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Low cost incubator for early infant critical care and life support.

I am the founder and CEO of Breegi Scientific, Inc. a startup biomedical company

Photo of Wisam Breegi
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Updates: How has your idea changed or evolved throughout the Prize? What updates have you made to this submission? (1500 characters)

We are new to the Prize and we are looking forward to learning of the resources and mentorship opportunities to make our product the best it can be and bring the technology to the areas of the world that are in drastic need of our solution.

Name or Organization

Breegi Scientific, Inc. We are collaborating with Boston University, Northeastern University and Suffolk University. In addition we are collaborating with several hospitals in Honduras.

Geography

We are located in Boston, MA. Our impact is focused on low resource setting in the USA and abroad.

What is your stage of development?

  • Advanced Innovator with 3 to 10+ years of experience in ECD

Type

  • For-profit

What is the stage of your proposal?

  • Prototyping: I have done some small tests or experiments with prospective users to continue developing my idea.

Describe how your solution could be a game-changer for your selected Opportunity Area (600 characters)

Millions of babies die within their first month of life. Many of these deaths are preventable. Babies at risk can be saved with simple, immediate care such as warming, phototherapy, respiratory support and protection from infections, which can be provided by incubators. They are an essential solution to provide controlled microenvironment to reduce Infant mortality and morbidity, which leads to billions of dollar in human and capital loses annually. Our low cost and practical neonatal intensive care incubator will provide all the functions of a regular incubator at a fraction of the cost.

Select an Innovation Target

  • Product: A new or enhanced physical product that creates value for end beneficiaries.

Tell us more about your innovation (1500 characters)

We support the earliest days of the baby's life. Our Incubator is the first multi-functional disposable low cost Neonatal Intensive Care Incubator (NICI), a class II medical device that require a 510k application in the FDA and has pending patents. With several innovative technologies, it is a practical user-friendly, efficient, low maintenance, inexpensive, incubator designed to significantly reduce neonatal mortality and morbidity. The device is less than 1% cost, size and weight of the regular hospital incubator. Our disruptive innovation will provide the critical necessities for neonatal critical care such as heat, humidity, HEPA ventilation, phototherapy and containment for stationary and for transport cases. It consists of two main components: 1) a disposable micro-controlled lightweight, low maintenance infant housing unit and 2) an electronic control module. Our X-ray compatible infant housing is designed for single use per infant up to one week to reduce nosocomial risks and cost of care and maintenance in small hospitals and rural area clinics. The electronic control module has optional wireless for remote monitoring to increase infant to caregiver ratio and data communication with specialists. The NICI is designed to run on a versatile convertible power source including rechargeable batteries, allowing the device to be used as a portable incubator, operable on site or in transport vehicle. It will provide any community with a NICU capability for a healthy start.

What problem are you aiming to solve? (3 sentences)

We are tackling and solving the neonatal health problem of premature and low birth weight babies in small and rural area communities by providing a low cost and highly efficient infant incubator. Lack of appropriate early neonatal care can cause long term moderate to severe disabilities such as learning or behavioral, in addition to higher risks of non-communicable diseases, which will cost billion of dollars and many lives.

Explain your idea (5000 characters)

