What is the name of your solution?
OpenFlexure Microscope
Provide a one-line summary of your solution.
A locally manufactured high performance digital microscope and slide scanner for medical diagnostics.
In what city, town, or region is your solution team headquartered?
Glasgow, UKWhat type of organization is your solution team?
Other, including part of a larger organization (please explain below)
If you selected Other, please explain here.
The OpenFlexure project began as an academic project. Some of the project core team members are employed at the University of Glasgow and University of Bath. Through research projects, OpenFlexure has been co-developed and tested by research institutions (Ifakara Heath Institute, Tanzania; Baylor College of Medicine, USA) and by a network of small manufacturers, primarily across sub-Saharan Africa. As the OpenFlexure project has matured, and more potential manufacturing partners are onboarded, it is clear that we need to establish a non-profit entity to govern the project. We hope that MIT solve will help us navigate this expansion.
Film your elevator pitch.
What specific problem are you solving?
Millions of people die each year in low and middle income countries from conditions that can be diagnosed by microscopy. Conditions from cancer to malaria depend on expert examination of patient samples by an experienced microscopist. Over 600,000 people die each year from malaria alone. The vast majority of these deaths are children under five, in sub-Saharan Africa. Cancer contributes a further 500,000 deaths per year in Africa, giving an annual total of over 1 million deaths per year in Africa from just two conditions which can be routinely diagnosed on a light microscope.
Access to diagnostics is a major health inequality. Without sufficient diagnostic capacity, deadly conditions go undiagnosed until it is too late to save patients' lives. Many efforts have tried to introduce diagnostic technologies into low and middle income countries. However, as these technologies were developed for the highly serviced context of high income countries' hospitals, they fail to save lives in areas with fewer resources and slower supply chains.
Donated equipment often sits idle due to a lack of spare parts, a lack of authorised engineers, and a lack of proprietary consumables. In sub-Saharan Africa, 70-90% of donated medical equipment lies unused. Operating a "closed shop" with respect to maintenance, spare parts, and consumables can help to ensure quality and reliability, but it also locks out regions that have not yet reached the purchasing power required to establish local sales and service infrastructure. Ultimately, this entrenches both health and financial inequality, as profits from healthcare technology reside in the rich countries where manufacturers are established.
The rollout of digital microscopy and whole slide imaging has revolutionised diagnostics. Automated digital pathology has not only improved record keeping and training, it also allows telepathology - consultancy with an expert based elsewhere. Automated slide scanning and AI-enabled healthcare are common in clinics in the Global North, but inaccessible in most areas of the world. This represents a disparity between the regions, widening the gap and preventing millions of patients from benefiting from the cutting edge technology employed in high income countries.
What is your solution?
The OpenFlexure Project takes a radically different approach to providing digital diagnostics to those who need them. We understand that local manufacturers are essential to providing diagnostic infrastructure that can be sustainably maintained. The microscope has been co-designed over 8 years by a diverse team of academics, medical professionals, and local manufacturers in sub-Saharan Africa.
The OpenFlexure Microscope is designed to provide a high performance and robust diagnostic solution that can be built and maintained by local manufacturers in the Global South. We have focussed on combining readily available components with custom 3D printed parts, to create an instrument that is easy to manufacture and maintain. The OpenFlexure Microscope employs exactly the same optics used in existing diagnostic microscopes. The high cost of traditional microscopes stems from the cost of specialised components for precise, automated positioning. One of our key technical innovations is a one-piece compliant mechanism that provides this precise positioning even when printed on an entry-level, low-cost 3D printer. Our microscopes have been built and used on all seven continents and in over 50 countries, so we are confident that we have designed a product that can be built in any setting, and our open license gives people and companies confidence to adopt it.
The project has been overwhelmingly successful at enabling the production of laboratory grade microscopes. However, this alone does not save lives. To enable medical diagnostics, the microscope must be available to medical professionals. This requires the local manufacturing partners in our network produce and sell the microscope as a diagnostic device. Diagnostic devices are highly regulated, and so our solution includes providing support and know-how for our partners to navigate (and at times, help develop) the regulatory requirement with producing medical devices at the point of care, rather than importing them.
