ShiVent

Shifa Technologies developed a simple and low-cost Non-Invasive Ventilator for patients with breathing problems due to COVID-19 or other respiratory illnesses called the ShiVent. 

It does not require electricity and functions on the principles of Bubble Continuous Pressure Airway Pressure (CPAP). It keeps the patients' airways open and prevents deterioration to a state where they need mechanical ventilators which are scarce and expensive. This way, hospitals, especially in low resource settings with unreliable power supply, can efficiently care for patients with COVID19.

The COVID-19 pandemic has been a strain on health systems globally. The high price and shortage of mechanical ventilatory systems have contributed to the death of thousands of patients. With developing countries seeing an upsurge in confirmed cases, many of them are at a loss as to how to tackle the challenge because of their dwindling health systems, resource constraints and challenges with power supply.

According to Life Bank Nigeria’s latest equipment census tagged Quip, Nigeria has as few as 288 mechanical ventilators serving almost 200 million people. 

This shortage presents a great access gap for patients who need life saving ventilatory support. 

With majority of patients presenting with mild to moderate symptoms; a simple, low cost ventilatory alternative which does not depend on electricity and is widely replicable can potentially prevent most patients from developing severe symptoms which would need mechanical ventilation, thus, giving developing countries like Nigeria a fighting chance against this disease.

Our solution is built on the principles of the “Bubble CPAP" - a well known means of generating airway pressure by bubbling expired air or oxygen through a fixed water column. Bubble CPAP has been successfully used in neonatal respiratory distress both in US, UK hospitals and in low-resource settings. This approach has been studied for use in adult respiratory distress and it turned out to be successful on healthy adults over the period of 30mins through which the test was carried out (Brendan H. Milliner, 2019).

In designing our solution, we took note of the requirements and guidance of the NHS and MHRA (Medicines and Health Regulations Authority) in the UK on the standards required for a ventilator and the advice from the Faculty of Intensive Care Medicine (Eddlleston, 2020).

The ShiVent design focuses on 2 key elements - a venturi mixer to enable a blend of oxygen and air, thus supporting the inhalation process and a Bubbler (Bottle + Specialised Cap) designed to create, sustain and regulate back pressure in the patient exhalation process. The ShiVent was particularly designed to deliver CPAP at a comparatively low cost by combining 3D printed parts with off the shelf components.

Our solution - the ShiVent, upon deployment will make a significant contribution towards the lives of patients with COVID-19 and other respiratory problems, thus contributing to the health and wellbeing of patients. The simplicity of the solution is especially attractive for developing countries that cannot cope with the  cost of expensive ventilatory devices.

In deploying this solution, we hope to work hand in hand with local collaborators, manufacturers, healthcare facilities, and academic institutions. In doing so, we would like to build the capacity of local Biomedical Engineers, Researchers, and Medical personnel to efficiently utilise, maintain and improve on the functionality of the device. This would build local capacity and productivity and generally improve patient outcomes even post COVID-19.

Our solution has enormous potential for improving healthcare delivery in health facilities, building the capacity of its workforce and saving precious lives.

Our solution is needed because it would provide health systems with an easily replicable, scalable and sustainable means of successfully treating patients with breathing problems. 

It fits perfectly with the challenge’s need to strengthen health systems in developing countries in terms of resource and capacity to deal with health challenges and pandemics.

Our solution would ensure the deployment of safe, efficient and easy to use ventilators together with a digital training and support platform to improve the capacity of health professionals to safely implement, maintain and use the device.

The innovation in the ShiVent lies in the following: 

1. Simplicity - it is designed to be simple and easy to operate and maintain by frontline health workers in settings where specialist manpower and ICU capacity is limited
2. Non-Electricity Dependence- This immediately alleviates the access barrier due to challenges of infrastructural deficits and energy poverty in low resource communities.
3. Scalability - designed with many of its components accessible in most countries making it easy to scale. 
4. Low Cost- frugal innovation, achieving efficiency with locally available cost effective raw materials.
5. Low Carbon- durable, fit for multiple sterilisable use over a specific life span and easily recyclable.
6. Digital and Data-Driven - hardware device will be paired with a digital training and support platform to easily train frontline health workers and gather usability data and feedback.