Currently, there are no affordable, fully functional incubators for low-resource settings and rural area clinics and small hospitals. Modern hospital incubators are stationary, large and heavy, and require a constant 110-240V electricity power supply. They are very expensive to purchase, complex and costly to disinfect and to maintain. Standard incubators can cost up to $80K. For the past four years, we have worked on research and development to build our hardware and software in-house, and in collaboration with several academic and medical research institutions. Our Incubator is the first multi-functional disposable Neonatal Intensive Care Incubator (NICI) for low resource settings, a class II medical device that require a 510k application in the FDA and has several pending patents. With several innovative technologies, it is a practical user-friendly, efficient, low maintenance, inexpensive incubator designed to significantly reduce neonatal mortality and morbidity. Our disruptive innovation and in-house developed software will provide the critical necessities for neonatal critical care such as heat, humidity, HEPA ventilation, phototherapy and containment for stationary and for transport cases with wireless capabilities. It consists of two main components: 1) a sterile and disposable micro-controlled lightweight infant housing unit and 2) a compact electronic control module. Our X-ray compatible infant housing is designed for single use per infant up to one week to reduce nosocomial risks and cost of care and maintenance. The electronic control module has optional wireless remote data communication and monitoring. The NICI is designed to run on a 12 volts versatile convertible power source, allowing the device to be used as a portable incubator, operable on site as a stationary incubator or in transport vehicle. We will offer our NICI for $225 (approximately $220 for the re-usable controller and only $25 for the disposable microenvironment). This means a baby in the developing world can have access to a life-saving incubator for about $3/day as opposed to more than $2,500/day in the USA (insurance reimbursed rate). With no royalties, our affordable, innovative, practical design and in-house development of our own software allows manufacturing cost to be minimal, which translate to an affordable, lightweight and fully functional infant incubator. We successfully built and tested our proof of concept technology and our prototypes in house and in collaboration with our partners. Our NICI is substantially equivalent to the predicate devices, and hence is classified as a class II medical device. With our current manufacturing and academic partners, and after laboratory testing our final beta prototype, a field assessment will commence at our partner hospitals. A healthy world and future starts with the first birth an infant inhales. It is very well documented that the first few days and weeks of life governs our future health and wellbeing. Infant mortality and morbidity is a complex problem with many contributing factors—a lack of affordable multi-functional incubators should not be one of them. Breegi Scientific, Inc., has the technology, the expertise and a solution that has been built from the ground up to meet the specific needs of hospitals in anywhere and especially in low resource settings. Our vision is a world where children around the globe have the opportunity to start life with the best odds for success.

Who benefits? (1500 characters)

Our low cost, lightweight and multifunction incubator will help to save the lives of premature, low birthweight and ill babies in rural areas and low resource settings are our beneficiaries. According to the American Academy of Pediatrics (AAP) up to 25% of newborns in neonatal intensive care units are being treated for drug withdrawals. It is what the group calls an alarming increase in addicted newborns. This increase is causing tremendous strain on resources and healthcare personal. Thus, there is a need for a lower cost solution in the United States, especially in rural areas and area where the opioid crisis in most critical. Breegi Scientific's NICI can be a viable solution to help confront this devastation. Breegi Scientific's Team has been to many clinics and hospitals in Honduras and verified that there is a very high and urgent need for our solution in third world settings. For the treatment of drug-induced babies in the US, we have interacted with thought leaders in the field that convinced us that our product has a high need in this area as well.

What kind of impact will your idea have? (1500 characters)

Early neonatal care is one of the utmost important factors of healthy start of childhood health and of a long lasting effect. It is well documented that early neonatal care have a lasting effect on the general health of a person. It will certainly decrease hospital visits afterward. At the same time, there is a profound effect on the socioeconomic health of the family. The use of our incubator will provide the parents the psychological and financial incentive to seek early medical care for their newborn baby. The low cost, lightweight and practicality will encourage the healthcare system and providers in small hospitals and rural aria clinics to provide and encourage the early use of incubators, which not only decrease the mortality and morbidity of newborn babies, but it will decrease tremendously the overhead cost and the financial burden on both the system and the families.

How does or how could your idea impact low-income children? (1500 characters)

Families lose work opportunities and wages while taking care of a sick newborn. They have to travel long distances to be with their sick baby. The treatment of premature babies, low birthweight and opioids addicted babies are a tremendous financial burden on families. Preterm birth is when a baby is born too early, before 37 weeks of pregnancy have been completed. In 2016, preterm birth affected about 1 of every 10 infants born in the United States. Preterm birth rates decreased from 2007 to 2014, and CDC research shows that this decline is due, in part, to declines in the number of births to teens and young mothers. However, the preterm birth rate rose for the second straight year in 2016. Additionally, and according to the CDC, racial and ethnic differences in preterm birth rates remain. For example, in 2016, the rate of preterm birth among African-American women (14%) was about 50 percent higher than the rate of preterm birth among white women (9%). Providing local hospitals and clinics with the important means of the availability and means of the incubator functions will impact positively low-income families.

