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The following is the structure of a Design History File at Texas A&M that is compliant with FDA CFR

820.30 Subpart C -- Design Controls. Do not deviate from this Quality Management Systems (QMS)
documentation and please follow appropriate version control and dating of changes to documents

Design History File

The She Box


This document is the confidential property of
(TMB Healthcare Systems) and may not be
reproduced without prior written consent

Approved By:
Author: Breanna Brocklesby
Author: Sahar Mohiuddin
Author: Chris Truong

Stamp here

Signature:
Breanna Brocklesby

Date:
5/5/2016

Sahar Mohiuddin

5/5/2016

Chris Truong

5/5/2016

The following is the structure of a Design History File at Texas A&M that is compliant with FDA CFR
820.30 Subpart C Design Controls. Do not deviate from this Quality Management Systems (QMS)
documentation and please follow appropriate version control and dating of changes to documents

Section
of DHF
Design
Input

Design
Process

Information Pertaining to Product Design


& Development to be Provided

Design
Output

Design
V&V

Quality System Document


Used

Clinical background, procedure


overview and mapping
Preliminary and final design
requirements and
technical/clinical considerations

Section 1. Problem Statement


and Clinical Need Statement
Development

Concept Development
Engineering studies (may be
used to refine Design Inputs in
addition to concept testing, i.e..,
exploration of problem to define
critical technical parameters)
Risk analysis documents (dFMEA,
aFMEA)

Section 3. Design
Requirements and
Specifications

Final Product design and


Specifications
Engineering drawings with
tolerances on critical dimensions
CAD models and Prototypes
Bill of materials &
Biocompatibility test matrix
Manufacturing & Assembly
Instructions
Validation & Verification Study
plan
Test protocols and references
Bench, animal, human Studies
Test reports
Biocompatibility test strategy (if
relevant and required)

Section 5. Solution Statement


and Drawings

Relevant Standards

ISO13485
FDA CFR 820.30
Subpart C

ISO13485
FDA CFR 820.30
Subpart C
ISO 14971

Section 2. Literature and


Product Review

Section 4. Concept Generation


and Selection
Section 6. Failure Mode Effect
Analysis (FMEA)

Section 7. Testing Plan

Section 8. Regulatory Aspects

ISO13485
FDA CFR 820.30
Subpart C
ISO 14971
ASME Y14.5
2009 (GD&T)
ISO 10993
ISO13485
FDA CFR 820.20
Subpart C
ISO 14971
ISO 10993
USP 788
IEC 60601 (for

electrical
hardware
devices)
All other documents such as meeting notes, design reviews, etc., should go into
separate labeled Appendices.

TABLE OF CONTENTS
Section 1: PROBLEM STATEMENT AND CLINICAL NEED STATEMENT DEVELOPMENT
1.1 Description of the teams understanding of the problem (1/2 page to 1 page)
1.2 Initial Problem Statement
1.3 Initial Clinical Need Statement

Section 2: LITERATURE AND PRODUCT REVIEW


2.1 Supporting Observations
2.2 Summary of Clinical Problem
2.3 Summary of Current Solution Landscape
2.4 Assessment of Emerging Technology
2.5 Gap Analysis Matrix
2.6 Market Analysis
2.7 Refined Problem Statement
2.8 Refined Clinical Need Statement

Section 3: DESIGN REQUIREMENTS AND SPECIFICATIONS


3.1 Target Customer and Rationale
3.2 User requirements
3.3 Summary Table of Design Specifications

Section 4: CONCEPT GENERATION AND SELECTION


4.1 Concept Generation

4.2 Idea Organization


4.3 Final Solution Selection

Section 5: SOLUTION STATEMENT AND DRAWING


5.1 Final Problem Statement
5.2 Final Clinical Need Statement
5.3 Solution Statement
5.4 Drawing(s) of Prototype Solution
5.5 Functional Block/Subcomponent Diagram or Flowchart

Section 6: INTELLECTUAL PROPERTY (IP) AND TECHNOLOGY TRANSFER


10.1 Memorandum of Understanding (MOU) for Confidentiality, Material Transfer, and Intellectual Property
10.2 Disclosure of IP
10.3 Title of Invention
10.4 Contributors
10.5 Description of IP
10.6 Project Funding
10.7 Student Team Member Contact Information Following Graduation

Section 1:

