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Innovate4Health Innovation

CPIP and ITIF Release Innovate4Health Report on Role of IP in Solving Global Health Challenges

Innovate4HealthThis past Tuesday, CPIP and the Information Technology & Innovation Foundation (ITIF) released our joint report: Innovate4Health: How Innovators Are Solving Global Health Challenges. The report details 25 important healthcare innovations that are being created by and for people in the developing world, where some of the most urgent challenges remain. Each of these innovations is supported by a strong intellectual property system, and many would not be viable without the security provided by these rights.

The video from our release event this past Tuesday can be found here and is embedded below. The full Innovate4Health report can be found here, and the Executive Summary is copied below. The individual stories can also be found here on the project’s Medium website.

Innovate4Health: How Innovators Are Solving Global Health Challenges

Executive Summary

Many of the world’s biggest challenges are health challenges. The good news is that, more than ever, people are meeting these challenges with innovative solutions.

While we still face great difficulties, people all over the world live better than ever before thanks to innovation. New medicines prevent or alleviate disease. New devices diagnose problems, repair bodies, and overcome physical challenges. Still other inventions keep vaccines and medicines fresh and effective or ensure their authenticity. New business models help innovation to happen and ensure that it reaches those who need it.

Many of these innovations are secured by intellectual property rights, which support the ability of innovators to invent and bring solutions to market. Property rights, particularly intellectual property rights, foster the freedom of many hands and many minds to work on challenging problems. They put decisions in the hands of those closest to problems—innovators with knowledge of potential solutions and caregivers and consumers who understand their own needs best.

With just a bit of reflection, it becomes clear that innovation and the property rights that secure it are key to meeting global health problems. Sometimes, however, the blinding light of necessity makes it hard to see this fact. When people are in need, it is all too easy to grow impatient with the rights of innovators. When that happens, innovators get treated as an obstacle.

We think that better public policy would result from better understanding of how innovation can meet global health challenges. Our organizations, the Center for the Protection of Intellectual Property (CPIP) at George Mason University’s Antonin Scalia Law School and the Information Technology and Innovation Foundation (ITIF), both non-profit, non-partisan research organizations, have teamed up to tell the exciting story of how innovation is making the world healthier.

Our Innovate4Health initiative culminates with this report, profiling 25 original case studies showcasing how innovators, many in developing countries, are tackling life-sciences/healthcare innovation in their nations and across the broader developing world. The 25 case studies are organized into the six following themes:

  • Adapting healthcare interventions for environments where resources and infrastructure are challenging;
  • Providing affordable and robust tests for diagnosing diseases;
  • Improving HIV diagnosis and care;
  • Affordable interventions to meet basic needs in challenging environments;
  • Getting healthcare to the people in places where it’s hard for people to come to the healthcare;
  • Fostering health innovation in emerging economies.

Collectively the case studies tell a compelling and inspiring story of how entrepreneurs are creating IP-enabled life-sciences innovations that are helping to tackle some of the world’s toughest health issues.

To read the report, please click here.

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Innovate4Health Innovation

Innovate4Health: SaTo Pan Delivers a Sustainable Solution to the Sanitation Crisis in Developing Nations

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4HealthBy Michael O’Keefe

Poor sanitation poses an ongoing threat to the health and well-being of people in the developing world. Severe health problems, death, and disease can be directly linked to unsafe hygiene practices that continue to plague many countries. A UN Fact Sheet notes that 2.3 billion people lack access to improved sanitation. Open-air defecation in particular is a widespread concern, as it leads to the spread of communicable diseases. According to the WHO: “Poor sanitation is linked to transmission of diseases such as cholera, diarrhoea, dysentery, hepatitis A, typhoid and polio.”

One way in which these diseases spread is through the lack of proper toilet or latrine facilities. The WHO claims that 2.4 billion people do not have access to such facilities, with 946 million instead practicing open-air defecation.

SaTo panIn 2012, with support from the Bill and Melinda Gates Foundation’s Water, Sanitation and Hygiene Strategy, and International Development Enterprises (iDE), American Standard Brands developed a potential solution to the hygiene problems stemming from the lack of proper toilet facilities. The SaTo pan – deriving its name from “Safe Toilet” – is an attempt to limit the transmission of disease by ensuring that the toilets being used are closed off from the open air, thus preventing insects or other vectors from communicating those diseases. The basic design is a plastic mold that fits into a concrete base over a pit, which means it can be used even when basic plumbing or sewer infrastructure is absent.

Smell-free, eliminates flies, easy cleanAccess to proper sanitation and clean water is vital for the health and safety of growing populations in both urban and rural areas. When human feces are not disposed of effectively, it can cause a number of health problems. Chronic illnesses spread by feces, such as enteropathy, encephalitis, and diarrhea, can weaken adults as well as children and prevent them from retaining nutrients, potentially causing health problems for their offspring as well. Even when human waste is disposed of in a pit, rather than left out in the open, disease vectors such as flies can potentially still access it, turning latrines into persistent sources of disease for whole communities.

Patent diagrams for SaTo panInvented by Jim McHale, Daigo Ishiyama and Greg Gatarz, the SaTo pan operates much like a trap door, using a counterweight to stay closed except for allowing the passage of waste. The plastic design is cheap and acts as an effective seal over the toilet. In addition to the sanitary benefits, the SaTo pan also acts as a basic safety measure. Because of the nature of some open-pit latrines, young children face the risk of falling inside. When installing SaTo pans in Uganda, one organization reported this as a notable benefit to the communities due to the particular design of latrines in the areas they worked in.

The research team at American Standard settled on the SaTo pan concept after observing the open-pit style latrines commonly used in Bangladesh. Before the pans were installed, such latrines remained open to the air at all times, which meant that not only was the smell free to travel, but flies and other insects could enter and exit the pit, carrying a host of diseases with them. As demonstrated in this video, the pan can be “flushed” after use with a pot of water, but otherwise blocks any unwanted traffic such as insects.

