Read the Conversation
Conversation highlights:
- United in diversity: MECOMED’s unique role across 70+ countries, and how trust, transparency, and early engagement with authorities underpin real progress in the region.
- Digital transformation: The shift from big data to AI/GenAI is reshaping MedTech, pushing for more agile frameworks as software and hardware increasingly merge.
- Trust as the backbone: In regulatory engagement, distributor training, and collaboration with authorities, trust emerged as the foundation of MECOMED’s work. It is what gives the industry credibility and accelerates access to innovation.
- Value-based care & the centrality of data: The region’s move toward outcomes, registries, and sandboxes - and seeing data as a true strategic resource.
- Diversity & women in MedTech: We appreciated the emphasis on elevating women into leadership roles and the pride in launching the Women in MedTech Network, and of course, Inna’s role as the driving force behind it.
- Most exciting times for life sciences: The sense that this is one of the most transformative periods in modern healthcare came through strongly.
EF: Could you give us an overview of MECOMED and the current priorities on your agenda?
RR: MECOMED is a trade association that covers the entire Middle East and Africa (except South Africa). The rest of the region is very large and has a significant population, so our first task is to set clear priorities. We prioritize by scope, by geography, and by the type of support we provide. At this stage, we focus on the most dynamic areas. Saudi Arabia is a major priority. We have a dedicated Saudi chapter that works on the policies, opportunities, and needs specific to the country. Our goal is to support the transformation taking place under Vision 2030, which is progressing quickly. In general, we are focusing on managing the wider regional transformation, not only in Saudi Arabia. Across the region, reforms and privatization programs are creating new opportunities for our members, including opportunities to do direct business.
Another key priority is digital transformation. The region is experiencing a major shift in healthcare technology. This includes biotechnology, pharmaceuticals, and medical technology. In medical technology, we are seeing the impact of generative AI and other new digital tools. Much of this began during the COVID period, when households worldwide gained constant internet access for education, business, and information. That shift helped accelerate the sharing of knowledge across society. In healthcare, digitization has moved rapidly from the early days of big data a decade ago to today, where data can be stored, retrieved, analyzed, and used at scale. Because of this, MECOMED created a digital health working group in addition to our existing groups, and it has been very active. As digital health expands, we also work on ensuring proper market access. This includes preparing the industry for programs such as health technology assessments and value-based healthcare. Before new technologies enter the market, strong regulatory systems must be in place. Our regulatory work is ongoing, and we see it as a continuous effort. In some countries, we help support the introduction of regulations, and in others, we help authorities create pathways that allow faster introduction of new technologies and products, including software that now blends with hardware.
Long term, we expect more integration between pharmaceuticals and medical devices. Some refer to this as deviceceuticals, where device technology is used to reach areas of the body that were previously difficult to access, such as parts of the brain or organs like the pancreas and liver. It is an exciting time for the field. We are also focused on strengthening regulation to make it more mature, consistent, and grounded in best practice. MECOMED has a small secretariat, but we make strong use of the collective expertise of our member companies, who work together in working groups on regulation, compliance, digital health, legal, human capital, and market access. All of this is done in full compliance with the policies that apply to each member and to our partners. We collaborate with our members, research-based companies, many of them Western and most from the United States. We have also opened membership to distributors, so their perspective and market feedback can be included in our discussions with authorities. Distributors are associate members and participate in our working groups.
Across healthcare and many other industries, the way business is conducted has evolved. We are far beyond the era of fax and telex. Companies want to be closer to the market, understand local needs, and train customer-facing teams so that the quality of service matches global standards. This is why we train distributors and place heavy emphasis on compliance. Having a shared code of conduct for interactions with healthcare professionals helps build trust with authorities and with the entire healthcare ecosystem. This trust ensures that new technologies reach the market more smoothly.
