Elle International

Across Sub-Saharan Africa health burdens for women are systematically underestimated, with an absence of data and datasets that exclude or undervalue important conditions. Women face barriers to care; a lack of access to diagnostics for conditions, and suboptimal treatment. In addition, there has been lower investment in women’s health conditions relative to their prevalence, reinforcing a cycle of weaker scientific understanding about women’s bodies and limited data to de-risk new investment.

Low- and middle-income countries (LMICs) are plagued by weak primary healthcare systems and poor digital infrastructure. No digital health records exist for individuals in Sub-Saharan Africa. The result is centralised datasets and trusted resources for patients and investigators are sparse, fragmented, and not shared among the communities they are meant to serve. Data management platforms to create a unified health record through data ingestion and to provide data governance to store, manage, share, find and use data critical for the implementation of AI in healthcare are beyond reach for LMICs. This ultimately costs lives, reduces the quality of life for women and girls, and precludes LMICs from participating in innovative R&D and realising benefits in the full potential of technological advances in healthcare.

The impact of digital technologies on the lives of women and girls, particularly in relation to sexual and reproductive health and rights, must be placed at the start of the effort to avoid the structurally flawed approach that over time leads to a proliferation of data silos. Under such conditions the collection, storage, and use of personal health data may happen without adequate consent or even awareness. Unauthorised access and use may have harmful consequences for individuals, particularly for women and girls.

The lack of systemised governance and empowerment of individuals has led to an alarming increase in “AI” deployments in health contexts in Sub-Saharan Africa where the underlying datasets and models are not available for interrogation and validation. Not only are proper scientific and engineering foundations necessary for improved outcomes, but the deployment of algorithms without transparency and accountability can perpetuate bias and discrimination, amplifying existing health disparities.

Lastly, any interventions to improve health outcomes must do so holistically by uniting the provision of critical products and services to systems for the assured provision of products and services to those in need. 

1) ElleHealth: The state-of-the-art patient driven data platform to enable the collection of comprehensive patient data, while preserving privacy, ensuring security, and placing the patient in full control where patients themselves contribute directly to health information.

2) ElleStudies: The state-of-the-art research platform to enable the collection of good quality healthcare data, in a trusted and safe way to revolutionise the management and tracking of chronic disorders and diseases.  ElleStudies aims to democratise exceptional care and the research process to accelerate effective diagnostics, treatments, and cures for women’s health. It provides the platform through which stakeholders can communicate traversing silos to share learning and enhance collaboration across initiatives to improve collective effort. It connects patients to verified information on best care practices, medical professionals, clinical trials, and similar patients near them to create community. ElleStudies addresses representation and equity for research recruitment that more accurately represent the diversity of disease.

3) Moxie: The smart menstrual product dispenser enabling the controlled access to menstrual care products across corporates, schools, and communities, and supporting the provision of connectivity in underserved communities. The dispenser is networked for efficient stock management and usage data is used to optimise resource allocation. Near Field Communication and biometrics are used to control the dispensing of items to prevent abuse in environments where the contents are free, and to control the dispensing of NSAID’s and vaginal rings.

4) The Elle mobile application: To support women and girls with access to trusted sources of information and the detection of gynaecological diseases and disorders. The application utilises a symptom-disease classifier and monitors whether a gynaecologist is warranted based on the observed symptoms.  The application is being developed to support AI driven diagnostic medical reasoning and conversation, which will be extended to a range of women’s health conditions.

5) Manufacturing: Production lines for pads, liners, tampons, and flushable wipes to provide women and girls with their choice of affordable, effective, and safe menstrual care. Fully localised in South Africa the product line, including the packaging, is plastic-free and biodegradable. No synthetic or semisynthetic fibres are utilised, and no bonding agents. The product line utilises the latest generation of manufacturing technology to incorporate organic plant-based fibres cultivated in South Africa.

6) Elle diagnostics: Elle has taken the lead on bringing to market two non-invasive point of care diagnostics for endometriosis, including an at home bioassay and a biosensor.

