One-line solution summary:
SurgiBox: Protecting mothers, newborns and obstetricians through safe surgical care - any time, any place.
Pitch your solution.
Approximately 297,000 women from low-and-middle-income-countries (LMICs) die in child-birth annually. Improved access to safe surgery could reduce up to 70% of maternal deaths. But a significant dearth in operating rooms exist in LMICs and those that do exist are either too far away or do not provide sterile environments needed. Furthermore, 70% of obstetricians are potentially exposed to patient-borne pathogens.
SurgiBox, an ultraportable low-cost operating room in a 10-pound backpack, addresses these challenges. SurgiBox provides protection to both patients and providers. Surgical teams seal a clear plastic bubble to the patient's skin and operate through ports. Rigorous testing shows the ventilated enclosure is four times cleaner than most state-of-art operating rooms.
Our goal is to provide safe surgery to mothers, infants and medical personnel who serve them - any time, any place. We envision a day when life-saving obstetrical surgery will no longer be a privilege afforded by the few.
Film your elevator pitch.
What specific problem are you solving?
951 million women worldwide do not have access to emergency obstetric care and the high risk of postoperative infection in non-sterile facilities often means death or long-term disability. Approximately 300,000 women die in child-birth every year - 99% of them in LMICs, overwhelmingly from preventable conditions (Holmer, 2015; WHO, 2019).
Mothers and infants need access to safe surgical care – timely access to surgical facilities and sterile conditions. There is no substitute to stem catastrophic bleeding, rescue stuck newborns or clear out deep pus pockets. 10%-15% of mothers in LMICs require C-Sections, but long distances to facilities often prevent access. C-sections are rarely performed in safe settings, making post-caesarean death 100 times more likely than in high-income countries (WHO, 2019).
By providing women and infants in LMICs with access to safe, accessible and cost-efficient surgical care, maternal mortality rates could be reduced by 70%, an estimated 160,000 infants saved and 20 million disability-adjusted life years averted every year (Meara, 2015; World Bank, 2015).
Surgical providers are at-risk with 85,000 providers, predominantly from LMICs, infected by patient bodily splatters every year. With an estimated 70% of obstetricians exposed to these splatters, protection is critical (Orji, 2012).
What is your solution?
SurgiBox is a medical device that enhances surgical treatment by providing operating room equivalent facilities to mothers, babies, and healthcare providers. It is an ultra-portable, battery-powered operating room that fits in a backpack.
SurgiBox provides a state-of-the-art surgical environment, without requiring an operating room or full personal protection equipment (PPE). This blocks contaminants from settling in the pelvic cavities of mothers during surgery.
SurgiBox is composed of a reusable environmental control unit to provide filtered air and a single-use surgical enclosure. Surgical teams seal the enclosure, a plastic bubble, to the patient's skin and operate through ports. The bubble stays clean through a HEPA-filtered airflow system, and the physical barrier shields providers from splatters. The positive internal pressure provides structural stability and additional protection against external contaminants. Each environmental control unit takes the place of an operating room ventilation system, with potential for expanding with future modules to monitor critical intraoperative data and facilitate training.
SurgiBox, developed at the MIT D-Lab, has undergone extensive bench-top and human factors testing including with surgeons from MGH, Doctors Without Borders, and the US military experienced in humanitarian missions. These tests have shown it to be four times cleaner than most advanced operating rooms.
Who does your solution serve, and in what ways will the solution impact their lives?
SurgiBox offers state-of-art levels of protection to patients and providers in low-resource and disaster/conflict-affected settings. Its non-reliance on infrastructure means that providers can strap on a backpack with the SurgiBox system and get to patients immediately. Setup to incision is in under two minutes.
For providers, SurgiBox means that infectious particles from patient bodily fluid splatters can be fully blocked. Especially relevant during COVID-19 pandemic, SurgiBox offers two critical benefits to providers. First, it can potentially reduce PPE requirements for each procedure because the bubble itself shields providers. Second, SurgiBox provides a barrier protection for patients’ incisions and for providers against bodily fluids which can carry high viral loads in pregnant women.