PROBLEM STATEMENT AND CLINICAL NEED STATEMENT DEVELOPMENT

1.1 Description of the teams understanding of the problem


Currently in developing countries there are high rates of pregnancy complications.
These complications could be preventable instances of anemia or severe cases of preeclampsia.
In any pregnancy complication, there are risk factors, such as unhealthy lifestyles or young age
pregnancies, that could have contributed to the development of the complication. These
complications prove costly to the quality of life of the mother and child after birth. Most of
these risk factors and complications are preventable or easily mitigatable but are not due to the
lack of basic reproductive health information. A simple checkup or vital sign tracking can help
pregnancies. Women with knowledge of reproductive health have a better chance of a healthier
pregnancy. Women in developing countries do not have access to this information. In many
countries, women are limited from this information because of geographic location, legal
restrictions, or social taboos. Many developing countries are made of rural areas with no
physical access to a doctor. Some countries do not allow contraceptives or abortions. Other
countries do not guarantee doctor confidentiality for underage pregnancies. Countries with
prominent religious influences have made underage pregnancies and contraceptives a taboo to
talk about. All these factor combined have made access to reproductive healthcare inaccessible
to many people. While many doctors and health organizations have tried to encourage people
to seek out information, the information, itself, is still limited to local areas.
1.2 Initial Problem Statement
Many pregnancy complications can lead to the death or decreased quality of life of a
mother or child. Pregnancy complications are rampant in developing countries and most can be
prevented with proper reproductive healthcare information. Healthcare information is limited in
developing countries due to a multitude of restrictions. An efficient system to deliver
information to the masses can combat the lack of reproductive health information. (Many
women in developing countries do not have the basic healthcare information to prevent
pregnancy complications.)
1.3 Initial Clinical Need Statement
In developing countries, there is a need for an efficient, unrestricted transmission of
reproductive health information to decrease the occurrence of pregnancy complications.

Section 2:

LITERATURE AND PRODUCT REVIEW

2.1 Supporting Observations


18% of pregnancy related deaths are due to preeclampsia [1]
60% of pregnant women in low-income countries do not have access to care during or after
pregnancy [2]
Many pregnancy complications are preventable through care or information but if left untreated,
can be detrimental. Preeclampsia, an easily mitigable complication, results in 76,000 maternal
deaths and 500,000 infant deaths per year. Even though this complication is preventable, women
in developing countries are seven times more likely to suffer from preeclampsia than their
counterparts in developed countries. Providing basic reproductive information can prevent
complications and save the lives of mothers and their children.
2.2 Summary of Clinical Problem
The specific clinical problems relevant to this design problem come with monitoring basic vitals
such as pO2, blood pressure, temperature, as well as measurements such as height and weight,
and then assessing the information to determine if it is within the normal prescribed range.
Medical Device or Therapy Design
I.

II.

III.
IV.

Anatomy and Physiology: Normal temperatures for humans reside in the range of
approximately 97.8and 99. Systolic blood pressure should not be above 120 mm
Hg and diastolic blood pressure should not exceed 80 mm Hg.
Pathophysiology: Without proper care, symptoms can go undiagnosed. This can lead
to a plethora of problems. Most importantly in pregnant women, is the risk of
preeclampsia. If elevated blood pressure levels are not detected in time, there may
be negative consequences to both the mother and baby. Without proper
information, women may not know what is happening to their bodies and/or how to
take care of it.
Clinical Presentation: Patients are females between the ages of 10-70. They may
also be pregnant. These women might have regular vitals or they may show signs
Clinical Outcomes: Using this device might help women live longer, healthier lives.
They will be provided with information that allows them to make better decisions as
well as a way to measure if they are within a healthy range for their age. The speed
and efficiency of this device may reduce the number of deaths related to pregnancy
as well as those due to lack of/misinformation.

V.

Epidemiology: 18% of pregnancy related deaths are due to preeclampsia. 60% of


pregnant women in low-income countries do not have access to care during or after
pregnancy. As of now, there is not a way for women in these countries to easily
receive information.
VI.
Economic Impact: The implementation of this device in third world countries may
reduce pregnancy related deaths, improving the overall health of a country, and
provide countries with ways to potentially get international aid/funding.
2.3 Summary of Current Solution Landscape
Device

Disadvantages

Benefits

Higi

- No way to communicate with user


- Does not provide much healthcare
information

Continuous tracking of lifestyle


choices; provides motivation for
users to live healthy

Healthnote Lifestyle
Shopping Kiosk

- No privacy
- Must have access to car to drive to
mall

-Easily accessible
-Engaging graphics to grab
customers' attention and
motivates them to use the kiosk
to find answers to their health,
food, and lifestyle questions

2.4 Assessment of Emerging Technology


Higi has implemented their device in dozens of supermarkets across the country. Their primary
aim is to provide users with a way to track their lifestyle choices and allow them to see how/if
they are improving their overall health. The offer a rewards program that entices users to keep
returning to and using their device. This device is free and available to anyone shopping in a
store where it is located. Additionally, users can create an account allowing them to travel to
other stations and have access to their previous records.
Healthnote Lifestyle Shopping Kiosks are being implemented in malls across the country. They
are small stations which provide users with access to lifestyle, health, and food questions. They
do not provide a system in which a user can create an account so they have access to previous
information if they reuse the device.

