Open ICU Alliance

The global critical care device industry which includes ventilators, oxygen delivery devices, patient monitors, infusion pumps, defibrillators and consumables is valued at $40B, with North America and Europe accounting for nearly 80% of market share. Barriers to entry include strict regulatory requirements, R & D costs and intellectual property protection which prevents development in resource limited areas. 

CoVent Challenge is reinventing the medical device development life cycle using global innovation challenges to create a portfolio of open source critical care technologies that are easily manufacturable, low cost, safe and effective. In partnership with global health agencies, these critical care devices will be manufactured and maintained locally and foster growth of the medical manufacturing infrastructure thus improving and developing stronger local supply chains. Scaling this model will not only transform global critical care by democratizing access to life-sustaining technologies, but will promote inclusive and sustainable industrialization.

 COVID-19 has exacerbated the already existing inequitable access of critical care resources for developing nations. In Africa, 41 countries have only 2,000 functional ventilators, with 10 African countries having no ventilators available. Even less expensive equipment, such as oxygen concentrators, nasal cannulas, face masks and oxygen saturation monitors can be difficult to find in these countries. Unfortunately, the WHO estimates that approximately 14% of COVID-19 patients will require oxygen support and about 5% will require mechanical ventilation, which leaves millions of patients without critical life-sustaining therapy. 

The highly profitable medical device industry is largely responsible for the lack of critical medical equipment in less developed nations. Large medical device manufacturers rarely invest in economical devices that are compatible and easily serviceable in these regions, and often retire otherwise viable products to increase reimbursements and revenue with next generation devices. Additionally, acquisition of medical equipment through NGOs and international support networks can take significant amounts of time that often results in donation of used equipment that may be incompatible or difficult to maintain.

In response to COVID-19 and the UN Sustainable Development Goals, we are creating a new model for medical device manufacturing and distribution in Africa. Our solution, Open ICU Alliance, uses a regenerative and distributive economic model to empower local manufacturing, servicing and the distribution of critical care medical equipment. 

To accomplish this, we launched our first innovation challenge, CoVent-19 Challenge, in April. CoVent Challenge is a global open-source challenge to design a rapidly deployable mechanical ventilator. This challenge resulted in 213 submissions of designs from over 40 countries, and 7 finalists are currently prototyping and testing their ventilators. The winning open-source designs will undergo rigorous requirement validation prior to identifying regional manufacturing partners and regulatory submissions. In partnership with the African Federation for Emergency Medicine, these ventilators will be distributed to pre-identified pilot sites within their clinical network in Africa.

Our second challenge, O2 Challenge, is an open-source challenge to design an “oxygen toolbox” that will contain all of the contents needed to efficiently generate and deliver oxygen, including nasal cannulas, venturi face masks, nonrebreathers and oxygen concentrators using low cost materials that can be reprocessed and optimized to minimize oxygen waste.

We aim to serve African nations that can benefit from increased access to and affordability of critical care devices. As COVID-19 has exposed for so many developing nations, inefficient supply chains and costly equipment have made it impossible for some countries to have the accessibility needed to keep their citizens alive. 

Our partnership with the African Federation of Emergency Medicine enables us, in the short term, to identify which countries are most affected by COVID-19 and in need of ICU equipment and ventilators in particular to serve the 5% of COVID-19 patients that need a ventilator.

Longer term, through our partnership, we can identify the unique healthcare infrastructure of each country - supply chain, stock of supplies, rural and urban dynamics, present inequalities, healthcare staff needs - and who are their most affected population and begin to rapidly disperse our medical equipment and to identify additional medical equipment needs.

We are committed to giving rural and urban healthcare value chains the ability to proactive prepare for epidemics and pandemics with low-cost, scalable medical solutions in order to increase their autonomy from global supply chains and build domestic resilency. Open ICU Alliance is not trying to find a band-aid solution, but instead create a fundamental new system to dismantle the problem at its core. Through collaboration across open-sourced solutions and the partnerships needed to understand individual national ICU service and distribution needs, a long term solution will emerge.

