Category: Innovate4Health

Categories
Innovate4Health Innovation

Innovate4Health: New Oxygen Machine Technology Confronts Blackouts in Emerging Nations

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

Innovate4HealthBy Andrew B. Levey

Oxygen therapy, where supplemental oxygen is used as a medical treatment, is vital to children with pneumonia. Rolling blackouts in Uganda and other developing nations, which can last for hours at a time, are stopping oxygen concentrators—machines that concentrate oxygen from the ambient air—from providing this vital therapy. Problems are worse in more remote places that lack an electricity infrastructure in the first place. As a result, children already vulnerable to pneumonia are denied effective treatment. Currently, pneumonia accounts for at least 18% of all deaths of children under 5 years old.

The World Health Organization has stated that methods for providing oxygen are needed in low resource settings to combat poor energy infrastructure and theft of needed supplies. Through their FREO2 Foundation, Professors Roger Rassool and Jim Black of the University of Melbourne are tackling this problem with the FREO2 – Siphon.

FREO2 has improved upon existing oxygen concentrator technology by locally storing oxygen at low pressure, available when needed to supplement a disconnection of energy to the machine. While developing a new approach to the technology, the team managed to keep costs low and produce a product suitable for remote relocations vulnerable to blackouts. Lack of reliable electricity has been addressed in other ways, but those methods are only sufficient for larger, more established medical facilities. More remote and desolate clinics needed a different solution.

Professors Rassool and Black developed a concentrator which utilizes running stream water to create a low-pressure vacuum, which can be used to separate oxygen from the air in the environment. The team determined that the central issue is not specifically energy related, but a matter of creating a difference in air pressure to create air flow. The final product is cost efficient, easy to use, and simple to operate. Taking a step back and re-imagining the basic concepts of an oxygen concentrator allowed the team to arrive at the conclusion that electricity was not needed. A working prototype is already operating in Gippsland, Australia, with planned expansion to other countries. Professor Rassool is conducting operational and field work studies in Uganda to begin implementation of the device where it is needed most.

FREO2’s patent application describes the foundational innovation. Concentrating oxygen from the atmosphere involves passing air over a “molecular sieve,” which removes nitrogen and leaves primarily oxygen behind. The energy to move the air across the sieve in older technology was electricity creating high pressure to push air into the sieve. Figure 2 from the patent application shows how a siphon operating between two levels of water can accomplish the same goal by pulling the air instead of pushing. The water flowing through the siphon will draw in air, shown in typical patent fashion with a number (13) and a line. Drawing in air creates a vacuum that can be used to pull air into the sieve and concentrate the oxygen.

Figure 2 from the patent application

The Bill & Melinda Gates Foundation and numerous others have recognized the value of the innovation, awarding the inventors funding to continue research, development, and deployment of their invention. FREO2 is posed to continue its research and manufacturing into the near future. Ultimately, the inventors hope to bring their start up to Australia whereby they would establish a network within the community and potentially form manufacturing capabilities for future deployments. As the inventors note, they have a long road ahead but the rewards to be reaped are great.

The FREO2 device will save lives. As the inventors emphasize, the innovative technology allows remote clinics to keep oxygen concentrators performing by simply utilizing available water sources, which will support their primary mission—saving lives. And the benefits of IP protection will help assure that they fulfill their mission.

#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.

Categories
Innovate4Health Innovation Patents

Innovate4Health: Nanobiosym’s Gene-RADAR Brings Real-Time Results for Zika Testing

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

Innovate4HealthBy Gabrielle Eriquez

Because there is currently no preventative vaccine for Zika, a mosquito-borne virus known to cause severe birth defects in pregnant women, the ability to obtain a fast and accurate diagnosis is critical. However, especially in the developing world where Zika’s presence is greatest, there are significant issues with current diagnostic tests: they are in extremely high demand, especially during the summer months, and, accordingly, are very costly.

Enter Nanobiosym’s Gene-RADAR: a tablet-sized device which can detect Zika RNA from human serum. Though it is currently only authorized for Zika testing pursuant to an FDA Emergency Use Authorization, this device has the potential to facilitate the availability of faster, cheaper Zika testing worldwide.

Due to the scale of the disease, getting tested for Zika is not as simple as a quick trip to a local clinic. Testing criteria prioritize pregnant women who have possibly been exposed to the virus. These criteria result in many others who are not pregnant, but still may have been exposed, being turned away from getting tested.

mosquitoThe problem is even greater in developing countries in Latin America. Poor areas lacking adequate sanitation and air conditioning are favorable breeding grounds for mosquitoes. The only advice that many of these countries give to women to combat Zika is to avoid pregnancy; however, these countries have the world’s highest proportion of unintended pregnancies.

The difficulties in preventing and combating Zika that impoverished people in Brazil face have been well documented. For those living in more affluent areas, Zika testing is available even for patients who are not pregnant. But at free public clinics in poorer neighborhoods (where it is easier to contract Zika), lines are out of the door. Symptomatic patients spend hours waiting, only to receive saline for dehydration and to still have to return if their symptoms persist.

The lack of available testing for many patients in developing countries is influenced by cost. Tests are typically hundreds of dollars. For those who can’t even afford window screens or insect repellant, affording a Zika test at this price is next to impossible.

Timing is the other likely factor contributing to this issue. Dr. Anita Goel, CEO and founder of Nanobiosym, noted that even in Florida, testing was back-logged due to medical centers having to ship patients’ samples to outside labs. Results could take up to five weeks to come back.

