Simply-Spiro

A cheaper alternative to spirometry tests to increase early detection of respiratory illnesses in low-resource contexts and developing countries.

Simply-Spiro is a spirometry test compatible with low-resource settings. Simply-Spiro provides information about a patient’s respiratory health, allowing for diagnosis of respiratory conditions, without the need for any additional devices or technical expertise. 

To diagnose a patient with respiratory conditions such as COPD, Simply-Spiro uses a patient’s breath to measure the two most relevant values: the Forced Vital Capacity (FVC), or total volume of air expired in the breath; and the Forced Expiratory Volume at the first second (FEV1), or volume of air expired in the first second of the breath. 

Simply-Spiro measures and displays these values without complicated machinery. The compact, portable, battery-powered device consists of an external, consumable breathing tube for the patient directly connected to a vertical chamber, which traps the expelled air. 

The volume of air expelled by a patient through the breathing tube causes the displacement of a movable ceiling through the chamber. The displacement of the ceiling would be measured by a pulley system fitted with an Arduino sensor. The Arduino would take the displacement data to calculate FEV1 and FVC and display this information on a small screen on the side of the device.   

We are trying to solve the limited availability of spirometry tests in low-resource settings. These tests allow healthcare providers to diagnose several respiratory conditions, including COPD, asthma, and emphysema. However, the cost of spirometers can range from 900 - 3000 USD, which limits their accessibility in under-resourced countries and regions. For example, a 2018 study found that, in Uganda, only 13.6% and 34.8% of private and public hospitals, respectively, offered spirometry. Often, however, these settings need spirometry the most. Additionally, current spirometry techniques require a degree of technical expertise. According to the 2018 study, only 34% of a group of technicians in Nigeria knew how to administer a basic spirometry test. 

The lack of spirometry in these settings can have dire consequences. According to the WHO, there are 3.23 million annual deaths from COPD, and that 80% of those deaths were in low- and middle-income countries. The lack of spirometry tests and training is a global health issue that Simply-Spiro hopes to tackle.

Simply-Spiro plans on serving clinics and hospitals in low-resource settings and developing countries. The creation of an affordable and easy-to-use spirometry test will allow for increased early detection of respiratory diseases such as COPD and asthma, ultimately leading to less deaths at the hands of these preventable respiratory diseases. Financially, accessing a spirometry test can be quite difficult. In fact, according to a 2017 study,  a spirometry test currently costs around 27.8 days’ worth of wages in Uganda. Thus, it can be difficult for a patient to prioritize getting early diagnosis. Simply-Spiro will bridge the gap between accessibility and early detection.  

In the past month, we have swept through a broad array of research focusing on COPD and other respiratory diseases in developing countries. We are currently sorting out a meeting with Rice 360° Institute for Global Health, an organization with a mission to solve global health issues, to potentially connect with their partners, such as Queen Elizabeth Central Hospital in Malawi, Africa, to get a more comprehensive dataset of our target population. 

We plan to first connect with local hospitals in Houston to test and refine Simply-Spiro. Additionally, we hope to connect with clinicians in both Houston and Malawi to ensure that the device meets set standards and develop a training program for respiratory technicians. 

We recently started the development process by looking at prior research related to the need for affordable spirometry tests for low-resource settings. Then, we were able to create preliminary design ideas and began our search for a mentor, especially within the context of our university, a process we are still in. After discussing the various design options, our team was able to finalize a single design, which is a refinement of one of those preliminary ideas with added capabilities. Overall, the concept stage is the most accurate stage of development for our team as we have justified the need for a simple and affordable spirometry test by doing background research, discussed different possible designs for the product, and decided on a final approach. Our next step is to develop an early prototype for concept testing. 

The core technology powering our solution is Arduino. Arduino is a robust open-source engineering tool that allows for small-scale customizable software and hardware development. It can be used to assemble and program a variety of robotic and electronic systems, and is at the center of Spiro-Simply. 

