Read the Conversation
Conversation highlights:
- The critical role of ABIMO is to bridge industry, government, healthcare institutions, and regulators to develop a strong national medical device sector.
- Raising awareness on the importance of prioritizing Brazilian manufacturing and fair market conditions.
- Work closely with Anvisa on regulatory alignment so Brazilian products can both compete at home and be exported.
- Elevating the health industrial complex as a true national priority and collaborating for its realization.
- The story of Braile Biomédica, with an origin in true Brazilian clinical need.
- Braile Biomédica covers over 200,000 patients annually, embodying the mission of providing accessible cardiac care solutions.
- Braile is investing heavily in innovation with over 8 new products in less than 5 years, proof that Brazilian medtech can innovate at a global level.
- Nearly 50 years of operation: longstanding, family-founded Brazilian medtech company with deep technical and clinical roots.
EF: As a member of the board of ABIMO, what opportunities do you see for local MedTech manufacturers in Brazil?
PB: Brazil has a unique healthcare structure with one of the largest public health systems in the world, serving over 200 million people. There are a lot of patients in need, and it is important to provide solutions to them. There is an enormous opportunity in the medical devices area.
The pandemic taught us an important lesson: while we remain open to imported products, Brazil cannot only be in a position of receiving products without developing our own manufacturing capabilities. We need strategic national policies to support this development. ABIMO plays a crucial role by bringing together industry, government, healthcare institutions, and regulators to support the development of a strong national medical device sector.
In my organization, Braile Biomédica, I know that I cannot be strong alone, and ABIMO serves as our voice as health policies are shaped by the government. Beyond the public system, Brazil also has a very large private healthcare sector, which presents additional opportunities for all of us.
EF: What are ABIMO's current priorities, and what specific opportunities do local manufacturing companies see?
PB: The government is working to establish the economic industrial complex of health, joining industry, government, technology centers, and universities to grow our industries. ABIMO's main goal is to work hand in hand with these players to make this vision a reality, as having projects is different from making them a reality.
We see the need to create a fair structure to be able to produce locally and contribute to the economy beyond health. We sometimes see that imported products have a more advantageous scheme than products we manufacture here. It's more expensive to manufacture here than to import, which creates unfair conditions. ABIMO works extensively on regulatory alignment with Brazil's ANVISA, ensuring fairness for national products compared to imported ones. This regulatory modernization isn't only about importing products; it's also about building capacity to export Brazilian products to other countries. The regulatory system in Brazil must be a stepping stone that allows us to compete in other countries and potentially make Brazil an important exporter of medical devices.
EF: What are your expectations regarding the recent agreement with India and the memorandum of understanding signed by the Minister of Health?
PB: We have huge expectations both as Braile Biomédica and as a Brazilian representative in ABIMO. This will open up very big opportunities for Brazilian companies that are prepared for expansion.
At Braile Biomédica, we have CE Mark certification, and we export to 45 countries, so we're well-prepared for this path. We've been in business for almost 50 years, making us a long-term company ready for these opportunities. India and the European community represent very big markets where we can expand significantly. However, getting certifications like the CE Mark is very complicated, expensive, and challenging. Medical device manufacturing in Brazil needs to be a national strategy. Countries like India and China have government partnerships and sponsorships for their local industries. We need that same commitment in Brazil. We need to continue working on what comes after signing the MOU. Crafting a holistic plan for industries, regulatory processes, and logistics is key. Without government support, smaller companies cannot access the financial resources they need to grow. The conscious recognition that medical devices are strategic for our country is not our decision alone; it's a national decision.
EF: How is 'health made in Brazil' perceived globally, and how can awareness of its importance be increased?
PB: In Brazil, we are hard workers who want a developed country. We have been working in recent years to reposition the role of Brazil in the world. We believe in education and in teaching the next generation how to do business ethically. I am at the Ethics Health Institute, and we say that we are little ants, an army of ants. Together, they can handle great loads. We're here to change our country and the reputation of a part of society. We are proud, hardworking people who do wonderful things. Civil society has a strong force, but we need to be together. We need to have our voice together, because alone we don't have a voice. We need to believe in ourselves and show the world our capabilities.
EF: What role do you see for Brazilian companies in providing accessible healthcare solutions globally?
PB: China did an amazing job in changing its quality of products and their perception. Indian pharmaceuticals went the same road; they are great and sell worldwide. Today, we cannot think only of Germany, Japan, or the United States. We're here to give access to high-quality, safe products to countries that cannot afford products designed and made in more expensive countries.
In our case, working with heart and vascular diseases, how can people in India, Brazil, and many countries in South America and Asia have access, if only companies in developed countries make these products? The world population is growing, so space for companies is always growing too. We're very proud that Braile is the biggest supplier of heart valves in Brazil. Last year alone, we took care of 200,000 people with our products. When you give this opportunity to a person, you're giving life to that person and their whole family. We're treating health, we're treating life.
EF: Braile Biomédica has now built a 50-year legacy. What are you most proud of?
PB: What makes us most proud is being alive. During these 50 years, we've had many challenges, ups, and downs. My father was a cardiac surgeon, and he founded this company. He was a pioneer of cardiac surgery in Brazil. He believed that for Brazil to develop cardiac surgery, there had to be an industry that could make products for that development. He developed his own heart-lung machine and made valves for his patients. We started as a solution for his patients, not as a company. He believed that if Brazil didn't have a Brazilian company, cardiac surgery wouldn't grow as it did, and he was right. Countries without a national industry don't develop surgeries like Brazil did. The company started in the 1960s as a solution for its patients, becoming a formal company in 1977. We believe in solving problems and saving lives. Our pride is giving the opportunity for more and more people to be treated for heart and vascular diseases, helping to save lives.
