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Design Controls for the
Medical Device Industry
Design Controls for the
Medical Device Industry
Third Edition

Marie B. Teixeira
CRC Press
Taylor & Francis Group
6000 Broken Sound Parkway NW, Suite 300
Boca Raton, FL 33487-2742

© 2020 by QARA Compliance Connection, Inc.

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Contents
Preface .................................................................................................................xi
Author .............................................................................................................. xiii

Chapter 1 Introduction.................................................................................. 1

Chapter 2 Device classification ................................................................... 5

Chapter 3 Overview of design controls ..................................................... 9

Applicability ....................................................................................................... 9
Design controls and the bottom line ............................................................... 9
When might design controls be considered? ............................................... 11
What are the benefits of design control other than the obvious
mandate? ........................................................................................................... 11
An idea is born ................................................................................................. 12
Ask the customer ............................................................................................. 12
Design controls and the customer ................................................................. 13
Design and development phases ................................................................... 13
The first phase: Definition—i.e., design input ........................................ 14
The second phase: Develop outputs—i.e., design and development ......15
The third phase: Design verification ........................................................ 16
The fourth phase: Design validation ........................................................ 17
The fifth phase: Product release ................................................................ 17
The sixth phase: Improvement and optimization .................................. 18

Chapter 4 Design and development planning ....................................... 19

Do we really need a plan? ............................................................................... 19
Design and development planning requirements ...................................... 20
Key elements of a design and development plan? ...................................... 24
Planning techniques ........................................................................................ 25
Gantt charts .................................................................................................. 25
When is a good time to use a Gantt chart? ......................................... 27
When might a Gantt chart not be appropriate? ................................. 27

v
vi Contents

PERT charts .................................................................................................. 27

What are the advantages of using PERT? ........................................... 27
When might PERT not be appropriate? ............................................... 28
Project planning—How do I get started? ..................................................... 28

Chapter 5 Design inputs: Part I ................................................................. 31

The concept document .................................................................................... 31
Design input ..................................................................................................... 33
What are design inputs?.................................................................................. 35
Design input requirements ............................................................................. 35
Where do design inputs come from? ............................................................ 37
How do we document our inputs? ................................................................ 38

Chapter 6 Design inputs: Part II ............................................................... 41

Performance characteristics—e.g., user requirements ............................... 42
Indications for use ....................................................................................... 42
Clinical procedure for use ......................................................................... 43
Relevant use setting/environment ........................................................... 44
Medical specialty of the user ..................................................................... 45
Patient population—inclusion/exclusion criteria ................................... 45
User interface/ergonomic considerations ................................................ 46
Product characteristics—i.e., product requirements................................... 47
Physical characteristics ............................................................................... 48
Chemical characteristics............................................................................. 49
Biological characteristics ............................................................................ 50
Selection of tests...................................................................................... 52
Environmental characteristics ................................................................... 53
Transport and storage ............................................................................ 53
Use environment .................................................................................... 54
Sterilization and sterile barrier characteristics ....................................... 55
Methods of sterilization......................................................................... 55
Aseptic processing ................................................................................. 56
Reusable medical devices ...................................................................... 56
Packaging and labeling characteristics .................................................... 58
Equipment interface characteristics ......................................................... 60
Safety and reliability characteristics ........................................................ 63
Marketing requirements ................................................................................. 64
Intended marketplace ................................................................................. 64
Contractual requirements .......................................................................... 65
Claims ........................................................................................................... 65
Labeling requirements ............................................................................... 67
Patents, trademarks, and licensing agreements...................................... 70
Clinical information.................................................................................... 70
Contents vii

Regulatory and quality assurance requirements ........................................ 71

Classification ................................................................................................ 71
Device approval requirements .................................................................. 71
Relevant regulatory or harmonized standards ...................................... 71
Labeling ........................................................................................................ 72
Contractual agreements ............................................................................. 72
Financial requirements ................................................................................... 72
Design specifications ....................................................................................... 73
One more step................................................................................................... 73

Chapter 7 Design outputs........................................................................... 75