Diagram of SaTo pan (Self-sealing trap door; seal shuts out flies, other insects, and odors)Crucially, the design of the pan allows for potential variations according to local customs and demands, such as using the facilities by squatting or sitting or adapting to the shape of the pit for the latrine. The core concept around which the pan is based is the counterweighted “flapper” itself. The counterweight is specifically set so that the flap remains closed until the additional force of water – not just the waste itself – is poured into the pan. The pour-flush mechanic also creates a liquid seal, with a minimal amount of water remaining on top of the flap after use to help ensure prevention of transmission of insects or gases. This approach, utilizing a basic mechanism while leaving room for responsive adjustments in design, allows the SaTo pan to be adapted globally while maintaining a simple but effective means of providing basic health benefits.

In 2015, American Standard received the Patents for Humanity award from the USPTO for its design of the (then-pending patent application) SaTo pan toilet. The counterweighted trapdoor is significantly more effective than standard squat-hole covers and avoids the risk of blockage that comes with more complex, alternative designs. Utilizing the patented design also allows American Standard to fully gauge the needs of the market, providing the basis for ongoing production and development.

Although American Standard is more generally known as a plumbing manufacturer, the SaTo pan has become a key part of their business structure. American Standard was purchased by the LIXIL Corporation in 2013, and brought within the LIXIL Water Technology (LWT) business unit in 2015. In 2016, LIXIL announced that it was establishing a special unit within LWT devoted to supporting continued development of the SaTo. Currently, three new alternative models of the SaTo pan are in development to meet the varying need of different regions. Although the initial design functions well in areas such as Bangladesh, bringing it to Sub-Saharan Africa presents new challenges, primarily that there is significantly less access to water. As the counterweight system relies on water for its operation, this poses a hurdle to its effectiveness in such regions.

American Standard has been able to use the SaTo pan design as the basis for a broad-ranging business strategy. From 2013-2014, American Standard implemented a donation program, Flush for Good, with each sale of one of its Champion toilets funding the donation of a SaTo pan. 500,000 have been donated to Bangladesh alone. Other donation programs include sending SaTo pans to Nepal after the recent earthquakes and partnerships with NGOs such as UNICEF and Save the Children. By the middle of 2016, SaTo pans had been installed in 14 countries, including Uganda, Haiti, Malawi, Nigeria and the Philippines.

#Innovate4Health is a joint research project by the Center for the Protection of Intellectual Property (CPIP) and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Devlin Hartline at jhartli2@gmu.edu.

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Innovate4Health Innovation

Innovate4Health: Daktari Diagnostics Takes on Africa’s Healthcare Challenges One Diagnostic Device at a Time

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4HealthBy Alex Summerton & Nick Churchill

Africa’s predominantly rural characteristic and limited medical infrastructure are among the region’s greatest challenges to implementing effective healthcare programs and policies for its residents. The high costs for patients associated with diagnosis and treatment in terms of money, time, and travel, along with cultural barriers, often result in individuals failing to seek treatment or only making initial consultations before abandoning the matter. Coupled with poor infrastructure, inadequate facilities, substandard equipment, and insufficient personnel, it is not difficult to see why Africa is still recognized as the setting for the world’s most difficult health crises by the World Health Organization (WHO).

hands taking a blood testOne solution to these problems is to effectively move clinics to the patients through point-of-care technologies. Daktari Diagnostics, located in Cambridge, Massachusetts, is an innovator in this field focusing on microfluidic techniques. These techniques allow the company to develop products that do not require large scale manipulation of high volumes of blood or other biological products. Thus, diagnostic technologies can be made smaller and used anywhere they are needed. Its slogan “Anywhere. Care.” underscores its commitment to developing a cheap, and lightweight, portable diagnostic device to detect HIV, Hepatitis C Virus (HCV), and sickle cell disease.

Efforts eradicating disease are two-part, regardless of where it occurs: diagnosis and treatment. No matter how much time, effort, money, and technology are spent on improving the treatment phase, failures to accurately and affordably diagnose can undermine even the greatest plans. For a rural populace, diagnosis can be frustrated by a number of factors. Many rural clinics do not have the facilities and equipment to conduct diagnostic tests. Reaching a medical clinic with laboratory services may require hours of travel by foot, and many patients fail to return for their results.

Africa is particularly susceptible to these problems. There exists a need for low cost, portable, and durable systems that can be used to facilitate immediate and accurate diagnosis of diseases that commonly affect the population. Lightweight point-of-care diagnostic platforms aim to meet WHO’s “ASSURED” criteria, a set of aspirational guidelines for creating diagnostics tools to meet the socioeconomic challenges of developing regions such as Africa.

However, developing point-of-care technology is costly, and attracting investors requires a reasonable expectation of return on their investments. The developing world is not often considered a lucrative market for the development of medical products. Developing technology that can meet the need of an effective point-of-care testing system and securing funding for the endeavor is a significant challenge.

Daktari Diagnostics machineDaktari (Swahili for “Doctor”) Diagnostics is working on the development of a point-of-care testing platform that meets the ASSURED standards. Daktari’s portable point-of-care platform, Daktari Virology, uses microfluidic techniques to test for both HIV and HCV. Microfluidic devices offer a number of advantages that directly address Africa’s challenges, including small sample sizes, low production costs, fast sampling and processing, and low power consumption. Using a single drop of blood, a microfluidic testing chip prepares the raw sample and performs the tests in one compact system.

For HIV testing, the technology uses a novel microfluidic technique to capture a key cellular indicator for the management of antiretroviral therapy in a patient’s blood. The device then uses nonoptical detection to count them. The effect is rapid testing that can give an accurate assessment of a patient’s HIV viral load in approximately half an hour.

