Medical Devices

5Medical Devices

The medical devices industry is one of the most important contributors to the national economy. Not only does it provide specialized jobs but it also strengthens Mexico’s strategic position in the North American region and globally. The sustained growth of this industry has pushed the country to integrate new technologies and to look toward further integration and a more complex specialization in device manufacturing.

Globally, Mexico ranks eighth as a medical devices exporter, with strong local hubs with potential to grow. The country’s strict, yet favorable, regulations make it an attractive destiny for mass production and according to AMID, Mexico’s ambitions include sourcing significant raw materials to strengthen our production capabilities, including the production of disposables, metal devices and plastic components. The country’s main commercial partner in this sector is the US, which has a new government administration that has promised to “bring back” manufacturing jobs to the US. However, associations like AMID are confident that USMCA will protect and strengthen Mexico’s position in the medical devices field.

This chapter analyses the challenges of meeting high and urgent demand for devices during the COVID-19 pandemic, the integration of homecare trends and future industry plans to boost local consumption of state-of-the-art devices that could potentially be a watershed for preventive healthcare in Mexico.

5Medical Devices

88 Analysis

Reducing Foreign Expenditure on Medical Devices

89 View From the Top

Ana Riquelme | Executive Director of AMID

90 View From the Top

Héctor Barillas | Director General of bioMérieux

91 View From the Top

Pablo Bufano | Managing Director of Dräger México

92 View From the Top

Carlos Jiménez | Director General of B. Braun Mexico

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Jordi Fernández | General Manager Mexico of Roche Diagnostics

94 View From the Top

Paul Barber | Managing Director of Getinge Mexico

95 View From the Top

Carlos Hernández | Director General of Beckman Coulter

96 View From the Top

Enrique Giraud | Managing Director of Fujifilm Mexico Javier Giraud | Medical Systems Vice President of Fujifilm Mexico

97 View From the Top

Carlos Franyutii | Sales and Marketing Manager of Healthcare Solutions at Canon Mexicana

98 View From the Top

Raúl Jacobo | Health Manager of CHG Meridian Mexico

99 View From the Top

Alejandro Von Mohr | Director General of Atramat

100 View From the Top

Carlos Pardo | Marketing and Sales Vice President of Levbeth Group

101 Analysis

A Mexican Ventilator to Stand Against COVID-19

Reducing Foreign Expenditure on Medical Devices

Read the complete article Despite Mexico’s role in the production of medical devices, the country imports around 90 percent of such devices. “Mexico spends US$25 per capita on medical devices whereas countries like the US spend around $500,” explains Ramses Galaz, CEO of GSE Biomedical, in an interview with MBN. The medical devices market represents around US$5 billion in Mexico, which means the country imports close to US$4.5 billion. According to Galaz, Mexico’s potential on technology development and quality in manufacturing could save the country around 70 percent of that US$4.5 billion expenditure if investment begins soon.

GSE Biomedical was part of the successfully developed Mexican ventilator to combat COVID-19, VSZ-20-2. Galaz explained that the pandemic exposed Mexico’s great dependency on foreign technology. Yet, despite the barriers, there are around eight ventilator developments. “However, from my experience, I know that taking a Class 2 development to our regulatory authorities takes a great deal of effort, indepth knowledge and investment,” he said.

MBN also spoke with Josué Garza, Director of Business Development and Operations at Insumos para la Salud, about the barriers to making medical devices development a reality in Mexico. “We are still missing resources and support for educational and talent activities, which is a big barrier for the country to accelerate and boost its abilities.”

Discussing the opportunity in the sector with MBN, María Luisa Gutiérrez, CEO of Medisi, explained that Mexican companies developing their own technology are normally participating with Class 1 devices, not 2 or 3, which are the most sophisticated. “The regulatory process has a lot to do with this because we really do not have the guidelines to develop a Class 3 medical device.” These regulatory gaps can represent a setback on investment and prevent the industry from generating a true economic spillover.

How could the country exploit this opportunity? “Mexico would have to begin with Class 1 devices, which require an investment of around US$200,000 to US$2 million. Class 2 developments require an US$8 million investment and Class 3 needs US$10 million or more,” said Galaz. While the return on investment for Class 3 development takes years to materialize, this is the only way to ensure a sustainable healthcare sector in the long term.

“Mexico has all the facilities and infrastructure needed to perform clinical trials and to grant approvals for medical devices,” explained Fernanda Villareal, Country Manager of Kiyeon Law, in an interview with MBN. Villareal highlighted Mexico’s leading profile for clinical trials due to the diversity of its population and COFEPRIS’ Rank 4 as a regulatory agency, which is the highest. “This enables the country to homologate certifications to grant equivalence for imported products.”

