Today’s guest post comes from Greg Skalicky, President, EVERSANA and Faruk Abdullah, President, Professional Services & Chief Business Officer, EVERSANA

Greg and Faruk walk through the marketplace pressures driving Direct-to-Patient commercialization models. They argue that a technology-enabled infrastructure,  combined with clinical and reimbursement support specialists, can improve  patients' access to new therapies, shorten the time to therapy, and enable better overall clinical outcomes.

Click here to learn more about EVERSANA’s Direct-to-Patient care model.

Read on for Greg and Faruk’s insights.
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Prepare to witness the convergence of strategy and science at the highly anticipated the DIA 2024 Global Annual Meeting! Immerse yourself in four days of conversations that don’t happen anywhere else, where strategic thinking seamlessly intertwines with scientific innovation: Elevate Your Professional Profile Expand your knowledge base with continuing education opportunities available virtually from June […]

The post Science Meets Strategy at DIA 2024 first appeared on ACRO.

The U.S. Food and Drug Administration posted a photo:

Geek Bar e-cigarette seized during joint federal operation that resulted in the seizure of $76 million of illegal e-cigarettes.

The proposed American Privacy Rights Act (APRA) has taken its first step U.S. House legislative process with several issue disagreements becoming more evident. On May 23, the U.S. House Committee on Energy and Commerce Subcommittee on Data, Innovation and Commerce approved the updated APRA, advancing the bill to full committee consideration. Just prior to the […]

The New York legislature passed two bills on June 7, 2024 directed at children’s use of online technologies – the Stop Addictive Feeds Exploitation (SAFE) for Kids Act (S7694) that restricts access to addictive algorithmic feeds and the New York Child Data Protection Act (S7695) that bans sites from collecting, using, sharing or selling personal […]

Two former board chairs of the Coalition for Healthcare Communication (CHC) were named as the Medical Advertising Hall of Fame (MAHF) 2025 inductees – Sharon Callahan, former Chief Client Officer at Omnicom Health Group (OHG), and Nick Colucci, former Chairman and CEO of Publicis Health/COO of Publicis Groupe North America. The inductees will be honored […]

I was surprised to learn from a recent press release that the American College of Cardiology is planning to have some live participants at its annual scientific sessions meeting in May. The college said it is also partnering with a technology company to offer these participants a wearable monitoring device “as an added safety measure...

Click here to continue reading...

<p>The European Commission (EC) granted marketing authorization for<b>&nbsp;</b>three ustekinumab biosimilars<b>:&nbsp;</b>Samsung Bioepis’ Eksunbi on 12 September 2024; Formycon’s Fymskina, and Fresenius Kabi’s&nbsp;Otulfi on 25 September 2024.</p>

Some 180 women were prescribed valproate, a medicine used to treat epilepsy and bipolar disorder, during their pregnancy within a 2.5 year interval, NHS data has revealed.

Researchers around the world are working at record speed to find the best ways to treat and prevent COVID-19, from investigating the possibility of repurposing existing drugs to searching for novel therapies against the virus.

The Royal Pharmaceutical Society has expressed its sadness at the death of Joy Wingfield, honorary professor of Pharmacy Law and Ethics at the University of Nottingham.

By Ankit Mahadevia, chairman of Spero Therapeutics, as part of the From The Trenches feature of LifeSciVC A common theme in startup literature is that by cutting a range of unnecessary tasks, a step-change in results will follow.  I’ve found

The post Keeping It Simple: What Really Matters For Emerging Enterprises   appeared first on LifeSciVC.

The good folks down at eyeforpharma have asked me to write a few blog posts in the run-up to their Patient Centered Clinical Trials conference in Boston this September. In my second article -Buzzword Innovation: The Patient Centricity “Fad” and the Token Patient - I went over some concerns I have regarding the sudden burst of enthusiasm for patient centricity in the clinical trial world.

Apparently, that hit a nerve – in an email, Ulrich Neumann tells me that “your last post elicited quite a few responses in my inbox (varied, some denouncing it as a fad, others strongly protesting the notion, hailing it as the future).”

In preparing my follow up post, I’ve spoken to a couple people on the leading edge of patient engagement:

• Abbe Steel, CEO of HealthiVibe, which is focused on bringing greater patient input into the earliest stages of trial design through focus groups and patient surveys
• Casey Quinlan, co-founder of Patients for Clinical Research, which aims to be a force in patient education and engagement for clinical trials

In addition to their thoughts, eyeforpharma is keenly interested in hearing from more people. They've even posted a survey – from Ulrich:

To get a better idea of what other folks think of the idea, I am sending out a little ad hoc survey. Only 4 questions (so people hopefully do it). Added benefit: There is a massive 50% one-time discount for completed surveys until Friday connected to it as an incentive).

So, here are two things for you to do:

1. Complete the survey and share your thoughts
2. Come to the conference and tell us all exactly what you think

Look forward to seeing you there.

[Conflict of Interest Disclosure: I am attending the Patient Centered Clinical Trials conference. Having everyone saying the same thing at such conferences conflicts with my ability to find them interesting.]

It is a surprisingly common peril among analysts: we don’t have the data to answer the question we’re interested in, so we answer a related question where we do have data. Unfortunately, the new answer turns out to shed no light on the original interesting question.

