Nick Churchill – UA LAW IP

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

Innovate4Health By 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 test One 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 machine Daktari (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.

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

Innovate4Health By 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.”

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