7) Elle SSA: Elle is the public benefit organisation leading the Elle Sub-Saharan Africa (Elle SSA) consortium, to initiate collaborations linking institutions in LMICs across academia, government, and industry to create a powerful nexus to democratise data, AI technologies, and the implementation of solutions to support accessibility of essential services to vulnerable communities, especially women. Elle is to serve as the custodian assuring the development and management of healthcare data at scale and the open sourcing of AI models trained on the data utilising approaches like differential privacy and federated learning, intended as benchmarks to advance diagnostics, treatments, and cures.

Elle’s drives change to improve the quality of life for women and girls. Unfortunately, women’s health is often simplified to include only sexual and reproductive health, which meaningfully under-represents the women’s health burden. Such myopia has resulted in failures to advance in research related to various women’s health conditions, in particular menopause, premenstrual syndrome, endometriosis, and polycystic ovary syndrome.

Whether at home, school, or the workplace, women are forced to endure needless suffering. As an example, in South Africa alone 7.7 million girls and women do not have the financial means to access proper menstrual care products, 7 million girls miss 25% of their schooling each month due to a lack of menstrual care (N Khamisa et.al, 2022), and 10% of women live with endometriosis with a 10-year average diagnostic delay.

Elle’s context is the following:

1) Scaling education and training by provisioning a mobile application as a safety net to analyse inputs and notification in case of increased chance of a serious gynaecological disease. In such cases the application connects women and girls to verified information on best care practices and medical professionals to guide them on their health journey.

2) Improving affordability and access by establishing world class manufacturing capacity in South Africa at scale to provision women and girls with agency over their bodies through their choice of safe and sustainable products, several of which incorporate diagnostics.

3) Improving access and scaling the assured provision (South African Parliament, 2023) of critical products to those in need through the Moxie dispenser. 90% of women experience menstrual pain and cramping around their period frequently inhibiting their daily activities. Moxie therefore supports dispensing of pain medication (NSAID’s) for pain management. In addition to essential menstrual care products, Moxie provides connectivity when deployed in rural communities to provision additional health services.

4) Development and provision of accessible and affordable point of care diagnostics for women’s health conditions to significantly reduce suffering and improve quality of life.

Figure 1

Figure 1: Source: McKinsey & Company

5) Often research and clinical trials are not representative of the diversity of the disease. Elle believes that universal participation in data collection from all demographic groups is essential to embed equity into this next chapter of healthcare. Elle is deploying ElleStudies to enable significant scale and accelerate research into women’s health disorders and diseases. With ElleStudies Elle will reach communities and focus on the inclusion of demographic groups who typically do not participate in research because of barriers created by lack of access to researchers and clinicians, cultural considerations, or low levels of medical literacy. 

Figure 2

Figure 2: Source: McKinsey & Company

6) To enable the provision digital healthcare and precision, individual, AI based healthcare services Elle is deploying ElleHealth for next generation electronic patient health records. ElleHealth supports data ingestion to empower individuals with agency over their unified health record and data governance to store, manage, share, find and use data critical for the implementation of AI in healthcare.

The team behind Elle has been in the making for several years and is comprised of a diversity of South Africa’s leaders in their respective fields. CEO of Elle International, Chelsea Anne Hornby has refined Elle’s approach over a decade of experience in working with women and girls in impoverished communities. It is this experience that has resulted in Elle being the only organisation pioneering a truly holistic and scalable solution. Under Chelsea’s leadership institutional stakeholders have tasked Elle to establish South Africa as the prominent and influential player in the women’s health ecosystem globally, creating opportunities for the emergence of industries that arise from the convergence of technology, harnessing the transformative potential for economic and societal benefit. 

To achieve the desired outcomes Elle is undertaking to:

a) Increase participation in Elle SSA.

b) Establish formal links between stakeholders and delineation of roles and responsibilities.

c) Increase understanding around data development, AI enablement, and the scalability of solutions.

d) Foster engagement with local communities and promoting inter-sectoral co-ordination and collaboration on implementation plans.

e) Identify priority data collaborations across climate, disease, and health.

f) Creating a forum for sharing ideas and communications.

g) Funding support.

h) Implementation priorities for ElleHealth, ElleStudies, and Moxie.