Outside the U.S., 4 billion people don’t even have access to this basic, albeit inefficient, centralized testing mechanism. “[In developing countries], clinical testing is offered by the occasional network of unregistered laboratories operating without regulatory oversight. Services might be of too poor quality to be of any worth in medical decision-making.” Timing is obviously crucial for pregnant women, but it is also important for any other potentially-infected person, since Zika can be transmitted sexually whether or not symptoms are present.

Gene-RADAR has the potential to remedy these issues by decentralizing and mobilizing testing, thus lowering cost and wait time. Gene-RADAR employs nanobiophysics to diagnose in real time diseases that contain DNA or RNA.

This foundational technology is not limited to Zika. The mobile device was an award nominee for Saving Lives at Birth’s 2015 Grand Challenge for Development for utilizing the platform to detect early HIV in infants in Rwanda. It was also presented in the same year as a diagnostic solution for other global pandemics such as Ebola.

Centralized lab platforms can run from several hundred thousand to one million dollars. Though Gene-RADAR’s cost is still being optimized, the goal is to make it affordable even to the poorest areas of the globe. In terms of wait time, Gene-RADAR should be able to return results in about an hour, eliminating the back-log problem that comes with centralized testing mechanisms.

Gene-RADAR is patented, and does not require running water, constant electricity, or highly-trained personnel to operate. The patented improvements over previous technologies both result in a smaller machine and improvements in the accuracy of testing.

The device’s footprint is much smaller than that of large, centralized testing machines. Gene-RADAR is tablet-sized and only 3.5 pounds, versus 50-plus-pound platforms that are certainly not mobile and likely do rely on constant electricity.

Gene-RADAR diagnosis is also more accurate than that of the other Zika tests currently available. Current testing methods that look for Zika-specific antibodies have a high proportion of false positives. Other tests, like Gene-RADAR, look for DNA or RNA. But these other tests also result in false positives by confusing a sequence with that of another Zika-like virus, such as Dengue. The advances in Gene-RADAR improve accuracy to solve these problems by detecting a virus’s precise RNA sequence.

From a public health perspective, testing as many people as possible in at-risk areas will help contain the virus. If people know quickly whether they’re infected, there is less of a chance of infecting others. Through multiple global initiatives, Nanobiosym’s next step is to increase production and distribution where the need is greatest.

According to Dr. Goel, patent protection via the Nanobiosym incubator has allowed this revolutionary technology to expand beyond the research labs. “Our incubator focuses on bringing together a holistic approach using physics, medicine, nanotechnology, and information technology to create new science or technology, then incubate it all into different products and spin-off companies that can transform how we solve some of the world’s greatest challenges.”

The innovative technology that is Gene-RADAR is a prime example of innovation working to promote groundbreaking solutions to real-world challenges. For Zika (and other diseases with genetic footprints), this means the potential for cheaper, faster, and more readily-available testing that would undoubtedly benefit global health.

#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.

Categories
Innovate4Health Innovation Patents

Innovate4Health: GRIT Leveraged Freedom Chair Brings Mobility to Developing World

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

innovate4healthThe World Health Organization (WHO) estimates that over 65 million people in the developing world need an appropriate wheelchair. Over 75% of people in the developing world live in rural areas, where standard wheelchairs do not work, as they are hard to mobilize over rugged terrain and rough local roads that may not be paved. Further, most wheelchairs are difficult to maintain: they are comprised of many pieces that are easy to break and hard to repair, and they are expensive to replace.

The Leveraged Freedom Chair (LFC) is a wheelchair that solves this international humanitarian problem. It enables people with disabilities in developing countries to gain mobility and independence, and it gives them the ability to navigate their environment in life-changing ways and at a viable cost. The LFC is built out of steel and bicycle parts that are commonly available in rural areas of developing countries. The parts and tools for maintenance and repair are inexpensive and commonly found. This makes it easier to repair the wheelchair at local bicycle shops or wherever spare parts may be found.

The construction of the LFC is engineered to meet the diverse challenges that arise in developing countries. The LFC uses a unique lever drivetrain which makes it both faster than conventional wheelchairs and sturdier when traveling over rough terrain. It does not use gears and derailleurs, which can be expensive and easily broken; it instead uses levers connected to the drivetrain to control velocity and speed. By using readily available bicycle parts in the production of the LFC, costs are kept down and users can maintain and repair the chairs themselves.

The lever construction is one of the high points of inventiveness of the LFC. Instead of pushing on the wheels like a regular wheelchair, LFC riders push on two levers, which are designed to be biomechanically efficient. LFC riders can shift gears by moving their hands up and down the levers. For smoother roads, riders push on a low part of the levers and shift into “high gear,” which enables them to travel 80% faster than a regular wheelchair on tarmac. For rougher terrain, riders push on a high part of the levers and shift into “low gear,” which enables them to ride over obstacles with 50% more torque than a regular wheelchair. The levers can be removed and stored on the wheelchair, which allows the LFC to be used like a regular wheelchair indoors.

The LFC was conceived and developed in 2007–2008 by four graduate students in the mechanical engineering program at MIT who then founded a company in 2012 called Global Research Innovation and Technology, or GRIT, to develop and commercialize their invention. The LFC has been in development since 2008. First-generation prototypes of the LFC were constructed in Kenya and Vietnam with community partners who were also local wheelchair producers. In 2014, GRIT secured Patent No. 8,844,959 for the LFC, a “wheelchair with level drivetrain.”

