PodTech™’s rapid test manufacturing facility: Localising health product manufacturing in the UAE

The peak of the Covid-19 pandemic may have passed, but its lingering effects continue to shape global health strategies.

During the pandemic, both developed and developing countries faced significant challenges in securing essential health products, underscoring the need for self-sufficient health sectors. This crisis revealed the importance of nearshoring or localising supply chains, to ensure a steady supply of critical medicines, vaccines and diagnostics.

The imperative for self-sufficient health sectors is strengthened by the intensifying climate crisis. As the world gets warmer, the burden of infectious diseases will grow. With changing lifestyles, non-communicable diseases (NCDs) are also on the uptick.

Within this multi-faceted scenario, most countries recognise three main objectives in minimising their reliance on international sources:

1. Public health

Domestically manufactured health and medical supplies would be more accessible to the general population and to governments for their public health campaigns. No delays from far-off suppliers, import costs, or gaps in regulatory compliance or product specifications. Localised manufacturing would help countries better manage immediate health threats and future emergencies.

2. Economic growth

Regional health product manufacturing can stimulate local job creation, foster technological expertise and drive overall industrial development.

3. Strategic autonomy

Localising manufacturing reduces a country’s exposure to risks associated with global supply disruptions such as those caused by natural disasters or geopolitical tensions. Producing essential items within their borders would give countries more autonomy in dealing with health and humanitarian crises.

The UAE, too, is committed to localising health product manufacturing. Recognising that medical diagnostics are essential to effective healthcare delivery, PodTech™ partnered with a leading medical device manufacturing company to build a rapid test manufacturing facility in the UAE. This project, with its state-of-the-art modular construction, fuses technological advancement and healthcare access, creating a factory of the future.

The UAE story

A market report by UnivDatos Market Insights valued the UAE’s diagnostic and medical testing market at USD 1.4 billion in 2022, with a projected CAGR of about 6.5% between 2023 and 2030.

This growth aligns with the broader movement in the UAE toward increased health sector funding – 8.4% of the federal budget was allocated to healthcare in 2022. This investment has led to the development of cutting-edge medical facilities, research centres, and hospitals, with diagnostic testing as the bedrock of their activities.

The expansion of the diagnostic testing market is also tied to the UAE’s strategic shift away from oil dependency. In 2021, the UAE launched Operation 300bn to grow an industrial sector worth AED 300 billion by 2031. This initiative focused on sustainable economic growth, clean energy, industrial innovation, and responsible consumption and production. Health products will be indispensable contributors to this ambitious project.

The state of healthcare and diagnostics access in the UAE

A self-sufficient health sector in the UAE goes beyond mere industrial development; it ensures superlative healthcare for its residents. The UAE has made significant investments in healthcare infrastructure to fulfil this commitment.

In 2019, the Dubai Health Authority launched the Dubai Diagnostic Centre, offering advanced diagnostic services and treatments to patients. The UAE has also adopted the latest clinical diagnostic technologies, such as point-of-care testing (POCT) and molecular diagnostics.

That said, market reports indicate that diagnostic tests, especially advanced ones, remain relatively costly. While the government finances much of the healthcare services, not all diagnostic tests are fully covered, leading to out-of-pocket expenses for patients and limiting access to essential tests.

On the regulatory front, the framework for diagnostics is still evolving. The Emirates Authority for Standardisation and Metrology (ESMA) sets standards for diagnostic tests and medical devices, while the Health Authority Abu Dhabi (HAAD), the Dubai Health Authority (DHA) and the Dubai Healthcare City Authority (DHCA) regulate the use of diagnostic tests in their respective regions. This fragmented regulatory landscape poses challenges for foreign suppliers of clinical diagnostics, who must navigate multiple approval processes.

Amidst these complexities, producing rapid tests domestically is an important element in the UAE’s journey of economic diversification and health sector self-sufficiency.

The growing demand for and current supply of rapid tests in the UAE

The demand for rapid tests in the UAE is on an upward trajectory for several reasons:

1. Population growth

The UAE’s population, including an expanding expatriate community, is growing. This increase, coupled with the demand for comprehensive healthcare services, is driving the demand for diagnostics.

2. Evolving disease burden

Lifestyle-related diseases or NCDs are on the rise in the UAE. Heart disease amongst the youth of UAE is increasingly common. Stroke, kidney disease and pancreatic cancer are among the top causes of death. This shifting epidemiological landscape calls for regular testing and health monitoring, and therefore greater demand for diagnostic tests.

