Improving Essential Trauma Care for the Poor
Summary
In 2024, SONA Global committed to make essential trauma care available to thousands of poor and vulnerable individuals affected by physical trauma via access to life-saving surgery. SONA Global will prepare two specialized open fracture care medical devices (the VATARA wound therapy vacuum pump and the AEFIX affordable external fixation clamp) for global distribution. They will also establish local manufacturing and supply chains, and achieve regulatory approval for both devices in preparation for local distribution. Alongside the devices, SONA Global commits to scaling up its educational programming, to train 10,000 healthcare providers how to use the devices and manage complex injuries before and after application of AEFIX and VATARA by 2027. Designed for equity and with extreme affordability in mind, the cost for VATARA will be reduced from $40,000 to $100, and the AEFIX from $500 to $5. This commitment will kickstart SONA Global’s effort to be the premier non-profit organization saving limbs and lives by improving access to essential fracture care worldwide.
Approach
SONA Global commits to establishing global distribution of novel, high quality devices to manage road-related injuries that it has designed for extreme affordability, local manufacturability, and to improve availability and access to treatment for one of the leading causes of morbidity and mortality around the world.
Design for equity is the core of SONA Global’s approach, with two devices developed and rigorously tested already. VATARA, a wound therapy vacuum pump, costs $100 retail compared to the $40,000 industry standard device and manages complex wounds equally well. SONA’s affordable external fixation (AEFIX) clamp costs $5, with equivalent mechanical performance compared to the $500 industry-standard clamp. Both are low-risk, easy to use, and desperately needed worldwide. Without these affordable devices, surgeons rely on donations, antiquated treatments, or provide no treatment at all, with vastly inferior outcomes.
For VATARA and AEFIX to be scaled globally, SONA Global will identify manufacturing and distribution partners in LMICs, strategically located to serve markets in Africa and Asia. Next, SONA Global will refine and test the manufacturing processes, formalize these relationships, and prepare for mass production and global distribution of the devices. Both VATARA and AEFIX require consumable supplies to be used in clinical practice. SONA Global will identify manufacturers of these consumable supplies and confirm their quality and affordability. A supply chain will be established to create assembled sets, packaged, warehoused, and ready for distribution. SONA Global will ensure quality systems are established and achieve regulatory approval for both devices in preparation for global distribution.
Alongside the devices, SONA Global commits to scaling up its educational programming, to train 10,000 healthcare providers how to use the devices and manage complex injuries before and after application of AEFIX and VATARA. This involves virtual case discussions with experts from Harvard and LMICs, multilingual resources for asynchronous learning, and dynamic online communities. These programs have reached 3,000 surgeons in 80 countries, to date, democratizing trauma education and focusing on needs of the poor. SONA Global commits to expanding its conference offerings, reaching a wider audience, creating an online portal with locally tailored curricula to match the greatest demand, and growing its network of surgeons dedicated to trauma care equity through education and innovation.
SONA Global is dedicated to making essential trauma care available for the poor and vulnerable through device innovation and surgeon education. Upon completion of this commitment, SONA Global intends to scale its affordable innovations and educational programming globally. SONA Global aims to be the premier non-profit organization saving limbs and lives by improving access to essential fracture care for the poor and vulnerable, in resource-limited settings and humanitarian crises worldwide.
Action Plan
SONA Global is on track to complete its new VATARA 2.0 pump design by the end of 2024, which will be tested by SONA Global’s partners at Harvard during the first quarter of 2025. The new design will be cheaper and easier to manufacture at scale.
SONA Global aims to raise $100,000 by Q2 2025. This will allow SONA Global to formalize relationships with prospective manufacturing partners, set up plastic injection molding and manufacturing/assembly of VATARA 2.0, and rigorously confirm the quality of the devices and consumable supplies through laboratory and clinical testing.
In Q3 2025, SONA Global aims to hire Operations, Product Development, and Business Development staff in preparation for global scale-up of its devices and educational programming. This will allow SONA Global to dramatically expand its educational programming that has already reached 3,000 surgeons, and aims to reach 10,000 providers by the end of 2025. SONA Global also aims to complete clinical trials of both AEFIX and VATARA in Sri Lanka and Rwanda by Q4 2025.
By Q1 2026, SONA Global commits to achieving regulatory approval and formalizing its manufacturing and distribution relationships in order to begin global distribution of VATARA and AEFIX. Both devices will be prepared for US FDA submission by Q2 2026, along with details of the processes and quality systems in place with local manufacturing, assembly, and distribution partners. Once it has achieved its commitment to prepare both devices for global distribution, SONA Global will then plan to launch VATARA and AEFIX in 10 pilot countries in 2027.
Background
Worldwide, trauma kills over 5 million people annually – more than HIV, tuberculosis, and malaria combined (Agarwal-Harding et al. 2016) . For every death, many more people suffer non-fatal injuries, more than three-quarters being musculoskeletal in nature (Agarwal-Harding et al 2015; Mathers & Loncar 2006) . Musculoskeletal injuries, especially fractures (broken bones) , are common due to road traffic collisions in low- and middle-income countries (LMICs) , as well as during violent conflicts and natural disasters.
Every year, 15 million open fractures (when the broken bone comes through the skin) occur in LMICs, where the skills and tools needed to treat these injuries are often unavailable or unaffordable (GBD 2019, Hofman et al 2005, Pouramin et al. 2019) . When treated inappropriately, open fractures have a high risk of severe disability, amputation, and even death, with enormous social and economic consequences especially for poor and vulnerable communities.
High quality, modern open fracture care requires specialized medical devices and well-trained surgeons. Two essential treatments for open fractures are negative pressure wound therapy and external fixation, used respectively to stabilize the complex wounds and broken bones. Although these therapies are considered the gold standard, the pumps for negative pressure wound therapy and the clamps used to assemble external fixation frames are often unaffordable for patients in desperate need worldwide. Moreover, training for surgeons in LMICs is frequently fragmented, lacking high-quality materials, mentorship, and opportunities for collaboration, further exacerbating the challenge of delivering effective trauma care. When combined with comprehensive training, mentorship, and access to these essential technologies, skilled surgeons have the potential to save limbs, lives, and livelihoods.
Progress Update
Partnership Opportunities
SONA Global is currently seeking funding of $100k to establish local manufacturing, supply chains of consumables, and regulatory approvals for their novel medical devices, in preparation for global distribution focused on equity. SONA Global is also seeking passionate individuals to join our team as we expand our manufacturing and supply chain systems, as well as our educational programming., SONA Global has a dynamic, passionate, and experienced team of surgeons, engineers, global health specialists, and innovators focused on making essential trauma care available to all. Their roots in the Harvard Global Orthopaedics Collaborative (HGOC) provide their foundation of expertise and an established global network of surgeons and organizations committed to serving the poor and vulnerable. SONA Global would be thrilled to work with anyone and any organization committed to improving trauma care, especially through innovation and education.