2.5 Gap Analysis Matrix


There are currently no companies in the United States that provide similar services to our
device. The closest competition comes from Higi who have designed a kiosk to monitor user's
lifestyle choices. Their kiosk is limited to data input and provides minimal feedback. This kiosk is
designed more for a user to track their daily activities and does not actually provide information
regarding health. There is room for improvement with their design in that there is no way for a
user to communicate with the kiosk and receive information from it. Our design can be
expanded to also include detailed explanations of body processes as well as provide information
regarding nearby doctors/treatments the user can pursue if necessary. Additionally, there is a
gap in vital sign measurement and analysis which can lead to the diagnosis of illnesses.
2.6 Market Analysis

Through market analysis we have learned that there is a definite need for a solution to
the lack of access to healthcare in developing countries. Specifically, womens healthcare
information is inaccessible to the majority of rural populations and there are not enough doctors
in these regions to treat these women. In areas which have poor internet connection or in which
any topics relating to women's healthcare are considered taboo, there are increased rates in
pregnancy related deaths due to preeclampsia, hemorrhaging, and basic lack of information.
There is also a need to be discrete when informing women and providing them the same privacy

they would receive at a doctors office. People will most likely not be willing to pay for a service
so the best source of funding will be from aid organizations, the U.S. Government, and
governments of countries in which we will be implementing our solution.

2.7 Refined Problem Statement


Pregnancy complications which lead to death may be due to a lack of information
provided to mothers as well as a lack of resources at which women can get check-ups and
determine whether they are having pregnancy related problems. There is a need for a system
that can provide accurate measurements and information to women to help them in making
decisions regarding their health.
2.8 Refined Clinical Need Statement
Developing countries have a need for a device that can provide reproductive and
general health information, potentially reducing the occurrence of pregnancy-related
complications.

Section 3:

DESIGN REQUIREMENTS AND SPECIFICATIONS

3.1 Target Customer and Rationale


The target market for this kiosk is women in developing countries who require access to
a doctor but who might not have the resources available to them in a convenient manner. These
women require basic physical analyses such as temperature, height, weight, body fat content,
and blood pressure monitoring that will provide them with information regarding their general
health.
3.2 User requirements
1. Must be able to detect the patients vitals and analyze them to determine if they are
within the normal range.
2. Must be able to provide healthcare information in multiple languages and if required,
should be able to speak to the user.
3. Must be easy-to-use; accessible through voice controls, touchscreen

3.3 Summary Table of Design Specifications


Customer or societal need
Durable Design
Inexpensive Power Source
Accurate Instruments
Understandable Communication
Sterilization
Reliable Information

Design Specification
Withstand > 3.4 kN
Corrosion Resistant for > 10 years
Self-Sustaining > 5 years
Power kiosk > 95% of the time
Use of local resources < 10 km away
Measurements > 85% accuracy
Touchscreen < 1.5 cm sensitivity
Sound adjustment from 60 - 70 dB
> 5 language options
Kill > 99.99% of microorganisms
Able to be Updated

Section 4:

CONCEPT GENERATION AND SELECTION

4.1 Concept Generation


-

What do we provide?
- Virtual Doctor
- General Healthcare diagnostics
- Service-based kiosk
- Heartrate
- Blood pressure
- Weight
- Temperature
- Height
- Retinal scanner
- Information based kiosk
- Emphasis on
- reproductive health
- diseases of the area
- neonatal care
Who do we target?
- Places where there is not prevalent access to healthcare
- Low income areas in US
- Developing countries
- Rural areas
Where do we target?
- Town centers
- On a smartphone app
- Local supermarkets
How do we power the device?
- Electricity
- Solar power
- Wind power

4.2 Idea Organization


Who do we target?

What can we
provide?

Where do we access
clients?

How do we power?

Low Econ Areas in US

Virtual Doctor
General Diagnostic
Service-based kiosk
Information based
w/reproductive
w/diseases
w/neonatal

Local supermarket
Town centers
Smart apps

Electricity
Solar Power

Town centers

Solar Power

Town centers
Local supermarket
Smart apps

Electricity
Solar Power

Developing Countries
Rural Areas in US

4.3 Final Solution Selection

Concepts Who

Cost
6

User Need
10

Ease of Service
8

Sum

Low Econ
areas in US

54

Developing
Countries

66

Rural Areas

64

When comparing who we can target and, by extension, where, the clients need for a
healthcare system was of first importance because need will predict usage of the device. Of next
importance was our ability to easily meet their need, which determines the overall feasibility of
developing our product. Lastly cost was the last factor because there are multiple ways to fund
our product. From these requirements, targeting developing nations is a logical choice.