The OpenFlexure project has focussed on creating an entirely open design, where the quality management is both robust and openly auditable. This readily provides the information for any manufacturer to verify the design, and to translate it for manufacturing appropriate for their context. Local engineers are much better placed to tailor products to their own context, overcoming regionally specific issues. This allows manufacturers to address their own challenges, such as allowing the microscope to cope gracefully with power outages, or working with consumables that can be sourced locally rather than requiring imported ones.
Local production builds crucial capacity in regions where diagnostics are unavailable. Local production of microscopes results in more robust medical supply chains, better availability of maintenance and spare parts, and retention of healthcare spending within the growing economies of the Global South. The OpenFlexure project is poised to realise these benefits for microscopy, and once successful will pave the way for a growing range of essential diagnostic technologies to be democratised.
Who does your solution serve, and in what ways will the solution impact their lives?
The primary beneficiaries will be patients in underfunded settings. Clinics in the Global South are often unable to perform basic diagnostic tests. This can lead to patients being required to travel hundreds of miles for testing, medics using damaged or improvised equipment, or presumptive treatment, where patients are prescribed scarce and often powerful medication based only on symptoms and patient history. This leads to treatment delays and to misdiagnosis of disease, both which can have deadly consequences. The OpenFlexure Microscope provides high-quality digital diagnostics that are context appropriate and locally certified, manufactured and maintained.
The OpenFlexure Microscope has been extensively tested for suitability to diagnose malaria, a disease caused by Plasmodium parasites which kills over 600,000 people per year. It has also been shown to be effective at diagnosing many cancers, including breast, oesophageal, and anal. Cancer contributes a further 500,000 deaths per year in sub-Saharan Africa. When diagnostic equipment is available, these conditions are routinely diagnosed, and when diagnosed early, the prognosis is generally positive.
Clinicians will benefit from the OpenFlexure Microscope, as it is able to automatically scan slides, freeing up the clinicians' time for other tasks. The World Health Organisation guidelines can require 100-200 fields of view be searched for a single malaria diagnosis. Automating this searching allows overworked pathologists to instead focus on skilled tasks, including interaction with patients. By purchasing this open design from a local manufacturer, rather than relying on donated equipment, a clinic can control all their microscopes on the same software, reducing the need for retraining on new equipment or maintaining multiple collections of spare parts for different systems. The microscopes will be deployed at the point of care, reducing the delay and cost of testing, and removing the risk of transporting physical glass slides. The OpenFlexure Microscope enables telepathology, designed for the specific challenges of remote communities. Challenges such as power outages, slow or unreliable internet, or untrained users currently limit access to existing telepathology platforms. This will make remote consultancy with experts in other cities or countries instantly accessible, rather than requiring travel or sample transport.
The OpenFlexure Microscope brings the benefit of digital record keeping to clinics in underserved areas. Digital archives of slides can be backed up remotely and retrieved quickly, providing a reliable and auditable diagnostic history without without the costs and risks of physical slide archival (risk of damage, fading stains, or a lack of physical space). These archived digital samples allow medical training to be performed on virtual slides. Virtual slides can be annotated and accessed on any device, allowing students to learn at their own pace, rather being limited by access to a microscope and suitable samples.
As the OpenFlexure Microscope is designed to be locally manufactured, it benefits both clinics and the wider local economy. Clinics will benefit from access to local engineers for repairs and servicing, vastly increasing equipment up-time. The local economy will benefit from a high-value manufacturing sector creating employment for numerous manufacturing and service engineers.
How are you and your team well-positioned to deliver this solution?
The OpenFlexure project has, since its inception, been co-developed with the communities it will benefit. Component availability differs vastly across the globe, so having a diverse network of manufacturing partners has focussed the project to adopt technologies that are globally appropriate. Our team comprises engineers, medics and software developers from around the world.
The power of a network that spans continents is that we have learned to deal with heat, humidity, power outages, and intermittent supply chains in a way that no team in a single country could. The first test manufacturing run of the 3D printed microscope stage in Tanzania in 2018 produced hundreds of microscope bodies. From these microscopes, and subsequent fatigue testing, we were able to implement processes and controls to navigate the harsh environment that these microscopes will face in the field.
The microscope has now been produced or used on every continent and in over 50 countries. It has been produced thousands of times by engineers, manufacturers, academics and hobbyists, who have never met or interacted with the original design team. We know we have a robust and internationally appropriate design that is both sufficiently high performance for medical diagnosis, and well-engineered enough for diverse environments.