SurgiBox is the solution born out of the efforts and insights of obstetricians and mothers. After a founding member experienced obstetrical complications herself, life-saving maternal care became a top priority. SurgiBox was optimized for obstetrical procedures through co-development with MGH, Doctors Without Borders and the US military - the latter two being the biggest providers of emergency obstetrical care in disaster/conflict settings. We collaborated closely with advisor Dr. Meena Cherian, an obstetrician who worked extensively in rural hospitals before spearheading the WHO Emergency and Surgical Care initiative.
Which dimension of the Challenge does your solution most closely address?
Expand access to high-quality, affordable care for women, new mothers, and newbornsExplain how the problem, your solution, and your solution’s target population relate to the Challenge and your selected dimension.
Over 10% of pregnancies develop complications, the vast majority of which are surgically-addressable, but in LMICs surgical care is difficult to access and often provided in unsterile conditions. Obstetrical providers in LMICs also face disproportionate risks of being infected by patient bodily fluids.
SurgiBox is an ultra-portable surgical environment. It is designed for obstetrical and surgical teams operating without access to sterile surgical facilities. SurgiBox makes surgery safer for both patients and providers. We seek to expand access to high-quality, affordable care for women everywhere who require surgery to prevent delivery-related mortality and morbidity.
Who is the primary delegate for your solution?
Dr Debbie Teodorescu, Inventor, Founder, President
What is your solution’s stage of development?
Pilot: An organization deploying a tested product, service, or business model in at least one communityIn what city, town, or region is your solution team headquartered?
Cambridge, MA, USAWhich of the following categories best describes your solution?
A new technologyDescribe what makes your solution innovative.
Put simply, there is nothing quite like SurgiBox on the market. The response from the global surgery and humanitarian community has been enthusiastic, and the already high demand a reflection of a real need.
SurgiBox delivers strong competitive advantages in its mission to reach maximum clinical impact. We leverage a critical paradigm shift: that safe surgery means protecting the mother, not necessarily protecting an entire room. This lets us leapfrog big infrastructural limitations.
Existing solutions typically divorce patient and provider protection. For patient protection, most existing solutions try to reduce operating theaters and ventilation systems to the size of semi-portable structures. Odulair provides a mobile operating truck using a generator to provide clear air. Sys Technologies Medi-T is an inflatable tent that requires two generators to keep the air sterile. Zonair 3-D is a bubble that is inflated with the help of a ventilation system connected to the grid.
Existing solutions to protect providers entail a patchwork of personal protective equipment with poor ergonomics, high costs, and burdensome supply chains. Unlike scrub gear and drapes, SurgiBox fully blocks infectious particles from a patient without imposing heavy and hot material on the medical practitioner. As a single item, it also simplifies supply chains by reducing the logistical footprint.
SurgiBox addresses the limitations of its competitors by eliminating high upfront and maintenance costs, providing comprehensive protection (skin, airborne, and passive barrier), freedom from external dependencies such as electricity or transportation - all in a small, easy-to-deploy kit.
Describe the core technology that powers your solution.
SurgiBox’s core technology comprises two parts. The first is a reusable environmental control unit, a battery-powered system that supplies HEPA-filtered air to the bubble enclosure. The bubble enclosure is a clear film bubble that is inflated by the environmental control unit through a proprietary internal airflow system to produce predictable airflow over the incision. It interfaces with the patient via either an antimicrobial incise drape or an elastic orthopedic port; is accessed through arm ports for either arms or actuators; and has a primary port to transport things in and out without affecting internal conditions.
SurgiBox has completed six generations of development and is currently in design for manufacturing (DFM). The core technology and development pipeline are covered by a strategic IP portfolio, completely owned by SURGIBOX INC. This affords us freedom to maneuver and innovate in critical enabling technologies including:
Supplying cost-effective laminar airflow;
Preventing aerosolized contamination;
Controlling environmental system function;
Novel user interface material;
Sterile entry/re-entry;
Compatibility with laparoscopic and robotic systems;
Integrating live sensing capabilities; and
System structural stability.