Numerous international funders are allocating funds to AI for women’s health in Sub-Saharan Africa, where in most instances the data and the underlying models are not available for interrogation. In the exceptional instance where the data and models are available, results are seldom replicated. Through Elle’s unique combination of on-the-ground and technical expertise Elle is leading the effort to establish proper scientific and engineering foundations including benchmarking for improved outcomes.

Benchmarking will enable:

• Metrics to support scientific discovery.
• Exemplars across a range of conditions. 
• Encourage use of FAIR metadata and reproducible results.
• Enable educational use of resources by researches with rich documentation and experience records.

The benefits include:

• Baseline performance on a given problem sets a target.
• Encourages the community to “develop” better methods.
• Availability of curated datasets increases openness.
• Fosters more efficient data-intensive scientific discovery.

ElleHealth:

ElleHealth has been built and tested. Elle is currently scoping the healthcare facilities who will participate in the pilot deployment.

ElleStudies:

ElleStudies has been built and tested. The design of the largest research study for endometriosis in South Africa is underway. Once the study design is complete it will be deployed through ElleStudies. Other research studies are also in design for deployment on ElleStudies including for gynaecological cancers.

Moxie:

The four models of Moxie dispensers exist as CAD files and Elle is finalising a run of protype units. In parallel patents are being filed locally and internationally for defensive purposes.

The design of the dispenser production line is underway which will be housed at Elle’s manufacturing facility in the Coega Special Economic Zone. The firm responsible is also responsible for the production lines of the automotive OEM's locally and internationally. 

Elle Diagnostics:

Elle is collaborating with Wits University on the prototype bioassay and biosensor for endometriosis. In parallel patents are being filed locally and internationally for defensive purposes.

Drug / therapeutic delivery:

Elle is in the process of filing patents for a novel drug / therapeutic delivery method. Full scale manufacturing of this product will advance as soon as the patent process is sufficiently advanced.

Elle mobile application:

The final components of the Elle mobile application are being concluded and the application will be released in the coming months.

Production lines:

The production lines for tampons, pads, and flushable wipes will be installed once the Elle manufacturing facility in Coega is complete. The development of this facility has only just commenced, and it is expected to be complete within two years.

Menstrual care kits:

The provision of menstrual care kits to impoverished communities is well established and has been underway for 8 years and served over 70 000 women and girls.

Education programmes:

Elle’s education programmes for schools, communities, and corporates is well established and has been deployed for more than 8 years reaching over 100 000 women and girls. The programme is now being extended to cover additional areas of women’s health.

Elle SSA:

The Elle Sub-Saharan African consortium has been established and Elle is presently seeking a programme coordinator to oversee its various activities as it begins to scale. 

While financial, technical, and access to new markets will be welcomed and beneficial to Elle, our success is not dependent on it. Our primary reason for applying to Solve is to join a community of like-minded leaders. We believe that by surrounding ourselves with fellow changemakers we will be better positioned to accelerates Elle’s progress in various areas. By leading and by being part of a strong ecosystem of change makers, we will be able to elevate discussions around women’s health, promote gender equality, and pave the way for economic opportunities. For Elle’s team this is not just an opportunity for personal growth; it's a chance to speed up transformative efforts in South Africa and beyond.

As discussed in the McKinsey report Closing the Women’s Health Gap: A $1 Trillion Opportunity to Improve Lives and Economies the challenges and opportunities in women’s health are significant. However, we can only drive change in collaboration with others and MIT Solve is an avenue to grow collaboration to substantively address challenges and realise opportunities that will impact the lives of hundreds of millions of women and girls across the globe.

Acknowledging the limited availability of digital infrastructure in LMICs presents an opportunity for Elle to implement state-of-the-art technology that integrates complex and sensitive data in a way that delivers transformative outcomes, enabling research and the application of AI services, while protecting privacy, ensuring security, the provision of products and services, and placing the individual in full control.

This requires Elle to unify the three-sided marketplace of women in emerging markets, academic researchers / medical professionals, and implementation partners.