Ana Riquelme

Executive Director of AMID

USMCA, Other Advantages Propel Medical Devices Sector: AMID

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More about this person Q: What is your reaction to US President-elect Joe Biden’s promise to “return” jobs in the medical devices sector and reduce US dependence on foreign countries in this area?

A: Joe Biden’s promise is understandable but the agreements we have with the US are backed up by USMCA. Mexico exports 80 percent of the medical devices it manufactures to the US. Many commercial rules allow companies to manufacture in Mexico under the same terms that are applied in the US, which facilitates trade, considering rules of origin and other matters. We have experts on quality, regulation and conformity certificates and we are confident of remaining a competitive hub for medical devices for export to the US. Mexico also is looking forward to obtaining significant raw materials to build components required by medical devices to strengthen our production capabilities, including the production of disposables, metal devices and plastic components.

Q: How far along is AMID’s proposal to introduce better regulatory standards for medical devices?

A: AMID is part of the Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector and we have been pushing regulation in Mexico and the Americas. One challenge we have faced is the presidential and Ministry of Health mandates regarding equivalence agreements. This has changed supply paradigm, with UNOPS now joining the party. But we are confident of a positive outcome once doubts have been cleared away. This measure goes against promoting local manufacturing and, therefore, is not beneficial to the sector and its future.

Q: What is required for Mexico to achieve more final production of medical devices in the country?

A: We will begin to manufacture final products in the country when the Mexican government recognizes how important this sector is as a generator of health and starts to support the industry, alongside prioritizing local consumption over foreign consumption. It also implies a commitment to device and technology adoption within the public sector. Furthermore, Mexico would have to create protocols that standardize the use of medical devices, which would ensure the availability of and access to homogeneous equipment and technology regardless of location.

Q: How did the sector respond to the needs of the COVID-19 pandemic?

A: The manufacturing of all devices used during COVID-19, from personal protection supplies to ventilators, multiplied by 10. This has been the largest growth we have experienced; however, we remain committed to non-COVID-19 patients who are experiencing other ailments. To this end, AMID and the pharmaceutical industry generated a care protocol within hospitals to ensure doctors could continue practicing safely.

Q: What has been your experience as a female leader in the healthcare industry ?

A: The medical devices sector is highly innovative and dynamic and this has helped open the doors to women. Our leadership in the industry is still limited but I am happy to see that each day there are more women heading important companies and being properly recognized.

Héctor Barillas

Director General of bioMérieux

Saving Lives With Faster, Better Diagnostics

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More about this person Q: bioMérieux had an active response to the COVID-19 pandemic and developed a diagnostic test, how did the company develop the test in such a short timeline?

A: Numerous teams, such as Regulatory Affairs, Quality, Product Labelling and Documentation, Industrialization and Production, Quality Control and Clinical Affairs, were mobilized to support the availability of the new test as quickly as possible. This project succeeded so quickly because everyone was aware of their responsibility and helped on top of their routine activities. It is an example of our spirit of collaboration and exceptional efficiency. In fact, we currently have not only one but five tests available.

In less than two months, bioMérieux was able to develop and brought to market its first PCR diagnostic test for the new coronavirus. This challenge was met thanks to the expertise and exemplary mobilization of multidisciplinary teams that were set up to support the availability of the new test as quickly as possible.

Q: What are the unique benefits of the diagnostic test? How does it compare to others in the market in terms of cost, accuracy, time to get results, scalability and ease of use?

A: All of our tests comply many international accreditations thanks to their excellent performance. In particular, our PCR Multiplex solution has great advantages thanks to its capacity to simultaneously detect several pathogens than can cause respiratory infections including SARS-CoV-2, Influenza and other viruses and bacteria in only 45 minutes, which will be highly relevant during winter period. Our solution is highly accurate, cost-efficient, does not requires complex infrastructure or specialized personnel on molecular biology, and it is scalable with the capability of processing up to 264 tests per day.

Q: What is bioMérieux’s formula to provide high value diagnostics and pioneering diagnostic innovation?

A: We offer complete solutions that focus on patients from the moment they enter the hospital to when they leave. In the field of microbiology, we are leaders not only in the area of bacteria, but also viruses and parasites. Our state-of-the-art diagnostic equipment allows a diagnosis to be done in under an hour, which means a patient can get help faster and more effectively. Our diagnosis solutions reduce the amount of human error that can lead to a misdiagnosis and decreases the application of inappropriate treatments. It also helps hospitals reduce the time allotted to patients.