Similar devices functioning on the same principle of Bubble CPAP are more popular for use in neonates.  Also, most CPAP devices are powered by electricity  which remains an unreliable resource in low resource settings across Africa, Asia and South America.
Also, our device seeks to compete favourably with a target proving at about one-fourth of average CPAP devices which cost $2,000.

The ShiVent is a new application in adults with COVID-19 of a widely utilised ventilatory technology called the Bubble CPAP, more popular for use in neonates.

CPAP is Continuous Positive Airway Pressure. It is a type of non-invasive ventilation (NIV) or breathing support. CPAP works by providing a positive pressure of air through the mask and into the airway, which helps to keep the airway open. This helps to prevent breathing difficulties, increase the level of oxygen in the lungs and removes the unwanted gas (carbon dioxide) out of the lungs (NHS, 2017).

“Bubble CPAP,” is a low-tech means of generating airway pressure by bubbling expired air or oxygen through a fixed amount of water. Bubble CPAP in neonates is delivered via nasal prongs and has been successfully used in neonatal respiratory distress both in US hospitals and in low-resource settings. This approach has been studied for use in adult respiratory distress and it turned out to be successful on healthy adults over the period of 30mins through which the test was carried out (Brendan H. Milliner, 2019).

The design of the ShiVent focuses on 2 key elements - a venturi mixer to enable a blend of oxygen and air, thus supporting the inhalation process and a Bubbler (Bottle + Specialised Cap) which is designed to create, sustain and regulate back pressure in the patient exhalation process. 

The ShiVent is to be aided by a digital training and support software to aid its  safe use and gather usage data.

Please find link to a video of the device in use by a consented healthy volunteer below: here

Links to evidence of the use and research of the technology are listed below: 

Brendan H. Milliner, S. B. &. J. D., 2019. A pilot study of improvised CPAP (iCPAP) via face mask for the treatment of adult respiratory distress in low-resource settings. [Online]

Available at: https://doi-org.ezproxyberklee.flo.org/10.1186/s12245...

[Accessed 09 April 2020].

Eddlleston, J., 2020. Letter regarding the Use of Continuous Positive Airway Pressure (CPAP) for COVID-19 positive patients. [Online]

Available at: https://www.ficm.ac.uk/news-ev...

[Accessed 9 April 2020].

NHS, 2017. Continuous positive airway pressure (CPAP) non-invasive ventilation. [Online]

Available at: https://www.gosh.nhs.uk/medica...

[Accessed 09 April 2020].

Activities - Research, Development, Trial and Deployment of a low cost ventilatory solution to support patients with breathing difficulties due to COVID 19 or other respiratory illnesses.

Output - The device called ShiVent is produced and distributed to hospitals along with a digital training and support platform.

Short term outcomes - 

1. Doctors learn a simpler way to support patients with breathing problems

2. Hospitals at all cadres of healthcare and in low resource settings are able  to afford a cheaper alternative for ventilatory support and can now provide life saving treatment

3. Patient who develop breathing difficulty can access the device at their local hospitals

Medium Term Outcomes -

1. Patients using the device experience improvements in their state of health 

2. Number of patients needing mechanical ventilation reduces

3. Need for ICU capacity reduces

4. More patients are treated despite unreliable electricity

Long Term Outcomes -

1. Increasing recovery rates of patients with COVID-19 and other breathing difficulties 

2. Reduced length of hospital stay due to illness

3. Improved quality of care

4. Improved health system 

Presently, our product has just passed 2 functionality test at the National Center for Exercise and Sports Medicine and Royal Infirmary Hospital, Leicester. We are working towards a CE mark in the next 2 months so we can mass produce and distribute across markets.

Presently we have received demand requests from businesses in Nigeria, India and Brasil and since all founders have links to those markets we intend to start there.