Elle recognises that potential gains will only be realised if the technology is implemented with the beneficiaries participating in its development. Therefore, at the core of this once in a generation undertaking are a series of critical community capacity strengthening activities that will enable this investment to succeed and be sustainable. To build a bridge between individuals, research, and industry, strong continuing support is needed and to this end Elle SSA is enabling a data driven business model that incorporates:

1) Sharing in the intellectual property of research commercialised from the data.

2) Charging industry partners a fee to access and analyse the data when bringing new therapies to market.

3) Licensing the platform to non-profit medical research foundations.

An overview of Elle's integrated, holistic solution:

Figure 3

Figure 3: Elle International, 2024

Elle does not catalyse change in isolation. As a leader, Elle initiates stakeholders across the environment to achieve collective outcomes. Collectively these outcomes support our long-term goal of transforming societal structures and empowering women and girls through promoting dignity, education, health, and socio-economic inclusion.

Elle’s theory of change:

Figure 4

Figure 4: Elle International, 2024

At Elle we integrate evidence into all stages of our work, providing assurance for all our initiatives. This includes evidence based on individual programme and project monitoring and evaluation, to improve impact and drive accountability to programme and project participants.

• Advocacy: By demonstrating real-world impact of key issues for girls and women Elle can provide decision-makers with the information they need to make informed decisions that can lead to effective and impactful policy actions.
• Continuous Improvement: With evidenced incorporated into the operational fabric of Elle, it encourages a culture of continuous improvement, allowing for the evolution of strategy based on successes and challenges.
• Accountability: The assurance driven approach fosters accountability to the communities we engage with, ensuring their needs and aspirations are at the forefront of our work.
• Programme Design: Evidence enables the refinement of programme design, to tailor intervention for more effective and relevant initiatives.
• Improved Decision-making: Evidence-based decision-making ensures more efficient and effective deployment of resources in all our initiatives.

As an example, the Elle Education Programmes target the following outcomes:

• Improve knowledge on menstrual and reproductive health for teachers and pupils.
• Appointment of a menstrual and reproductive health champion at the school following pre-menarcheal training.
• Improve access to menstrual care, tools, and medical professionals to deal with pupil’s unique needs during their menstrual journey.
• Reduce environmental impact.
• Improve school attendance.
• Reduce stigma around menstruation.
• Enable opportunities for project metrics to be evaluated and utilised for project concept expansion across other areas in need.

The following are results from Elle Education Programmes at schools in South Africa after 6 months:

• An overall 50% increase in attendance during menstruation. 
• Nearly 60% increase in girls staying the full school day.
• 84% of girls reported being more confident in dealing with their menstruation.
• 89% of girls reported feeling less ashamed speaking about and seeking assistance concerning their menstrual and reproductive health. 

The ultimate impact of Elle’s efforts involves growing strategic partnerships, extending community engagement, and rigorous monitoring to ensure maximum impact in women’s health. Over time our approach is to continue a phased rollout, robust user education, and continuous improvement based on user feedback and impact evaluation. This will include scaling beyond SSA. The five-year targets are:

• > 1 billion individual menstrual health items manufactured.
• > 55 million USD in annual revenue.
• > 50 000 installed Moxie dispensers (with revenue from installations in corporates subsidising installations in rural communities.)
• >20 million monthly active users on the Elle application.
• Deployment of AI driven diagnostics for at least three menstrual health conditions, including endometriosis.
• Local drug manufacturing with partners for at least one menstrual health condition.
• 15 research studies across women’s health with ElleStudies.
• Deployment of AI services in support of maternal health and menopause. 
• >10 million patient driven health records on ElleHealth in support of AI in healthcare with implementation partners in rural communities across Sub-Saharan Africa.
• > 300 new jobs created in South Africa.