To secure rights in its microfluidics technology, Daktari has been diligently working to assemble a patent portfolio around its innovations. Its website lists over 20 patents already granted internationally and even more applications pending. Leveraging these rights has helped Daktari overcome the challenges associated with conducting expensive R&D for the developing world by securing several rounds of funding. Daktari is using this capital to develop its microfluidics assaying technology for other diseases. In January, Daktari met a funding milestone in a partnership with Merck by completing the design of a prototype HCV point-of-care system suitable for commercial production. Recently, Daktari licensed its technology for integration into a connectivity platform that enables healthcare providers to assist global health officials by monitoring and reporting disease data in real time.

Point-of-care testing is a realistic approach to overcoming challenges in improving diagnostic and monitoring technologies in developing countries, where space, money, time, and training are often limited. Utilizing its intellectual property rights, Daktari continues to develop the technologies that can address some of the world’s most pressing health needs and connect its innovations with the communities that need them.

CPIP has previously discussed the benefits of point-of-care testing in its profile of Fydor Biotechnologies’ Urine Malaria Test, a device enabled by patented technology licensed from John Hopkins University, and ITIF has highlighted a public-private partnership that created the Visitect CD4 point-of-care HIV test.

#Innovate4Health is a joint research project by the Center for the Protection of Intellectual Property (CPIP) and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Devlin Hartline at jhartli2@gmu.edu.

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Innovate4Health Innovation

Innovate4Health: Augmented Reality Technology Helps Bring Surgical Expertise to Conflict Zones and the Developing World

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4HealthBy Gleb Savich

The majority of people in the world do not have access to safe and affordable surgical care. More than 2 billion people cannot receive surgical care simply because there are no surgical facilities where they live. Up to 3 billion more people do not have access to surgical care that is safe, timely, and affordable. The availability of surgical care is extremely uneven around the world. While 95% of the population of South Asia and several regions of Africa lack access to surgical care, less than 5% of the population of the high income areas of North America and Western Europe lack such access.

doctors in surgeryThe problem of access to surgical care may be particularly acute in conflict zones, where the need is often the greatest. Getting much-needed surgical expertise in war-ravaged countries is already a nearly impossible task. To make matters worse, in such countries as Syria, Yemen, and Sudan, targeting healthcare workers and facilities for destruction has become a warfare strategy.

Talal Ali Ahmad is a Boston-based Lebanese entrepreneur who built his career in mobile phone development. While on a mission to El Salvador as a volunteer for the Global Smile Foundation, he observed firsthand the obstacles faced by doctors providing healthcare in remote regions. Leveraging his background in mobile phone technology, Ahmad began developing tools that allow surgeons to remotely assist their colleagues with surgical procedures.

To further develop and implement the technology, Ahmad teamed up with Nadine Hachach-Haram, a London-based Lebanese surgeon. Together, they founded Proximie, bringing together a team of clinicians, engineers, and designers. In 2016, Ahmad obtained a patent on his invention and secured the backing of a Lebanese venture capital firm, Cedar Mundi Holdings.

Diagram. Top center box: Electronic Health Records 180. Bottom center box: Server 120. A two-way arrow connects the boxes. Left box: Local Site 110. A doctor (labeled 14) stands by a bed (labeled 160). Right box: Remote Site 130. A doctor (labeled 150) stands by a computer (labeled 170). Two-way arrows connect the bottom center box with both the left and right boxes.The augmented reality technology that Ahmad and his team developed, also called Proximie, is simple. It uses any pair of computers, tablets, or smartphones with cameras. One unit is located at the site of surgery, and the other is at a remote location. A surgeon at the remote location can observe the surgical field as 2D or 3D images or a real-time video feed. Using a touchscreen, the remote surgeon can make markings that are overlaid on the images of the surgical field and transmitted to the surgical site. For example, the remote surgeon can mark where to make an incision. The remote surgeon and the local team can communicate with each other by audio or text.

A more sophisticated version of Proximie utilizes a dataglove that senses the position and movements of the wearer’s hand. The hand movements of the remote surgeon wearing such a glove are overlaid on the images of the surgical field and transmitted to the site of surgery, guiding the local team on how to perform a procedure.

Proximie utilizes existing technology and can be implemented on any suitable device or platform. Its simple interface allows doctors to use the platform with just a few days of training. This simplicity and accessibility is critical. Dr. Hachach-Haram explains: “What attracts us to this is that the challenges facing public healthcare are hugely complex, yet the solutions offered by technology are beautifully simple. This idea of bringing forms of surgery to places where they haven’t been available before with nothing more than an internet connection and mobile devices seems very powerful to us.”

Fig 5. Diagram. Medical Instruction Interface in rectangle. Participants (labeled 510) in upper left box: Drs. John Smith, Mary Jones, and Paul Davis. Live video in lower left box, labeled 520; image of baby’s face, labeled 521. Boxes under image labeled 1, 2, 3, +, and an arrow, all labeled together as 522. Center box: Work area, labeled 530. Large image of baby’s face, labeled 531. Selection on nose, marked 532. Ruler for scale, marked 534. Boxes underneath marked 1 through 5, labeled 533 together. Long right box, Snapshots, labeled 540. Three images on top of each other of baby’s face. Top labeled 541, with arrow pointed at baby’s left nostril and labeled 542. Middle labeled 541, with arrow pointed at baby’s right nostril and labeled 542. Bottom labeled 541, with selection of baby’s mouth labeled 542. Boxes underneath marked 1 through 3 and labeled together as 543.Proximie conducted its initial trials in 2015 in collaboration with the Global Smile Foundation. Surgeons in the U.S. guided teams in Peru and El Salvador in repairing cleft palates of local children. The following year, surgeons in Gaza, Syria, and Iraq performed wound surgeries assisted by their colleagues in Lebanon using Proximie.

Dr. Abu-Sitta, a plastic surgeon, used Proximie to lead surgeries in the Gaza strip from his home base in Beirut, hundreds of miles away. In one such surgery, he showed the local surgeons in Gaza how to repair a blast injury. In another, he showed them how to operate on a congenital hand anomaly. Previously, Dr. Abu-Sitta tried helping overseas surgeons by sending them audio recordings, photos, and X-rays. But Proximie is far more interactive. Dr. Abu-Sitta notes: “We wanted to push the idea that with only the minimum hardware, and minimum infrastructure you can still pull it off. With just two tablets, iPad to iPad, we’re able to perform this surgery.”

