Page 1

M o b i l e s o l u t i o n f o r B re a s t C a n c e r s c re e n i n g i n d e v e l o p i n g c o u n t r i e s .

Earl Pineda

/

Final Degree Project

/

Advanced Product Design Master’s Program

/

Spring 2010


/Contents

Time Plan____________________________________ page 1 - 2 . Research : Breast Cancer_______________________ page 5 - 14 Introduction Design Opportunity Breast Cancer Basics Common Mythes

. Research : Technology_________________________ page 15 - 36 Manual Breast Examination Mammography Digital Tomosynthesis Ultrasound Elastography Magnetic Resonance Imaging Thermography Breast specific Gamma Imaging Breast Pap test Technology Evaluation

. Research : Users______________________________ page 37 - 62 What I want to learn... Umea University Mammography Center Philippine Breast Cancer Network Manila Capitol Medical Center Thermal Imaging Section Bangkok Breast Cancer Support Group Ghana Breast Health International The role of Emotions Target Countries: Lower-middle income


Temperature considerations Mapping the system Screening Strategy Insights

. Goals and Wishes_____________________________ page 63 - 64 . Creative Process______________________________ page 65 - 112 Inspiration and Design Attributes Relevant Technologies Brainstorming Sketch Ideation Concepts Defined Key Questions System Map Workflow Scenario Concept Development Mockup Testing Cultural Considerations Logo

. Final Design__________________________________ page 111 - 132 Closed Configuraton Open Configuration Human Generated Power Interface Design Dimensions Package and Components

. References___________________________________ page 133- 135


/Timeplan

JANUARY

FEBRUARY

MARCH MI D -P res e n t a t i o n 3 concepts +sketch models + c o n c e p t va lid a t io n (if p o s s i b l e )

Anders tutoring

R esearch co n c l u s i o n an d I deat i o n p ro g re s s

A u di t o r i u m A NOUNC E M E N T o f D egree P ro j e c t

Su bm i t D egre e T I T L E t o MA Co o rd i n a t o r

TRIP TO ASIA

. . 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 2

U N D E R S TA N D I N G p h a s e

Analysis phase

in t e r n e t r e s e a r c h

concept development concept directions

insights field research

c

idea generation

frameworks areas of opportunities

sketching & form dev. prototyping & user tests

p r o g r a m w r iting

PAGE 1

concept validation


APRIL

M AY

J

G r adu a t i o n D i n n e r !

P resen t at i o n o f a l l M A degree pro j ect s a t U I D

D EA D LI NE F i n a l re p o r t an d su po r t i n g m a t e r i a l s

D egree EX A MI N AT I O N

D EA D LI NE D i gi t al R e p o r t

Anders tutoring

“ 5 w eeks t o f i n al e� P rese n t a t i o n

25 26 27 28 29 30 31 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 01 02 03 04 05 06

concept refinement

finalization

a d j u stments sketch detailing a n d s p e c s fin a l v a l i d a t i o n CAD Modeling rendering report writing m o del making

PAGE 2


PAGE 3


What sparked my initial interest in breast cancer was an article from the Harvard School of Public Health that indicated a significant increase in breast cancer in the developing world. I wanted to learn more about women’s health issues, and I believe that breast cancer is one issue that can potentially affect any woman.

RESEARCH : BREAST CANCER

PAGE 4


/Introduction

Breast cancer in developing countries: An unforseen health priority Breast cancer is not a new issue in the world’s richer countries. But recent research showing the increasing prevalence of breast cancer in the developing world and the significantly younger age of its victims, has put more focus on the women of these poorer countries. Previous data had indicated that women of the developing world have a proportionally lower incidence of breast cancer cases, compared with richer nations such as the US. Some have attributed this discrepancey to the fact that women of developing countries have more children, at a younger age and breast feed on a normal basis, behaviors that benefit breast health. Such statistics can make it seem as if breast cancer is not really an issue in developing countries. Now, new research has shown otherwise. Harvard School of Public Health Dean Julio Frenk has called breast cancer in developing nations “an unforeseen health priority”.

PAGE 5


The true prevalence in most developing countries is unknown, because of limited data, poor diagnosis and insufficient record-keeping. But new Harvard research estimates these poorer countries will account for about 55 percent of the world’s 450,000 expected breast cancer deaths this year. The research has also indicated that women are getting the disease at a much younger age in the developing countries, about 10 years younger than compared with the United States. And no one can explain why. Not surprisingly, diagnosis is often made late in the game. While roughly 60 percent of breast cancer cases in the United States are detected at Stage 1, only 5-10 percent of cases in Mexico are. More than half of Mexican breast cancer cases are detected in Stage 3 or 4, when the disease is much more difficult to treat. Worldwide, more than half of diagnosed patients in poorer countries die of breast cancer, compared to 24 percent in richer nations. Thus, stage of diagnosis is a clear target for improvements. The obvious obstacles include the lack of political will, lack of adequate health-care infrastructure and resources, lack of access to early detection; and cultural barriers in getting women to attend for screening, and overcoming the social stigma associated with breast cancer.

PAGE 6


/Design Opportunity

Globally, breast cancer is the most lethal form of cancer for women in the world. About half a million women die from the disease every year. There are 1.35 million new cases just this year and about 4·4 million women are believed to be living with breast cancer. It is estimated that 1.7 million women will be diagnosed with breast cancer within a decade—a 26% increase from current levels. By 2050, 70% of all breast-cancer cases worldwide will be in developing countries.

PAGE 7


Design Opportunity Breast cancer in developing countries is an interesting design topic because not only do these women lack the resources and expertise for adequate healthcare, but there also exists inherent cultural intricacies, making the implementation of breast examinations even more challenging. So the design challenge is to make a device that is ultra-portable, using advanced technologies, creating an approriate form and designing a system that is culturally sensitive and less intimidating. Such a device can yeild tremendous benefits to women of these poorer, remote communities, giving them access to advanced technology for the early detection of breast cancer, possibly saving many lives in the long run with early treatment.

PAGE 8


/Breast Cancer

Basics

Cancer is when a cell looses its ability to divide normally, resulting in unregulated, uncontrolled growth. This growth forms a lump or mass called a tumor. Tumors can be benign or malignant. Benign tumors are not cancerous, but are removed to prevent possible health risks. Once removed, they typically do not reappear. Cells of benign tumors do not invade other tissues. Malignant tumors, on the other hand, are cancerous. Malignant tumors recruit blood vessels (in a process called angiogenesis) to feed their growth. As it grows, it can invade nearby tissues or it can break away from the primary tumor and spread to other parts of the body via the bloodstream or lymphatic system. This process is called metastasis. Breast Cancer is when a malignant tumor has formed from cells within the breast. About 85 percent of breast cancers begin in the mammary ducts, while about 15 percent arise in the lobules. When abnormal cells grow inside the milk ducts, but have not spread to nearby tissue or beyond, the condition is called ductal carcinoma in situ (DCIS). DCIS is a non-invasive breast cancer as confined within the ducts, but has the potential to become invasive. Invasive breast cancer occurs when abnormal cells from inside the lobules or ducts break out into nearby breast tissue. When the cancer cells find their way into the lymph nodes, they are able to metastasize to other parts of the body. Breast cancer becomes lethal when it invades and compromises other organ systems like bone, liver, lungs and brain.

PAGE 9


Cancer stage is based on the size of the tumor, whether the cancer is invasive or non-invasive, whether lymph nodes are involved, and whether the cancer has spread beyond the breast.

Doctors usually use the TNM staging system to determine how far a cancer has spread. The cancer is described by three characteristics: Size (T stands for tumor) Lymph node involvement (N stands for node) Whether it has metastasized (M stands for metastasis) From these values, they can tell a patient which “stage� cancer she has.

Stage 0 - Carcinoma in situ Atypical cells have not spread outside of the ducts or lobules, the milk producing organs, into the surrounding breast tissue. Referred to as carcinoma in situ, it is classified in two types: Ductal Carcinoma In Situ (DCIS) - very early cancer that is highly treatable and survivable. If left untreated or undetected, it can spread into the surrounding breast tissue. Lobular Carcinoma In Situ (LCIS) - not a cancer but an indicator that identifies a woman as having an increased risk of developing breast cancer.

Stage 1 - Early stage invasive breast cancer The cancer is no larger than two centimeters and has not spread to surrounding lymph nodes or outside the breast.

Stage II Stage 2 breast cancer is divided into two categories according to the size of the tumor and whether or not it has spread to the lymph nodes: Stage II A Breast Cancer - the tumor is less than two centimeters and has spread up to three auxiliary underarm lymph nodes. Or, the tumor has grown bigger than two centimeters, but no larger than five centimeters and has not spread to surrounding lymph nodes. Stage II B Breast Cancer - the tumor has grown to between two and five centimeters and has spread to up to three auxiliary underarm lymph nodes. Or, the tumor is larger than five centimeters, but has not spread to the surrounding lymph nodes. Stage III Stage 3 breast cancer is also divided in to two categories: Stage III A Breast Cancer - the tumor is larger than two centimeters but smaller than five centimeters and has spread to up to nine auxiliary underarm lymph nodes. Stage III B Breast Cancer - the cancer has spread to tissues near the breast including the skin, chest wall, ribs, muscles, or lymph nodes in the chest wall or above the collarbone.

Stage IV The cancer has spread to other organs or tissues, such as the liver, lungs, brain, skeletal system, or lymph nodes near the collarbone.

PAGE 10


/Breast Cancer

Basics

There are more than 100 types and subtypes of breast tumors, according to the World Health Organization. Some breast tumors are harmless, such as fibroadenomas and intraductal papillomas. Other early stage breast tumors are harmful but well contained to the tumor site, and these are ductal carcinoma in situ (DCIS) and lobular carcinoma in situ (LCIS). Invasive, or infiltrating, breast cancer is diagnosed when cancer cells that started in your milk ducts or lobes spread to, or invade, healthy surrounding tissue. Invasive breast cancer has the potential to travel to other parts of your body through your bloodstream and lymph system. Here are the most common types of breast cancer: Ductal Carcinoma In Situ A type of early breast cancer confined to the inside of the ductal system. Generally referred to as a pre-cancerous condition. It is well contained, not invasive, and can be very successfully treated. Usually removed during a lumpectomy Infiltrating ductal carcinoma (IDC) IDC is the most common type of breast cancer representing 78% of all malignancies. It starts in your milk ducts, then breaks out and invades nearby breast tissue. These lesions appear as stellate (star like) or well-circumscribed (rounded) areas on mammograms. The stellate lesions generally have a poorer prognosis. Medullary carcinoma A less common form of invasive breast cancer found in only 5% of all breast cancers diagnosed. It is a type of invasive ductal carcinoma (IDC) and takes it name from its color, which is close to the color of brain tissue, or medulla. These medullary carcinoma cells tend to form a clear boundary between the tumor and healthy tissue right next to them. This type of tumor shows up well on a mammogram. Tubular Carcinoma It is a rare subtype of invasive ductal carcinnoma (IDC), accounting for only 1-2% of all breast cancer cases. The cancer cells have a distinctive tubular structure when viewed under a microscope. Tubular carcinoma of the breast is less likely to spread outside the breast than other types of breast cancer. It’s also easier to treat. It has an excellent 10-year survival rate of 95%.