This is sometimes referred to as the Streetlight Effect – a phenomenon aptly illustrated by Mutt and Jeff over half a century ago:

This is the situation that the Tufts Center for the Study of Drug Development seems to have gotten itself into in its latest "Impact Report".  It’s worth walking through the process of how an interesting question ends up in an uninteresting answer.

So, here’s an interesting question:

My company owns a drug that may be approvable through FDA’s 505(b)(2) pathway. What is the estimated time and cost difference between pursuing 505(b)(2) approval and conventional approval?

That’s "interesting", I suppose I should add, for a certain subset of folks working in drug development and commercialization. It’s only interesting to that peculiar niche, but for those people I suspect it’s extremely interesting - because it is a real situation that a drug company may find itself in, and there are concrete consequences to the decision.

Unfortunately, this is also a really difficult question to answer. As phrased, you'd almost need a randomized trial to answer it. Let’s create a version which is less interesting but easier to answer:

What are the overall development time and cost differences between drugs seeking approval via 505(b)(2) and conventional pathways?

This is much easier to answer, as pharmaceutical companies could look back on development times and costs of all their compounds, and directly compare the different types. It is, however, a much less useful question. Many new drugs are simply not eligible for 505(b)(2) approval. If those drugs

Extreme qualitative differences of 505(b)(2) drugs. Source: Thomson Reuters analysis via RAPS

are substantially different in any way (riskier, more novel, etc.), then they will change the comparison in highly non-useful ways. In fact, in 2014, only 1 drug classified as a New Molecular Entity (NME) went through 505(b)(2) approval, versus 32 that went through conventional approval. And in fact, there are many qualities that set 505(b)(2) drugs apart.

So we’re likely to get a lot of confounding factors in our comparison, and it’s unclear how the answer would (or should) guide us if we were truly trying to decide which route to take for a particular new drug. It might help us if we were trying to evaluate a large-scale shift to prioritizing 505(b)(2) eligible drugs, however.

Unfortunately, even this question is apparently too difficult to answer. Instead, the Tufts CSDD chose to ask and answer yet another variant:

What is the difference in time that it takes the FDA for its internal review process between 505(b)(2) and conventionally-approved drugs?

This question has the supreme virtue of being answerable. In fact, I believe that all of the data you’d need is contained within the approval letter that FDA posts publishes for each new approved drug.

But at the same time, it isn’t a particularly interesting question anymore. The promise of the 505(b)(2) pathway is that it should reduce total development time and cost, but on both those dimensions, the report appears to fall flat.

• Cost: This analysis says nothing about reduced costs – those savings would mostly come in the form of fewer clinical trials, and this focuses entirely on the FDA review process.
• Time: FDA review and approval is only a fraction of a drug’s journey from patent to market. In fact, it often takes up less than 10% of the time from initial IND to approval. So any differences in approval times will likely easily be overshadowed by differences in time spent in development. 

But even more fundamentally, the problem here is that this study gives the appearance of providing an answer to our original question, but in fact is entirely uninformative in this regard. The accompanying press release states:

The 505(b)(2) approval pathway for new drug applications in the United States, aimed at avoiding unnecessary duplication of studies performed on a previously approved drug, has not led to shorter approval times.

This is more than a bit misleading. The 505(b)(2) statute does not in any way address approval timelines – that’s not it’s intent. So showing that it hasn’t led to shorter approval times is less of an insight than it is a natural consequence of the law as written.

Most importantly, showing that 505(b)(2) drugs had a longer average approval time than conventionally-approved drugs in no way should be interpreted as adding any evidence to the idea that those drugs were slowed down by the 505(b)(2) process itself. Because 505(b)(2) drugs are qualitatively different from other new molecules, this study can’t claim that they would have been developed faster had their owners initially chosen to go the route of conventional approval. In fact, such a decision might have resulted in both increased time in trials and increased approval time.

This study simply is not designed to provide an answer to the truly interesting underlying question.

[Disclosure: the above review is based entirely on a CSDD press release and summary page. The actual report costs $125, which is well in excess of this blog’s expense limit. It is entirely possible that the report itself contains more-informative insights, and I’ll happily update that post if that should come to my attention.]

Your daily light exposure impacts your health. A new study finds that too much light at night and not enough natural light during the day can be harmful. This story first aired on Morning Edition on Nov. 4, 2024.

NPR's Leila Fadel talks with actor Patrick Dempsey about his efforts to raise money for cancer treatment and prevention.

Sudan's civil war has displaced 10 million citizens. Here are profiles of two young people from the most vulnerable groups: an unaccompanied minor caring for twin brothers, a woman who was raped.

For people with diabetes, glucose monitors are a valuable tool to monitor their blood sugar. The current generation of these biosensors detect glucose levels with thin, metallic filaments inserted in subcutaneous tissue, the deepest layer of the skin where most body fat is stored.

Medical technology company Biolinq is developing a new type of glucose sensor that doesn’t go deeper than the dermis, the middle layer of skin that sits above the subcutaneous tissue. The company’s “intradermal” biosensors take advantage of metabolic activity in shallower layers of skin, using an array of electrochemical microsensors to measure glucose—and other chemicals in the body—just beneath the skin’s surface.

