hotspot -WSS

hotspot

author：Wikipedia 2025-09-30 09:29:51 - browse：3

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： Food as medicine: CMS rules hamper 'prescribing' of fruits, veggies
Next article： See how much Covid

WSS

My yearlong odyssey to get my son’s ADHD medication covered

Let's speed up science by embracing open access publishing

New brain studies show LSD's effects on the brain in full color

Ionis drug prevents swelling attacks due to hereditary angioedema

EU regulator recommends expanding Mounjaro approval to obesity

Elizabeth Holmes banned from government health programs

focus

hotspot

hotspot

Jerome Adams on the need for new antivirals for Covid

Letters to First Opinion on caregivers, digital health, and more

Wildfire smoke exposes gaps in outdoor worker protections

ASCO: AstraZeneca's hat trick, and palliative care's spotlight

Sports medicine is finally prioritizing gender equality

Innovation in antibiotics is ailing. 'Brain drain' may kill it

Tori Bowie and the unacceptable rates of Black maternal death

Innovation in antibiotics is ailing. 'Brain drain' may kill it

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

Let's speed up science by embracing open access publishing

explore

ASCO: AstraZeneca says CAR

Ionis drug prevents swelling attacks due to hereditary angioedema

Innovation in antibiotics is ailing. 'Brain drain' may kill it

At ASCO, pharma leaders speak of advances in 'smart bomb' drugs

ASCO24: AstraZeneca won cancer’s big meeting. Can it fulfill its $80B ambition?

Change Healthcare can notify patients about the breach, HHS says

explore

leisure time

hotspot

focus