PULSE OXIMETER

DISPLAY SYSTEM Project Proposal Feasibility Report

Nick McKee, Benjamin Wohl, Taylor DeHaan, Scott Block ENGR 339 Senior Design Project, Ca lvin College

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2014, Nick McKee, Benjamin Wohl, Taylor DeHaan, Scott Block and Calvin College

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1 Executive Summary

The PODS wrist pulse oximeter will reduce the risk of pilots succumbing to hypoxia while flying at high

altitude. The problem with current pulse oximeters is that they are bulky and are worn on the finger,

disincentivizing pilots to wear them during an entire flight. PODS pulse oximeter and warning system

seeks to passively monitor a pilots oxygen level through reflectance oximetry and then warn a pilot when

they are in danger of not having enough oxygen in their body. This team of four Electrical and Computer

Engineers has created a basic pulse oximeter prototype and business plan to deliver this highly marketable

and valuable product. Given the current market value for pulse oximeters stands at 1.6 billion yearly and

the size of the pilot market is over 600,000 people, it will take about 3,265 units at $500 each to be a

profitable company in its first year. This equates to roughly 0.1% of the pulse oximeter market and 0.5%

of pilots. This data plus the success in prototyping has lead PODS to determine that this product is

marketable and feasible.

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Table of Contents

1 Executive Summary.....................................................................................................................2

2 Introduction ................................................................................................................................7

2.1 Project Description ..............................................................................................................7

2.2 Need for Solution.................................................................................................................7

3 Project management ....................................................................................................................7

3.1 Team organization ...............................................................................................................7

3.1.1 Team members .............................................................................................................7

3.1.2 Advisors ......................................................................................................................8

3.2 Meeting Times.....................................................................................................................8

3.3 Schedule .............................................................................................................................9

3.4 Budget ................................................................................................................................9

3.5 Method of Approach ............................................................................................................9

3.5.1 Stage One ....................................................................................................................9

3.5.2 Stage Two .................................................................................................................. 10

3.5.3 Stage Three ................................................................................................................ 10

4 Design ...................................................................................................................................... 10

4.1 System Architecture ........................................................................................................... 10

4.1.1 Probe ......................................................................................................................... 10

4.1.2 Amplifier and Filter .................................................................................................... 11

4.1.3 Analog to Digital Converter ........................................................................................ 11

4.1.4 Microprocessor........................................................................................................... 11

4.1.5 Display Driver............................................................................................................ 12

4.1.6 Display ...................................................................................................................... 12

4.1.7 Speaker ...................................................................................................................... 12

4.2 Design Norms.................................................................................................................... 12

4.3 Design Criteria .................................................................................................................. 13

4.3.1 Ergonomics ................................................................................................................ 13

4.3.2 Display System .......................................................................................................... 14

4.3.3 App Development....................................................................................................... 14

4.4 Design Alternatives............................................................................................................ 14

4.4.1 Oximetry.................................................................................................................... 14

4.4.2 Display Connection .................................................................................................... 15

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4.4.3 Physical Device (Probe) .............................................................................................. 16

4.5 Design Decisions ............................................................................................................... 17

4.5.1 Microprocessor........................................................................................................... 17

4.5.2 Analog to Digital Converter ........................................................................................ 18

5 Operations ................................................................................................................................ 20

5.1 Legal form of Ownership ................................................................................................... 20

5.2 Company structure ............................................................................................................. 20

5.3 Decision making authority .................................................................................................. 20

5.4 Significant compensation and benefits packages .................................................................. 20

6 Industry Profile and Overview.................................................................................................... 21

6.1 Industry background and overview...................................................................................... 21

6.2 Major Customer Groups ..................................................................................................... 21

6.2.1 Aviation ..................................................................................................................... 21

6.2.2 Military...................................................................................................................... 21

6.2.3 Medical...................................................................................................................... 21

6.2.4 Emergency Response Units ......................................................................................... 21

7 Business Plan ............................................................................................................................ 22

7.1 SWOT Analysis................................................................................................................. 22

7.1.1 Strengths .................................................................................................................... 22

7.1.2 Weaknesses................................................................................................................ 22

7.1.3 Opportunities ............................................................................................................. 22

7.1.4 Threats....................................................................................................................... 22

7.2 Marketing Strategy ............................................................................................................ 22

7.2.1 Demographics ............................................................................................................ 22

7.2.2 Customers' motivation to buy ...................................................................................... 23

7.2.3 Market size and trends ................................................................................................ 23

7.2.4 Advertising and promotion .......................................................................................... 23

7.2.5 Plans for generating publicity ......................................... Error! Bookmark not defined.

7.3 Competitive Analysis ......................................................................................................... 24

7.3.1 Existing Competitors .................................................................................................. 24

7.3.2 Potential Competitors.................................................................................................. 25

7.3.3 Market Survey............................................................................................................ 25

7.4 Cost Estimate .................................................................................................................... 25

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7.4.1 Development Costs ..................................................................................................... 25

7.4.2 Fixed Costs ................................................................................................................ 26

7.4.3 Variable Costs ............................................................................................................ 26

7.5 Feasibility ......................................................................................................................... 26

7.5.1 Income Statement ....................................................................................................... 27

7.5.2 Balance Sheet............................................................................................................. 27

7.5.3 Cash Flow Statement .................................................................................................. 27

7.5.4 Break-even Analysis ................................................................................................... 27

7.5.5 Ratio Analysis ............................................................................................................ 27

8 Testing ..................................................................................................................................... 27

9 Conclusion................................................................................................................................ 30

10 Acknowledgements ............................................................................................................... 31

11 References ............................................................................................................................ 32

12 Appendix 1: Maxim MAX1416 Data Sheet ............................................................................. 33

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Table of Figures

Figure 1. Level 1 Block Diagram ....................................................................................................... 10

Figure 2. Company Structure ............................................................................................................. 20

Figure 3. Test Circuit ........................................................................................................................ 28

Figure 4. SPI SCLK Signal Measured During a Transaction ................................................................ 29

Table of Tables Table 1. Work Breakdown Schedule ....................................................................................................9

Table 2. Bluetooth/WiFi/ZigBee Comparison Summary ...................................................................... 15

Table 3. Microprocessor Decision Matrix ........................................................................................... 18

Table 4. Analog to Digital Converter Decision Matrix......................................................................... 19

Table 5. Finger Device Decision Matrix ............................................................................................. 19

Table 6. Development Cost ............................................................................................................... 25

Table 7. Fixed Cost........................................................................................................................... 26

Table 8. Variable Cost ...................................................................................................................... 26

Table 9. Income Sheet....................................................................................................................... 34

Table 10. Statement of Cash Flow ..................................................................................................... 34

Table 11. Break Even Analysis .......................................................................................................... 36

Table 12. Ratio Analysis ................................................................................................................... 37

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2 Introduction

2.1 Project Description

The Pulse Oximeter Display System (PODS) teams project seeks to solve the problem of pilots in

unpressurized airplanes crashing due to hypoxia. This project will provide a remedy to the problem by

creating a pulse oximeter to monitor a pilots oxygen levels throughout flights and issue warnings if they

are in danger of becoming hypoxic. A few constraints include: designing the oximeter to be comfortably

worn for hours at a time and not interfere with the pilots range of motion or use of hands, the system

displaying the oxygen levels, pulse, etc. must be able to be easily seen by the pilot and provide visual and

auditory warnings when oxygen levels get too low.