Biolinq just concluded a pivotal clinical trial earlier this month, according to CEO Rich Yang, and the company plans to submit the device to the U.S. Food and Drug Administration for approval at the end of the year. In April, Biolinq received US $58 million in funding to support the completion of its clinical trials and subsequent submission to the FDA.

Biolinq’s glucose sensor is “the world’s first intradermal sensor that is completely autonomous,” Yang says. While other glucose monitors require a smartphone or other reader to collect and display the data, Biolinq’s includes an LED display to show when the user’s glucose is within a healthy range (indicated by a blue light) or above that range (yellow light). “We’re providing real-time feedback for people who otherwise could not see or feel their symptoms,” Yang says. (In addition to this real-time feedback, the user can also load long-term data onto a smartphone by placing it next to the sensor, like Abbott’s FreeStyle Libre, another glucose monitor.)

More than 2,000 microsensor components are etched onto each 200-millimeter silicon wafer used to manufacture the biosensors.Biolinq

Biolinq’s hope is that its approach could lead to sustainable changes in behavior on the part of the individual using the sensor. The device is intentionally placed on the upper forearm to be in plain sight, so users can receive immediate feedback without manually checking a reader. “If you drink a glass of orange juice or soda, you’ll see this go from blue to yellow,” Yang explains. That could help users better understand how their actions—such as drinking a sugary beverage—change their blood sugar and take steps to reduce that effect.

Biolinq’s device consists of an array of microneedles etched onto a silicon wafer using semiconductor manufacturing. (Other glucose sensors’ filaments are inserted with an introducer needle.) Each chip has a small 2-millimeter by 2-millimeter footprint and contains seven independent microneedles, which are coated with membranes through a process similar to electroplating in jewelry making. One challenge the industry has faced is ensuring that microsensors do not break at this small scale. The key engineering insight Biolinq introduced, Yang says, was using semiconductor manufacturing to build the biosensors. Importantly, he says, silicon “is harder than titanium and steel at this scale.”

Miniaturization allows for sensing closer to the surface of the skin, where there is a high level of metabolic activity. That makes the shallow depth ideal for monitoring glucose, as well as other important biomarkers, Yang says. Due to this versatility, combined with the use of a sensor array, the device in development can also monitor lactate, an important indicator of muscle fatigue. With the addition of a third data point, ketones (which are produced when the body burns fat), Biolinq aims to “essentially have a metabolic panel on one chip,” Yang says.

Using an array of sensors also creates redundancy, improving the reliability of the device if one sensor fails or becomes less accurate. Glucose monitors tend to drift over the course of wear, but with multiple sensors, Yang says that drift can be better managed.

One downside to the autonomous display is the drain on battery life, Yang says. The battery life limits the biosensor’s wear time to 5 days in the first-generation device. Biolinq aims to extend that to 10 days of continuous wear in its second generation, which is currently in development, by using a custom chip optimized for low-power consumption rather than off-the-shelf components.

The company has collected nearly 1 million hours of human performance data, along with comparators including commercial glucose monitors and venous blood samples, Yang says. Biolinq aims to gain FDA approval first for use in people with type 2 diabetes not using insulin and later expand to other medical indications.

This article appears in the August 2024 print issue as “Glucose Monitor Takes Page From Chipmaking.”

A thimbleful of soil can contain a universe of microorganisms, up to 10 billion by some estimates. Now a group of researchers in Bath, United Kingdom, are building prototype technologies that harvest electrons exhaled by some micro-species.

The idea is to power up low-yield sensors and switches, and perhaps help farmers digitally optimize crop yields to meet increasing demand and more and more stressful growing conditions. There could be other tasks, too, that might make use of a plant-and-forget, low-yield power source—such as monitoring canals for illegal waste dumping.

The research started small, based out of the University of Bath, with field-testing in a Brazilian primary school classroom and a green pond near it—just before the onset of the pandemic.

“We had no idea what the surroundings would be. We just packed the equipment we needed and went,” says Jakub Dziegielowski, a University of Bath, U.K. chemical engineering Ph.D. student. “And the pond was right by the school—it was definitely polluted, very green, with living creatures in it, and definitely not something I’d feel comfortable drinking from. So it got the job done.”

The experiments they did along with kids from the school and Brazilian researchers that summer of 2019 were aimed at running water purifiers. It did so. However, it also wasn’t very efficient, compared to, say, a solar panel.

So work has moved on in the Bath labs: in the next weeks, Dziegielowski will both turn 29 and graduate with his doctorate. And he, along with two other University of Bath advisors and colleagues recently launched a spinoff company—it’s called Bactery—to perfect a prototype for a network of soil microbial fuel cells for use in agriculture.

A microbial fuel cell is a kind of power plant that converts chemical energy stored in organic molecules into electrical energy, using microbes as a catalyst. It’s more often used to refer to liquid-based systems, Dziegielowski says. Organics from wastewater serve as the energy source, and the liquid stream mixes past the electrodes.

A soil microbial fuel cell, however, has one of its electrodes—the anode, which absorbs electrons—in the dirt. The other electrode, the cathode, is exposed to air. Batteries work because ions move through an electrolyte between electrodes to complete a circuit. In this case, the soil itself acts as the electrolyte—as well as source of the catalytic microbes, and as the source of the fuel.

