Respira!: An Extremely Affordable Device for Better Asthma Care
This entry has been selected as a finalist in the
Disruptive Innovations in Health and Health Care: Solutions People Want competition.
More than 8 million children in Mexico suffer from asthma. These children and their families travel up to several hours to urban hospitals where they endure long waits to get relief from acute asthma attacks. More troubling still, these families are sent home from the hospital without the means to prevent further attacks. This all but ensures a vicious cycle of frightening and expensive returns to the hospital, and leads to a national asthma fatality rate that is the 8th highest in the world (1.45%).
The physicians in Health Centers, which provide nearby, free primary care to uninsured Mexicans, can recognize asthma and have access to the medication necessary to treat asthma attacks, but they lack effective, affordable devices to deliver that medication. Mexican Health Centers are stocked with asthma inhalers, which inexpensively create aerosol particles of medication, but these devices are not sufficient to deliver the medication to a child's lungs. Successful use of an inhaler requires that a child coordinate a deep breath with discharging the inhaler. This is challenging for a young child, particularly one gasping in the midst of an asthma attack. As a result, medication does not reach the lungs but is instead absorbed in the mouth and throat, where it causes undesirable systemic side effects.
To overcome these problems, inhalers are used in combination with a device commonly called a “spacer.” A spacer is a chamber that attaches to an inhaler, captures the discharged medication and holds it until the patient inhales it. In spite of their effectiveness, these devices are unavailable in Mexican Health Centers due to their cost (~ $50 plus distribution). Using paper and a precise system of cuts and folds, we have designed a spacer that can be produced for approximately 25 cents, a cost reduction of more than 99%. Furthermore, the device can be distributed as a flat sheet to be folded into a usable form on-site, so hundreds can be sent for the cost of a stamp.
About You
Location
Project Street Address
Project City
Project Province/State
Project Postal/Zip Code
Project Country
Your idea
Focus of activity
Technology
Year the initiative began (yyyy)
2007
Positioning of your initiative on the mosaic diagram
Which of these barriers is the primary focus of your work?
Complex, expensive medicine
Which of the principles is the primary focus of your work?
Push work down the chain of command
If you believe some other barrier or principle should be included in the mosaic, please describe it and how it would affect the positioning of your initiative in the mosaic:
This field has not been completed
Name Your Project
Respira!: An Extremely Affordable Device for Better Asthma Care
Describe Your Idea
More than 8 million children in Mexico suffer from asthma. These children and their families travel up to several hours to urban hospitals where they endure long waits to get relief from acute asthma attacks. More troubling still, these families are sent home from the hospital without the means to prevent further attacks. This all but ensures a vicious cycle of frightening and expensive returns to the hospital, and leads to a national asthma fatality rate that is the 8th highest in the world (1.45%).
The physicians in Health Centers, which provide nearby, free primary care to uninsured Mexicans, can recognize asthma and have access to the medication necessary to treat asthma attacks, but they lack effective, affordable devices to deliver that medication. Mexican Health Centers are stocked with asthma inhalers, which inexpensively create aerosol particles of medication, but these devices are not sufficient to deliver the medication to a child's lungs. Successful use of an inhaler requires that a child coordinate a deep breath with discharging the inhaler. This is challenging for a young child, particularly one gasping in the midst of an asthma attack. As a result, medication does not reach the lungs but is instead absorbed in the mouth and throat, where it causes undesirable systemic side effects.
To overcome these problems, inhalers are used in combination with a device commonly called a “spacer.” A spacer is a chamber that attaches to an inhaler, captures the discharged medication and holds it until the patient inhales it. In spite of their effectiveness, these devices are unavailable in Mexican Health Centers due to their cost (~ $50 plus distribution). Using paper and a precise system of cuts and folds, we have designed a spacer that can be produced for approximately 25 cents, a cost reduction of more than 99%. Furthermore, the device can be distributed as a flat sheet to be folded into a usable form on-site, so hundreds can be sent for the cost of a stamp.