Much of our clinical work to date, carried out by Ifakara Health Institute, Tanzania, used solely microscopes built and maintained in Tanzania, by Tanzanian engineers and technicians. While this work has been overwhelmingly positive, there remains significant effort to build up trust that locally produced diagnostic equipment can equal the quality of imported devices.
Building trust in locally manufactured and maintained devices requires an open, honest, commitment to best practices in the design and manufacturing of in vitro diagnostic devices. This is complicated in many countries where the local regulators only have experience in confirming the certification of imported devices. Any work to enable local manufacturing of medical devices must also consider the need for capacity building within local regulatory bodies. Our network has already started this process in Tanzania and Cameroon.
Every aspect of the OpenFlexure Microscope's design has been influenced by its ongoing co-development process. Eight years of global partnerships has created a reliable device that is proven to be robust to the harsh conditions in which it is needed. This is not an academic project looking for global partnership. This is an established global partnership looking to make the final regulatory push to get affordable and appropriate diagnostic devices into the hands of clinicians around the world.
Which dimension of the Challenge does your solution most closely address?
Increase capacity and resilience of health systems, including workforce, supply chains, and other infrastructure.Which of the UN Sustainable Development Goals does your solution address?
What is your solution’s stage of development?
PrototypeWhy are you applying to Solve?
The OpenFlexure Project has grown from a small laboratory experiment into a global community project. The network is centred on a robust open source design, and individual partnership agreements between research and business partners for specific funded projects. As our network moves into regulated manufacturing, we have a growing need to formalise the project's governance.
Our network is built around an open hardware model, in which all intellectual property is released under a perpetual, non-exclusive license, that permits commercial use. This empowers local manufacturers by ensuring that they will always be free to use the design without external control by an overseas rights holder. However, this creates a challenge when fundraising due to the unconventional IP model, and the unclear legal relationship between partners within the network.
Supported by MIT Solve, we will establish a nonprofit responsible for equitable project governance, and supporting the relationship between other partners in the network. We are looking for support to help to refine the business model of both our manufacturing partners and the network as a whole. This will be a network built around a principle of openly shared intellectual property, paying partners for finite goods and services as is typically done in successful open source software companies.
Alongside business model development, we are looking for support as we translate the prototype design into a manufactured medical device. This transition will see activity shift from the network developing a single open source design, to us supporting each local manufacturer in setting up compliance and quality procedures, attaining local certifications, and ultimately launching a commercial product.
We believe there is a strong case to be made that the best way to ensure that life saving diagnostics are available in underserved areas is to support local manufacturing. This distributed manufacturing model is novel, especially in the highly regulated domain of medical device manufacturing. But with support from Solve, we are confident that our pilot manufacturing partners in Tanzania (BTech) and Cameroon (Mboalab) will be able to bring a high-quality life-saving product to market in their local communities. The lessons learned from these pilots will give us runway to support other manufacturing partners around the globe, to bring life-saving diagnostic microscopy to communities that desperately need it.
In which of the following areas do you most need partners or support?
Who is the Team Lead for your solution?
Dr Richard Bowman
What makes your solution innovative?
The core technological innovation of the OpenFlexure Microscope is the stage design that allows a low-cost entry-level 3D printer to produce a scientific instrument capable of sub-micron positioning. This design has been iterated openly for 8 years. The project has pioneered a new open source hardware methodology that ensures that all aspects of the design and documentation are openly available, consistent, and clear.
The OpenFlexure Microscope is one of the first and best examples of open source hardware for medical and scientific applications. It challenges the assumption that medical technology must always be proprietary, secret, and restricted. While restrictive intellectual property and closed-shop service contracts may ensure high quality in rich countries with strong infrastructure, this prevailing business practice excludes most of the Global South. Restricted access to consumables, spare parts, and company-certified technicians makes it impossible to run modern equipment in much of the Global South even when funding is available for the initial purchase. The products available today are also almost exclusively designed for highly serviced locations, relying on stable power, clean air, and solid internet connections. Our model instead empowers local engineers and entrepreneurs to create products that are suited to their context, based on a common well tested design for the core hardware and software required.
