GOAL 3 - Low-cost Patient monitoring

Every year more than 2 million neonates in LMICs die from treatable conditions like infectious diseases. Many of them are born in a hospital setting but are not diagnosed in time due to a lack of good equipment and a shortage of (well-trained) staff. Patient monitoring systems are used to help diagnose clinical deterioration, and reduce the pressure on the staff. However, according to the WHO, up to 70% of equipment in LMIC doesn’t function.

GOAL 3 is developing a tablet-assisted multi-parameter, easy to use, vital signs monitor for neonates in LMICs, designed with local stakeholders. This system will make it easier for physicians and nurses to interpret the data from the patient monitoring systems. In the future we will add an algorithm to automatically detect critical deteriorations in an early stage.

We expect that our solution can reduce in-hospital neonatal mortality rates by at least 20% if successfully implemented.

Every year more than 2 million children in LMIC die on the consequences of severe infections like sepsis, mostly in hospital settings. The majority of these deaths can be prevented with improved quality of care. This can be done by decreasing the time to diagnosis, as every hour delay causes a 10% increase in mortality rate. In most situations antibiotics are available, but treatment is initiated too late. The main cause is that sepsis is difficult to recognize at an early stage, especially in LMIC where the people and equipment needed for this early recognition are lacking.

Continuous monitoring of vital signs is one of the key targets for recognizing these conditions in an early stage, as vital signs change early in the course of infections. In most low-resource settings this is done manually which is labour intensive and less accurate, the shortage and undertraining of healthcare staff in LMIC is fueling this problem - estimated shortage of 15 million healthcare workers by 2030.

Existing monitoring systems are too expensive, complicated and often do not function. According to the WHO up to 70% of monitoring equipment is malfunctioning. The reason is that most existing systems are designed for high-income settings.

GOAL 3 develops an integrated patient monitoring system that addresses these challenges. Through a combination of a monitoring device with a robust, durable and user-friendly design, a new ballistographic sensor and a smart algorithm running on supportive tablet-based software we create a monitoring system that automatically detects early signs of sepsis. Combined, these features contribute to a system which is supportive for doctors and nurses working in low-resource, low-staff settings.

The GOAL 3 monitoring systems consists of the following components:

• A robust and durable monitoring device which uses these sensors:

  • Pulse oximeter, applied as in other systems

  • ECG, applied as in other systems

  • Ballistographic sensor, placed underneath the cover of the mattress. No need to be changed between patients. 

• Software application running on tablets for improved functionality and intuitive use, enabling remote (multiple patient) monitoring

• Algorithm-based analysis of monitoring-data combined with clinical data to automatically detect changes in vital signs that indicate sepsis displayed on the tablet. Recent studies indicate that this approach could lead to a diagnosis up to 6 hours before current standards.

Our solution serves health workers in low- and middle-income countries. In these countries, hospitals are understaffed and staff is often undertrained. Also, in many cases, medical technology is malfunctioning (40-70% by WHO) making adequate diagnosis nearly impossible. These healthcare workers have a big need for tools to help them make better, earlier diagnoses so that treatment can be started on time. This could save an enormous amount of lives of young vulnerable children. 

Our CEO, Niek Versteegde, is an MD specialized in tropical medicine and international health that worked in Tanzania and erected a neonatal intensive care department. This helps us understand what is needed for hospitals and other health centers in this context. 

By actively piloting our product, we further improve our understanding of the problem and the context. Our first pilot is scheduled for September 2020 in Malawi. In this pilot, we engage and work with local health workers to make sure we design the best solution fitting their needs.
Combined, the members of GOAL 3 have spent more than 10 years years of researching the problem talking to stakeholders, reading articles, and actively visiting hospitals.

As GOAL 3, we align with this challenge by improving access to high-quality and affordable care for newborns. We do this by improving the in-hospital diagnostics for newborns. Initially in intensive care settings, at a later stage, it could evolve to broader settings such as rural health centers. GOAL 3 aligns with SDG 3 and its subgoal of reducing neonatal mortality by more than 50% by the end of 2030. Our target population, hospitals in LMICs, have the highest numbers in neonatal deaths which is why we are focused on this field.