Design output requirements .......................................................................... 76
Typical design outputs .................................................................................... 77
Device master record ....................................................................................... 78

Chapter 8 Design review ............................................................................ 81

Not another meeting! ...................................................................................... 81
FDA and design review................................................................................... 81
Design review requirements .......................................................................... 82
Design team members ..................................................................................... 83
Design review focus ........................................................................................ 83
Design review elements .................................................................................. 84
Design review meetings.................................................................................. 85
Phase 1—Design input phase review ....................................................... 86
Phase 2—Design and development phase review ................................. 87
Phase 3—Design verification phase review ............................................ 88
Phase 4—Design validation phase review .............................................. 89
Phase 5—Design release and approval for sale (i.e., product launch) ... 89
Phase 6—Use design review meeting ...................................................... 90
Documenting the design review ................................................................... 91
Meeting dynamics ........................................................................................... 91
Communication skills................................................................................. 91
Did they get it? ............................................................................................. 92
Listen and validate ...................................................................................... 93
Accept the bad news ................................................................................... 94
Monitor and measure ................................................................................. 94
Don’t confuse motion with progress ........................................................ 95
Meeting minutes.......................................................................................... 95
Making decisions that solve problems ..................................................... 95

Chapter 9 Design verification .................................................................... 99

What is the purpose of design verification? ................................................. 99
What is design verification?............................................................................ 99
Design verification—Definitions ................................................................... 99
viii Contents

Design verification requirements ................................................................ 100

Design verification process ........................................................................... 101
Verification activities ..................................................................................... 101
A word of advice ............................................................................................ 104

Chapter 10 Risk management.................................................................... 105

Why? ................................................................................................................ 105
How does risk management fit into design and development? .............. 105
What is risk management? ........................................................................... 107
The risk management process...................................................................... 107
Risk analysis ................................................................................................... 108
Human factors and the risk management process ................................... 109
Risk evaluation ............................................................................................... 112
Risk control ......................................................................................................113
Risk review ......................................................................................................115
Post-production risk management ...............................................................116

Chapter 11 Design validation .................................................................... 119

Why validate? ..................................................................................................119
What is design validation?.............................................................................119
Design validation requirements .................................................................. 120
Design validation process ............................................................................. 124
Validation activities ....................................................................................... 126
Design validation results .............................................................................. 126
Risk assessment of medical device materials and the finished device ...... 127

Chapter 12 Biocompatibility ...................................................................... 129

Duration of use ............................................................................................... 130
Degree of invasiveness .................................................................................. 130
Biological effects/end points ........................................................................ 132
Biological testing considerations ................................................................. 132
Regulatory aspects of biocompatibility ...................................................... 134
Biocompatibility testing programs .............................................................. 139
Phases of biocompatibility testing ............................................................... 140
Screening tests ................................................................................................ 142
Systemic toxicity ............................................................................................. 142
Cytotoxicity and cell cultures ...................................................................... 144
Evaluation using extracts ......................................................................... 144
Evaluation by direct contact .................................................................... 145
Evaluation by indirect contact ................................................................. 146
USP biological tests ........................................................................................ 146
Irritation tests.................................................................................................. 147
Sensitization tests ........................................................................................... 148
Contents ix

Hemocompatibility tests ............................................................................... 148

Implantation tests........................................................................................... 150
Mutagenicity tests (genotoxicity) ................................................................. 150
Supplemental testing ..................................................................................... 151
Carcinogenicity testing ................................................................................. 152
Reproductive and developmental toxicity ................................................. 152
Biodegradation ............................................................................................... 153

Chapter 13 Design transfer ........................................................................ 155

Importance of design transfer ...................................................................... 155
Design transfer requirements ...................................................................... 156
Design transfer ............................................................................................... 157
The design transfer checklist ....................................................................... 157
Design release ................................................................................................. 159

Chapter 14 Design change.......................................................................... 161

Why control design changes .........................................................................161
Design change examples................................................................................161
Design change requirements........................................................................ 163
Design change procedure ............................................................................. 163
Evaluation of design changes ....................................................................... 163
Documenting design changes ...................................................................... 165