The OpenFlexure Project has not only pioneered in its own practices of design, the project has continued to refine and document its methodology to allow others to follow in its footsteps. The need for locally-manufactured, context appropriate medical equipment was thrown into sharp focus in the first wave COVID-19 pandemic. Despite thousands of engineers devoting thousands of hours to technology development, the impact was underwhelming. Progress was often impeded by a lack of clear methodology for hardware design collaboration, a limited understanding of local and international regulatory frameworks, and limited partnerships between designers and manufacturers. By establishing the OpenFlexure model as a successful pathway to equitable and appropriate local medical manufacturing, we will be better prepared for future medical emergencies.
A growing number of open hardware products have achieved global success, such as RepRap desktop 3D printers and Arduino microcontrollers. Bringing that local empowerment to the highly regulated medical device industry will be transformative. Establishing a medical device industry builds desperately needed capacity in underserved regions, and creates the capability to respond quickly to global medical supply chain disruptions such as those seen during the COVID-19 pandemic.
Describe in simple terms how and why you expect your solution to have an impact on the problem.
Our specific plan is to advance the OpenFlexure Microscope through the product development lifecycle, to prove the principle of local manufacturing of certified in vitro medical diagnostics. This will have an immediate healthcare impact, helping to diagnose deadly conditions such as malaria. We have already build a robust prototype, and refined this into a stable, mature product that is undergoing clinical evaluation. Our pilot project in Rwanda is already using the microscope for medical education - a region with no previous access to digital pathology is now running remote training sessions from scans from our device.
Our longer-term impact will come through capacity building of manufacturers, regulators, and hospital staff. Our network is currently focussed on supporting our local manufacturing partners in Tanzania and Cameroon to set up quality managed manufacturing and to gain regulatory approval. The benefits of this go beyond the availability of a single product in a specific region. The capacity built will enable our partners and other companies to establish a medical device sector across developing economies.
The power of our solution comes from working openly as a global collaboration. We capture both formal documentation and informal know-how through open repositories and forums, and evaluate our work openly. This is a powerful tool for sharing knowledge, and has led to many new partners joining the network with confidence in the technology. This openness has also allowed third parties to implement and evaluate the technology, for example in the Phillippines [https://doi-org.ezproxy.canberra.edu.au/10.1371/journal.pgph.0002070], where the OpenFlexure Microscope was independently built and evaluated in a range of clinical scenarios and found to be promising.
Once our partners in Tanzania and Cameroon have successfully brought the microscope to market as a regulated medical device, we are confident that the information needed for other manufacturers to follow in their footsteps will be readily available. As the design and development process has been open since inception, this will provide a roadmap for the distributed design and manufacture of other medical devices.
Stakeholder engagement exercises, including interview, surveys, and workshops, were conducted in Tanzania and Cameroon as part of previous academic projects. These highlighted a local appetite, at government level and within healthcare services, to establish and use local suppliers, as a means to circumvent supply chain difficulties. We have engaged with regulators, particularly Tanzanian Medical Devices Authority, on the subject of approving a locally manufactured microscope. This will be the first such product to be approved by the regulator; currently imports make up the bulk of approved devices. The regulator is keen to develop the process and to see a pipeline of locally developed devices reaching the market. Long-term, the impact of improved regulatory and medical manufacturing capacity will far surpass the impact of any one device.
What are your impact goals for your solution and how are you measuring your progress towards them?
Our ultimate goal is to end the disparity in access to high quality healthcare services between high and low income countries. Specifically, we need to overcome the most pernicious problem with medical technology in low and middle income countries: supply chains. While the high cost of today's medical technology is a significant barrier, it is the supply chain for spare parts, proprietary consumables, and authorised service personnel that leads to much donated medical equipment lying inoperable.
By establishing local manufacturing of quality-managed medical devices, we can reduce the reliance on unreliable international supply chains. Locally manufactured devices can be locally repaired, and if they are based on open designs they may be serviced, repaired and used even if the manufacturer stops supporting them.
Our solution will lead to improved access to malaria diagnostics for patients, initially in Tanzania and Cameroon. This can be measured by tracking sales and usage of microscopes once products reach the market, allowing us to estimate how many patients have benefited from an improved diagnosis. This metric is only useful once a product has passed regulatory approval, but is a very direct measure of the reach of our solution.
To monitor progress towards regulatory approval, we track development against the Technology Readiness Level scale, which measures the solution's progress from idea to reality. We currently estimate the OpenFlexure Microscope is at TRL 6, having been demonstrated in relevant clinical environments. The TRL scale is relatively coarse-grained, but provides a good way of measuring progress towards the milestone of achieving a marketed medical product.