The company now manufactures the LFC in India with a local partner and sells it in bulk for $250 per chair to non-governmental organizations (NGOs) and other development organizations. The aid agencies and NGOs that purchase the chair generally distribute the LFC to users free of charge. In 2015, the GRIT management team estimated that it had shipped almost 1,200 LFCs to 17 countries, including Guatemala, Haiti, Kenya, Uganda, Tanzania, India, the Philippines, and Vietnam.

The team at GRIT runs the company as a “social enterprise,” pursuing a social mission (like a nonprofit) but also retaining the ability to make money off their patented invention. As a for-profit social enterprise, GRIT can accept money from nonprofit foundations that is congruent with its mission, but it can also raise private equity like a regular startup.

GRIT has earned numerous awards and honors for the LFC, including winning a Patents for Humanity Award from the U.S. Patent and Trademark Office in 2015.

After spending several years developing the LFC, GRIT decided to build upon its patented technology and develop wheelchairs similar to the LFC but more suited to use in first-world countries. The GRIT Freedom Chairs are somewhat sleeker in design, and have certain features that appeal to first world riders, such as a lightweight frame, optional customization, and the ability to be folded and stored in the trunk of a car. The sale of these chairs is intended in part to defray the costs of distributing chairs at or below cost in developing world countries. GRIT Freedom Chairs afford users access to previously-inaccessible terrains, and offer versatility to a broad array of riders, including American veterans. They are directly marketed in the U.S. in order to keep costs down.

People with limited mobility in developing countries face many daunting obstacles, and the lack of appropriate wheelchairs can severely limit their mobility, opportunities, access, and independence. The GRIT Leveraged Freedom Chair is an elegantly simple, inexpensive, and ingenious device that confers freedom to wheelchair users in the developing world. Its underlying technology, secured by vital U.S. patents, is also the basis of the GRIT Freedom Chair, which likewise transforms the lives of users in the developed world. Both the LFC and the Freedom Chair rely on secure property rights that enable their parent company to develop and market life-changing products that users can afford to ride, repair, and maintain. The “all-terrain wheelchair” is truly an invention with worldwide relevance and reach.

#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.

Categories
Innovate4Health Innovation Patents

Innovate4Health: Treating Neonatal Jaundice in the Developing World with D-Rev’s Brilliance

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

Innovate4HealthBy Nick Churchill

Severe neonatal jaundice kills over 100,000 newborn babies annually and causes severe brain damage to thousands more. In most cases, the condition can be treated by simply shining a blue light on a baby’s skin. However, each year more than 6 million infants worldwide do not receive adequate treatment. The problem is particularly severe in low-income countries, where many hospitals cannot afford the equipment to treat jaundice.

To address this global health problem, the innovators at D-Rev, a non-profit firm based in San Francisco, designed a high-performance, affordable device called Brilliance to treat severe neonatal jaundice. Brilliance has been praised by users as “effective and user-friendly,” and it was honored as the top innovation in the Health category of the 2016 Tech Awards. Since the introduction of the first Brilliance model in 2012, D-Rev estimates that the device has treated over 250,000 babies and has averted approximately 3,400 infant deaths and disabilities.

Neonatal jaundice occurs when a newborn has elevated levels of bilirubin in the blood. Approximately 18% of babies have severely high levels of bilirubin, which, left untreated, can lead to brain damage, cerebral palsy, hearing loss, and even death. Severe jaundice can be treated with a process called phototherapy, which involves placing the baby under special blue lights. When the light is absorbed by the infant’s skin, it helps break down bilirubin. Treated properly, severe jaundice usually does not cause lasting damage.

Phototherapy has long been recognized as a simple and effective treatment for severe neonatal jaundice; but at around $3,000, traditional phototherapy devices are prohibitively expensive for many hospitals in developing countries. Hospitals that can obtain a traditional unit are often unable to afford the maintenance and repair costs necessary to keep it running. The unreliable electrical systems in many developing countries can cause voltage spikes that damage device components. Commonly used fluorescent lamps require frequent replacement. As a result, phototherapy is unavailable to babies in many developing communities.

D-Rev is a product development company founded in 2007 to provide world-class, affordable healthcare technologies to people living on very low incomes. After learning that severe jaundice continues to cause brain damage in many parts of the world, D-Rev staff members visited hospitals in India and Nigeria to assess the availability of effective phototherapy and found that most of these hospitals did not have phototherapy devices that met standards for care. With the problem identified, D-Rev’s design team got to work.

D-Rev’s advanced devices, for which they are seeking a patent, uses LEDs that last 60x longer than fluorescent lamps, saving hospitals over $240 per year on replacement bulbs. Brilliance is designed to withstand a range of power fluctuations without affecting performance and operates without cooling fans or filters, so there are fewer parts to maintain. The device is height-adjustable and can be integrated with the wide variety of other critical neonatal medical equipment found in hospitals serving low-income communities.

Importantly, D-Rev’s devices are inexpensive to manufacture, which allows D-Rev to sell them for hundreds, instead of thousands, of dollars. The newest model incorporates the technology in their patent application, which ensures light intensity levels remain consistent across the treatment area at any angle of tilt. D-Rev also developed an integrated light meter to help healthcare providers ensure that infants receive appropriate doses of light, something many low income hospitals were previously unable to do. Thus, the innovations developed by D-Rev are improving the technology and reducing cost, making much needed treatments more accessible in the developing world.

