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Changemakers Forum:
Entry: An extremely affordable device to enable the treatment of asthma in rural Mexico
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Pocas veces un invento reúne características tan trascendentes: atender una necesidad de grandes proporciones (asmáticos existen en cualquier comunidad) a un bajísimo costo. A veces se atiende esa necesidad pero con costos promedios... este es bajísimo. Si voto por este proyecto el alcance nacional será el que gane.
Saludos y felicidades al equipo promotor.
Laura Torres
Bravo!!!! es algo similar al aerochamber......muchas veces esto esta fuera de muchos de nuestros presupuestos,pero cuando uno tiene dos hijos asmáticos.....los has visto sufrir porque nadie te decia que eran asmáticos internamientos tras internamientos hospitalarios que terminaban en complicaciones como bronquitis o bronquilitis,rinofaringitis o faringitis...... Animoooooo,este es el comienzo del cambioooooo en cuanto a esta enfermedad que a uno como madre preocupa que te digan que no es curable,solo tratable.........pronto con tantas investigaciones y avances científicos confío en que pueda ser curable. Saludos y cuentan con nuestro apoyo.
Dear Mr. Green,
Please forgive my excitement!
Having seen your product, I just wanted to get into production directly!
I am also an entrepreneur and I would like to produce this design for the good of the children and people of the middle-east.
The benefit if there is going to be left when we substract the costs can be shared with a fund that we may chose together.
So bye for now, and please accept my best regards till I receive your urgent reply.
Alihan Asyan
Mech.Eng.
Leap and the net will appear!
HAs great potential for universal distribution and ease of use. Should make a difference world wide.
As a mother of an asthmatic daughter, I am particularly familiar with rushing to emergency rooms to get treatments. I commend you on this research. It is indeed needed in other countries and might be helpful here in the US too.
Congratulations.
Great to lower the cost of spacers and ease inhaler use. Vital part of asthma treatment, especially for children who struggle with coordination using an inhaler alone.
In the interim, and COMPLETELY free of cost / external technologies, there was a project some years ago looking at plastic drinks bottles (1litre in this case - though size probably not too critical) as low cost spacers. These can be made locally from bottles that would otherwise be trown away and simply pollute!
One simply makes a hole in one end of the bottle to fit the inhaler and breathes through the bottle opening. The fit of the inahler can be made quite snug quite easily - tape helps but not essential. The shape of the bottle is not dissimilar to a spacer and a (small and admittedly very imperfect!) randomised trial showed it was as good as a commercial spacer.
Not as designed as the spacer in this project but still much better than no spacer. I hear similar bottle spacers have worked well in Africa and other parts of Asia
For reference, please see:
ii. Kerac M, Montgomery H, Johnson N. A low cost spacer device used for asthma treatment in a Calcutta street clinic to improve efficacy of metered dose inhalers. Tropical Doctor 1998; 28, 228-9
Do get in touch if you need details of this work: mkerac@hotmail.com
Good luck with this project,
Marko
Registrar & Lecturer in Paediatrics, College of Medicine, Malawi
& PhD Student, Centre for International Health & Development, London, UK
What a great way to reduce cost and make it affordable to all people! Hope the trial goes well in Mexico, then make it available for US patients. -Victoria
Absolutely a great way to keep costs down and how it's made affordable to everyone, seeing someone have an asthma attack who only has some generic drugs is heart breaking when you can't do anything about it and hope their inhaler is working or full.
I was not involved in the development of this product or its distribution model, but I recently helped Mr Green with a presentation of his spacer, and I wanted to comment on its smart design, which is not detailed above. One of the greatest parts about this invention, IMHO, is its simplicity of use and form. The spacer starts out as a flat sheet cut out in a special pattern, which means it can be shipped in bulk at a very low cost. Assembling it requires 4 simple folds, which I learned in just a minute or two. During our presentation I taught several children how to do it; they caught on right away. What I like best about this product is its potential to empower families with young asthma sufferers and to spare their kids the ordeal of going to the hospital with such an elegant and efficient design.
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
Mr Green:
Your entry is very impressive, and very useful. It will no doubt save lives. We are a leading technology brokerage serving the consumer products market. We are able to provide access for your invention with senior executives at some of the world's most prestigious consumer health care companies. To the extent that it would be helpful to you, and you have interest, let me know if we can offer service to you.
Best regards and good luck,
Michael Fruhling
President/CEO
bfs innovations, Inc.
www.bfsinnovations.com
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!
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
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
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
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