Universal Strip Reader (Graduation Project)

MAEER’ s

MIT INSTITUTE OF DESIGN

Graduation Project 2017

Universal Strip Reader Sponsor

CareNX Innovations Pvt. Ltd. Student

Dhanashree Manohar Industrial Design (Product Design)

Industry Guide Faculty Guide

Shantanu Pathak Prof. Dhimant Panchal

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The Graduation Project Evaluation Jury recommends DHANASHREE MANOHAR to be awarded the Graduation Degree of the MIT Institute of Design, Pune IN INDUSTRIAL DESIGN (PRODUCT DESIGN) herewith, for the project titled “UNIVERSAL STRIP READER” MEMBERS: NAME

ORGANISATION

on fulfilling the further requirements by*

(*Subsequent remarks regarding fulfilling the requirements.)

GRADUATION PROJECT 2017 PROGRAMME: PG

Chairperson of the Jury

SIGNATURE

USR Universal Strip Reader

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ACKNOWLEDGEMENTS I would like to express my deepest appreciation for all the guidance, help and support of numerous people.

Prof. Dhimant Panchal, my faculty and mentor, for being an awe inspiring influence throughout my academic life. For all the teachings and inputs along every step of the way. For being an understanding guide and always inspiring me with his narratives and wisdom, and many excellent observations.

CareNX team, for accepting me into their midst with open arms and being very helpful throughout my time with them. It was a very different experience working along with such a diverse group of people. I would specially like to thank Shantanu Pathak and Aditya Kulkarni for guiding and encouraging me to achieve the most, and being patient in the face of my shortcomings. You guys have been a huge inspiration for me since the very first day. I would also like to thank Zeeshan Anjum, for his never ending help throughout the project. And to my friend Varnika, my lunch partner, confidant and dear friend who was always there for me.

Garima Kaushik, for being my rock through these years. For being a patient listener, smiling at my irrational doubts and being a serene calming presence, and always knowing the right thing to say. It was truly my lucky day when we were allotted rooms together. I would also like to acknowledge all my friends at MITID, my life would have been colourless without you guys in it.

I would also like to acknowledge, My mother, forever nagging me to finish my work, My father, for never nagging to finish my work, And my brother, for his supreme indifference.

Table of Contents

Acknowledgements Introduction

1

Section 1 Overview

4

Section 2 Secondary Research

12

Section 3 Primary Research

26

Section 4 Iterations

50

Section 5 Design Concepts

63

Section 6 Final Design and Detailing

78

Section 7 Bibliography

101

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Introduction

Pritee (Business Development), Kunj (Biomedical Research Engineer), Shantanu (Co-Founder), Zeeshan (Embedded Hardware Lead), Aditya (Co-Founder), Malhar (Business Development Head), Vaishali (Software Intern), Varnika (Software Intern)

From left to right: Pritee, Kunj, Shantanu, Zeeshan, Aditya, Malhar, Me, Vaishali and Varnika.

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THE WORKPLACE About CareNX

CareNx Innovations is a spin-off start-up from IIT Bombay India. CareNx relies on smart phone ecosystem to develop affordable point-of-care health care technologies to expand healthcare institutions’ outreach to the underprivileged sections. Specifically, CareNx focuses on technologies related to the Maternal and Child Healthcare (MCH) with the aim of reducing Maternal Mortality Ratio (MMR) and Child Mortality Ratio (CMR) in the developing world.

CareNx plans to make process of developing healthcare solutions more unique and specific. CareNx aims of a cleaner procedural interface which will make healthcare problem identification, customer segment identification and solution provision very simple at early stages of the product. At a full potential, CareNx will provide a solution to the healthcare organizations which in turn will utilize the best technology for the healthcare provision.

CareNx will reach to individual institutions with a solution of real need and value. It will use state of the art as well as simplest technologies to ensure that problems are being solved in a sustainable manner. This had helped institutions to reach remote areas, provide healthcare, maintain data and reduce operational cost than existing available outreach programmes.

CareNx has developed two novel technologies for MCH:• CareMother:- CareMother is a mobile pregnancy care solution for early identification of high risk pregnancies. CareMother includes a portable kit of medical devices and a smart phone application to be used by hospitals, NGOs and other healthcare institutions through their existing chain of health-workers. Since its inception in 2015, CareMother has reached out to more than 3000 pregnancies across 60+ villages and increased early high risk detection rate by 33% than the existing system.

• Universal Strip Reader (USR):- USR is the world’s first smart phone assisted point-of-care diagnosis technology that is being developed to enable healthcare institutions perform mass screening of micronutrient deficient population (mainly women and children under-5 in resourcepoor settings. Mass screening becomes impossible due to high cost of tests in pathology labs, remoteness, non-portable screening devices, special skill-set and storage requirements. USR will enable on-field/ at-door screening in a cost effective, easy-to-use manner and immediate interventions can be made as instant test results will be available.

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Section 1

Overview

PROJECT BRIEF

The Brief: To design a healthcare technology device for screening of Haemoglobin and Non Communicable Diseases in remote areas using mobile platforms.

Methodology: Primary Research Research based on the problem statement, current ground zero scenario, why the need for the device, various market competitors in the same bracket, user research, scenarios in which the device will be used, case studies, mood boards etc.

Secondary Research Micronutrient deficiency, POCTs, Testsduring pregnancy, etc.

Deliverables: Working prototype for the scanning device.

BASELINE SURVEY

The problem statement for USR has emerged through an actual experience.

CareNx was running the pilot of a project in Mumbai slums and in 40 villages of Aurangabad district in Maharashtra state of India. The pilot was to validate a pregnancy care solution (By the name of CareMother) that CareNx had developed. This pilot project covered more than 1500 pregnancies for antenatal care in 8 months.

The analytical study over the patient records showed that, more than 60% women with iron deficiency (low Hb) and more than 28% women with lowweight (less than 45Kg) suffered from high risks during pregnancy. Also significant number of low birth weights are reported for the newborns. This study along with the other studies (nutrition survey) has shown that both these pilot locations have micronutrient deficient population and often suffer from related complications. Both these regions have performed significantly below the state average of wellness baseline.

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PRODUCT CONCEPT FOR USR

Universal Strip Reader (USR) is a smart phone assisted point-of-care technology which can screen various micronutrient deficiencies instantly. It senses the change in colour on the test strip (colorimetric) due to the micronutrient level, quantifies and displays the result on the wirelessly connected smart phone screen.

Presently, USR works with various colorimetric test strips (Vitamin C, D and minerals like Iron, Calcium and Zinc) from different certified vendors for screening micronutrient deficiency. Simultaneously, CareNX has also associated with a clinical R&D organization in USA to include deficiency tests of vitamin A and minerals Iodine and Folic Acid.

The novelty of USR technology comes from the following innovations:1. USR works with various colorimetric test strips from any vendor (different shapes, sizes, calibration methods). This gives freedom to user for selection of strips and reduce the cost 2. USR doesn’t even need a lab expert or a skilled person to use these strips

3. A new test can be configured in the software by updating the smart phone App. To achieve this, we built novel Image Processing and Machine Learning algorithms on smart phone instead of designing separate hardware for each test/strip 4. Moreover the software also contains a self-calibration component that makes use of past test records from cloud to periodically calibrate the functioning of the device. This gives certainty about accuracy of the device over time 5. USR uploads all test results in the electronic format on the cloud through the smart phone internet connection. It also works when internet is not available and synchronizes the results whenever it becomes available the next time 6. Health institutions can perform data analysis over the electronic test records to estimate deficiency trends, portion of the deficient population, geographical deficiency patterns etc. This can provide meaningful insights to make early and timely interventions 7. Other similar solutions (not for micronutrient deficiency diagnosis though) like Aina, iCAlq, Nutriphone, uCheck etc. depend upon particular smart phone, operating system and strips; whereas USR is free from all these dependencies 6

COMPONENTS

The USR technology has three primary components: • Existing colorimetric test strips from vendors/OEMs • A sensing hardware device (reader) • A smart phone that connects wirelessly (using Bluetooth) to this sensing device to process, instantly display and upload the test results

The sensor can read well-established lateral flow assay and solid-phase assay (dipsticks) strips available from authorized vendors to perform tests like Hb, Ferritin, Vitamins (C, D), Minerals (Zinc, Calcium). The software intelligently handles dependencies that arise due to different vendor strips even though the same hardware device is used for the sensing part. Due to this novelty in the software, a Universal reader can be designed which is simple, lightweight and portable. This approach has made USR suitable for reading any type of futuristic colorimetric strips just by updating the calibration part in the App instead of designing a special new sensing hardware.

To keep track of whether USR gives accurate measurements after being used for a longer time, a self-calibration module is integrated in the software to calibrate the sensor periodically. This calibration will guarantee that the accuracy of the sensing hardware is not compromised even after its use for a longer time. Other secondary features of USR involve reading multiple strips at the same time, non-dependency over specific type of smart phone or OS, wireless connectivity to the smart phone for computation and electronic record storage over the cloud. Finally, a web portal provides access to all the test records captured by USR for further data analysis purposes.

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REQUIRED STANDARDS

USR needs to follow following standards before going to the market:CE, FDA • CE Mark: The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity" • FDA Approval: “FDA approval” means that the FDA has decided the benefits of the approved item outweigh the potential risks for the item’s planned use.