The Bath, U.K.-based startup Bactery has developed a set up fuel cells powered by microbes in the soil—with, in the prototype pictured here, graphite mats as electrodes. University of Bath

Fields full of Watts

In a primary school in the fishing village of Icapuí on Brazil’s semi-arid northeastern coast, the group made use of basic components: graphite felt mats acting as electrodes, and nylon pegs to maintain spacing and alignment between them. (Bactery is now developing new kinds of casing.)

By setting up the cells in a parallel matrix, the Icapuí setup could generate 38 milliwatts per square meter. In work since, the Bath group’s been able to reach 200 milliwatts per square meter.

Electroactive bacteria—also called exoelectrogens or electricigens—take in soluble iron or acids or sugar and exhale electrons. There are dozens of species of microbes that can do this, including bacteria belonging to genera such as Geobacter and Shewanella. There are many others.

But 200 milliwatts per square meter is not a lot of juice: enough to charge a mobile phone, maybe, or keep an LED nightlight going—or, perhaps, serve as a power source for sensors or irrigation switches. “As in so many things, it comes down to the economics,” says Bruce Logan, an environmental engineer at Penn State who wrote a 2007 book, Microbial Fuel Cells.

A decade ago Palo Alto engineers launched the MudWatt, a self-contained kit that could light a small LED. It’s mostly marketed as a school science project. But even now, some 760 million people do not have reliable access to electricity. “In remote areas, soil microbial fuel cells with higher conversion and power management efficiencies would fare better than batteries,” says Sheela Berchmans, a retired chief scientist of the Central Electrochemical Research Institute in Tamil Nadu, India.

Korneel Rabaey, professor in the department of biotechnology at the University of Ghent, in Belgium, says electrochemical micro-power sources—a category that now includes the Bactery battery—is gaining buzz in resource recovery, for uses such as extracting pollutants from wastewater, with electricity as a byproduct. “You can think of many applications that don’t require a lot of power,” he says, “But where sensors are important.”

Did that rock move, or is it a squirrel crossing the road? Tracking objects that look a lot like their surroundings is a big problem for many autonomous vision systems. AI algorithms can solve this camouflage problem, but they take time and computing power. A new camera designed by researchers in South Korea provides a faster solution. The camera takes inspiration from the eyes of a cat, using two modifications that let it distinguish objects from their background, even at night.

“In the future … a variety of intelligent robots will require the development of vision systems that are best suited for their specific visual tasks,” says Young Min Song, a professor of electrical engineering and computer science at Gwangju Institute of Science and Technology and one of the camera’s designers. Song’s recent research has been focused on using the “perfectly adapted” eyes of animals to enhance camera hardware, allowing for specialized cameras for different jobs. For example, fish eyes have wider fields of view as a consequence of their curved retinas. Cats may be common and easy to overlook, he says, but their eyes actually offer a lot of inspiration.

This particular camera copied two adaptations from cats’ eyes: their vertical pupils and a reflective structure behind their retinas. Combined, these allowed the camera to be 10 percent more accurate at distinguishing camouflaged objects from their backgrounds and 52 percent more efficient at absorbing incoming light.

Using a vertical pupil to narrow focus

While conventional cameras can clearly see the foreground and background of an image, the slitted pupils of a cat focus directly on a target, preventing it from blending in with its surroundings. Kim et al./Science Advances

In conventional camera systems, when there is adequate light, the aperture—the camera’s version of a pupil—is small and circular. This structure allows for a large depth of field (the distance between the closest and farthest objects in focus), clearly seeing both the foreground and the background. By contrast, cat eyes narrow to a vertical pupil during the day. This shifts the focus to a target, distinguishing it more clearly from the background.

The researchers 3D printed a vertical slit to use as an aperture for their camera. They tested the vertical slit using seven computer vision algorithms designed to track moving objects. The vertical slit increased contrast between a target object and its background, even if they were visually similar. It beat the conventional camera on five of the seven tests. For the two tests it performed worse than the conventional camera, the accuracies of the two cameras were within 10 percent of each other.

Using a reflector to gather additional light

Cats can see more clearly at night than conventional cameras due to reflectors in their eyes that bring extra light to their retinas.Kim et al./Science Advances

Cat eyes have an in-built reflector, called a tapetum lucidum, which sits behind the retina. It reflects light that passes through the retina back at it, so it can process both the incoming light and reflected light, giving felines superior night vision. You can see this biological adaptation yourself by looking at a cat’s eyes at night: they will glow.

The researchers created an artificial version of this biological structure by placing a silver reflector under each photodiode in the camera. Photodiodes without a reflector generated current when more than 1.39 watts per square meter of light fell on them, while photodiodes with a reflector activated with 0.007 W/m² of light. That means the photodiode could generate an image with about 1/200th the light.

Each photodiode was placed above a reflector and joined by metal electrodes to create a curved image sensor.Kim et al./Science Advances

To decrease visual aberrations (imperfections in the way the lens of the camera focuses light), Song and his team opted to create a curved image sensor, like the back of the human eye. In such a setup, a standard image sensor chip won’t work, because it’s rigid and flat. Instead it often relies on many individual photodiodes arranged on a curved substrate. A common problem with such curved sensors is that they require ultrathin silicon photodiodes, which inherently absorb less light than a standard imager’s pixels. But reflectors behind each photodiode in the artificial cat’s eye compensated for this, enabling the researchers to create a curved imager without sacrificing light absorption.

