The GlobalDiagnostiX project

The goal of the GlobalDiagnostiX project is to develop, in partnership with local actors, a digital, ultra-robust, and affordable medical x-ray equipment adapted to the needs and constraints of low and middle-income countries. The context of countries in the global South is such that the system must be extremely robust, in particular it has to withstand heat, humidity, dusty environments. Since e. The GlobalDiagnostiX solution shall also withstand power outages and strong fluctuations of the electrical network which are causing up to 1/3 of failures of electrical medical systems. Considering the lack of trained professionals in these countries, the system must be easy and safe to operate and require minimum maintenance. Additional teleradiology services will allow hospitals that do not have radiologists to send X-ray images specialized centers and remote experts that can quickly deliver a remote diagnosis.

Finally and very importantly, the system must be affordable i.e. the total cost of ownership (including purchase, operating, maintenance and repair costs over the whole product lifecycle) has to be radically reduced compared to existing solutions.

For this it is necessary to innovate, not only in technology but also in the methodology, using collaborative projects that build on realities on the ground and that are economically viable. This is a unique project and, if successful, will blaze the trail for a whole new approach to the design of medical devices.

A multidisciplinary alliance

The GlobalDiagnostiX project has resulted in the establishment of an alliance of more than 40 researchers, engineers, and specialists, from all ﬁelds, under the leadership of EssentialTech program.

In Switzerland, the alliance involves several EPFL laboratories, a dozen of HES-SO research groups (from the health, engineering and design ﬁelds), the Paul Scherrer Institute, the EssentialMed Foundation, who initiated the project , the Swiss Tropical and Public Health Institute (SwissTPH) and the CHUV (Lausanne University Hospital).

In developing countries, the project partners include the University Hospital of Yaoundé (CHUY) in Cameroon, the University Research Center on Energy for Health Care (CURES) in Cameroon, and local stakeholders in Africa and Asia

First feasibility prototype assembled in March 2015. Copyright: Alain Herzog, EPFL
First x-ray images acquired in the laboratory
Workshop at the CURES center in Cameroon. Copyright: HE-ARC
User interface simulator. Copyright: HE-ARC

Roadmap

Our approach

This project is based on the methodology of the CODEV-EssentialTech program. Both the technology and the business model are jointly developed considering the whole life-cycle of the equipment, trying to optimize the total cost of ownership, for example by including logistics, training and maintenance aspects. Several experts and stakeholders are involved during this process to guarantee the appropriateness of the system in the local context.

Manufacturing

The device must be designed to optimize the manufacturing processes - i.e. minimizing cost, maximizing efficiency and ensuring high quality.
Manufacturing, subcontracting and sourcing strategies for each part and component of the system are crucial elements of the whole supply chain optimization. Industrial partners may be selected for their specific expertise and skills, their low manufacturing costs, or their location in the deployment countries – which allow reducing the taxes and shipping costs but also allow building local capacity.

Logistics

Logistics optimization is a key driver for the equipment conception.
Weight and volume should be contained for easier and cheaper transportation and storage.
All subcomponents, materials and chemicals should withstand shocks, vibrations and rough handling as well as the high temperatures found in transportation container.

Sales

Sales & Marketing

The product must be appealing and attractive with strong competitive advantages against the high-end imaging systems as well as the donated devices of well-known brands.
The device must be affordable but still perceived as a very high-performance and high-quality imaging system, which is safe and easy to operate. Involvement of key opinion leaders in the development of the device is decisive for its further acceptation by the different stakeholders.
The value proposition consists in an appropriate imaging system with a total cost of ownership (purchase price plus all life cycle costs) reduced by a factor 10 with respect to existing x-ray systems. The unique business model with encompass the product plus 10-year maintenance costs.
Several useful features will be sold as additional options.

Assembly

The different parts must be easy to assemble locally in deployment countries, with basic tools and without any risk of error.
The assembly strategy (how, where, when, by whom, etc.) is an important aspect of the system design, cost and quality.

Controlling

Quality control

Quality assurance and quality control are absolutely critical and the related processes must be anticipated and facilitated by the system design.
Testing and calibration shall be easily and safely performed by local technicians to ensure that the device is secured and fully functional.
Some remote and/or automated testing and controlling schemes may be implemented to strengthen the quality processes.

Commissioning

Installation and commissioning

The whole system installation should be straightforward and self-explanatory, requiring no sophisticated tools, no complex procedures nor advanced skills.
The software will guide the technician during this process with an explicit and intuitive interface, making extensive use of pictures, animations and automatic checks.

Training

Teaching and training local staff is a key success factor for a safe, efficient and durable use of the product.
Some competence must be developed for all the functions, from maintenance technicians to radiography technologists and physician radiologists. As these functions are mostly unavailable in resource-poor countries, some creative solutions must be developed such as task-shifting, continuous education, distance learning and teleradiology.
Some IT solutions are required for the integration of e-learning tools such as tutorials and simulations, as well as an Internet connection for remote support and training.

Use

Software interface and all mechanical controls should be ergonomic and intuitive for an easy, safe and effective usage.
The design should induce behaviors that reduce the staff and patient dose exposure as well as the stress on the device components. It should prevent theft and misuse, but also incite for regular preventive maintenances.
Potential users and local partners are involved in the project from the very beginning through an approach combining context insight and user-centered design.

Preventive Maintenance

Preventive maintenance

Targeting a long lifespan and low operating cost, the design should largely reduce the need for maintenance and repair. However, it should encourage and facilitate simple preventive maintenance when required to extend the product lifespan.
Telemaintenance capability would allow performing remote diagnostic of the whole system to anticipate possible failures but also support calibration and maintenance procedures.

Repair

While the device performance, robustness and cost are three of the main challenges, the repair processes must also be optimized in order to reduce the lifecycle costs and downtime periods. Therefore, basic diagnostic should be straightforward and some subparts should be easy to replace by new ones supplied by regional hubs or repaired by accredited experts.

Recycling

The system design should exclude components that represent a potential hazard for the environment as much as possible.
Decommissioning and disposal of the system must be simple and its cost should be balanced by the recycling of some parts and components.

Engineering

Research and development

All components of the fully digital (DR) imaging system shall be designed to be very efficient, robust, cost-effective and well adapted to the context of the hospitals in resource-constrained settings. In particular, the device must meet the following criteria:

provide high-quality images acquisition and an advanced digital radiography workstation (for diagnosis).
allow for several hours of uninterrupted work despite of low-power and very unstable power supply.
withstand high levels of temperature, humidity and dusty environement.
be safe and easy to use, even by partially-trained staff from different cultures and languages.
exceed 10-year lifecycle with very low operating costs without consumable and requiring few maintenance and repair.
comply with applicable international standards and regulatory directives.