Chapter 15 Design history file ................................................................... 167

Why do we need a design history file? ........................................................167
What is a design history file? ........................................................................167
Design history file requirements ..................................................................167
Design history file elements ......................................................................... 168

Chapter 16 The FDA inspection technique ............................................ 171

Oh no! The FDA investigator is here ........................................................... 171
General design control requirements.......................................................... 171
Design and development planning ........................................................ 171
Design input ............................................................................................... 172
Design output ............................................................................................ 172
Design review ............................................................................................ 173
Design verification .................................................................................... 173
Design validation .......................................................................................174
Design transfer ...........................................................................................174
Design changes ...........................................................................................174
Design history file ......................................................................................174
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x Contents

Appendix A: Design controls procedure ................................................. 175

Appendix B: Design input document ....................................................... 199
Appendix C: Product claims sheet ............................................................ 203
Appendix D: Input/Output design traceability matrix......................... 205
Appendix E: Project approval form........................................................... 207
Appendix F: Design phase review meeting record ................................ 209
Appendix G: Risk analysis ......................................................................... 215
Appendix H: Clinical evaluation report .................................................. 221
Appendix I: Design transfer checklist ..................................................... 225
Appendix J: Design change form .............................................................. 227
Appendix K: Approval for sale form ........................................................ 229
Appendix L: Engineering change order form ......................................... 231

References ....................................................................................................... 241

Index ................................................................................................................ 243
Preface
Since the design control requirements were formally mandated by the
Food and Drug Administration’s (FDA’s) Quality System Regulation (QSR)
in June of 1997, and multiple revisions have been made to the International
Standard ISO 13485, expectations for compliance with design con-
trol requirements have evolved. Further, as regulatory authorities have
become more focused on ensuring the safety and efficacy of products,
what may have been considered acceptable a number of years ago may
not be acceptable today. As such, a company’s design control program
should be dynamic in nature and continue to evolve in accordance with
current standards and industry practice.
It is hard to believe that it has been over 16 years since the book
was first published and, although the design control requirements have
not changed significantly during that time, my participation in FDA and
Notified Body audits have implied that the deliverables required to dem-
onstrate compliance have changed. Having been responsible for imple-
menting quality management systems to meet domestic and international
requirements and working as a consultant to medical device manufactur-
ers for the past 20 years, I have had the benefit of working for and with all
types of companies, both large and small, manufacturing a broad range
of devices and using varying design control systems. This exposure has
enabled me to develop practical methods to meet standard requirements
and comply with external regulatory body requirements.
My main goal in writing the third edition is to keep the book cur-
rent with respect to design control requirements and current with respect
to the methods used to comply with third-party expectations for com-
pliance. In this third edition, the scope of the book has been updated to
address ISO 13485:2016 requirements for design control and to reference
associated Medical Device Single Audit Program (MDSAP) design con-
trol requirements. The book has also undergone a major revision in an
effort to provide more detail for understanding and implementation of
the design concepts. Additionally, the majority of the appendices have
been revised or replaced with more current templates.