Together, vertical slits and reflectors led to a camera that could see more clearly in the dark and isn’t fooled by camouflage. “Applying these two characteristics to autonomous vehicles or intelligent robots could naturally improve their ability to see objects more clearly at night and to identify specific targets more accurately,” says Song. He foresees this camera being used for self-driving cars or drones in complex urban environments.

Song’s lab is continuing to work on using biological solutions to solve artificial vision problems. Currently, they are developing devices that mimic how brains process images, hoping to one day combine them with their biologically-inspired cameras. The goal, says Song, is to “mimic the neural systems of nature.”

Song and his colleague’s work was published this week in the journal Science Advances.

This article appears in the November 2024 print issue.

Surgical stitches that generate electricity can help wounds heal faster in rats, a new study from China finds.

In the body, electricity helps the heart beat, causes muscles to contract, and enables the body to communicate with the brain. Now scientists are increasingly using electricity to promote healing with so-called electroceuticals. These electrotherapies often seek to mimic the electrical signals the body naturally uses to help new cells migrate to wounds to support the healing process.

In the new study, researchers focused on sutures, which are used to close wounds and surgical incisions. Despite the way in which medical devices have evolved rapidly over the years, sutures are generally limited in capability, says Zhouquan Sun, a doctoral candidate at Donghua University in Shanghai. “This observation led us to explore integrating advanced therapeutics into sutures,” Sun says.

Prior work sought to enhance sutures by adding drugs or growth factors to the stitches. However, most of these drugs either had insignificant effects on healing, or triggered side-effects such as allergic reactions or nausea. Growth factors in sutures often degraded before they could have any effect, or failed to activate entirely.

The research team that created the new sutures previously developed fibers for electronics for nearly 10 years for applications such as sensors. “This is our first attempt to apply fiber electronics in the biomedical field,” says Chengyi Hou, a professor of materials science and engineering at Donghua University.

Making Electrical Sutures Work

The new sutures are roughly 500 microns wide, or about five times the width of the average human hair. Like typical sutures, the new stitches are biodegradable, avoiding the need for doctors to remove the stitches and potentially cause more damage to a wound.

Each suture is made of a magnesium filament core wrapped in poly(lactic-co-glycolic) acid (PLGA) nanofibers, a commercially available, inexpensive, biodegradable polymer used in sutures. The suture also includes an outer sheath made of polycaprolactone (PCL), a biodegradable polyester and another common suture material.

Previously, electrotherapy devices were often bulky and expensive, and required wires connected to an external battery. The new stitches are instead powered by the triboelectric effect, the most common cause of static electricity. When two different materials repeatedly touch and then separate—in the case of the new suture, its core and sheath—the surface of one material can steal electrons from the surface of the other. This is why rubbing feet on a carpet or a running a comb through hair can build up electric charge.

A common problem sutures face is how daily movements may cause strain that reduce their efficacy. The new stitches take advantage of these motions to help generate electricity that helps wounds heal.

The main obstacle the researchers had to surmount was developing a suture that was both thin and strong enough to serve in medicine. Over the course of nearly two years, they tinkered with the molecular weights of the polymers they used and refined their fiber spinning technology to reduce their suture’s diameter while maintaining strength, Sun says.

In lab experiments on rats, the sutures generated about 2.3 volts during normal exercise. The scientists found the new sutures could speed up wound healing by 50 percent over the course of 10 days compared to conventional sutures. They also significantly lowered bacteria levels even without the use of daily wound disinfectants, suggesting they could reduce the risk of post-operation infections.

“Future research may delve deeper into the molecular mechanisms of how electrical stimulation facilitated would healing,” says Hui Wang, a chief physician at Shanghai Sixth People’s Hospital.

Further tests are needed in clinical settings to assess how effective these sutures are in humans. If such experiments prove successful, “this bioabsorbable electrically stimulating suture could change how we treat injuries in the future,” Hou says.

The scientists detailed their findings online 8 October in the journal Nature Communications.

The teachings of Mahatma Gandhi were arguably India’s greatest contribution to the 20th century. Raghunath Anant Mashelkar has borrowed some of that wisdom to devise a frugal new form of innovation he calls “Gandhian engineering.” Coming from humble beginnings, Mashelkar is driven to ensure that the benefits of science and technology are shared more equally. He sums up his philosophy with the epigram “more from less for more.” This engineer has led India’s preeminent R&D organization, the Council of Scientific and Industrial Research, and he has advised successive governments.

What was the inspiration for Gandhian engineering?

Raghunath Anant Mashelkar: There are two quotes of Gandhi’s that were influential. The first was, “The world has enough for everyone’s need, but not enough for everyone’s greed.” He was saying that when resources are exhaustible, you should get more from less. He also said the benefits of science must reach all, even the poor. If you put them together, it becomes “more from less for more.”