The development process integrates iterative rounds of:
lab bench-top testing of parameters such as sterility and airflow distribution;
human factors testing at Massachusetts General Hospital (MGH) and by our field collaborators to assess system performance during full-length simulated surgeries on mannequins; and
field testing to assess logistical and operational fit.
Provide evidence that this technology works.
We are using the MIT D-Lab to complete bench-top testing and have conducted bench-top and human factors testing with partners including full-length procedural simulations with fully-equipped operations rooms and patient simulators at MGH, as well as in vivo testing through MGH’s Trauma Research Lab. SurgiBox was also part of a two-week training deployment to assorted settings such as a simulated cholera village, in which everyday emergencies like obstetrical emergencies kept happening despite the cholera-related overload of the local health system.
SurgiBox's performance characteristics have been verified via peer-reviewed bench-top studies. Key parameters include:
Ultra-portability: Entire system fits easily into 30-liter backpacks.
Rapid setup: Setup time from patient opening kit to incision time is less than two minutes and is intuitive.
Ergonomics: From views of the surgical field to headlamp compatibility to arm range of motion to interpersonal instrument handoff, SurgiBox has been extensively designed and tested to fit seamlessly into surgical workflows.
Environmentally sound: The enclosure portion is disposable in the same way as disposable PPE, and the environmental control system and frame require no special processing prior to reuse.
Active resistance to contamination: Testing showed that users can get their arms in and out of the enclosure, and bring items in and out repeatedly, without contaminating hands on sleeves or introducing contaminants into the enclosure.
(The product demo is seen in Minute 1:21 of the Pitch video entry. A related publication is available here.)
Please select the technologies currently used in your solution:
What is your theory of change?
The following model illustrates our Theory of Change:
Our main input, the SurgiBox device, is currently under regulatory review and design-for-manufacturing process. After a field pilot in 2021, SurgiBox units will be distributed to partner organizations in LMICs with limited access to safe surgery for mothers and infants. We will continue to form partnerships to reach as many mothers as possible.
SurgiBox will provide training and assistance as required. As a result, obstetrical surgery teams in LMICs will be equipped to perform life-saving interventions wherever the patient, gain greater knowledge of safe surgical care and be better protected from patient-borne pathogens.
Short-term, we expect higher access to life-saving surgeries for mothers and infants, safer procedures, reduced rates of provider exposure to patient-borne pathogens and faster delivery of surgical interventions. Long-term, we aim to transform maternal surgical care throughout both low-resource and disaster/conflict-affected areas. We will do this by dramatically reducing the number of maternal and neonatal deaths and disability-adjusted life years (DALYs) caused by lack of access to safe surgery and by protecting the lives of obstetrical teams.
To ensure a strong logical flow from our inputs to our long- term outcomes, we have consulted at every stage with a wide-range of stakeholders including surgeons, humanitarian/disaster relief workers, business professionals, regulatory advisors, engineers and biotechnology experts. Their feedback informed all aspects of our Theory of Change.
SurgiBox is the result of a comprehensive data-driven design process that ensures its efficacy and potential for impact. We worked intensively with numerous obstetrical and surgical team members to ensure that SurgiBox addresses the particular needs of mothers and infants and fits seamlessly into existing health provider workflows in the unique conditions of low-resource and disaster/humanitarian settings. SurgiBox’s components - the Surgical Enclosure and Environmental Control Unit - underwent extensive bench-top and human factors testing in collaboration with surgeons from MGH, Doctors Without Borders, and US military personnel experienced in humanitarian missions. Notably, a field setting simulation with the US military found more user cases than expected. That study, along with data from feedback from Doctors Without Borders, inspired the latest generation of SurgiBox.
Select the key characteristics of your target population.
