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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
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
Design
Output
Design
V&V
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
Relevant Standards
ISO13485
FDA CFR 820.30
Subpart C
ISO13485
FDA CFR 820.30
Subpart C
ISO 14971
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 1:
Section 2:
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.
Disadvantages
Benefits
Higi
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
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.
Section 3:
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:
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
What can we
provide?
Where do we access
clients?
How do we power?
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
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:
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
Electrical
Engineering
Electrical
Engineering
Electrical
Engineering
Ensure that
instruments inside
kiosk is sanitized
Section 6:
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)
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.