CLSI, NGSP • CLSI: The Clinical & Laboratory Standards Institute (CLSI) provides standards and guidelines for medical professionals through its unique consensus process.

• NGSP:The purpose of the NGSP is to standardize Hemoglobin A1c test results to those of the Diabetes Control and Complications Trial (DCCT) and United Kingdom Prospective Diabetes Study (UKPDS) which established the direct relationships between HbA1c levels and outcome risks in patients with diabetes.

BUSINESS INNOVATION

The business innovation lies in the way CareNX approaches the needs of the customer. The product made would be unique, carefully crafted and acts as a decentralized service for their exact requirements. CareNX will reach the customers through already established distribution channels of pharmaceutical companies, strip vendors and global impact agencies so as to cover maximum number in the minimum time. Moreover, USR will be designed in a scalable fashion such that it poses minimum hardware & OS dependency and maximum software dependency. With this approach, USR can be configured to perform new tests just by updating the software on the mobile device.

USR will allow the test results to be monitored over cloud, hence the customer can customize the set of tests USR should perform according to their needs. They will also have a choice for opting for a subscription or recharge based model. Moreover, USR devices can also be rented to the customer for a fixed amount of time i.e. say for few days of screening camps etc. There are a lot of different opportunities to strategize business propositions to different stakeholders due to the enormous flexibility in the product customization.

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IMPACT ANALYSIS

Mass screening for micronutrient deficiency analysis is a huge challenge for healthcare institutions in the resource poor settings of the remote regions. Due to this, a high MMR and CMR can be seen in such a critical remote regions. In this light, USR will allow government and healthcare implementing agencies to use point-of-care diagnosis for micronutrient deficiency in the settings where a high prevalence of malnutrition exists.

Immediate suggestion from mobile App and interventions/supplementation by health-worker or doctor will save complications for the deficient.

USR data will allow doctor/health policy makers to plan regional supplementation/fortification strategies based upon the exact deficiency identification for individual or masses and to assess the impact in future.

Companies and organizations working on nutritional solutions can be mapped with targeted regions.

Following are the impact metrics that will be considered while accessing the social impact of USR:1. Number of women and children screened for the deficiency analysis 2. Deficiency cases detected and immediate suggestion or interventions made by the App 3. Follow-up visits showing improvements after the interventions are made

4. Analysis of geographical micronutrient deficiency and supplementation/ fortification policies implemented by the healthcare implementing agencies or the government 5. The quality and robustness standards of USR, so as to be used by the health-workers in the remote regions.

The main direct beneficiaries of USR technology will be pregnant women and children under age 5.

TESTS PERFORMED BY USR Lateral Flow Assay HbA1c Iron/Ferritin Vitamin D NCD Pregnancy

Dry Blood Spot Haemoglobin Iodine

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VALUE PROPOSITION FOR DIFFERENT STAKE HOLDERS

HOSPITALS/ GOVERNMENTS/ DOCTORS/ PHARMACEUTICALS

STRIP MANUFACTURERS

PATIENTS

Mass screening and tests at center becomes quick diagnosis and additional revenue source

Engage doctors/ hospitals more efficiently

Quick results: Low cost, save time and quick reports

Profile speciality with various tests (Urology, Gynaecology, Diabetes, Cardiology)

New market opportunity with increase in sales of strips

Low cost (dependent upon doctor and hospital decision)

Non dependency on any specific vendor, thus easy management of cost effective procurement

Availability of strips in retail can make it available for consumers to use at family level in future Monitoring of pattern of consumption and plan sales

Single device for family for multiple tests or regular tests

No expert or infrastructure required thus increases reach

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Section 2

Secondary Research

MATERNAL HEALTH

Maternal health refers to the health of women during pregnancy, childbirth and the post-partum period. While motherhood is often a positive and fulfilling experience, for too many women it is associated with suffering, ill-health and even death.

Generally the mother will have to go through some screening tests during her pregnancy to try and find out any health problems that could affect her or the baby, such as infectious diseases, Down’s syndrome or physical abnormalities. These tests can help the mother make choices about care or treatment during her pregnancy or after the baby is born.

The first rounds of prenatal tests generally include blood tests to determine the mothers blood type, iron levels to check for anaemia, blood glucose levels to check for diabetes, Rh factor (if the mother is Rh negative and the father is Rh positive, the foetus may inherit the father’s Rh-positive blood, which could cause the mother’s body to make antibodies that can harm the foetus. The mother will also be tested for HIV, hepatitis B, and Syphilis, as well as whether the mother is immune to Rubella, since an attack of this illness, especially in the first three months, can cause birth defects.

MATERNAL AND FOETAL TESTING

To evaluate the health of a pregnancy and fetus, many types of prenatal tests may be performed. The following list contains a brief listing of all the screening tests required: • Maternal and Foetal Testing Overview • First Trimester Screening • Second Trimester Screening • Alpha-fetoprotein (AFP) • Ultrasound • Chorionic Villus Sampling • Amniocentesis • Foetal Blood Sampling • Foetal Monitoring • Foetal Movement Counting • Non-stress Testing (NST) • Biophysical Profile (BPP) • Doppler Flow Studies One of the major screenings in the blood tests are for micronutrient deficiencies which can occur due to lack of necessary nutrition. These tests help to determine the overall growth and development of the child.

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MICRONUTRIENTS

Essential vitamins and minerals are dietary components required in small quantities to support virtually all metabolic activity, including cell signalling, motility, proliferation, differentiation and apoptosis that regulate tissue growth, function and homoeostasis. These fundamental biological roles, in early life, enable the fetus to develop and mature into a healthy neonate. Vitamins and minerals support every stage of maternal, placental and fetal interaction to enable a healthy gestation.

Micronutrients receiving most attention in pregnancy, and commonly provided as supplements, include vitamins A, D, E, folate, B12, B6, and C, iron, zinc, iodine, copper and selenium. Although other B-complex vitamins (such as, niacin, riboflavin and thiamine) are nearly always also included in dietary supplements, their individual metabolic roles are less well-specified in pregnancy.

MICRONUTRIENT FUNCTIONS DURING PREGNANCY Micronutrients support maternal health and fetal development throughout gestation through processes that are integrated across maternal, placental and fetal compartments. Micronutrient function in human pregnancy is typically inferred from in vitro studies and experimental animal models, observational data in human studies, and a limited number of human trials that have explored metabolic mechanisms and outcomes. Overall, we have a limited in vivo understanding of specific, causal mechanisms by which micronutrients act through the materno-placental fetal axis to influence human pregnancy outcomes.

Adverse health outcomes of gestational micronutrients deficiency Short Term: • Miscarriage • Stillbirth • Birth defects • Small size of gestational age • Preterm birth

Long Term • Death • Altered growth, body composition • Compromised cardiometabolic, pulmonary and immune function • Poor neurodevelopment and cognition 14

BENEFITS OF MICRONUTRIENTS Implantation

Peri conception/ epigenetic effects B6

B12

D

E

Fol

Cu

I

Se

Zn

B12 Fol

Maternal and paternal

Placental

C

D

E

Fol Fe

Offspring

0

Zn

A

E

Cu

Fe

2

Blastocystogenesis

4

Fol

Cu

Fe

Se

Zn Vascularization, hormone production

Nutrient transfer regulation

Fol Morphogenesis, Organogenesis Zn

6

8

B12

D

B12 Fol

10

12

Embryogenesis

Fol

Cu

Fe

I

Neurological development

Zn

Tissue deposition, body composition

14

16

18

20

40

Fetal development Vitamins Gestational age (Weeks)

Minerals

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MICRONUTRIENT DEFICIENCY

Micronutrient deficiency is a lack of essential vitamins and minerals required in small amounts by the body for proper growth and development. Micronutrient deficiencies affect more than two billion people of all ages in both developing and industrialized countries. They are the cause of some diseases, aggravate others and are recognized as having an important impact on worldwide health. Important micronutrients include iodine, iron, zinc, calcium, selenium, fluorine, and vitamins A, B6, B12, B1, B2, B3, and C.

Deficiencies in micronutrients such as iron, iodine, vitamin A, folate and zinc can have devastating consequences. At least half of children worldwide ages 6 months to 5 years suffer from one or more micronutrient deficiency, and globally more than 2 billion people are affected. If a woman is malnourished during pregnancy, or if her child is malnourished during the first two years of life, the child’s physical and mental growth and development may be slowed. This cannot be made up when the child is older – it will affect the child for the rest of his or her life.

Micronutrient nurture affects maternal capacity to conceive and support pregnancy through to birth. Micronutrient deficiencies have been linked to compromised conception, length of gestation, and fetal development and growth, which can lead to pregnancy loss, preterm delivery, small birth size, birth defects, and long-term metabolic disturbances. Deficiencies in micronutrients involved in one-carbon metabolism, including folate and vitamins B6 and B12, might contribute to disturbances in gametogenesis, fertilization, and development of the embryo before implantation. These nutrient deficiencies might also adversely affect DNA with long-term consequences. Other micronutrient deficiencies have also been associated with early reproductive failure. For example Vitamin E deficiency is linked to miscarriage in an early pregnancy. Also severe selenium, zinc, and copper and iodine deficiencies have also been associated with miscarriage.

The common micronutrient deficiency diseases are: • Iron deficiency: Anaemia.

• Iodine deficiency: Goitre and Cretinism • Vitamin A deficiency: Xerohthalmia etc.