Q: With respect to antibiotic resistance, what else can be done to mitigate this issue in Mexico?

A: We are already working with several institutions, including a number of associations that are focused on antibiotic resistance. Here in Mexico, there is a network for epidemiological vigilance, with its main base in Monterrey. They gather data from hospitals to map the development of resistance. This can be done with a software that allows data to processed immediately. Lastly, public awareness is also important. People need to know that they should not just take antibiotics without a proper study of their problem.

Pablo Bufano

Managing Director of Dräger México

An Integral Provider is the Best Ally During a Crisis

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More about this person Q: How has Dräger improved its market share in the private sector?

A: Dräger has grown its sales in the private sector in medical equipment and consumables. We are reaching more private hospitals around the country and offer financing programs to access equipment and consumable consumption.

Q: Dräger created a protocol to digitalize data and enable communication between devices. What is the status of this project?

A: Dräger devices are now following this protocol, which fully guarantees process digitalization. Even our older equipment has the capacity to interconnect and achieve information digitalization. The protocol is already available worldwide but we expect Europe to be the first to adopt it as its hospital networks favor digitalization and technology. With this protocol, Dräger intends to gather as much information as possible to support doctors during their decision-making process. The protocol provides information on patients and their actual status, helping doctors, anesthesiologists and nurses.

Mexico lacks the hospital infrastructure and equipment necessary to build a communication network for devices. The country does have public and private hospitals that have digitalized their practices and many others are working toward this goal, but COVID-19 has highlighted that Mexico’s hospital capacity still has concerning deficiencies.

Q: What new products or solutions is Dräger planning to introduce to the Mexican market?

A: We are about to introduce a new anesthesia machine called Atlan. We hope to introduce a new ventilator technology that is already in other countries. It is going through the regulatory process in Mexico.

Q: Amid the global pandemic, how has demand for your services and solutions grown?

A: We are seeing a significant increase in global demand, especially for ventilators, and increased demand for ventilation accessories and light respiratory protection. Usually, hospitals are our customers but up to date, health authorities or government agencies are increasing asking for our products. Despite all efforts, the demand for ventilators and protective masks is well above the capabilities of the entire industry. In Mexico, we have incoming orders for ventilators but this year we will not deliver more than what was already arranged. However, we are selling more monitors, which is new and positive for hospitals expanding their ICU capacity. While the pandemic is a terrible situation, hospitals will end up being properly equipped.

Q: How is Dräger contributing to helping Mexico overcome the pandemic?

A: Dräger has been intensively working on the service part of its offering. We hold service contracts with IMSS and INSABI to check on their existing equipment, so we have been quick to react and provide the proper maintenance. We have prioritized ventilator equipment calls, which are coming at a very high speed.

Carlos Jiménez

Director General of B. Braun Mexico

Learning Tool Helps Companies Become Integral Providers

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More about this person Q: How has the company’s commitment to the company grown?

A: Depending on third parties is not our strategy as there are many factors that can impact our operations. Having our processes centralized – logistics, accounting and staff – allows us to maintain control but most importantly, to provide many benefits to our employees. Our new distribution center (CEDIS) will boost our growth in the next six to eight years, according to our projections, and we also have the option of expanding it because it is was built according to a modular infrastructure concept. The main goal of the CEDIS is to have more capacity to serve the large volume orders that we receive from the government. B. Braun participated in the last tender under the government’s new centralized purchasing scheme and winning that tender meant a lot of growth. On-time delivery is key for the government, so B. Braun has to tackle all challenges related to logistics, which is why CEDIS was key for our development. Additionally, we have exclusive transportation and drivers.

As for CEDIS, it is an infrastructure that will serve us for our current operation and our growth for the next six to eight years, with the possibility of expanding the building under a modular concept, which allows us to directly serve businesses high-volume government sector. For example, in the most recent consolidated tender E5, B. Braun was the company that participated with the highest number of codes, being assigned in an important way, and that we are already executing directly from our CEDIS. For the metropolitan area, we have our own transport and delivery service and, with the support of logistical third parties, we complete the distribution network in foreign areas.

CEDIS has been a project that has brought an important benefit with this option of participating in large volume projects directly and we still have many more products that we want to bring to Mexico to participate with even more presence and with more impact on the system of health in Mexico.

Q: What makes B. Braun an integral provider for healthcare in Mexico?