After successfully designing an affordable and effective phototherapy device, D-Rev’s next challenge was to find a way to deliver Brilliance to the hospitals that needed it most. D-Rev’s CEO, Krista Donaldson, recognized that the firm would need help to establish a sales and distribution network, noting, “We knew we needed to license in this case.” To achieve its goals, D-Rev needed to find a partner willing to manufacture its products and distribute them to hospitals and clinics in the poorest communities in the world.

D-Rev licensed its technology to Phoenix Medical Systems, a neonatal equipment firm based in India, who agreed to manufacture and distribute Brilliance while capping its price. The licensing agreement was structured so that D-Rev would take a smaller royalty on sales to public and district hospitals, which tend to serve lower-income patients. In this way, D-Rev used its intellectual property rights to align the incentives of Phoenix’s sales team with D-Rev’s goal of reaching those patients who are most in need of affordable phototherapy.

Donaldson has explained why D-Rev’s protection of its intellectual property “is a prerequisite to having the broadest possible impact.” First, intellectual property rights allow D-Rev to ensure that the quality of its products remains consistent. As Donaldson notes, a medical device “cannot fail the user, particularly a user in a vulnerable population.” Second, inconsistency erodes consumer trust, which limits the impact of a product. Third, D-Rev recognizes that designing an effective product does not necessarily solve the targeted problem. By retaining control of its intellectual property, D-Rev can ensure consistent manufacturing of its products, sustainable delivery to users who need it, and continued maintenance and support. Finally, D-Rev protects its intellectual property because the market is “the most economically sustainable and scalable way” of reaching their intended customers.

D-Rev has demonstrated that the value of intellectual property goes beyond incentivizing life-saving innovation like Brilliance. Intellectual property rights empower innovators to increase their impact by partnering with market leaders like Phoenix. As Donaldson concluded: “To succeed, serious partners (for-profit or non-profit) must also make an investment, and none are willing to do that with the threat of knock-offs.”

#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.

Categories
Innovate4Health Innovation

CPIP & ITIF Launch “Innovate4Health” Policy Research Initiative

Innovate4HealthIn celebration of World Intellectual Property Day on April 26, 2017, the Center for the Protection of Intellectual Property (CPIP) today joined with the Information Technology and Innovation Foundation (ITIF) to launch “Innovate4Health,” a joint project to promote the critical role that intellectual property rights play in spurring innovative solutions to pressing global health challenges.

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. They fund individual careers and industries dedicated to fixing health problems, as well as the businesses that get these solutions to individuals.

Our Innovate4Health project is providing case studies that describe how IP-driven innovation is tackling some of the world’s toughest health issues, including:

• A cooler that ensures vaccines are safe in areas without power;
• A portable eye examination kit to move care out of the office and into the field;
• Retractable syringes to prevent needlestick injuries;
• A baby warmer that can adapt to volatile electricity conditions;
• Point-of-care testing for malaria that anyone can use;
• A smartphone app that instantly checks the authenticity of pharmaceutical drugs; and
• A new anti-inflammatory drug derived from Brazil’s diverse ecology.

Learn more about Innovate4Health here.

Categories
Innovate4Health Innovation

Innovate4Health: Meeting the Needs of Rural Africa with Fyodor’s Point-of-Care Testing for Malaria

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

Innovate4HealthBy Jaci Arthur

Every year, more than 200 million cases of malaria are reported worldwide. It can often be mistaken for a less serious malady, as symptoms include “fever, chills, and flu-like illness.” If quickly identified, the disease is treatable. Yet more than 655,000 people, mostly children in sub-Saharan Africa, died from malaria in 2016.

Expeditious diagnosis of the disease can result in faster treatment and lower mortality rates. The patented Urine Malaria Test (UMT) developed by Dr. David Sullivan, a Johns Hopkins Bloomberg School of Public Health professor and microbiologist, addresses this global challenge by offering a rapid, accurate, more convenient, and less expensive alternative to traditional laboratory testing. The UMT is also the first point-of-care (POC) test for malaria that does not require the use of trained personnel or a blood sample.

90% of all malaria-related deaths in 2015 occurred on the African continent. Much of this can be attributed to a lack of access to health services and personnel due to poverty, remoteness, and a general lack of healthcare infrastructure. According to a 2011 report, about 31% of Ethiopians live on less than $1.25 a day. Even when health services are free of charge, trips to medical facilities are quite costly for the average, rural African because patients will often have to take an entire day off from work to travel.

In Niger, a patient may have to walk more than four hours to receive medical treatment at an overcrowded, ill-equipped facility. Many people turn to presumptive diagnosis or self-medication at the first sign of a fever, resulting in widespread drug resistance and more expensive treatments. Meanwhile, others gamble on the chance it is simply a virus that will pass, never seeking diagnosis or treatment.

On average, there are 1.15 health workers for every 1,000 people in sub-Saharan Africa, with numbers as low as 0.4 physicians for every 10,000 people in countries like Chad. The few laboratories in rural areas that can identify diseases such as malaria are underfunded, short-staffed, and ill-equipped. Although there are several POC tests for malaria, most of them require trained personnel taking a blood sample. Having a proper diagnosis within twenty-four hours of the onset of symptoms can reduce the mortality rate, but such diagnosis is difficult for most Africans. All these factors lead to a deadly combination, especially for those in rural Africa.

Maryland-based Fyodor Biotechnologies was founded in 2008 by Nigerian biotechnologist Eddy Agbo specifically to address these problems. In 2009, the company was granted an exclusive worldwide license from Johns Hopkins University to research, develop, and commercialize the UMT.