The main factor that distinguishes us from current competitors is that we design specifically for and in collaboration with LMICs. The circumstances in LMICs are so significantly different than the devices of our competitors that demonstrate shortcomings for use in these settings. High-end systems (e.g. GE, Philips) offer too high-quality functions, which are difficult to use and maintain. In addition, these systems are very costly, €15.000 for 10 years, and thereby not affordable for LMICs. Low-end models from Asian producers (e.g. Contec) are affordable but not durable and lack the required functions with no maintenance services leaving the monitors malfunctioning. Devices developed for LMIC by non-profit organizations are durable but offer limited functionality (e.g. LifeBox). Initial conversations with comparable company Neopenda are held where GOAL 3 is merely focused on the software- and data systems and Neopenda more on the hardware side of the industry, offering opportunities for collaboration.

The GOAL 3 monitoring system will eliminate the above-stated shortcomings by using a simple, user-friendly, and durable monitoring system for hospitals in LMICs with minimal buying and service costs. 

In terms of innovation, the system can be seen as a frugal innovation. By reducing complexity and increasing robustness we make this technology accessible. The software application enables integration with existing systems and use of predictive algorithms for automated recognition of critical illness. Combined these features lead to a monitoring system that everybody can use, that always works and automatically signals critical illness even when there are few skilled health workers.

The GOAL 3 monitoring systems consists of the following components:

• A robust and durable monitoring device, connected to a tablet for central monitoring, and using these sensors:

  • Pulse oximeter, applied as in other systems

  • ECG, applied as in other systems

  • Ballistographic sensor, placed underneath the cover of the mattress. No need to be changed between patients. This technology is rather novel and is only used in other settings at this time, tests and pilots with this technology show positive results. 

• Software application running on tablets for improved functionality and intuitive use, enabling remote (multiple patient) monitoring

• Algorithm-based analysis of monitoring-data combined with clinical data to automatically detect changes in vital signs that indicate sepsis displayed on the tablet. Recent studies indicate that this approach could lead to a diagnosis up to 6 hours before current standards.

Co-founder Bart Bierling developed and tested a new patient monitoring device for neonates in LMIC. He worked in the NICU of the Maxima Medical Centre in Veldhoven together with experts from Philips to test the ballistography sensor [1][2]. 

The combination of a monitoring device with a tablet and the suitability of the ballistographic sensor was tested there in a first set of iterations to improve the first designs. This prototype is the foundation of the GOAL 3 monitoring system.

The main components of the monitoring system are clinically tested and medically certified parts manufactured by established companies. 

Medical equipment that has been designed in collaboration with clinicians from LMIC have shown to be more effective in these settings.

Algorithm based analysis of diagnostic data is used in many settings, including LMIC. To apply it for this indication in patient care is a relatively small and logical step which is suggested in recent literature [3].

[1] https://www.researchgate.net/publication/328258799_A_Ballistographic_Approach_for_Continuous_and_Non-Obtrusive_Monitoring_of_Movement_in_Neonates

[2] https://www.researchgate.net/publication/332241396_Monitoring_the_respiratory_rate_of_preterm_infants_using_an_ultrathin_film_sensor_embedded_in_the_bedding_a_comparative_feasibility_study

[3] https://www-sciencedirect-com.ezproxyberklee.flo.org/science/article/abs/pii/S016926071831602X

Theory of Change

ACTIVITIES

- Selling patient monitoring solutions

- Creating health ecosystem for hospitals

OUTPUTS

- Vital signs monitoring neonates

- Digital health solutions hospital

The GOAL 3 patient monitoring systems initially help doctors and nurses make better diagnosis on the conditions of their patients. The GOAL 3 system is an open system that can be coupled with current EPR and other digital health solutions making the system increase in value. This coupling holds many positive future outcomes to a hospital. 