3. Medical tourism

The UAE’s world-class healthcare infrastructure attracts patients from all over the world. In the 2020-2021 Medical Tourism Index, Dubai and Abu Dhabi ranked 6th and 9th, respectively. Arab countries account for 30% of the USD 100 billion global medical tourism market. Demand for rapid tests from the burgeoning health and medical tourism market makes regional manufacturing all the more attractive.

As the demand for rapid tests grows, there is often a gap between the need and availability of tests, particularly during health crises. The challenge is not only to provide rapid tests but also to ensure affordable rapid tests that are easily accessible by the general population. Additionally, these diagnostics must meet the specific regulatory and testing requirements of local governments; international suppliers aren’t always able to tailor their products to address these regional needs.

Key buyers of rapid tests in the region are:

1. Healthcare providers like hospitals, clinics, pharmacies, and diagnostic laboratories involved in patient diagnosis.
2. Government and public health authorities responsible for public health surveillance and emergency response.
3. Businesses and organisations, especially in sectors like hospitality, events and travel, that need testing to ensure workplace safety and compliance with health regulations.
4. Regional partners with distribution agreements in the Middle East.

Historically, these buyers have sourced their diagnostics from one of four sources:

1. Foreign suppliers who import rapid diagnostic tests from manufacturers overseas. This pathway has been plagued by lengthy and complex supply chains, high costs and delays.
2. Large multinational companies with global networks have secured a significant share of the diagnostics market but global demand fluctuations and supply chain constraints can disrupt consistent, predictable supply.
3. Emergency procurement channels are important sources of diagnostic tests during high-demand periods like disease outbreaks, but sourcing through such channels can be a costly affair.
4. Stockpiling and purchasing through intermediaries like distributors has provided access to required diagnostic tests during emergency periods but this approach can also be challenging and expensive.

Increasing demand and these sourcing challenges underscore the importance of developing a localised supply of rapid tests in the UAE.

Localising rapid test manufacturing to secure supply

The ability to source essential diagnostic tests from local suppliers can help healthcare providers and public health authorities circumvent many existing challenges.

Domestic manufacturing facilities can adapt quickly to fluctuating regional demand within the region, ensuring timely production and distribution, which is crucial to managing outbreaks.

By eliminating the need for importation and reducing reliance on intermediaries, domestic manufacturing lowers the costs of rapid tests and makes them more accessible to the local population. This is particularly vital during times of high demand, such as the Covid-19 pandemic, when international prices may surge or supply chains may be disrupted.

Localising rapid test manufacturing aligns with the UAE’s strategic goals of industrial development and economic diversification. Establishing this infrastructure will create jobs and foster local expertise in high-tech manufacturing. These advancements will also serve as an impetus for the development of other industries, positioning the UAE as a global hub for innovation and technology.

PodTech™’s cutting-edge POD technology: The future of health product manufacturing

Relying on international suppliers for rapid tests is no longer an option for the UAE. As the demand for rapid tests increases, making provisions to meet that demand through local production offers strategic, economic and public health benefits. It is also clear that the UAE has no time to lose. If it wants to meet its industrial goals for 2031, the country must industrialise on a war footing.

A leading medical device manufacturing company in the UAE has risen to the challenge and chosen PodTech™’s cutting-edge POD technology to establish its first rapid test manufacturing facility.

An accelerated timeline to meet urgent needs

PodTech™ was invited to supply our 3Pfs (pre-engineered, prefabricated, and pre-validated) portable biopharma factory system to help fill this gap, making essential diagnostics more accessible and developing the UAE’s healthcare capabilities. From start to finish, the rapid test manufacturing facility project was implemented quickly to address urgent needs. With a timeline of 3 to 4 months, the project timeline was significantly shorter than that of traditional factory construction for a similar scope of products, which can take as long as 12 to 24 months.

This accelerated timeline includes the commissioning stage, which covers finalising the design and layout for optimal flow, acquiring, installing, and calibrating necessary equipment, conducting trial runs to ensure quality assurance, staff training on process and operations, regulatory compliance, including approvals, permits, and certifications, and resolving final issues to optimise performance. With the completion of this stage, the facility will transition into full operational status, ready to produce and distribute rapid diagnostic tests in the UAE.