Open ICU Alliance does not have any direct competitors because our model is not solely focused on products or services themselves, but rather on the reinvention of supply chains from start to finish. We believe it is possible to radically democratize access to low-cost, critical care medical devices, as well as to develop them locally, but this effort has lacked the focused resources and partnerships to make possible. As we have watched during this global pandemic, countries put themselves in precarious positions by relying on medical equipment imports and donations. And for many developing countries, this is not just a challenge faced during pandemics, but at all times. Developing nations with limited healthcare budgets are not able to outbid wealthier regions for scarce critical care resources, leaving their populations to suffer either because there is no access to ICU equipment, or because the equipment received is outdated. Our solution is unique because we hope to “reverse the equation” of for-profit global-scale medical equipment development and distribution through open-sourced, collaborative innovation, and partnerships with local communities and systems that lead to medical facilities and infrastructure equality.

CoVent Challenge is taking an innovative approach to medical device development by implementing crowd-sourced, open innovation research and development. By reducing the upfront development and intellectual property costs typically associated with medical technology development, we are able to target low cost, minimum viable products using lean methodology that can have incredible impact in low-resource areas. Our model for local manufacturing is dependent on the creation of simple, scalable medical technologies that are capable of being manufactured, assembled, tested and serviced with limited production costs.

Our first open innovation challenge, CoVent-19 Challenge, resulted in 213 ventilator designs from 43 countries, and 7 fully functional ventilator prototypes. These 7 finalist ventilators included:

1. InVent: https://grabcad.com/library/in...

2. RespiraWorks: https://grabcad.com/library/re...

3. CORE Vent: https://grabcad.com/library/co...

4. Baxter Ventilator:https://grabcad.com/library/ba...

5. OPVent: https://grabcad.com/library/op...

6. SmithVent: https://grabcad.com/library/sm...

7. LungEvolve: https://grabcad.com/library/lu...

We will be selecting one winning ventilator on July 1, 2020, which will undergo the necessary validation testing prior to applying for regulatory approval. This testing will focus on compliance with essential medical electrical equipment standards (IEC 60601-1) and other ventilator consensus standards (ISO 80601-2-12). Additionally, we will partner with a medical device certification firm to generate supporting evidence that the ventilator complies with applicable safety standards. Following any necessary design modifications, we will submit for FDA Emergency Use Authorization, while also navigating the regulatory requirements for use in our international target sites.

Please see our Theory of Change document with the Google Docs link below:

https://docs.google.com/docume...

Open ICU Alliance does not currently serve a population. We do not expect to serve any individuals in the first year due to the extensive networking required to build the types of relationships and partnerships that will enable us to understand needs, infrastructure and supply chains. Within the first six months we will focus our resources on networking, open source ventilator manufacturing and launch our second open-sourced challenge by the end of the first year, which will target the development of a noninvasive oxygen toolbox. Within five years, we would like to have two open-sourced, affordable, scalable Open ICU solutions in the market in Nigeria and begin expanding into other countries in Africa.

Within five years we would like to have two open-sourced, affordable and scalable ICU services in the market in Nigeria. We would like to expand into other markets, ideally creating domestic supply chains within each country for domestic autonomy and resiliency. While our model cannot be entirely replicated due to each country’s unique healthcare system, we will have developed a replicable framework of challenges, education, certification, and manufacturing to develop necessary partnerships for success.

The biggest challenge Open ICU Alliance will face is establishing effective partnerships that will be necessary to carrying out our model. We have identified two main categories of partnerships to be successful. The first being partners that can help us understand the landscape of current infrastructure, challenges and needs in our target markets. The second being the production and distribution networks needed to move open-sourced equipment. Each target market will require both local and global partners with whom we can work to navigate both potential cultural and political opportunities that may impact the ability to source and manufacture devices.