There are also important differences between pharmaceuticals and medical devices. One major difference is the life cycle. Medical devices typically have an 18-month life cycle. If regulatory approval in a country takes eighteen months, patients will not receive the latest technology. For this reason, we work closely with authorities to encourage more efficient and robust approval cycles that maintain safety while enabling timely access. Medical devices also require training of medical personnel. This is why we see more training centers and more investment in developing local skills related to the use of medical devices and technology. We aim to support sustainable progress in every part of the healthcare system.
EF: How would you describe the region’s regulatory environment, including approval timelines and harmonization, particularly with respect to emerging technologies?
RC: Our work covers the Middle East and Africa, which includes more than 70 countries. The region is highly diverse, especially in its regulatory systems. Some countries are only beginning to adopt basic regulations and import controls. Others already have complete regulatory frameworks that include site registration and product registration. Many fall somewhere in between. Because of this, regulatory teams often need to prepare separate submission files for each country, tailored to each country's specific requirements. This is why our main message is to encourage regulatory alignment across the region. We want countries to build their systems in line with international standards and best practices. For example, we reference documents from the International Medical Device Regulatory Forum.
The goal is not to create new systems from scratch, but to build on what already works. This helps authorities use their resources more efficiently and speeds up access to new technology. Medical devices have short life cycles, and resources are limited. Even agencies like the United States Food and Drug Administration (FDA), which has around two thousand reviewers for medical devices in its CDRH Unit, say they do not have enough capacity to create unique requirements for every situation. They prefer alignment with global standards.
We hope the region can move in the same direction. Achieving this cannot be done alone. It requires cooperation among health authorities, industry, trade associations, national regulators, and all MedTech stakeholders. Trust is the foundation. We need open communication, not only when problems arise, but throughout the entire process. This is the approach we follow at MECOMED, along with our regulatory affairs committee. Transparency is equally important. Manufacturers need to demonstrate which new technologies are coming to market. Regulators need to share upcoming guidelines and expectations for technical documentation. This helps both sides engage properly. We are pleased to take part in many initiatives, including consultations on draft regulations. Participating early helps us give feedback before rules are finalized. We also join working groups and discussions with health authorities to move forward together.
In the end, we all share the same goal: giving patients in these countries access to medical technology. A device can be very safe, but if it does not reach the market on time, we are not meeting our objective and not achieving regulatory excellence. Progress takes time. It is a marathon, not a sprint. When we work together, even the most difficult conversations can lead to constructive outcomes. Our regulatory affairs committee includes around 350 professionals, bringing many years of experience to this shared mission. Our North Star is safe and effective access to medical technology for patients. If we view each other as partners on this healthcare journey, we can achieve this goal.
EF: Given the vast range of medical devices from basic tools to complex robotics, how do you balance this?
RR: We are dealing with about two million SKUs, and each SKU can include several sizes and variations that must be reviewed. This is why harmonization is so important. Because of the trust we have built, the region's diversity, and the rapid pace of change, we are pleased to see that authorities are becoming more open. Public consultations were almost unheard of in the region a few years ago. Three to five years ago, they were rare. Today, they are fully established, and many stakeholders participate actively. We also participate in regulatory sandboxes and think tanks, and authorities draw on the expertise of our member companies. This is valuable, and we are glad to contribute.
This progress would not be possible without MECOMED’s strong focus on compliance, including how we handle conferences and meetings. We prioritize value, not the number of events. That is why we use the conference vetting system, which carefully reviews venues, topics, timing, and overall purpose. This ensures that when funds are used for education, they support the right objectives and ultimately benefit patients. At first, this system faced some resistance, but now its value is widely understood.
EF: What are the challenges and opportunities of a value-based care model, and what does a system that rewards clinical outcomes look like?
IN: Governments across the region often speak of value when outlining their healthcare transformation plans. Many national visions include value as a key element of future healthcare delivery. It is an appealing idea, but it is not easy to put into action. Measuring value requires reliable data, and in many places the required datasets either do not yet exist, are still being developed, or are unusable because they are incomplete or not organized in proper registries. Still, there are countries in the region leading the way by building robust datasets and sharing them publicly. One example is the Sandbox initiative in Dubai, which invites multinational companies and startups to work with existing datasets called Nabidth. By accessing this data, companies can conduct research, develop benchmarks, and measure outcomes. Similar initiatives exist in Abu Dhabi, where certain datasets are available through the Malaffi platform. Saudi Arabia and Egypt are also working on building registries and databases. We now live in a world where data itself carries tremendous value. Many people say data is the new gold =or the new oil.