2.2 Need for Solution

Each day pilots put their lives at risk launching their airplane into the sky. These risks include

technological failures and weather hazards, among many others. There is one risk, however, that pilots

easily overlook: hypoxia. Hypoxia is a condition where the body lacks adequate oxygen to function

properly leading to impaired judgment and loss of consciousness. The FAA states that pilots flying above

10,000 feet must be on some form of oxygen, but this regulation fails to account for two crucial factors:

the exact altitude when hypoxia begins to onset in a pilot; and if a pilot is getting sufficient oxygen

through their oxygen supply. Low oxygen levels at high altitude affect each person differently based on a

variety of factors, including fitness level or tobacco use, putting some at risk of becoming hypoxic before

10,000 feet. It stands to reason that all pilots should have access to a device that measures the level of

oxygen in their blood. Furthermore, this device must be comfortable to wear and not inhibit a pilots

dexterity in any way. Finally, this device should clearly display and issue a warning when a pilot is in a

potentially dangerous situation.

3 Project management

3.1 Team organization

The team consists of four senior engineers in the electrical and computer concentration. The project is

divided into separate tasks and each member of the group is in charge of a different part of the project.

3.1.1 Team members

Nick McKee: Nick is an electrical/computer engineering concentration from Arlington Heights, Illinois.

He has also been a four-year member of the Calvin College Cross Country team and also of the Calvin

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College Track and Field Team. He has experience working as a controls engineer intern. He has been

assigned the task of researching business components of the project.

Taylor DeHaan: Taylor is a senior electrical/computer engineering student from Excelsior, Minnesota.

Taylor has interned for Seagate Technology in Bloomington, Minnesota over the summer of 2013 and

again in Longmont, Colorado over the summer of 2014. He is currently continuing his work from the past

summer in a part-time intern position and has accepted a permanent role in the Advanced Storage

Development team at Seagate starting the summer of 2015. Taylors role in team consists of lead

research, system design, and team webmaster.

Benjamin Wohl: Benjamin is an electrical/computer engineering concentration student from Canton,

Michigan. He is a four-year starter and captain of the Calvin College baseball team. He has been assigned

the task of researching the display unit as well as developing team posters and presentations throughout

the course of the project.

Scott Block: Scott is an electrical/computer engineering concentration student from Grand Rapids,

Michigan. The past 8 years of his life have been spent serving in the military with two overseas tours to

Iraq and Afghanistan. As a software engineering inter, Scott worked at Visteon Corporation during the

summer of 2014. He was tasked with researching the microcontroller and editing the teams work.

3.1.2 Advisors

The teams main advisor is Professor Mark Michmerhuizen. He received his BSE from Calvin College

and went on to obtain his MSEE from the University of Michigan and his MBA from Grand Valley State

University. He worked in industry for 22 years before joining the staff at Calvin College. Professor

Michmerhuizen mainly aided the team by giving feedback on design ideas and by giving professional

advice.

The team was also in contact with Taylors father, Doug DeHaan, a private pilot and avid aviation

enthusiast. He originally proposed the project idea to the team after seeing a tangible need for the device

in private aviation. Throughout the year, he has provided specifications and possible features for the

device and has provided input from other pilots on the project.

3.2 Meeting Times

The team normally meets at 1:00 pm each Monday. At this time, tasks are divided up and all relevant

information is communicated to each member. The team also meets from 2:30 pm till 3:20 pm every

Monday, Wednesday and Friday for the regularly scheduled senior design class time. All other meeting

times are scheduled as necessary.

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3.3 Schedule

See Table 1 below for the teams schedule.

Table 1. Work Breakdown Schedule

Task Name Duration Start Finish Predecessors

Fall 2014 44 days Wed 10/8/14 Mon 12/8/14

Oral Presentation 2 days Fri 10/10/14 Mon 10/13/14

Project Brief for

Industrial consultant

6 days Wed 10/8/14 Wed 10/15/14

Project website 7.5 days Mon 10/13/14 Wed 10/22/14

Project poster 8 days Wed 10/22/14 Fri 10/31/14

PPFS 44 days Wed 10/8/14 Mon 12/8/14

Introduction 1 day Wed 10/8/14 Wed 10/8/14

Background & Research 1 day Thu 10/9/14 Thu 10/9/14 7

Scope 2 days Fri 10/10/14 Mon 10/13/14 10

Design Criteria 3 days Tue 10/14/14 Thu 10/16/14 13

Design Alternatives 2 days Fri 10/17/14 Mon 10/20/14 18

Feasibility 1 day Tue 10/21/14 Tue 10/21/14 21

Cost/budget 1 day Wed 10/22/14 Wed 10/22/14 22

Schedule 1 day Thu 10/23/14 Thu 10/23/14 23

Business plan 1 day Fri 10/24/14 Fri 10/24/14 24

Conclusion/review 1 day Mon 10/27/14 Mon 10/27/14 25

Appendix 1 day Tue 10/28/14 Tue 10/28/14 26

Rough draft 24 days Wed 10/8/14 Mon 11/10/14

Review/polish PPFS 5 days Tue 11/11/14 Mon 11/17/14 28

3.4 Budget

The team was allotted an initial budget of $500 dollars for prototyping and other peripherals to the

project. Thus far, the team has procured a Raspberry Pi and its necessary accessories (i.e. memory card,

break out wires, and power supply), a high resolution analog to digital converter, various LEDs, and

photodiodes. The accrued amount spent on these components is $72 leaving $428 left in the budget for

future prototyping.

3.5 Method of Approach

3.5.1 Stage One

The team will research the pulse oximetry industry and current products available to consumers. This

research includes looking into design alternatives. This is also when the selection of which components to

use for the different aspects of the project takes place.

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3.5.2 Stage Two

The team will focus on getting all the individual components of the project working. This involves

building a bench top prototype to make sure that all of the components will work together. This stage is a

transitional stage between one and three.