One of the surgeons that conducted the surgery in Gaza described his experience: “It is like the consultant is with you in the same room, giving you an opinion so that the surgery can be perfect.”

In addition to helping surgeons in remote areas and conflict zones to benefit from the expertise and real-time guidance of experts located elsewhere in the world, Proximie can be a valuable training tool. Proximie has partnered with the Royal Free Hospital and University College London in the U.K. and Yale Medical School in the U.S. to provide support for medical students. “Surgeries are being streamed from the Royal Free Hospital theaters and the students can log on and interact directly with the operating surgeon. Students can also capture and store photos and videos on Proximie’s cloud-based server for future learning,” explains Dr. Hachach-Haram.

Driven by their belief that everyone should benefit from the same high quality of healthcare and training opportunities, no matter where they live, the Proximie team continues to develop their technology to increase access to surgical care and training around the world.

#Innovate4Health is a joint research project by the Center for the Protection of Intellectual Property (CPIP) and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Devlin Hartline at jhartli2@gmu.edu.

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Innovate4Health Innovation

Innovate4Health: Indian Startup Develops Nanomaterial Filter to Help Solve Global Drinking Water Crisis

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4HealthBy Gleb Savich

Access to clean water remains a critical issue on a global scale. According to the latest statistics by the World Health Organization (WHO), 844 million people lack a basic drinking water service and at least 2 billion people use contaminated water that can transmit cholera, dysentery, typhoid, polio, and other diseases. Contaminated drinking water causes more than 500,000 deaths each year. And in low- and middle-income countries, more than one-third of the health care facilities lack even soap and water for handwashing.

many hands catching water under a faucetThis drinking water crisis disproportionately affects the poor in the developing world. However, problems with access to safe drinking water may arise in any part of the world due to man-made or natural disasters—including in the United States. One recent example is the public health crisis that erupted in Flint, Michigan, where drinking water became contaminated with lead when the city switched to a different water source.

Natural disasters may disrupt the water supply in areas that normally have access to safe drinking water. As of October 2017, over a month after Hurricane Maria devastated the island of Puerto Rico, many of its residents still did not have access to clean water, precipitating an outbreak of leptospirosis, a rare bacterial disease.

Climate change, population growth, and urbanization pose further challenges to water supply systems. According to the World Health Organization, by 2025, half of the world’s population will be living in water-stressed areas. These varied challenges to one of humanity’s most fundamental problems require flexible and creative solutions. 

Dr. Thalappil Pradeep is a professor in the Department of Chemistry at the Indian Institute of Technology (IIT) Madras. His decades of research focusing on nanomaterials has led to several discoveries that have already begun to help solve the global problem of access to clean drinking water.

The first breakthrough came in 2004 when Dr. Pradeep’s team developed nanoparticles that can break down certain pesticides dissolved in water. Many of these chemicals are not removable by standard water filters and have been shown to pose environmental and health risks. Although the use of some of these pesticides is banned, the compounds persist in the environment decades later. The problem is particularly relevant in India, one of the world’s largest pesticide producers, where pesticide water contamination is a serious problem in certain areas.

enlarged image of a moleculeThe pesticide removal technology developed by Dr. Pradeep and his colleagues works by utilizing the ability of gold and silver nanoparticles to bind pesticides from flowing water through adsorption. Dr. Pradeep and his coinventor obtained both Indian and U.S. patents on their technology and licensed it to Eureka Forbes, an Indian manufacturer of vacuum cleaners and water purifiers.

The technology is estimated to have reached 7.5 million people and is the first nanomaterials-based water filter to be commercialized. To further develop nanomaterials-based water filtration technologies, Dr. Pradeep and his team founded a startup, InnoNano Research, in 2004.

Their next breakthrough came in 2012, when the team developed a novel nanomaterial capable of being adapted for the removal of multiple types of water contaminants. The new filter, dubbed AMRIT for Arsenic and Metal Removal by Indian Technology, can remove microbial contamination as well as arsenic, iron, and other heavy metals from drinking water.

The antimicrobial properties of silver ions were well known, but their large-scale implementation for water filtration had been hampered by technological obstacles, such as lack of suitable substrates in which to embed the ions. The novel nanoparticle material developed by Dr. Pradeep and his team solves these issues.

Silver nanoparticles are embedded in this material to remove microbes, while the incorporation of other compounds allows for the removal of other contaminants. For example, the incorporation of iron achieves the removal of both iron and arsenic. Thus, this technology allows for manufacturing of multistage filtration systems suitable for particular needs.

Discussing this filtration system, Dr. Pradeep explains: “If this will be useful for water, it has to be very cheap, have a low carbon footprint, require no electricity, and should not contaminate water sources in the process.” And his team’s technology meets these challenges. According to : Dr. Pradeep, manufacturing requires no heating or electricity and uses materials with a low carbon footprint.

Removal of arsenic from drinking water is of particular interest in India, where ground waters used for drinking and irrigation are often contaminated with dangerous levels of arsenic. To begin addressing this problem, by the summer of 2016, AMRIT filters were installed in 750 locations in several Indian provinces, providing clean water to nearly half a million people.

In 2016, InnoNano Research succeeded in securing one of the largest investments for an Indian tech startup when it obtained $18 million from Nanoholdings LLC, a U.S. venture capital firm specializing in investing into material science-based energy and water startups. This investment is particularly significant in light of the difficulties that Indian startups often face when it comes to scaling up their technologies.

Dr. Pradeep explains: “We have no efficient mechanisms for partnering, scaling and incubating – those are the lacunae in our system.” While universities provide startups with access to labs and research grants, more funding is needed to achieve the scale necessary for further product development.

