As a means of introduction, could you please describe the origins of ALDIMED, how it started, its development the past couple of years and where it stands today?
ALDIMED represents the medical technology industry in Latin America; this is a Colombian initiative and one of its founders. The Executive Board of this association is composed by Peru as President and Colombia as Vice-president. That being said, the organization actively participates in events all around the continent. The idea is to share experiences about regulations, and to share the dynamics and progress of the medical devices sector. This is a way of responding to the dynamism of the market. In terms of big trends of the medical device industry, the most crucial issue at the moment is the raising of quality standards.
In the next few months, Minister Gaviria will implement some important reforms that will impact the pharmaceutical and health industries. What impact will this have on medical device companies?
We think that everything that is happening with the health sector – particularly this reform – will directly impact the restructuring of the public institutions and the initiative for a better flow of resources along the value chain. It is the same for the introduction of new technologies; it is very different from the pharmaceutical industry. Our sector is constantly innovating in increments rather than making radical changes, meaning that ANDI is looking for efficiency in its processes. The regulatory framework and the modification of the POS and No POS is central. Having strict norms will allow Colombia to have better access to HEALTH technologies worldwide.
Colombia has a good reputation to provide a good environment for medical device companies. What do you think about the potential of the sector?
According to estimates by Espicom, the medical device sector correlated to roughly 1.1 billion USD in 2012, with more than 10 percent growth from last year. 90 percent of medical devices in Colombia are importers. However, national medical devices companies have been successful, and some of them are even exporting to Central America and other parts of South America.
One of the missions of the Chamber of Medical Devices – ANDI is to integrate and promote the development of medical devices and its position in the international scene. What have been the challenges of the association?
Our main mission is to represent the interest of Colombian manufacturers and distributors of medical devices not only compiling and sharing information, but also coinciding positively with the need of having fair ethics codes. We are inspired by the best practices of other associations such as Advamed and Eucomed (Medical Devices Associations). the Chamber of Medical Devices tries to align on the best practices, transparency in the market, and codes of ethics, some of which have already been adopted by Colombian companies. We all agree on the fact that we have to make progress on operational efficiency and standards of quality in terms of regulation. The process of sanitary registration is a big challenge: in some countries the processes are much too long and this delays access to technology for the population.
What are the main challenges that your members are facing today?
One of the main challenges is the operative efficiency of the sanitary registration process. Regulatory framework is crucial for the companies’ competitiveness. Additionally, we have to consolidate the best practices of manufacturing. This will lead to better access and standard for the population.
We are betting on IETS as a key player to implement a solid evaluation processes technologies. The CPS can also work together with the public sector in the same direction: to improve the system and the life condition of people.
What is your vision for the medical devices sector for the future?
Although some progress has been made, Colombia as a nation will have to strive farther in terms of ethics, transparency, and good practices. ANDI needs to participate actively in this sense, and propose new standards to the government in order to create an improved system. I would like the medical devices sector to be perceived by the government and its entities as strong and serious, with a concern for ethics and good commercial practices. The medical device sector has to be aligned with rigid international quality standards. This sector in Colombia depends on importats and it has to respect the international framework.
You have been the Executive Director of the ANDI’s Chamber of Medical Devices for three months. What would be your personal objective in four years?
I would like the medical device industry to be recognized by others as having an excellent and harmonized quality standards and as a ethic sector and promote a high quality healthcare technology for the benefit of the population.
What would be your final message for our readers?
Colombia has an organized private sector, with clear and established rules of the game. We are welcoming the best technology required for our country. The healthcare sector really needs to think about patients first, and bring the best and appropriate technology to cover their needs.