Innovation
Define the innovation
More than 8 million children in Mexico suffer from asthma. These children and their families travel up to several hours to urban hospitals where they endure long waits to get relief from acute asthma attacks. More troubling still, these families are sent home from the hospital without the means to prevent further attacks. This all but ensures a vicious cycle of frightening and expensive returns to the hospital, and leads to a national asthma fatality rate that is the 8th highest in the world (1.45%).
The physicians in Health Centers, which provide nearby, free primary care to uninsured Mexicans, can recognize asthma and have access to the medication necessary to treat asthma attacks, but they lack effective, affordable devices to deliver that medication. Mexican Health Centers are stocked with asthma inhalers, which inexpensively create aerosol particles of medication, but these devices are not sufficient to deliver the medication to a child's lungs. Successful use of an inhaler requires that a child coordinate a deep breath with discharging the inhaler. This is challenging for a young child, particularly one gasping in the midst of an asthma attack. As a result, medication does not reach the lungs but is instead absorbed in the mouth and throat, where it causes undesirable systemic side effects.
To overcome these problems, inhalers are used in combination with a device commonly called a “spacer.” A spacer is a chamber that attaches to an inhaler, captures the discharged medication and holds it until the patient inhales it. In spite of their effectiveness, these devices are unavailable in Mexican Health Centers due to their cost (~ $50 plus distribution). Using paper and a precise system of cuts and folds, we have designed a spacer that can be produced for approximately 25 cents, a cost reduction of more than 99%. Furthermore, the device can be distributed as a flat sheet to be folded into a usable form on-site, so hundreds can be sent for the cost of a stamp.
Context for Disruption:
The current system of asthma treatment in Mexico leads to a vicious cycle of asthma attacks, long and costly trips to the hospital, and returns home to await the next attack. In the short term, our inexpensive, intuitive spacer will short-circuit this cycle by enabling treatment in local Health Centers instead of urban hospitals. These Centers are already stocked with the medication and know-how to treat acute attacks. By providing this much-needed device, we break down the wall that keeps the community physician from giving the suffering child the medication she needs.
In the long term, we believe this innovation is sufficiently affordable and easy-to-use that it can be distributed directly to patients and their families. Used in the home, this device will enable not only the rapid treatment of acute attacks, but also a more comprehensive prevention strategy. Patients would use the spacer together with an inhaler to give the preventive medication that is known to dramatically decrease the number of acute attacks.
This rethinking of asthma management will yield savings and improvements in quality of life for patients and their families. The reduced cost will benefit the Mexican health care system, which will avoid unnecessary, expensive emergency room treatments, as well as patients' families, who will save bus fares and lost wages. With the knowledge that treatment is easily accessible, or even in the home, the anxiety and limitations in activity that plague asthma sufferers and their families will be greatly diminished. Importantly, this simple device empowers asthma patients and their families to take an active role in managing their disease.
Delivery Model
The distribution of our spacer will follow two models as our scale grows. For the initial stages of our distribution, we will be working in a single Jurisdiction within the Mexican Secretaria de Salud (SSA, the ministry that provides health care to Mexico's uninsured) containing ten Centers and one hospital. We will mail our flat, unassembled device directly to doctors at local Health Centers. As we transition to a contract manufacturing relationship and larger order volumes, our distribution strategy will change. In this second phase we will take advantage of the fact that our customers -- the SSA and large, consolidated generic pharmacy companies -- have central warehouses where we can ship large volumes of our product for satellite distribution. This partnership will allow our company to scale up while keeping our personnel headcount low.
Because Mexican families are accustomed to traveling to urban hospitals to receive asthma treatment, we also have a plan in place to educate them about the availability of care at nearby Health Centers. First, we are working with the urban hospitals to inform patients who travel there that their attacks could be treated by their local Centers. The hospitals have been eager to participate because the asthma patients siphon time and money from the overburdened emergency rooms. Second, each Health Center has a team of volunteer health promoters who visit the homes of local residents and inform them about new health initiatives. The Center physicians have agreed to teach the health promoters about the device and the Center's improved ability to treat acute asthma attacks. The promoters will then convey this information to the families of children with asthma.