Leveraging intellectual property enables startups to raise funds necessary to bring their innovations to those who need them. With the help of Nanoholdings LLC, Dr. Pradeep hopes to expand the company’s operations into Africa, Southeast Asia, and Latin America, and to continue developing the technology to filter out other dangerous contaminants found in drinking water.

#Innovate4Health is a joint research project by the Center for the Protection of Intellectual Property (CPIP) and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Devlin Hartline at jhartli2@gmu.edu.

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Innovate4Health Innovation

Innovate4Health: DNAe Enhances HIV Treatment By Monitoring the Effectiveness of Antiretroviral Therapy

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4HealthBy Alex Summerton

HIV/AIDS is a complex disease presenting a range of challenges for all stages of a patient’s progression. Effective detection, diagnosis, management, and monitoring are all crucial, and problems anywhere in the treatment chain can make later stages more difficult or undo the careful work of earlier stages. Significant technological improvements in healthcare have increased the effectiveness HIV/AIDS treatment in the developed world. However, many of these advances are inaccessible to developing world countries for reasons of cost, size, complexity, or infrastructure requirements.

Developments in the use of Ion Sensitive Field Effect Transistors (ISFETs) by DNA Electronics (DNAe) has resulted in a new method for monitoring the effectiveness of antiretroviral therapy (ART). Where traditional ART effectiveness monitoring techniques often require bulky, specialized equipment with a large laboratory footprint and long turnaround times, new ISFET based testing is quicker and far more discrete as the entire testing platform has been reduced to a USB stick and requires only half an hour to perform a test.

enlarged image of microscopic cellsART comprises the administering of a combination of antiretroviral drugs inhibiting HIV’s ability to infect and reproduce in healthy cells. HIV, like any pathogen, can develop resistance to the drugs used to treat it. Monitoring is crucial to ensuring ART is effective, and when treatment isn’t it becomes necessary to switch the drugs used. Several indicators can give a window into the efficacy of treatment, either by directly or indirectly monitoring the presence of HIV. The recommended method of monitoring for HIV treatment failure is testing the concentration of viral bodies in the blood stream, or the “viral load.” The World Health Organization recommends testing every 6 to 12 months to balance the cost of testing with the need to ensure the effectiveness of ART.

However, with accuracy comes costs. Testing equipment is roughly the size of a photocopier, requires support infrastructure, and takes up considerable laboratory space, limiting its deployment and making testing costly. Testing also requires preparatory work and trained support staff, further limiting where testing is carried out. For developing countries with HIV/AIDS crises, these attributes often limit monitoring technology to large urban areas. This imposes additional costs on persons living with HIV in rural areas who often must pay for a trip to test the efficacy of their ART and a return trip days later to receive the results.

Professor Christofer Toumazou of Imperial College London and DNAe have created a method for viral load testing using ISFETs to detect subtle changes in blood caused by the presence of HIV. Using ISFET technology overcomes challenges of cost, time, and complexity. DNAe has also used ISFETs to overcome the size and centralization issues by implementing its innovative testing technology on a USB stick. A USB based ISFET testing platform boasts several advantages over traditional equipment that decrease the cost and burden imposed by testing. Dramatically smaller size means increased portability and reduced power demand, untethering testing from the lab and allowing it to travel to patients. ISFET testing technology also operates far more quickly than current testing methods. Current tests take days to perform. DNAe’s USB test returns an accurate result in 20 minutes, allowing patients to receive results in a single visit. Furthermore, USB implementation reduces the complexity of testing and consequently the need for extensive training to perform tests.

Genealysis, DNAe’s underlying ISFET technology, operates by detecting changes in pH caused by the reaction of HIV genes on a specialized microchip. The change in pH is sufficient to change the electrical state of the chip and turn it on. Thus, Genealysis uses these pH changes to identify the presence or absence of HIV in the blood by measuring pH changes related to HIV RNA and monitoring if the ART is working.

Professor Toumazou formed DNAe to commercialize his innovations in DNA analysis with a mission “to bring dramatic, life-changing improvements to healthcare and beyond with fast, simple and scientifically sound products.” The patented ISFET technology serves as the backbone of DNAe’s business operations, allowing it to secure the necessary funding for further research and development. Genealysis is currently being adapted for a sepsis diagnosis platform with the same improvements in testing time, accuracy, and cost ISFETs have shown for HIV testing. DNAe’s intellectual property rights have allowed it to secure over $70 million in investment from the U.S. Department of Health and Human Services for research and development to expand its diagnostic technology to other innovative, life-saving applications, including rapid detection of biothreat agents, antimicrobial resistant infections, and influenza. DNAe has also used its patents to increase the speed of innovation and adoption of this important technology by granting non-exclusive licenses to certain life science companies.

HIV is a disease for which treatment lasts a lifetime. Technological improvements at all stages of a patient’s progression, detection, diagnosis, treatment, and monitoring help lessen the burden HIV imposes. ISFET technology is a promising avenue to reduce the burden ART monitoring imposes on persons living with HIV in the developing world, and DNAe is poised to adapt its patented innovations for other life-saving applications.

#Innovate4Health is a joint research project by the Center for the Protection of Intellectual Property (CPIP) and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Devlin Hartline at jhartli2@gmu.edu.

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Innovate4Health Innovation

Innovate4Health: Nike’s Innovations Provide Comfort and Independence to People with Disabilities

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4HealthBy Nick Churchill

Many amputees, stroke victims, and people with movement disabilities rely on specialized clothing to support their daily lives. Participation in society, whether in the developing or developed world, requires being appropriately dressed. Not only can difficulty in dressing inhibit social and professional interactions, but it can also make it difficult to travel to a health care facility to receive treatment for a disability.

This problem is particularly acute with respect to shoes. Not everyone has the dexterity required to insert their foot into the small opening of a standard sneaker, let alone to tie traditional laces. Unlike a loose fitting sweater or elastic waistband, which can be sufficient to make shirts and pants functional, a shoe must be well-fitted to support a person who has difficulty walking.

