Project Prana

The shortage of ventilators is a universal problem that directly results in higher mortality rates among COVID-19 patients with acute respiratory distress syndrome (ARDS). We have developed the Individualized System for Augmenting Ventilator Efficacy (iSAVE), a rapidly deployable platform to safely support multiple  patients using a single vent. iSAVE leverages off-the-shelf components readily available to intensive care unit (ICU) caregivers, enables patient-specific volume and pressure control, and incorporates safety features to mitigate cross-contamination. iSAVE costs <$75/unit and can be assembled within 10 minutes by non-critical care physicians. We have demonstrated the capacity of the iSAVE to support a range of respiratory clinical states through bench top and in vivo preclinical experiments and reported. If iSAVE reduces demand for ventilators by just 25%, we estimate cost savings of at >$75M across Asia and Africa, compared with low-cost ventilators ($500/vent) and >$2B compared to ICU ventilators ($20,000/vent).

The shortage of ventilators is a universal problem that directly results in higher mortality rates among COVID-19 patients with acute respiratory distress syndrome (ARDS). Ventilator splits have been previously proposed and developed. However, lack of control of volume and pressure among individual patients has prevented uptake in the clinic and faced significant criticism from medical communities.  Non-personalized ventilation strategies in ARDS patients can induce further lung injury and be incredibly dangerous to patients. COVID-19 projections anticipate a global shortage of over 1 million ventilators. Shortages are more severe in low and middle-income countries (LMICs) that possess few ventilators at all. The COVID-19 pandemic has compounded these shortages. There is a need for affordable and scalable solutions that would not require capital investment to acquire costly equipment that can be prone to breakdown in the long term.

We have developed the Individualized System for Augmenting Ventilator Efficacy (iSAVE), a rapidly deployable platform to more safely use a single ventilator to simultaneously support multiple critically-ill patients (up to 6 patients). iSAVE leverages off-the-shelf components readily available to intensive care unit (ICU) caregivers, enables patient-specific volume and pressure control, and incorporates safety features to mitigate cross-contamination between patients and flow changes due to patient interdependencies within the respiratory circuit. iSAVE costs <$75 per kit, compared with $5000+ per ventilator, and can be assembled within 10 minutes by non-critical care physicians. We have demonstrated the capacity of the iSAVE to support a range of respiratory clinical states through bench top and in vivo preclinical experiments and recently published these results in a top-tier peer-reviewed journal (10.1126/scitranslmed.abb9401).

Health systems in LMICs lack significant ventilator inventory, with some nations having fewer than 100 ventilators country-wide. While this may be sufficient in normal times, pandemics and health emergencies can drastically increase demand for ventilators. In such times, hospitals and clinics should have alternatives to either purchasing significant new, costly equipment, or triaging and prioritizing ventilator usage across patients, resulting in inferior care for some patients. The iSAVE is a simple, accessible, and scalable solution that could save patient lives during the COVID-19 pandemic as well as afterwards, by augmenting ventilation capacity in LMICs. 

The 'Health Security & Pandemics" challenge calls for "improved solutions for prevention, accurate detection, and rapid response" to pandemics, as well as "solutions that focus on preventative and mitigation measures that strengthen access to affordable primary healthcare systems, enhance disease surveillance systems, and improve healthcare supply chains".

This project is in line with both these targets. In the short-term, iSAVE enhances health system capacity to respond to pandemics by not compromising on care delivered to patients. Longer-term, it enhances capabilities of health systems worldwide while lowering costs, improving access to affordable healthcare for global populations.

The shortage of ventilators is a universal problem that directly results in higher mortality rates among COVID-19 patients. Low-cost and emergency ventilators have been developed to address the cost barrier associated with the acquisition of new ventilators at scale. However, their manufacturing and deployment relies on supply, assembly, and distribution chains which can be disrupted by public health crises involving lockdowns and import/export restrictions. The use of new ventilator designs has also raised safety concerns, as clinical staff would need to operate unfamiliar technology. Ventilator splits have been previously proposed and developed. However, lack of control of volume and pressure among individual patients has prevented uptake in the clinic and faced significant criticism from medical communities.  Non-personalized ventilation strategies in ARDS patients can induce further lung injury and be incredibly dangerous to patients.

Our project uses only existing, FDA-approved, off-the-shelf components. This avoids the significant hurdles associated with developing brand new products. The use of strategic valves also maintains pressure and volume control for each patient individually, unlike all previously proposed vent splitters. This lack of control has been the primary obstacle preventing clinical uptake of this approach. Familiarity with components also facilitates uptake and use by clinicians familiar with respiratory system components. 

The core technology of our platform lies in strategic use of off-the-shelf hardware components to enable fluidic control. Using a variety of flow and pressure valves, we enable patient-specific control of ventilation parameters (including tidal volume and positive end expiratory pressure (PEEP)) that are otherwise not controlled when ventilation is split. All components are FDA-approved for medical use, facilitating translation.

We have demonstrated the capacity of the iSAVE to support a range of respiratory clinical states through bench top and in vivo preclinical experiments and recently published these results in a top-tier peer-reviewed journal:

Srinivasan S, Ramadi KB, Vicario F, Gwynne D, Hayward A, Lagier D, Langer R, Frassica JJ, Baron RM, Traverso G. A rapidly deployable individualized system for augmenting ventilator capacity. Sci Transl Med. 2020:eabb9401. doi: 10.1126/scitranslmed.abb9401.