3.5.3 Stage Three

The team will integrate the different aspects of the bench top prototype into one working model. This

model and the final design report will serve as the final deliverable for this project.

4 Design

4.1 System Architecture

In the following sections, the system architecture is broken down into individually described components.

Below is a Level 1 block diagram of the system.

Figure 1. Level 1 Block Diagram

4.1.1 Probe

The probe component seem above consists of light-sources and photo sensor. The light sources will be the

emitters of red and infrared light needed for pulse oximetry, the non-invasive measurement of blood

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oxygen saturation. The light emitters will require a source of power and could be controlled by the

microprocessor used in the system in order to manage the amount of power expended. The photo sensor

in the probe will measure the light transmitted through or reflected off of the users skin. The light seen

by the sensor is used to calculate oximetry data. The sensor is connected to the amplifier used in the

system. On the mechanical side, the probe, in addition to housing the light-emitters and the photo sensor,

will be able to be comfortably worn by the user while maintaining the proper contact required to measure

oximetry data.

4.1.2 Amplifier and Filter

The signal from the probes photo sensor is amplified so that the appropriate signal processing can be

accomplished. The amplifier will be multi-staged, with a minimum of a voltage amplification stage and

an output stage. Additionally, an active or passive low pass filter network will be designed in order to

eliminate unwanted noise. The interface between the amplifier and the probe will consist of a ground and

signal wire. The amplifier and filter will also require a power source and will provide the amplified signal

to the analog to digital converter.

4.1.3 Analog to Digital Converter

The analog to digital converter takes the continuous amplified and filtered analog signal and converts it to

a discrete-time digital signal for processing. The converters specifications - such as resolution, sampling

frequency, bandwidth, and accuracy - must be appropriate for the range of signals produced by the

amplified and filtered photo sensor. Like the probe and amplifier, the analog to digital converter requires

a power source and interfaces with the amplifier and filter system component through ground and signal

wires. The converter outputs a series of logic level wires proportional to the resolution of the converter.

4.1.4 Microprocessor

The systems most vital component, the microprocessor, will perform all the processing of the oximetry

data in order to produce graphical representations for blood oxygen saturation and heart rate.

Additionally, the microprocessor runs the algorithms designed to monitor the users blood oxygen

saturation and issue warnings when blood oxygen saturation level drops below the specified threshold.

The microprocessor is also the most flexible component of the system as there are numerous different

features that can be found in microcontroller packages. The important aspects to consider when selecting

a microcontroller are: price, power consumption, number and type of inputs and outputs (I/O), and

application suitability. Other factors which are not required but add desirability are: built in analog to

digital converter, integrated antenna, Linux based operating system, and pre-programmed communication

protocols.

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4.1.5 Display Driver

The display drivers purpose in this system is to take the output from the microprocessor intended for the

display and generate the appropriate signals to make the display show the intended graphics. At a high

level, the display driver interfaces between the display and the microprocessor. The display driver may

likely be built into the display used for this system.

4.1.6 Display

The display provides a visual for the data, graphics, and warnings as well as any other necessary

information to the user. The display must be of an appropriate size/resolution in order to accurately

display the information from the microprocessor such as graphing of heart rate or blood oxygen

saturation. On the physical side, the display will be able to withstand a fair amount of abuse and must

have a mounting system similar to that of modern GPS allowing the pilot place it to suit his needs. The

display also requires a power supply in the form of a rechargeable battery or a wired plug in power

supply. The display interfaces with the processor through either a wired connection or wirelessly through

a receiver.

4.1.7 Speaker

The speaker provides auditory warnings to the pilot when triggered by the microprocessor. The speaker

must be loud enough to combat the noises found the cabin of a small aircraft and be clearly

distinguishable from other possible warnings from the airplane itself (i.e. stall warnings, autopilot

disengage, et al). The speaker interfaces with the microprocessor and will be housed in either the display

or microprocessor module.

4.2 Design Norms

Trust

Design should be trustworthy, dependable, reliable, and avoid conflicts of interest

Due to safety being the primary goal of this project, the design norm of Trust is paramount. This project is

frivolous without a pilot putting their trust into using the device to correctly measure, monitor, and

communicate blood oxygen levels to prevent hypoxia. Furthermore, this trust encompasses all levels of

design, production, and application; with potential life and limb at risk, all aspect of the device must be

dependable, safe, and reliable in many circumstances and environments since a malfunction could result

in danger for the user. Finally, the reliability of the device is extremely important since the task of flying

an airplane is a demanding and often stressful process. Therefore, the pilot should not have to worry the

device is functioning properly and trust in it if it could fail at a crucial time.

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Transparency

Full disclosure both in the design process and to the public, regarding options, effects, defects, and

tradeoffs.

Similar to the design norm of Trust, the norm of Transparency is crucial to this project. In order to

establish trust with the users, all relevant details of the project must be disclosed. If any defects are

discovered, these absolutely must be disclosed since a failure to do so could result in fatal crashes. Also,

all effects of the device the users ability to operate an aircraft be must be disclosed immediately in order

to stay true to the projects core goal of preventing crashes. Finally, transparency includes providing the

performance tests and corresponding results to identify the limitations and feasibility of application for

this device under different circumstances. Disclosing as much relevant information as possible contributes

the users sense of security thus building a relationship of trust.

Integrity

Design should have completeness, harmony of form and function, promote human values and

relationships, and be pleasing and intuitive to use

The final design norm identified for this project is Integrity. This design norm offers the user closure and

value when using the device. Closure in the sense that it was created with them in mind to relieve the

mental burden of having to worry whether the device is functioning properly and value through keeping

them safe by using an intuitive and well thought-out interface. The design norm of Integrity heavily

affects the design of the user interface on the display system as the norm dictates that the interface must

be both pleasing to use and highly functional. The design norm of Integrity also complements the design

criteria of ergonomics and dictates that the ergonomics of the device should also be balanced with its

functionality. With these considerations in mind, the device will be the very example of integrity.

4.3 Design Criteria

4.3.1 Ergonomics

The design of the pulse oximeter must be comfortable and easy to wear. If it is a hassle to put on or wear,

pilots will not be as likely to buy or use it. The design is going to focus on making the pulse oximeter into

a small band that is worn around the w. This will allow for pilots to have a full range of motion in their

hands and fingers, a large improvement over the current pulse oximeters on the market. This new pulse

oximeter will be comfortable for pilots to wear from takeoff to landing.