In procurement, we are encouraging a shift away from short-term budget cycles toward evaluating medium and long-term value. We work closely with government stakeholders and regional group purchasing organizations. Examples include NUPCO in Saudi Arabia, the Unified Purchasing Program in the UAE, and UPA in Egypt. These organizations are starting to look beyond yearly budgets and consider the long-term impact of technologies, especially digital solutions.
These technologies are often costly, so it is important to measure their long-term benefits for patients and for the public. For instance, they may reduce hospital stays, support home care, or lower revision rates for orthopedic or cardiovascular procedures. Many factors contribute to a technology's overall value, and we could discuss them for hours. But to keep it simple, the most important priority for our region today is to generate value by using data.
EF: How are countries in the region using health data and new technologies to meet growing healthcare needs, and what challenges come with this?
RR: Everything we are discussing is not a trend or a buzzword. It comes from real necessity. When we look at the Middle East and Africa, one thing stands out. At first glance, the region appears very young, and the average age is indeed low. This creates strong momentum for the workforce and the future. But at the same time, people are living longer and better, which means the population is aging. As a result, healthcare needs are increasing faster than the system’s capacity in many areas of the region, including in Saudi Arabia. This is why governments are turning to technology to expand coverage and improve access more quickly. In Saudi Arabia, for example, the creation of healthcare clusters aims to reduce the need for centralized care. Given the size of the country, patients should not have to travel across long distances to reach specialist hospitals. Similar shifts are happening across the region.
As Rana and Inna mentioned, strong regulation is essential to manage this growth and ensure safety. At MECOMED, we view regulation as a positive force. Deregulation would lead to serious problems, especially with the arrival of new technologies that may be costly today but deliver long-term benefits through improved outcomes and fewer revision procedures. In Saudi Arabia, there are efforts by authorities to increase healthy life expectancy by nine years in the future. It is not enough to extend lifespan. The goal is for people to live those additional years in good health so they can remain active, contribute to society, and delay retirement. These are key priorities that MECOMED monitors closely.
As the voice of the industry, we work regularly with authorities, group purchasing organizations such as UPA in Egypt and Nupco in Saudi Arabia, and other stakeholders. Challenges do exist. For example, privacy laws can require data localization, affecting large datasets used in clinical studies, remote monitoring, and telemedicine. MECOMED addresses these issues through our legal team and consistent collaboration with authorities. In the past, we often worked on exceptions to existing laws. Today, through public consultations, we aim to help shape the right framework from the start. We truly believe this is an exciting period. Innovation is bringing new technologies, treatments, and techniques that can improve patient care across the region, including Africa. Rana has also led important capacity-building work in Africa over several years.
RC: This was a three-year project we carried out as part of the MDRC (Medical Device Regulatory Convergence) initiative that was a global regulatory capacity-building program led by USAID (US Agency for International Development) and ANSI (American National Standards Institute), with support from ADVAMED. Our role in this project was part of the Africa scope. We strongly believe that it is no longer just about building capacity. It is also about maintaining capacity. You have to keep learning, because the moment you stop improving, you begin to fall behind. This is especially true in the fast-moving world of medical technology.
The project focused on three key African countries, Kenya, Ghana, and South Africa. Together with the United States Food and Drug Administration, we supported training for national regulatory authorities on important regulatory topics, current global trends, and international frameworks. This included areas such as the Medical Device Single Audit Program, technical file review, conformity assessment, and essential principles. It was a comprehensive regulatory curriculum designed to strengthen regulators' capabilities across the continent. The impact has been significant. We now see more African regulators joining the International Medical Device Regulators Forum as affiliate members. It is inspiring to see countries from the continent participating in international forums and engaging with major regulatory jurisdictions. I am proud of this progress and of the region taking a more active role on the global stage. This was one of the most important outcomes of the project, and we hope to see similar developments in the Middle East in the future.