SHORT TERM OUTCOMES

- Improved monitoring of neonates

- Better diagnosis neonatal patients

- Empowerment of health workers

- Better care for newborns

MEDIUM TERM OUTCOMES

- Improved digital health ecosystem hospitals (EPR, Supply-chain solutions)

- Improved efficiency hospitals

- Improved effectivity hospitals

LONG TERM OUTCOMES

- Reduced neonatal mortality rates

Goal SDG 3: -50% by the end of 2030

Overall, GOAL 3 exists to improve the healthcare for all by making quality healthcare accessible to everyone around the world. One long-term goal that GOAL 3 is pursuing is reducing the neonatal mortality by 50%, linked to the SDG sub-goal, at the end of 2030.

In the current situation, GOAL 3 is initiating its pilot. The product in this pilot is not yet clinically ready to be used as a diagnostic tool. This makes the current serving population 0. Estimated is that with the next pilot will have a multicentre study, where the systems can be used for simple diagnosis. This study in 5 hospitals in East-Africa will measure around 1000 neonates helping doctors diagnose based on their vital signs patterns. This study will be leading in designing and developing the MVP, which is estimated to launch around 2022-2023. When this MVP is launched, it will be integrated together with a lead client in over 20 hospitals. This number is expected to grow rapidly. The estimation for impact by 2025 is 1.000.000 neonates monitored with an expected 20% decline in mortality by infectious diseases. 

To summarize:

Current: 0

One year: 1000

Five years: 1.000.000

The goals for the coming year are to further test and validate our system and market. We do this in combination with development of strategic partnerships to make sure that we can reduce the time-to-market. By performing a multi-site clinical study, in various different hospitals in East-Africa we want to evaluate the system in a more complex environment. 

After this study is completed and results are positive, we will  accelerate the development of our prototype into a medically certified product. 

We expect to sell 1000 monitoring devices by 2024, with these sales numbers growing with 100% over the year. This will result in an impact of over 1.000.000 lives of newborns but will also impact efficiency and knowledge in hospitals and influence many other terrains. Overall GOAL 3 aligns to Sustainable Development GOAL 3 to drastically reduce the mortality in neonates by 2030. To achieve this, we measure our impact actively and are impact driven in everything we do. 

By converting as a company more and more from hardware to software, we create integrations between existing and new systems increasing our impact in a scalable way. We expect to do this in a way that our lives impacted can grow with more than 100% over the years following 2024.

First of all, GOAL 3 only has small barriers in extending the pilot and limited travel and finance due to the COVID-19 crisis. However, for the coming years, GOAL 3 will have some barriers in financing because it will take at least 2 years before a product is ready for the market that can be sold. More specifically, a funding gap between $2 and $4 million is estimated to bring our first product to market. 

When the product is ready, GOAL 3 will face some legal and regulatory barriers in getting the product certified and making sure that data is handled with good care. In the current situation, GOAL 3 lacks experience in this process, which means that more experience needs to be attracted to overcome this gap. 

Commercially, GOAL 3 is in a tough market where a lot of big MedTech companies do not actively sell because of low margins, hard distribution and long tenders. This brings a barrier with questions such as: Who will buy the GOAL 3 product? What can they afford? What should the business model look like?

On the cultural aspect, GOAL 3 will also have barriers because the current healthcare setting is not comparable to Western settings. Routines are followed on a completely different way, people are trained differently and even for the patients, the trust in a hospital is different. 

GOAL 3 is aware of these barriers and is actively mapping them to make sure they can be overcome in the future.

Financial barriers are overcome by actively searching for existing technologies and products that have a shorter time-to-market. These kind of technologies and products can provide GOAL 3 with earlier revenues. 

Cultural barriers are overcome by actively involving people from the context in GOAL 3. Also, by partnering with big NGOs such as Cordaid and Amref, many barriers can be overcome by leveraging their experience. In addition we look for partnerships with organisations that have large networks and are experienced in the implementation and operational side of innovation. 

Legal barriers can be overcome by involving experienced medical product designers in the process. We are already in further talks with many firms and individuals that can help us in this manner. Also, we have involved legal advice in our board of advisors to make sure that all challenges are covered. 

Commercial barriers are overcome by large willingness-to-pay, feasibility and market studies in which GOAL 3 tries to dive deep into the market, making sure that we can fully understand and that the right choices are made commercially. Also, GOAL 3 is actively looking for a lead client that wants to roll out the GOAL 3 product together to make sure that distribution, market experience etc. is covered.