A: We are making all the necessary investments to bring and distribute more innovative products for the health system. For example, our investment in 2020 in Mexico exceeds MX$120 million (US$5,347.91) only in equipment, such as hemodialysis pumps, infusion pumps, equipment for orthopedic implants, intercranial precision monitoring for head injuries and products that can promote technological development in the hospitals. As a way to contribute to the Mexican health sector, B. Braun has presented one of our most successful models, which is the rental of equipment. This reduces the impact of capital requirements, in both the public and private sectors, and optimizes the operating costs of institutions.

Apart from this, we are very interested in introducing more pharmaceutical products in Mexico. We have a strong line of medical devices, but we also have a pharmaceutical line focused on injectable solutions. Additionally, we work closely with associations such as CANIFARMA and AMID to ensure that our products can be delivered to Mexican patients and to ensure a good relationship with the government to resolve any complications in documentation or processes, especially during the COVID-19 when all deliveries must be made in a timely manner.

Jordi Fernández

General Manager Mexico of Roche Diagnostics

Comprehensive Diagnosis Solutions for Today and Tomorrow

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More about this person Q: How does Roche Diagnostics address the needs of patients?

A: A fundamental pillar of how Roche Diagnostics meets the needs of the sector with its diverse solutions is through the positive impact that it can deliver to patients, with methods supported by innovation and development. The company has a clear commitment to invest in R&D. Last year, Roche Diagnostics spent some CHF 11.6 billion (approximately US$13.503 billion) on R&D at the global level. This is one of the reasons we are a global leader in the healthcare industry.

Q: How has Roche Diagnostics demonstrated its quality during the pandemic?

A: One of the key demonstrations during the pandemic has been the effort and speed at which we have delivered highquality diagnostic solutions. Quality is extremely important because not all diagnostic solutions available today have the sensitivity and specificity that is required for COVID-19 patients. We have almost 10 COVID-19 tests in global markets, though these are not yet available in the Mexican market because they must first go through the country’s regulatory process.

Q: How does Roche Diagnostics identify solutions suited for the future?

A: The company is very decentralized. It is also very close to the market, the main stakeholders and patients. We also have almost 125 years of experience improving people’s lives. All of this puts us in a favorable position to meet future needs and deliver personalized healthcare. The most important stage of the process is direct testing with patients. This enables us to develop preventive solutions that can help with early diagnosis of any disease so patients find appropriate treatments sooner.

Q: How do the company’s software support solutions complement its clinical diagnostics solutions?

A: Digital solutions have grown rapidly over the past few years, diversifying the ways in which we can provide value to patients who we value the most. The value of digital solutions can be viewed from connectivity between our solutions and its integration to the electronic healthcare records (EHR). We have solutions to help healthcare professionals treat patients more effectively across several therapeutic areas such as diabetes, oncology, infectious diseases, among others.

Q: Does the company have any other solutions that will soon reach Mexico?

A: We continue to focus on diseases that represent heavy burdens across the globe. We are developing specific tests in the oncology field, which will give results far more quickly and will help increase survival rates for patients. Similar developments are ongoing in the cardiovascular area, as well as for diabetes. We have not stopped any of these developments due to COVID-19 and we are aiming to expand the access our solutions into other pathologies like infectious diseases, metabolism illnesses and other chronic diseases.

Paul Barber

Managing Director of Getinge Mexico

Operating Room Digitalization a Priority for Swedish Tech Giant

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More about this person Q: Which would you identify as Getinge’s largest contribution to Mexico’s healthcare system?

A: Our largest contribution to Mexico’s healthcare system is our wide range of products. Mexico, especially in the public sector, has problems investing as there are not always enough capital resources available to buy new equipment, which can be quite expensive. So, many procedures are made possible in Mexico by the use of integrated service providers, which rent services to hospitals. We have seen this with anesthesia, endoscopic and cardio procedures, which are offered on a rental or procedure basis. Getinge has a wide portfolio of equipment and consumables that are ideal for this business model, including our anesthesia machines, ventilators, sterilizers and life-support systems.

Q: How is Getinge incorporating digitalization and what benefits does this bring to doctors?

A: We are aunching a new software called Torin for the optimization of operating rooms. It is a surgical procedure programming software that is already being used in some countries where it has shown to increase OR efficiency by 30 percent. We now have our first demo unit for this software in Mexico. Our OR offering includes the T-Doc software for instrument traceability and the Tegris digital integration software; there is a growing interest in OR digital integration but so far it is only implemented in very high-end hospitals or in certain OR’s.

Q: What benefits do your customers get from connecting their devices to Getinge Online?