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4.3.2 Display System

The display system for this product focuses on simplicity and ease of use. The most critical times for

display are when a pilot is starting to suffer from symptoms of hypoxia. If a pilot becomes confused, this

system must display the data in an easy to understand way so its interpretation is comprehensible. The

display is being designed to be a small touch screen device that could be mounted in a convenient place in

the cockpit. The warning system will be based on the level of oxygen in the blood. This data will be

received from the finger worn pulse oximeter and transmitted to the warning system. This system will

then give out status messages to the pilot. The warning system will measure the change in blood oxygen

levels in an effort to predict hypoxia and give warnings before the pilot reaches a critical state.

4.3.3 App Development

The app would either take the place of the display system or work alongside it. We are hoping that it will

be able to display the same data that would be shown on the display screen. Having the display system on

an app will lower the cost of development and the cost of the finished product.

4.4 Design Alternatives

4.4.1 Oximetry

A pulse oximeter is an electronic device which measures blood oxygen saturation non-invasively. This

method is effective at determining oxygen saturation as it utilizes the light absorptive characteristics of

hemoglobin and the pulsating nature of blood flow in the arteries to aid in determining the oxygenation

status in the body1. In addition to the LEDs and photodiodes, a pulse oximeter also employs a number of

other components, most notably: a microprocessor, analog to digital converters, digital to analog

converters, a display system, and amplifiers. When designing an oximeter, they are two different methods

of measuring blood saturation which must be examined.

4.4.1.1 Transmittance Oximetry

A transmittance pulse oximeter measures blood oxygen saturation by producing two beams of light at

different wavelengths (red and infrared) via light-emitting diodes (LEDs) and by measuring the light

transmitted through the users fingertip via photodiodes1. Transmittance pulse oximeters make up the

vast majority of consumer pulse oximeters.

1 (Oximetry n.d.)

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4.4.1.2 Reflectance Oximetry

A reflectance pulse oximeter also produces two beams of light but instead of measuring the light

transmitted through the users skin, it measures the light reflected by the users skin. From a design

perspective, the primary difference between the two is that a reflectance pulse oximeter does not require a

thin section of the users body in order to obtain measurements. A recent study on the differences of

transmittance and reflectance pulse oximetry published in the Anesthesia & Analgesia Journal showed

that both methods were equivalent in accuracy and performance2.

4.4.2 Display Connection

4.4.2.1 Wired

One option for connecting the oximeter sensors and circuitry with the digital display system is using a

hardwired connection. The benefits of using a hardwired system include: low-cost, no speed restriction,

no additional power consumption. Drawbacks of using a wired connection include: vulnerable to fraying

and depredation, potentially could snag on the many controls in a cockpit, could inhibit pilots range of

motion, and physically limits the placement of the display system.

4.4.2.2 Wireless

Alternatively to a wired connection, a wireless system could be used in order to connect the oximeter

sensors, circuits, and microprocessor to the display system. Within wireless systems, there are a number

of technologies which must be considered individually, however, there are some benefits that they all

share. A few such benefits include: no limits on the pilots range of motion, eliminating the possible

snagging and general physical limitations of wires, overall flexibility. Conversely, a few drawbacks

include: additional power consumption, additional cost, additional complexity and circuit board space. A

table summarizing the details of each of the three wireless technologies described in the proceeding

sections can be seen below.

Table 2. Bluetooth/WiFi/ZigBee Comparison Summary

Bluetooth WiFi (IEE 802.11n) ZigBee

Operating Frequency (GHZ) 2.4 2.4 and 5 2.4

Range (m) 10 1-100 1-100

System Resources (KB) 250 1,000 4-32

Data Rate (Mb/s) 5.76 600 2

Power Consumption Medium High Very Low

2 (Wax 2009)

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4.4.2.3 Bluetooth

Bluetooth is a type of wireless technology which utilizes radio frequencies over a spectrum 2.4 to 2.485

GHz in order to achieve wireless communication3. Bluetooth also uses a technology called adaptive

frequency hopping in order to minimize interference with other radio waves present across its frequency

spectrum. The maximum range of a Bluetooth device is roughly 10 meters3. When compared to ZigBee

and WiFi, Bluetooth achieves moderate battery consumption4. Finally, Bluetooth uses about 250 KB of

system resources and has a maximum data rate of 5.76 Mb/s.

4.4.2.4 WiFi (IEE 802.11)

WiFi, also known by the Institute of Electrical and Electronics Engineers (IEEE) standard 802.11 (in the

context of this paper, 802.11n will be used), is a wireless technology which operates in the 2.4 and 5 GHz

bands5. WiFi, whose primary goal is high data rates, has a maximum data of 600 Mb/s and uses over 1

MB of system resources. WiFi also has a range anywhere from 1 to 100 meters. Although WiFi has very

high speeds, when compared to ZigBee and Bluetooth, it has very high power consumption4.

4.4.2.5 ZigBee

ZigBee, the final type of wireless technology considered for the proposed design, operates in the 2.4 GHz

frequency band. ZigBee uses between 4 KB to 32 KB of system resources and achieves data rates up to 2

Mb/s4 over a range of 1 to 100 meters. ZigBee, whose primary design features are low-cost and low-

power, has very low power consumption when compared to WiFi and Bluetooth. Another unique feature

of ZigBee, in addition to very low power consumption, is ZigBees ability to support extreme ly large

mesh networks (over 64 devices)4.

4.4.3 Physical Device (Probe)

4.4.3.1 Headset

The majority of pilots wear some form of headset to eliminate outside noise and communicate with the

tower and other passengers. Reflectance oximetry would lend itself to this design. It is also possible that

with some clever design work, transmittance oximetry could work by putting the sensor in the headset.

The argument for putting the sensor in the headset is that the headset already has a wired connection to

the plane, allowing the design to take advantage of that wire, minimizing the hindrance and danger to the

pilot. The current costs of headsets may prove to be the biggest detriment as researching and prototyping

would be difficult for this project and its budget.

3 (A Look at the Basics of Bluetooth Technology n.d.) 4 (ZigBee Technology n.d.) 5 (IEEE 802.11 Standards Tutorial n.d.)

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4.4.3.2 Bracelet

A bracelet would take advantage of the reflectance oximetry and could be made large enough to have a

power supply to support wireless capability. It also would not limit the dexterity of a pilot's fingers. The

biggest challenge related to this design is that the bracelet needs to remain comfortable for the whole

flight all while it must maintain good contact with the skin for accurate oxygen readings.

4.4.3.3 Finger Attached

A sensor in a ring or clip on device for the finger is currently available on the open market. This allows

for easier research and prototyping, but may limit the wired/wireless options. The simplicity and small

design of the device lends to comfort and allowing good mobility for the pilot, but also presents heavy

constraints on the size of the device.