Nike addressed the problem of well-fitted shoes for disabled people by developing FlyEase technology, which incorporates a zipper that extends around the heel of the shoe. This allows the wearer to create a large opening in the back or side of the shoe, slide in his or her foot, and close and tighten the shoe, all with one hand. Following on its success, Nike is currently working on a design for completely hands-free athletic shoes that can accommodate people of all abilities.

The original impetus for a shoe design with improved accessibility was CEO Mark Parker’s desire to help a Nike employee who had recently suffered a stroke. Renewed attention was given to the project in 2012 when high school student Matthew Walzer wrote an open letter to Nike explaining the importance of accessible, supportive footwear. Walzer has cerebral palsy, and his doctors predicted that he would never walk on his own. But with the help of crutches and Nike basketball shoes, which provide enough ankle support, he can. Nevertheless, Walzer’s independence was limited because he only had flexibility in one hand, which made it impossible for him to tie his own shoes.

The letter from Walzer explaining the challenges he faced made its way to Tobie Hatfield, the Senior Director of Athlete Innovation at Nike, who reached out to Walzer and began working on prototypes that could address his needs. After testing several iterations, Hatfield developed the patented FlyEase system, which has given Walzer the independence he sought. Nike sells several styles of basketball and running shoes that incorporate the FlyEase technology.

Nike went a step further to support innovation in shoes to help those with physical challenges by hosting the Nike Ease Challenge, an open innovation competition that sought a more hands-free design for performance footwear. The winner of the $50,000 cash award was Brett Drake, a civil engineer from Cheyenne, Wyoming. Drake’s design, which was inspired by snowboard boots, incorporates a hinged rear panel that pops open, allowing the wearer to slide in his or her foot before locking the panel back into place. The panel is secured by magnets strong enough to secure the shoe on the wearer’s feet, but light enough not to significantly add to the weight of the shoe. Drake will continue to work with Nike as it refines and tests his concept.

Open innovation contests like the Nike Ease Challenge are enabled by strong, well-defined IP rights. Collaborating with other firms or individuals provides opportunities for new, innovative ideas, but it also involves inherent risks and uncertainties. A carefully planned IP strategy can mitigate these risks and thereby facilitate cooperation. Collaborators can delineate existing IP rights and establish guidelines for how to share the value of the anticipated innovations up front. It would be irrational for a company to invest resources into a development project without the protections, which can provide reasonable expectation of return on its investment.

figure of a Nike shoeThe Nike Ease Challenge Official Rules provides some insight into how Nike overcame the risks associated with an open innovation contest. Participants granted Nike a limited license to all rights in their designs for the purposes of reviewing and testing them. Participants also granted Nike the right to use their likenesses for purposes related to the competition or a resulting product. The conditions allow the innovation contest to take place in an orderly manner, while preserving the ability of both parties to manage commercialization of any viable final product.

Nike rose to the challenge issued by Matthew Walzer, and it continues its efforts to develop an athletic shoe that is supportive and truly hands-free. Shoes featuring Nike’s FlyEase technology are available in men’s, women’s, and kids’ sizes and styles. Through an open innovation plan made possible by an intelligent IP strategy, Nike took another step towards a laudable goal: it crowdsourced an ingenious design that could help people of all ability levels achieve a new degree of independence and comfort.

#Innovate4Health is a joint research project by the Center for the Protection of Intellectual Property (CPIP) and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Devlin Hartline at jhartli2@gmu.edu.

 

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Innovate4Health: Embrace Infant Warmers Help Save Lives of Preterm Babies in Developing Countries

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4HealthBy Gleb Savich

Preterm birth is the leading cause of death for children under five years old. An estimated 15 million babies are born before 37 weeks gestation each year, and nearly 1 million children under five die due to complications associated with such births. Nearly three quarters of them could be saved with current interventions. The disparity in survival rates of preterm babies based on a country’s wealth is startling. In high-income countries, almost all of the babies born after 32 weeks survive, but in low-income countries, only half survive.

Hypothermia is a significant factor contributing to the death of preterm babies. Preterm newborns are particularly vulnerable to hypothermia because they cannot generate enough heat to warm themselves on their own. They also have less stored fat to insulate themselves against heat loss. Infant incubators are commonly used in neonatal care units to help preterm infants maintain safe body temperature. Such equipment costs thousands of dollars and requires a stable source of electricity to operate.

Healthcare interventions in the developing world often prove ineffective. Expensive equipment donated to hospitals in the developing countries is often useless because a stable electricity supply and replacement parts are unavailable. Despite long-term efforts of well-intentioned people, innovative solutions have been needed to meet these local challenges rather than more donations of existing technology.

diagram of an infant in an infant warmerSpecifically, there has been a need to design infant incubators that address the unique challenges of the developing world. Embrace infant warmers, which were developed through a project class at Stanford University called Design for Extreme Affordability, were designed to meet these challenges. Embrace infant warmers have won several awards, including the Economist Innovation Award and TED Fellows award.

Projects start with developing-world challenges in mind, and students create innovative solutions that address problems with using existing technology. An integral part of the course are need-finding trips, during which the students learn about the needs of the target community while on location. This enables the students to formulate an appropriate design process while also establishing deep connections with the members of the community.

The challenge leading to Embrace was to create a cheap infant incubator. They started by visiting hospitals in Nepal, and they quickly realized that most births occur in villages far away from hospitals with stable sources of electricity. Donated infant incubators were available, but they were left in storage because the birth facility lacked the infrastructure to use the machines.

The team designed a portable device capable of maintaining the infant at approximately body temperature without having to be continuously connected to an electricity source. It is able to do so by utilizing specialized temperature-regulating materials that keep a near-constant temperature despite gaining or losing heat energy.

diagram of an open infant warmerThese materials are called “phase change materials” because they melt or solidify (in other words, they change phases) near body temperature. People normally think about the transfer of heat energy as making one thing warmer or another thing colder, but this is not true during a phase change. For example, during solidification, the material releases heat energy, which can be used to keep the infant warm, but it maintains its own temperature because the heat comes from the process of solidification rather than a loss of temperature.