An additional challenge we face and will continue to face is financial. While we have received positive feedback on our concept and extraordinary in-kind support from manufacturing companies, testing companies, biomedical device design companies and more during our first open-source challenge to develop a ventilator, most of the quickly offered, pro-bono work was in response to a rapidly growing, but unknown coronavirus pandemic. As the pandemic normalizes and both global and national economics suffer from recession, the outpouring of support has and will slow down, making it more difficult for us to access the funds needed to turn prototype designs into validated and produced ventilators.

While identifying the correct partners will take time, we’re grateful to have initiated conversations with the WHO, AFEM, as well as fellow nonprofits who already operate and have ties to our local target markets. We have also initiated a partnership with Nigeria’s National Agency for Science and Engineering Infrastructure (NASENI) that will launch an educational series that will help Open ICU Alliance better understand local needs and infrastructure while building partnerships with individual local actors while providing guidance on developing a local device development infrastructure. We are hopeful that by continued pursuit of partners who have been successful in the region or who have local ties, that we will be able to overcome these barriers. 

To overcome our financial barrier, Open ICU Alliance will continue to identify and pursue potential philanthropic and government funding sources. It is our hope that through the existing partnerships and the evidence of impact that resulted from our initial in-kind donations we will be able to highlight our unique value proposition in a field crowded by many ideas and solutions. Furthermore, we have engaged a number of advisors and consultants who are working with us to develop a sustainable business model to ensure that Open ICU Alliance relies not only upon grant funding, but upon sustainable revenue generation by monetizing a few of our services and products.

We have filed as a 501(c)(3), but are awaiting approval, which is delayed due to COVID-19.

Our core team initially started small, but since early 2020, we’ve built a substantial network of committed team members, including; advisors, partners, and volunteers. Each member brings valuable expertise to the team and is dedicated to achieving meaningful global impact. Collectively, we have expertise across each aspect of our value chain, comprising 48 teammates. Currently, all of our staff are part-time and serve on a volunteer basis. Our team has significantly expanded with the help of our in-kind sponsors who have provided support in launching and managing the challenge, communications and web design, medical device development, and testing.

As a team, we understand the importance of diverse expertise and thought leadership. Our diversity of experience and expertise is an incredible asset that aids itself to developing unique and innovative solutions for especially challenging problems. Lastly, as individuals we have incredible networks that allow a project like Open ICU Alliance to continue to network and partner with the right people in Nigeria to create the supply chain necessary to provide ICU services. 

Our core team includes several anesthesiologists, intensivists and respiratory therapists from Massachusetts General Hospital, experts in ventilator and critical care device development and members of international consensus standards committees for medical devices. Our advisors and partners include leaders of the US Embassy in Lagos, experts in critical care device development in Africa, the Executive Vice Chairman of NASENI and several local Nigerian healthcare advisors. Our challenge partner, VentureWell, has supported early-stage innovators, their ventures, and the innovation and entrepreneurship ecosystems that are critical to their success for over 25 years, and has helped to launch more than 1,300 ventures that have raised nearly $1 billion in public and private investment. Finally, we have a number of volunteers supporting our marketing, public relations, fundraising, and programmatic efforts.

Open ICU Alliance currently partners with stakeholders in the US and Nigeria. These partnerships include advisory, contributions in-kind, programmatic and funding assistance. Our partners span our current ventilator design challenge, are helping develop our upcoming O2 Toolkit challenge, and supporting our longer-term solutions. The existing partnerships are described below, but we are continuing to pursue new partners to meet the changing needs of our innovation challenges and model.

• Hack/Fund: advisory and programmatic sponsor

• Ximedica: programmatic and in-kind partner

• Wilson Sons. 