In the current situation, GOAL 3 has 3 full-time employees involved. This team is extended with 6 part time participants and more than 20 advisors that are involved in a regular basis. GOAL 3 is bootstrapped and finances most of its employees through share constructions. When the budget gives way, more monetary rewards can be provided.

Clinical development will be addressed by Niek Versteegde, who is the founder and chief executive officer of GOAL 3. Niek is a medical specialist working in the hospitals of the Netherlands and Tanzania and developing clinical solution for supportive monitoring system to timely predict sepsis. 

Technical development will be addressed by Tijs Versteegde, who is an experienced embedded system engineer and Bart Bierling, the founder and chief product officer of GOAL 3. He is an industrial designer and was involved in many health-related projects. 

Business development will be addressed by Balt Leenman and Jelle Schuitemaker, who are experienced and creative entrepreneurs. Both are responsible for bringing GOAL 3 forward during marketing and commercialization process. 

Financial development will be addressed by Kevin Gerrits, who is serving as a chief financial officer for Goal 3 Kevin has more than 15 years of experience in financial professional working for Ernst and Young (EY) in various senior roles. He will be leading the legal and financial structure of the company during the whole process from development of monitoring system to implementation in LMICs.

The team of GOAL 3 has a large network in sub-Saharan Africa and is in contact with NGOs in the Netherlands and with key opinion leaders of companies such as Philips. Altogether, the teams complementary experiences and capabilities, together with the drive, passion and motivation to make this a commercial success makes GOAL 3 unique. 

First, GOAL 3 works together with the Amsterdam Medical Centre (AMC), being a leading hospital and research institution in the Netherlands who partnered with us in the development of our first systems. Where The Queen Elizabeth Central Hospital (QECH) in Blantyre, Malawi is a partner via the AMC. Second, Also GOAL 3 works together with technical research institute TNO, who works with us on the development of novel sensor technology. Third, GOAL 3 also works with the National eHealth Living Lab in the Netherlands, supporting with advice in study design for clinical research. Lastly, GOAL 3 is in explorative talks with MedTech engineering companies for outsourcing parts of the development and with various well-known NGOs on collaborations in the roll-out of our products.

GOAL 3 has a two-sided business model, where on one side, revenues will be generated through hardware transactions and on the other side, revenue is generated through software and service fees, which can be billed monthly or yearly and can also be paid upfront for the first years. This model is being evaluated with major stakeholders in the industry, possibilities in a pay-per-use model or a more hybrid platform driven business model are also being explored.

In the first 3 years, GOAL 3 is expecting to only generate little revenue. This is because major attention is drawn towards the development and testing of the MVP. After these 3 years, the MVP can be sold. GOAL 3 aims to sell its monitors via a hardware fee combined with a service and service fee. Expected is that GOAL 3 will be profitable after 5-6 years after founding, so 2 years after launching its MVP.

For GOAL 3, major challenges are in the lack of experience in commercializing healthcare in low- and middle-income countries. Also, both technically and financially, big challenges lay ahead. The Solve community is full of engaged entrepreneurs that went out and have just done it, this spirit, energy, network and knowledge is something we really need to make our dream come true. The fact that this platform is MIT driven and US based helps us to find new overseas connections and make sure that we think and act globally in solving our challenges.

In our partnership, we would love to connect with SDG driven impact entrepreneurs from other countries to share best practices. Also, the MIT community can help us much further on technical areas. Lastly and more importantly, by helping each other find funding opportunities, we can benefit from the strength of the community.

For us as a start-up from the Netherlands, finding support from the US is hard. The MIT solve program can help us take a flight in finding partners, colleagues, funding and expertise overseas. Especially the MIT Health faculty and the Bill & Melinda Gates foundation could get us on the road with support, academical knowledge, network and funding. Also, other solve members such as Khushi baby and Neopenda can help us ignite our movement.

One of the major problems in the health care workforce in Low- and middle income countries is the lack of staff. Our solution is tackling this problem by enabling the healthcare workers to work more effective and efficient. We are actively tackling the newborn mortality rates with our system and are integrating tools to help health workers work better. Our CEO has been a tropical doctor in a rural hospital in Tanzania and knows what is needed in these settings to improve quality of care. 