PAGE 11


Mucinous Carcinoma (Colloid) It is another rare form of invasive ductal carcinoma (IDC), representing approximately 1-2% of all breast carcinoma. This type of breast cancer’s main differentiating features are mucus production and cells that are poorly defined. It also has a favorable prognosis in most cases. Lobular Carcinoma In Situ Although it sounds like cancer, lobular carcinoma in situ (LCIS) is actually an indicator that you have a higher chance of developing breast cancer in the future. LCIS is an area of abnormal tissue growth that occurs within — and stays within — the lobules or milk glands located at the end of the breast ducts. Infiltrating Lobular Carcinoma (ILC) Infiltrating lobular carcinoma is a type of breast cancer that usually appears as a subtle thickening in the upper-outer quadrant of the breast. This breast cancer type represents 5% of all diagnosis. Often positive for estrogen and progesterone receptors, these tumors respond well to hormone therapy. Inflammatory Breast Cancer (IBC) Inflammatory breast cancer is a rare and very aggressive type of breast cancer where cancer cells infiltrate the skin and lymph vessels of the breast. When the lymph vessels become blocked by the breast cancer cells the breast typically becomes red, swollen, sometimes with an orange peel texture, and warm. Inflammatory breast cancer does not produce a distinct mass or lump that can be felt within the breast. The lack of a lump or mass also makes inflammatory breast cancer difficult to detect by mammograms. IBC accounts for 1% to 5% of all breast cancer cases in the United States.

Paget’s disease of the nipple Early symptoms include redness or crusting of the nipple skin’ symptoms of more advanced disease often include tingling, itching, increased sensitivity, burning, or pain in the nipple. This usually signals the presence of breast cancer beneath the skin. But it accounts for less than 5 percent of all breast cancers PAGE 12


/Breast Cancer

Common Myths

Myth 1:

FACT:

“Cancer is an insignificant issue in low middle income countries.�

Cancer is the second most common cause of death in low middle income countries (LMC), more than respiratory infections and diseases, HIV/AIDS, diarrheal diseases and tuberculosis.

Deaths by common diseases in LMC: Cancer

4.4 million

Respiratory infection

3.5 million

Respiratory diseases

3.0 million

HIV/AIDS

2.7 million

diarrheal diseases

1.8 million

tuberculosis

1.5 million

Data from New England Journal of Medicine 356:3 based on World Health Organization 2005 data

PAGE 13


Myth 2:

“Breast cancer only affects countries of wealth.”

FACT: The majority of breast cancer deaths (55% in 2002) occur in developing rather than developed countries. And, it is much more likely that a woman with breast cancer would die in developing countries than developed countries.

Mortality/Incidence Ratio United States

0.25

Europe

0.35

Africa

0.45

India

0.48

Southeast Asia

0.45

Data from Globocan 2002 based on The International Agency for Research on Cancer data

Dr. Benjamin Anderson, Breast Health Global Initiative Presentation: “Guideline Implementation of Low and Middle Income Countries” at the University of Washington Continuing Medical Education

PAGE 14


PAGE 15


It was important to understand the various technologies involved in breast cancer detection I had to find a technology that would satisfy specific criteria of portability, speed and accuracy. Keeping in mind that the device is intended to screen populations of women in many different locations, some potentially difficult to reach.

RESEARCH : TECHNOLOGY

PAGE 16


/Initial Research

Current detection methods

Clinical or Self Breast Examination This is the simplest and most practical method of breast cancer detection. First, a visual inspection is done to check for any abnormalities or physical changes in the breast such as color, size, shape, texture, nipple retraction, discharge, etc. Then, the hand is is used as an instrument to feel along the breast in a pre-defined pattern, paying attention for any irregularities such as masses or lumps. A clinical breast examination (CBE) is when a health professional performs an examination of your breast. A breast self examination (BSE) is when a woman performs it on herself.

Advantages • BSE can be done in your own privacy • BSE can be done anytime • More likely to be done than machine based tests • Doesn’t require any expensive equipment Disadvantages • Time consuming. A thorough examination should take 10 min per breast • Requires training and knowledge on what to look for • Clinical Breast exam might be embarrassing to some

PAGE 17


Initial visual Inspection of breasts

It is advisable to perform a manual breast exam in a warm room or while taking a warm shower because the tissues of the breast will be more relaxed and easier to examine. In the shower, soap will make it easier for the fingers to glide of the breast, making it easier to concentrate on the texture underneath.

Three middle fingers should be used to apply pressure to the breast and work around the breast in a pre-defined pattern.

Manual breast examinations can be done lying down or standing.

PAGE 18


/Initial Research

Current detection methods

MAMMOGRAPHY (the current standard) A mammogram is essentially an x-ray of the breast. The breast is compressed flat between two plates, and x-ray images are shot at different angles. The images obtained are scanned by a doctor for characteristic masses and/or microcalcifications that might indicate breast cancer. Breast cancer, which is denser than most healthy nearby breast tissue, appears as irregular white areas, sometimes called shadows.

A woman undergoing a mammogram.

Used as a screening tool and a diagnostic tool.

Advantages • Good at detecting DCIS, the earliest form of breast cancer • Reliably detects calcifications • Faster than MRI (10 min or less) Disadvantages • Uses ionizing radiation, a known carcinogen • Tumor must be large enough to be detected which takes about 10 years to develop. • Imaging is more difficult with breasts that are dense or breasts in younger women. • Tissue overlap makes it difficult to distinguish breast cancer. • Requires uncomfortable, often painful squeezing of the breast. • About 10-30% false negatives

The uncomfortable breast compression procedure.

The final x-ray film of a mammogram.

PAGE 19


Mobile mammography bus These mobile mammography buses are useful for some remote areas, but they require roads and a lot of power.

“Portable” mammography machines These are examples of “portable” mammography units. But even these seem too big to transported easily to remote locations.

Digital Mammography has advantages over film higher resolution use of computer assisted detection software easily shared in telemedicine

PAGE 20


/Initial Research

Current detection methods

Digital Tomosynthesis (Digital 3D mammography) Breast tomosynthesis is a recently developed three-dimensional imaging technique that acquires images of a stationary compressed breast at multiple angles. The breast is compressed between two plates, but with less pressure. Then, an x-ray tube is rotated over an arc of 30 degrees and images are made every 3 degrees. There is no need to compress the breast at different angles as in conventional mammography. A total of 11-15 images are acquired during a single exposure equaling the radiation dose of one 2D mammography image. The individual images are then reconstructed into a series of thin high-resolution slices that can be displayed individually or in a dynamic mode.

Advantages • Less pressure and pain than conventional mammography • Less radiation for each exposure than conventional mammography • Can be used for breast cancer detection in dense breasts • Reduces the effect of tissue overlap • Less radiation for each exposure than conventional mammography

Disadvantages • Still uses ionizing radiation • Tumor has to be devloped enough to be detected

PAGE 21

Redesigned Siemens MAMMOMAT Inspiration full field digital mammography machine incorporates screening, diagnosis and tomosynthesis into a single digital platform. It looks nicely designed with more comfortable form elements, color accents, and a mood light function, but its size limits it to becoming a permanent fixture in a hospital.


Seimens Mammomat

Digital mammogram (left) vs. tomosynthesis images (right). The tomosynthesis image shows the mass more clearly wih architectural distortion.

PAGE 22


/Initial Research

Current detection methods

ULTRASOUND A breast ultrasound uses high frenquency sound waves to create an image of the tissues inside the breast. The procedure involves a transducer being gently passed back and forth over the breast. The “echoes” created as a result are then recorded by a computer that makes an image of the breast tissue and displays it on a monitor.

A woman undergoing a handheld ultrasound.

Ultrasound cannot image the entire breast at once, so it’s used for a diagnosis and staging rather than a screening tool.

Advantages • Does not use x-rays or radiation • No compression, pain-free • Can be used for dense breasts or silicone-implanted breasts • High-contrast images • Can scan areas of the breast close to the chest wall • Less expensive than CAT scan or Breast MRI

Sound waves bounce of different tissues differently.

Disadvantages • Cannot image the whole breast at once • Cannot detect microcalcifications -- the most common feature of tissue around a tumor • Low specificity, or inability to accurately distinguish cancerous lesions from benign ones • Lacks spatial resolution • Requires a well-trained and experienced operator

PAGE 23

The dark mass is indicative of breast cancer.


3D Breast Ultrasound

Portable Ultrasound devices

Automated Breast Ultrasound is a proprietary technology that methodically scans a woman’s breast capturing up to 350 ultrasound images that can be reconstructed and reviewed in 3D.

Ultra-portable hand-held devices

U systems Somo V. 3D ultrasound machine captures a 14.5 x 17 x 5cm volume of data.

Rendered image can be navigated at any angle and any dimension.

PAGE 24


/Initial Research

Current detection methods

Elastography Elastography is basically an ultrasound with an added dimension. Elasticity is the way a solid moves in response to a force. Elastography improves ultrasound’s specificity by utilizing conventional ultrasound imaging to measure the compressibility and mechanical properties of a lesion. Since cancerous tumors tend to be stiffer than surrounding healthy tissue or cysts, a more compressible lesion on elastography is less likely to be malignant. An elastogram: The first picture is taken with an ultrasound. Then a second picture is taken with just a small amount of controlled pressure applied to the breast. A computer program compares the two images and produces a map showing how elastic the different regions are.

A woman undergoing an ultrasound elastography

Advantages • Does not use x-rays or radiation • No compression, pain-free • Can be used for dense breasts or silicone-implanted breasts • High accuracy in distinguishing benign from malignant lesions • Almost eliminates false positives, thus reducing rate of benign breast biopsies Disadvantages • Cannot image the whole breast at once

A sonogram and elastogram image (in color)

PAGE 25


Visual demostration of how elastography works 4 layer Jello mold with colors red, yellow, green and orange An almond placed between the red and yellow layers to represent a hard object such as a tumor

A light pressure is applied using a plastic spoon.

The almond doesn’t change shape (if it looks like it does, that’s because of optical distortion through the gelatin). But the more flexible (elastic) gelatin bends under pressure, because it is more elastic than the almond.

Aixplorer ultrasound machine with Real-Time ShearWave™ Elastography software

PAGE 26


/Initial Research

Current detection methods

Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (MRI) uses a strong magnetic field and radio waves to create a detailed pictures of the internal architecture of the breast. Especially to determine size and and location of the cancer, and spatial relation for multiple tumors. During a breast MRI, the patient is positioned on a special table inside the MRI system opening where a magnetic field is created by the magnet. Each total MRI exam is typically comprised of a series of 2 to 6 sequences, with each sequence lasting between 2 and 15 minutes. An “MRI sequence” is an acquisition of data that yields a specific image orientation and a specific type of image appearance or “contrast.” Advantages • Provides more detail than other imaging modalities • Does not use x-rays or radiation • Can image both breasts at once and axilla area • Can image dense breast tissue and breasts with implants • Good at finding invasive breast cancer that spread beyond the primary tumor • Easily acquire direct views of the breast in almost any orientation

A woman having a breast MRI.