Four factors contributed to PodTech™’s success in streamlining and completing the project in such a short timeline:

1. Prefabrication and modular construction techniques significantly cut down on construction time.
2. Fast-tracking of permits and approvals expedited the regulatory aspects of the project.
3. Focused project management via dedicated project teams accelerated project implementation.
4. PodTech™ leveraged existing infrastructure to avoid duplication of efforts.

Addressing diverse medical needs

The new facility addresses various medical needs by producing a wide range of cutting-edge products, including:

• Hormone markers test kits: HCG, LH, HAV, IgM
• Liver disease test kits: HBsAg, HCV, dengue NS1
• Tropical disease testing kits: Covid-19, malaria, chikungunya, Zika IgG/IgM, Flu A+B
• Respiratory disease test kits: strep A Test, RSV test, MP antigen test
• Non-virus infectious disease tests: Leptospira IgG/IgM, Brucella
• Specialised tests: gastrointestinal diseases, sexually transmitted diseases, inflammation markers, women’s health, drug abuse diagnostics

A factory of the future

PodTech™ led the construction of this cutting-edge facility, meticulously designing both external pod structures and internal cleanroom setups.

The facility comprises four intricately designed pods, including three main pods and one utility pod. From cleanroom partitions and an HVAC system to internal electrical configurations and vinyl flooring of the 105 sqm area, the PodTech™ team managed every aspect of the project, marrying precision engineering with innovative design to ensure the smooth operation of the manufacturing process.

The utility pod is designed to provide support services, such as essential utilities, needed for the other pods to operate smoothly. In addition to environmental controls for temperature, humidity, and air quality, the utility pod includes routine maintenance and repair systems for equipment.

The three production pods are fully equipped to deliver high-quality rapid tests for diverse medical needs. From material storage to component assembly, from sealing of finished products to their packaging and preparation for distribution, the pods are equipped for end-to-end manufacturing operations. Most critically, the pods are designed to support in-process quality control checks throughout the sequence of manufacturing steps. This ensures that in the process of streamlined manufacturing, there are no compromises with product safety and quality.

Efficiency, scalability and flexibility for internationally competitive manufacturing

Our podule™ clusters are a powerful solution for modern diagnostic manufacturing. Their efficiency, scalability and flexibility are the results of innovative technology, engineering excellence and hands-on project management.

Whether designed for rapid tests or any other health products, PodTech™’s podules™ offer key features which set them apart from other factory setups:

1. Modular design:

• Scalability: Podule™ clusters are designed with a modular approach, allowing for easy expansion and scaling of production capacity. This means that as demand increases, additional pods can be added without requiring major overhauls.
• Flexibility: Their modular nature makes clusters adaptable to various manufacturing processes and product types. In the UAE plant, the facility can pivot quickly between different diagnostic tests or even other types of medical devices.

2. High efficiency:

• Streamlined production: Each podule™ is a compact, integrated unit that houses multiple manufacturing functions, optimising space and reducing the need for extensive infrastructure. This streamlined workflow improves overall production efficiency.
• Automation: Advanced automation within the pods enhances production efficiency, consistency, and accuracy, minimizing manual handling and the potential for human error.

3. Rapid deployment:

• Quick setup: The prefabricated and pre-configured nature of podule™ clusters allows for rapid deployment and installation, which is crucial for meeting urgent production needs.
• Reduced lead time: The rapid setup of our pods enables facilities to start operations more quickly compared to traditional manufacturing setups.

4. Cleanroom capabilities and quality control:

• Built-in QC features: Each podule™ is equipped with integrated quality control systems to ensure that each batch of products meets the required standards and specifications. This includes real-time monitoring and data collection for quality assurance.
• Controlled environment: In the same vein, podule™ clusters are designed to maintain strict cleanliness and control over environmental conditions, essential for producing high-quality health products with minimal risk of contamination.

5. Sustainability:

• Energy efficiency: Our design incorporates energy-efficient technologies and systems, contributing to the facility’s overall sustainability and reducing operational costs.
• Waste management: Efficient waste management systems within the pods help minimize environmental impacts and ensure proper handling of manufacturing by-products.

PodTech™ is committed to mainstreaming 3Pfs biopharmaceutical infrastructure, providing scalable solutions where they are needed most. We look forward to empowering healthcare accessibility worldwide.