Maternal micronutrient adequacy during pregnancy might alter the health and development of offspring during infancy, childhood, and even adulthood. The postnatal effects of the deficiency are various. It affects the infant and child mortality, the growth and body composition of a person, the Cardiometabolic, pulmonary and immune function, Neurodevelopment and cognition and many more.

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Women living in low-income countries are often unable to meet the micronutrient demands of pregnancy due to a chronically poor diet. At the same time, the costs of assessing biochemical indicators of individual micronutrients have led to few population estimates of deficiencies during pregnancy. This situation has given rise to the term ‘hidden hunger’, referring to a lack of knowledge as to the extent and consequences of this nutritional burden.

Let us understand how and why this problem is prevalent and persistent.

As per WHO, annually 300,000 pregnant women and 22,000 children under age 5 die in India due to consequences of micronutrient deficiency i.e. Vitamin A and minerals Iron & Zinc respectively. Globally, 6.6 million children under age 5 born are mentally impaired due to Iodine deficiency and 200,000 babies born poses neural tube defects due to Folic Acid deficiency. In most of the cases, micronutrient deficiency in mother causes high risk pregnancy and results into higher Maternal and Child Mortality Ratio (MMR and CMR) while births. Even after the birth, child suffers from deficiency due to improper nutritional diet.

These deficiency cause child to be mentally and physically unhealthy while growing phases. Timely deficiency diagnosis of a child wouldn’t happen as deficiency screening doesn’t happen at an early stage. For the health institutions or governments in these remote areas, this problem remains unsolved mainly due to unavailability of easy-to-use diagnostic tools that can screen micronutrient deficiency on-field.

Following are the few reasons why the problem is not very well solved:1. Pathology labs are not easily reachable and accessible due to remoteness 2. The lab readers are typically expensive (USD 1000-5000) and hence not commonly available at remote locations 3. Mass screening is not possible due to high cost of pathology lab tests, longer time, skill-set requirements, sample storage requirements 4. The pathology lab strip analysers are not portable 5. The pathology lab strip analysers would work with a certain strip. So multiple analysers for various deficiency tests are required 6. Different types of strips from various vendors increases the screening test expenses

As per National Rural Health Mission Report

Healthcare in Indian Villages

• 700 million people live in 636000 Indian Villages • Majority of people die due to preventable and curable diseases like diarrhoea, measles and typhoid • 66% of rural Indians do not have the access to the critical medicines • 31% of the population travels more than 30 kms to seek healthcare in rural India

• Rural Health centres are critically short of trained health medical person • 8% primary health centres do not have doctors • 39% PHCs do not have lab Technicians • 18% PHCs do not have a pharmacist Source: Rural Healthcare: Towards a Healthy Rural India GraamVani article Published 13th July 2016

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WHAT IS POINT-OF-CARE TESTING?

Point-of-care testing (POCT), or bedside testing is defined as medical diagnostic testing at or near the point of care—that is, at the time and place of patient care. This contrasts with the historical pattern in which testing was wholly or mostly confined to the medical laboratory, which entailed sending off specimens away from the point of care and then waiting hours or days to learn the results, during which time care must continue without the desired information.

In many cases the simplicity was not achievable until technology developed not only to make a test possible at all but then also to mask its complexity. For example, various kinds of urine test strips have been available for decades, but portable ultrasonography did not reach the stage of being advanced, affordable, and widespread until the 2000s and 2010s.

Today IT is often viewed as a “simple” test, but there was nothing simple about it until the more complex technology was available. Similarly, pulse oximetry can test arterial oxygen saturation in a quick, simple, non-invasive, affordable way today, but in earlier eras this required an intraarterial needle puncture and a laboratory test; and rapid diagnostic tests such as malaria antigen detection tests rely on a state of the art in immunology that did not exist until recent decades. Thus, over decades, testing continues to move toward the point of care more than it formerly had been.

POCT is often accomplished through the use of transportable, portable, and handheld instruments (e.g., blood glucose meter, nerve conduction study device) and test kits (e.g., CRP, HBA1C, Homocystein, HIV salivary assay, etc.). Small bench analyzers or fixed equipment can also be used when a handheld device is not available—the goal is to collect the specimen and obtain the results in a very short period of time at or near the location of the patient so that the treatment plan can be adjusted as necessary before the patient leaves. Low cost medical tests that provide results almost instantly and which are the best way to reach places where access to health network is challenging.

PoCT’s have first, second and third generation instruments.

First generation devices are called Rapid Diagnostic Tests (RDT). They are very cheap devices, upto a dlollar per test and most of them meet the assured criteria.

Second generation devices enable professionals to perform nucleic acid amplification tests (NAAT) in order to detect the genetic material of the virus or infecting organism.

Third generation devices use mobile technology. They are, for instance, devices that can be connected to a low-end mobile phone (2G) in order to send data to other sources.

Benefits of PoCT’s: Major benefits are obtained when the output of a POCT device is made available immediately within an electronic medical record. Results can be shared instantaneously with all members of the medical team through the software interface enhancing communication by decreasing turn around time (TAT). A reduction in morbidity and mortality has been associated with goal-directed therapy (GDT) techniques when used in conjunction with POCT and the electronic medical record 18

MOBILE HEALTH

Mobile health, also known as mHealth, is a general term describing the use of mobile phones and other wireless technology in health care.

Mobile health is a subset of telehealth, with a particular emphasis on the use of mobile phones for communication between patients and health care providers. It also includes the use of wireless medical devices for monitoring patients remotely. One popular instance of mobile health care is using text messaging to send information and reminders to patients.

Remote patient monitoring is another form of mobile health care involving devices that monitor patient health and then send the data electronically to a health care provider.

MOBILE HEALTHCARE TECHNOLOGY

How is ‘mobile technology’ revolutionising healthcare?

A universal point of care testing solution which can perform multiple tests through single device, solves the problem of upgradation and calibration is in high demand. Lateral flow assay, microfluidic assay and solid phase dipstick is considered fastest growing market for point of care of mass screening solution.

Some basic tests can be done at the clinic at affordable cost and this can reduce the wait time, cost and enable quick diagnosis and treatment. We see with driving force of additional revenue and reduced wait time at clinic will lead quick adoption of such devices.

Mobile health also takes place within the clinical setting. Health care professionals are using smartphones and other mobile devices to communicate with each other, to access electronic health records (EHRs) and to educate patients.

Mobile Health Apps are a very good example of obtaining health benefits from the emerging healthcare revolution from the click of a button on your smart phone.

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MICRONUTRIENT DEFICIENCY DETECTION TESTS

GENERAL TEST FOR ANAEMIA DETECTION

Iron deficiency: Anaemia

NAME: Clinical Signs

Iron deficiency is the most common micronutrient deficiency in the world and has far-reaching and serious adverse affects on health. Anaemia detection is often used as a screening test for iron deficiency.

Anemia occurs when the total volume of red blood cells (and/or the amount of hemoglobin in these cells) is reduced below normal values, as defined by healthy populations. Anaemia results from one or more of the following processes: defective red cell production, increased red cell destruction, or blood loss.

CATEGORY: No Blood Sample, NonInvasive

There are often multiple causes for anaemia. People suffer from both nutritional anemia (impaired red-cell production) and from parasitic diseases such as malaria (red blood cell destruction) and intestinal worms (blood loss). Although iron deficiency is the most common cause of anaemia, especially among younger children and women of child-bearing age, other nutrient deficiencies, such as folate and vitamin B12, can also contribute to anemia.

Inspection of conjunctivae, nailbeds, gums, and skin for pallor.

Used at the village level of health care.

Minimal training and equipment required.

NAME: Filter Paper Methods CATEGORY: NonDilutional, Non-Lysed A capillary blood spot collected directly on filter paper is compared to a printed set of color standards.

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NAME: Copper Sulfate

NAME: Lovibond Comparator

CATEGORY: Nondilutional, non lysed

CATEGORY: Nondilutional, non lysed

The test is based on the fall (or flotation) of a drop of whole blood in a copper sulfate solution of a known specific gravity. A drop of blood will sink or float for the first 10 to 15 seconds, indicating if the specific gravity of the blood is equal to, greater than, or less than that of the copper sulfate solution.

Useful for screening programs.

Simple, inexpensive, and rapid.

Either a whole blood sample or a blood sample diluted in ammonia or Drabkin’s solution is put into a tube and compared to a series of coloured glass standards(discs), using a visual comprator. The depth of the red colour of each glass standard corresponds to a certain hemoglobinlevel

NAME: Hematocrit, Centrifuge

NAME: BMS Hemoglobinometer

CATEGORY: Non-Dilutional, NonLysed

CATEGORY: Nondilutional, lysed

Whole blood is collected in a microhematocrit tube and centrifuged at sufficient speed And for sufficient time to pack red blood cells into a mass measured on a reader as a percentage of total blood volume.

Useful at a health center level. Simple procedure.

Several specimens can be measured at one time.

Simple, inexpensive, and rapid.

A glass chamber is filled with blood that has been lysed with saponin, then placed in a viewing instrument. A grey wedge in the viewer is moved until the two color fields match, and the results are read from a scale on the side.

Useful as a screening device in clinics.

Accurate, portable, and inexpensive.

A permanent glass standard is provided.

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NAME: 1. Photometry Colorimetry 2. Spectrophotometry

NAME: HemoCue CATEGORY: Non-Dilutional, Lysed Whole blood is converted to azide methemoglobin in a disposable, chemically treated cuvette and then measured photometrically at a specified wavelength (565nm).