Disadvantages • Does not detect DCSI (Ductal Carcinoma In Situ) • Leads to many false-positive findings because it can’t distinguish between cancer and benign breast tissue such as fibroadenomas. • Very expensive • Time consuming (30-60min) • Patient has to remain still in an uncomfortable position for long periods • Require injection of contrast agents

PAGE 27

An MRI image showing a lesion in the left breast. Both breasts can be imaged at the same time.


Conventional Mammography (on the left) Computer Enhanced Breast MRI (on the right). The mammogram of a sixty-year-old woman shows a mass in her left breast, while her right breast appears to be disease free. A lumpectomy to remove the tumor in her left breast was planned and a pre-operative MRI was also scheduled. As shown in the image on the right, the computer-enhanced MRI detected two unsuspected additional masses (circled in photo) in the patient’s right breast. Based on the data from the MRI, a double mastectomy was performed on this patient, most likely saving her life

The patient passes through the “donut hole” of the MRI machine, and has to lay still for 2-15min MRI sequences.

From a patient point of view, it is not comforting that the health professional must stay in a separate adjacent room as the MRI is being performed.

Breast MRI can be done on breasts with implants.

Special table for breast MRI with two openings to accomodate the breasts.

PAGE 28


/Initial Research

Current detection methods

Digital Infrared Thermal Imaging (DITI) or Thermography Thermography is basicaly a thermal photo of the breast using infrared technology. The patient basically stands infront of a special digital infrared camera, and images are captured at different standing positions, frontal, left breast and right breast angles. It is well known that tumors are associated with vascularization. Tumors need to develop blood vessels (for nutrients and oxygen) in order to grow to a size greater than 1/10th of an inch in diameter. A thermogram detects the heat signature of highly active tumor cells based on this angiogenesis. A positive result can indicate a pathology (a disease like breast cancer) or an anatomical variant. When a Thermogram is positive, the job of differential diagnosis begins using other tools like mammography, ultrasound or MRI. Thus Thermography can be used as a first line screening tool before more invasive or expensive tests are done.

A woman undergoing Digital Infrared Thermal Imaging.

Advantages • Non-invasive • No contact, no compression, painless • Sensitivity of approx. 90% • May indicate pre-cancerous formation 8-10 years earlier than any other technology can see it • Can detect breast inflammatory disease (not detectable by mammography) Disadvantages • Requires a specific room temperature (19-23 C) for body acclimation • Undersurface of the breasts may not get accurate temp. readings in morbidly obese women and breast size greater than DD A thermogram showing highest temperature in black (left) and highest

PAGE 29

temperature in red, orange, yellow (right)


Typical Theromography appointment PRIOR TO APPOINTMENT • Wait at least 3 months after breast surgery, chemotherapy or radiation • No drinking of alcohol for 24 hours prior. • Avoid any tanning of your chest for at least 3 days prior. • The imaging may be invalid if you have had a significant fever within 36 hours of the examination. • Avoid ultrasound, mammography, MRI or CAT for at least 3 days prior. • No sauna, steam-room or hot/cold packs in contact with the breasts for at least 24 hours prior. • Avoid extreme exercise (running, biking), physical stimulation, compression of the breasts for 12 hours. DAY OF THE APPOINTMENT • Do not shave your underarms or use any skin creams, lotions, deodorants or powders on your breasts or underarms. • No exercise, bathing or showering or breast feeding for 1 hour prior to your appointment. • No tobacco use, or hot or cold beverages for 2 hours prior to your appointment. DIGITAL IMAGING SESSION PREPARATION STAGE • Complete a questionnaire on your breast health and family history. • Undress to the waist to allow your breasts to come into equilibrium with the temperature of the room (19-23 degrees Celsius) for approximately 10 minutes. SCREENING STAGE • The technician will have you stand with your hands on your head. • Three (3) images will be taken with the digital infrared camera; right, left and frontal views. • Cold Challenge: You will put your hands in cold water for one (1) minute. This is a cold challenge to your blood vessels. Normal blood vessels will constrict; abnormal blood vessels don’t respond in the same way. • Another three (3) images will be taken.

Progression of Angiogenesis from corresponding heat changes

PAGE 30


/Initial Research

Current detection methods

Breast-specific Gamma Imaging (BSGI) also known as Molecular Breast Imaging (MBI) In breast specific gamma imaging, the patient is injected with a radiotracer (Technetium Tc99m Sestamibi) that is absorbed by all the cells in the body. Due to their increased rate of metabolic activity, cancerous cells in the breast absorb a greater amount of the tracing agent than normal, healthy cells. The patient’s breast is then positioned between two plates with minimal pressure. A nuclear medicine scanner -- also called a gamma camera -- then scans the breast and looks for any areas where the radioactive substance is concentrated, appearing as “hotspots”, which suggests breast cancer.

A woman whose breast is being positioned for Breast Specific Gamma Imaging.

Advantages • Can detect small early stage cancers, less than 10 mm in diameter • Requires less breast compression than a mammogram • Comparable sensitivity but superior specificity compared to MRI • Can be used for dense breasts Disadvantages • Test takes about 40 minutes • Requires the injection of a radiotracer • Can lead to false positives because benign conditions such as fibroadenomas can absorb the radiotracer • Requires breast compression, but less pressure than mammogram

BSGI results compared with that of a mammogram. In the BSGI

PAGE 31

images, the cancers are easily differentiated as “hotspots”


Dilon Technologies is the company that makes the breast specific gamma imaging unit.

These images from the Mayo Clinic in Minnesota show a standard mammogram, left, and molecular breast imaging from a study performed on a 45-year-old patient. The mammogram was interpreted as being negative, but the BSGI image shows cancer, indicated by the arrow.

This particular BSGI unit is relatively portable, and can be moved from room to room, but still not portable enough to take into remote locations.

PAGE 32


/Initial Research

Current detection methods

Breast Pap Test This test is based on the premise that abnormal cells in your nipple fluid is related to an increased risk for breast cancer. The procedure involves the attachment of the Halo device’s suction cups to each breast, and with vacuum, heat and compression cycles, nipple aspirate fluid is obtained, which is then tested for precancerous cells at a laboratory. Nipple aspirate fluid comes from the breast milk ducts, where nearly all (95%) of invasive breast cancers begin.

Advantages • Non-invasive • No radiation or radiotracers • May be able to help determine your risk for breast cancer up to seven years earlier • 5 minute procedure that can be done with regular check-up

The Halo device suction cups.

A woman undergoing a breast pap.

Disadvantages • Cannot get immediate results • Requires a separate laboratory to test the nipple aspirate.

The nipple aspirate is removed by a swab and sent to a lab for analysis.

PAGE 33


Illustration of the Halo breast pap procedure.

The suction cup is fitted onto the breast.

Suction is applied usint a vacuum.

Compression cycle.

A fluid sample is obtained.

Heat is applied during the suction.

The Halo machine by Neomatrix is the only fully automated breast pap machine FDA approved on the market.

Possible Breast Pap results: • No fluid: normal (not increased) risk for breast cancer • Benign nipple discharge: may be caused by medicines, infections, intraductal papillomas, or pregnancy • Fluid containing normal cells: twice the normal risk for breast cancer • Fluid containing abnormal cells: your risk for breast cancer increases to 4-5 times the normal risk PAGE 34


Breast Pap test

Molecular Imaging

Thermography

MRI

Elastography

Ultrasound

Tomosynthesis

Mammogram

Te c h n o l o g y E v a l u a t i o n

Clinical Breast Exam

/Initial Research

Sensitive Specific Portable Fast results Low electrical consumption Non-invasive Painless Low cost For dense breasts

Fast results = test takes 15min or less Portable = able to carry by hand Low electrical consumption = able to be powered by battery Non-invasive = no radiation Painless = no compression, no injection

PAGE 35


Based on my preliminary research and evaluation of the different technologies, Thermography or Ultrasound with Elastography seem to be the best choices for a portable breast cancer screening device for remote underserved locations. Elastography has the advantage over Thermography in terms of its superior specificity, its ability to distinguish benign from malignant tissues. Thermography has an advantage over elastography in terms of speed of the test, its ability to scan both breasts simultaneously. Furthermore, ultrasound with elastography requires a highly skilled technician to properly position the transducer to find the cancer. In my opinion, Thermography might be the better of the two as a “first line� screening tool. It will be able to detect abnormalities of the breast, which would include malignancies. All abnormalities are not necessarily malignant, but all malignancies are abnormal. Thus the detection of any abnormalities can then be tagged for further investigation with other diagnostic tools that are more specific but might be more invasive, like mammography. As a screening tool, I believe Thermography can do a good job of clearing a given population of women and narrowing the focus to those with detected abnormalities. Since screening is done to a larger population, the least invasive tests should be performed. Once the abnormal cases are identified, then the use of more specific, but invasive tests like mammograms can be justified.

PAGE 36


PAGE 37


It was important to meet the various stakeholders involved with breast cancer, from the health care worker to the patient to the advocat. Talking and observing potential users of a product enables a better understanding of them, to get in touch with their needs and desires. This helps to design a more informed and relevant product.

RESEARCH : USERS

PAGE 38


/Field Research

What I want to learn...

For my research, I wanted to meet with the following stakeholders: • Breast cancer patients • Doctors or nurses who specialize in breast cancer • Organizations involved with outreach and advocacy of breast cancer in the developing world

PAGE 39


I would like to see a typical journey that a patient would go through for breast cancer screening, if possible. I would like to understand -- what they knew about breast cancer; what kinds of personal and cultural perceptions they had about the disease; what made them go for breast cancer evaluation in the first place; what was their experience during the process; and what would enhance their experience if they had a choice. To answer some of these questions, I will visit the Bangkok Breast Cancer Support Group, which is a volunteer organization run by breast cancer survivors. I want to be able to talk with some doctors and nurses who specialize in breast cancer. I would like to see a demonstration of the equipment they use to detect breast cancer such as mammography, ultrasound or thermography. I would like to understand -- what does their breast cancer screening protocol entail; what type of technology do they wish they had at their disposal; what are some of the issues involved with breast cancer screening in these poor remote locations; what they think about thermography as a screening tool. To answer some of these questions, I will visit the Manila Capitol Medical Center Thermal Imaging Section to see their thermography device, and I will visit the Umea Univeristy Hospital Mammography Department to see their equipment and speak with some of their radiologists. I will also speak with Dr. Benjamin Anderson, founder, chair and director of the organization Breast Health Global Initiative, who does a lot of work with breast cancer in low and middle income countries.

