leisure time -WSS

leisure time

author：knowledge 2025-08-23 23:16:45 - browse：7

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： BioMarin wins approval for gene therapy to treat hemophilia A
Next article： Change Healthcare cyberattack affects 25% of CVS/Aetna insurance claims

WSS

Lack of health data on LGBTQ+ people has serious consequences

Families look for replacement for GSK asthma drug Flovent

Fetal cell organoids grown from amniotic fluid, study finds

See how much Covid

Change Healthcare: What is it, why does its cyberattack matter?

BMI, flaws aside, is found to be useful estimate of body fat in youth

hotspot

leisure time

focus

FDA approval of Sarepta Duchenne genetic therapy gives me hope

Ultragenyx gene therapy for rare liver ailment succeeds in late

Continuity nursing helped my family in our darkest PICU moments

Harvard's David Sinclair gets blowback over aging

Medicare details structure of new drug price negotiation program

Kaiser's Risant Health gobbled up Geisinger. Who is next?

Tori Bowie and the unacceptable rates of Black maternal death

Ionis drug prevents swelling attacks due to hereditary angioedema

At least 13 dead in Texas as scorching temps continue

HIV drugs protect against transmission, even in unprotected sex

explore

At ASCO, AstraZeneca reports strong data for breast cancer drug

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

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

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

He's 19 months old and has one of the world’s rarest diseases

Cord blood banking comes at a high cost to babies

knowledge

knowledge

leisure time

explore