xi
xii Preface

In a book such as this, which covers the design control requirements

applicable to a broad range of products and companies, it is often dif-
ficult, and likely impossible, to include every opinion or interpretation of
the requirements or present the information in a manner that addresses
everyone’s specific situation. Given this diversity, the intent of this book
is to present a practical review of the design control requirements and
provide practical and proven tools and techniques for meeting the design
control requirements and third-party auditor/investigator expectations.
Manufacturers can and should seek out technology-specific guidance on
applying design controls to their particular situation.
Author
Marie B. Teixeira is the founder and principal consultant for QA/
RA Compliance Connection, Inc. in Odessa, Florida. QARACC is a world-
class consulting company providing expert management and guidance
for its clients in all aspects of global quality management and regulatory
affairs. Under her direction and guidance, her clients have received ISO
9001, ISO 13485, CE, and MDSAP certification and obtained regulatory
clearance for their medical devices internationally.
Before beginning this venture, she was Director of Quality Assurance
and Regulatory Affairs at Bioderm, Inc., a start-up medical device com-
pany in the Tampa Bay, Florida, area where she designed, directed, and
implemented the policies and procedures that established this company’s
compliance with global regulatory requirements.
Ms. Teixeira was also Quality Systems Manager for Regulatory Affairs
at Smith & Nephew’s Wound Management Division in Largo, Florida.
In addition to directing the planning, development, and implementation
of Smith & Nephew’s ISO 13485, FDA GMP, and MDD 93/42/EEC regula-
tory efforts, she implemented and directed the company’s internal audit
program and management review system. It was her direction and guid-
ance that allowed Smith & Nephew’s Wound Management Division to
achieve ISO certification in less than a year, as well as their MDD certifica-
tion one year later.
Ms. Teixeira began her career as a Quality Engineer for Raytheon,
GTE Government Systems, and Sparton Electronics. During her tenure
at these companies she was responsible for establishing and implement-
ing quality assurance programs and procedures, leading supplier and
customer audits, developing and performing quality system and audi-
tor training, initiating and managing corrective actions, and developing
and implementing supplier certification programs. During her tenure at
Sparton, she managed the company through its initial ISO certification
and subsequent surveillance audits.

xiii
xiv Author

Marie Teixeira holds a BS in Industrial Engineering and Operations

Research from the University of Massachusetts at Amherst. She is a mem-
ber of the American Society for Quality. Ms. Teixeira is an ASQ-Certified
Quality Manager and Quality Engineer and an Exemplar Global Principal
Auditor. Ms. Teixeira was also an active member of an international task
force CEN/TC257/SC-DETG10—whose objective was to standardize
medical device nomenclature. Ms. Teixeira recently authored her third
edition of the book titled Design Controls for the Medical Device Industry.
She has also published numerous quality-system-related CD-ROM
training modules and related informational handbooks and has conducted
numerous quality system training seminars.
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the others are Hoy L., Rex S., William X., Edith M., Frances W.. Anna
and Truman. Hoy L.. the eldest son, is a graduate of Eastman's
Business College, in Poughkeepsie, Xew York, and was regarded as
the leading member of his class. The other children are students in
Kendall College in Muskogee. Mrs. Harsha is devoted to her church
work, and since 1890 has been the president of the local Woman's
Christian Temperance Union of this town. In 1891 thev erec
Methodist Episcopal" and church schools admitted parents could not
pay th opened and they rented t certainly an earnest workc was one
of that honorable met in Washington, D. C Union convention. 1 :ted
a hall and 1 ad a school for boys before the Presbyterian sch >ols a
hnitted them. After these boys, they then taugli t the pom- children
whose eir tuition until 1S98, when public schools were heir building
fo that purpose. Mrs. Harsha is ;r in the cause ot teni] erance and
humanity. She body of God's in >ble w ■men who, in March, 1900,
".. at the annual Won an's Christian Temperance' the chief objec s
i^i which was to bring before
The text on this page is estimated to be only 20.05%
accurate