Embrace infant warmers look like a swaddle or a tiny sleeping bag that cradles an infant. A temperature-regulating element is placed between the inner and outer fabric layers of the infant warmer. This element contains the phase change material, chosen so that it melts or solidifies around normal human body temperature.

The temperature-regulating element can be heated or cooled to the desired temperature utilizing a recharging unit plugged into an electrical outlet or by placing the element into warm or cool water. Thus, no electricity is required to use the device. But even intermittent power sources can be beneficial because the unit can be charged when it is not in use. Once at the desired temperature, the temperature-changing element is inserted between the fabric layers of the infant warmer. One current version of the infant warmer maintains the desired temperature for at least 4 hours.

diagram of a baby in an unrolled baby warmerTo further advance their invention, the team founded the Embrace Innovations company and have begun developing a strong patent portfolio. Secure and effective patent rights allow the enterprise to grow and adapt in furtherance of their mission. This includes adopting strategies such as providing products through for-profit and nonprofit mechanisms and contracting with third-party manufacturers to produce the devices. Income derived from the initial innovations can then be used for additional projects that will further benefit the developing world.

Today, Embrace infant warmers are manufactured by Phoenix Medical Systems in India and are available for a small fraction of the cost of standard incubators. The nonprofit arm of the company, Embrace Global, is a part of Thrive Networks, an international NGO that utilizes evidence-based innovations to improve the lives of underserved populations in Southeast Asia.

The Embrace team has also gone on to develop other products: sleeping bags and swaddles for infants under the brand, Little Lotus. Like Embrace infant warmers, these products utilize phase change materials to ensure optimal sleeping temperature for babies. A portion of proceeds from every purchase of a Little Lotus product goes to providing access to Embrace infant warmers, showing how parallel projects can be used to benefit vulnerable populations in the developing world.

With the help of Embrace Global and its partners, Embrace infant warmers have been used to care for over 200,000 low birth weight and premature infants across 20 countries in the developing world. This is the result of both the important innovation and the forward-thinking development that can only occur when inventors have control over the ideas they create.

#Innovate4Health is a joint research project by the Center for the Protection of Intellectual Property (CPIP) and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Devlin Hartline at jhartli2@gmu.edu.

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Innovate4Health: Miriam Bridges the Gap Between Developing-World Infrastructure and Cancer Detection

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4HealthBy Alex Summerton

Originally a disease diagnosed only in developed countries, cancer is now a leading cause of death in the developing world with over half of all new cases annually. The rise in cancer in the developing world is attributed to improving technological, medical, and socioeconomic conditions. People are living longer due to reducing other causes of mortality such as infectious disease, unsanitary conditions, and maternal and infant mortality. The result is populations living long enough to begin seeing end of life diseases like cancer.

However, the advances leading to the higher prevalence of cancer in the developing world have not been accompanied by the advances to fight it. Treatment costs remain prohibitively high. Detection occurs late during the disease’s progression, generally after symptoms begin to present and chances of survival decrease. Underdeveloped infrastructure makes accessibility to screening and treatment difficult. Doctors’ offices can be remote and crowded, and trained oncologists are few and far between, leaving necessary expertise inaccessible to patients.

The overall effect is a developed-world disease outstripping developing-world technology and infrastructure.

Miroculus aims to combat the challenges of cancer screening, in both the developed and developing world, by providing accurate, low-cost, and accessible technologies that can be easily deployed at the earliest stages when treatment is cheaper and more effective. Founded by Alejandro Tocigl, Foteini Christodoulou, and Jorge Soto, Miroculus is developing a method of screening for cancers via microRNA.

The flagship product of Miroculus is Miriam, a cancer detection platform enabling accurate, early screening of cancer. Debuted at TEDGlobal in 2014, Miriam is a non-invasive tool that can rapidly screen for a wide range of cancers. Its design means it can be deployed during routine health examinations, rather than as part of cancer testing once symptoms have presented. Miriam works by assaying blood for the presence of microRNAs. Miroculus’s team has shown that certain microRNAs in a patient’s blood are correlated with specific types of cancer. So far, Miroculus has proven the concept of enabling Miriam to detect pancreatic, lung, breast, and hepatic cancer.

gloved hand holding screening toolMiriam achieves its goals through a simple yet elegant construction, requiring only a camera, computer, and testing substrate in a standard well plate. Each well contains a reactant keyed to a specific microRNA. A patient’s sample is added to each well and tested for the presence of microRNA. When the particular microRNA in the well is present in the patient’s sample, the reaction produces a luminescent effect. Miriam’s camera monitors these reactions by recording the change in luminosity of the wells during testing, sending these images via Miriam’s computer to Miroculus’s cloud computer. Miroculus then analyzes the pattern to determine which microRNAs are present and whether the patient has cancer.

Miriam’s advantageous three piece construction provides low-cost implementation while remaining clinically effective. Driven by Miroculus’s objective to democratize cancer screening technology, a Miriam testing platform can be created using cheap and readily available technologies in the developing world. During Miriam’s first debut, one of the founders showed the technology being deployed via a 3D-printed test chamber and a smartphone. Both 3D printing and smartphones are viewed as platforms for bringing developed-world medical technologies to the developing world. Combining innovative biological science and versatile technology such as 3D printing and smartphones allows Miriam to substitute for complex specialized equipment requiring far more training and resources to implement.

Miroculus is employing a blend of IP protections in the distribution of Miriam. It is combining an open source release of how to construct the Miriam platform, including copyrighted design plans for making the 3D printed device, with patent protection over its microRNA based testing method. Choosing to use this dual IP protection allows Miroculus to ensure a quality product in real world use with sufficient income to both run the company and develop the next generation of technologies.

