A self-administered anti-choking device needs to generate suction without requiring any human force, while respecting the lungs and functioning when needed, even after being stored for a long time. Opportunity Health is working on an anti-choking device with a CO2 cartridge, designed for this scenario. In chapter 64 of “Toque de Ingenio,” Germán Alejandro Sánchez and Nicolás López de Aguileta explain the origin of the idea, how the mechanism works, and what is required to certify a Class IIa medical product.
Guest: Germán Alejandro Sánchez and Nicolás López de Aguileta, who are presented in the episode as the creators of the Opportunity Health device. Interview published: October 14, 2025. Episode: 64. Duration: 1 h 17 min.
In this episode:
- Why a CO2 cartridge and a multi-stage Venturi system replace the user’s effort/force.
- How the volume of air extracted is limited to avoid damaging the lungs.
- What regulatory and validation pathways differentiate a prototype from a CE-marked product?
The interview was recorded in Montcada i Reixac, with both guests having just arrived from Navarra. At that time, the team had a functional prototype, a design that was nearly finalized, and a funding round underway to achieve the CE marking.
Choking while alone: the problem that gave rise to the project.
Germán recounts that the idea originated from a family meal in 2022, during which his older brother suffered a complete choking incident. His father, who had training in first aid, performed the Heimlich maneuver and saved his life. The question that remained was what would have happened if his brother had been alone.
When searching the market, he found that all available solutions required a third person and human effort. Germán describes the current protocol: five inter-spinal taps and five abdominal compressions, and points out that this manual maneuver is not part of it. Those who are alone must go out and ask for help before losing consciousness.
Germán has provided figures that highlight the issue. According to INE (Spain’s National Statistics Institute), 3,546 people died in Spain in 2022 due to choking, three times more than in road traffic accidents. 90% of these deaths involved individuals over 65 years old. Hypoxia begins after approximately four or five minutes, and an ambulance typically takes over eight minutes to arrive in urban areas.
With that starting point, Germán parked his small design business and founded Opportunity Health in August 2024. The aim was a self-application aid, usable while sitting, standing, or lying down, which was referred to as “Yarnasa,” a game incorporating “arnasa,” meaning “breathing” in Basque.
Create suction without human force: CO2 cartridge and multi-stage Venturi.
Existing devices, as described by Nicolás, operate through mechanical force. The most common type resembles a blockage remover with valves; another is a large syringe with a plunger. In both cases, it’s necessary to hold the mask and push simultaneously, applying two forces that compromise the seal.
The Opportunity Health device separates the user’s energy. A CO2 cartridge powers a multi-stage Venturi system, which generates negative pressure in the mask. The guests explain it as three Venturis in series – each stage closes when a minimum vacuum pressure is reached, and the next continues to extract airflow.
That configuration achieves better performance with the same amount of gas as a single-stage Venturi. It allows for multiple shots from a single cartridge, and provides multiple opportunities for the person being restrained. In a demonstration using an aerial simulation, the discharge lasts less than one second.
German emphasizes that the innovation isn’t in the individual components, but in how they’ve been combined to create the deflector. This is a common situation in product design and development: The solution emerges when established technologies are used to address a very specific need.
Limit the extracted volume to ensure safe usage.
A device that draws air from the lungs raises an obvious question: what happens if it’s activated after the blockage has cleared? Germán explains that the equipment doesn’t regulate pressure or flow – those are determined by the suction – but rather the duration of its operation, and consequently, the volume extracted.
The basis of this approach relies on an average lung capacity of four to five liters, and the fact that more than one liter is present within the airways. The device extracts a maximum of two liters – a volume that, according to their testing, is sufficient to clear blockages and prevents the lungs from collapsing.
“We are assuring you that nothing further will happen to you”.
German Alejandro Sánchez 29:18.
That reasoning also reflects the order of market entry. Validation will begin with adults, and from the age of 12, the respiratory system is considered developed. Subsequently, versions for children and newborns will arrive, with a smaller mask and a different volume, following previous validations.
Certifying a medical device of class IIa without being able to perform a simulated choking test.