A: We have two product lines that can be connected to our online service Getinge Online: one focuses on acute care products, including ventilators and anesthesia machines, and the other deals with sterilizers. These products are becoming increasingly popular as a growing number of hospitals understand the benefits of connecting their equipment to Getinge Online, which includes instant access to data, remote diagnosis to optimize the devices’ performance, maintenance and remote diagnostics to ensure that technicians arrive with a full set of tools and parts and are able to fix the equipment on their first visit.

Q: What are the main lessons Getinge learned from the COVID-19 outbreak?

A: This crisis has shown us that the most sophisticated device is not necessarily the most effective one for optimal patient outcomes. Ventilators have been a priority. Our factory has increased production by 160 percent. Our goal is to produce 26,000 devices this year, of which we expect to install over 400 units in Mexico, Central America and Caribbean region this year. Our other priority is our new product Stericool: a low temperature sterilizer. During this crisis, low temperature sterilizers have been highly convenient as their working cycles are very fast and they are delicate with instruments.

Q: What products will Getinge introduce to Mexico this year and what difference will they make in the local market?

A: In Mexico, we are introducing a series of next-generation operating tables and by the end of this year, we will introduce two new devices for extracorporeal oxygenation life support.

Carlos Hernández

Director General of Beckman Coulter

Innovative Diagnostic Test Reduces Overall Costs

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More about this person Q: How has Beckman Coulter boosted its presence in the Mexican market?

A: Over the past two years, we were able to dabble in the public sector. We have had an important number of product releases and our unique technology has opened new opportunities for Beckman Coulter. We have launched the new hematology platform DxH 900 which includes an innovative early indicator for sepsis, which is one of the most aggressive and dangerous ailments during hospital stays. Beckman Coulter is focused on patient-centric solutions and these kinds of tools have increased our presence in the market.

Q: What has been the reception for Beckman Coulter’s diagnostic test for prostate cancer?

A: The product has attracted interest from the public sector, mainly from Hospital General de Mexico, Hospital DR. Manuel Gea Gonzalez, INCMNSZ and Centro Medico Naval. Using this test might reduce the number of patients that require invasive prostate biopsies. Although the benefit of the product is clear, we still have a major opportunity to generalize adoption of this novel test at public and private institutions.

Chronic degenerative diseases worsen with age, meaning the patient will require follow-up and attention. For these groups, going into a biopsy is already a risky decision. With diagnostic tools such as our test for prostate cancer, the hospital reduces operation room occupation. Due to its increased specificity phi (Prostate Health Index) has potential to reduce unnecessary biopsies by 30 percent. The test also reduces diagnostic wait times as the results are returned in just a few days.

Q: Based on your work in Mexico, what trends are shaping clinical diagnostics?

A: Sepsis is an important trend shaping clinical diagnostics, which is why we developed the Early Sepsis Indicator for our hematology platform DxH 900. This endemic problem for hospitals has recently worsened because patients are arriving in more critical condition. Sepsis is an often-difficult condition to be detected early and sepsis shock is one of the most expensive and dangerous conditions for hospitals to treat.

COVID-19 is and will be the major clinical diagnostic trend for the market. We are developing and will soon launch serology tests to determine if the person shows antibodies and could have developed immunological response to COVID-19. Beckman Coulter has worked on an assay that detects antibodies against the virus spike protein that may be more likely to confer immunity, delivering higher sensibility and specificity in the early days of infection and also not impacting on laboratory regular workflow.

Q: How is Beckman Coulter improving access to its solutions and bringing its technology closer to Mexican patients?

A: It is very important to gather clinical and pharmacoeconomic evidence generated at the hospitals where we are present. This allows us to prove to clients that the investment they are making is actually contributing to their practices and saving them further costs, increasing patient’s quality of life and safety.

Enrique Giraud

Managing Director of Fujifilm Mexico

Javier Giraud

Medical Systems Vice President of Fujifilm Mexico

Device Innovation Delivers Long‑Term Benefits

Read the complete article Q: What are the company’s strengths in home care and device interoperability trends?

EG: The market in Japan is driven toward constant innovation, which is reflected globally at Fujifilm. Home care and device interoperability to facilitate diagnosis and treatment is pushing innovative changes to make our equipment smaller and lighter, meaning they are easier to transport.

Fujifilm is consolidating different studies generated by a wide variety of medical devices to provide an integral treatment to the patient. Our technological platform allows us to combine different data coming from the diverse equipment we have for various specialties, such as imaging and endoscopy.

JG: When developing new technologies, our goal is to provide better image resolution and this has led us to develop devices that provide high-resolution images with considerably less direct radiation in a much more compact, portable device. The creation of portable devices makes home care a reality.