Primary Users: The status quo results in clinicians having to make difficult triaging decisions that prioritize ventilator use across patients that would all benefit from ventilation. Our interviews with clinicians indicate that they would welcome a solution that avoids having to do this. At the same time, uncontrolled ventilator splitting poses a significant risk to all patients, which is why the medical community rarely employs this approach. Our interviews revealed that this same rationale prevented uptake and use of low-cost, improvised ventilators by clinicians, primarily a lack of familiarity with the technology coupled with decreased control compared with standard ventilators. Because of this, our approach utilizes only components clinicians are familiar with and does not substitute the fundamental need for a standard ventilator. 

Institutions: While hospitals prioritize the quality of care they provide, their ability to respond to rapidly changing demand levels is hampered by pragmatic fiscal considerations. Unlike normal fluctuations in ventilator demand, pandemics such as the ongoing COVID-19 one result in exponentially higher levels of demand. As such, simply producing more ventilators is not a sustainable path. Our technology multiplexes existing capacity to match the exponential demand increase, by supporting up to 6 patients per vent. It does so as a fraction of the cost (~$70 per kit, >$5k for 'emergency vent, >$20k for ICU vent).

Implementation: We anticipate that the iSAVE kit will only be used in times of ventilator shortage, and can be incorporated into a hospital's emergency preparedness plan. Hospitals would have a certain number of kits in stock that are deployed only should the need arise. Through our conversations with hospitals across the world, all have indicated the need for regulatory and clinical testing, as well as detailed guidance on how to use the kits. These are our next priorities: (1) pursue FDA regulatory approval for our kits, (2) finalize plans for pilot clinical testing, and (3) produce detailed guidance documents for use.

Current: N/A still in testing

In one year: Anticipate deployment in at least 2 LMICs, total population >20 million.

in 5 years: Deployment across 20+ LMICS, >2 Billion people

Our next steps involve deploying and distributing iSAVE. This involves 3 parallel efforts: (1) regulatory approval, (2) partnerships with suppliers and distributors in select countries, and (3) training and guidance documents for safe assembly and use. We are in the process on seeking FDA EUA approval, although will need to pursue formal approval through 510k pathway for longer-term viability. We have also begun reaching out to worldwide partners and have supplied test research kits to major hospital systems in Mexico, Bangladesh, and Uganda. 

Within 12 months, we plan to have FDA approval through EUA, pilot testing of iSAVE in clinical care, and anticipate iSAVE kits being stocked and used at at least one major hospital in LMICs. Within 5 years, we hope to have a established industry partner for supply and distribution of iSAVE kits to at least 20 LMICs that stock and utilize iSAVE kits.

Market: Country-specific sociopolitical barriers. Regulatory and bureaucratic hurdles in specific countries may impede the testing and deployment of our technology.

Financial: Funds required for testing and supplying kits, paying for regulatory pathways and approval, and distribution.

Cultural: Convincing would-be users of technology safety and efficacy.

Market, Regulatory and bureaucratic hurdles: Establish specific partnerships with key institutions in each country to navigate local landscape.

Financial: Apply for grants and solicit donations from individuals and organizations. If possible, secure pro bono arrangements with appropriate legal, regulatory, and advisory firms.

Cultural: Continue pilot testing of technology in patients, enlist support of key opinion leaders in clinical and research realms of respiratory care. Produce and distribute education and guidance material on iSAVE technology. Market technology at relevant respiratory care and global health conferences.

Four Part-time currently.

Our interdiscIplinary teams combines three diverse skillsets: Engineering, medicine, and business operations. Founders posses extensive expertise in engineering, medical device design, translational medicine, and clinical care. One founder also has a strong background in management consulting, and private/public equity. This combination of disciplines enables the team to be able to drive clinical uptake of a novel engineering solution on a global level

Massachusetts Institute of Technology: Team includes MIT engineers who designed, manufactured, and tested the iSAVE.

Brigham and Women's Hospital: Clinician collaborators at BWH include critical care doctors who give continued feedback and input on clinical usage and guidelines.

Phillips: Expert industry collaborators work on respiratory care devices, guiding design, manufacturing, and assembly processes for the iSAVE.

Our business model relies on selling iSAVE kits to hospitals and health systems globally. We partner with medical device manufacturers who assemble the kit, which is composed of all FDA-approved components. Distributors then ship these kits worldwide, as needed, to our customers. In some countries, we will work with an agent to handle import logistics and deliver to our final costumer, hospitals.

We are raising funding money through applying to translational grants and soliciting donations. These funding sources will allow us to pursue regulatory approval and pilot clinical trials, crucial to establish our customer basis. Units will be sold at a margin to allow us to cover operating costs. Current employees are working part-time, pro-bono. Revenue streams from sales will be used to cover purchasing costs, hire personnel, and compile training and guidance documents to facilitate use. We also intend on continuing to apply for grants to iterate on our technology and expand capabilities to other respiratory care devices, such as oxygen masks and nasal cannulas.

We are a multidisciplinary team of established engineers and clinicians with a proven track record of transformative translational research. Our solution presented here, iSAVE, stands to be able to impact an enormous proportion of the global population, by enhancing health security for LMICs and preparedness for pandemic and non-pandemic health emergencies. The Elevate Prize for Health Security would propel deployment of our technology across a wide range of countries. The prize would enable us to establish partnerships with governments, NGOs, and health systems, and allow us to tailor our technology to their needs. Establishing strategic partners early in deployment would also allow us to focus on other aspects of deployment, such as education and training. We would also seek to use The Elevate Prize to engage with local manufacturers and distributors, to ensure iSAVE kits can be readily supplied to each health system without absolute dependence on global supply chains. Our team combines world-class expertise in engineering, respiratory medicine, translational medicine, medical devices, health entrepreneurship,  and business operations. The Elevate Prize would accelerate iSAVE deployment across health settings, potentially saving millions of lives worldwide.