To test the deployment and efficacy of Miriam, Miroculus has elected to employ open source distribution of Miriam. Instructions for building a fully functional Miriam are currently available on GitHub, including 3D printing instructions and software, firmware, and hardware instructions for a testing computer implemented on Arduino. These documents and code are published under open source licenses. This owner-driven free exercise of rights provides Miroculus with two major advantages. First, Miroculus can enjoy open collaboration and improvement on Miriam’s design and software. Second, making Miriam open source can encourage the adoption of the technology leading to additional economies of scale and providing Miroculus reputational benefits in the marketplace.

Miroculus is also utilizing patent protection for aspects of Miriam that require technical sophistication beyond having access to a 3D printer. It is globally seeking patents for testing wells and the detection system. By patenting the disposable wells, Miroculus can secure a return on its research and investment into Miriam. Because Miroculus views supplying the testing wells as the best income strategy for the technology, with revenue from supplying platforms being only incidental, Miroculus will be able to leverage the low-cost adoption of Miriam afforded by delivering an open source platform.

Miriam is a story of modern technology being used to bridge the gap between the developed and the developing world. Miroculus has a goal of enabling cheap, routine screenings for a wide range of cancers to lower the costs, both economic and human, of the disease. By making its testing device easily available, Miroculus aims to reach its goal of accessibility. And by securing patent protection for its testing wells, Miroculus will be able to ensure a return on its technology. This will allow further development and democratization of the necessary technology for combating the world’s most pressing diseases.

#Innovate4Health is a joint research project by the Center for the Protection of Intellectual Property (CPIP) and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Devlin Hartline at jhartli2@gmu.edu.

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Innovate4Health: Nutriset Uses Patents and Trademarks to Fight Severe Malnutrition Across the Globe

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4HealthBy Nick Churchill

Malnutrition is one of the greatest global health challenges, particularly with regard to children and pregnant women in developing countries. Undernutrition contributes to nearly half of all deaths among children under the age of 5 and has lifelong consequences for physical and cognitive wellbeing.

Nutriset has confronted the global malnutrition problem head-on by developing a range of innovative nutritional products and using its intellectual property to help developing countries reach nutritional autonomy.

Malnutrition is a blanket term that includes both undernutrition and micronutrient deficiency. An estimated 11 percent of the world’s population, or 815 million people, are undernourished. Undernourished people are particularly vulnerable to disease and death, and both undernutrition and deficiencies in micronutrients can prevent proper growth and development. Undernutrition causes children to underperform in school and makes adults less able to work, perpetuating a cycle of poverty. It can also be deadly. Children suffering from severe acute malnutrition, characterized by very low weight and visible muscle wasting, require urgent treatment to survive.

Severely undernourished patients have traditionally been treated with powdered foods which are dissolved in water before consumption. These powdered products carry risks of dosage errors and bacterial contamination, and they are likely to cause diarrhea in undernourished patients. They also tend to have short shelf lives, particularly in tropical climates.

Nutriset was founded in 1986 by Michel Lescanne with the mission of “focusing on research in the field of humanitarian nutrition, developing innovative solutions and acting as an interface between the worlds of humanitarian aid, nutritionists and food industry technologies.” Since then, Nutriset has developed several therapeutic milks, pastes, and tablets. In 1996, Nutriset partnered with Dr. Andre Briend to create Plumpy’Nut®, the first ready-to-use therapeutic food (or, RUTF) for the treatment of severe acute malnutrition.

This new product was field tested in Malawi by Dr. Mark Manary, who discovered that RUTFs were much more effective than traditional treatments. Dr. Manary was able to clear his hospital’s malnutrition ward and use RUTFs to treat his patients at their homes, while increasing the recovery rate from 25% to 95%. Given the product’s success, Dr. Manary recognized the long-term impact RUTFs could have if they were manufactured in the countries that needed them. Together, the doctors simplified the recipe so it could be produced locally.

A woman and child sitting on a bend next to a box. The woman is giving the child something to drink.Plumpy’Nut® has a long, 2-year shelf-life, is formulated to avoid diarrhea-type side effects, and can be eaten right out of the packet, eliminating the risks of dosage errors and contamination associated with mixing a powder with water. Plumpy’Nut®’s long shelf-life, effectiveness, and ease-of-use have led to a rise in community-based treatment of acute malnutrition and have made it possible to treat children in areas that were not reached by traditional methods.

Nutriset has used its patent rights to further increase access to its technologies in developing countries through its PlumpyField® network. Nutriset partners with local entrepreneurs in franchise-like relationships to create sustainable production systems in developing countries. In addition to benefiting from Nutriset’s reputation and manufacturing experience, network partners are given access to Nutriset’s patents and trademarks. The franchise-like system based on granting rights to use its intellectual property allows Nutriset to ensure that all products being locally produced by network members embody the innovations that actually help those suffering from malnutrition. And by supporting the local manufacture of its innovative products, Nutriset enables its partners to provide jobs to local people, source raw materials from local farmers, and customize the products to address the specific nutritional needs of their communities, while decreasing dependency on foreign organizations.

The PlumpyField® network consists of 9 members based in Central America, Africa, Asia, Europe, and the U.S. While the majority of the products are still manufactured in France and the U.S., members in developing countries continue to increase their production capacity, bringing the network’s total capacity to 117,400 metric tons. In 2016, the network’s products were used to treat nearly 8 million children. Thanks to Nutriset’s focus on incentivizing local capacity, that number will surely rise. According to the United Nation’s Food and Agriculture Organization, increasing local production is one of the best ways of ensuring long-term food security. Nutriset’s success in this endeavor would not be possible without its intellectual property rights.

The story of Plumpy’Nut® and PlumpyField® illustrates the power of intellectual property rights to improve and save lives. Not only do IP rights encourage the development of innovative products, they can be used to implement sustainable solutions to some of the world’s most pressing health challenges.

#Innovate4Health is a joint research project by the Center for the Protection of Intellectual Property (CPIP) and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Devlin Hartline at jhartli2@gmu.edu.