Fujifilm is also moving toward more interoperability. Today, all our devices are interconnected and we have been implementing AI for years on many devices for mammograms, radiographies, X-rays, magnetic resonance and, more recently, ultrasounds and endoscopy. With our interoperable open platform called REiLI, we are allowing new technology developments even from other companies or developers to deliver the best solutions for healthcare.

Fujifilm’s innovative technologies are making it easier for doctors to identify the damage to the respiratory system of patients suffering from COVID-19. The company has been exploiting AI for some time; however, the ReiLI platform has allowed us to prove its functionality in an open-source way.

Q: How has Fujifilm Mexico positioned itself in the booming market of digital technologies?

JG: While the benefits of these developments are obvious, there is still a great deal to do to fully adapt interoperability to benefit different areas. Many medical units tend to be isolated, which is why Fujifilm Mexico is introducing our developments to the medical environment so companies can start incorporating them more naturally into their work.

We are working with the Ministry of Health of Veracruz where Fujifilm has installed an interconnected environment between the area of ultrasound, endoscopy and radiology that allows them to communicate across areas, hospitals and the whole ministry. This means that patients’ clinical records can be stored in one place.

Q: What new development is Fujifilm introducing to Mexico in the near term?

JG: We have been working on a C-arc development, which is intended to be introduced in Mexico by the end of 2020. This has the same characteristics as our compact and Nano developments. It is built to be smaller and with a lower radiation dose. We developed this device alongside our imaging and endoscopy areas.

Carlos Franyutii

Sales and Marketing Manager of Healthcare Solutions at Canon Mexicana

Universal Healthcare Demands Refurbishment of Obsolete Equipment

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More about this person Q: How is Canon Medical Systems shaping the future of medical imaging and diagnostics in Mexico?

A: Technology has changed a great deal throughout the years and its impact has been beneficial for medical practices. The images that Canon Medical Systems generate provide more information to doctors to support their diagnosis and allow them to write very precise prescriptions. The company believes that the future is promising for medical image digitalization.

Q: How is digitalization changing healthcare practices and how can it be implemented in Mexico’s fractured system?

A: Canon provides solutions that optimize costs, which range from the introduction of a medical system to its maintenance and operation. Canon Medical Systems focuses on workflows that can lead to a better and more efficient image, which also impacts a doctor’s daily practice as it provides an opportunity for early detection of a possible medical condition or issue. Our products are user-friendly in terms of process, use and diagnostics. Our goal is to reduce burden on both the healthcare systems and the patient.

Q: How do your services incorporate technologies and digitalization models such as electronic clinical records?

A: The introduction and use of electronic clinical records has been in the works for both the private and public healthcare sectors, but the progress so far has fallen short of expectations. Also, the current conditions of the Mexican healthcare system do not allow the smooth and correct functioning of a cohesive electronic record. The Mexican public sector incorporates a variety of entities such as IMSS, ISSSTE, SEDENA, SEMAR and PEMEX. Between them, there is no in-depth coordination, which is necessary for the correct use of an electronic clinical record. Having a universal healthcare system can create the right conditions to accomplish a unique health record. Canon Medical Systems is the first link in the imaging process. Our products and services help to integrate a digital image that allows high portability. Canon Medical Systems’ software for digital solutions allows a more efficient handling of images, while complying with the industry’s standards and current healthcare needs.

Q: How does Canon Medical Systems improve the health and quality of people’s lives through its diagnostic products?

A: Canon Medical Systems values its products based on their added benefits, the high quality of the image, high productivity and lower operational costs. All these benefits can translate to the patient’s treatment and to a doctor’s daily practice. By using our imaging products and services, a doctor will be operating with the best images, the most efficient workflows and the knowledge that the information generated by the equipment can be managed on different systems.

Q: What new products and services will Canon Medical Systems introduce to Mexico’s healthcare sector this year?

A: We are launching a new optical coherence tomography especially for angiography. Right now, we are focusing mostly on products for ophthalmology and digital radiology.

Raúl Jacobo

Health Manager of CHG Meridian Mexico

Heavy IT Integration Proves Beneficial in ‘Odd Times’

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More about this person Q: How did the pandemic impact your operations and how did you adapt?

A: CHG Meridian did not stop any operations during the pandemic. We attended our clients and acquired a few more. We are a highly digital company, therefore switching to a fully remote working model was an easy transition for us. We have been very active in the market throughout this time.

Furthermore, we are supporting our global clients with their digital transition. One of our biggest verticals worldwide is technology equipment. The demand for mobile technology equipment has picked up a lot during this time. We believe that this is going to further grow our business in 2021.

