United colonoscopy coverage change 'may cost lives,' doctors say

FDA poised to publish guidelines for clinical trial diversity

DIEP, the 'gold standard' of breast reconstruction, is under threat

Readout Newsletter: H5N1 bird flu vaccine, Cytokinetics, Gilead

Biden outlines 'new path' to provide student loan relief after Supreme Court rejection

H5N1 virus can be tracked in retail milk, scientists say

knowledge

JPM pitch from hospitals? Revenue streams outside of patient care

JPM 2024 Review: Hope for the XBI, deals from J&J, Merck, GSK

Medicare Advantage coverage denials need scrutiny, senators say

Fauci's latest grilling in Congress: 9 hours, behind closed doors

ASCO eve: Let’s set the table for this year's meeting

ASCO eve: Let’s set the table for this year's meeting

focus

hotspot

explore

entertainment