Beyond five years the strategy is to accelerate the advancement of the Elle digital ecosystem, specifically the diagnostics and AI services. This will entail scaling the deployment scope of ElleHealth and ElleStudies to provide the datasets for training and inference for the implementation of AI services in support of a healthcare model providing predictive, preventative, and personalised care. Two key attributes of the Elle ecosystem are fundamental to achieving this, namely the data management architecture, and the vast deployed user base across the Elle digital ecosystem. Through harmonising fragmented and complex data with AI, and responsibly monetising returns from empowering and supporting the medical and research communities, Elle will be well positioned to revolutionise healthcare where providing solutions for resource constrained rural and impoverished communities serves as a model for the rest of the world. While it is easy to speak of such things, we have taken concrete steps towards realising these objectives. In addition, several multinationals are partnering with us to bring these objectives to fruition.

Following five years of deployment as a platform for next generation electronic patient health records in Sub-Saharan Africa, the lower bound estimate of the data value is 113 million USD annually. Based on research work with a Big Four professional services firm, within 10 years of deployment the annual revenue potential exceeds 1 billion USD. Crucially, the services through the platform are provided at no charge resulting in significant economic and societal impact for rural and impoverished communities. 

Technology is at the core of Elle’s approach, this includes:

Figure 5

Figure 5: Elle International, 2024

1. Nonwoven organic plant-based fibre production

• Cutting edge manufacturing of organic plant-based fibres.
• ML driven predictive maintenance.
• Real time data analysis of to optimise the parameterisation of the manufacturing process to improve resource efficiency and lower environmental impact from operations.

2. Elle Product line

• Tampons, sanitary pads, flushable sanitary wipes all utilise sustainable organic plant-based fibres and are fully biodegradable.
• No adhesives.
  
• Sustainable packaging. 
• Cutting edge manufacturing technology with the world’s first deployment of products incorporating diagnostics.
• ML driven real time quality assurance.
• ML driven predictive maintenance.
• Real time data analysis of to optimise the parameterisation of the manufacturing process to improve resource efficiency and lower environmental impact from operations.
• Data driven supplier assurance platform based upon an extension of IBM Food Trust for transparent sourcing providing unprecedented transactional data in real time.

3. Moxie

• Location services to help women and girls locate dispensers.
• Near field communication (NFC) and biometrics to control the dispensing of items and assure provision.
• Mobile connectivity to provision connectivity to impoverished communities.
• Connectivity provisions usage patterns and demand, the optimisation of stock levels, stock mix, and dispenser location, as well as information on machine diagnostics.
• IoT remote device management platform for over the air updates, data collection and analytics, and application integration.

4. ElleHealth

• Deployed on Google Cloud Platform.
• Supports a schemaless data approach, data ingestion, and utilising ML to process the data into a unified health record.
• Differential privacy and federated learning to provision data for research.
• Advancing frameworks like the Generally Nuanced Deep Learning Framework (GaNDLF) as a general-purpose framework for AI in healthcare to define end-to-end clinical workflows for various healthcare use cases.
• Supports secure, offline-capable, data-driven solutions for healthcare workers in low-resource settings.
• ML driven language translation services to support the diversity of languages prevalent across Africa.

5. Point of care diagnostics for endometriosis

• Utilises gold nanoparticles for biomarker detection.
• Incorporates a ML driven diagnostic model. 

6. ElleStudies

• Deployed on Google Cloud Platform.
• Supports auditing requirements for compliance with the United States Code of Federal Regulations Title 21 Part 11.

7. Data management platform

• Key data architecture underpinning the Elle digital ecosystem. 

8. Elle mobile application

• Built on Flutter and running on AWS Amplify.
• ML driven symptom disease classifier.
• ML driven language translation services to support the diversity of languages prevalent across Africa.
• Under development is the incorporation of AI for diagnostic medical reasoning and conversations.

Full time staff: 6

Part time staff: 4

Contractors: 20

8 years. 

Leadership:

Elle was founded by a woman and is run by a woman. Women occupy most of Elle’s leadership positions. Elle’s focus on women’s health and empowerment is a beacon to other organisations and Elle has been recognised for leadership in this regard.

Accolades:

2024

• Woman of Stature Awards Finalist, Healthcare.

2023

• Empire Partner Foundation Award, Leadership and Community Builder.
• Accenture Gender Mainstreaming Award Finalist, Health Services Sector and Positive Role Model.