My own life experience inspired me, too. I was born to a very poor family, and my father died when I was six. My mother was illiterate and brought me to Mumbai in search of a job. Two meals a day was a challenge, and I walked barefoot until I was 12 and studied under streetlights. So it also came from my personal experience of suffering because of a lack of resources.

How does Gandhian engineering differ from existing models of innovation?

Mashelkar: Conventional engineering is market or curiosity driven, but Gandhian engineering is application and impact driven. We look at the end user and what we want to achieve for the betterment of humanity.

Most engineering is about getting more from more. Take an iPhone: They keep creating better models and charging higher prices. For the poor it is less from less: Conventional engineering looks at removing features as the only way to reduce costs.

In Gandhian engineering, the idea is not to create affordable [second-rate] products, but to make high technology work for the poor. So we reinvent the product from the ground up. While the standard approach aims for premium price and high margins, Gandhian engineering will always look at affordable price, but high volumes.

The Jaipur foot is a light, durable, and affordable prosthetic.Gurinder Osan/AP

What is your favorite example of Gandhian engineering?

Mashelkar: My favorite is the Jaipur foot. Normally, a sophisticated prosthetic foot costs a few thousand dollars, but the Jaipur foot does it for [US] $20. And it’s very good technology; there is a video of a person wearing a Jaipur foot climbing a tree, and you can see the flexibility is like a normal foot. Then he runs one kilometer in 4 minutes, 30 seconds.

What is required for Gandhian engineering to become more widespread?

Mashelkar: In our young people, we see innovation and we see passion, but compassion is the key. We also need more soft funding [grants or zero-interest loans], because venture capital companies often turn out to be “vulture capital” in a way, because they want immediate returns.

We need a shift in the mindset of businesses—they can make money not just from premium products for those at the top of the pyramid, but also products with affordable excellence designed for large numbers of people.

This article appears in the November 2024 print issue as “The Gandhi Inspired Inventor.”

Manu Prakash spoke with IEEE Spectrum shortly after returning to Stanford University from a month aboard a research vessel off the coast of California, where he was testing tools to monitor oceanic carbon sequestration. The associate professor conducts fieldwork around the world to better understand the problems he’s working on, as well as the communities that will be using his inventions.

Prakash develops imaging instruments and diagnostic tools, often for use in global health and environmental sciences. His devices typically cost radically less than conventional equipment—he aims for reductions of two or more orders of magnitude. Whether he’s working on pocketable microscopes, mosquito or plankton monitors, or an autonomous malaria diagnostic platform, Prakash always includes cost and access as key aspects of his engineering. He calls this philosophy “frugal science.”

Why should we think about science frugally?

Manu Prakash: To me, when we are trying to ask and solve problems and puzzles, it becomes important: In whose hands are we putting these solutions? A frugal approach to solving the problem is the difference between 1 percent of the population or billions of people having access to that solution.

Lack of access creates these kinds of barriers in people’s minds, where they think they can or cannot approach a kind of problem. It’s important that we as scientists or just citizens of this world create an environment that feels that anybody has a chance to make important inventions and discoveries if they put their heart to it. The entrance to all that is dependent on tools, but those tools are just inaccessible.

How did you first encounter the idea of “frugal science”?

Prakash: I grew up in India and lived with very little access to things. And I got my Ph.D. at MIT. I was thinking about this stark difference in worlds that I had seen and lived in, so when I started my lab, it was almost a commitment to [asking]: What does it mean when we make access one of the critical dimensions of exploration? So, I think a lot of the work I do is primarily driven by curiosity, but access brings another layer of intellectual curiosity.

How do you identify a problem that might benefit from frugal science?

Prakash: Frankly, it’s hard to find a problem that would not benefit from access. The question to ask is “Where are the neglected problems that we as a society have failed to tackle?” We do a lot of work in diagnostics. A lot [of our solutions] beat the conventional methods that are neither cost effective nor any good. It’s not about cutting corners; it’s about deeply understanding the problem—better solutions at a fraction of the cost. It does require invention. For that order of magnitude change, you really have to start fresh.

Where does your involvement with an invention end?

Prakash: Inventions are part of our soul. Your involvement never ends. I just designed the 415th version of Foldscope [a low-cost “origami” microscope]. People only know it as version 3. We created Foldscope a long time ago; then I realized that nobody was going to provide access to it. So we went back and invented the manufacturing process for Foldscope to scale it. We made the first 100,000 Foldscopes in the lab, which led to millions of Foldscopes being deployed.

So it’s continuous. If people are scared of this, they should never invent anything [laughs], because once you invent something, it’s a lifelong project. You don’t put it aside; the project doesn’t put you aside. You can try to, but that’s not really possible if your heart is in it. You always see problems. Nothing is ever perfect. That can be ever consuming. It’s hard. I don’t want to minimize this process in any way or form.

Acadia Pharmaceuticals did not disclose the buyer of the priority review voucher. The biotech received the voucher last year alongside the regulatory decision that made its drug Daybue the first FDA-approved treatment for the rare disease Rett syndrome.

The post Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M appeared first on MedCity News.

When it comes to the effects that the upcoming Trump presidency will have on healthcare, attendees’ attitudes ranged from cautiously optimistic to fairly anxious. Some of the issues they highlighted included mental health parity, telehealth prescribing flexibilities, and the role of Robert F. Kennedy Jr.