Longer term, we believe our model will pave the way for both medical microscope production in other low and middle income countries, and will build capacity for the local production of other medical devices to follow. We are able to track both the number of countries where medical microscope production has been established, and the growth of the local medical device industry in countries following the approval of the OpenFlexure Microscope.
As an open project, another significant measure of our impact is the size, diversity, and activity of the our network. That includes both the core developers and manufacturers, and the many people around the world making use of the designs. This is primarily monitored through the project's online forum, where a diverse community of over four hundred people share progress, applications, tips, and improvements. There is also a growing body of academic literature produced by those using the OpenFlexure Microscope in scientific research, assessing its clinical usage, or adapting the design for other uses.
Describe the core technology that powers your solution.
The OpenFlexure Microscope uses affordable sensors and embedded computing, combined with desktop 3D printing, to implement an advanced automated microscope with readily available off-the-shelf parts and minimal tooling costs.
The precise positioning mechanism was our first step-change innovation, achieving the fine mechanical performance required for a microscope in a structure made orders of magnitude more cheaply. This is done using a three dimensional, monolithic flexure stage. A key enabling technology is desktop 3D printing, specifically the now-ubiquitous fused filament fabrication technology. This enables complex structures to be accurately replicated by a machine costing only a few hundred dollars. OpenFlexure was the first demonstration of 3D printed flexures for precision micropositioning, and its mechanism would be difficult or impossible to manufacture any other way. The intricate, interlocking mechanism enables the OpenFlexure Microscope's sample and focus stages to be small, stiff, and precise - while being fabricated from a few dollars of raw material in a matter of hours. This replaces the more usual machined metal components, which must be manufactured to precise tolerances for bearings to run smoothly - a process that is much more expensive both per item and as an initial start-up cost.
Embedded computing also plays a key role in the OpenFlexure Microscope: the ability to build in edge computing to the device, which follows an Internet of Things architecture, allows us to calibrate and test every device on a regular basis. This permits the use of inexpensive consumer-grade sensors and components, as we can enable exhaustive self-calibration on every microscope. The same embedded computing also allows microscopes to run unattended, and without a dedicated control computer per microscope. This simplifies information technology infrastructure requirements, and frees up valuable technician time for other duties.
The OpenFlexure Microscope's traction within its growing community is enabled by its open source development and its clear and consistent documentation. As the open source hardware space is considerably less mature than the open source software space, we have needed to develop our own software tooling to enable this accessibility. Our software tooling allows for integrating documentation into the design repository, automatically generating high-quality renderings of assembly steps, and automatically generated bills of materials. This is essential for keeping a complex collaborative design accessible to everyone within our global network. All software to support the design is also released under an open source license, to empower other open hardware projects.
Which of the following categories best describes your solution?
A new technology
How do you know that this technology works?
The first academic paper on the OpenFlexure Microscope was published in 2016 [https://doi-org.ezproxy.canberra.edu.au/10.1063/1.4941068]. The microscope comprised a translation stage, a compact and robust optics module, a digital camera, an embedded computer, and software. This paper demonstrated the sub-micron positioning of the flexure stage, and its accurately, repeatability, and stability. A follow up paper in 2020 [https://doi-org.ezproxy.canberra.edu.au/10.1364/BOE.385729] demonstrated the significantly improved optical performance, a wider array of imaging capabilities, emerging features such as auto-focus and tile scanning, and a deeper consideration of distributed manufacturing. A paper is currently being written to document the release of a stable design for mass manufacturing.
All components of the microscope have undergone extensive technical evaluation, including peer-reviewed papers on our camera calibration [https://doi-org.ezproxy.canberra.edu.au/10.5334/joh.20], our software [https://doi-org.ezproxy.canberra.edu.au/10.1098/rsos.211158], and an our improved auto-focus procedure [https://doi-org.ezproxy.canberra.edu.au/10.1111/jmi.13064]. Further papers are in the pipeline evaluating our automated scanning and image tiling technology.
Four locally manufactured OpenFlexure Microscopes were in routine use by our technician at Ifakara Health Institute, in Bagamoyo Tanzania for over two years, while others were tested in two smaller Tanzanian clinics. In all settings, malaria parasites were clearly visible to both expert and novice users [paper in preparation]. Evidence of the clinical application of the OpenFlexure Microscope for histopathology include papers evaluating its utility in both Brazil [https://doi-org.ezproxy.canberra.edu.au/10.1016/j.stlm.2024.100145] and the Philippines [https://doi-org.ezproxy.canberra.edu.au/10.1371/journal.pgph.0002070].