The hemoglobin value is displayed digitally.

Useful for surveys or where high accuracy is important.

NAME: Sahli CATEGORY: Dilutional,Visual Color Match

Method is suitable for clinic use.

Cost is low for procurement and re-supply. Test is relatively easy to perform.

Whole blood is pipetted into dilute hydrochloric acid (0.1mol), hemolyzed and converted to acid hematin. The solution is further diluted until the color matches that of two identical standards placed to the left and right of the dilution tube. The hemoglobin concentration is read from the graduated scale on the dilution tube as g/dl or as a percent of normal.

Technique is suitable mostly for central reference laboratories.

CATEGORY: Dilutional Photoelectric Method is highly accurate; results Color Match are objectively quantified.

The cyanmethemoglobin method To accurately measure hemoglobin, is the international standard for photoelectric devices are used to hemoglobin determination, as stable assess the amount of light absorbed reference solutions are available for by a blood sample. When a colored calibration. solution is illuminated with visible light, certain wavelengths of light will be absorbed while others will be transmitted. By measuring the amount of light absorbed, one can measure the concentration of a substance in the colored solution.

The hemoglobin level is derived by comparing absorbance of the sample to known standards.

Cyanmethemoglobin and oxyhemoglobin are the two compounds most commonly used for spectrophotometric and photometric/ colorimetric measurements. Two types of instruments can be used to measure absorbance: filter photometers/ colorimeters and spectrophotometers.

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HAEMOGLOBIN COLOUR SCALE STRIPS, COPACK

Hemoglobin Colour Scale: Copack It comprises a box of test strips and a small card with six shades of red that represent haemoglobin levels at 4, 6, 8, 10, 12 & 14 g/dl respectively.

The device is simple to use: A drop of blood is placed on the test strip and after a waiting time of about 30 seconds the colour of the blood spot is matched immediately against one of the hues on the scale. This will indicate whether the patient is anaemic and, if so, the severity of anaemia in clinical terms.

Extensive testing and field trials have been carried out on the performance of Haemoglobin Colour Scale. An international validation study and several published papers have confirmed its reliability when used in general health centres and antenatal clinics, and in blood transfusion centres for donor selection because it assesses levels of anaemia much more effectively

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LATERAL FLOW ASSAYS RAPID LATERAL FLOW TEST STRIPS Lateral flow test strips based on the principles of Immunochromatography exist for a wide array of target analytes.

The first tests were made for the detection of human chorionic gonadotropin (hCG). Today, there are commercially available tests for monitoring ovulation, detecting infectious disease organisms, analyzing drugs of abuse, and measuring other analytes important to human physiology.

Most lateral flow test strips are modeled after existing immunoassay formats. Thus, test strips for hCG are typically sandwich assays; and drugs of abuse are analyzed by competitive or inhibition assays. In serum assays, antibodies are detected as indicators of various disease states.

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Section 3

Primary Research

CURRENT SCENARIO IN RURAL HEALTHCARE Healthcare is the right of every individual. But lack of quality infrastructure, dearth of qualified medical functionaries, and non-access to basic medicines and medical facilities thwarts its reach to 60% of population in India. A majority of 700 million people live in rural areas where the condition of medical facilities is deplorable. Considering the picture of grim facts there is a dire need of new practices and procedures to ensure that quality and timely healthcare reaches the deprived corners of Indian villages.

Though a lot of policies and programs are being run by the government, the success and effectiveness of these programs is not always possible.

Sometimes the problems arises due to the sheer area of population that needs to be covered, putting impossible strain on the already limited task force. In rural India, where the number of Primary Healthcare Centers (PHCs) is limited, 8% of the centers do not have doctors or medical staff, 39% do not have lab technicians and 18% PHCs do not even have a pharmacist. Due to this, these canters while battling their understaffing problems, stretch themselves thin over the areas they need to cover.

Due to non accessibility to public health care and low quality of health care services, a majority of people turn to the local private health sector as their first choice of care. However, private health care is expensive, often unregulated and variable in quality. Besides being unreliable for the

illiterate, it is also unaffordable by low income rural folks.

The key challenges in the healthcare sector are low quality or care, poor accountability, lack of awareness, and limited access to facilities.

Various organizations are coming together for improvements in healthcare and technology plays a crucial role to facilitate this. Information and communication Technology provides hosts of solutions for successful implementation of these changes. Several organizations are working alongside the government and NGOs to help relieve the burden on the public health system using mobile technology.

India has over 900 million mobile phone users and this factcan be leveraged to employ better practices in even the remote areas. Mobile and IVR services have an extensive reach across the demography. Focusing on this, the best tools and solutions can and are reaching the rural markets. This has indeed revolutionized the landscape of the healthcare industry, by using technology to enhance the quality of care and bridge the gaps in healthcare services in rural India.

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Government Hospitals

Healthcare NGOs

Existing Healthcare Providers

Private Hospitals and Clinics

PHCs and Anganwadis

PHYSICAL INFRASTRUCTURE Healthcare is the right of every individual. But lack of quality infrastructure, dearth of qualified medical functionaries, and non-access to basic medicines and medical facilities thwarts its reach to 60% of population in India. A majority of 700 million people live in rural areas where the condition of medical facilities is deplorable. Considering the picture of grim facts there is a dire need of new practices and procedures to ensure that quality and timely healthcare reaches the deprived corners of Indian villages.

Though a lot of policies and programs are being run by the government, the success and effectiveness of these programs is not always possible.

Sometimes the problems arises due to the sheer area of population that needs to be covered, putting impossible strain on the already limited task force. In rural India, where the number of Primary Healthcare Centers (PHCs) is limited, 8% of the centers do not have doctors or medical staff, 39% do not have lab technicians and 18% PHCs do not even have a pharmacist. Due to this, these canters while battling their understaffing problems, stretch themselves thin over the areas they need to cover.

Due to non accessibility to public health care and low quality of health care services, a majority of people turn to the local private health sector as their first choice of care. However, private health care is expensive, often unregulated and variable in quality. Besides being unreliable for the illiterate, it is also unaffordable by low income rural folks.

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GOVERNMENT HOSPITALS Government hospitals are the first point of contact with medical care for people living in rural areas. These hospitals provide basic medical care free of cost, or else at a minimal cost.

But, a majority of these hospitals are located in major cities, and hence are not accessible by people living in remote village areas. This is a major pain point for people who need immediate access to medical facilities, but have to travel long distances to claim it. In general, most of the rural population travels more than 30 kms to get access to healthcare.

When people from surrounding rural areas come to visit these centrally located government hospitals, along with the urban population, this puts undue pressure on the already limited resources of the institution. This can lead to discrimination and improper delivery of medical care.

PRIVATE HOSPITALS Since at many times government hospitals are time consuming or inaccessible for the rural public, the private hospitals and clinics become the first point of contact for many seeking medical care. Most of these clinics and private hospitals are costly and unaffordable by the low income group.

This at times discourages people from a seeking immediate health care.

Due to this, people tend to wait for a medical emergency in order to go seek medical care.

Again with these facilities mostly being situated in urban city centers, they geographically become inaccessible to many.

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Various NGOs working for Mother and Child health care

NGOs Various NGOs collaborate with government and private hospitals and clinics to provide cheap health care for the low income population. These NGOs also work to spread awareness about hygiene, basic sanitation, nutrition, etc.

They also collaborate with various other institutions and government bodies to provide health care facilities to those in need.

These NGOs further mobilize task forces to work in areas suffering from epidemics, natural disasters,etc. They facilitate the community health workers and ASHA workers in their tasks for the betterment of those in need.

NGOs also collaborate with corporate companies as part of their CSR to getr medical aid and medical devices to the low income group.

PHCs AND ANGANWADIS Primary Health Centre(PHC) are state owned rural health care facilities.

They are essentially single physician clinics, and are a part of the government funded public healthcare system.

Anganwadi is a type of rural mother and child care centre, which provides basic health care in villages.

Both the PHCs and Anganwadis become first point of contact with a medical care facility for rural areas.

The ANM(Auxillary Nurse Midwife), ASHA ( Accredited Social Health Activist) and AWW(AnganWadi Worker) connect and report to these health care facilities in order to provide the best possible care in rural areas.

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APPLIANCE SUPPORT Based on the size of the healthcare facility, the devices for conducting tests defer. Bigger hospitals have heavy duty devices which can process a large number of tests in a short period of time. Smaller institutions have different range of devices for conducting their tests. Depending on the health care facility, the whole process of testing differs. The type of machines used, and the process of testing is elaborated through the following case studies.

CASE STUDIES Case studies were conducted in order to understand the healthcare setup in rural and urban areas. The available facilities, environments, services, process of tests, and devices used were studied.

Patients from rural areas on the outskirts of the city visit the hospital for treatment. Because of the low cost of the tests, the hospital sees hundreds of visitors daily.

Government Hospital: SSG hospital, Vadodara

There are many treatments that the hospital offers for the people under the low income group, making it affordable for them.

This is a prime instution set up by the erstwhile ruler of Baroda, Maharaja Sayajirao II. It was taken over by the Gujarat Government in 1907. Since then it has been run as a state funded government hospital.

It has a state of the art Diagnostics Centre and Pathology Lab. Because of the scale of the hospital, depending on the rush of the patients, sometimes the tests are referred to various path labs around the city. Though most of the time all testing is done in the pathology department itself.