I would like to visit some non-governmental organizations involved with the outreach and advocacy of breast cancer in the developoing world. I think they have access to and valuable information about the front line of breast cancer screening in underserved remote communities. I would like to understand -- what is being done to educate and reach out to women about breast cancer; what are some of the common misconceptions about breast cancer from local women; what is the importance of screening in these communities; what kind of tools are being used for screening and education; and what can a portable screening device do for their efforts. To answer some of these questions, I will visit the Philippine Breast Cancer Network, which engages in grass roots educational and outreach efforts in communities througout the Philippines. I will contact the Breast Health Global Initiative, an organization founded by Fred Hutchinson Cancer Research Center and Susan G. Komen for the Cure that developed “Guidelines for International Breast Health and Cancer Control – Implementation in Low and Middle Income Countries.” I will also try to contact the Ghana Breast Health International, an organization that has been very successful in its efforts to spread the word about breast cancer and perform many public breast cancer screenings around Ghana.

PAGE 40


/Field Research

Umea University Hospital Mammograph Center

I visited the mammography department at the Norrlands University Hospital in Umea, where I met with Kerstin Bjurling, a supervisor who performs screening and clinical mammography and ultrasound with her team of three. Kerstin gave me a tour of their facilities and explained a bit about their screening protocols. They have a total of two Siemens Mammomat digital mammography machines and two Accuson ultrasound machines with elastography. The department has just recently transitioned from film mammography to all digital mammography. Kerstin finds digital mammography more favorable, because the higher resolution makes it easier and convenient to read. Currently they have to compare the new digital images with film images take during the patient’s last screening, which is not so convenient. In Vasternorrland, a northern county in Sweden, there is very good maintenance of breast health, with approximately 90% of women coming in for screening compared with 70% in bigger cities like Stockholm or Gothenburg. It is recommended for women between 40 - 54 years old to be screened every 18 months, and women 55 - 74 years old to come in every 24 months. On average, the mammography department does about 1000 screening per week, with four images per patient. In Sweden, for women under 25 years, rather than using mammography, ultrasound is preferred. And mammograms are not used for pregnant or breast feeding women.

PAGE 41


I was especially interested in ultrasound, and Kerstin gave me a demonstration of the Accuson machine in one of the ultrasound room. Based on our coversation, I learned the following: Ultrasound can scan a large part of the breast to get a general overview of breast health. It can also see vascularization of breast cancer. If there is a lesion, just push lightly to see if it is stiff (Elastography)

In the ultrasound room, there are two monitors. This is primarily for ergonomic purposes for the healh worker.

The Accuson ultrasound control unit

A ball mouse is used to navigate the software.

Kerstin handling the transducer, which hangs by the size of the unit.

It can see as deep as the rips, especially when the women lies down because the breast flattens out. The field of view can be wided to look at a larger section of the breast. A special transmission gel is applied to the patient’s skin where the transducer will contact. To scan the breast using ultrasound can take only a few minutes, but if there are many lesions, it might take a half hour.

PAGE 42


/Field Research

Philippine Breast Cancer Network

I visited the Philippine Breast Cancer Network (PBCN) in Manila, where I had the opportunity to interview the president of the organization, Mr. Danny Meneses and one of his nurses, Christy. PBCN was started in August 28th, 1997 by Rosa Francia-Meneses as a direct result of the 1st World Conference on Breast Cancer in Kingston, Ontario, Canada. Rosa was the late wife of Danny, who died of breast cancer at the age of 48 on Sept 2000. During her 43 month battle with breast cancer, Rosa was commited to a global movement for the eradication of breast cancer. She was the lone Philippine breast cancer delegate in the 1st World Conference on Breast Cancer in Kingston, Ontario in July 1997; she then started PBCN; she was a Plenary Speaker in the Brussels World Conference on Breast Cancer Advocacy in March 1999; and finally she was a Keynote Speaker in the 2nd World Conference on Breast Cancer in Ottawa in July 1999. After her death, Danny continues the fight against breast cancer through PBCN.

MISSION

OBJECTIVES

ACTIVITIES

To end breast cancer through action and policy intiatives that support: 1. Replacement of mammography with safer and more reliable methods; 2. Development of non-toxic and non-invasive treatments; 3. Elimination of preventable causes, including those in the environment; 4. Universal access to the best available health care and information for all. * To sustain a national network of breast cancer victims, fighters, action groups, concerned individuals and supportive entities; * To engage in massive education and awareness of the causes, prevention and treatment of breast cancer; * To provide communication for information and awareness about breast cancer as a major environmental issue; * To help Filipinos afflicted with breast cancer by developing support systems that meet their unique needs; * To work and lobby for legislative agenda for the prevention and eradication of breast cancer; and * To promote openness and accountability in breast cancer research. * Breast Cancer Resource Center * Project BRCA - an intensive training course for breast cancer activists * Orientations on breast cancer - detection and and treatment options * Wellness Program at the Tiaong Breast Haven * Symposiums on “Breast Cancer and the Environment” * Formation of Breast Cancer Action Groups * “Ang Hinaharap” - PBCN’s newsletter * Internet communications

Christy, Danny and me in the PBCN headquarters in Manila

PAGE 43


“Our point of view is from the view of the woman, and how to prevent breast cancer, as opposed to the point of view of the medical sector, which focus on the cure.” “The doctors in the Philippines maintain an old school view of breast cancer and still insist on complete breast removal as a treatment.” “There is no medical accountability in the Philippines.” “Breast examination is not part of a woman’s regular OBGYN exam. Breast cancer is under the umbrella of surgery. It doesn’t make sense.” “It is a fallacy that younger women should not be concerned with breast cancer.” “We are totally against mammography and radiation.” “When mammography says that you are positive for a malignancy, that breast cancer has already been in you for at least 5 years. And ultrasound is unreliable unless the cancer reaches a certain maturity.”

The Philippines has the highest rate of breast cancer in Asia and ranks 10th in the world. Yet, the country lacks the resources, infrastructure and political commitment needed to make a true impact against the disease. PBCN was started by breast cancer victims for breast cancer victims. They are an organization dedicated to outreach and advocacy for breast cancer victims. I was especially interested in their grass roots efforts to go into different communities, some rural, and educate the women about breast cancer, what it is and is not, it’s causes, prevention, and screening. Christy performs clinical breast examinations to those who have a concern. Their focus is on prevention from a standpoint on physical and emotional well-being, diet, and especially, the environment. They are concerned with three groups of women: 1) women diagnosed with breast cancer, to give them the knowledge and information, so that they make fully informed decisions; 2) women not yet diagnosed with breast cancer, to give them information on the possible causes of breast cancer and what they could do to prevent them; 3) women who are not yet born PBCN is strongly opposed to invasive screening methods such as mammography. “Why try to detect breast cancer with a known carcinogen?” Thermography, on the other hand, is welcomed by the group. They have an entire page on their small website dedicated to the technology. And, they regularly refer women with breast cancer concerns to one of only two breast Thermography sites in Manila. I was able to visit one of these sites for a first hand look at their Digital Infrared Thermal Imaging machines.

“Mammography has a high margin of error, up to 40% for women under forty years old because of dense breast tissue.” “Women are recommended to have mammograms every year. Each year you are negative, until finally they tell you that you are positive. There was no prevention during this time, just more radiation with each mammogram. That is not early detection.” I have always been searching for alernatives to mammography. I found Thermography, and I have been referring patients for the past 10 years. I am confident in the technology. It has helped a lot of women.” “If we had the money, we would buy our own thermography machine to take with us. Unlike the mammogram, it can reallly be portable” “The problem with thermography is that you have to be enclosed in a cold room in order to take a shot.” “Thermal imaging detects abnormalities. Not abnormalities are malignant, but why wait for a malignancy for intervention. We should act on precaution.” “Many women in the villages believe if there is no cancer in the family, they can’t get breast cancer.” “Pilipino women feel the breast is very private area, and won’t discuss it. For younger single women, they are afraid they will not loose suitors. For married women, they don’t want their family to worry about them. They bear the cross.” “Early detection is important because it is empowering, the woman can take charge of her health sonner.”

PAGE 44


/Field Research

Capitol Medical Center, Thermal Imaging Section, Manila Philippines

With a referral from Danny and Christy from the Philippine Breast Cancer Network, I went to the Capitol Medical Center in Manila, Philippines, to meet with Grace Buscan, a thermography operator and her supervisor, Chet Manansala. They gave me a brief overview of their standard procedure for breast thermography and a demonstration of how their digital infrared thermal imaging machine worked. Although they were one of only two thermography centers in the Philippines, their DITI machine was about 15 years old. It was relatively bulky, fixed on rails for adjustments, and required 2 cups of liquid nitrogen to function. There was also a large noisy, airconditioning unit right above the DITI camera and patient area for the purpose of keeping the patient cool during the procedure. The computer base station with the DITI software was an older model PC.

PAGE 45

Chet Manansala (left) and Grace Buscan (right)

an airconditioner above the patient testing area

the DITI computer base station with thermography software

the Digital Infrared Thermal Imaging (DITI) camera

First, the patient is given a list of Do’s and Don’ts prior to the actual procedure. On the day of the procedure, she is given a questionaire about health and family history.

the DITI unit is adjusted to the patients size and optimal distance from the patient, which should be about 1 meter


liquid nitrogen is taken from a holding tank.

3 photos of the breast are required: frontal, left lateral, and right lateral

two cups are poured into the DITI unit, using a syrofoam drinking cup. The newer digital infrared thermal imaging technology does not require liquid nitrogen.

thermal values are compared between the left breast and the right breast to determine levels of hyperthermic asymmetry.

the doctor fills out two forms based on the results of the test.

PAGE 46


/Field Research

Bangkok Breast Cancer Support Group

I visited the Bangkok Breast Cancer Support group in Bangkok Thailand, where I interviewed two breast cancer survivors, Aurora and Anita, who regularly engage in support groups, breast cancer outreach and advocacy. The group was initally formed for expatriates with breast cancer issues, who don’t have a strong family support network around them in Bangkok. I was particularly interested in their outreach to outlying villages around Bangkok. During these outreach visits, they educate the local women about breast cancer, how to do self breast examinations and who to contact if they have concerns. Although mammograms are part of the health benefits in Thailand, it might take a long time, so sometimes the BBC group pays for mammograms and health visits as they see a need. They also provide a support function to those who discover that they have breast cancer. They meet with these patients, visit them in the hospital, providing much needed emotional support and care.

PAGE 47


“I know that If they find it at an early stage, then they can still help you.” “I can relate to the anxiety when you are diagnosed, the fear that you feel.” “We go to where there are large groups of women, like schools and companies. We teach them self breast examinations, and what to do when you find something.” “Sometimes you have this ‘white coat syndrome’, when you see someone with a white doctor’s coat, you get scared and anxious. This happens to me too.” “Many women in these remote areas are not aware, they don’t even know what is breast cancer.” “When i had my mammogram, I hated it because it hurt my boobs. But the pain and the radiation of mammograms is a necessary evil.” “A portable screening would be a great tool so we don’t have to bring the women into the city for screening. So much can be avoided like the travel, the anxiety of waiting.”