As its name suggests, the UMT tests a patient’s urine, rather than blood, for “novel Plasmodium proteins,” and it provides results in less than twenty-five minutes, thus abating fears, eliminating the need for presumptive diagnosis, and reducing costly, lengthy, and unnecessary trips. Unlike other tests for malaria, the UMT can be taken at home and is as easy to use as an at-home pregnancy test. The UMT is currently priced at about two dollars each; however, Dr. Agbo intends for the price to be reduced once production increases.

Preclinical studies were conducted by researchers at Johns Hopkins University, and the UMT is currently in clinical validation. Fyodor intends to seek concurrent regulatory clearance from both the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) and the US Food and Drug Administration (FDA).

Initial commercialization efforts will be focused in Dr. Agbo’s home country of Nigeria before expanding to other areas significantly affected by malaria. Nigeria accounts “for 25% of all malaria cases in the African region.” Testing is also currently underway at Fyodor Biotechnologies for a “second generation broad-based Urine Malaria Test (UMT-Broad),” which will be useful for detecting other types of infection.

Fyodor Biotechnologies stepped onto the global market specifically to meet the needs of people in malaria endemic regions and reduce the mortality rate associated with this treatable disease. The company relies heavily on its exclusive license to Johns Hopkins University’s patent, as research, development, and production of the UMT are currently its sole function.

Fyodor’s two-dollar, at-home test is the perfect counter to claims that intellectual property rights, specifically patents, result in expensive healthcare and a lack of access to necessary medical services. Intellectual property rights have made quick, efficient, low-cost, and convenient testing for malaria a reality.

The UMT provides an ideal example of how patented innovation can conquer global challenges. It is a reasonable, rapid, efficient, convenient, economical alternative to a system that cannot meet the needs of the rural poor. And it is a reminder that innovation and intellectual property rights can work together for the common good.

#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.

Categories
Innovate4Health Innovation

Innovate4Health: Protecting Patients with VanishPoint Retractable Syringes

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

Innovate4HealthNeedlesticks are not just the fear of 4-year-olds receiving their vaccinations; they are also the source of blood-borne infections afflicting millions of healthcare practitioners. When a conventional needle is left exposed after use on a patient, it can accidentally stick another person, such as a healthcare worker. The accidental needlestick can infect that person if the patient had any blood-borne diseases. Recent estimates place the number of needlestick injuries in the United States at more than 300,000 per year, with infection by HIV or Hepatitis as possible consequences.

The spring-retractable syringe, VanishPoint, was created to prevent needlestick injuries and ameliorate other unsafe injection practices.

Worldwide, the problem from needle injuries is even greater. The risks from needlestick injuries can increase with other unsafe injection practices, such as needle reuse and improper medical waste collection. These practices are more likely to occur in developing countries. The consequences of these unsafe injection practices include 21 million hepatitis B infections per year and 41% of new cases of hepatitis C.

The conventional syringe leaves the needle exposed after the injection is complete. Until a healthcare worked places the syringe in a specially-designed plastic garbage container, it remains exposed and capable of harming anyone nearby. Unfortunately, over 1.8 billion conventional syringes are sold each year in the United States. These outdated syringes account for more than half of needlestick injuries.

syringesThomas J. Shaw, founder of Retractable Technologies, created a technological solution to the problem after seeing a television report of a doctor who contracted HIV from an accidental needlestick. He designed a single use spring-loaded syringe that immediately pulls the needle back inside the just-used syringe. Thus, the needle is automatically covered and incapable of harming anyone.

The basics of how the syringe works are simple enough to explain. The needle is engaged for use when the package is opened. A nurse or other practitioner fills the syringe normally. However, when the plunger is fully depressed to inject the patient, a spring pulls the needle back into the body of the syringe. Before the nurse has moved the syringe away from the patient, the needle is already covered and incapable of causing injury.

Despite the simple concept, designing a functional and usable product took ingenuity and persistence. Shaw purchased pigs feet from a local butcher to test his designs in his workshop. In the classic mode of biomedical innovators including Jonas Salk (inventor of the polio vaccine), he first tested his device on himself.

Retractable Technologies, Inc.From these initial tests, Shaw founded Retractable Technologies, and the value of his innovation was immediately recognized. He received awards from the National Institute for Drug Abuse at the National Institutes of Health to further develop his work and eventually commercialize it. Congressional representatives touted the important advances of this small business. The final product, the VanishPoint syringe, embodies his innovation.

The challenges faced by Shaw and Retractable Technologies in entering the medical device market have been extensively chronicled. The way hospitals purchase supplies such as syringes advantages large incumbent sellers and manufacturers over small startups such as Retractable Technologies. The story of Shaw’s disruption of the automatic safety syringe market was even turned into a feature-length movie.

Retractable Technologies confronted this challenge by relying on its patent portfolio. The patents covering the syringe included patents on the retractable needle design as well as tamperproof features that protect against intentional as well as accidental misuse. Large, established manufacturers could have easily copied Retractable Technologies’ designs from the published patents. However, these patents assured that Retractable Technologies could protect its innovation against invasion.

syringesThe value of the retractable syringe design has been important to advancing health care goals worldwide. The World Health Organization has recognized the value of the technology in Australia, China, Indonesia, and Gambia among others. According to the Global Alliance for Vaccines and Immunizations, African countries continued using auto-disable syringes after the completion of international aid programs because of the public health benefits. These benefits include not only the prevention of needlestick injuries, but preventing needle reuse, which had undermined other vaccine initiatives.