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Private Hospital: Sterling Hospital, Vadodara Sterling is a multi-speciality hospital situated in the heart of the city. The hospital boasts of a huge Pathology Department with state of the art devices.

Since it is a private chain of hospitals, the rates for conducting tests are on the higher side. The major patient population is from the urban area, with a very small faction of the low income group.

Private hospital in a semi-urban setting: Dhavale hospital, Palghar Dhavle Hospital is a multi-speciality hospital located in the semi-urban/ rural area in the outskirts of urban Mumbai. They have an at par Pathology Department, which sees patient cases from around the rural settlements on a daily basis.

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Drishti Pathology Lab, Palghar

Jetalpur Anganwadi, Vadodara

The Drishti Path Lab is situated in the semi-urban/rural setting of the town of Palghar, located on the outskirts of Mumbai. The lab is stocked with state of the art equipments. Their clientele is generally the residents of Palghar and neighbouring areas like Boisar, Virar, Dahan, etc.

The Jetalpur anganwadi is located in the heart of the city of Vadodara, in the the then village centre of Jetalpur area. This anganwadi acts as a pre-primary centre for kids, and as a counselling centre for young mothers and soon to be mothers. They generally do hand out necessary information regarding health care, hygiene, contraception, child rearing, nutrition, etc.

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Coagulation machine Hb machine

Biochemistry semi automatic analyser

For Electrolyte determination 34

PROCESS OF COLLECTION Depending on the health care setup, the methods of conducting the tests and processing differs.

Health camps

Health Clinics

The blood is collected, is tested at that instant Sometimes for lengthy tests it is collected and taken to labs for testing. the results are announced later.

Generally at a clinic, the physician refers the patient to a certain pathology lab for getting the required tests done. Very rarely, if the clinic is associated with a certain path lab, the required samples are collected on the spot and sent for testing. The results are collected by the patient gets treatment at the clinic itself.

Pathalogy Labs The blood is collected in the appropriate container. It is then sent for testing. the patient typically gets the results in maximum 3-4 days time depending on the type of test.

Also there are various collection centres which are connected to one pathology laboratory. At the collection centres, the blood, urine etc samples are collected, and then sent to the testing centre for processing.

Hospitals Most of the major hospitals have their own pathology labs for conducting tests. The patients admitted have their necessary tests conducted at the hospital itself, and do not need to go to a specific path lab to get tests done.

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The cutting of a vein to draw blood is known as Venipuncture. The whole process is called Phlebotomy and the person who is skilled to do this is called a Phlebotomist.

Necessary equipment for sample collection.

Order of draw for blood sample: First - blood culture bottle or tube (yellow or yellow-black top) Second - Coagulation tube (light blue top) Third - non additive tube (red top) last draw - additive tubes 36

HUMAN RESOURCE - MANPOWER

ASHA: Accredited Social Health Activist ASHA workers are health activists in the community who create awareness on health and its social determinants and mobilize the community towards local health planning. In general, ASHA workers attend weekly meetings at their local primary health center and make home visits to people in the community as needed.

Some of their allotted tasks are: • Create awareness and provide information to the community on determinants of health such as nutrition, basic sanitation and hygienic practices, healthy living, and work conditions.

• Provide information on existing health and welfare services • Councel women on birth preparedness, safe delivery, care of young, breastfeeding and complementary feeding, immunizations, contraception, and prevention of common infections, including sexually transmitted infections.

• Mobilize the community and facilitate access to health services.

• Work with Village Health and Sanitation Committee of the Panchayat to develop a comprehensive health plan.

• Accompany pregnant women and children requiring treatment/ admission to nearest health facility.

• Carry essential provisions (ORS packets, TB medicines, Iron and folic tablets, disposable delivery kits, oral contraceptive pills and condoms) for use in the community.

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ANM: Auxiliary nurse midwife, commonly known as ANM, is a villagelevel female health worker in India who is known as the first contact person between the community and the health services. ANMs are regarded as the grass-roots workers in the health organisation pyramid. Their services are considered important to provide safe and effective care to village communities. The role may help communities achieve the targets of national health programmes.

ANMs works at health sub-centres. The sub-centre is a small village-level institution that provides primary health care to the community. The subcentre works under the Primary Health Centre (PHC). Each PHC usually has around six such sub-centres.

Relation with ASHA workers: The Accredited Social Health Activist (ASHA) is a community health worker. Depending on the area covered by the sub-centre, each ANM is supported by four or five ASHAs. ANMs are supposed to take weekly or fortnightly meeting with ASHAs to review work done the last week or fortnight. ANMs guides ASHAs on aspects of health care.

With the Anganwadi Worker (AWW), the ANM acts as a resource person for the training of ASHAs. The ANM motivates ASHAs to bring beneficiaries to the institution. The ASHA brings pregnant women to the ANM for checkups. She also brings married couples to the ANM for counselling on the family planning. The ASHA brings children to immunisation sessions held by the ANM. The ASHA act as bridge between the ANM and the village.

AWW: The basic job of Anganwadi workers is extremely important and needs to be carried out in the most efficient manner possible. They need to provide care for newborn babies and ensure that all children below the age of 6 are immunized. They are expected to provide antenatal care for pregnant women and ensuring that they are immunized against tetanus. In addition to this they provide post-natal care to nursing mothers.

Since they primarily focus on poor and malnourished groups, they provide supplementary nutrition to children below the age of 6 and nursing and pregnant women. They ensure that regular health and medical check-ups for women 15- to 49-years-old take place and that all women and children have access to these check-ups. They work toward providing pre-school education to children who are between 3 and 5 years old

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A health workers paraphernalia

Left: An ASHA worker training textbook.

Depending on the topic of the week, they are given the appropriate knowledge on how to deal with certain situations, etc.

Left: A front cover sample of a health care booklet given to new mothers.

It contains all the necessary medical information, as well as the immunization schedule and care.

All community health workers like ASHA, ANMs, AWW are trained for handling the medical and counselling needs of their charges in their allotted rural areas.

The workers themselves go through the necessary training in order to be qualified, and have to report to their superiors once a week.

They are armed with the necessary equipments and knowledge to deal with any arising situations.

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The community health workers are assigned an area to cover. One ASHA worker per 1000 people from the population is generally the norm. The workers go from door to door in order to check up on their patients. While doing so they are each assigned a kit to carry.

The contents of the kit are: Baby weighing scale Thermometer Gentian violet Cotton Gauze Soap and soap case Flip book PNC cards Refferal slips (Depending on the state, the contents vary at times.)

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as

rHealth: It is a bluetooth connected device which uses lasers of various light intensities to come up with a diagnosis, from flu to pneumonia and ebola within a few minutes

EXISTING SOLUTIONS as

HemaApp: HemaApp measures hemoglobin levels and screens for anaemia noninvasively by illuminating the patient’s finger with a smartphone’s camera flash.

TouchHb: LEDs shine light through the nail.

as

Cor: It utilises surface blood sucked from the skin to measure blood chemistry at home.

A photodiode on the other end interprets the absorption patterns to produce an intant reading of the volume of hemoglobin in the patients blood.

3000 tests can be carried out, after which probe must be changed. The cost of one test is just Rs. 5. uChek: uChek is a smartphone based urine and blood sugar testing device. It used urine multiparameter strips to conduct various urine based tests and give instant results.

as

DCN LAF reader: It is a point of care reader which analyses lateral flow assays to give a quantitative reading. as

Optricon: It is a Lateral Flow Assay reader which works on the concept of image processing.

as

Dario: Dario is a handy device which uses strip cartridges to monitor blood sugar levels on the go.

as

Scanadu: It scans the skin of the patient to measure BP, temperature,heart rate and pulse oxymetry.

as

mReader: It is LAF reader which all blood chemistry tests.

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EXISTING SOLUTIONS There have been many technological advancements in medical health care.

In order to innovate, to understand the need of the hour, one needs to ask the right questions such as: What is the state of art on this invention? What does the present state of art not provide for, and what problems not being addressed? What is the gap in the technology- cost- specifics for each type of specimen?

There are various devices and ground breaking technology which addresses the need to solve the problem. Most of these technologies work on the concept of Point of Care, since POC tests are the need of the hour. Instead of listing it, a matrix has been created, to understand the benefits offered by each innovation at a glance.

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EXISTING SOLUTION FEATURES Features/ Products

Aina

iCalq

Nutriphone

uChek

Pathology Lab

USR

Country

India

USA

USA

UK

Everywhere

India

Parameter tests

HBA1c, Hb,Glucose, Cholesterol

Malaria, Hb, Urine, Glucose, Thyroid, iodine,Filovirus

Vitamin B12,D, cholesterol

DBS checks

All tests

Allmicronutrients, HIV, malaria, Pregnancy, Hb,Glucose, HbA1C, HBsAg

Type of calibration

Semi quantitative

Semi quantitative

Semi quantitative

Semi quantitative

Quantitative

Semi quantitative

Vendor dependency

Yes

Yes

Yes

Yes

No

No

Hardware/ Software dependency

Yes

Yes

Yes

Yes

Yes

No 43

GAPS IN THE TECHNOLOGY Solution/ Principle

Laboratory based HPLC/AAS analyzer

Reliability

Highly reliable

Specimen: Blood, Urine, Dry Blod Spot, Saliva

Gold standards

Individual point of care devices (digital)

Close to standards

Specimen: blood,Urine

High variability with different parameters

Cost

Challenges/ Limitations

Expensive

Very expensive and limits the availability Large space and environment conditions Needs high capital investments Annual maintenance and calibration cost

Moderate but limited tests

For every new test buy new device Spearate calibration and maintenance Remote upgrade not possible High coston consumables

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USER STUDIES

Based on the research done, it can safely be assumed that there will be two different types of interaction patterns with the device, hence two different users. • One will be the ASHA worker or rural health worker, who will be in interaction with the device for the maximum amount of time. • The other will be the patients who come to the required setup for the necessary tests. They will come in contact with the device only once, i.e. during the test.