Q: What are the latest upgrades you have made to TESMA, your digital platform for asset management?

A: TESMA is one of the pillars of CHG Meridian. Approximately every two years we do a new release with improved capacities. The platform, which is web-based, is very user friendly and one of the latest upgrades made it mobile-friendly. Being web-based means that clients do not need to download a software program to use it, regardless of the device. We have the philosophy to simplify asset management to our customers, therefore we constantly increase the capabilities of TESMA.

Q: What are the considerations for hospitals when adopting more technology?

A: Science and technology are always evolving, and it is important that hospitals promote new trends among their doctors and patients. With new technology and innovative equipment, the hospital can build competitive advantages such as better doctors, shorter and less invasive procedures, new treatments and a better branding. However, there are important cost deliberations. Sometimes, a hospital only conducts five procedures for a specific treatment a year. For any new equipment, the hospital needs to justify a minimum number of procedures to make it costefficient and do affect the income statement.

Q: How would more public-private sector collaboration impact the penetration of new technologies?

A: I think the public sector is overburdened. Collaboration between the two sectors would benefit everyone. If a private hospital can negotiate the provision of a certain procedure for the public sector, it would greatly help public hospitals and patients. On the other hand, this would also serve as strong branding for private hospitals and will bring income to finance other projects.

Q: What should the sector learn from the pandemic?

A: During the pandemic the sector experienced an increase in technology and digital demand between doctors and patients. All hospitals should have a solid technology base to respond quickly to new trends. Those that did well adopted WHO’s recommendations very early. Some hospitals created separate COVID-19 and nonCOVID-19 areas. These hospitals are not necessarily the vanguard of technology and equipment but they were at the forefront when implementing safety measures. Using smart financial options, like leasing, can save cash to act fast in situations like this.

Alejandro Von Mohr

Director General of Atramat

Infrastructure and Innovation Investment to Lead the Market

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More about this person Q: How has Internacional Farmacéutica’s new plant supported Atramat’s operations?

A: The plant, called S&Mohr America, is a co-investment between Atramat and our Turkish partners that have 25 years of expertise in anesthesia and ventilation circuits. The regulatory process for this plant began in 2020, meaning that in just a couple of months, we obtained all the necessary regulatory certificates, including Good Manufacturing Practices, ISO 13485 and CE Mark. We have been commercializing these circuits for about two months in Mexico and we will soon start exporting them to five Latin American countries.

Q: How is Atramat innovating in the sutures market and what are some of your recent contributions to the sector?

A: Right now, due to the pandemic, the market is ruled by respiratory products. Hospitals have reduced considerably the number of regular surgeries, as a result our strongest business line which are surgical supplies have decreased in demand. However, we have already started to experience growth in demand and we hope to start seeing a recovery by the end of the year regarding surgical supplies.

Regardless of the pandemic, the company has not stopped innovating. In the end of 2019, we acquired a company in Germany called Santec Medical GmbH, which is dedicated to innovate in the field of cardiac surgery. They developed a new product that allows a less invasive and safer procedure for the repair or replacement of mitral valves. While Atramat does have experience in this field this is the first time that we are growing significantly in this market.

This is a strategic step for these types of applications that are an essential life support for patients. This acquisition allows us to continue innovating through that company and to be able to commercialize such products in all markets where we are present.

Q: As one of the world’s largest supplier of surgical sutures, how did Atramat respond to the COVID-19 outbreak in Mexico?

A: We have a very strong distribution network that covers all private and public entities which was especially useful during the pandemic and enabled us to keep our distribution undisrupted for the continuity of the surgeries in Hospitals in Mexico and Worldwide.

Q: How will the government’s decision to create a new distribution center for medical devices impact Atramat’s operations?

A: We continue participating in regular government tenders to keep offering our top-quality devices at a very competitive price. It is not yet clear if essential or primary-need products will also be subject to the new purchasing and distribution management that the government is undertaking. However, we are one of the main distributors for UNICEF in surgical sutures, so we can use this experience to the UN acquisitions purchases with the Mexican government.

Carlos Pardo

Marketing and Sales Vice President of Levbeth Group

Tech Innovation for Less‑Invasive Endovascular Solutions

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More about this person Q: How has the group’s presence developed in Mexico?

