Mecomed is the largest medical devices, imaging, and diagnostics trade association in the Middle East and Africa (MEA). Rami Rajab, chairman, highlights the role of the association in shaping the region’s regulatory environment and industry code of conduct, the giant transformation that digital health has brought about, and explains how Mecomed’s different working groups work to provide better patient outcomes.
Can you begin by introducing your decades-long experience with medical devices and the role of Mecomed as the main medical technology industry association in MENA?
I started working in medical devices in Saudi Arabia 35 years ago with one of the largest distributors in the country, establishing the market in various cities. After a few years, I joined Medtronic, spending time between the Middle East and Europe with the company and have continued to work in the medical devices sector for different companies, geographies and different subsectors such as cardiology, neuro-surgery and diagnostics.
In 2007, four medical technology companies joined together to create an industry association, Mecomed, understanding that it was important to collaborate to ensure that we competed on a level playing field across the countries we covered. The idea was to mimic other trade associations such as AdvaMed in the United States or Eucomed in Europe, looking to shape the industry, keep patients first and put in place a code of conduct, rules and regulations, to monitor interactions between healthcare professionals (HCPs) and companies.
Over time, Mecomed grew significantly and now has close to 50 members, we are happy to be the voice of the industry with authorities, payers, and providers. We believe in good citizenship and work hard to create a responsible and successful industry in the different countries where our members operate; we are one of the few trade associations that deal with multiple countries and continents.
Our focus began in the Gulf region since it is where the regional offices of large manufacturers are located. Since many countries did not have specific regulations at that time, it made sense to do it centrally. Over time, most companies opted to have a presence in other countries which made the circle grow to cover the Levant region and North Africa. Mecomed has great expertise amongst its six working groups with around 500 people supporting them. Our members cover the entire region through different local offices; the association also reaches Sub-Saharan countries and others like Pakistan through collaboration with local groups.
What role do distributors have in the association, considering their importance in many of the MEA markets?
The association was founded by manufacturers, but we cannot deny that distributors are our natural extension and partners in the market as our representatives. The manufacturers have a legal and moral obligation to ensure that their representatives follow the same compliance rules and ethics codes. Fortunately, as the association’s members got closer to each other, understanding the markets, distributors followed the same path, better understanding the laws and duties when interacting with HCPs.
Today, the majority of Mecomed’s members are manufacturers but we also have third-party providers. We have started a third-party certification program for distributors which makes them fully aware of duties and responsibilities and a better prospective partner for international manufacturers.
Can you walk us through the association’s structure, its different working groups, and the priorities of its members?
The first step taken by Mecomed was to establish a compliance committee in charge of harmonizing a set of rules for all members, dictating how they should behave vis-a-vis HCPs and the overall market. Compliance is the passport to doing business in any market or region because it provides security for companies, allowing them to succeed without fear. In the beginning, our regulations were stricter than those in place locally, which is perhaps why Mecomed has been given international awards. The code of conduct is constantly renewed to cover new technological developments and has been officially adopted by various countries.
Our second working group is the regulatory committee which works to understand the changing regulations across the region and provides help – in the form of capacity building and experience sharing – to local stakeholders in places where regulations are still undergoing development. The committee has established a dashboard showing all of the requirements to register products in any given country, which is a treasure trove for any company looking to reduce the time to market; in this context, I must say that the Saudi FDA is a leading regulator.
The third committee is market access which role is to analyze, understand the needs and capacity of a given market, and since its introduction, it produced white papers on several important topics such as new therapies, value-based procurement, and digital health.
The fourth internal group is the talent and human resources committee, which focuses on sharing best talent management practices, both global and regional, updates members on localization requirements such as in the GCC and works to reduce the gender gap in the medical technology industry.
The association also has a digital group that takes care of helping the region adapt to the digital future.
Finally, we have a legal committee and a communications group that provide highly important services to all members.
MedTech companies have had a crucial role in the pandemic, especially at the beginning with the rise in demand for PPE and ventilators. Can you explain how Mecomed and its members were impacted by the crisis?
The pandemic has had an impact on all of us and we have continued to facilitate a permanent flow of products such as PPE and ventilators. Since COVID-19 has been a catalyst for digital health, the association has worked to help countries build capabilities, educating stakeholders on the use of technology and pushing to expand tech transfer in places that want to increase local production.
One specific area enhanced by the pandemic was diagnostics. Our members worked very hard to supply all the necessary tests to the population; the objective now is to ensure that diagnostic solutions provide faster and more reliable results. There is an opportunity to reach more patients and have them diagnosed before they go to see a doctor through digital-based solutions.
Moreover, we have seen a rapid evolution of medical devices which has created a challenge in terms of time to market in regulated markets. Our message to stakeholders is that we can save time and help patients more efficiently by having faster market access.
Medical technology companies play a significant role in digital health by providing products and services that generate and capture data. How can the industry collaborate closer with authorities to ensure that their role in diagnosis and better patient outcomes is better understood?
That situation is closely related to market access, whose definition is to understand the market, understand the epidemiology and the population to see who can benefit of a certain therapy, but then comes the economic side, where we must understand if a government is able to allocate budget for specific treatments. The role of market access is to highlight the therapeutic needs of a certain market; it is part of value-based healthcare since countries can make significant savings by diagnosing patients earlier, before their condition worsens.
The Saudi medical equipment market is expected to reach USD 3.8 billion in 2023, according to Mecomed’s own data. How important is the market for the industry and what trends should our readers know about?
Saudi Arabia is the major market in the region in terms of population and budget. The Saudi government has invested heavily in healthcare and we, as an industry, consider it to be a strategic market in which most of Mecomed’s companies have a presence, some directly after joint-ventures and partnerships, and others through distributors. One area of interest for Saudi Arabia is digitalization and data as evidenced by the Ministry of Finance’s smart health initiatives.
The initiatives are related to artificial intelligence and the use of digital health to create solutions for the population and to speed up their processes; there are many types of digital technologies that can help with early diagnosis and system efficiency. The industry is quite interested in these initiatives which were discussed recently during sessions about Vision 2030.
As we understand it, the authorities’ idea is to rely more on the private sector and transform the government’s role, making it more of a regulator, thus creating efficiencies. Companies are enthusiastic about working with the Ministry of Health to drive the new initiatives. Mecomed will put expertise and know-how in the hands of the market, believing that it has an important role in supporting the government’s actions.
With a relatively young population, how do you evaluate the region, both HCPs and patients, in terms of digital technology adoption?
There is a big disparity in the level of digitalization in the Middle East and Africa, but we believe that digitalization is coming fast and strong. To improve, the industry must work to educate regulators about the safety and possibilities provided by the technology, and HCPs about the best use of the products and services. Finally, we must work to help educate patients too, since they are set to play a big role in managing their own health at a time when tools will make it possible to perform testing and monitoring from home. This last part entails wiser regulations around data privacy, and, for example, the Saudi and UAE governments have already enacted laws in that regard. Countries are looking at ways to anonymize data to keep the privacy of patients and doctors.
The world is changing, and it is a beautiful change because, on one side, equipment is getting better and smarter, and, on the other, people are taking more responsibility for their own health, changing the way we perceive hospitals. The transformation will take time, but we will get there by collaborating with HCPs and governments.