Montserrat Galindo
Head of Market Access
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Mexico Needs Stronger HealthTech Regulations: Masimo

By Miriam Bello | Tue, 08/09/2022 - 13:16

Q: What has driven Masimo’s leading position in monitoring technologies around the world?

A: Masimo works for value-based healthcare and is committed to patients and technological innovation. Our mission focuses on improving non-invasive monitoring technologies while also offering cost-effective solutions to institutions and patients. The company was created with the mission to put the patient at the center to improve healthcare, which has been a constant over the years.  Our mission represents it all: Improving Patient Outcomes and Reducing Cost of Care.

Q: What has been Masimo’s journey in positioning its solutions in the Mexican market?

A: Despite our well-known competition, we have an advantage because of our differentiated technology. Masimo focuses on technological innovation thanks to our strong research background and R&D and clinical areas. What makes us different is our work to innovate using our existing technology. We continue to improve and benefit patients and institutions.

Our technology can be connected to other monitors and equipment to better track the patient, allowing us to see the parameters other manufacturers use and integrate them into a single solution that provides doctors with all available data.

The aforementioned is reflected in patient safety, efficient decisions and better quality of health path attendance.

Q: What has the company learned from working in this market and how have you implemented your business model in the country?

A: Masimo arrived in Mexico five years ago. The market is new but we already have important representatives and commercial partners who have fallen in love with the brand. They have helped us position the brand in Mexico. We are learning and adapting to the changes in the Mexican laws regarding acquisitions in the private sector.

Q: What strategies has Masimo implemented so the patient can access this technology?

A: We are working closely with hospitals. Instead of offering a single product, we provide them with comprehensive solutions in accordance with their needs and support them throughout the installation process. We are present in 70 percent of the most important hospitals in the US and we know that we can have the same level of success in Mexico.

Q: How has Masimo positioned its solutions in the Mexican market?

A: We have joined local associations and chambers. Mexican regulations still require the differentiation of medical devices from pharmaceuticals because they are very different. To be able to offer integral services and solutions, the government must facilitate the acquisition of and promote access to new medical devices. It takes an average of four years from the launch of a medical device until the patient can access it. By the time a customer can use it, most of its components have changed.

Q: How does the Digital Health Law help medical tech regularization and what can be done in the industry?

A: Many medical devices receive constant software updates but there is not much clarity on how these updates will be regulated. The Federal Customs is not aligned with the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), sometimes we are asked to comply with regulations for the sale of computer or stationery equipment. But these processes are not linked to sanitary registration because authorities have not determined how to properly register this type of equipment.

The industry must work together because the well-being of the patient is our common objective. Only through collaboration will we have an impact.

Q: What are Masimo’s market goals for Mexico in the next three years?

A: We want to position ourselves in the country and generate awareness of our brand and high-quality products. We are still not well-known in Mexico, so we want to be part of the conversation among manufacturers to establish ourselves as a high-quality brand, with benefits for the patients, healthcare professionals and healthcare institutions.


Masimo is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative sensors and patient monitors.

Miriam Bello Miriam Bello Senior Journalist and Industry Analyst