Key Operational Partnerships
We are working closely with partners in the San Francisco area and in Mexico to facilitate the testing and implementation of our device.
Instituto Tecnológico y de Estudios Superiores de Monterrey
This project was developed as a partnership between students and faculty at Stanford University and ITESM. ITESM faculty members will share their experience in getting new technologies approved and integrated into the Mexican health system.
Monterrey Metropolitan Hospital and Children's Hospital
We will perform clinical testing in these urban hospitals, which receive several asthma patients each day. The hospitals will also play a key role in our education plan.
Secretaria de Salud, Jurisdiction 3
We have met with jurisdiction officials and arranged to conduct pilot studies in their ten Health Centers and hospital.
Respiratory Clinic, Lucile Packard Children's Hospital
We are working with the physicians and respiratory therapists at this nationally recognized clinic to adapt their asthma treatment plan and educational materials for use in Mexican Health Centers.
Nektar Therapeutics
This industry leader in respiratory drug delivery will guide the bench-top testing of our device. These tests will allow us to measure the amount of medication that is transmitted by the device in order to define a recommended treatment plan that is tailored to its performance.
Impact
Financial Model
Over the first five years of our venture, we will grow from two employees to a total of five. The efforts of our employees will initially focus on fundraising and engineering and then transition to operating, accounting, and sales and marketing by year five.
The sole source of revenues is our paper spacer product. Fundraising will cover operating losses in the early years, and will be described in more detail below.
There are several categories of expenses, but by far the largest expense is personnel costs of salaries and benefits, which account for 73% of total expenses in year one and fall to 54% of total expenses in year five. Other categories, like legal, marketing, clinical trial, and engineering expenses account for 26% of total expenses in year one and fall to 10% of total expenses in year five.
Based on the number of children with asthma in Mexico and the frequency of their attacks, we expect to achieve shipments of nearly 2.5 million spacers by the end of year five.
What is your annual operating budget?
234,000
What are your current sources of revenue? (please list any sources that are foundation grants)
None
Effectiveness
Not yet known
Which element of the program proved itself most effective?
Not yet known
Number of clients in the last year?
0
What is the potential demand?
Asthma attacks account for one million emergency room visits per year in Mexico. Studies indicate that 90% of these cases can be managed by using an inhaler combined with a spacer. This represents an annual demand for 900,000 spacers.
One 1999 study in Mexico found that each acute asthma attack treated in an emergency room cost the health care system $224. This same study indicated that most treatments took nearly 15 hours in the emergency room. Our own research in Mexico indicated that, on average, the patient’s family would incur a cost of $40 in bus fares and lost wages for every acute attack. Based on these numbers, we estimate that our solution will save the people and health care system of Mexico nearly $240 million per year.
Scaling up Strategy
Over the next year, we will focus on prototype refinement and pilot testing in the ten clinics and one hospital in Jurisdiction 3. The goal of this phase is to define the optimal design and materials for the device and establish its efficacy in prototypical Mexican Health Centers.
In year two, we will focus on scaling up our manufacturing and distribution capacity and developing traction with the greater SSA. This will likely involve a transition to contract manufacturing and distribution to centralized SSA warehouses in Mexico. Our increased capacity will coincide with implementation of our device in 407 Centers and seven hospitals in the state of Nuevo Leon.
In year three, assuming our initial efforts demonstrate the value of our product to both the Mexican health care system and the children of Mexico, we believe the SSA will be interested in placing our product in Centers throughout the country. To prevent a countrywide roll-out from overwhelming our company and our contract manufacturer, we will ramp up to serve an additional one-third of the country's clinics and hospitals every six months. Since the SSA of Mexico consists of 15,571 Centers and 449 hospitals, this translates to a market of 5,000 Centers and 100 hospitals starting in April 2009, then 10,000 Centers and 250 hospitals by October 2009, and finally all SSA Centers and hospitals by April 2010.
