PDCs: A Vital Drop in the Ocean of Funding for Pediatric Devices.

This article is an in-depth examination of the role of pediatric device consortia (PDC) in the development of innovative devices. Looking at the funding model, and at how the challenges that arise in the development of medical devices differ from the development of drug therapies, the article looks at how PDCs can help OEMs with not only funding, but also expertise, regulatory guidance, and more. There is also an examination of some successful devices that have been backed by PDCs, and a comparison with how pediatric devices are funded in Europe to who how the true value of the FDA's PDC grant program.

Reversing the Innovation Pathway Could Be the Key to Cost-Efficient Health Care.

Throughout history, the world's biggest technological innovations have emerged from rich countries. Resource availability, economic prosperity that supports specialization in key areas of science and industry, and the concentrated centers of learning that such economies create all support this model. But history sometimes turns back on itself, and this is one of those moments.

DNA Testing for Preventative Health: Do Outcomes Justify Continued Investment?

In The U.K., a heated debate is raging in the genetics community about a not-so-new technology and its role in public health. Cheap genetic tests to discover our ancestry have become familiar consumer products, and our genes can tell us a lot about our ancestry, so it is an appealing idea that they can tell us about our susceptibility to serious diseases. Polygenic risk scores (PRS)-generated by sequencing multiple parts of a person's DNA-are said by some to hold the key to helping people avoid everything from type 1 diabetes to cardiovascular disease and cancer. This could herald a new era of preventive medicine, and the U.K. is investing heavily, but ultimately, whether or not this a good investment is still being determined.

Double Vision: Study of U.K. Twins Provides New Insight Into Human Wellbeing.

Back in 1992, when Prof. Tim Spector of King's College London set up a study to investigate the incidence of osteoporosis and other rheumatologic diseases in monozygotic (identical) twins, little did he know how much the project would expand its horizons. From a few hundred identical twins, the cohort has grown to more than 15,000 identical and nonidentical twins across the U.K., aged between 18 and 100, and a host of diseases and conditions are under the microscope (Figure 1). Now, TwinsUK has one of the most deeply characterized adult twin cohorts anywhere in the world, providing vast quantities of data for longitudinal studies of health and aging.

Ensuring AI Is Helpful and Not Harmful in Health Care.

The presence of artificial intelligence (AI) is spreading fast through almost every industry, and health care is no exception. Data-based decision-making software is becoming pervasive in all facets of modern life, and the AI-enabled chatbot ChatGPT is having a seismic impact on the public perception of AI.

An Injection of Innovation: How Drug Delivery Systems are Changing.

The market for injectable drugs is booming, fueling both a wave of innovation in device design and a debate about the relative pros and cons of injectables versus oral medication. As regulators continue to approve injectable medications that could replace daily pill regimens, particularly long-acting drugs that could improve patient compliance, it is legitimate to ask whether injectables will one day become the norm.

The Gene Editing Juggernaut is Picking Up Speed.

CRISPR-Cas9, the tool for editing genes by precisely cutting DNA and letting the body's natural DNA repair processes take over, deservedly led to Nobel prizes in 2020 for its pioneers, Emmanuelle Charpentier and Jennifer Doudna. Since their breakthroughs in 2012, the technology has moved forward in leaps and bounds, and techniques to manipulate genes that were once the realm of science fiction are becoming very much science "fact."

To Sleep, Perchance to Dream.

Most of us know the restorative value of an early night, so on some level we instinctively understand that sleep is good for both the body and the mind. Now, a growing body of research is starting to show just how vital sleep is to our overall health and longevity. Some believe that laughter is no longer the best medicine-sleep is.

Has COVID Taught Us to be Better Prepared for the Next Pandemic?

Although it is too soon to say we have reached the end of the COVID-19 pandemic, scientists, politicians, and ordinary citizens are looking to the future and asking the same question-will there be another one? The simple answer is yes.

Wearable Tech Marks a Breakthrough for Scanning the Brain.

Today, the World Health Organization (WHO) reports that one in four people are affected by mental or neurological disorders, 50 m suffer from epilepsy, and 50 m from Alzheimer's disease. According to the Journal of Neurosurgery, 69 m globally have some type of traumatic brain injury. With these numbers rising daily, there is an urgent need to understand what is happening inside the brain. Brain scanning technology has advanced dramatically in recent decades, but it still faces significant limitations.

