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Improving Access to World-Class Devices

Wed, 09/09/2015 - 13:11

Q: What is your overview of the medical device industry in Mexico and what role does AMID play?

A: The medical device industry is extremely large, encompassing several fields from sutures to NMR spectrometers. The industry is divided into several niche areas so it is difficult to define it as a whole, as each sector behaves differently. The main commonality of the industry is its extremely fast growth in Mexico and its potential to contribute both to the health and economy of the country. COFEPRIS divides the industry according to risk. The council has a list of basic medical devices that do not need to be registered, and the others are classified into different groups, all of which have different requirements. The problem is that once a medical device has been approved by COFEPRIS it can be sold to the private sector in Mexico but not to the public one, since it must first be approved into the National Formulary. To be incorporated into the National Formulary, a product needs approval by the General Health Council (GHC) which selects products according to the needs of the Mexican population. After the GHC has approved a specific device it must then undergo a second revision by each specific institution which aims to incorporate it. Thus, when a product is approved by COFEPRIS, it can only reach a very small percentage of the public, as most of the Mexican population uses public health services and hospitals belonging to IMSS and ISSSTE.

Q: What are the main trends seen in the market for medical devices?

A: Several areas are being innovated. An area that is growing is interconnectivity among devices to allow a faster and easier transfer of information. Several hospitals are attempting to digitize their electronic records in order to make them easier to access by doctors, which will allow these hospitals to provide faster and more efficient services for patients. Another trend is minimally invasive surgery which requires smaller and more advanced equipment but is less traumatic for patients. Long-term implants, which can last a patient’s whole life, are also a focus in the industry. All new developments focus on preserving patient health while being safe for use by medical professionals.

Q: Mexico is the ninth largest exporter of medical devices worldwide – do you believe the industry can grow further?

A: Mexico can grow as an exporter of medical devices and incorporate itself into the top three, but the process will be challenging as several steps must be taken in order to accomplish this. The first is improving the internal market for medical devices. Mexico’s internal consumption of medical devices is relatively low and in order to attract external investments into the country this has to improve. While we are in ninth place as medical device exporters, we are in 26th place as consumers. The second is to promote the consumption of more Mexican raw materials as at this point their use is minimal. Alongside the Treasury’s General Directorate of Light Industries, we are analyzing the market in order to determine the main requirements of the manufacturing industry in Mexico. We want to bring together international manufacturers of medical devices and local producers of raw materials in order to foment cooperation, strengthen the sector, and promote the growth of the local industry.

Q: What is needed to strengthen R&D in Mexico?

A: Our government needs to provide more incentives within this sector. At this point there are some initiatives from CONACYT, but Mexico is still far from becoming an industry that generates innovative medical devices. We are working alongside IMSS’ innovation division to bring R&D to Mexico. Now we are focusing on applied research, which will eventually allow the sector to develop basic research.

AMID is also aiming to generate clinical studies to determine the efficacy of medical devices. These studies are currently not being brought to the country as we do not have adequate regulatory guidelines for their implementation. In Mexico we have large health institutions, experienced doctors and nurses, and a large patient pool, especially in terms of obesity-related diseases such as diabetes. As a result, performing clinical studies in Mexico would be ideal for several companies in the US and Europe. Mexico has many experienced doctors with innovative ideas, thus we are hoping to collaborate with the IMSS to develop strategies for these doctors to develop their own research lines.

Q: COFEPRIS recently removed 573 medical devices from the list of products requiring registration - what impact has this had?

A: Removing these devices from the market will be beneficial for COFEPRIS as it will allow their regulators to spend more time analyzing innovative medical devices. This will allow medical devices to come to the country faster to help improve the lives and productivity of Mexicans. In fact, less than 10% of the Mexican patients have access to innovative medical devices today. The medical devices industry is the most complex for COFEPRIS as it is under constant renovation and so it submits the largest amount of registries for examination. In AMID we currently have 7,100 sanitary registries for 310,000 products with COFEPRIS and over the next five years we are planning to introduce 1,400 new products. These numbers only represent the 24 companies that belong to AMID, rather than the sector as a whole. COFEPRIS is drafting new regulations for pharmacovigilance which aim to oversee whether these medical devices are safe and to notify regulatory authorities of every negative effect or side effect. The goal is to ensure the safety and quality of every product released onto the market.

Q: How would you describe approval timelines for medical devices?

A: Approval processes are extremely lengthy and can take several years. A common problem of these long timelines for the approval of medical devices is that while a product is being approved new variations are being created, meaning that the recently approved products are outdated when they finally reach the market. There are currently less new medical devices being introduced to the market in comparison with generics as the evaluation process for medical devices is based on the guidelines for pharmaceutical approval, so it has many unnecessary requirements. Clinical trials for pharmaceuticals require a large number of people and are extremely expensive. On the other hand, medical devices require a smaller population and shorter timelines so they remain state-ofthe-art when they are approved. One of our goals is to collaborate with regulatory authorities to generate specific guidelines for medical devices.

Q: Distribution chains for pharmaceuticals have changed enormously over the past few years – have they also changed for medical devices?

A: Distribution channels have certainly evolved over the last few years. Mexico is too vast for all medical device companies to have a presence in each region of the country, especially as medical devices require specialized services. Thus we require our distributors to be highly qualified in the installation, use, and repair to provide a timely service for each given device. Distributors are essential partners for us and we require that they be experts on their fields. Distributors have evolved and are now much more professional. AMID’s companies are conscious of the importance of partnering with professional distributors to be able to provide better services and face less risks.

Q: What other training services do you offer for distributors?

A: We have a committee that focuses on ethics and compliance as we believe these to be cornerstones for all negotiations. Compliance is a pillar for us and we were the first association in Latin America to publish an ethics code for healthcare. All companies that belong to AMID are committed to conducting business with the utmost transparency and honesty and we are pushing our distribution partners to follow these standards. As well as our ethics committee we provide two different training services, the first designed to help doctors and nurses keep up to date on the latest medical devices on the market and their use. Since medical devices evolve so fast, physicians are often unaware of the latest devices so we train professionals on the safe use of these new technologies. In 2014 we provided training for more than 25,000 medical professionals among all of AMID’s members, a number that continues to grow each year. The second one, which we are implementing alongside our Committee for Regulatory Affairs and COFEPRIS, are workshops for our associates to create simplified dossiers for new products according to the authorities’ requirements. We are trying to introduce good practices for the introduction of new sanitary registries. AMID is also preparing a training program on the impact of the new norm for the Recognition of Revenue for all General Directors of our companies.