We will also diversify our client base by selling to generic pharmacies, which are found all over Mexico and will facilitate the delivery of the spacer directly to the homes of asthma patients. If both the Jurisdiction 3 pilot and the Nuevo Leon proof go well, our plan is to begin selling to a small number of generic pharmacies in year three.
Stage of the initiative:
0
Expansion plan:
Our immediate efforts are focused on refining our design, performing clinical testing and identifying appropriate manufacturing and distribution strategies. Although this first phase is somewhat labor-intensive, it allows for great flexibility and ensures that we can respond swiftly to feedback from initial users.
Once these goals are met, we are poised to scale up to meet demand. By employing contract manufacturing, we can select plants with the excess capacity to comfortably meet increased orders. By taking advantage of the SSA channels already established for distributing medication, we have in place a distribution network that is already scaled to accommodate the entire country of Mexico.
We are seeking funding to support the early design and testing phases of this venture, but we expect that the ease of scalability will mean that once full-scale production begins, revenue from the spacer will more than offset our costs.
Origin of the Initiative
This project began with a trip to the Higueras Health Center in Nuevo Leon, Mexico. There I met Jose Antonio, a young physician working and living in this Center. He told me the story of Jesus, a child arriving with his mother in the middle of the night and gasping for breath. Jose Antonio knew the right treatment immediately but had no way to deliver it. Although he had a refurbished nebulizer sitting in the corner of the room, it had not worked for years. He then took me to a side room with a humidifier and explained how he desperately tried to get medication to Jesus’ lungs by pouring it into the humidifier, closing the door and hoping. It was the combination of his own feeling of frustration, the powerlessness and anxiety of the child’s mother, and the suffering and fear of the child that compelled me to address this need.
This Entry is about (Issues)
Sustainability
What are your two main challenges to finance the growth of your initiative
Our main challenges are to find seed funding to refine our design and to establish the efficacy of our device.
How did you hear about this contest and what is your main incentive to participate?
I heard about the contest through an email announcement. I am excited to participate to get exposure for my idea and potentially connect with others who can help to develop it with advice and funds.
The Story
Do you have an annual financial statement?
We have only a projected financial statement.
Do you currently have an annual financial statement that tracks profit/loss?
No
Please describe the amount (and/or type) of funding you need to implement your initiative, at year 1 and at year 5.
We will require fundraising to support us for two years, after which we will become self-sustaining. The total funds required are $575,000 spread over two years in milestone staging. The first round will finance our design refinement and pilot in Jurisdiction 3; the second round will support expansion to the entire state of Nuevo Leon; the third round will allow us to begin rolling out to all of Mexico. Our target funding organizations include traditional nonprofit foundations, new social entrepreneurship funds, and sponsors with direct interests in both Mexico and health care.
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Comments
Great innovation. Keep developing! I would use it with my child population. Good Luck. -Ralph
Thanks for the encouragement, Ralph. Good luck to you as well!
Eric
Dear Eric:
We are developing Kiosk-based Clinics for Masses. One of the diseases the KIosk-based Clinics will treat is asthma. I would, therefore, be interested in following up your innovation.
Thanks,
BP
Your kiosk-based clinics do seem like a promising setting to implement our spacer as part of an asthma treatment plan. You allude to this in your distribution model, but I am curious to know more about how medications and equipment will be supplied and replenished at the kiosks. Overall, yours is a highly scalable business model that could really have a broad impact on rural health. I look forward to discussing this further.
Best,
Eric
I just met with an entrepreneur in Chicago that has invented a molded plastic attachment that goes on the inhaler and it makes a sound when the breadth is being taken in. This is the time when the cylinder should be pressed. This device already has FDA approval and was designed for production under 25 cents. Plume studies were done to demonstrate the superiority of this device over spacers and direct inhalers.