Is the End of Malaria in Sight?

Malaria is a disease that has plagued humanity since ancient times. Mentioned in Chinese scriptures from almost 5,000 years ago, and throughout Greek and Roman literature, it is caused by Plasmodium parasites, which infect humans through the bite of the infected female Anopheles mosquito. Though it is both preventable and curable, it kills hundreds of thousands of people every year.

Optogenetics: Using Light to Excite the Brain.

In 2005, Edward Boyden of Stanford University and Karl Deisseroth of MIT opened up a new field of research-optogenetics-that offered the potential to revolutionize the treatment of neurological conditions. Their quest to genetically encode brain cells to be photosensitive has unlocked a toolkit that researchers are adding to consistently, and the implications for neuroscience and neuroengineering are vast.

Looking Disease in the Eye.

The eyes are said to be the windows of the soul, but they are increasingly the door to diagnostic information that could transform the lives of millions of people. Age-related macular degeneration (AMD), diabetic retinopathy, and glaucoma are the big three causes of permanent loss of vision, while severe neurological diseases like Alzheimer's and Parkinson's are on the rise. Thanks to new technologies for imaging the eye, the early signs of all of them can be detected earlier.

The PACE of Change Proteome editing could help treat diseases that antibodies and drug therapies cannot reach.

At a time when a global vaccine program is being rolled out at unprecedented speed, the world is more aware than ever before of the wonders of medical science. There are, however, many diseases that remain beyond the reach of modern medicine and the potency of some of our most widely used therapies are waning.

Spellchecking for the Story of Life With CRISPR-Cas9 and Base, Prime Editors.

Just four letters-A, G, T, and C-make up the alphabet of the genome. It may seem simple, but a small difference in spelling can create mutations that result in life-threatening diseases. Gene variants that cause genetic diseases come in many varieties. Transition point mutations cause conditions such as progeria, the rapid aging disease. Transversion point mutations cause sickle-cell disease and other major disorders. Small insertions can cause Tay-Sachs, which stops nerves working properly and is usually fatal, and deletions can result in cystic fibrosis.

Healing Gets a Helping Hand.

The human body is miraculous in its capacity to heal but it can always use a little help. Wound care traditionally consists of little more than a protective barrier, possibly with an antibacterial agent, to cover the damage while the body works its magic. Now, a new technology has opened up a more active approach to encouraging healing.

Chips Hold the Key to Reproductive Health.

Female reproductive medicine may not have been entirely overlooked in the history of medical research, but it has never been given the attention that it deserves. There are signs, however, that the spotlight is turning toward the most essential of human processes.

The Human Touch: Practical and Ethical Implications of Putting AI and Robotics to Work for Patients.

We live in a time when science fiction can quickly become science fact. Within a generation, the Internet has matured from a technological marvel to a utility, and mobile telephones have redefined how we communicate. Health care, as an industry, is quick to embrace technology, so it is no surprise that the application of programmable robotic systems that can carry out actions automatically and artificial intelligence (AI), e.g., machines that learn, solve problems, and respond to their environment, is being keenly explored.

Moving Objects with Your Mind: A Technique That Transmits Instructions Directly from the Motor Cortex May Potentially Allow Us to Control Machines with the Power of Thought.

The best ideas are often simple in nature, though complex in detail, and great in potential. The stentrode is a perfect example, combining the familiar off-the-shelf technologies of a stent and an electrode. When situated in the brain, a stentrode could open the door to direct communication between thought and machine.

The \"Age\" of Opportunity: European Efforts Seek to Address the Challenges of an Aging Population and Also Create Opportunities for Economic Growth and Innovation.

For the last ten years, Peter Wintlev-Jensen has been immersed in one of the greatest challenges the world will have to address in the decades ahead-the unprecedented aging of the population not only in Europe but also across the globe. This trend is reshaping consumer spending, challenging established economic models, driving the development of new industry and service sectors, and forcing a rethinking of key policy areas within health and social care. To quantify the challenge from a U.K. perspective, a recent report from the nonprofit organization Age UK showed that the country now has more people 60 or over than under 18 and more pensioners than children under 16. Just as striking, the number of people over 65 will rise almost 50% by 2030.