Innovation: What makes your concept innovative? (5000 characters)

According to the World Health Organization, worldwide each year 22M babies are born with low birthweight, 15M are born prematurely and over 3.3M die within their first month. Many of these deaths are readily preventable. Many babies at risk can be saved with simple, immediate care such as warming, phototherapy, respiratory support and protection from infections, which can be provided by incubators. They are an essential solution not only as functionality but also as a one unit of controlled microenvironment to reduce Infant mortality and morbidity, which leads to billions of dollar in human and capital losses annually. Our solution is the first state-of-the-art highly affordable disposable Neonatal Intensive Care Incubator (NICI), which saves babies’ lives by tackling multiple medical newborn challenges in low resources settings. Our solution is built to address multiple challenges that are unique to a LMIC setting such as hypothermia, jaundice, hypoxia and disease cross contamination. Currently, there are no affordable, fully functional incubators for low-resource settings. Modern hospital incubators are stationary, large and heavy, and require a constant 110-240V electricity power supply. They are very expensive to purchase, complex to disinfect and to maintain. Standard incubators can cost up to $80K. Recent innovations can only treat one condition and do not function as incubator. In addition, they do not prevent disease cross contamination. Our disruptive innovation offers the same multiple functionality as modern hospital incubators, but at a cost and weight less than 1% of comparable solutions. Our Incubator is the first multi-functional disposable Neonatal Intensive Care Incubator (NICI), a class II medical device that require a 510k application in the FDA and has a pending patent and a provisional one. With several innovative technologies, it is a practical user-friendly, efficient, low maintenance, inexpensive, incubator designed to significantly reduce neonatal mortality and morbidity. Our disruptive innovation will provide the critical necessities for neonatal critical care such as heat, humidity, HEPA ventilation, phototherapy and containment for stationary and for transport cases. It consists of two main components: 1) a disposable micro-controlled lightweight infant housing unit and 2) an electronic control module. Our X-ray compatible infant housing is designed for single use per infant up to one week to reduce nosocomial risks and cost of care and maintenance. The electronic control module has optional wireless for remote monitoring to increase infant to caregiver ratio and data communication. The NICI is designed to run on a versatile convertible power source, allowing the device to be used as a portable incubator, operable on site or in transport vehicle.

Scale: Describe how your idea could reach a significant number of end-users. (1500 characters)

The reason our product will scale is due to its ultra low cost. We will offer our NICI system for $225, which includes a disposable $25 one week disposable sterile housing unit. With no royalties, our affordable, innovative, practical design and in-house development of our own software allows manufacturing cost to be minimal with a healthy return. Within five years of launching NICI, we are aiming to capture 10% of our potential market within the estimated total addressable market of over 20 million neonates worldwide that need immediate intervention and care. From a customer perspective, starting at the base of the pyramid and moving up offers an attainable and affordable entry price with a disruptive innovation.

Feasibility: Where are you with understanding the feasibility of your idea? Describe what you’ve done so far and your plans. (3000 characters)

For the past four years, we researched and developed in-house innovative hardware and software to address the needs and challenges of our neonatal intensive care incubator. We have recruited highly experienced team in business, biomedical engineering, material development, regulatory, public health and medical. We have filed several patents. We have raised close to $500,000 in private investment, and partnered with several manufacturing facilities to manufacture our product and to scale future production. We partnered with several prominent universities in the Boston area (Boston University, Northeastern University, Suffolk University and Tufts University). With our current manufacturing and academic partners, and after laboratory testing our final beta prototype, a field assessment will commence at our partner hospitals in Honduras. With a letter of support from the Vice-President and the Minister of Health of Honduras and written agreements of collaborations with several hospitals in Honduras and Boston University, Breegi Scientific Inc. is well positioned to study the efficacy of our technology and collect clinical data on site.

Business Viability: How viable is your business model? (5000 characters)

We have spent more than four years building upon the concept of a disposable incubator and have researched the market and discussed the project with a myriad of advisors and consultants. We successfully built and tested our technology and built our prototypes in-house and in collaboration with our partners.

HCD: How have you used human centered design to build or refine your concept? (5000 characters)

We have spoken with doctors, parents, nurses, mid-wives, and neonatal specialists while designing the prototype. When we field test the NICI in upcoming clinical assessments in Honduras, we are planning to focus on human centered design and other human factor elements of the NICI.