A: Our group consists of a number of companies that work together. BMC Medical develops and manufactures medical devices; Angio Medical sells and distributes medical equipment, devices and medical products; Endovascular Health Services, or EHS, installs medical equipment in hospitals and clinics; CETE trains doctors, technicians and nurses in using our devices and the latest technology; CONRAZON, a nonprofit association, provides medical care to people with limited resources; BMA develops and commercializes natural diet supplements; and lastly, LABTAM distributes pharmacogenetic tests or DNA tests. Additionally, Levbeth Medical distributes medical devices for endovascular therapy on seven specialties

Our developer and manufacturer BMC has two factories in Mexico, both located in Nuevo Leon. Of the devices we sell, 85 percent go to the public health sector and 15 percent to the private sector.

Q: What new products have you added to your lineup?

A: In 2019, we launched and distributed a special stimulation device for Parkinson’s and another one to treat pain. This is a unique device because it can be operated by a doctor from an iPad, allowing the doctor to program the stimulation according to the particular condition of the patient. The patient can monitor their own parameters with an iTouch device. This system already existed but we brought the latest technology to the market.

CP: This year, various BMC products will receive the registration from COFEPRIS. One of these is a device called WEB that is used to treat brain aneurisms. We expect this device, for which we have distribution rights in Mexico, to be registered by May.

Q: How do your different companies come together to strengthen the group’s capabilities?

A: For many years, we have been investing in developing our manufacturing capabilities here in Mexico. BMC’s plants are the first in Mexico to manufacture many of what we know as Class 3 devices. In the US border region, there are many plants with an export calling. Instead, we manufacture for the Mexican market, although we are also targeting the rest of Latin America. We want to make high-quality devices at a better cost in order to increase access to these devices.

Q: What improvements would you like to see the regulatory framework?

A: This is a very regulated industry. The registry process with COFEPRIS takes between two to three years. Before getting to the registry phase, we have several phases of development and production. Some of the products we have developed originated from the ideas of local doctors who approach us. In other cases, we buy the technology, conducting the legal acquisition of intellectual property, and then develop products from this. At BMC, we have an engineering department with six biomedical engineers. They develop a prototype, search for the material, build the product and test its performance and biocompatibility.

A Mexican Ventilator to Stand Against COVID-19

Read the complete article Ventilator availability was among the main concerns at the beginning of the COVID-19 pandemic. The necessity drove Mexico to draft quick acquisition plans and prodded entrepreneurs to start developing or to at least contribute to the development of these technologies.

In August, INCMNSZ announced the creation of the ventilator VSZ-20-2, developed alongside Metalsa, Proeza, FEMSA, Torrey, Bocar Group, GSE Biomedical, Coppel, Lodi Automotríz, TLM, Tecnológico de Monterrey, Lanix Med, Steris, Universidad de Monterrey, Ternium, Nemak and TINC with the technical and regulatory evaluation of COFEPRIS, CONACYT and CENETEC.

To learn more about this development, MBN spoke with Guillermo Domínguez Cherit, Deputy Director of the Critical Medicine Area at INCMNSZ, who took part in the ventilator’s creation. “Years ago, the institute developed a ventilator that mimics the workings of a syringe. We took this prototype and designed an engine that would move a cam to drive a piston and push the air,” he said. Dominguez Cherit clarified that the device is intended to be used only during the pandemic; VSZ-20-2 will not become the standard ventilator for ICUs.

Development began in March after the institute, together with the Ministry of Foreign Affairs, made a public announcement inviting companies to join the project. Metalsa was in charge of assembly at its manufacturing plant in Apodaca, Nuevo Leon, where a space was certified by COFEPRIS for medical equipment manufacturing. The first 20 ventilators were acquired by Fundación Carlos Slim to be donated and distributed to four hospitals in San Luis Potosi, Yucatan, Coahuila and Guerrero.

The titanic effort brought together many well-intentioned actors and stands as an example of the alliances and cooperation that have resulted from the COVID-19 pandemic. During the device’s presentation, Ramsés Galaz, Director General at GSE Biomedical, highlighted that the “the VSZ-20-2 emergency ventilator is further proof that collaboration between the government, academic institutions and the private sector can lead to successful projects for the benefit of all Mexicans.”

Developers also drafted an open manual of the device’s operating functionality and made all guidelines necessary for its correct use open source. Moreover, the coalition also offered training for professionals who were to use the device.

Biomedical professionals involved in the VSZ-20-2 project, such as Luis Fernández, Founder and CEO of TINC, have been vocal about the importance of their profession to the healthcare system and the seriousness of an entrepreneurial development to solve the crisis. “It is time for our national industry to start revamping itself to produce national solutions for national needs. We need to set things into motion by supporting national entrepreneurship and intrapreneurship and enhancing our current regulation to facilitate growth in the coming years,” said Fernández in an interview with MBN.