• Funding and Contribution In-Kind Partner 

  • VentureWell

• Contributions In-Kind and Advisory Partners

  • AFEM (The African Federation for Emergency Medicine)

  • Government of Ogun State, Nigeria

  • Grabcad/Stratasys 

  • Wilson Sonsini

  • Ximedica

  • Hack/Fund

  • NASENI (National Agency for Science and Engineering Infrastructure)

  • Ambu Distributer(s)

We have identified several commercial opportunities at each stage of the development lifecycle to build a self-sustaining, resilient financial model. We seek mentoring on how to ensure financial sustainability. 

Our key beneficiaries are:

1. Medical facilities and supply chains

2. The patients needing ICU care

We provide them the low-cost, scaleable ICU services to have domestic autonomy from the global medical device conglomerates that make the acquisition disproportionately difficult for developing countries. 

Some options to create additional revenue streams for the financial stability are:

High profile innovation challenges which attract sponsorship from corporations, high net worth individuals and large non-profit organizations. 

Certification and training for services throughout the supply chain. 

Central Component Sourcing from off-the-shelf options, sourced in cheaper ways like 3D printing. 

Our pre-revenue operation will be funded with philanthropic contributions as well as technology and innovation grants. These will be used to fund our innovation challenges which is how we expand our product portfolio, to cover staff costs to help us establish the partnerships and commercial relationships required to distribute our devices to our target markets, and to cover set-up costs for our initial pilot in Nigeria. We are also exploring corporate sponsorship for our innovation challenges as an additional source of funding.

We have already identified the path to our first revenue generating customer through a partnership with the African Federation for Emergency Medicine, and are in the process of setting up a first pilot in Nigeria which will see us train and certify a local manufacturer to produce our first device for sale to local hospitals. We believe this can be a blueprint which we can replicate and scale to other countries in Africa, with revenue streams coming from training, certification and component sales. Through this partnership, we also have the opportunity to set up local manufacturers through an own-social enterprise in regions where there are no existing local manufacturers. This will allow us to expand our revenue sources to include device sales, while at the same time attracting regional development funding aimed at creating new skills and work opportunities for the local population.

We need to identify mentors and connect with cross-sector leaders to help with several aspects of our foundational plan in developing the Open ICU Alliance. Establishing the correct partnerships with accomplished leaders in global health and global technology development will be essential for our success in this project. MIT Solve’s expertise in open innovation and technology development challenges is highly relevant to our plans for open-innovation based medical device development. Additionally, we will need the MIT Solve platform for project exposure and networking on an international scale. Lastly, this venture will require significant investment and funding from philanthropic organizations and we hope that MIT Solve can provide valuable introductions to potential funding partners.

It is imperative that we determine a long term financial model, knowing that grants will not provide the resiliency needed to create the long term outcomes we are committed to. 

Understanding that the beneficiaries of our Open ICU tools will not be our funders, we will utilize the 9 months to determine who our key audience is and what would incentivize their engagement with our services. 

There are 3 main groups of organizations that we would like to partner with - local healthcare workers and clinical NGOs, medical device manufacturing and distribution agencies, and biomedical engineering educational and industrial organizations.

WHO

USAID

PATH - https://www.path.org/ - nonprofit organization that develops medical devices

SGS - https://www.sgs.com.ng/ - medical device testing and certification lab in Lagos, Nigeria

MDaaS - https://www.mdaas.io/ - MIT Ideas Global Challenge/TechStars/Harvard innovation lab (build and operate modern, tech-enabled health facilities for Africa's next billion)

LifeBox - https://www.lifebox.org/professional/partners/

EBB IDEAS

BMES https://www.bmes.org/

https://en.wikipedia.org/wiki/International_Medical_Equipment_Collaborative

https://projectcure.org/donate-supplies-equipment-info

https://www.ewh.org/

Engineers without Borders

Doctors without Borders

We believe that our Open ICU solution is a transformational innovation that can have enormous global impact in expanding access to life-saving, critical care resources globally. The Elevate Prize would not only provide the initial capital required to fund the development and testing of our early Open ICU products, but will provide us with the mentorship and networking needed to succeed in implementing this global program.