4.5 Design Decisions

4.5.1 Microprocessor

When evaluating different microcontroller packages with microprocessors, the team identified 4 key

fields: cost, processing power, hardware flexibility, software flexibility, and size. Cost was considered as

the final design should be at a similar price point to other oximeters currently on the market. Processing

power (clock speed, RAM, graphics processors, etc.), was considered since the microcontroller will need

to run various algorithms for oximetry computation and monitoring in addition to providing a graphical

display. Hardware flexibility was considered since, depending on the final design, the microprocessor

may need to interface with devices like the analog to digital converter through different interfaces and be

able to utilize Bluetooth, WiFi, or ZigBee. Software flexibility was considered since the software for

oximetry measurement and monitoring, graphical interface, and interfacing with hardware may require

various high-level languages and libraries. Finally, size was considered to align with the design criteria of

ergonomics although the microcontroller will most likely be mounted on the external display and thus

will not need to meet the constraints of being wearable. These considerations outlined were placed into a

decision matrix with equal weighing and maximum possible scores of five which can be seen in Table 3

below.

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Table 3. Microprocessor Decision Matrix

Raspberry Pi B+ Arduino Yun Jennic JN5148

Cost 3 1 5

Computing Power 5 4 1

Software Flexibility 5 3 1

Hardware Features 5 5 2

Size 2 3 5

Total 20 16 14

As seen in Table 3, the Raspberry Pi B+ was determined to be the best microprocessor package for the

project. One key feature of the Raspberry Pi which distinguished itself from the other considerations was

an onboard graphics processor as this will enable the final design to be able to provide a low latency

graphical display of oximetry readings as well as real time graphs of things like heart rate. Another key

feature of the Raspberry Pi was its status as a single board computer and its subsequent ability to compile

and run high level languages like Python, C/C++, and Java as this will allow the software to be developed

in almost any language desired.

4.5.2 Analog to Digital Converter

When choosing which analog to digital converter (ADC) to use, the team considered the 16-bit, 500

samples/second Maxim MAX1416, the 10-bit, 200k samples/second Microchip Technology MCP3008

and the 12-bit 100k samples/second Microchip Technology MCP3202. One thing to note about the

possible choices identified is that only dual in-line package (DIP) chips were considered they offer the

most flexibility for prototyping on breadboards. The four features considered when evaluating which

analog to digital converter to use included: sampling frequency, resolution, number of channels, power

consumption, and additional features. These features were then scored out of five and placed in a

decision matrix seen in Table 4 below.

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Table 4. Analog to Digital Converter Decision Matrix

MAX1416 MCP3008 MCP3202

Sampling Frequency 1 5 4

Resolution 5 2 3

Number of Channels 3 5 3

Additional Features 5 0 0

Power Consumption 5 2 2

Total 18 14 12

The result of the decision matrix seen in Table 4 is that the Maxim 1416 ADC is the best choice for the

project. A few of the important categories which it proved to be the best option was in resolution, power

consumption, and additional features. Although 16-bits may be a higher resolution than is needed for the

final design, the team determined that for the prototype, it was best to go with a high resolution as it

provided the most room for data analysis. The MAX1416 proved to be the best choice for power

consumption as, according to its datasheet which can be seen in the appendix, its max power consumption

is 1mW whereas the two Microchip Technology ADCs have a max power consumption of 3mW. Finally,

the MAX1416s additional features of a programmable gain amplifier (PGA) and digital filtering was key

in distinguishing itself from the other ADCs as these two features eliminate the need for an additional

preamplifier and filter network between the probe and the ADC.

4.5.3

Table 5 below shows the decision matrix for the different physical devices the scores are based off a

maximum score of 5. The decision is based off cost to implement, mobility for the pilot, design aspects

and, size. From this decision matrix it was decided that a Bracelet design is the best option for this

project.

Table 5. Finger Device Decision Matrix

Headset Bracelet Finger Attached

Cost 1 3 2

Mobility 4 4 3

Design 3 3 1

Size 3 3 4

Total 11 13 10

20

5 Operations

5.1 Legal form of Ownership

This company will plan to be a limited liability company (LLC). The one main advantage to this form is

the protection from personal liability for business decisions and actions. If the company incurs any debt

along the way, the companys members are safe in terms of their personal assets. This doesnt mean that

the members are shielded from other acts of injustice in the workplace. The two other positives of an LLC

is the sharing of profits as the members see fit as well as much less record-keeping compared to other

forms of organization.

5.2 Company structure

Figure 2. Company Structure

5.3 Decision making authority

Each officer will have authority over each of their assigned teams in their department. All final

department decisions will be made by the chief officers. The final decisions of the company will

ultimately rest in the hands of the President, having the final decision making authority.

5.4 Significant compensation and benefits packages

As the PODS company is on the smaller side, the amount of compensation and benefits will be smaller

compared to the larger corporations. A 401K plan will be given to each employee, as well as some

employee stock ownership plans. Employees will also benefit from a total of two weeks paid vacation and

a few allotted sick days.

21

6 Industry Profile and Overview

6.1 Industry background and overview

The first device to measure blood oxygen saturation was developed by Karl Matthes in 1935. This device

is was much more crude and invasive than the simple finger devices on the market today. With a focus on

ergonomics and comfort, the pulse oximeters currently are easy to use and very accurate. The PODS

Company will focus on smaller design and better ergonomics while keeping the accuracy as important as

before. A more intuitive display system is also a major focus.

6.2 Major Customer Groups

6.2.1 Aviation

The initial purpose of PODS was to sell the design or products to airlines that were in need of a better

oximeter display system. The simplicity and ease of using the product would make the older pulse

oximeters obsolete. The design is geared more towards, but not limited to, the private pilots sector of

aviation.

6.2.2 Military

Similar to the private pilots, the air force may be able to use the product in the same manner. There would

need to be some high end adjustments as well as higher quality control for these applications, but they are

a possible consumer of the product.

6.2.3 Medical

The design of the PODS pulse oximeter could prove to be more beneficial to the everyday hospital

patient. The smaller device would cause less discomfort than the bulky finger ones used today, as well as

giving more important information to the nurses and doctors. Once again, the need for a high-end product

would put some pressure on the quality control of the devices sold to the medical field.

6.2.4 Emergency Response Units

The smaller design as well as the wireless display will prove to be much simpler for medical teams in

ambulances to use. Quicker and easier is the whole goal of these units, so the PODS product will be a

clear advantage.

22

7 Business Plan

7.1 SWOT Analysis

7.1.1 Strengths

A strength of the company is the uniqueness of the product. There are no pulse oximeters which are only

worn on the wrist so an opportunity exists to meet that need. Another strength of this company is the

ability to expand the into more than just the target market. The project was designed for the use by a

subsection of pilots but could move into other areas like medical devices.