Aurora Cornelio

“We tell them what breast cancer is, we give them information. It isn’t the end of the world if you find it. I’m living proof” “Some Thai women believe that if someone in your family had breast cancer, you will probably have it too. Young women don’t think they will get it. It is difficult to get them interested in breast cancer.” “Breast cancer might not be a top priority because there might be other more important concerns such as finances, feeding their family” “Most breast cancer is detected too late, stage 3 or 4. So our pupose is to help them detect it earlier. There is a better chance of survival. That is why education and early screening is so important. “ “Even self examination takes a while, to get the knack of it.” “In Thailand, mammograms are provided for free at their provincial hospitals, but it takes a long time to get one, could be 6 months.” “If it is a mammogram used for initial screening, it would not be good because it involves radiation.”

Anita Taychakhoonavudh

“An early screening tool would be good, and if there is a positive, then they can get a mammogram and talk with the doctor.”

PAGE 48


/Situation Analysis

Breast Care in Ghana, Africa

I was not able to go to Africa. But I found an organization on-line called the Breast Care International (BCI), a non governmental organization, which was conceived on October 2002, “to create breast cancer awareness among Ghanaian women, especially the rural women since they form the majority, educate them of the existence of breast cancer, undertake Screening Exercises, Diagnosis, Counseling, Treatment, Rehabilitation as well as Research into the various breast pathologies especially breast cancer in Ghana.” BCI is managed and directed by a specialist surgeon Dr. (Mrs.) Beatrice Wiafe Addai who is a specialist in Breast Pathology at Peace and Love Hospital in Kumasi supported by a dynamic team of chemical pathologist and well trained nurses in breast examination. They believe that the key to saving life is early detection. “It is estimated that a an aggressive approach to breast cancer screening and management may reduce breast cancer mortality by 20 - 50%.” They do this primarily by giving talks to women at churches, or other venues where there are large groups of women, giving them information about breast cancer and providing clinical breast examinations using a trained team of nurses. Ghana now has a breast clinic, part of the Peace and Love Hospital, a 1,000 bed hospital in Kumasi. BCI screening team performing clinical breast examinations on local women

Since BCI extends their effort to rural towns and villages that are underserved, I believe that a portable screening tool could be an invaluable asset to be able to screen more women with less man power. PAGE 49


Breast Health Center in Kumasi, Ghana

Dr. Beatrice Wiafe Adda (center in yellow dress) with BCI screening team

Cultural misconceptions about breast cancer Women were asked “why did you not come in?” • Cancer is fatal anyway, so why do you need an early diagnosis • Cancer is caused by social misbehavior > Oral/nipple contact > Dirty clothing > Wearing money in bra • If I go to a hospital, they will just cut off my breasts • Because they cut off the breast, the cancer will spread A woman wih Stage IIIB breast cancer who refused a mastectomy.

PAGE 50


/The role of Emotions

There are many emotions associated with breast cancer. Some of these emotions are common with breast cancer screening, especially emotions that are related to what is yet “unknown”. Many studies have been done that try to determine the role of emotion in breast cancer screening on women of different ethnicities, cultures, and socioeconomic backgrounds.

These are a some common emotions associated with screening:

Concern Fear Anxiety Worry Regression Denial Dissociation Embarrassment Fatalism

PAGE 51

more specifically... fear of breast cancer diagnosis fear of pain and discomfort fear of embarrassment fear of the medical establisment fear of screening components fear of radiation fear of surgery or hospitalization “non-specific” cancer worry undifferentiated fear general anxiety individual phobias

Fatalism Fatalism is associated with beliefs that life events are inevitable and that one’s destiny is not within one’s own hands. Individuals with a higher level of fatalism are less likely to engage in breast cancer screening.

Negative Emotions Negative emotions such as fear and anxiety, have been found to be associated with breast screening behavior. Anxiety, fear, and worry can be both facilitators and barriers of breast cancer screening. These emotions can trigger avoidance behavior, for example, in women who fearful of bad results. But at the same time, they can be motivators for women in their attempt to ease their worries by getting the breast cancer screenings done.


These are some major findings by different empirical studies that have been done over the last two decades, examining the role of emotion regulation as related to breast cancer screening behavior: • Worry about breast cancer seems to promote screening • Screening greatest at intermediate levels of worry. • Anxiety positively related to intention to screen. • Symptomatic women who identified their lump as a concern had significantly more anxiety than women who did not. • Denial causes symptomatic women to delay breast cancer screenings. • Symptomatic women who did not identify their lump as a concern used denial and avoidance as coping mechanisms. • Women who screened had more readiness to face problems realistically. • Embarrassment regarding screening procedures was negatively associated with screening. • Treatment efficacy perceptions are important factors in screening behavior

This figure shows a conceptual model depicting the relations between aspects of cancer fear/anxiety, their function and impact on screening behavior. (Consedine et al, 2004)

PAGE 52


/ Ta r g e t c o u n t r i e s

The design concept will be targeted for lower-middle income countries. Lower-middle income countries are more likely to have the resources and infrastructure for breast cancer treatment programs, but they often lack early detection. On the other hand, in low income countries, we are introduced to a situation where resources are so limited and competing demands so great that breast care programs make litle sense to create. In countries like Somalia, for example, death by starvation are a much higher concern than death by diseases such as breast cancer. PAGE 53

Data from the World Bank (http://web.worldbank.org)


Countries based on World Bank income groupings for 2006

PAGE 54


/ Te m p c o n s i d e r a t i o n s

...if there were no climate controlled rooms

As part of a breast cancer screening protocol based on thermography, it might be important to take into consideration the local climate. Thermography is best done in a room with a temperature of 19 - 23 Celsius. But in places where there are no temperature controlled rooms, the season becomes a critical factor. In this case, thermography would be best performed during the cooler periods of the year, which Iâ&#x20AC;&#x2122;ve highlighted in pink (average temp <25C) for the following climate graphs. In hotter climates, like Philippines or Thailand for example, the evening might be the best time for breast cancer screening in order to minimize thermal artifacts and obtain the best results.

PAGE 55


Climate graphs of some lower-middle income countries

The blue line represents the low temp, probably during the night, and the red line represent the high temp, of the day.

Data from http://www.climatetemp.info/

PAGE 56


/Mapping the System

It was important to identify and organize the system to understand the key elements and relationships around breast cancer. Based on this map, the focus of my project is primarily within the realm of Prevention and Screening. However, there is constant interplay between Awareness, Prevention/ Screening, and Diagnosis/Treatment. Breast cancer must be tackled on all these different fronts. PAGE 57


PREVENTION SCREENING

AWARENESS

Lifestyle Smoking Caffeine Stress

Advocacy

Campaigns

Patient rights

Marketing Pamphlets Ribbons and bracelets

Where? Churches Markets Gatherings of women

Diet Fat intake Alchohol

Volunteers

Cultural issues

Compliance

NGOs Screening Trips

Education Symposiums Lectures Meetings

Rural Urban Remote locations Underserved communities

Annual physical Breast self exam

Peer to peer Word of mouth

Fundrasing Drives Walk-a-thons Concerts Festivals

Consistency

Environment Household chemicals Air quality Water quality Soil

Demographics

Thermography

Mother to daughter

Patient Government

Clinical breast exam Doctors Health workers

Health Policy

Privacy

Ultrasound Health care costs

Mammography

Insurance

Dignity

Biopsy MRI Tomosynthesis Breast specific gamma imaging

Surgery Lumpectomy

Medicines Anti-cancer Pain Depression

Mastectomy

Chemotherapy Radiation Therapy Hormonal Therapy

Support Emotional Financial Family Friends Empathy groups

DIAGNOSIS TREATMENT PAGE 58


/Screening Strategy

Since screening is done to a larger population, the least invasive tests should be performed. Once the abnormal cases are identified, then the use of more specific, albeit invasive tests like mammograms can be justified.

Out of 1,000 women, maybe only three women will be found to have breast cancer. With this in mind, it makes little sense economically to use breast cancer detection such as mammography for screening large populations of women in poorer countries. Moreover, since mammography uses x-rays, it is unacceptable to subject a majority of healthy women to potentially harmful doses of radiation, that might even spark breast cancer formation. Thermal imaging detects breast abnormalities in a highly sensitive, yet inexpensive and non-invasive manner. Not all abnormalities are malignant, but all malignancies are abnormal. Thus, thermal imaging can be used to successfully screen breast cancer cases into a smaller pool of abnormal findings, letâ&#x20AC;&#x2122;s say 50 women for example, 5% of the original number. These 50 women can then proceed with more specific, yet more expensive and invasive tests like mammograms and biopsies for the accurate diagnosis of breast cancer. Such a screening strategy could save a lot of time, resources and effort in the fight against breast cancer in developing countries.

PAGE 59


Out of 1,000 women, maybe only three women will be found to have breast cancer. Since screening is done to a larger population, the least invasive tests should be performed. Thermal imaging detects breast abnormalities in a highly sensitive, yet inexpensive and noninvasive manner. Not all abnormalities are malignant, but all malignancies are abnormal. Once the abnormal cases are identified, then the use of more specific, albeit invasive diagnostic tools, like mammograms can be justified.

Thermal imaging

mammogram

= 10 women

= individual with breast cancer PAGE 60


/Insights

Breast cancer is not just a disease for old women. Early detection is empowering.

Most breast cancer is detected too late.

Mammograms arenâ&#x20AC;&#x2122;t really preventive.

Early detection improves survival.

To detect breast abnormalities, Thermography is a good tool.

PAGE 61

A portable screening tool can increase access to more women.

The problem is Thermography requires a cool room.

Breast cancer might not be a top priority in these communities .

A portable screening tool could decrease waiting time and anxiety.

Seeing a white coat makes me anxious.


Based upon my research, it seems like a need does exist for a portable breast cancer screening tool for use in underserved

However, there is one major issue in using Thermography for my concept design. It requires the patient be in a cool room or dip

locations, where rural women know little about breast cancer and lack the means to travel far to have themselves checked. However, a piece of equipment alone cannot solve the breast cancer crisis in these low and middle income countries. It has to be part of a larger, well-planned concerted effort by the government and community to promote the health care systems, public education and awareness about early breast cancer detection combined with access to proper diagnosis and treatment.

her hands in ice water for one minute as part the â&#x20AC;&#x153;cold challengeâ&#x20AC;? part of the procedure. This is in order to obtain optimal thermal resolution between skin surface heat and the heat associated with breast cancer vascularization. This issue only came to my attention when I was in the Philippines, talking in a hot room with Danny and Christy from PBCN, who stressed this issue. In the Capitol Medical Center Thermal Imaging Section, the huge air-conditioner on top of the thermography area was also painfully visible.

I will still focus on designing a physical product for breast cancer screening, but might also put some emphasis on other parts of the system, for example, such as culturally relevant design solutions that would encourage women to be more proactive in their own health.