The post How Did Attendees at a Behavioral Health Conference React to Trump’s Victory? appeared first on MedCity News.

Value-based care contracting is especially difficult for behavioral health providers, Taft Parsons III, chief psychiatric officer at CVS Health/Aetna, pointed out during a conference this week.

The post CVS Health Exec: Payers Need to Stop Making Behavioral Health Providers Jump Through Hoops In Order to Participate in Value-Based Care appeared first on MedCity News.

Building trust while simultaneously building products, selling, recruiting, and fundraising can feel impossible. But it’s required whether you have the time or not, and it doesn’t stop no matter how big you grow.

The post The Trust-Building Playbook: 5 Tips Every Digital Health Marketer Needs to Know appeared first on MedCity News.

Among the topics INVEST will highlight are AI in life sciences, the investor perspective in healthcare and strategic priorities for hospitals.

The post A Sneak Peek of INVEST 2025 Agenda appeared first on MedCity News.

In vitro diagnostics (IVDs) play an indispensable role in modern medicine. Health care providers routinely rely on these tests—which analyze samples such as blood or saliva—to help diagnose conditions and guide potentially life-altering treatment decisions. In 2017, for example, clinicians ordered blood tests during about 45% of emergency room visits in the United States, according to the Centers...

The United States is grappling with two severe health crises: the COVID-19 pandemic and an opioid epidemic that appears to be worsening as more people deal with stress and isolation as they face increased barriers to medical care. Preliminary numbers for 2020 show that overdose deaths were outpacing the record-setting number of more than 71,000 fatalities in 2019.

Yesterday’s conference sessions surfaced interesting questions and approaches regarding the post-acute sector, bundled payment, emergency medicine and anesthesia. Post-Acute Focus: With more and more focus on the need to rationalize and re-organize the post-acute sector, we have seen multiple industry leaders start to evolve their strategies.  I blogged yesterday about AccentCare’s interesting strategy in the...… Continue Reading

Learn how to take simple x/y coordinates, and create map polygons shaped like holiday images, that can be plotted using SAS/Graph's PROC GMAP.

NEW YORK – Moves by major US fast-food chains to temporarily scrub fresh onions off their menus on Oct 24, after the vegetable was named as the likely source of an E. coli outbreak at McDonald’s, laid bare the recurring nightmare for restaurants: Produce is a bigger problem for restaurants to keep free of contamination than beef. Onions are likely the culprit in the McDonald’s E. coli outbreak across the Midwest and some Western states that has sickened 49 people and killed one, the US Department of Agriculture said late on Oct 23. The company pulled the Quarter Pounder off its menu at one-fifth of its 14,000 US restaurants. In past years, beef patties dominated the dockets of food-borne-illness lawyers, before US federal health regulators cracked down on beef contamination after an E. coli outbreak linked to Jack in the Box burgers hospitalised more than 170 people across states and killed four. As a result, beef-related outbreaks became much rarer, experts say.

NEW YORK — McDonald's on Sunday (Oct 27) ruled out beef patties as a source of the E. coli outbreak linked to Quarter Pounder hamburgers, which has killed at least one person and sickened nearly 75 others. "We remain very confident that any contaminated product related to this outbreak has been removed from our supply chain and is out of all McDonald's restaurants," the fast-food chain's chief supply chain officer Cesar Pina said in a statement. The Colorado Department of Agriculture said that all subsamples from multiple lots of McDonald's brand fresh and frozen beef patties had tested negative for E. coli, adding that it had completed beef testing and does not anticipate receiving further samples. McDonald's said it would resume distribution of fresh supplies of the Quarter Pounder and that it is expected to be available in all restaurants in the coming week, according to the statement.

David Duchovny and Gillian Anderson didn't speak to each other for "weeks at a time" when they worked on The X Files. The 64-year-old actor and Gillian, 56, enjoyed huge success with the iconic sci-fi series — but the duo actually had a turbulent relationship for many years. David said on the Fail Better podcast: "There was a long time, working on the show, where we were just not even dealing with one another off-camera. And there was a lot of tension. Which didn't matter, apparently, for the work cause we're both f****** crazy, I guess. We could just go out there and do what we needed to do." Gillian was amazed that they achieved so much success while their off-screen relationship was so tense.

Monday blues were non-existent at the Singapore Indoor Stadium yesterday (Nov 11) as fans of Blackpink's Lisa strolled into the venue in their Y2K-style outfits inspired by the Thai singer's Rockstar music video. Singapore was the first stop for the 27-year-old's first solo fan-meet tour and needless to say, the excitement could be felt, and heard. Once the lights turned off and Lisa appeared, the screams were deafening. The show started with a bang, fittingly with her self-titled hit song Lalisa. Usually at fan-meets of K-pop idols, the special effects are kept to a minimum unlike concerts. PHOTO: UnUsUaL Entertainment But at Lisa's, the performances were elevated with bursts of pyrotechnics and visual effects. After the first song, she sat down for a few interactive segments. During Welcome Lisa, she tried local delicacies like kaya toast and chicken rice.

