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Medical Devices for Developing Countries:

Medical Devices for Developing Countries:. Design Constraint and Approaches. Amit J. Nimunkar ( Presenter ) Jonathan Baran David Van Sickle Naresh Kumar Pagidimarry John G. Webster. September 6, 2009. University of Wisconsin-Madison St. Cloud State University. Healthcare Inequality.

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Medical Devices for Developing Countries:

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  1. Medical Devices for Developing Countries: Design Constraint and Approaches Amit J. Nimunkar (Presenter) Jonathan Baran David Van Sickle Naresh Kumar Pagidimarry John G. Webster September 6, 2009 University of Wisconsin-Madison St. Cloud State University

  2. Healthcare Inequality Healthcare spending per capita Developed countries Developing countries Lack of proper medical technology leads to diagnoses based on incomplete information Therefore, there is need for low–cost medical solutions to make the proper healthcare resources accessible, especially to developing countries

  3. Engineering World Health – Madison Chapter “Deliver medical expertise and equipment to underserved nations” Students in Mongolia inspecting a heart/lung machine UW–Madison BME students Medical Mission Tanzania, India, Honduras, Mongolia, Zimbabwe Non–profits – HHF, SRW

  4. Motivation Asthma and chronic obstructive pulmonary disease (COPD) affect more than half billion individuals internationally Worldwide, one in every 250 deaths attributed to asthma (255,000 in 2005); 80% in low–and–middle income countries In India, Acute respiratory infections account for 13% of all deaths with a 25% mortality rate in children under five Pictures taken from Nature.com and news4u.co.in

  5. Price Point • $250 • $350 Software Medical Record Keeping Databasing Telemedicine Initial Design This strategy doesn’t work

  6. Design Constraints • Accuracy, Reliability and Durability • Most important design considerations • Cost must be minimized to provide access to technology • Harsh environmental conditions in rural settings demands durability • Size and weight • Less in weight and portable due to lack of space in hospitals • Devices could be carried from one hospital to another • Material • Material should be available in the intended country to manufacture the device Fleisch and Lilly spirometer design made of PVC

  7. Design Constraints • Power requirements • Only 55% of households in India are electrified, more than 20 million households without power • High levels of transmission and distribution losses and poor record for outages • Medical devices operated on battery are important to provide electrical isolation • Ease of manufacture • If the devices are manufactured and sold in a country, manufacturing process needs to be considered • Facilities available • In India, there are seven physicians and eight nurses per 10,000 people • High cell phone penetration of over 11 per 100 people with customer base of 93 million • Introducing wireless and telemedicine technology in healthcare

  8. 1. The reasoning behind the procedure and what it measures is explained to the patient. 2. Proper techniques to perform the procedure are explained in detail and shown to the patient. 3. Improper techniques including coughing, slouching, and taking an extra breath are illustrated and discouraged. 4. The first stage of the incentive component of the A/V promotes the patient to give maximum effort with loud encouragement. Design Constraints • Language issues • In India, 29 languages spoken by more than a million people • Population dynamics • In India, 27.8% population is rural • 57% population in age group of 15 to 59 years • Overall literacy rate is around 63.8 %

  9. Implementation in Target Country • Medical Device Registration • Central Drug Standard Control Organization, in India approves medical devices manufacturing • Currently very few medical devices need registration, spirometer and pulse oximeter are not included at this point in time, in India • Standards • Spirometer designed according to ATS and ISO 26782 standard • All devices designed according to IEC 60601–1 standard for electrical safety

  10. Implementation in Target Country • Intellectual Property • Indian Patent Office for patents • Intellectual property continues to be one of the concerns western companies face upon entry into India • Perseverance from WTO for better IP laws • Exporting and Importing • Medical devices subject to export fall into two categories, legally marketed and unapproved devices • Legally marketed devices are intended for distribution within the United States

  11. More information Open Spirometry BME Design Course Homepage Engineering World Health–Madison Chapter

  12. Acknowledgements BME Department CoE UW–Madison BME students Dr. Willis Tompkins Dr. Robert Radwin

  13. Medical Devices for Developing Countries: Design Constraint and Approaches • Suggestions? • Potential Collaborations? • Opportunities?

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