GOAL 3 summary

Every year more than 2 million neonates in LMICs die from treatable conditions like infectious diseases. Many of them are born in a hospital setting but are not diagnosed in time due to a lack of good equipment and a shortage of (well-trained) staff. Patient monitoring systems are used to help diagnose clinical deterioration, and reduce the pressure on the staff. However, according to the WHO, up to 70% of equipment in LMIC doesn’t function.

GOAL 3 is developing a tablet-assisted multiparameter, easy to use, vital signs monitor for neonates in LMICs, designed with local stakeholders. This system will make it easier for physicians and nurses to interpret the data from the patient monitoring systems. In the future we will add an algorithm to automatically detect critical deteriorations in an early stage.

We expect that our solution can reduce in-hospital neonatal mortality rates by at least 20% if successfully implemented.

Our system aims to work with innovative algorithms that help doctors make better diagnosis on their patients. These algorithms work with Ai to improve their accuracy over time. Especially since health care workers in LMIC are undertrained and hospitals understaffed, the Ai can really make a difference in working more efficient. 

GOAL 3 Summary

Every year more than 2 million neonates in LMICs die from treatable conditions like infectious diseases. Many of them are born in a hospital setting but are not diagnosed in time due to a lack of good equipment and a shortage of (well-trained) staff. Patient monitoring systems are used to help diagnose clinical deterioration, and reduce the pressure on the staff. However, according to the WHO, up to 70% of equipment in LMIC doesn’t function.

GOAL 3 is developing a tablet-assisted multiparameter, easy to use, vital signs monitor for neonates in LMICs, designed with local stakeholders. This system will make it easier for physicians and nurses to interpret the data from the patient monitoring systems. In the future we will add an algorithm to automatically detect critical deteriorations in an early stage.

We expect that our solution can reduce in-hospital neonatal mortality rates by at least 20% if successfully implemented.

The GOAL 3 patient monitoring system and the platform that will be created shares the values of the Bill & Melinda Gates foundation. We want to empower hospitals, doctors and healthcare workers in working better, more efficient, tackling problems in undertraining, understaffing and the enormous mortality rate in newborns. 

Summary GOAL 3

Every year more than 2 million neonates in LMICs die from treatable conditions like infectious diseases. Many of them are born in a hospital setting but are not diagnosed in time due to a lack of good equipment and a shortage of (well-trained) staff. Patient monitoring systems are used to help diagnose clinical deterioration, and reduce the pressure on the staff. However, according to the WHO, up to 70% of equipment in LMIC doesn’t function.

GOAL 3 is developing a tablet-assisted multiparameter, easy to use, vital signs monitor for neonates in LMICs, designed with local stakeholders. This system will make it easier for physicians and nurses to interpret the data from the patient monitoring systems. In the future we will add an algorithm to automatically detect critical deteriorations in an early stage.

We expect that our solution can reduce in-hospital neonatal mortality rates by at least 20% if successfully implemented.

The GOAL 3 software platform can make an impact on thousands of hospitals through Africa and other Low- and middle income areas. By better software integrations, hospitals can work more efficient and the healthcare system can be improved. This software platform can be initiated through our patient monitoring system and can be scaled by partnering with other providers.

Summary GOAL 3

Every year more than 2 million neonates in LMICs die from treatable conditions like infectious diseases. Many of them are born in a hospital setting but are not diagnosed in time due to a lack of good equipment and a shortage of (well-trained) staff. Patient monitoring systems are used to help diagnose clinical deterioration, and reduce the pressure on the staff. However, according to the WHO, up to 70% of equipment in LMIC doesn’t function.

GOAL 3 is developing a tablet-assisted multiparameter, easy to use, vital signs monitor for neonates in LMICs, designed with local stakeholders. This system will make it easier for physicians and nurses to interpret the data from the patient monitoring systems. In the future we will add an algorithm to automatically detect critical deteriorations in an early stage.

We expect that our solution can reduce in-hospital neonatal mortality rates by at least 20% if successfully implemented.