Within a year, We intend to deploy 6000 units across Nigeria, India and Brazil at an equal ratio. Nurture the user community to gather feedback on usability and patient response. These feedbacks and the simplicity of our solution will enable us improve the product in a quick turnaround time. 

In 5 years we intend to have grown regionally serving both adults and neonates across Africa, Asia and South America.

Acquire Regulatory approvals- CE Mark on our product

Roll out a pilot across- Nigeria, India and Brazil

Activate digital platform

Mass Manufacture

Commercialise and distribute

Develop supply chain to enter more markets 

1. Regulatory Approvals
2. Pilot
3. Manufacturing & Distribution

1. Regulatory Approvals- we in the process of applying for our CE mark. We are seeking regulatory advice with Oxford Global Guidance, Cheata, Medilink and BioCity to support us through this phase. 
2. Pilot- we are also seeking funds for our pilot project before we mass produce
3. Manufacturing - we intend to adopt a distributed manufacturing approach where our moulds are manufactured at a central location and distributed to partners in each country who can locally manufacture and distribute to medical facilities.

However, these are challenges we hope to get by with through the first year and by the 2nd year we should be better positioned to deliver our product to medical facilities.

Not Applicable

The core team is composed of 4 people working full time and one person part-time. We also work with external consultants that work on specific aspects of the project based on their specialty such as Clinical Suitability and Risk Assessment, Intellectual Property protection, Regulatory Approval and Business Development.

The team is composed by Dr. Yusuf Shittu, a Medical Doctor with up to five years of experience in Global Health Innovation, conceptualising, and leading health interventions targeted at vulnerable groups in Nigeria. https://www.linkedin.com/in/yusufshittu/

Yusuf Bilesanmi, a Power and Infrastructure Professional with business & project development experience from Japan, Europe and Anglophone Africa. Yusuf won the most scalable idea award at the 2019 UNLEASH SDG Innovation Labs in Shenzhen China. He is presently a PhD student at Loughborough University, UK. https://www.linkedin.com/in/yusuf-oladipupo-b-b3650612/

Ricardo O'Nascimento is a designer specialized in electronic textiles, digital manufacturing techniques, and materials. He has extensive experience in developing prototypes for interactive wearable systems, as well as User Experience design and graphic design. Currently, he is a Ph.D. candidate at Loughborough University.
 https://www.linkedin.com/in/ricardo-o-nascimento-0b85b228/

Gaurav Nanajkar is a Chartered Mechanical Engineer with several years of industrial experience in design and analysis of a variety of mechanical systems such as rolling mills, electric arc furnaces and PEM fuel cells. https://www.linkedin.com/in/gaurav-nanajkar-ceng-mimeche-70203a3a/

Pawel Nycz is a Heating Ventilation and Air conditioning engineer, installation and product design specialist with 14 years of experience in industry. Currently PhD Researcher at Loughborough University working on project involving Stirling engines,  Sodium heat pipes and thermal energy storage systems. https://www.linkedin.com/in/pawe%C5%82-nycz-5b5a66a0/

Advisors 

Dr Andrew Hall - Consultant and Lead Clinician for Sleep Disorders Service, University Hospitals Leicester, UK 

https://www.linkedin.com/in/andrew-hall-a1ab38167/

Dr Sanjiv Nichani - Senior Consultant Paediatric Intensivist, University Hospital Leicester, UK. Honorary Senior Lecturer, Leicester Medical School, UK 

https://www.linkedin.com/in/dr-sanjiv-nichani-43916136/?originalSubdomain=uk

Advisors 

1. Dr Andrew Hall - Consultant and Lead Clinician for Sleep Disorders Service, University Hospitals Leicester, UK
2. Dr Sanjiv Nichani - Senior Consultant Paediatric Intensivist, University Hospital Leicester, UK. Honorary Senior Lecturer, Leicester Medical School, UK

Regulatory Approvals

1. Oxford Global Guidance

Business Development-

1. Medlink
2. BioCity
3. Cheate

IP Application

1. Franzosi (EU)

Given the recent Covid 19 pandemic medical facilities around the world have been in dire demand for ventilators. In low resource setting with limited power infrastructure the need extends beyond ventilators to power systems to power the ventilators, hence we have developed a low cost, non electric non invasive ventilators to support patients who experience respiratory challenges.