Many lower-middle income countries fall within tropical areas of the globe, where the temperature rarely dips below room temperature, and finding an airconditioned room or ice water in remote regions might be challenging. However, this dilemma might be tackled by a design solution. Maybe the thermography based breast cancer screening protocol would take into account the season, and specific areas would be targeted during the cooler months. In places with hotter climates, maybe the test can be done during the evening when it is coolest. For the cold challenge part of the thermography procedure, there are various phase change materials capable of cooling that might be employed.

Iâ&#x20AC;&#x2122;ve evaluated various breast cancer detection modalities. Based upon certain criteria such as portability and energy efficiency, ease and speed of test, patient comfort and safety, digital infrared thermal imaging (Thermography) seems to be the best solution for a first line breast cancer screening tool for the developing world. Thermography will be able to filter out normal breasts from abnormal breast pathologies in a non-invasive and painless manner. Then abnormal findings can be referred for further tests using other diagnostic tools that are more specific, such as mammography and biopsy, yet invasive and expensive.

PAGE 62


/Goals and Wishes

We must shift the emphasis from “detection and treatment” to “early, accurate screening and prevention. PAGE 63


Design intent To design a portable imaging device for breast cancer screening in low middle income countries.

Design goals The device will be portable, able to be carried by one person The device will be designed so that the sensitive hardware is protected during transport, but accessible during use. The procedure will be non-invasive, safe and painless. The device will have a simplified interface so that it is easily learnable. The device will be primarily used for acquiring data, not for complex analysis.

Design wishes The device could take into consideration cultural sensitivities. The device could have the option of being recharged by human generated power when no electricity is available. The device might incorporate more than one technology for breast cancer screening. The device might be able to be used by the patients to test themselves as a personal in-home device.

PAGE 64


PAGE 65


CREATIVE PROCESS

PAGE 66


/Inspiration

portable

trustworthy

PAGE 67

Design attributes

professional

neutral

intuitive

safe

unobtrusive


Form inspiration

PAGE 68


/ R e l e v a n t Te c h n o l o g i e s

Thermal Imaging cameras

This camera represents some of the most current technology for digital infrared thermal imaging. This is the 7320 Epidermal Thermal Imaging Professional Series (ETI-P) camera system, by the company Infrared Cameras Inc. It is one of a number of digital infrared cameras approved by the FDA for breast thermography. Based on the website, it is the camera considered best in class for this particular application since it is said to be capable of discerning thermal differences as small as 0.027 C. And at 1 meter, it can spatially resolve areas 1.1mm in size.

The package is basically a camera and a laptop lacking in design considerations.

The cameraâ&#x20AC;&#x2122;s small size makes it very portable.

7320 Epidermal Thermal Imaging Professional Series (ETI-P) camera specifications.

The camera can focus as close as 4 inches, which might allow a closer proximity between the patient and the health care worker, or the patient can hold the camera for a self image capture.

The camera only requires 1 watt of power, capable of being powered by computer USB connection. That means that this technology has very low power consumption and can potentially be powered by kinetic winding, which might be ideal in locations with no electricity. The camera operating temperature is -20 to +50 C, which allows a camera like this to be operable in hotter climates typical of many developing countries. And the camera does not require any cryogenic cooling. Old cameras like the one Iâ&#x20AC;&#x2122;ve seen at the Capitol Medical Center in Manila, required liquid nitrogen for cooling.

PAGE 69

IR Flash Professional Thermal Imaging Analysis Software, designed for multiple applications, not dedicated just for breast imaging.


A look at the internal components... Different configurations...

Bae Systems SCC500 camera hardware

Handheld cameras Tripod mounted

Portable Workstation Fixed, wall mounted

PAGE 70


/ R e l e v a n t Te c h n o l o g i e s

Human Generated Power

There might be circumstances where the breast screening device is used in very remote areas where electricity is limited or erratic. And because an infrared camera consumes very little power (1 Watt), the idea of having a human generated power source integrated into the device is logical. Rather than a laptop, the device can be redesigned with a smaller screen and â&#x20AC;&#x153;stripped downâ&#x20AC;? hardware and interface to be even more effecient.

Freeplay mechanical charger recharging a cell phone.

There are many different ways of harnessing human generated power via a dynamo, such as a winding, stepping, rolling, or pulling. And there are already a variety of available devices powered by these methods. A dynamo works by inducing electricity into a coil by moving a magnetic field in a constant motion. The voltage is increases with an increase in the number of wire turns in the coil, the size of the coil or the strength of the magnetic field.

Schematic of a dynamo

Sony ICF-B01 wind up radio. Just one minute of cranking wiil generate enough power for one hour of AM or 40 minutes of FM reception. The winding power can also be used to recharge your mobile phone.

PAGE 71


Freeplay Weza portable energy source powered by step action. 5 minutes of steping can be used to jump start a 4 cylinder car.

Potenco PCG1 personal device charger based on pull-string power generation. One minute of pulling provides 45min play on Nintendo DS.

ideaForge mechanical charger uses either cranking (wind-up mode) or rolling (roll-on mode) to power devices. The early prototypes of the OLPC (One Laptop Per Child) computer had an integrated hand crank power generator. But that idea was later abandoned in favor of a separate pull string generator.

Other interesting concepts.

PAGE 72


/ R e l e v a n t Te c h n o l o g i e s

Telemedicine

Telemedicine is a rapidly developing application that might be worth considering since my concept includes breast screening in underserved remote areas. Telemedicine refers to the use of communication and information technologies, including the internet, to facilitate the delivery of health care between two distant sites. There are different forms of telemedicine: Store-and-forward; Remote monitoring and Interactive services. Store-and-forward telemedicine involves acquiring medical data (like medical images, biosignals, etc) and then transmitting this data to a doctor or medical specialist at a convenient time for assessment offline. It does not require the presence of both parties at the same time.

Remote monitoring.

Remote monitoring, also known as self-monitoring/testing, enables medical professionals to monitor a patient remotely using various technological devices. This method is primarily used for managing chronic diseases or specific conditions, such as heart disease, diabetes mellitus, or asthma. Interactive telemedicine services provide real-time interactions between patient and provider, to include phone conversations, online communication and home visits. Many activities such as history review, physical examination

PAGE 73

Interactive Telemedicine.


There are a number of cases that indicate how telemedicine can have a positive benefit to health care delivery in the developing world. Telehealth in the Developing World is a book that compiled accounts of how real individuals are pioneering telehealth to confront real health delivery problems in their respective countries.

In Indonesia, a project to develop a telemedicine system for primary community health care. The system included teleconsultation and telediagnosis applications, medical information display software, a blood pressure and fetal heart rate interface, and an ECG interface

This is an example of telemedicine session for reinforcement of training. Telehealth can provide value, particularly when it is employed to strengthen and support a local team, rather than simply being used to import expertise from outside Telehealth is a term closely associated with telemedicine, but emcompasses a broader definition of remote health care that does not necessarily involve clinical services.

However, from the perspective of telehealth activity in the world as a whole, there has been relatively little use of telehealth in developing countries so far. One obvious reason is the information and communication technology (ICT) environment, including the cost of IT hardware and software and the limited availability of fast broadband and mobile networks.

Since my concept involves screening in remote underserved locations, I envision the use of telemedicine, particularly the Store-and-forward type, to send captured thermographic images to other experts around the globe for further analysis, and possibly even to the patientâ&#x20AC;&#x2122;s own mobile phones for their own records to be shown during a future breast health examination.

Dematologists and medical staff at Mbarara university hospital, Uganda selecting and processing difficult cases of skin diseases for teleconsultation.

PAGE 74


/Brainstorming

I conducted a brainstorming session with some classmates to try to find some ideas around a few topics:

A) How to spread awareness of breast cancer in a community

B) How to power a device when electricity is unavailable

C) How to cool the hands and body without ice

A few simple brainstorming rules learned from IDEO PAGE 75


Here are a few interesting ideas:

A

B

C

free sponge with every screening

using running water

alchohol

awareness wrist band with mark for each person you tell

movement from peopleâ&#x20AC;&#x2122;s fans

cooling spray

patient platform, step-on

ice cold cloths

separate solar panel attachment

dry ice

awareness advertisement with bra purchases

PAGE 76


/Ideation

In these series of ideation sketches, I was thinking about the patients privacy and possible desire to do a self scan. In this scenario, the woman would hold the device and point the camera towards herself. Thus, the device would need handles and a camera positioned pointing toward the patent.

The handles can fold and create a protected case.

PAGE 77


PAGE 78


/Ideation

In these series of ideation sketches, I was thinking of integrating two technologies, an infrared camera and an ultrasound. The infrared camera would be used to filter a population, and any abnormalities detected can be further analyzed using the more specific ultrasound technology. This represents the best possible combination for a feasible portable device, giving the doctor more tools to detect breast cancer.

I was inspired by a tote style form to be able to accomodate the hardware necessary for the two technolgies.

A table from th device more e technic

PAGE 79


The screen and keyboard would need to be protected.

et could be removed he main body of the in order to make it ergonomic for the cian.

PAGE 80


This form was softer and the frame shows ruggedness, but no protection for the hardware.

/Ideation

In these series of ideation sketches, I was just trying to explore form. An infrared camera could come in potentially any shape. But what I think is important in determing the final shape is how it functions within the workflow and how itâ&#x20AC;&#x2122;s perceived by the health worker, but more importantly, the patient. It has to express ruggedness and portability, yet the softness of a medical product.

These forms protected the hardware like the camera and interface, but it looks too agressive like a snake.

PAGE 81


An option for solar or human powered recharge would make the device more feasible in remote areas where electricity might be limited.

The fact that the camera has to face in the opposite direction as the interface made it difficult to incorporate within the same form. Maybe it could be split up into two bodies.

PAGE 82


/Ideation

In these series of ideation sketches, I was focusing on the patients perception of the medical device. I wanted to make the visible surface as calming and sculptural as possible, hiding the techology on the other side only seen by the technician.

The camera could be look like it was causing a tension on a surface, like a pulling or pushing adding to a sculptural effect. PAGE 83


This â&#x20AC;&#x153;sandwichâ&#x20AC;&#x153; form allows the protection of the interface elements between two bodies. The second body could be used as solar panels or human powered charger.