In addition to the technology and clinical focussed papers, we have also produced papers focussing on the technical challenges of co-developing medical devices [https://doi-org.ezproxy.canberra.edu.au/10.1109/ghtc46280.2020.9342860], and on capacity and responsible innovation in medical technology research[https://doi-org.ezproxy.canberra.edu.au/10.1111/dewb.12340]. A white paper was also produced by the Englelberg Centre for Innovation Law & Policy at the NYU School of Law considering the OpenFlexure Microscope as a case study for distributed manufacturing.
Further papers cover adapting the OpenFlexure Microscope technology for a fixed objective microscope [https://doi-org.ezproxy.canberra.edu.au/10.1364/OE.450211], optical fibre alignment [https://doi-org.ezproxy.canberra.edu.au/10.1364/OE.384207], super-resolution microscopy [https://doi-org.ezproxy.canberra.edu.au/10.12688%2Ff1000research.21294.1], and optical sectioning microscopy [https://doi-org.ezproxy.canberra.edu.au/10.1364/OE.461910]. These adaptations were produced away from, and often independently of, the core design team. This is the gold standard for any distributed manufacturing project, indicating that the documentation, designs and component choice are all applicable in other settings.
In addition to the evidence in the literature, thousands of OpenFlexure Microscopes have been reproduced by labs and individuals in over 50 countries using our open documentation, verifying that the OFM is a mature, well-tested, and reproducible design. [https://openflexure.discourse.group/t/where-are-you-ofm-location-survey]
Please select the technologies currently used in your solution:
If your solution has a website or an app, provide the links here:
https://openflexure.org/
How many people work on your solution team?
The core development team currently includes two full time researchers based at the University of Glasgow, and part time contributions from two academics at Glasgow and Bath. Our local manufacturers currently employ around 10 staff in each of BTech, Tanzania and Mboalab, Cameroon.
Our wider network includes numerous clinical partners (including the Baylor College of Medicine Director of Global Pathology), global manufacturing partners focussed on non-medical production, contributors to our open source repositories, and an online community comprising around 400 forum members who take different roles including support, education, and testing, on a volunteer basis.
How long have you been working on your solution?
The OpenFlexure Microscope was conceived in 2015, and first published in 2016, 8 years ago. The project received its first funding six years ago in 2018, at which point the team was able to expand and fund full-time researchers, as well as clinical and manufacturing partners in Tanzania. Our network held its first international gathering (OpenFlexureCon) in 2022, with in-person attendees from Europe, North America, South America, and Africa, and remote participation from Asia.
Tell us about how you ensure that your team is diverse, minimizes barriers to opportunity for staff, and provides a welcoming and inclusive environment for all team members.
The OpenFlexure Project is not yet a formal entity, although we are advancing plans to adopt a more formal structure including an advisory board. Leadership of the project has been driven by academic funding to date, which was steered by a group including representatives of the local manufacturers, Tanzanian healthcare researchers, UK academics from the physical sciences, and experts in global health research. Our advisory board for the open project will include a diverse range of countries and disciplines, and we will endeavour to recruit a panel that is diverse against other criteria as well.
Equitable partnership has always been at the core of our work, and indeed the whole structure of the project around open licensing and open development was designed to enable meaningful, two-way interaction with a wide range of groups. The success of OpenFlexure so far has been underpinned by the mutually respectful partnerships we have built across disciplines and continents, and sharing ownership of the technology, both formally (through open licensing) and practically (by ensuring different partners are all able to contribute to co-development) has been a key goal. We have also devoted efforts to documenting the challenges and solutions we have encountered and implemented with regard to equitable working in this space [https://doi-org.ezproxy.canberra.edu.au/10.1109/ghtc46280.2020.9342860 and https://doi-org.ezproxy.canberra.edu.au/10.1111/dewb.12340].