Value Proposition- Is to deliver to medical facilities / practitioners a low cost, non electric non invasive ventilator to support patients with respiratory challenges and a digital platform to train medical practitioners on its use.

Customers- Medical Institutions, DFI, Governments etc.

Key Partnerships- Mould Manufacturer, Local Manufacturer, Logistics- We intend to produce our mould from one manufacturer for consistency and quality and then distribute product manufacturing through local partnerships who will produce and distribute to our clients on our behalf.

Income Stream- We intend to sell each product for $500. We will only invest in the mould manufacturing. With our local partners we intend to offer our mould and our digital platform. The local manufacturer will be responsible for manufacturing to our standards at their own cost and deliver to our customers.We will sell at $500 to the customer and offer $150 per product to our local manufacturing partner. Each product is traceable through our blockchain system and digital platform.

In the first year we are seeking grants and investment. We seek to raise $160,000 to pay for regulatory approvals, manufacture mould and build local partnerships across Nigeria, India and Brazil.

We intend to be financially sustainable through profitable sales through our local partners.

We are presently seeking grants and hope to make up the shortfall with raising investment capital.

Our biggest motivation as social innovators for applying to Solve is our overwhelming desire to create solutions that can strengthen healthcare systems in low resource settings. 

These challenging times have shown us just how important it is for us as a multi-racial team to unite in our passion for creating solutions that can help everyone, everywhere. 

We hope that through the Solve programme, we can leverage on the vital networks and support structures that exist within its amazing framework to bring our ideas to reality. 

The Solve programme is the right fit for our project as it would potentially give us the network, mentorship, advisory, funding and partnerships we need to get our technology to all those who desperately need it even beyond COVID-19.

The Solve programme can help us contribute to health system strengthening and capacity building in areas of great need.

We would require more support with seed funding to pilot our product in a clinical setting and navigate through the regulatory barriers that may delay the device's access to market. 

Similarly, advise and support with regards to the best revenue model to adopt and partnerships with stakeholders in the Marketing and Distribution Value Chain would go a long way to ensuring our solution gets to those who need it the most faster and seamlessly. 

Lastly, support with Monitoring and Evaluation through user feedback and clinical research would give the device further validation and improve outcomes.

We would like more partners in the following areas: 

• Technical Expertise/Advisory - in the area of Biomedical Engineering, Anaesthesia and Intensive Care, MedTech Innovations and Regulation, IP Protection and Business Development.

• Seed Funding - in terms of grants and investment to enable commencement of Clinical Feasibility Trial and Product Manufacturing.

• Network - with relevant stakeholders such as government bodies, NGOs, Medical Device Manufacturers, medical associations, hospital managements, marketing and distribution channels to guarantee access to market

The idea for this project came from a genuine desire to make an innovative contribution towards the fight against COVID-19. Following the participation of two members of the team - Dr. Yusuf Shittu and Yusuf Bilesanmi at UNLEASH Global Innovation Lab, last November, we felt the need to contribute our expertise to creating a potential solution to help low resource settings. 

Dr. Yusuf's award winning idea at the programme of using a low-cost Bubble CPAP device in newborn babies fuelled the motive for developing an adult version, which could potentially be useful in adults with COVID-19. 

Dr Yusuf himself works on the frontlines of healthcare in the UK, supporting the fight against COVID -19 directly as a Doctor and in his spare as an innovator, brainstorming with the team on ways to create a solution that could potentially contribute to patient survival especially in low resource settings. 

The rest of the team - PhD students at Loughborough University offer their expertise, time and finances to developing the solution, despite the pressure of their academics.

The Elevate Prize for Health Security would greatly support our plan to fulfil the necessary Regulatory and Manufacturing barriers ahead of us on our road to market