PAGE 84


/Concepts

3 concepts defined

focus points

1) Thermographic camera, built-in interface, solar/kinetic recharge option

• for very rural areas with little or no electricity • simplicity for health worker

2) Thermographic camera allows patient to do self imaging

3) Thermographic camera and ultrasound in-one, built in interface

PAGE 85

• patients privacy • ergonomics • home-use

• more diagnostic tools for the doctors • more comprehensive screening • patient to avoid additional visits


Based on the feedback from the middle presentation, I have chosen to focus on the first concept, a basic thermographic camera with a built-in simplified interface. I might also include the option of a kinetic mechanism for rechargeability in areas with little or no electric power. The second concept, where the patient might be able to scan herself, is less suitable and much more complex . It adds the complexity of a learning curve for each new patient. Even with the most intuitive solution, the machine would potentially be subject to more damage. Also, as a device requiring patient physical contact, it would need to be cleaned between sessions, which means the added burden of more cleaning supplies. The third concept, a dual technology device with thermography and ultrasound, might be the most ideal from a medical standpoint, but is compounded by the issue of cost. The cost range of a portable ultrasound is from $25,000 to $100,000. The cost of a thermographic imaging device can be significantly less than this, potentially pricing around $1,000 to $5,000. For communities of developing countries and the small non-governmental organizations tackling the breast cancer issue, expensive technologies like ultrasound are often out of reach. PAGE 86


/Key Questions Answered

I was concerned with two issues that complicated my concept. One issue is the high temperatures in some developing countries; the absence of temperature controlled rooms in some communities could be problematic. The second issue is the cold challenge part of a Thermography protocol, which would require access to ice or ice cold water. Some remote commuties might not have access to ice cold refrigeration. I got into contact with 6 different thermography centers in the United States to get some insight on these key questions:

Karin Grumstrup RN, NP www.yourbreasthealth.com

PAGE 87

Tirza L. Derflinger, CTT The Thermogram Center www.thermogramcenter.com

Renee Russo and Jenna Montgomery Thermography Center of Sonoma www.thermography-sc.com

Jackie Kane CCT www.ThermographyCenterSB.com

Dr. William Cockburn, DC, FIACT, FABFE www.BreastThermography.org www.Academy-of-Medical-Infrared-Training.com

Karla Porter, RT(R)(CT)ARRT, CTT Windrose Clinic Thermography www.Windroseclinic.com


Q1) The patient has to acclimatize to room temperature (19-23C) for 10 min before the images are taken. What might be the highest acclimatization temperature possible?  Many developing countries are in warm environments and remote locations might not have air conditioned rooms.  Some thermal Imaging cameras are capable of discerning thermal differences as small as 0.027 C, so wouldn’t it be possible to acclimate at around 30C for example?

All of the clinics followed protocol (19-23C). One thermographer said she had success at 25C They agree no real studies have been done. Temp is more a legal requirement than a scientific one.

Until a scientific study is done to determine the optimal temperature differential between the patient and the ambient temp, a strategy must be implemented to visit communities with limited electricity during colder seasons.

Q2) After the first set of images, the patient must under a “cold challenge” by submersing hands into ice water for one minute in order to constrict the normal breast blood vessels. Then a second set of images are taken. Are both sets actually needed? Are the first and second image sets just compared? Or are they actually integrated by the software so you only have a normalized image in the end?   Do you really need both sets of images?

All of the clinics no longer use the cold challenge. It is no longer a legal part of protocol.

No cold challenge will means a more streamlined workflow and no ice needed! PAGE 88


/Work Flow

Atypical thermography protocol had to be redefined to work in developing world environment. This would also help me to better understand how my device could fit into the workflow and make it more efficient. This is from the perspective of the health care worker.

Preparation (by Receptionist)

(by Doctor/Thermologist)

greet patient on arrival

retrieves data from reception

accesses patientâ&#x20AC;&#x2122;s images from the network or from SD card.

give patient forms (general health, family history)

explains to patient procedure specifics

compares thermal values between selected points on left and right breasts

positions patient for first image

can consult with outside experts for discussion of results via web.

inputs patient identification

can send the images directly or send a link from the network.

helps patient fill out form as needed input patient data into computer explains procedure to patient

sets level

fills out the Thermal Image Analysis form with the results and recommendations.

sets span greets patient and offers a seat captures first image (frontol view) tells patient to refer to poster illustrating the other poses captures right oblique view captures right later view captures left oblique view captures left later view ushers patient to consultation area

PAGE 89

Consultation

(by Technician)

ushers patient to acclimatization area

There would be different staging areas with different functions within the overall workflow.

Imaging

explains thermography results and what it means makes recommendations to patient and additional referrals if necessary


This is from the perspective of the patient. The patient’s journey might include Discovery and Approach, for example, in a scenario where a woman knows little about breast cancer.

Discovery

Preparation

Imaging

Consultation

first hears about breast cancer topic at church from group

answers a few questions. must meet some requirements to be screened now

greeted by a technician who sits behind the screening device

greeted by certified thermologist/ doctor

stands in front of screening device about 1 meter away

sits down with thermologist, both looking at the images on a laptop

instructed by technician verbally

listens and discusses the results with the thermologist

learns about free screening

inquires to get more information

NO shaving underarms or chemicals on breast NO breast feeding or bathing 1 hour prior NO tobacco or hot drinks 2 hours prior NO compression of breast 12 hours prior NO alcohol 24 hours prior

discusses with family

if requirements not met, must return when ready

told to refer to poster in front of her illustrating the different poses

is told that the images shows healthy breasts/no abnormalities

decision to go to the free screening for more info and maybe even a test

meets all requirements for a screening now

pose for the first scan

is told that the images show abnormalities, “hot spots”

Approach goes to free screening location greeted by a volteer

gets questions answered

fills out questionaire about general health and family history

waits for the device to blink indicating the scan was successful

ushered to private acclimatization area

poses for next scan

removes shirt

repeats process for 5 different poses

sits without touching breasts for 10-15 minutes to acclimate to room temp

puts shirt back on

proceeds to imaging area

told to come back in one year

tries to understand the implications of the results and discusses options gets referral for more specific tests mammography or ultrasound

proceeds to consultation area

patient can choose to receive images on her cellphone for future reference.

given information on how the breast screening will work decision to get the free screening

PAGE 90


/Scenario

1

Maria Conchita Guadalupe Ruiz Gonzales a.k.a. Maria 37 yrs old Tzintzuntzan, Mexico three children little/no knowledge about breast cancer doesnâ&#x20AC;&#x2122;t know family history of cancer

2

Maria is at church and learns that there is a group giving

After church, Maria goes to the groupâ&#x20AC;&#x2122;s information booth

information about breast cancer and free screenings.

to get some more information. She takes an information pamphlet home to read and show her husband.

3

4

Today

< 2 Hrs

< 1 Hr

< 12 Hrs

< 2 Hrs

< 24 Hrs

Maria learns about breast cancer and why screening

She follows the directions on what to do before she goes in for

is important. She read about the self breast exam, but

screening - NO shaving or beauty products of underarms and

would prefer to get the free screening from an expert.

breast; NO breast feeding 1 hr prior; NO tobacco or hot drinks 2 hrs prior; NO breast compression 12 hrs prior; NO alcohol 24 hrs prior

PAGE 91


5

6

7

She goes to the church hall where the breast cancer group

She fills out the form with the help of a volunteer, general

The first part of the screening involves temperature acclimation.

set up a few rooms for the breast screenings. They tell her

information and questions about her general health.

Maria is taken into a room with divided privacy areas, where she is told to remove her shirt and wait for 10 min.

more about the screening what it is, how it is done.

8

9

10

After 10 min, Maria moves to another part of the room where

She understands that this procedure is basically just colored

Thatâ&#x20AC;&#x2122;s it?! She puts back on her shirt and sees the doctor

she is greeted by another woman and takes a seat in front of

photos of her chest area. She is instructed to do 5 different

about her test results. The doctor (or health worker who

her and a small curious device. She feels quite comfortable

poses, guided by photo examples on the poster in front of

consults with a doctor via telemedicine) tells her that there

with their dialogue.

her. She sees a pink circle on the device blink at each pose.

is no abnormal finding and she should do it again in one

The images are sent to a remote server, available for analysis.

year.

PAGE 92


/Concept Development Sketches

A few requirements for my concept are: 1) a form that will enable the camera and screen to be protected during transport. 2) a form when open, its camera points to the patient while the buttons and screen face the Thermography tech. 3) a form that expresses my main design attritubes

These key doodles sparked the idea that will lead to the final form and concept.

PAGE 93


PAGE 94


/Concept Development Sketches

PAGE 95


PAGE 96


/Early CAD work

I modeled an early concept form in Solidworks to evaluate the mechanism.

In this concept, the camera lens and the screen are proteced in the closed position similar a computer laptop. To open, the camera swings 310 degrees around a pivot, which also doubles as the handle. In the open position, the camera faces the patient, while the screen and buttons are facing the thermography technician. PAGE 97


I also made some low-fi screenshots to quickly visualize the aesthetics of the concept form and determine if the form conveys my original design attributes.

Portable

Intuitive

Unobtrusive

Professional

Neutral

Trustworthy

Safe

PAGE 98


/Mock Ups

Physical mockups were made with foam board. These mockups were necessary to evaluate the conceptâ&#x20AC;&#x2122;s size, form and functional mechanisms. It was especially important to test the mockups on real users to understand their general perception and understanding of the product form and functionality. First one mockup was made and tested. Observations and recommendaitons were noted, and adjustments to the design were implemented. Then a second mockup was created and tested on additional users. The users were encouraged to talk out-loud while they tested the mockups to extract information in real time.

PAGE 99


Mockup #1

Mockup #2

CLOSED Configuration

OPEN Configuration

PAGE 100


Different ways of

/ M o c k u p Te s t i n g

OPENING

The test subject was somewhat

a

familiar with my project. But she had no knowledge of the form. I asked her different ways she would hold, open and interact with the device.

a

b

b

c

She felt. that the keypad was too tall for her hands.

CARRYING PAGE 101


She felt that the device was a bit unstable, that it could slip and fall flat. What could help is a locking mechanism on the joint, or at least

Different ways of

a graduated adjustment (like the

ADJUSTING

tension is some volume controls).

camera angle

a

b

She felt that her fingers could be pinched between the components when opening or closing. Maybe an

c

indentation or texture that would help guide the fingers on where to hold the device would solve the problem.

PAGE 102


With the smaller mockup #2,

/ M o c k u p Te s t i n g

she also preferred opening it in the air before placing it on

This was the first time that

She preferred opening the

this test subject has seen the

device in the air, before

device. She opens it up from

placing it on the table to

the side.

save time and have the

the table.

proper orientation of the device.

the

She also felt comfortable

camera component did not

holding the device like a

communicate that it should

book.

The

sharp

edge

of

have contact with the tabletop She feels that mockup #2 is easier to

surface.

understand and feels better holding it, better proportions. â&#x20AC;&#x153;Handling it is easier because it is smaller, but any smaller and

At first she had difficulting

it would give me the feeling that it is not

figuring out the orientation,

that accurate. . The fact that it is round

until she was told the the

makes it feel like it is one shape, a unit.â&#x20AC;?

camera flipped around 310 degrees.

1 PAGE 103

2


Adjusts camera angle by pushing forward the camera component or pulling the The shape and size make it

main body back or forth.

easier to handle in multiple ways. â&#x20AC;&#x153;It is the right size, not too big, not too small.

CRANK-BASED HUMAN POWERED RECHARGE

The concept is that the device can be recharged with human generated

a

b

power, specifically a pump action. She held the body to secure the device while pumping and also did so using the handle, which she felt was more comfortable.

PAGE 104


She felt that the size had to do

/ M o c k u p Te s t i n g

something with the quality or the capability of the device. Here she is opening each of the mockups.