Making a project open does not guarantee inclusiveness or equity of access: there are still barriers in terms of skill, culture, and resources to participation. OpenFlexure has adopted a code of conduct[https://openflexure.org/conduct/] clarifying expectations of all participants, and setting the tone for respectful and inclusive conversation. Our online forum provides a welcoming way in to the project, removing the technical barrier of interaction through the software-focused GitLab repository. Significant staff time is devoted to answering questions and moderating the forum to ensure it remains an inclusive and supportive environment. On a more technical level, we have also implemented a fully-open software toolchain for every aspect of development. This means there is no barrier to participation based on access to expensive CAD package licenses.
What is your business model?
The wider OpenFlexure Project network contains many legal entities each with their own business model. Given their familiarity with their local economy and supply chain, we do not intend to interfere with each local business model. In order to access the medical market, it is necessary to have a product made by a specified "legal manufacturer", who is responsible for quality and compliance in a particular country. Our legal manufacturers will be local engineering companies, and their revenue would come from microscope sales, spare parts, and service contracts. We have verified that production of microscopes based on the OpenFlexure design would be financially sustainable, and result in a purchase price that can compete with existing, imported products while offering significant benefits due to local support and improved supply chain resilience.
While non-exclusive intellectual property makes it possible, in principle, for other companies to compete, the regulated medical market is highly quality-sensitive and therefore unlikely to favour cheap imports. Cheap imports wouldn't carry the same certification as from the original manufacturer, and wouldn't be able to offer long term local support and service.
We actively encourage more companies to set up production of products based on the open design for the microscope, but we do not believe this would be an attractive proposition where a local supplier already exists, particularly in the medical space. However, both our pilot medical manufacturing partners are strongly involved in local efforts to grow capacity in high tech products, and have been very supportive of other start-ups bringing related products to market.
One aspect of the business model that needs formalising is how we fund design, development, and project governance in the long-term. We plan to establish a non-profit to govern the project and the design. The business model of this non-profit will be to raise funds from voluntary contributions from manufacturers who rely on the underlying design, and to undertake consultancy/service contracts when new or existing manufacturers need a significant investment of time or resources for training or for specific hardware developments. All IP for the project will remain openly licensed for all.
Do you primarily provide products or services directly to individuals, to other organizations, or to the government?
Organizations (B2B)What is your plan for becoming financially sustainable, and what evidence can you provide that this plan has been successful so far?
The core development team has been funded to date by academic research grants: we have secured around £3M in support of this project since 2018, across the Universities of Bath, Cambridge, and Glasgow. We anticipate some level of academic support will continue, with a growing body of research work relying on the microscope.
We envisage the project will form a lightweight legal entity (most likely a charitable incorporated organisation in the UK and/or a C-Corp in the USA) to provide governance, oversight, and clarity around IP ownership. This entity would have minimal running costs, supported by voluntary royalties from manufacturers and service providers, and contracts for support or consultancy. Most of the activity and financial turnover will happen in the local manufacturing companies.
Local manufacturers have a clear route to sustainability in the form of revenue from product sales and servicing. Initial market research has shown that a sale price of up to £1000 would be competitive with imported products and give a vastly wider feature-set, and that this would yield an acceptable profit margin for the local manufacturer. Service contracts and replacement parts guarantee a continuous income even after facilities have been supplied with microscopes, and indeed those facilities are incentivised to support the company in order to guarantee continuity of support and ensure uptime. We estimate that investment of about £500,000 would be needed to bring the microscope to market as a medical device in either Tanzania or Cameroon. Due to our collaborative network we estimate the investment to establish medical manufacturing in a second country would be £300,000. This would reduce further for subsequent countries, as the network builds capacity and the know-how to ensure quality and support in new regions.
There is also significant scope for microscopes to be provided as part of a diagnostic service, where microscopes and telepathology services are supplied to healthcare facilities without a dedicated expert pathologist. This would ideally take place within a country, for example a large referral hospital providing services to a region or the whole country, but could also be supplemented by international experts providing diagnostics or training services to build domestic capacity.
Whether through a service model or traditional purchasing of products and maintenance, the market for improved diagnostics in Africa is a significant one, with the potential for substantial government contracts and additional income from private facilities and overseas donors. Our model will retain these funds within the countries where manufacturing happens, creating sustainable businesses and growing the high tech economy, as well as providing a healthcare impact.
Solution Team
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Richard Bowman Dr, University of Glasgow
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Dr Joe Knapper University of Glasgow
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Dr Julian Stirling Freelance
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Our Organization
The OpenFlexure Project