PATH, a non-profit organization devoted to health innovation, highlighted the introduction of VanishPoint syringes in Peru as an important step in advancing public health goals. In addition to preventing injuries in the clinic, PATH noted that the syringes increased safety in waste disposal, where some waste handlers had described needlestick injuries as “common.”

Prevention of needlestick injuries and infections has been a decades-long challenge for public health. From humble beginnings and the story of one infected doctor, Thomas Shaw’s invention shows how one innovator can revolutionize health care. Patents have given him protection in the U.S., but his innovation knows no borders.

*Images courtesy of Retractable Technologies

#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.

Categories
Innovate4Health

Innovate4Health: mPedigree Battles Counterfeit Drugs Through Innovative Verification System

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

Innovate4HealthCounterfeit medicines sold under a product name without proper authorization are a serious threat to global public health. Classified by the World Health Organization (WHO) as substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products, counterfeit drugs are regularly designed to appear identical to genuine products. However, they fail to effectively treat the disease or condition for which they were intended, and in some instances, they can cause adverse reactions or death.

A recent BBC investigation revealed a multi-billion-dollar global trade in counterfeit drugs resulting in 120,000 deaths a year in Africa alone. And though counterfeit drugs affect economies, health care systems, and patients worldwide, developing nations are most at risk, with an estimated counterfeit rate of 10%-30% of medicines sold. The prevalence of unauthorized drugs in countries with less advanced health care systems has created a dangerous pharmaceutical market with few resources to help consumers distinguish between a drug that could potentially save their life and something that might kill them.

hands holding a phone and a box of "Black Secret Mineral Creme to Powder Foundation SPF 15"In 2007, Ghanaian tech entrepreneur Bright Simons set out to address this troubling threat to public welfare by creating a way to quickly confirm the legitimacy of a pharmaceutical. Realizing that low literacy and technical capacity were limiting the efficacy of existing consumer-targeted controls such as holograms and bar codes, Simons wanted to create a user-friendly system that would help consumers instantly check the authenticity of a drug using their mobile device. Simons envisioned a verification mechanism that would not only enable consumers to protect themselves against dangerous counterfeits, but also help pharmaceutical manufacturers defend their brands and shield shopkeepers from the liability of selling fake drugs.

Simons partnered with drug companies and other stakeholders to upload pedigree information from individual packs of medicine into a central registry using standard mass serialization methods similar to those employed in the radio-frequency identification (RFID) barcode system familiar in the United States and other developed countries. Calling his company mPedigree, Simons built a mobile verification service that enables consumers to text a product code that is then checked against the registry of authentic medicines, instantly verifying that the medicine they’ve acquired is legitimate and safe.

Since forming mPedigree in 2009, Simons has brought his system to Nigeria, Kenya, and India, with pilot programs in Uganda, Tanzania, South Africa, and Bangladesh. In 2015, mPedigree codes appeared on over 500 million drug packets from clients such as AstraZeneca, Roche, and Sanofi, and its verification network has been essential in combating a serious counterfeit antimalarial drug scheme that was putting thousands of Africans at risk.

Though mPedigree is best known for its work with pharmaceutical certification, Simons has expanded its verification system to address counterfeits in other industries through his development of the cutting-edge supply chain transformation technologies, EarlySensor and Goldkeys.

mPedigree’s EarlySensor technology offers a proactive solution to companies plagued by unauthorized imitations by identifying patterns in counterfeiting activity and alerting partner government agencies of suspicious trends. The project “scans large pools of authentication, traceability, supply chain & logistical referencing, and user-generated data to mine insights and plot evolving patterns” to empower both manufacturers and consumers to predict counterfeiting activity before it occurs. EarlySensor technology is currently used by three major pharmaceutical and cosmetic companies in Nigeria, and empirical analysis has shown a 65% reduction in the circulation of counterfeit versions of their brands.

With Goldkeys, mPedigree has developed a set of web tools to provide brand owners with “complete, real-time, control of key events in their supply chain.” The technology enables companies to manage distribution networks and retail point integration, as well as track end-consumer activity through web applications and cloud computing. Goldkeys also allows consumers to “call in” their product by voice call or text on a mobile device to ensure authenticity and receive consumer support.

mPedigree - Bringing Quality to LifeThrough the combination of EarlySensor and Goldkeys, mPedigree’s innovative technology is facilitating the protection of both brand owners and consumers and ensuring that data collection and authentication mechanisms are leading to the safer distribution of medicines, cosmetics, seeds, and other essential products.

As a company dedicated to helping others protect their product reputation and brand, mPedigree understands the importance of effective IP rights and has utilized patent, copyright, and trademark protection in the development and commercialization of its own brands and services. In the early days of the company, as it formed partnerships with tech and pharmaceutical industry giants, mPedigree was careful to retain the rights to its creations, with Simons stating in a recent interview that, “[w]e had one interest to protect: our intellectual property.”

hands holding a phone and a seed packetBy providing a dynamic link between consumers and manufacturers, mPedigree is making communications at the point of purchase routine and creating value for consumers, manufacturers, regulatory agencies, and sellers. A project ten years in the making, mPedigree is built on the recognition that protecting intellectual property—both mPedigree’s and its clients—can save lives.

Bright Simons’ vision and dedication to fighting the counterfeit drug epidemic in Africa and beyond through pharmaceutical verification is a testament to the vital role innovation and technology play in confronting global challenges, and as its motto states, mPedigree is indeed “bringing quality to life.”