I do not see any mention of regulatory approvals mentioned but I am not familiar with the medical system in Mexico and maybe none are necessary.
I will be happy to connect you with the inventors.
Prashant
Dear Prashant,
Thanks for your comment. I would indeed be interested to learn more about this invention.
One important feature of our device that distinguishes it from the other low-cost options I am aware of on the market is the addition of a mask. For adults and children over the age of about six, inhaler attachments with a mouthpiece can be used effectively to deliver medication to the lungs. However, studies have shown that younger children require a device with a mask in order to get good transmission. Because asthma disproportionately affects young children (80% of asthma sufferers in Mexico are under 8), it is crucial to address this population.
Regarding regulatory issues, we did not address them in depth in this proposal, but we are working closely with our partners at ITESM to move our device through this process in Mexico. In the US, our spacer/mask combination is classified as a Class 2 device that will follow a 510(k) regulatory procedure.
Eric
I wanted to provide an update on our progress since I first posted this competition entry. I have added some new photos from our partners in Mexico who have been performing pilot studies with our asthma spacer. The response from doctors, patients and family members has been positive and their feedback has helped us to further refine our design. We are currently collecting data to demonstrate the health benefits and cost effectiveness of the device, with an eye towards a more aggressive rollout.
Cheers,
Eric
Dear Mr. Green:
The ingenuity of this invention could make a remarkable impact here in the United States in addition to the developing countries. How far along is this project from becoming implemented in Mexico? We would also like to challenge you to think of how you could introduce this in the U.S. where some may be skeptical of "cheap" medical substitutes. Please share any insights!
Thank you in advance for your response!
Changemakers Team
Dear Changemakers Team,
Thanks so much for your support so far and for your question. In developing this project I have spent a lot of time thinking about the larger question of how to translate the principles of extremely affordable design for medical device development. Issues such as complex regulatory processes and a resistance to cheap substitutes (about which I will have more to say below) make this challenging, but ultimately I am hopeful for the future of this nascent field and excited to demonstrate its potential.
As for our current status, we are finalizing protocols for a pilot implementation of our device that we hope to begin this fall in Mexico City. Once we have finished incorporating feedback from this trial into our design, we will be ready for a broader implementation in Mexico.
All of our initial efforts focus on Mexico because we conceived this project to address a specific unmet need observed there. As I have reflected more on the global asthma epidemic and presented this work to audiences in the US, it has become clear that US asthma patients share many elements of this need. An inexpensive spacer could certainly improve the treatment of asthma for many patients in the US and I am very motivated to explore the needs of US asthma patients and provide the technology to address them.
As you mention, bringing this device to the US will require increased attention to the aversion of patients and doctors to cheap medical substitutes. Interestingly, the problem of credibility for inexpensive medical devices has come up repeatedly in interviews in Mexico. This has given us the opportunity to understand more deeply what aspects of a device give the impression of “cheapness.” One important thing we learned was that equipment being used for a purpose it is not designed for is more likely to be viewed with suspicion. This explains patients’ strong resistance to using household items, such as cups or paper bags, as spacers for inhalers, even though they are shown to increase drug delivery. We have found that the evident thoughtfulness and precision of our design helps us to overcome such concerns, irrespective of the price paid for the device.
We have also learned that patients and doctors trust equipment more if they have a clear indication that it is working. In the case of a spacer, users said it increased their confidence to see aerosol entering the chamber from the inhaler and leaving with the patient’s breath. We have incorporated this feature into our design and found that it has dramatically reduces the skepticism of users.
I have no doubt that patients and doctors in the US will have additional unique concerns that we have not encountered in Mexico. By conducting extensive user testing of our device, we hope to understand these doubts and address them through a combination of user education and improvements in our design.
Best,
Eric
These are fantastic insights into what makes a device "good enough" for patients. It's especially interesting how you can often address these concerns with simple design features. Thanks for sharing with us and best of luck!
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