IN: I would like to add something to the discussion about capacity building. We do not focus only on building the capacity of external stakeholders. We also work on developing skills within the industry itself. Historically, our region has been viewed as part of the EMEA, which includes Europe, the Middle East, and Africa. Because of that, many regulatory systems here tend to follow either the United States Food and Drug Administration or the European market requirements. Today, the situation is changing, and the industry in our region needs to be upskilled. Most technologies used here are developed abroad, and companies must be prepared for the new wave of innovation coming our way, including AI-powered devices, robotic surgery, advanced data management, and many emerging skills. For this reason, we invest heavily in capacity building within the industry. We sometimes hear concerns such as, What if we train our people and then they leave? But the real question is, what if we do not train them and they stay? It is far more important to equip people with the skills they need so that we can rely on them to bring the best possible technologies to patients.
EF: How do you balance the needs of high-growth African markets with the rapid innovation demands of the Gulf region?
RR: We serve a population of about 1.7 billion people. Our region includes both the highest and the lowest GDP per capita levels. As you said, we call ourselves the Middle East, but in reality, the region is far from being in the middle. We are constantly engaging with our markets, focusing on our patients, and adapting to rapid change. Education is at the center of everything we do. Even within MECOMED, our own team challenges itself to stay up to date with the latest technologies. When you meet a minister or an official, you often have only a few minutes to explain something complicated, so you must understand it very well. This is why we invest time in producing reports and publications, sometimes with partners like PwC or IQVIA, and sometimes independently. We believe in showing results, not just talking about them.
The medical device sector is moving extremely fast. Our member companies are transforming, and you can see how much their product portfolios have changed. Many innovations now come from startups, which larger companies then acquire. Research and development itself has changed. We are seeing more digital tools, robotics, and precision medicine. In the past, only one or two companies in our association worked with robotics. Now we have entire groups working on it. Digital twins and improved data use are accelerating approval timelines, even for medicines. For example, Artificial Intelligence (AI) and Generative AI (Gen AI) have shifted from experimental tools to core strategic assets in clinical research. AI integration now accelerates trial timelines by 30–50% and can reduce overall costs by up to 40%. Almost every week, we hear news about new solutions or treatments. The COVID period played a significant role in this shift by accelerating digitization, data sharing, and public health awareness.
The hospital of the future will look very different. More care will happen remotely, while hospitals will focus mainly on procedures. Antimicrobial resistance will remain a challenge, so reducing time spent in hospitals is beneficial. Home care is becoming more common, and research shows that older adults monitored remotely often do better at home. Robotics will play an increasingly important role in elderly care, and technologies like exoskeletons are moving from science fiction into reality. We need to be ready for this future, and education is essential. We continue to build capacity both within companies and among our distributors, who are becoming key partners for the future. Many countries, especially Saudi Arabia, are encouraging companies to have a direct presence as part of localization policies. MECOMED itself is planning to establish a presence in Saudi Arabia. Localization is becoming common across the region, and we work with authorities to build and maintain capacity so that local markets benefit. Diversity is also a major priority for us. It matters at every level, including leadership positions. In many countries, including Europe and the United States, women are still underrepresented in senior roles, even in the largest corporations. At MECOMED, we are proud of the work we have done to support women in MedTech, and Inna has been the driving force behind this initiative.
IN: MedTech remains highly male-dominated. We wanted to create opportunities for women who are already succeeding in their careers and help them grow further. We have seen several strong examples of women advancing, and today, companies are taking this issue much more seriously at the corporate level. We created a Women in MedTech network, open to anyone working in the sector. We recently launched a mentorship program with mentors and mentees who meet regularly, all in compliance with the proper guidelines. We also invite women from executive boards to share their experiences, how they reached their positions, and what challenges and opportunities shaped their journey. We have many impressive women across all career levels, from board members to executive assistants, and we are developing meaningful projects within the network.