Kerstin was the nurse at the Mammography and Ultrasound section of Umea University Hospital. Since she is familiar with many types of breast detection equipment, it was important to get her feedback on the concept mockups.

She

had

never

seen

the

concept, and when presented with mockup #1 for the first time, she was confused about the orientation of the device.

We she finally understood the

1

concept, she felt that it was an

2

interesting and “clever” idea.

“Both mockups are small enough to carry. “It’s as big as my handbag so it feels very handy.”

She felt that there should be lock so that it won’t open when

PAGE 105

it is being carried around.

1


2

Between mockup #1 and mockup #2, if it doesnâ&#x20AC;&#x2122;t make any difference with the quality

She tried different movements for the crank-

of the results, mockup #1 is a

based human generated power.

better size. She thinks that mockup #1 is easier to handle and use. Overall, it is more comfortable. Mockup #2 is just a little big and clumsier to hold.

She felt that this was the most comfortable way to engage the pump action if you donâ&#x20AC;&#x2122;t have to make a large movement.

PAGE 106


/Cultural Issues

Countries have many diverse cultures. Each culture might have different sensitivities to the concept of nudity. In some cultures for example, topless nudity is a common occurance, while in other cultures, skin exposure is more modest, if not banned completely.

Furthermore, there might also be a shyness specific to each person. Some women, despite the culture they belong, might just be uncomfrortable with the idea of being topless in front of others... PAGE 107


Option 1

In order to succeed in different cultural settings, the concept should include options to tackle the issue of an individualâ&#x20AC;&#x2122;s cultural or personal sensitivity to nudity...

Options to maintain patients privacy, if desired: 1) Install a curtain separating the camera side and the screen side of the device. 2) Perform the procedure with the patient in the dark. Patient can see the technician, but the technician can only see patient through the IR camera.

Option 2

PAGE 108


/Fictitious logo

Iâ&#x20AC;&#x2122;ve created a fictitious brand logo associated with my device. The graphic is inspired by the spectrum of color, on which the infrared radiation being emitted is visualized on a thermogram. The spectrum within the circle represents the scanning of a breast.

PAGE 109


PAGE 110


PAGE 111


FINAL DESIGN

PAGE 112


Battery indicator

/Final Design : closed configuration USB Connection

Rubber Inputs cover

Power input induction magnetic connect

Anti-slip

PAGE 113


Latch

Latch release

PAGE 114


/Final Design : open configuration

PAGE 115


Handle Power button

Protective gasket

Pink LEDs

Interface softkeys

Latch fastener

PAGE 116


/Human Generated Power

The concept includes a way to recharge the battery using human generated power. Although the device can be charged using an electrical power cord, there might be some instances when electricity is not readily available, such as in very remote areas or during blackouts. In these rare cases, human generated power could be used to recharge the battery so that work can continue uninterrupted. In this concept, the rotation of the camera around its pivot in a pumping action, or simply opening and closing the device a few times in between sessions, is kinetic energy that is harnessed and used to sustain the battery charge. The device is equipped with dual dynamos on either side of the handle, that are engaged during the pumping action or when the handle is rotated.

PAGE 117

Rechargeable Battery


dynamos

Pumping action to charge the battery Stabilize the main body with one hand and pump the camera body with the other hand. The anti-slip also doubles as gripping areas for this purpose.

PAGE 118


/Color and Finish

For the trim, different colors were explored. Pink seems to be the best choice to keep consistent with the global breast cancer movement which is represented by a pink ribbon and the color pink.

I wanted to minimize the color, just using it as an accent to signify the breast cancer movement.

The anti-slip could also be treated with color. It could match the trim, or it could match the handle, or both. PAGE 119

The challenge is finding the delicate balance between feeling rugged and looking like a professional medical device.


The handle should be made of rubber texture to maintain a good grip. A darker color contrasts with the main body to signify it as a grabbing point. It also masks dirty areas better than a light color.

In this iteration, the main body is a dark grey, to make it feel more rugged. It also contrasts with the clean white area of the interface, which should be sealed and protected when in the closed configuration. However, the overall expression seems more like a sport equipment rather than a medical product.

This is the chosen color combination. The trim is a glossy pink plastic, the main body is a light grey rubber composite. The interface area is semi-gloss white, the soft keys are matte white. The handle is a dark grey rubber capped by pink anodized aluminum rings. The inputs cover and the interface gasket is also a dark grey rubber. PAGE 120


/Final Design : point of view

PAGE 121


PAGE 122


/Final Design : Interface

Different Thermogrophers use different cameras equipped with different software packages for thermal imaging. Often the software is not specific for one type of application, like medical breast imaging. Rather, they are designed to be more universal to accomodate other applications such as electrical, mechanical, process control, surveillance, energy audits, etc. Thus, these software packages are equipped with as much functionalities as possible. I don’t know too much about the software infrastructure or all the functionalities used by medical thermographers. But I asked different thermography centers to explain in simplest terms, about their basic set-up and the adjustments they need to make for a typical thermography session. I wanted to design a simple, “stripped-down” interface with a clear linear logic. Only the most necessary functionalities are incorporated, just enough for the medical thermologist to accomplish the task of obtaining and storing the data. The data can be passed to the doctor for analysis and diagnosis.

PAGE 123

1 Input patient’s ID number The patient ID number is associated with the hard paper copy of the patient questionaire and history form. Push NEXT to go to SPAN settings.

2 Set the Temperature Span The temperature settings can vary with each patient (each person has a different body temperature), so it must be set for each patient. Push BACK to edit Patient ID. Push NEXT to go to LEVEL settings.

3 Set the Level The thermal image should have most of the breast areas in the blue-green temperature ranges, and the images should have no black areas. Push BACK to edit SPAN. Push NEXT to go to CAPTURE mode.

4 Capture the image Push the Capture button for each of the 5 different views. (No need to push NEXT for the next image, just push the Capture button again.) The Span and Level should remain unchanged. When the Capture buttton is pushed, an image file is generated and automatically stored in the SD memory card. Push NEXT for new patient. (Pushing NEXT at the Capture stage will create a new patient file and start back at 1.)


Image file format: Patient ID#__photo#.raw i.e. B038419_1.raw B038419_2.raw B038419_3.raw B038419_4.raw B038419_5.raw

PAGE 124


/Dimensions

10 20

170

100

30

35

210

210

290

290

30

60

Back View PAGE 125

170

Front View

Side View (closed)


170

R20

150

30 210

140째 30 145 0

40째

Camera componet

Side View (open)

45

PAGE 126


/Package

The volume of the device is more than enough to accomodate the components. It could have easily been designed smaller to minimize the dead space, but there comes a point where too small could be perceived as not robust, not accurate or not a serious medical device. Furthermore, the final size was determined based on insights from the mockup tests. In the end, it was a compromise between a size small enough to be handled easily yet large enough for better working ergonomics and a general positive perception.

PAGE 127


ir camera Lens

handle crank gear

ir camera ccd

camera hardware soft keyboard solid state memory

dual dynamo generator

led screen

battery

main board input hardware

PAGE 128


/Final Design : In context

PAGE 129


The tabletop nature of the device allows the health care worker to sit face-to-face with the patient, in close proximity, not behind a wall like in mammography. It is intended to establish a more personal relationship between the patient and the health worker and to encourage more dialogue, similar to a conversation at a cafe between friends. This is a more dignified setup that can help the patient feel more comfortable and relaxed during her breast cancer screening.

PAGE 130


/Final Design : In context

PAGE 131


PAGE 132


/References Articles

“Breast cancer in developing countries”, The Lancet, Volume 374, Issue 9701, Page 1567, 7 November 2009 “In developing countries, breast cancer strikes women a decade earlier” by Vanessa Valenti, Nov. 3, 2009 from http://www.undispatch.com/breast-cancer-strikes-women-decade-earlier-developing-countries “Poor countries see troubling rise in breast cancer” by By Lauran Neergaard, Nov. 3, 2009 from http://www.google.com/hostednews/ap/article/ALeqM5iwaJ2Q0qtJiyolpDAsW7WhYkriSgD9BNUD6O0 “Breast cancer danger rising in developing countries”, by Alvin Powell, April 16, 2009 from http://news.harvard.edu/gazette/story/2009/04/breast-cancer-danger-rising-in-developing-countries/ “Westernizing” Women’s Risks? Breast Cancer in Lower-Income Countries” by Peggy Porter MD, New England Journal of Medicine, Volume 358:213-216, January 17, 2008 “Breast Cancer: Statistics on Incidence, Survival, and Screening” from http://www.imaginis.com/breasthealth/statistics.asp “Controlling Cancer in Developing Countries”, April 2007 from http://www.dcp2.org/file/79/DCPP-Cancer.pdf “Stigma of breast cancer in developing countries costs lives” from http://news.bio-medicine.org/medicine-news-2/Stigma-of-breast-cancer-in-developing-countries-costs-lives-6759-1/ “Breast Cancer Imaging: Mammography, Ultrasonography, and Magnetic Resonance Imaging”, by Anthony Lee, Jan 5, 2008 from http://cancer.suite101.com/article.cfm/breast_cancer_imaging “Tumors grow faster in younger women” May 7, 2008 from http://esciencenews.com/articles/2008/05/07/breast.cancer.tumors.grow.faster.younger.women Consedine, N. S., Magai, C., Krivoshekova, Y.S., Ryzewicz, L. & Neugut, A. I. (2004). Fear, Anxiety, Worry, and Breast Cancer Screening Behavior: A Critical Review. Cancer, Epidemiology, Biomarkers & Prevention, 13, 501-510. Consedine, N. S., Magai, C., & Neugut, A. I. (2004). The contribution of emotional characteristics to breast cancer screening among women from six ethnic groups. Preventive Medicine, 38, 64-77. Wootton, R.,Patil N.G., Scott R.E., Ho K., Telehealth in the Developing World, © 2009 Royal Society of Medicine Press Ltd

PAGE 133

Presentations

Breast Health Global Initiative: Guidline Implementation of Low and Middle Income Countries, Dr. Benjamin Anderson at the University of Washington Continuing Medical Education http://depts.washington.edu/cme/online/anderson.php

Videos

http://www.youtube.com/watch?v=aaS3VIyltJQ http://www.youtube.com/watch?v=eFXEgO76Jrc http://www.youtube.com/watch?v=1jK62-48PB0 http://www.youtube.com/watch?v=BdDoHAwFZ7s http://www.youtube.com/watch?v=tHYcsBRbpOo http://www.youtube.com/watch?v=-fcjRIbmnic&feature=related http://www.youtube.com/watch?v=j_iq2CrItng&feature=related http://www.youtube.com/watch?v=k7BPYHHVSx0&feature=related


Websites: Breast Cancer Basics

Websites: Breast Cancer Detection

PAGE 134


Websites: Breast Cancer in Developing Countries

Websites: Thermography

PAGE 135

Earl Pineda Degree Report 2010  

Report for final degree project, Advanced Product Design Master's Program 2010, Umea Institute of Design: A mobile solution for breast canc...

Read more
Read more
Similar to
Popular now
Just for you