Which of the UN Sustainable Development Goals does your solution address?
How many people does your solution currently serve? How many will it serve in one year? In five years?
The current number of people you’re serving: We have trained hundreds of humanitarian health care professionals in the use of SurgiBox through our current partnerships. We are currently undergoing FDA regulatory approval and finalizing human factors testing requirements to be able to launch SurgiBox into field settings where it can serve patients.
The number you’ll be serving in one year: Through our current partnerships, we expect to save the lives of 100,000 people - including 10,000 mothers undergoing emergency obstetrical surgery and their infants - with SurgiBoxes and protect the lives of half a million providers.
The number you’ll be serving in five years: As a result of multiple contracts with US military, humanitarian and ambulatory surgery facilities, we expect to save the lives of at least 500,000 patients - including 50,000 mothers undergoing emergency obstetrical surgery and their infants - and protect the lives of millions of providers in five years’ time.
What are your goals within the next year and within the next five years?
Our goal within the next year is to get SurgiBox into the hands of providers to start saving lives by early 2021. Within one year’s time, we aim to save the lives of 10,000 women and their infants. To meet this goal, we expect to meet the following milestones:
Manufacturing: Finalize manufacturing phase II.
Testing: Finalize testing requirements through our current partnerships with MGH, Doctors Without Borders and MIT-D Lab. We will run the last bench-top testing at the end of manufacturing and resume human factors testing at MGH. We will conduct field pilots in humanitarian/conflict context with Doctors Without Borders by early 2021.
Regulatory clearance: Through the guidance of our regulatory advisors, we are in the process of obtaining FDA clearance. We have just submitted an application for classification as an Emergency Use Authorization approved device which should allow for a fast FDA response. Our conservative estimate is to obtain FDA clearance by Q4 2020 and soon thereafter obtain 510k submission to ensure SurgiBox will be able to stay on the market long term.
Within five years’ time, we will have saved the lives of 500,000 patients including 50,000 mothers and their infants. We expect to reach this goal through:
Current partnerships with Doctors Without Borders and the US military - the biggest providers of emergency obstetrical care in disaster/conflict settings; and
Relationships with other organizations focused on saving maternal and newborn lives.
What barriers currently exist for you to accomplish your goals in the next year and in the next five years?
Financial: We require an additional $500,000 to $1 million for manufacturing, regulatory process, patents, salaries and testing requirements. Any additional amount raised would allow for the production of more units. Our main hurdle is raising sufficient funds to expedite our manufacturing process and enter the market in time to assist with current and potential future waves of COVID-19.
Partnerships: Creating additional partnerships to ensure the distribution of SurgiBox to all those in need is paramount.
Cultural: As with any product, we expect an adjustment period for practitioners to get used to using SurgiBox. We have been particularly attentive to studying first encounters with SurgiBox.
Market: Navigating the humanitarian market is not always clear, particularly regarding procurement processes. So far we have been lucky enough to create relationships with humanitarian organizations who immediately connected to the product as fitting their needs. Presently we require additional information on procurement processes within government departments such as FEMA and international organizations such as the WHO.
How do you plan to overcome these barriers?
We plan on raising an additional $500,000 to $1 million in Series A funding and pursuing customer leads to generate revenue. We are also trying to identify advisors who could guide us through our business strategy and market decisions as outlined in the last response.
In the present COVID-19 scenario, new potential customers and partners are approaching us to inquire about our solution. We now actively track sales opportunities and recently conducted a market survey of over 400 healthcare professionals. This survey gave us supportive information on the priority of medical claims, and we will continue to poll our market for additional marketing insights in the future.
To address the cultural barrier, we continuously solicit feedback from our partners training the medical professionals who will be using SurgiBox and provide suggestions to address any adjustment discomfort.
What type of organization is your solution team?
For-profit, including B-Corp or similar modelsHow many people work on your solution team?
5 full-time, 5 part-time, 1 volunteer, 3 contractors and 2 interns
How many years have you worked on your solution?