These users can be segregated into two types.

The health workers/nurses/doctors who will be conducting the tests with the given devices become the Primary Users as they will be engaging with the device for a long time.

The patients who undergo the various deficiency tests through the device become the Secondary Users. they will come in interaction with the device only while giving sample, repeated only a few times over the period.

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USER SCENARIOS

The USR device is a Point of Care screening device. Its uses are multi fold, and since it is meant to be an easy-to-transport table top device, it can be used in various scenarios.

1.The device can successfully be used in health camps in two ways: a) For the tests, first the blood is collected in samples and then taken to a laboratory for testing (mostly used in PHC’s) b) The device is used as a POCT during the health camp.

2. ASHA workers or ANMs use the device on their rounds as a POCT,going door to door to get the pregnant mothers tested for various deficiencies.

3. The device can be used in an rural PHC for testing.

4. The device can also be used in major hospitals/ clinics for getting a speedy diagnosis.

5. Since the device will be handy and easy to carry, it can be used in disaster prone areas, very remote areas, or any place where it will be difficult to access medical facilities for diagnosis.

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PRIMARY USER: HEALTH WORKER

EXPERIENCE MAPPING

Think and Feel Under-equipped, Overwhelmed, Helpless

See

Hear

Many people suffering from diseases and other problems due to lack of infrastructure

Need for proper health care facilities in rural areas

High mortality ratio,specially amongst women and children due to lack of healthcare facilities

Try and help as many people as possible

Say and Do

Do as you are told by the superiors

Education and awareness Fighting Ignorance

Pain

Gain

Keeping the motivation alive, Convincing the patients to seek medical care Fighting prejudices, blind faith etc.

Work satisfaction, Respect in the community, Gain in current on field knowledge

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SECONDARY USER: PATIENT (PREGNANT MOTHER)

EXPERIENCE MAPPING

Think and Feel Scared, confused, feeling helpless Cost crunch for medical help Lack of trust for medical institutions

See

Hear

Costly services

Services and Devices are too costly

Travelling long distances to avail services

Use household remedies to treat.

Long waiting at a medical centre

Focus more on work

Say and Do Aviod going to cities to get proper screenings due to work load Ask neighbours or elders(non medical folk) for medical advice

Pain

Gain

Improper screening of diseases, Out of reach facilities physically and economically, lack of trust

Timely medical attention, proper healthcare provided within reach and in a convenient fashion 48

INFERENCES

• Invasive readings are trusted by doctors • There is a need for low cost devices which provide accurate readings.

• These devices will go to far off rural places, hence they need to be robust and should seamlessly fit with the overbuilt ecosystem and workflows without adding complexity or risk.

• Remove unnecessary complexity to make tasks simpler, easier, faster and safer.

• The device needs to be cost effective and non proprietary.

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Section 4

Iterations

APPROACH TO DESIGN

The design approach for this particular problem as been solved in a ‘PartTo-Whole’ approach. Hence the following part of this chapter and the subsequent chapters has been arranged in the sequence of solving each parts of the problem.

The requirement of the device design was such, that it was necessary to first design the smaller parts, or the ‘Function Points’ first, which would help determining the proof of concept. These parts were then sent for validation and vigorously tested in order to achieve the required results. Once the results were established and the design of the functioning part was finalised, the design of the corresponding parts was tackled. Once all the necessary functioning parts were designed satisfactorily, then only the whole product was designed. Here, truly form followed function.

This chapter will elaborate on each and every minute aspect of the design of the ‘Functional Points’.

FUNCTIONS OF THE DEVICE

The USR device has two main functions.

• Color sensing: for reading Hemoglobin levels • Image processing: for getting readings from Lateral Flow Assay These two functions have their own family of circuits. These circuits, form the two branches of the device, which are connected to a central processing controller.

The complete components of the USR device are as follows: Sensors: • Color sensor • Camera sensor Communication module • Bluetooth module Supporting components • 5V LED strips • 150 ohm resistors • GPB • Ic7805 • Connector wires • Power connector 3D printed • Color sensor holder 51 • Camera Holder

HEMOGLOBIN PROCESSOR

In order to calculate the hemoglobin content in a dry blood spot, the Colorimetry approach as chosen. Here, the colour sensor detects the colour of the dry blood spot, and corresponds the colour value to the hemoglobin content in the blood and gives a result in g/dl values.

The color sensor has a RGB and a colour light sensing element. An IR blocking filter, integrated on-chip and localized to the colour sensing photodiodes, minimizes the IR spectral component of the incoming light and allows colour measurements to be made accurately.

Supporting Medium: Most of the Hb devices have a dependency on the strips that are used for testing. Due to these dependencies, the device becomes proprietary, due to which its price rises. The tests are conducted at a high price and hence are not accessible by all.

Here, CareNX has sought to eliminate this dependency, by choosing a strip which will be universally available, and free from vendor dependency.

The paper strips manufactured by Copack are recomended by WHO for Hb screening and are cheap and widely available. Since these strips are available everywhere, and cheap in terms of cost, they make the test very cheap and affordable by one and all.

SENSOR Housing for sensor: A suitable housing to hold the colour sensor and the incoming strip was to designed.

Cartridge: Based on the form of the housing designed, a suitable cartridge was designed. The need for the cartridge was felt as it would be a protective medium between the blood spot and the sensor, protecting the sensor and other hardware from blood contamination.

Based on the principles of Colorimetry, a set pattern of conducting the test had been established initially.

• Place the strip in the cartridge.

• Calibrate device to start the test.

• Now, prick the patients finger. Clean off the first drop of blood that appears.

• Now place the drop of blood onto the exposed strip of paper.

• Now place the cartridge onto the housing.

• Wait for 30 seconds and click on start test on the Application.

• The strip will be processed by the colour sensor and the results will be displayed on the mobile screen.

Based on this established pattern, a housing for the sensor was designed, along with the cartridge to place the strip.

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ITERATIONS ITERATION 1

ITERATION 2 Initially, various combinations of the sensor housing and strip cartridge were carried out in order to achieve maximum accuracy.

Sensor Housing

The initial assembly contained a flat slab to hold the strip. The colour sensor will come on top of the housing, the sensor and LED of the chip contained in the rectangular cut-out shown in the housing image.

A different type of housing was developed. Instead of rectangular opening, an elliptical opening was designed, in order to experiment which type of reading gives the most accurate results.

Gap between strip and sensor: 2mm Sensor Housing

Issues: Due to surface tension, blood sticks to side walls of the cartridge.

Also it is believed that the oval opening is covering a part of the sensor, preventing it to function to its full accuracy.

Gap between strip and sensor: 3mm Accuracy in reading: 80% Cartridge

Assembly

Issues: Achieving absolute blood coverage in the exact spot was difficult. This gave an inaccurate reading.

Because on 3mm gap between sensor and strip, accurate reading might not be possible Inference: Reduce distance between strip and sensor Get the blood spot loaded accurately

Accuracy in reading: 80%

Cartridge

Assembly

Inference: Reduce distance between strip and sensor Get the blood spot loaded accurately Experiment with different types of openings in the housing for the sensor.

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Experiments and different iterations with 3D printed parts to test the validity of the assumptions. A set colour was determined to calibrate the device.

With each different iteration, the accuracy increased and it was possible to pinpoint each problem. Trials were done to solve the issue in the next iteration and get maximum possible accuracy to establish the proof of concept

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ITERATION 3

ITERATION 4

Cartridges of different thickness were experimented with to achieve maximum accuracy.

Next, variations in the housing were tried out, keeping the cartridge steady at 1mm thickness.

Thickness of cartridges: 0.4mm, 0.6mm, 0.8mm

Gap between strip and sensor: 2mm Accuracy in reading: 85% (approx)

Accuracy in reading: Variable

Cartridge

Assembly

Issues: Due to a certain limit of the resolution of the 3D printer, the cartridge with 0.4mm thickness was not be feasible to print 0.6mm cartridge caused problems during the insertion of the strip 0.8mm thickness did not show a greater accuracy in readings

Housing 1

Issues: Due to surface tension, blood sticks to side walls of the cartridge.

Loading the blood spot was still a pressing issue.

Inference: The opening of Housing 2 provides the blood spot below to be better analyzed by the sensor, showing greater accuracy than Housing 1 Reduce distance between strip and sensor Experiment with different types of openings in the housing for the sensor.

Inference: Experiment with distance between strip and sensor Get the blood spot loaded accurately Housing 2

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Sectional view

Sectional view

Sectional view

Option 1

Option 2

Option 3

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ITERATION 5

ITERATION 6

Next, variations in the cartridge were experimented with. The elliptical opening situated in the centre of the strip was changed, in order to see if it affects the readings.