Nicolás, a biomedical engineer, handles the regulatory aspect. He explains that the suction device is a Class IIa medical product because the vacuum power is not provided by the user, but by the cartridge. This class requires an authorized body to assess safety and efficacy before granting the CE marking.
The main difficulty lies in demonstrating clinical effectiveness. While tests are conducted on patients using thermometers or patches, it’s impossible to induce choking in order to test a device.
“How do we scientifically validate this, and how do we clinically validate this device”.
Nicolás López de Aguileta 43:16.
The strategy, which wasn’t finalized at the time of the interview, incorporates several approaches. One involves justifying the analogy with existing products that utilize similar technologies, an option that, at a European level, requires a very robust justification. Another includes tests using sensorized dummies to measure pressures, and potentially, tests on cadavers.
This is further compounded by the quality management system and the rule that all testing must be conducted using the device as it will be sold. The team has regulatory consulting, maintains communication with notified bodies, and collaborates with the University of Navarra on the clinical side.
Design for the way it’s used: a non-puncture cartridge and maintenance.
A survival product can be stored for years. Edgar asks what happens to a punctured cartridge over many years, as even a small leak would render it empty. The guests respond that the new design uses a cartridge that doesn’t have a threaded opening and isn’t perforated from the start.
The system is a two-stage design and will not operate unless both functions are activated. When activated, an internal spike pierces the cartridge through impact, releasing the gas at that moment. The requirement, as you’ve described it, is that you shouldn’t ask someone who is choking to change the cartridge.
The same concern underlies the proposed business model. Germán describes a distribution strategy – indirect, through distributors – targeting residential properties, schools, nurseries, and restaurants, offering a rental scheme with everything included: the device, an annual maintenance certificate, and consumables such as cartridges and masks.
The defibrillator is the reference point. The guests do not rule out direct sales with an annual inspection, as with a fire extinguisher, but stress the need to ensure that the device is in working order when it is needed.
Team, funding, and patent before industrializing.
Germán reports that a health accelerator in Navarra showed him everything he needed: regulatory aspects, investors, finance, prototyping, and intellectual property protection. He concluded that a single person couldn’t achieve the CE marking and began building his team: Iñigo Almazán for industrial design, materials, and manufacturing, the Navarra-based company Darwin Biomed for design and prototyping, and Nicolás for regulatory matters.
The functional prototype shown in the episode has already been used to validate the system; the next version is focused on the regulatory dossier. This transition prototype and the certifiable unit was well advanced, with details still to refine, but industrialisation could not begin until CE marking had been obtained.
On the financial side, the project had early investors and a loan of €100,000, and was preparing a new funding round of half a million euros, with CE marking as its goal.
The accelerator had requested a patentability study, and the European patent was applied for in January or February and was currently in process. Edgar commented that, in thousands of projects, he had rarely seen patent conflicts. Germán acknowledged that at his previous company, products were launched to market without patent protection, but within the healthcare sector, things operate differently.
What can another development team learn?
The Opportunity Health case offers four key lessons for anyone developing an emergency product or medical device:
- To remove the pressure from the user. When the context is one of panic, the product needs to function effectively; separating the power source from the user’s action completely altered the design.
- Prioritize safety limits over raw power. Defining the maximum volume derived from physiological data provided a design criterion and a justification for certification.
- Asking in advance about the validation process. In a medical product, the type of evidence and the strategy used to gather it are as important as the technical aspects, when it comes to shaping the design and the timeline.
- Design the state of rest. A contingency team can go years without being used; the un-fired cartridge, expired dates, and maintenance are all part of the product.
At the time of the interview, Opportunity Health had not yet entered the market. The team was planning to launch it between the end of 2026 and the beginning of 2027, with the investment round open and the European patent pending.
In i-mas, we support projects that move from a functional prototype to a manufacturable and documented design, also within the healthcare sector. If your device needs to function flawlessly and meet demanding regulations, Tell us about your project..
To continue reading: How is an electronic medical device developed?.
Source of article: Interview with Edgar Guerrero, featuring Germán Alejandro Sánchez and Nicolás López de Aguileta on “Toque de Ingenio.” The excerpts cited link to the relevant minute of the conversation. The project recommendations presented are a summarized editorial from i-mas.