*Images courtesy of mPedigree Global Image Archives

#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.

Categories
Innovate4Health

Innovate4Health: Eye Exams On-the-Go with PEEK

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

Innovate4HealthHundreds of millions of people worldwide have vision problems that could be fixed or relieved if only they were diagnosed early enough. Unfortunately, current eye screening equipment is expensive, bulky, and requires specialists to operate it. As a result, the vast majority of patients in the developing world have limited or no access to eye screening services and often suffer unnecessarily from eye problems.

Innovative new applications for smartphones promise to take eye exams out of the doctor’s office and bring them to the people who need them most. Several promising solutions have emerged. Not only are they mobile, but they are also affordable and non-specialists can operate them.

These solutions could benefit vast numbers of people. According to data from the World Health Organization, 285 million people worldwide are visually impaired. Of this group, 39 million are blind and 246 million have low vision. About 90% of visually-impaired people live in low-income countries, where there is an acute shortage of practicing ophthalmologists. Yet, 80% of all visual disorders could be treated or even prevented if diagnosed at the outset.

When it comes to eye disorders, early diagnostics is the key. In fact, four out of five cases of visual impairment can be prevented or cured if timely detected. But in developing countries, there is a huge disparity between population size and the number of eye care providers. In Kenya, for example, there are only 86 ophthalmologists to cover a population of over 40 million people. Many of those who need eye care live in rural, distant areas and are often unable to get to clinics or hospitals to seek help until after it is too late. As a result, millions of people in low-income countries are losing their vision.

PEEK kit laid outOne promising example of these new mobile diagnostic applications for eye care is the Portable Eye Examination Kit, or PEEK. PEEK is essentially an eye clinic that fits in a pocket. It combines both a traditional ophthalmoscope and a retinal camera in a smartphone, enabling affordable, fast, and easy eye examinations in the remotest of communities. PEEK consists of an app and a clip-on camera adapter that slides over a smartphone. Designed to be operated by community workers with minimum to no training, PEEK brings a low-cost and simple-to-use eye screening technology to the most underserved places of the world.

PEEK was born from Dr. Andrew Bastawrous’ frustrating experience trying to bring eye care to rural Kenyans. Bastawrous, a British eye surgeon, experienced a logistical nightmare attempting to transport the bulky, costly, and fragile eye equipment to remote areas of Kenya in 2007. Back then, Bastawrous was a PhD student at the London School of Hygiene and Tropical Medicine, working on a study of eye diseases that involved setting up 100 clinics in rural Kenya. One of the biggest problems facing Bastawrous was that the villages he visited often had no electricity or road access, making it very difficult to transport and use medical equipment.

However, Bastawrous observed that these remote villages did have cellular phone coverage. From that observation came the idea of a smartphone-based ophthalmic tool. To make this idea a reality, Bastawrous teamed up with software developer Stewart Jordan, biomedical engineer Mario Giardini, and ophthalmologist Iain Livingstone to found PEEK Vision. Since 2011, the PEEK team has relied on its expertise in international eye health, biomedical engineering, and ophthalmic research to develop smartphone-based visual assessment tools.

phone showing PEEK app imageHow does PEEK work? An app and a clip-on adapter use the smartphone’s built-in camera and flash to perform various eye exams within seconds. From basic testing for visual acuity, color and contrast sensitivity, and cataracts to scanning the retina, PEEK examination tools can help identify patients who need cataract surgery and detect early signs of diabetes, malaria, and other diseases. The PEEK clip-on adaptor itself can be made with a 3D printer and works with common smartphone models such as iPhone, Samsung, HTC, and Sony.

PEEK also enables efficient remote screening and treatment. A healthcare worker using PEEK can scan over 1,000 people per week. With minimal training, even non-healthcare workers can operate PEEK. Workers in the field can send information to eye care specialists, as PEEK makes high-quality images for further diagnosis and treatment readily available. PEEK also records patient contact information and GPS data, which it then emails to the treating physician.

The developers of PEEK have used IP rights to coordinate the development and deployment of this technology. They applied for a U.S. patent and have already obtained a U.S. trademark registration. PEEK tools are still in the process of being approved by the U.K. Medicines and Healthcare Products Regulatory Agency and the U.S. Food and Drug Administration.

PEEK is working with NGOs and private donors to deploy the technology. It received funding from the Queen Elizabeth Diamond Jubilee Trust in 2013 towards testing the technology in different communities around the world. In 2014, the company started a crowdfunding campaign on Indiegogo to seek additional funds. Donors had an option either to purchase a PEEK kit for themselves or to donate it to a clinic in need.

PEEK is a great example of how innovation can address global healthcare challenges. It is a low-cost and easy-to-use invention that builds on widely-available, popular technology. It has a tremendous potential to improve millions of lives.

*Images courtesy of Peek Vision Ltd

March 13, 2017, update from PEEK Vision: “Peek is a growing team and is working with many partners to achieve its mission to create tools and knowledge that radically increases access to eye care worldwide. In 2016 Peek Vision Ltd was set up as a company and any profits go to its owner, the Peek Vision Foundation.”

#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.

Categories
Innovate4Health Patent Law

Innovate4Health: Global Good’s “Arktek”: A Life-Saving Super-Thermos Vaccine Cooler

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

Innovate4HealthMore than 1.5 million children die every year from diseases that existing vaccines could prevent. Why aren’t these children vaccinated? One big reason is that vaccines need to be kept cool until they reach patients, but that’s a really hard task in parts of the world where power is unreliable.

