Open ICU Alliance

Richard Boyer, MD, PhD. is originally from South Florida. He received his B.S. in biomedical engineering and computer science from Johns Hopkins (2007) and his M.D., PhD from Vanderbilt University (2016). Richard is finishing his anesthesia residency at Massachusetts General Hospital and will be joining Weill-Cornell Medical Center as a Van Poznak scholar in September 2020.

Richard is the co-founder of an NIH- and NSF-funded startup company, where he leads product development of noninvasive technologies for monitoring patient volume status using peripheral venous waveform analysis. Richard has over 10 years of experience in developing Class I and Class II medical devices, both in industry as a senior research and development engineer at Baxer, and in academia.

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.

Open ICU Alliance seeks to elevate the issue of access to high-quality, affordable critical care equipment in countries that typically rely upon developed nations and donations to provide critical health care services. Access to critical health care services and equipment is a problem that MIT Solve is familiar with and committed to solving. In lieu of many band-aid solutions, we hope to 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.

At the start of the COVID-19 surge in Massachusetts, I was quarantined for three weeks due to potential exposure while working in the ORs at MGH. I spent most of my time hearing about the ventilator shortage in places like New York City, and in Italy that made me worried for my community and for the places that did not have access to critical care supplies. At first I thought I would seek to design a low-cost, rapidly deployable mechanical ventilator with my colleagues at MGH, but after some exploring I saw that there were many designs and challenges out there. I realized that I could apply my expertise in biomedical engineering to not just design a ventilator, but help ensure that open source designs became products for those communities who need them. After conversations with our current partners, I realized that a global innovation challenge was just the start. In collaboration with our colleagues, we could work closely with developing nations to build local infrastructure to identify, design and manufacture critical care medical devices that would democratize access to medical supplies and upend reliance upon device companies.

With thirteen years in the biomedical device industry, I've seen how large international medical device companies are able to significantly up-charge the price of medical devices while also limiting the design process to those within the industry. What motivates me to pursue this work is the power of global, open-source innovation and collaboration. Seeing so many people come together in our challenge and ones alike it around the world, who seek to build solutions not for profit, but to put skills to use in support of global solutions shows me that it is possible to change the narrative of how this work can be done. We have the ability to reinvent how critical care supplies are designed and developed around the world. Our first initiative, the CoVent-19 Challenge, has demonstrated that we should not have to and we don’t have to wait for a global pandemic to highlight the need for enhanced medical supplies or to bid up the price of supplies. I’m eager to work in concert with our partners to make this possible.

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.

It’s not difficult to identify challenges we’ve faced in relation to our project. We organized and started in the face of a pandemic, while social distancing, with a background in medicine and in biomedical engineering, but without a background and connections in running a global innovation challenge. We started with an idea, though without the infrastructure in place: no partners, no funders, no staff; just a small group of thoughtful, committed people hoping to change the world and willing to go above and beyond to build a global community of innovators. Because we recognized the threat of COVID-19 and the need to act quickly, we worked urgently to reach out for support. We asked those with expertise for guidance, we reached out to organizations and those with the skillsets we needed for support and guidance, and we innovated and executed quickly as we developed new skills. Our determination and willingness to ask for help and feedback enabled us to launch quickly and continue to learn along the way.

While I've had the opportunity to serve as a leader throughout my time in medical school, residency, and as a founder of a small medical device company, the leadership experience I'm most proud of has been my work with CoVent Challenge. As shared previously, this project came together quickly, nimbly, and with a bold vision that needed a lot of support in the execution. When I initially developed this idea, I was sitting in my home on quarantine, however, within 24 hours of sharing out this vision with my fellow anesthesia residents and the department at MGH, we build a team of 13 residents and 20 attending physicians and administrators who were willing to bring and develop new talents to help our initial ventilator challenge come to life. As a leader of this effort, I quickly realized where I could leverage my insights and expertise and where I would need support, especially as our full team had to balance time leading CoVent and also continuing to work in ICUs with COVID-19 patients. I worked closely with my team to identify our teams, to delegate responsibilities, and to find ways to communicate and collaborate despite many challenging schedules. 

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.

Please find a description of our theory of change here: https://docs.google.com/document/d/1Gb9zXcDlFXSzEtsyVc5gWAUjPsBtzxZf0gOfL82c1l0/edit

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.

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

• 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.

The partnerships we listed as in-kind partnerships as is any media generated. We have received two grants in May 2020, including a $10,000 global health technology development grant from VentureWell and a $25,000 WorkTogether grant from UpWork.

With the support of partners and funders, this work will be carried out by a combination of 2 full-time staffers and a team of volunteers. An initial investment of $500,000 will be critical for funding two staff members in addition to assisting with testing, prototyping and regulatory costs for our first Open ICU product, a rapidly deployable critical care ventilator sourced from the CoVent-19 Challenge. Additionally, we are partnering with VentureWell, NASENI, AFEM and Hackers/Founders in applying for economic development grants to expand biomedical manufacturing capabilities in Nigeria.

Our estimated expenses for 2020 are approximately $300,000 to fund the continued development, testing and initial manufacturing of the Open ICU ventilator that has been sourced from our first challenge. With an additional $200,00, we will host our second planned open innovation challenge, the O2 Challenge, which will target the development of a noninvasive oxygen toolbox for low-resource healthcare systems.

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. Specific organizations include:

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/

BMES https://www.bmes.org/