Tell us more about you (3000 characters)

My firsthand experience of feeling helplessness not to be able to save my own newborn son, Danny, in war ravaged country during the Gulf war made me very conscious of the fact that we might have the best equipment to save lives, but it might be the exact reason why they fail! Since then, this project to bring a life-saving technology to low resource settings got its roots, but it started as a project in 2013 after I learned of the startling statistics while my son, Danny, was studying for his master’s degree in Global Public Health at Boston University. Namely, I learned that there are currently more than 3.3 million babies that die each year due to the lack of access to neonatal incubators before reaching their first month and there are more than 15 million babies that require access to incubators, but that do not receive it. A great many of these babies are born with developmental problems. I knew there could be a solution, so I started Breegi Scientific with the idea of creating a low cost but technologically sophisticated technological solution. My passion and believe is that a purpose on this earth to make our lives and of the others better. I have led other humanitarian projects to save the lives of many families and children from persecution. In 2008 and for 5 years I have led and spearheaded the effort to sponsor and help over 2500 people from the Mandaean minority (an old Judeo-Christian sect) to settle in the United States, mainly in Worcester, MA. I have training in veterinary medicine. for two decades my focus was studying and researching new methods and drugs to treat human diseases and illnesses. I finished my postdoctoral training in human gastroenterology at Tufts University. I have led and directed preclinical research in many fields such in neonatal and the effect of oxygen on premature babies.

Do you have the people and partners you need to do what you’ve described? (600 characters)

Yes. As described earlier, we have great partners whom not only believe in the soundness of the business plan, but more so in the mission of the company. We managed to create more than a partnership, we created an alliance to achieve our goal of a low cost, highly innovative and fully multifunctional incubator. Many field experts, business partners, academic institutions and several international healthcare institutions and officials in countries like Honduras, Costa Rica, Guatemala, Uganda and India.

As you consider your next steps, what kinds of help could you use? Is there a type of expertise that would be most helpful? (1800 characters)

We realize the enormity of the problem, nationally and internationally to expand our business globally in low resource settings. We need experts in global marketing, sales, distribution, and guidance in regulatory framework in many of the countries where the NICI is desperately needed.

Would you like mentoring support?

  • Yes

If so, what type of mentoring support do you think you need? (1200 characters)

Ideally, we would like support in both regulatory affairs in bringing the NICI to market in low resource settings. We would also like to have mentorship in the global distribution of our product in low resource settings.

Are you willing to share your email contact information submitted on OpenIDEO with Gary Community Investments?

  • Yes, share my contact information

[Optional] Biography: Upload your biography. Please include links to relevant information (portfolio, LinkedIn profile, organization website, etc).

An inventor, scientist, entrepreneur, humanitarian and human rights advocate. Twenty years of medical experience, leadership and business management. Led several national and international organization and spearheaded the resettlement of over 2500 Mandaean refugees. https://www.breegiscientific.com https://www.linkedin.com/in/wisam-breegi-3a1b554 http://bostonvoyager.com/interview/meet-dr-wisam-breegi-breegi-scientific-mailing-address-woburn-office-boston-university-commonwealth-ave/

[Optional] Attachments: Please upload relevant attachments or graphics or show us how you prototyped.

[Optional] Video: You are invited to submit a 30-60 second video that introduces you and/or your team and your idea.

Our CEO, Wisam is introducing our team and NICI, and the incubator-use between our lead hospitals and those in low resource settings, such as in Honduras.

Mentorship: How was your idea supported? (5000 characters)

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Updates: How has your idea changed or evolved throughout the Prize? What updates have you made to this submission? (1500 characters)

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Name or Organization

Breegi Scientific, Inc.

Geography

We are a startup located in Boston, Massachusetts. We have a working space within Boston University. Our mailing address: 120 Bedford Rd. Woburn, Ma 01801

What is your stage of development?

  • Advanced Innovator with 3 to 10+ years of experience in ECD

Type

  • For - Profit

What is the stage of your proposal?

  • Piloting: I have started to implement my solution as a whole with a first set of real users.

Describe your submission in one clear sentence

Breegi Scientific is developing the first fully-functional, ultra low cost disposable neonatal intensive care incubator (NICI) to low resource settings, with all of the life saving features that pre-mature babies need for survival at birth, including heat, ventilated air, humidity, and phototherapy, all in a sterile micro-environment.

Select an Innovation Target

  • Product: A new or enhanced physical product that creates value for end beneficiaries.

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