9
Why are you and your team well-positioned to deliver this solution?
Dr. Debbie Teodorescu, Founder, Inventor. A Harvard Medical School graduate with a Masters in Engineering, Debbie is a MGH Attending Physician. She is the inventor of SurgiBox and manages the technical, organizational, and clinical innovation aspects.
Dr. Mike Teodorescu, CEO. Harvard educated in business and engineering, Mike worked at Microsoft, holds several patents, and advises the US government on innovation strategy. Mike leads the business strategy.
Stephen Okajima, CTO. A biomedical and computer engineer with experience in medical device development for austere settings, Stephen manages all R&D activities.
Dr. David King, Surgical Director. David is a trauma surgeon at MGH, Director of MGH Trauma Research Lab, Harvard Surgery Professor, US Army surgeon and full colonel. He oversees MGH testing and field testing planning.
Dr. Meena Cherian, Maternal Health Advisor. Meena founded WHO’s Emergency and Surgical Care program. She is an obstetric anesthesiologist and obstetrician with extensive experience in LMICs.
Macauley Kenney, COO: A MIT-educated engineer, Macauley led a social enterprise’s operations in Colombia and consulted for the Impact Investment Exchange to identify barriers to US maternal healthcare. She leads SurgiBox’s operations.
Sashidhar Jonnalagedda, CDO. An experienced project manager and electrical engineer, Sashidar worked with WHO andICRC in LMICs. He manages partnerships and the regulatory strategy.
Dr Daniel Brown, CFO. Harvard educated in management and accounting, Dan worked on governmental and PwC Capital Markets panels. He oversees SurgiBox's financial management.
Karen Bernstein, Development Director: A former NGO and UN employee working in humanitarian/conflict settings, Karen leads on fundraising.
What organizations do you currently partner with, if any? How are you working with them?
Our current partnerships include:
Doctors Without Borders: Co-developing the prototype and conducting bench-top testing to prepare the groundwork for the field pilot in early 2021.
US Air Force Special Forces Alison Group (ASFOC): SurgiBox won the Small Business Innovation Research (SBIR) Phase I award and, more recently, the Phase II award and secured a MOU with ASFOC. During the SBIR Phase II, AFSOC and other potential customers will provide feedback and work with us to launch field pilots. The US government usually grants sole-source contracts upon successful completion of the SBIR Phase II.
Massachusetts Institute of Technology D-Lab: We are celebrating our 9th year of collaboration with MIT D-Lab, where most of our prototyping and bench-top testing occurs. Our collaborators at D-Lab have helped enthusiastically and provided next-generation innovations such as collapsible ECUs for easier transport.
EssentialTech EPFL: We benefit from EPFL’s experience conducting advanced market/supply chain analyses for medical innovation geared towards LMIC and humanitarian settings.
Massachusetts General Hospital: We have developed full-length procedural simulations with fully-equipped operations rooms and patient simulators at MGH, and in vivo testing through MGH’s Trauma Research Lab.
Healthnovations International: We work with Healthnovations to reach patients affected by disasters.
Geneva Foundation for Medical Education and Research (GFMER): Led by our advisor Dr. Meena Cherian, GFMER partners with global healthcare providers to collect data and share best practices. GFMER has shaped our impact strategy on how to best transform the standard of obstetrical and surgical care.
What is your business model?
We divided our maternal health market into two categories: chronic and emergency access.
Chronic access concerns existing infrastructures such as low-resource hospitals and obstetric/gynecological clinics where SurgiBox can be used as a reinforcement. According to NGO stakeholders, based on current surgical volumes at least one device kit is needed per hospital to translate into at least one fully-functioning operating room. By 2030, two-thirds of LMICs could reach a minimum operative volume of 5,000 surgical procedures per 100,000 population (Meara, 2015). Demand would increase with surgical capacity and cases.