2021

• World Women Leadership Award. 

2018

• Runner up Cell C Hangman SA’s greatest Entrepreneur and Innovator.

2017

• GIBS Business Awards Social Impact and Innovation. 

DEI position:

At Elle, diversity and inclusion aren’t afterthoughts, they’re central to our success. Innovation drives our business forward and we know that disruptive, breakthrough ideas come about when diverse teams look at challenges from different angles. Our culture values difference, fosters inclusion and promotes collaboration, to ensure every employee is empowered to drive impact.

Elle’s diversity, equity, and inclusion statement:

At Elle we believe that diversity, equity, and inclusion are fundamental values that enrich our workplace and community. We are committed to fostering an environment where everyone feels valued, respected, and empowered to contribute their unique perspectives and talents.

We recognise that diversity encompasses a wide range of dimensions, including but not limited to race, ethnicity, gender, age, sexual orientation, disability, religion, socioeconomic status, and cultural background. We understand that these differences make us stronger as a team.

Elle’s commitment to equity means striving to create fair and just opportunities for all individuals, regardless of their backgrounds or circumstances. We work to identify and address systemic barriers that may prevent certain groups from fully participating and succeeding within our organisation.

Inclusion is a cornerstone of all that we do. We actively cultivate an inclusive culture where everyone feels welcome, heard, and supported. We promote open dialogue, collaboration, and mutual respect, fostering an environment where diverse perspectives are not only valued but also essential for innovation and growth.

We understand that achieving true diversity, equity, and inclusion requires ongoing effort and commitment. We are dedicated to continuously learning, evolving, and holding ourselves accountable to these principles. By embracing diversity, promoting equity, and fostering inclusion, we strive to create a workplace where all individuals can thrive and reach their full potential.

Supply Chain Partners:

Elle is the pioneer for IBM Food Trust in Southern Africa, pioneering the platform for supply chain transparency. This enables Elle to provide assurance around supplier commitments to the values Elle and its stakeholders hold dear including those in DEI.

Elle is comprised of commercial and non-commercial operations with revenue from commercial operations sustaining non-commercial activities.

The following product lines are included in commercial operations:

• Tampons
  
• Sanitary pads
• Flushable wipes
• Menstrual cups
• Period underwear
• Dispensers
• Vaginal rings
• NSAID’s
• Diagnostics (bioassays and biosensors)
• Drug and therapeutic delivery

The following product lines and services are included in non-commercial operations:

• Elle mobile application
• ElleHealth
• ElleStudies
• Diagnostics (AI driven)

Ecosystem approach:

Where the production of physical products scale near linearly with each additional unit, the costs of digital products and services do not, allowing for rapid deployment and scale. Every 24 months Elle will produce over 1 billion individual items across the commercial product line. This output in conjunction with the unification of the three-sided marketplace through assured provision and digital platforms and diagnostic services at no charge will drive significant adoption of the Elle digital ecosystem. The target lower bound of active monthly users on the Elle digital ecosystem within 5 years is 20 million. 

Data driven model:

Elle is to serve as the custodian assuring the development and management of healthcare data at scale and the open sourcing of AI models trained on the data utilising approaches like differential privacy and federated learning, intended as benchmarks to advance diagnostics, treatments, and cures. To build a bridge between individuals, research, and industry Elle SSA is enabling a data driven model that incorporates:

1) Sharing in the intellectual property of research commercialised from the data.

2) Charging industry partners a fee to access and analyse the data when bringing new therapies to market.

3) Licensing the platform to non-profit medical research foundations.

To date Elle has grown without dependence on outside investment. Elle’s manufacturing operations are being project financed and Elle has distribution agreements locally and internationally covering the entire product line.

We are confident in our ability to carry out the work having already coalesced academia, government, industry, and technology investment from leading global firms. Elle is in the process of securing additional grant funding to significantly scale the non-commercial projects beyond pilot ensuring impact and sustainability.

At the time of this submission, Elle is in the process of negotiating a capital raising mandate for commercial operations with one of the Big Four firms.