234 HISTORY OF INDIAN TERRITORY. congress the anti-

canteen measure. There are the Young Woman's Christian
Temperance Union and the L. T. L. organizations here, and both
receive hearty support and encouragement fn m Mrs. Harsha, who is
a devout Presbyterian. Mr. Harsha is well known as a member of the
Masonic fraternity, in which he lias attained the Knight Templar
decree, and in his life he exemplifies the beneficent spirit of the
order. Few men have so large and pleasant an acquaintance in the
Creek nation as \Y. S. Harsha. During the years of his residence in
Okmulgee and Wetumpka he became sufficiently conversant with
the language to speak t<> the Creeks in their own tongue. When
the United States court was established in the Indian Territory he
was a member of the first grand jury empaneled. Probably no grand
jury ever had more difficult problems to confront or performed its
duty in a more satisfactory manner than this. In the spring of 1SS9,
when with the progress of events Muskogee organized a municipal,
government, the very handsome vote by which Mr. Harsha was
elected a member of the city council shows the high regard in which
he is held by bis fellow townsmen. JAMES C. McALESTER. The name
of James Burner McAIester is on the roll of leading business men in
the Choctaw nation, and lie who bears it has won success which
many an older man might well envy. He was born in the city of
McAIester June 7. 1876. his parents being j. J. and Rebecca (Burney)
McAIester, both of whom are yet residents of the town which bears
their family name. Their son, James B., acquired his early education
in the country schools near Wapanucka, fifteen miles from Atoka.
After studying there for a year and a half he was obliged to leave on
account of ill health, but soon entered the public schools at
McAIester, later continuing his studies in the Marmaduke Military
Academy at Sweet Springs. Missouri, where he remained until 1804.
In that year he matriculated in Yanderbilt University, at Nashville,
Tennessee, as a student in the law department, and there remained
until he had mastered the branches which form it< curriculum,
whereupon he was graduated. He next went to Poughkeepsie, New
York, and took a commercial course in Eastman's Business College.
Thus well equipped by superior educational privileges, he [Link]
to South McAIester and assumed the management of the mercantile
establishment of his father, there remaining for a year. On the
expiratii n of that period he established the hardware store which he
still conducts, and has made it a profitable source "( income, for his
honorable dealing, reliable methods and earnest desire to please the
public have secured to him a very gratifying patronage. His business
interests, however, have n t been confined to one line alone, lie is
the treasurer of the Home National Building & Loan Association, or
South McAIester. and is the owner of considerable business property.
His farm <
The text on this page is estimated to be only 21.13%
accurate

HISTORY OF INDIAN TERRITORY. 235 twenty miles

northwest of South McAlester, is planted with corn and cotton, and is
one of the finest in the territory. In September, 1899. Mr. .McAlester
was united in marriage to Miss Asa Jewett. a daughter of Edward
Jewett, of Paris, Texas, and they now have one child. Rebecca Leo.
He is a member of the I. O. O. P.. Ancient Order of United Workmen,
of the Modern Woodmen of America, and of the Benevolent and
Protective Order of Elk-. He exercises his right of franchise in support
of the men and measures of the Democracy and is allied with the
Methodist Episcopal church. South, contributing to its support and
aiding in its work. Throughout his career his record has been
creditable, and he is one of the popular, highly esteemed and value,!
young men of South McAlester. JAMES REXXIE. James Rennie, who
is doing an extensive business as a representative of eighteen fire-
insurance companies, make.- bis home in Paul's Valley. He was born
in Toronto, Canada, on the t,q of November. 1846. and acquired his
education in Hamilton. Canada. He entered upon his business career
in the capacity of clerk, and in 1S72 lie went to Xew York city, where
for three years he was in the employ of the Michigan Central Railway
in the Xew York offices. In January. 1875. he t< > k up his abode in
Tishomingo, in the Chickasaw nation, where he was engaged in
clerking for his brother, Alexander Rennie. a pioneer settler of that
town. After one year -pent with his brother James Rennie removed
to Whitebead Hill, where he was engaged in merchandising for
nearly thirteen years. In 1887 he came to Paul's Valley, where he
carried on a general store for three years, but on the expiration of
that ] eriod he clispi seel of his mercantile interests. Through the
succeeding seven years he held the office of postmaster, and at the
present time he is engaged in the tire-insurance business,
representing eighteen different companies, lie writes a large
business, receiving a liberal patronage, for he represents old and
reliable companies. Mr. Rennie has been twice married. His first wife,
now deceased, was a member of the Clu ctaw nation, and unto
them were born two children, who are living: Hazel and George B.
For his second wife Mr. Rennie chose Miss Nannie Hutching, of
Lawrence. Kansas. Snciallv he is connected with Vallev Lodge. Xo. 6.
F. & A. M.. Crescent Lodge, No. 1 -,. K. of P., and Paul's Valley Lodge.
No. 16, I. O. O. F. REV. JOSEPH S. MURROW. D. D. The stamp
designating true nobility of character must ever ti nating tr le n lility
of chai 1 the bro v oi ■ lie who sethie strife' and ledicates hi- 1 'the
ding crowd's ignoble strife" and dedicates hi- life to the uplifting of
his
The text on this page is estimated to be only 21.25%
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under command of i disti nction by his . the father of our