Gap between the strip and the sensor was experimented with, seeing how the readings change as the distance increases or decreases.

Gap between strip and sensor: 2mm

Gap between strip and sensor: 2mm

Accuracy in reading: 85% (approx)

Accuracy in reading: 85% (approx)

Cartridge

Issues: Due to a certain limit of the resolution of the 3D printer, the thickness of the cartridge towards the lower values were not feasible.

Cartridge 1

Inference: The opening in Cartridge 2 provided better results without contamination, as was the case in cartridge 1.

Inference: Experiment with distance between strip and sensor proved fruitful upto a certain extent.

Get the blood spot loaded accurately Housing

Issues: Loading blood onto the smaller opening proved difficult.

Larger opening needed more quantity of blood, which was difficult for patients suffering from anaemia.

Cartridge 2

A pipette could be used to load blood onto the strip, solving the issue of it not transferring onto the paper.

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ITERATION 7

ITERATION 8

In iteration 7, we changed the orientation of the sensor and strip and how they will interact with each other.

The sensor was placed in the bottom and cartridge and strip were to rest on top of it.

Once everything was in place, the blood drop just needs to be placed onto the strip and the sensor would start the reading.

Next, variations in the cartridge were experimented with. The elliptical opening situated in the centre of the strip was changed, in order to see if it affects the readings.

Gap between strip and sensor: 2mm Accuracy in reading: 92% (approx)

Accuracy in reading: 92% (approx) Cartridge

Housing

Issues: The distance between the strip and sensor was still an issue. It was difficult to reduce the distance more than 2mm.

A little tweaking was needed in the opening for the sensor.

Inference: This method reduced the human error caused by the previous methods. It increased the accuracy.

There was a risk of device contamination.

Cartridge

Housing

Issues: The distance between the strip and sensor was still an issue. It was difficult to reduce the distance more than 2mm.

Inference: As compared to the previous iteration, having a rectangular cut out gave better results.

It was observed that having a tight opening for the sensor increased the accuracy.

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ITERATION 9

ITERATION 10

Here, we eliminated the cartridge all together. The paper strip would directly be channelled into the sensor housing and the blood drop will be loaded from the top.

This variation was just an experimental iteration to check whether external light elements affect the reading of the sensor.

If they did, then the orientation and housing of the sensor would need to be redesigned.

Accuracy in reading: 92% (approx) Issues: There is a doubt that external light elements affect the reading of the sensor.

Housing

Inference: This method improved the accuracy of the test.

Have to experiment with the housing to see if shadow interferers with the readings.

Issues: There was not observed any considerable difference between the readings of the previous and current experiment.

Housing

Inference: External light elements, shadows, etc. do not affect the readings of the device. The illumination of the LED is strong enough to cancel the effect of the external light elements.

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VALIDATION AT KEM HOSPITAL, MUMBAI

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Assembly of parts for the device. A certain set distance was needed to establish the camera sensor to achieve maximum accuracy. In order to provide proper illumination, LED lights were provided around the lens for proper focus and crystal clear image for processing.

The two branches of circuits come together to connect to the main controller and processor. Keeping in mind the volume of wires, adequate spacing is provided in order to hold the whole structure together in the form.

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THROUGHPUT

Lets calculate the throughput for the USR Hb device.

Lets assume it takes 3 minutes to run the complete test. This can be broken down into:

Use-cases of the product are: 1. Camps 2. Hospitals Both these scenarios present busy working conditions, with a lot of pressure to complete tests in a certain amount of time. Hence by understanding the throughput of the device, one can calculate how exactly the device will function in a given period of time. Based on these calculations, one can decide on the number of processing channels to provide in a device. For example, if the Hb device is to be used in a very busy environment, where it is required that an ‘x’ number of tests be processed in ‘y’ amount of time, the number of openings for processing can be determined by simple calculations. This can justify the number of processing points to be given in any device.

Generally for any device, higher initial cost/ capital is accepted, but a high recurring cost causes problems with the overall spending of the device.

• • • •

1 minute for getting fresh apparatus and setup 1 minute for sample loading 30 seconds for the blood spot to dry 30 seconds for the test to process

Now it takes 3 minutes for one test to complete.

In an hour 20 tests can be completed.

For a busy hospital or health camp, per hour 20 patients can be processed.

If the need is for more tests to be processed /hour, then either the input processing points of the device can be increased, or the test run time can be decreased.

If for the same test 2 slots are given, then 40 tests can be run in an hour. Similarly, if the test run time is reduced to say 1 minute/test, then 60testscanbe processed in an hour, and 480 tests/day (assuming 8 working hours) Giving more number of openings, leads to more hardware support, which increases the cost of the device.

Since the device is to be used in a rural clinic setting, 20 patients can comfortably be processed per hour. Hence a single opening will suffice.

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Section 5

Design Concepts

e

DESIGN CRITERIA

The following design criterias were kept in mind before starting the design iterations for the device.

• Logistics- Product needs to go to remote areas in order to help the mothers who cant access the costly medical devices/ services/ clinics.

• The device needs to be robust and strong. It should be easy to handle by laymen without any medical experience.

• Ease of use: Interface/ User experience of the device should be such that it is easy to use by everyone.

• The device should be simple and easy to use during mass screenings.

• Conducting the tests should not be very time consuming, for it will be difficult to use during health camps or in busy hours in the clinic.

• The device needs to be such that it is portable and easy to transport.

• The device should be designed keeping in mind the different types of strips, their manufacturing, sizes, shapes etc.

• If possible, the device can have provisions for future changes in slotsor smaller parts, without changing the whole device body.

Desirable solutions for health care: • Seamlessly fit within the overbuilt ecosystem and workflows without adding complexity or risk • Understand the scenarios where the device will be used. How people function in these given scenarios.

• Remove unnecessary complexity to make tasks simple, easier, faster and safer.

• Truly empathize with the user, understand his requirements out of the device • Address the needs, priorities, desires, perceptions and motivations of the many different user groups.

• There is a need for emotional design, a good user experience.

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Thoughts and scribbles on paper

IDEATION 1 Balance Corresponding words:

Equilibrium Poise Stability Steadiness

Micronutrient deficiency causes imbalance in the body. For a healthy life, healthy pregnancy and baby, balance in the body is very important.

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Various form development sketches for the concept of balance

Determining the form understanding the relation with the inner circuits

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Form modelling trials Block modelling/ 3D models 68

Form render trials 3D models

Colour experiments

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IDEATION 2

Push Pull Trying to understand the semantics of the form, and the function involved, the basic action for testing is putting the strips in the device, conducting the tests and removing the strips. Hence the most major action of using the device is ‘Push and Pull’.

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Various form development sketches for the concept of push pull

IDEATION 3

Soft The philosophy behind this concept is that many people are afraid of needles. Even if someone is not afraid of needles, they don’t enjoy the sensation of getting the finger pricked.

Since pregnant mothers will have to undergo the deficiency tests,and other tests more than once during their term, it can cause them harbouring negative feeling with the device. Some might also be tempted to forgo the tests in order to avoid the finger pricking.

To counter this effect, I felt the need to emulate the sensation of relief on touching a soft surface, like that of pressing a cotton bud to your fingers after a test.

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CHANGE IN ORIENTATION

A switch in the order of placing the circuits was tried. Instead of a horizontal setting, a vertical setting was tried. This helped to make the product more compact, utilizing the saace to the maximum.

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Section 6

Final Design and Detailing

FORM MODELLING TRIALS

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The LED panel combines the activeend of the device together. It is meant to draw the eye in a straight line between the two loading points, i.e. for Hband for the Lateral Flow Assay.

Opening for loading blood spot

Because of the off setted location of the two loading points, in case of conducting simultaneous tests, there will be no clashes while loading the sample.

Hb strip loading Top of the device is meant to be perceived as a comforting hand, taking the blood into itself. The curve of the surface is meant for the user to feel the need to place the finger there.

DC jack and Main Switch in the back.

Front of the device tilts backward, the bottom jutting out.

This is to draw attention to the opening for the Lateral Flow Assay.

Since this device is meant to be a table top instrument of use, the tilt also stabilises the device from toppling over.

LED screen

Opening for LateralFlow Assays

Since the Lateral Flow Assays differ in width, an adjustable channel opening is provided. This opening can accommodate different thickness’s.

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FINAL DESIGN VIEWS VERSION 1

Once the overall form was finalised, attention was given to details.

For the Hemoglobin screening test, a major threat was that of contamination. The patient was supposed to place finger onto the device to deposit the blood spot onto the strip. During this, there was every chance that the blood spot might touch the surface of the device, sticking to he sides of the opening. The next person using this could come in contact of the previous patient’s blood. Now if the previous patient was say HIV positive, this would pose a very huge risk to all the users of the device who would use it after him.

Autoclave for sterilising the metal strip

To solve this problem, the strip around the immediate area of the opening for loading blood for Haemoglobin could be made of metal, and could be detachable. USR device could be accompanied by an autoclave, where this metal strip could be loaded and sterilised for use. This would ensure a clean and healthy device, the use of which would not be of harm to its patients.

Issues: This increases the cost of the device considerably. Also care has to be taken to carry both the devices together. If one stops working, the other becomes redundant.

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From left to right: Top view of the device.

It shows the opening for loading blood spot for Haemoglobin screening test.

The strip can be removed and cleaned and sterilised in an autoclave.