7.1.2 Weaknesses

One of the weaknesses of this product is that people may not see the need for it. To combat this, a large

amount of resources will go into developing a marketing plan and advertising campaign explaining the

value in measuring blood oxygen saturation and added level of safety wearing it brings. Another

weakness is that it is a start-up company. PODS cannot take advantage of things larger companies have

access to like economies of scale, readily available capital, brand recognition, assets or investment.

7.1.3 Opportunities

There is a large opportunity for this company to grow quickly due to the uniqueness of this product. As of

yet, there is no product out on the market that meets pilots needs in the same way that this does. If this

product demonstrates reliability and improves pilot safety then there will be more opportunities to meet

customers needs.

7.1.4 Threats

A large threat is another company getting to market sooner with a similar product. To address this, the

product must get to market as quickly as possible in order to gain the largest chunk of the market. There is

also a risk of larger companies coming into the market with similar products but undercutting PODS

established price point.

7.2 Marketing Strategy

7.2.1 Demographics

The demographic currently being researched is private pilots who fly non-pressurized airplanes. Another

demographic that we are targeting are charter aviation companies that charter non-pressurized aircraft.

Pilots flying pressurized airplanes are not at high risk to hypoxia but hope to market to them on the basis

of pressurization failures and that it will generally improve their safety.

23

7.2.2 Customers' motivation to buy

Customer motivation to buy this product stems from it being comfortable to wear and improving a pilots

safety. These features along with an easy to read display will help a wrist worn pulse oximeter stand out

from others.

7.2.3 Market size and trends

The market for pilots is not incredibly large. It is estimated that there are 617,128 certified pilots in the

United States6. ...the market for pulse oximeters in the U.S., Asia Pacific and Europe is expected to grow

to over $1.3 billion by 2020. This market includes a range of monitors and sensors including bedside,

handheld and fingertip monitors; disposable and reusable sensors. Market growth can be attributed to cost

savings of reprocessed disposable sensors and the lower price point of consumer pulse oximeters that are

selling well through retail.7

7.2.4 Advertising and promotion

7.2.4.1 Message

In order to best market this pulse oximeter system, the focus will be on two main factors: the safety that

comes from wearing the oximeter and the practicality of the design. The emphasis will be on the fact that

wearing a pulse oximeter for the duration of the flight increases pilot safety by reducing their risk to

hypoxia. A secondary emphasis will be placed on how easy the system is to use. The final emphasis will

be on how the pilot will barely notice wearing the device while flying.

7.2.4.2 Media

The target market for this project is a very specific group of people so we plan to market to them mainly

through the use of magazine and internet ads. We will focuses are efforts on AOPA Pilot Magazine,

Flying Magazine, and Plane & Pilot Magazine. As for internet ads, using websites like Google, Amazon

and many aviation retailors should yield the best results.

7.2.4.2.1 Desired imagine in market

This product needs to be affordable to compete with low cost of a finger worn oximeter. With that said,

the number one concern is to make sure that the pulse oximeter is constructed with high quality parts. The

PODS brand should be something that can be trusted in the private aviation industry. It is also understood

6 (Pilot certification in the United States 2014) 7 (Pulse Oximeter Market Expected to Grow to over $1.3 Billion by 2020 in the U.S., Asia Pacific, and Europe

Combined 2014)

24

that aviation in general is a very expensive hobby so pilots might be more willing to spend more money

on a device that will offer them an added level of safety.

7.2.4.2.2 Comparison against competitors prices

Most blood oxygen monitoring systems that include an external display are in the range of $1,000 to

$3,000. Most of these machines have more capabilities beyond blood oxygen monitoring. With our price

point of $500 we will be much cheaper than similar medical systems.

7.2.4.2.3 Discount Policy

We will offer a discount policy for any company that buys ten or more devices. We will reduce the price

by a set amount in hopes off incentivizing larger piloting companies to buy our product. As competitors

enter the market we realize that we may have to decrease or price in order to stay competitive. We believe

that we will be able to do this and still make a profit.

7.2.4.2.4 Gross Profit Margin

With the price point set at $500 we anticipate a gross profit margin of 11%, 19% and, 23% for the first

three years of the business.

7.2.4.3 Distribution Strategy

PODS will mainly sell its product through online distributors. We hope to employee at least one sales

person in the next few years whose job it will be to sell packages of our products to larger firms. The

warehouse will be located in the Midwest with easy access to most areas of the United States.

7.3 Competitive Analysis

7.3.1 Existing Competitors

There are two main competitors in this market. The first is Covidien and the second is Masimo. Both of

these companies produce various pulse oximeter devices that are used in health care settings.

7.3.1.1 Covidien

Recently acquired by Medtronic, they are a global healthcare products company and manufacturer.

Covidien was identified by iData Research as battling for the top spot in the global market for pulse

oximeters. Their focus is primarily on oximeters for medical uses such as homecare.

7.3.1.2 Masimo

Masimo is a manufacturer of patient monitoring products and is primarily known for their pulse

oximeters. In 2012, they were the number 1 seller of oximeters to hospitals and was identified as battling

for the top spot in the global market for pulse oximeters. While their primary focus is on oximeters for

25

hospitals, they recently released an oximeter that plugs into smart phones, targeting the aviation and sport

users.

7.3.2 Potential Competitors

Concord Health Supply

SantamedicalTM

Nonin Medical

7.3.2.1 Impact on the Business

Many of these companies have products similar to ours that are used as pulse oximeters for sports and

personal use. These companies have more experience marketing to pilots and also have brand names that

are known and respected in the industry. They each hold a large part of the market and would be hard to

compete with if they came out with a product similar to what PODS has come up with.

7.3.3 Market Survey

A market survey for this product showed many interested buyers. Most pilots use a pulse oximeter

sparingly and if we can design it to not be in the way most will use our product.

7.4 Cost Estimate

7.4.1 Development Costs

Development costs for the project are shown in the table below. These costs are based on the assumption

that engineering jobs cost the company $80 per hour. These costs do not include salaries of employees or

other cost other than costs that are specific to the development of our product.

Table 6. Development Cost

Hours Total

Cost ($)

Specification 120 9600

Planning 1000 80000

Testing 1000 80000

Electrical Design

Hardware

200 16000

Electrical Design Software 1500 120000

Marketing 100 8000

Industrial Design 500 40000

Prototypes 2000

Total 4420 365600

26

7.4.2 Fixed Costs

Fixed costs for the first year of operation are shown in the table below. The costs are estimates based on

research done by PODS. The research was based off of cost that other small business experience.