The second category is acute needs, particularly disaster relief and humanitarian mission situations, where SurgiBox would be used as a rapid deployment and ultraportable unit. In these settings, the destruction of infrastructure has severe consequences for maternal health emergencies: C-sections, postpartum hemorrhage control, and other procedures are common surgical needs following a disaster. This category can be divided into two market segments, military and disaster relief NGOs. Based on interviews with US military and NGO physicians and logisticians, SurgiBox would be valued over existing surgical tents given its minimal footprint and self-contained nature.
SurgiBox is well-positioned to improve the health of mothers and health workers in austere environments. It is cost effective compared to alternatives such as truck-mounted operating rooms and reduces the cost burden of sterile drapes and gowns. The expected reduced surgical site infection rate translates into less maternal and neonatal mortality/morbidity, as well as shorter hospital stays, resulting in healthcare cost reduction.
Do you primarily provide products or services directly to individuals, or to other organizations?
Organizations (B2B)What is your path to financial sustainability?
Our key goal for financial sustainability is direct revenue from selling products: in the case of the minimal viable product, a Keurig model featuring the reusable environmental control unit and the single-use bubble enclosure.
The key to our go-to-market strategy is to make each market segment (military, NGOs, ambulatory surgical centers) feel that SurgiBox is custom-tailored to their specific needs, hence our significant investment in upfront testing, co-development, and partnership/team-building. We plan to enter the military and humanitarian markets first, simultaneously, using premium pricing in developed military markets to help subsidize lower margins in developing humanitarian markets.
Our overall mission is to save as many lives as possible - thus, using a cross-subsidization model that combines grants and premium pricing strategy to ensure that we can deploy SurgiBox to as many humanitarian and development settings as possible. Additional partnerships with government agencies and international organizations could also help subsidize the costs of deploying SurgiBox through our lower-budget NGO partners. Specific to being able to reach our maternal target group, outside of our current humanitarian NGO partners, we are in touch with stakeholders at UNFPA and various NGO maternal health divisions.
In addition, we are strongly considering whether to begin a Series A funding round to build a full organization with sales and marketing teams, customer service, and advanced engineering. Part of our funding round will include applying to organizations such as the Global Innovation Fund and possibly obtaining additional resources from the Wellcome Trust.
Why are you applying to Solve?
SurgiBox stands at a crossroads. We would value the mentorship and strategic support of Solve and MIT advisors to propel us forward and help us protect as many women, infants and providers tasked with saving their lives, as possible.
In particular, we seek advisors who could guide us through medical device business strategy decisions and pricing. As previously outlined, deeper knowledge of procurement processes in government departments such as FEMA and international organizations such as WHO would help us identify potential market opportunities and how to best navigate them. As we face the many decisions that are part of the natural growth process of a start-up in this domain, the knowledge and experience of seasoned professionals are critical.
In which of the following areas do you most need partners or support?
What organizations would you like to partner with, and how would you like to partner with them?
We currently partner with the MIT D-Lab. To achieve our impact goals, we would gratefully appreciate connections with mentors and advisors specialized in business strategy, supply chain logistics, warehousing and distribution techniques. We would welcome the opportunity to connect to those with knowledge of the med-tech and medical consumable industries and the related philanthropic space. We also would be interested to connect to other Members who have synergistic products, and in general, join a large network of stellar social impact entrepreneurs to share ideas and connections.
Please explain in more detail here.
Our current challenges are distribution to LMICs and finding a sustainable business model. We therefore seek support from medical device business strategy experts with knowledge of social enterprise business models, particularly setting up marketing and sales divisions. We would also benefit from expertise in navigating government and international organizations' procurement processes.
Additionally, ideals partners would facilitate introduction to and collaboration with distribution partners such as humanitarian organizations, ambulatory surgical centers, NGOs taking a leading role in long term surgical capacity-building, NGO physicians and logisticians, US military department and foreign health ministries in countries with low-resource hospitals and obstetric/gynecological clinics.
Solution Team
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Dr Debbie Teodorescu Founder, SurgiBox
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Solution Name:
SurgiBox