Front view of the device: The front view shows the LED screen. The screen will act as a communicating surface, which will show: • Whether the device is one • The Bluetooth is on and connected • Device is ready for testing • Test is in progress Bottom: The back panel will hold the power function of the device. It will have a DC jack and a power switch.

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FINAL DESIGN

With a few tweaks to the previous version, the final version was devised.

Here, the cartridge holding the strip has been removed. This reduces the material need. Since there was device dependency in the previous iteration, the metal strip has been removed. Instead a flat platform is cut into the surface of the device, which lets the strip slide in and holds it in place. The LED present in the sensor shines through the small circular opening and illuminates a circle on the strip which shows exactly where the blood spot should be placed and how much area it should cover.

The surfaces of the device have been made flat, in order to facilitate ease of manufacturing.

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Different angle views of the device.

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The controller and Bluetooth will be affixed to the back first. Then the camera will be fixed onto its base, after which the coloursensor will be slid into place.

Once all the connections are established, the back will slide into place.

Blown up front view of device with circuit

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Blown up back view of device with circuit

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Sectional View with assembly 87

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COLOUR For deciding the colour of the product, several factors were kept in mind: • The device should look simple to use.

• It handling should not be confusing.

• The focus should remain on the function of the device With this in mind, a very light gray colour was chosen for the top of the device, where the Hb strip will slide into place. This block houses the whole working parts of the device, hence the need to make it seem denser. The rest of the body has a smooth shiny dull white colour. Since the device is going to be operational in a medical setting, white helps dignify cleanliness and calm.

WIth the grey top and the LED screen, the eyes are drawn to the big slot in the bottom which will take the LFA for testing.

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INTERACTION WITH THE DEVICE

In terms of the user interface of the device, the user will have minimum interaction with it. Once the device is turned on, it stays on till all the tests are finished. The pattern of interaction of the user with the device will be as follows: • The user turns the device on.

• Connects the device with his smart phone through application.

• For Hb test, the user slides the strip into place, the sensor recognises the strip and self calibrates.

• Once calibration is done, the device intimates the user that it is ready for test.

• User places blood drop,the device starts processing the sample.

• For LFA, the user slips the LFA into the slot, and starts test through his cellphone application.

• The results of the test appear on the cellphone screen.

• Once all work is done, user disconnects application.

• Turns the device off.

Chronology of actions: Turns on device

Power symbol is lit

Connects smartphone bluetooth

Bluetooth symbol is lit

Slides strip into place, device calibrates

Ready symbol pops up on the screen

Test is processing

The processing symbol flickers

• Test is completed

Process symbol turns off

• Disconnects device

Bluetooth symbol is turned off

• Turns off the device

Power symbol turns off

Universal symbols denoting Power on/off, Bluetooth and processing have been selected so that they can be understood by one and all.

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Top view of device

LED of Hb sensor On placing the strip, the smart sensor will recognise that the strip has been placed. On placing the blood drop, the device will start the test.

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Both the tests can be run simultaneously. There location of the slots is such that there is ease in loading blood sample.

The display lights on the screen start glowing, communicating that the device is on, bluetooth connected etc.

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APPLICATION UI

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MANUFACTURING

The USR device has been designed with the technology of 3D printing in mind. It is a device which can be custom made according to the requirement and demand. CareNX having the access to a 3D printer, can manufacture each piece by themselves. This will prove to be a cheaper alternative than getting the device manufactured through mass production facilities. Since mass production requires a set number of pieces to be produced at a time to make the manufacturing economical, it wont be feasible to produce a large number or parts and assembling them at will according to demand. Also since the project is still under research, it will go through many hardware development stages before being completely ready for mass manufacturing. Hence at its current stage, clearly defining the manufacturing outputs of the device is out of scope.

The technology of 3D printing gives the company added edge, as the dependency on a manufacturing unit is removed. Hence keeping this in mind, the device body can be manufactured in any of the material filaments available like ABS or PLA. Both the materials are rigid and give the device body a toughness and durability. They can withstand high temperatures, hence no disfigurement will occur if the device is exposed to high temperatures. Also, at the right prinitng resolution, the prints have a very smooth finish, which makes the device look good.

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MANUFACTURING AND MATERIALS

For future use, when the device passes the research phase and is ready for mass manufacturing, a few criteria need to be kept in mind before selecting materials.

• • • • • • • • • • • •

Moving parts Preventing hospital - acquired infections (HAIs) Regulatory concerns Device classification Ideal cost per pound range Characteristics of the product How it is handled by end user How it gets cleaned The strength, durability and wear resistance of the body Will it be exposed to extreme heat / cold?

Does it need to be waterproof Should it be water/ chemical/ body fluid resistant (This will determine whether the original resin needs to have an additive like a glass or mineral powder filler, a UV stabilizer etc.

Post moulding considerations • • • • • •

Whether or not product gets printed Has labels applied Gets assembled, glued or welded together Texture Grip Fingerprint resistance

The most common materials used for medical devices are: • Polyvinyl Chloride PVC • Polypropylene PP • Polyethylene PE • Polystyrene PS • Nylon • Polyethylene trepthalate PET • Polyamide PA • Polycarbonate PC • Acrylonitrite butadiene ABS • Polyetheretherketone PEEK • Polyurathane PU 98

MANUFACTURING AND MATERIALS

The device will be used in: • PHCs • As a POCT device • Health camps • Hopsitals etc Due to the various scenarios in which the device will be used and come in contact with different types of patients, the device needs to have the following attributes: • Simple to manufacture • Ergonomic, comfortable and aesthetic • Should prevent Hospital Acquired Infections HAIs • Should be easy to clean with alcohol swab • Durable and wear resistant • Should be able to withstand a wide range of temperatures • Waterproof • Water/chemical/body fluid resistant

According to the necessary parameters for selecting a suitable material for this device, ABS (Acrylonitrite butadiene Styrene) seems the most fitting.

It is a light weight material, which is easily manufactured. ABS polymers are resistant to aqueous acids, alkalis, concentrated hydrochloric and phosphoric acids, alcohols and animal, vegetable and mineral oils. Fibers (usually glass fibers) and additives can be mixed in the resin pellets to make the final product strong and raise the operating range to as high as 80 °C (176 °F). Pigments can also be added, as the raw material original color is translucent ivory to white.

The device can be injection moulded to perfection, making a tough and rigid product which can withstand the wear and tear of transportation.

The device will be transported and used in various situations where a sterile environment is not possible. In order to prevent HAIs, an antimicrobial coating on the outer device, as well as on the sensor housings, will help prevent infections.

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Section 7

Bibliography

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https://qz.com/244161/this-little-device-has-the-potential-to-transform-healthcareacross-the-developing-world (11:16, 04-03-17) {Dengue} http://www.jmitra.co.in/ourdivision/diagnosticdivision/rapidtestkits/denguerange/ diagnose_dengue_card.aspx (11:28, 04-03-17) http://money.cnn.com/2016/06/03/technology/malaria-blood-test-device (11:44, 04-0317) {Malaria} https://www.scientificamerican.com/article/paper-diagnostic-tests-could-save-thousandsof-lives (15:33, 04-3-17) http://www.livemint.com/Politics/ruVU9yiEmbG9JXwFgQzU0O/IIT-Kharagpur-USvarsity-develop-lowcost-rapid-blood-test.html (16:08, 04-03-17) http://www.gramvaani.org/?p=1629, article dated: 13th July 2016) Rural Healthcare: Towards a Healthy Rural India ,GraamVani article, Published 13th July 2016 http://searchhealthit.techtarget.com/definition/remote-patient-monitoring-RPM http://searchhealthit.techtarget.com/Briefing-A-look-at-mobile-health-care-trends-andtechnologies https://www.anylabtestnow.com/tests/micronutrient-test/ https://labtestsonline.org/understanding/analytes/vitamin-d/tab/test/ http://motherchildnutrition.org/index.html https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3740071/ https://www.ncbi.nlm.nih.gov/books/NBK11761/ https://scholar.google.co.in/scholar?q=vitamin+d+deficiency+detection+test&hl=en&as_ sdt=0&as_vis=1&oi=scholart&sa=X&ved=0ahUKEwj53Nq1h7VAhUIuo8KHRWWCN4QgQMIJTAA

• • • • • • • • • • • • • •

http://www.medicaldevice-network.com/projects/x-ray-sterilization/x-raysterilization6.html http://www.mddionline.com/article/selecting-materials-medical-products-pvcmetallocene-polyolefins#tab2 http://www.steritouch.com/antimicrobial-products/antimicrobial-plastics-andcompounds/ http://health.howstuffworks.com/pregnancy-and-parenting/pregnancy/fetaldevelopment/10-must-have-tests-during-pregnancy.htm https://www.whattoexpect.com/pregnancy/pregnancy-health/prenatal-testing-initialblood-workup/ https://www.whattoexpect.com/pregnancy/screenings-and-tests-during-pregnancy/ http://www.who.int/mediacentre/factsheets/fs348/en/ http://www.nhs.uk/conditions/pregnancy-and-baby/pages/screening-testsabnormality-pregnant.aspx http://www.sphereproject.org/ https://www.quora.com/What-are-the-main-challenges-faced-by-rural-healthcare-inIndia http://www.gramvaani.org/?p=1629 http://www.sevamandir.org/health http://haemoglobincolourscale.com/ http://www.publichealthreviews.eu/show/

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