In order to determine the FEV1 and FVC values, Simply-Spiro utilizes an Arduino-pulley-string system attached to the movable ceiling of the vertical chamber. As the patient breathes through the mouthpiece, the induced in-chamber volume of air displaces the ceiling and that displacement is measured by the Arduino to produce FEV1 and FVC. 

In the long-term, following prototyping and an early launch of Simply-Spiro, we hope to transition away from Arduino into a independently-made electronic assembly, more compact and streamlined than the Arduino prototype. We envision that this will further reduce manufacturing costs. 

Currently, our solution serves 0 people as the solution has not been launched yet. If our design has proven to be successful, our goal is to serve at least ten clinics/hospitals in low-resource areas in the upcoming year.

Our impact goals for the next year include the following: 

1. Donate our device domestically to at least five local clinics, community health organizations, and nonprofits that work with under-served communities.

2. Contact international distributors for the transport and utilization of our device in at least five clinics in developing countries. 

3. Increase the use of spirometry tests in participating hospitals/clinics by at least 25% by the end of 2022.

4. Pitch Simply-Spiro to several physicians to see its potential as a direct-to-consumer product for at-home respiratory data collection.

We hope to achieve our goals by firstly creating a suitable spirometer alternative. We plan to prototype and clinically test our device. After the product is finished, we will mass manufacture it and make it accessible through donations to nonprofits and other organizations that can help us distribute the device. Additionally, we are considering if the device should be directly used by consumers and hope to lay the groundwork to sell it. 

We plan to measure progress by tracking the number of patients that are able to get a spirometry test before and after distributing our device. We also hope to track the cost-effectiveness of the Simply-Spiro (cost of Simply-Spiro vs decreasing cost of treating respiratory illnesses). Since our ultimate goal is to reduce complications due to late-stage diagnosis of respiratory diseases, we also plan to track community mortality rate attributed to respiratory diseases and percentage of hospitalizations due to respiratory diseases. These indicators are inspired by indicators associated with the United Nation Sustainable Development Goal #3. 

Financial Barriers: 

As an independent project, our team will need to secure funding to prototype and later mass manufacture the device. Additionally, there is a startup cost associated with getting the device to hospitals and clinics in low-resource contexts. 

Technical Barriers:

We foresee some difficulties in incorporating Simply-Spiro into low-resource/developing countries’ healthcare systems. We hope to address this with appropriate training and education.

Cultural Barriers: 

With the introduction of a device that we hope will fill a previously nonexistent niche, there may be some hesitations to user adoption. Certain cultures globally also may not be familiar with spirometry. 

Legal Barriers:

As a medical device, our solution would need to seek a letter of substantial equivalence from the FDA for it to enter the market in the U.S.

Market Barriers: 

We have to evaluate the viability of Simply-Spiro becoming a direct-to-consumer product in the existing large medical device sector and its ability to prove as a funding source for donations (of Simply-Spiro units) to low-resource settings.

Our team background comprises a diverse skill-set. Our team members have experience in nonprofit management. In the past, one of our team members worked with COOs of hospitals and nonprofit board members to encourage healthcare workshops in the community. Through this experience, he hosted a conference for over 1800 individuals. Additionally, with some of us coming from an underserved community (Rio Grande Valley), we are well aware of the effects healthcare accessibility can have on lifestyle and wellbeing. These experiences allow us to understand the population that we want to serve. 

Our team has a great deal of engineering skills and experience as well. Our members have programmed with Java, JavaScript, and C++. Some of our members are currently in the process of learning Matlab and Python. We have limited experience with Arduino, but all members are currently expanding our ability to robustly use the tool.  

We also have a background in research, including projects and experiments in medical app-development, wet-lab work, material science, and electrical engineering. We believe that these experiences will aid us in immensly constructing our solution. 

Simply-Spiro seeks to improve the quality of life of a wide array of populations. It will especially have impact on woman as recent studies show that there are increasing rates of deaths caused by COPD in woman than men.