Concepts What

User Need
5

User Want
8

Design Feasibility
10

Sum

Virtual Doctor

10

10

150

General
Diagnostic

170

Service-Based

146

Info-Based:
reproductive

199

Info-Based:
neonatal

174

Info-Based:
diseases

153

When deciding on what service to provide to developing nations, design feasibility is the
first concern. While a virtual doctor would be a useful product, the design requirements are too
complicated and unavailable in developing nations. The second design requirement is the
clients desire for the service. The user must know why the information is important in order to
want to use the product. Lastly, the relative user need is taken into account based on the threat
towards their lives if the service is not provided. Based on these criteria, the reproductive infobased kiosk meets the requirements the best. In order to fully allow the kiosk to inform on
reproductive health, services will also be incorporated into the design.

Section 5:

SOLUTION STATEMENT AND DRAWING

5.1 Final Problem Statement


Pregnant women have no confidential and reliable source of reproductive health
information.
5.2 Final Clinical Need Statement
There is a need for an accessible self-serve source of information that does not rely on a
developing countrys insufficient pool of doctors and nurses.
5.3 Solution Statement
To combat the lack of information, we designed a kiosk that would allow users to gain
information in a confidential and reliable way. The kiosk would bring attention to the
importance of reproductive health information and then provide the information that is needed.
The kiosk will provide women with information that is absent from their society like family
planning, contraceptives, STDs, and pregnancy. The information will introduce the concept of
regular checkups and provide enough information for women to take care of themselves. The
kiosk will also have simple instruments so that users can measure BMI, blood pressure, and
body temperature. The kiosk will provide normal ranges for a healthy lifestyle and recommend
doctor visits if the measurements are not within range. The women will be more aware of their
own bodies and more conscious of pregnancy problems.
The kiosk will be sanitary as to not incubate and transmit diseases from user to user.
The kiosk will be able to withstand a moderate amount of force and corrosion from the
environment.

5.4 Drawing(s) of Prototype Solution


Figure 1: Isometric view of kiosk

Figure 2: Front view of kiosk

Figure 3: Front facing view of inside kiosk

5.5 Functional Block/Subcomponent Diagram or Flowchart


Subcomponent Title
Metal Casing

Computer

Touchscreen
Medical
Instruments (weight
plate, Ultrasound,
blood pressure cuff,
body temperature
sensor)
UV Light Emitter

Technical Description
A metal alloy frame for to
protect and house the inner
components
System to integrate individual
electrical components

Contributing
discipline/skillset
Mechanical
Engineering

Design Specification
Addressed
Ensure durability to
force and corrosion

Electrical
Engineering

Easy-to-use interface
and store and
information
Easy to use and easy to
understand
Measurement accuracy
and possibility

Screen for users to interact and


gain information from
Instruments to measure
patients

Electrical
Engineering
Electrical
Engineering

Tool to emit a UV light

Electrical
Engineering

Ensure that
instruments inside
kiosk is sanitized

Figure 4: Flowchart of program

Section 6:

INTELLECTUAL PROPERTY (IP) AND TECHNOLOGY TRANSFER

6.1 Memorandum of Understanding (MOU) for Confidentiality, Material Transfer, and Intellectual
Property
6.2 Disclosure of IP
IP matters will be handled through Texas A&M System Technology Commercialization (TTC).
The following information will be considered by TTC when deciding how to proceed with
protection of IP.
6.3 Title of Invention
i)

TMB Healthcare Systems: The She Box

6.4 Contributors
Name
Sahar Mohiuddin
Chris Truong
Breanna Brocklesby
Professor John Hanks

Affiliation
Texas A&M
Texas A&M
Texas A&M
Texas A&M

Contact Information
(email, phone)

Role on Project
Meeting Coordinator
Transcriber
Task Manager
Mentor

6.5 Description of IP
Women in developing nations require access to easily understandable reproductive
health information to make decisions concerning their own health. The She Box incorporates
systems to provide health information and recommendations, biological measurements, a selfservice computer interface, and a private enclosure.
Searching on USPTO database shows there are other patents that provide individual
technical aspects that are implemented in our design. The first is Devices and methods for
health tracking and providing information for improving health, which describes how a device
will compare a biological measurement to a standard value and inform the user on
nonconformity. However, our product will inform the user also about blood pressure, which is
not a parameter addressed in the patent. Another patent, Medical kiosk and method of use
describes a system similar to The She Box, with the system in an enclosed and private space
that provides information. However, it accomplishes this with a teleconference system. . Our

kiosk does not have internet capabilities that would facilitate communication through it. This
allows for our device to be fully autonomous when being deployed in the field, letting the
device access more remote people.