TORONTO — A teenager is in critical condition in a British Columbia children's hospital, sick with Canada's first presumptive human case of avian influenza. "This was a healthy teenager prior to this, so no underlying conditions," said provincial health officer Bonnie Henry in a news conference on Tuesday (Nov 12). "It just reminds us that in young people this is a virus that can progress and cause quite severe illness and the deterioration that I mentioned was quite rapid." British Columbia health officials said on Saturday the province had detected Canada's first human case of H5 bird flu in a teenager.

The Public Service has expressed its commitment to implementing flexible work arrangements (FWAs) for its employees, taking into account the workforce's changing needs. In a written answer to a Parliamentary question posed by Choa Chu Kang GRC MP Zhulkarnain Abdul Rahim on Monday (Nov 11), Minister-in-charge of the Public Service Chan Chun Sing said the Government recognises the growing need for FWAs, given Singapore's demographic changes and its ever-changing demands on Singaporeans. Zhulkarnain had asked whether the Civil Service will continue to support flexible working arrangements despite some companies in the private sector requiring employees to work from the office five days a week. Grab Singapore, for example, said it will enforce its five-day return-to-office mandate starting Dec 2, reported CNA. Referencing the Tripartite Guidelines on FWA Requests (TG-FWAR), which will be enforced starting Dec 1, Chan stressed the importance of such arrangements in supporting working caregivers, encouraging workforce re-entry, sustaining labour force participation, and attracting and retaining talent.

SINGAPORE – The police are investigating deepfake nude photos of Singapore Sports School (SSP) students that were created and spread by other students. In response to queries from The Straits Times, school principal Ong Kim Soon said SSP is “aware of the incident involving the creation and sharing of deepfake photos by our student-athletes”. “The school does not condone such harmful behaviour,” he said, adding that it has launched an investigation and lodged a police report. The police, in response to queries from ST, confirmed that a report was lodged and investigations are ongoing. A reader who identified himself as a parent of a victim had alerted ST in an e-mail on Nov 12 about the deepfake nude images that were being circulated. “Many parents of affected female students in Singapore Sports School are making police reports about deepfake nude photos of their daughters generated by male students from the school,” the parent said. When contacted, the parent said that female teachers were also targeted, and that the school has offered affected students counselling.

JAKARTA — Indonesia said on Monday (Nov 11) it does not recognise China's claims over the South China Sea despite signing a joint maritime development deal with Beijing, as some analysts warned the agreement risked compromising the country's sovereign rights. Beijing has long clashed with its Southeast Asian neighbours over territory in the South China Sea, which it claims sovereignty over in almost its entirety via a "nine-dash line" on its maps that cuts into the exclusive economic zones (EEZ) of several countries. Joint agreements with China in the strategic waterway have for years been sensitive, with some claimant states wary of entering into deals they fear could be interpreted as legitimising Beijing's vast claims. An arbitral tribunal in 2016 said the Chinese claim, based on its old maps, has no basis under international law, a decision China refuses to recognise. A joint statement issued at the weekend during Indonesian President Prabowo Subianto's visit to Beijing mentioned the two countries had "reached important common understanding on joint development in areas of overlapping claims".

SEOUL — South Korean President Yoon Suk-yeol recently began practising golf, for the first time in eight years, in preparation for future meetings with US President-elect Donald Trump, Yoon's office confirmed on Tuesday (Nov 12). South Korean media said Yoon visited a golf course on Saturday for a sport his office said he had last played in 2016. "A lot of people close to President Trump... (told me) President Yoon and Trump will have good chemistry," Yoon told a press conference on Thursday, after congratulating Trump by telephone on his win. Former Trump administration officials and influential Republicans had offered to help build ties with the incoming president, he added. Analysts said Yoon may seek to find a way to capitalise on a personal friendship with Trump to advance Seoul's interests as Trump's "America First" foreign policy plans and his unpredictable style play out in his second term. South Korean companies rely heavily on trade with the United States, and during Trump's first term, the countries clashed over cost-sharing for the roughly 28,500 US troops stationed in South Korea as a legacy of the 1950-1953 Korean War.

During a 20-minute discussion of Pakistan, Chidambaram asked Burns to treat groups "aimed at India" in the same way we treated "the groups directed against Americans in Afghanistan."

‘If Mumbai attack suspects arrested in Pakistan are freed, India is at fault'

In a June 11 meeting, Prime Minister Singh assured Under Secretary Burns of his strong personal commitment to strengthening further India's ties to the United States.

During a March 28 meeting with Assistant Secretary or South and Central Asian Affairs Boucher, Foreign Minister-designate Shah Mehmood Qureshi confirmed that the new government wanted to work with the U.S. to combat extremism, increase trade and extend cooperation with India and Afghanistan.

Zardari made repeated pleas for drones to be "put in Pakistan's hands" so that Pakistan would own the issue and drone attacks (including collateral damage) would not provoke anti-americanism.

President Musharraf also asked the U.S. to put more pressure on India to negotiate over Kashmir, concluding that the time is ripe for resolution of the issue.

‘India does not want to play into the hands of terrorists by shunning dialogue.'

In Ambassador Mulford's January 7 farewell call on External Affairs Minister Pranab Mukherjee, the Minister said he understood the seriousness of the error in releasing sensitive intelligence from the Mumbai terrorism investigations and pledged that the Ministry would not further disseminate that information.