A new, patented “super thermos,” the Arktek Passive Vaccine Storage Device, aims to solve this global challenge. The Arktek was developed by Global Good, a collaboration between the Gates Foundation and the innovation lab of Intellectual Ventures.

The Arktek mends gaps in the “cold chain,” the refrigerated vaccine supply chain. Breaks in the cold chain occur because power is unreliable or minimal in many places. Also, many people live in places that cannot be reached by refrigerated transport. These gaps make it impossible to keep the vaccines fresh, and thus render them unusable in less than a week’s time.

In 2008, the Gates Foundation challenged Intellectual Ventures to help fix the cold chain problem. The resulting collaborative effort, spearheaded by Global Good, invented the Arktek Passive Vaccine Storage Device, nicknamed the “super-thermos” and the “keg of life” by Bill Gates.

The Arktek keeps vaccines at a temperature between zero and eight degrees Celsius for 30 to 60 days, depending on outside temperatures and humidity. Testing shows that it retains its cooling capacity even when outdoor temperatures rise to 43 degrees Celsius (110 degrees Fahrenheit). It does not rely on outside sources of electricity or other power. This is a major step forward in vaccine cooling systems, especially in much of the developing world, in which stand-alone cold storage devices struggle to keep vaccines at proper temperatures for a maximum of five days.

The “super-thermos” bears some resemblance to an ordinary coffee thermos. In 2013, the leader of the vaccine cooler development team described it as “a super-insulated, double-walled [bottle] that holds the vaccine and ice in the middle in an inner bottle. A vacuum space separates it from the outer bottle, like a large coffee thermos.” The device combines a double-walled bottle filled with vacuum insulation with multi-layer insulation technology of the type used to protect spacecraft from extreme temperatures. It holds approximately 16 pounds of ice.

Incredibly, a vaccine kept in the Arktek for weeks will be as cold as the moment it was placed inside. No powered refrigeration or additional ice is needed.

Keeping vaccines cold isn’t the only problem that the Arktek solves. Gaps in the cold chain tend to occur in places where travel is rugged and environments are challenging. Also, sophisticated medical facilities are rarely waiting at the end of a gap in the cold chain. Any solution has to be extremely tough and user-friendly.

The Arktek meets these challenges by providing near-indestructible structural integrity and high-usability in the field. To make the device sturdy, user-friendly, and easy to maintain and use, the development team at Global Good sacrificed a bit of longevity in favor of efficiency. The sixth and current prototype is therefore created for maximum efficiency, and can hold routine vaccinations for approximately 200 children or a village with a population of 6,000.

Other features help both local users and remote health officials to monitor the integrity of the vaccines. Sensors measure key information at 15 minute intervals, including the Arktek’s interior temperature, its exterior temperature, and how long it has been opened. It alerts users when temperatures begin to rise too much, and even has an LED light that comes on when a user opens the lid.

The data collected by the Arktek’s sensors is extremely accessible to all concerned. On-site users can download data logs using a simple USB stick. Meanwhile, an antenna sends data via SMS to a local telephone number every day at midnight. It provides remote personnel a summary of the day’s temperatures, location, and statistics recording when the device has been opened and for how long a period. Finally, a GPS sensor allows health officials to track the location of the devices at any given time.

During pilot testing, Global Good found the sensors to be particularly useful. For instance, if a health official was not using the device properly, Global Good was notified, and could contact the official directly and assist with training them appropriately. Armbruster observed that this kind of monitoring could eventually be relegated to local ministries of health to enable them to ensure that “they have a reliable cold chain all the way to the end point.”

Armbruster sees the Arktek as best-suited to modest villages of 5,000 to 15,000 people, in which it will be cost-effective to have a device that can be refreshed once a month by health officials. He says it may be somewhat less-suited to larger villages of 25,000 to 50,000 people, in which a large solar-powered or ice-lined refrigerator is feasible. And it may not be necessary in locales that have a reliable and consistent source of power. The cost per unit for this device currently ranges from $1,200 to $2,400, which makes it relatively affordable to health officials in the developing world.

Currently, the Arktek is in the early adoption stage of development. The WHO has “prequalified” the Arkteks under its Performance, Quality and Safety (PQS) program, which is an important seal of approval for government procurement. Global Good has collaborated with the Clinton Health Access Initiative, PATH, UNICEF, and other United Nations organizations to conduct field trials of the Arktek in Ghana, Senegal, Ethiopia, and Nigeria.

While the Arktek is still being refined for further roll-outs, it has already seen some action where it could do the most good. For example, it has stored vaccines for tuberculosis, polio, influenza, whooping cough, tetanus, hepatitis B and diphtheria. In 2014, Global Good donated 30 Arkteks to help the WHO deliver vaccines during the Ebola outbreak; and in the following year, it donated Arkteks to Nepal to assist with vaccinations after the 2015 earthquake.

Global Good is relying on property rights and commercial distribution to develop and deploy the Arktek. Aspects of the technology have been patented. Meanwhile, Global Good is currently partnering with AUCMA, a leading refrigeration manufacturer, to help commercialize Arktek and produce it at scale at an affordable price.

In 2016, Global Good received a “Patents for Humanity” award for the Arktek from the U.S. Patent and Trademark Office.

The Arktek is a vivid illustration of how patented innovation can tackle global challenges. It’s a clever, pragmatic and practical invention with a global reach and import. It reminds us that secure property rights can generate, develop and disseminate life-saving solutions to seeming intractable problems.

#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.