Medical Devices for Developing Countries:

September 6, 2009

University of Wisconsin-Madison

St. Cloud State University

Design Constraint and Approaches

Amit J. Nimunkar (Presenter)Jonathan Baran David Van Sickle

Naresh Kumar Pagidimarry John G. Webster

Healthcare Inequality

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

Healthcare spending per capita

Developed countries

Developing countries

Engineering World Health – Madison Chapter

Students in Mongolia inspecting a heart/lung machine

“Deliver medical expertise and equipment to underserved nations”

UW–Madison BME students Medical Mission

Tanzania, India, Honduras, Mongolia, Zimbabwe

Non–profits – HHF, SRW

Motivation

Pictures taken from Nature.com and news4u.co.in

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

Initial Design

Software

Medical Record Keeping

Databasing

Telemedicine

Price Point•$250•$350

This strategy doesn’t work

Design Constraints

Fleisch and Lilly spirometer design made of PVC

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

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

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 %

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.

Implementation in Target CountryMedical 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

Implementation in Target CountryIntellectual 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

More information

Open Spirometry

BME Design Course Homepage

Engineering World Health–Madison Chapter

Acknowledgements

BME Department

CoE UW–Madison

BME students

Dr. Willis Tompkins

Dr. Robert Radwin

Medical Devices for Developing Countries:

Design Constraint and Approaches

Suggestions?

Potential Collaborations?

Opportunities?