Table 7. Fixed Cost

Fixed Costs ($)

Utilities (500 per month) 6000

Salaries 240000

Advertising 10000

Insurance ($30 per month) 360

Manufacturing

Management

35100

Employee Benefits 124650

Development 10000

Total 426110

7.4.3 Variable Costs

Variable costs for the first year of the business are shown in the Table below. These costs are based off

producing 4000 units in the first year.

Table 8. Variable Cost

Variable Cost ($)

Direct Material 500000

Direct Labor 200000

Variable Manufacturing 100000

Employees 140400

Sales Commission 360,000

Shipping 20000

Total 1320400

7.5 Feasibility

From the calculation of the different costs associated with the project it was found that the design is

feasible. From the costs that have been estimated in the previous sections we believe that PODS can be a

profitable company. Over time we hope to reduce the cost of our product after the initial startup loan is

paid back. A Pro-Forma Income Statement and Cash Flow Statement were used to analyze the financial

feasibility of PODS LLC. They are descried in the following sections of the report with the tables

provided in the appendix.

27

7.5.1 Income Statement

At a price point of $500 per unit the company has a net income after tax of $289,530 in the first year. In

the second and third year the company has net income after tax of $611,793 and $862,018 respectively.

7.5.2 Balance Sheet

A balance sheet is not included due to the fact that all inventory is used each year and all good produced

are sold. The assets of the company can be reduced to available cash. The company debt is simply the

bank debt at 10% interest rate while the equity is the original $50,000 invested in the company by the

owners.

7.5.3 Cash Flow Statement

From the cash flow statement PODS has decided to only reinvest what is needed for working capital and

to use the remaining profits to pay off company debt. This will help the company to reach its goal of

paying off its bank debt in six years.

7.5.4 Break-even Analysis

At the ideal price point for our product 3,265 units need to be sold in the first year to break even. This

equates to 1,632,104 dollars of sales. After the first year, the number of units that need to be sold to break

even decreases due to the high startup design cost of the company. The break even sales volumes for year

two and three are $1,168,284 and $1,070,851, respectively.

7.5.5 Ratio Analysis

The ratio analysis is detailed in the appendix section of this report. From this it can be seen that the profit

margin for the first three years of the companys life are 11%, 19% and, 23% respectively. This shows

that we be able to pay off bank debt and cover expensive that the company may encounter.

8 Testing

After choosing the ADC and microprocessor to use for the project, the team procured the two components

and began working on building a system on a breadboard. This system consisted of the ADC, a

phototransistor, and the Raspberry Pi. The goal of this system is to convert the data from the

phototransistor via ADC and sample, analyze, and graph the digital data with the Raspberry Pi. Testing

this involved designing a basic phototransistor circuit, building the circuitry for the ADC, and setting up

and working out the bugs on the serial peripheral interface (SPI) between the Raspberry Pi and the ADC.

Additionally, testing involved developing basic software to read in the data from the Raspberry Pis SPI

port for graphing. A picture depicting the circuit built can be seen in Figure 3 below.

28

Figure 3. Test Circuit

The team successful in getting the SPI working on the Raspberry Pi and sending data over SPI and read it

back in a closed circuit. The team successfully build a phototransistor circuit and observed the change in

current output from the transistor as it received different levels of light. Finally, the team successfully

implement a Python script which read in SPI data and generated an animated graph. At this point,

however, the team was not able to get the ADC to work.

Debugging for the ADC was performed by measuring the voltages on the different pins such as GND,

VDD, VREF-, VREF+, etc. and ensuring these were appropriate per the datasheet. The team then began

debugging the SPI connection between the ADC and the Raspberry Pi by probing the master in slave out

(MISO), master out slave in (MOSI), serial clock (SCLK), and slave select (SS) pins with an

oscilloscope. For these experiments, the oscilloscope was adjusted so that it trigged on a falling edge

voltage of 1.1v (selected as it is between 3.3v and 0v) in order to capture the signals on the 4 different SPI

pins. A picture of the signals found on the SCLK during one SPI transaction can be seen in Figure 4. In

particular, measuring the signal on the SCLK during a SPI transaction proved helpful as the team

determined that, based on the timing diagram found on the ADCs datasheet, the SPI mode was not set

correctly. The team rectified this situation be changing the SPI mode on the Raspberry Pi to match the

mode required by the ADC. Despite this discovery, the team was still not able to get the ADC to work

and is currently continuing to debug the system.

29

Figure 4. SPI SCLK Signal Measured During a Transaction

30

9 Conclusion

PODS sees the wrist worn pulse oximeter as the future of pulse oximeters. Taking advantage of

reflectance oximetry and market shift away from a pulse oximeter on the finger gives PODS a unique

place in the market which it hopes to translate into a successful business. The project is feasible as

demonstrated by the successful preliminary testing of the components and supporting research. There are

still problems to overcome, specifically getting the ADC to work correctly, however this should not stand

in the way of the completion and presentation of a working unit. The PODS product will keep pilots safer

and help to mitigate risk of hypoxia associated with flying at high altitudes in an unpressurized cabin.

31

10 Acknowledgements

Professor Mark Michmerhuizen

Professor Michmerhuizen is the main advisor for team 12.

Class Advisors

Professor David Wunder, Professor Ned Nielson and Professor Jeremy VanAntwerp all assisted the

team through their lectures.

Industrial Consultant

Eric Walstra provided sound guidance and strategies for approaching the different aspects of this project.

32

11 References

n.d. "A Look at the Basics of Bluetooth Technology." Basics | Bluetooth Technology Website. Accessed

November 7, 2014.

n.d. "IEEE 802.11 Standards Tutorial." IEEE 802.11 Standards.

n.d. Mouser. www.mouser.com.

Newegg. n.d. Raspberry Pi B+ Broadcom.

http://www.newegg.com/Product/Product.aspx?Item=N82E16813142003&nm_mc=KNC-

GoogleAdwords-PC&cm_mmc=KNC-GoogleAdwords-PC-_-pla-_-Embedded+Solutions-_-

N82E16813142003&gclid=CNbm08us7sECFc1_MgodhnEAWg.

n.d. "Oximetry." Health Library, John Hopkins Medicine.

n.d. "Oximetry." Health Library. John Hopkins Medicine.

2014. Pilot certification in the United States. May 11. Accessed October 9, 2014.

http://en.wikipedia.org/wiki/Pilot_certification_in_the_United_States.

2014. Pulse Oximeter Market Expected to Grow to over $1.3 Billion by 2020 in the U.S., Asia Pacific,

and Europe Combined. September 15. Accessed October 2014. http://globenewswire.com/news-

release/2014/09/15/666015/10098590/en/Pulse-Oximeter-Market-Expected-to-Grow-to-over-1-3-

Billion-by-2020-in-the-U-S-Asia-Pacific-and-Europe-Combined.html.

Wax, David B., Philip Rubin, and Steven Neustein. 2009. "A Comparison of Transmittance and

Reflectance Pulse Oximetry During Vascular Surgery." Anesthesia & Analgesia 109.6 1847-849.

n.d. "ZigBee Technology." ZigBee Alliance.

33

12 Appendix 1: Maxim MAX1416 Data Sheet

34

Table 9. Income Sheet

PODS

Pro-Forma Statement of Income

Year 1

Year 2

Year 3

Sales revenue 2,500,000

3,000,000

3,600,000

Variable Cost of Goods Sold 1,000,000

1,200,000

1,400,000

Fixed Cost of Goods Sold 169,750

169,750

169,750

Depreciation 71,450

129,595

102,553

Gross Margin 1,258,800

1,500,655

1,927,697

Variable Operating Costs 110,000

130,000

155,000

Fixed Operating Costs 616,250

256,000

256,000

Operating Income 532,550

1,114,655

1,516,697

Interest Expense 92,250

166,050

129,150

Income Before Tax 440,300

948,605

1,387,547

Income tax (40%) 176,120

379,442

555,019

Net Income After Tax 264,180

569,163

832,528

Table 10. Statement of Cash Flow

PODS

Pro-Forma Statement of Cash Flows

Year 1

Year 2

Year 3

Beginning Cash Balance -

1,730,630

2,010,388

Net Income After Tax 264,180

569,163

832,528

Depreciation expense 71,450

129,595

102,553

Invested Capital (Equity) 50,000

-

-

Increase (decrease) in borrowed funds 1,845,000

(369,000)

(369,000)

Equipment Purchases (500,000)

(50,000)

(20,000)

Ending Cash Balance 1,730,630

2,010,388

2,556,469

36

Table 11. Break Even Analysis

PODS

Break - Even Analysis

Year 1

Year 2

Year 3

Sales revenue

2,500,000

3,000,000

3,600,000

Less: Variable Costs:

Variable Cost of Goods Sold

1,000,000

1,200,000

1,400,000

Variable Operating Costs

110,000

130,000

155,000

Total Variable Costs

1,110,000

1,330,000

1,555,000

Contribution Margin

1,390,000

1,670,000

2,045,000

Less: Fixed Costs

Fixed Cost of Goods Sold

169,750

169,750

169,750

Fixed Operating Costs

616,250

256,000

256,000

Depreciation

71,450

129,595

102,553

Interest Expense

92,250

166,050

129,150

Total Fixed Costs

949,700

721,395

657,453

Income Before Tax

440,300

948,605

1,387,547

37

Table 12. Ratio Analysis

Year 1

Year 2

Year 3

Total Fixed Costs 949,700

721,395

657,453

Contribution Margin % 56%

56%

57%

Break Even Sales Volume 1,708,094

1,295,919

1,157,374

Break Even Sales Unit Volume 3,416.19

2,591.84

2,314.75

Equipment

Depreciation

Purchases

Year 1

Year 2

Year 3

Equipment Purchases Year 1 500,000

71,450

122,450

87,450

Equipment Purchases Year 2 50,000

7,145

12,245

Equipment Purchases Year 3 20,000

2,858

71,450

129,595

102,553

MACRS Rates (7-year recovery period) 0.1429

0.2449

0.1749

Interest Expense:

Annual interest rate on debt 10%

Year 1

Year 2

Year 3

Average debt balance 922,500

1,660,500

1,291,500

Interest expense 92,250

166,050

129,150

Ratio Analysis

Year 1

Year 2

Year 3

Gross Margin of Revenue 0.76

0.59

0.55

Profit Margin 0.11

0.19

0.23

Net Asset Turnover 2.89

1.60

1.58

Debt to Equity Ratio

37

0.63

1.19

1 Executive Summary2 Introduction2.1 Project Description2.2 Need for Solution3 Project management3.1 Team organization3.1.1 Team members3.1.2 Advisors3.2 Meeting Times3.3 Schedule3.4 Budget3.5 Method of Approach3.5.1 Stage One3.5.2 Stage Two3.5.3 Stage Three4 Design4.1 System Architecture4.1.1 Probe4.1.2 Amplifier and Filter4.1.3 Analog to Digital Converter4.1.4 Microprocessor4.1.5 Display Driver4.1.6 Display4.1.7 Speaker4.2 Design Norms4.3 Design Criteria4.3.1 Ergonomics4.3.2 Display System4.3.3 App Development4.4 Design Alternatives4.4.1 Oximetry4.4.1.1 Transmittance Oximetry4.4.1.2 Reflectance Oximetry4.4.2 Display Connection4.4.2.1 Wired4.4.2.2 Wireless4.4.2.3 Bluetooth4.4.2.4 WiFi (IEE 802.11)4.4.2.5 ZigBee4.4.3 Physical Device (Probe)4.4.3.1 Headset4.4.3.2 Bracelet4.4.3.3 Finger Attached4.5 Design Decisions4.5.1 Microprocessor4.5.2 Analog to Digital Converter4.5.35 Operations5.1 Legal form of Ownership5.2 Company structure5.3 Decision making authority5.4 Significant compensation and benefits packages6 Industry Profile and Overview6.1 Industry background and overview6.2 Major Customer Groups6.2.1 Aviation6.2.2 Military6.2.3 Medical6.2.4 Emergency Response Units7 Business Plan7.1 SWOT Analysis7.1.1 Strengths7.1.2 Weaknesses7.1.3 Opportunities7.1.4 Threats7.2 Marketing Strategy7.2.1 Demographics7.2.2 Customers' motivation to buy7.2.3 Market size and trends7.2.4 Advertising and promotion7.2.4.1 Message7.2.4.2 Media7.2.4.2.1 Desired imagine in market7.2.4.2.2 Comparison against competitors prices7.2.4.2.3 Discount Policy7.2.4.2.4 Gross Profit Margin7.2.4.3 Distribution Strategy7.3 Competitive Analysis7.3.1 Existing Competitors7.3.1.1 Covidien7.3.1.2 Masimo7.3.2 Potential Competitors7.3.2.1 Impact on the Business7.3.3 Market Survey7.4 Cost Estimate7.4.1 Development Costs7.4.2 Fixed Costs7.4.3 Variable Costs7.5 Feasibility7.5.1 Income Statement7.5.2 Balance Sheet7.5.3 Cash Flow Statement7.5.4 Break-even Analysis7.5.5 Ratio Analysis8 Testing9 Conclusion10 Acknowledgements11 References12 Appendix 1: Maxim MAX1416 Data Sheet