inistei - and died in i was horn in Smith after her husband's 23<5
HISTORY OF INDIAN TERRITORY. fellow men. A mure than
superficial investigation is demanded when one essays to determine
the mental struggle and the spirit of unselfish devotion that must
animate the man who gives all that he has and all that he hopes to
he to service in the great vineyard of lite, seeking reward only in that
realm "where ninth and rust do n< >t corrupt and where thieves do
not break through and steal." Preparations for and labors in the
priesthood are perforce exacting, demanding an ever ready
sympathy, a broad intellectuality and an unswerving fidelity. Scoffing,
cynicism and careless irreverence would often he silenced if only the
inner life of those who minister in holy places might he laid open for
inspection. Honor is due and honor will he paid when once there
comes a deeper understanding of the truth. Through almost a half-
century Joseph Samuel Murrow has directed his labors to the
dissemination of the gospel among the people of the Indian
Territory. He was born in Jefferson county. Georgia. June 7. 1835.
His paternal grandfather. William Murrow, was a native of South
Carolina and one of the heroes of the Revolutionary war. He was
General Francis Marion and according to records w< loyalty and
bravery. His son. the Rev. John Murroi subject, was born in South
Carolina, was a Baptist 1 Georgia in 1868. hie wedded .Mary Amelia
Badger, wl Carolina and died in Georgia, in [868, only eight days
demise. She was a refined, aristocratic southern woman of
exceptional brilliant intellectual attainment.-., and was known far and
wide for her superior womanly qualities. Her father was Joseph
Badger, a well known and distinguished citizen of Smith Carolina. Of
German de-cent, her maternal grandfather, the Rev. Mr. Haunbaum,
was burn in Germany, and after crossing the Atlantic to the new
world became pastor of the First Lutheran church in Charleston,
Smith Carolina. L'nto Rev. John and Mary A. Murrow were born four
son;, namely: William J.. Jonathan 11.. John A. and Joseph S. All
became Baptist ministers, and the two last named are yet living. In
taking up the personal history of Rev. Joseph S. .Murrow we record
the life work of one who has ever devoted his energies and labors to
the benefit of his fellow men. He acquired his preliminary education
in Springfield Academy, in Effingham county, Georgia, and later
studied in Mercer University, the leading Baptist educational
institution of that state. He was an earnest and indefatigable
student, a close reasoner and a logical thinker. and completed his
college course in less time than must of his classmates. He pursued
his studies in anticipation of entering the ministry. lie joined the
Greenfork Baptist church in Burke county. Georgia, at the age of
nineteen years, and the following year w; Mr. Murrow'- interest and
syi Indians, who in the '30s and '40s and Mississippi to the Indian
Territo as a missionary under the auspices remained continuously
since, being: s licensei 1 to preach ipathy v e reearly direel :ed to lad
emig rate el fr'on 1 Ge< irgia, Al v. and in 1S5- 1 ime t 0 the re if the
I '.ant: ist chu rch. Here Iot onlv the oldest missi miary hi
The text on this page is estimated to be only 19.12%
accurate

HISTORY OF INDIAN TERRITORY. 237 one of the oldest

white residents of the territory. He first located in the Creek nation,
near the present town of Eufanla. At that time there was not a mile
of railroad west of St. Louis. He remained in the Creek nation until
the breaking out of the Civil war. when he was appointed
Confederate states agent of the Seminole Indian-, holding that p
isition until the cl'^e of hostilities, during which time he attended to
the distribution of fi od to three thousand refugee Indians. Those
who knew Rev. Murrow in that period declare, as evidence of his
scrupulous honesty, that lie never appropriated for bis personal use
one cent of the large amount of fund- furnished him by the
Confederate government for taking care of the Indians. This i-
certainly a great contrast to the well known practice of many
government officials of those days. Mr. Murrow continued his
missionary labors among the Creeks for a period of four years, -pent
a similar time with the Seminole Indians, and during the remaining
thirty-six years he has labored principally among the Choctaw
Indians. He located a* his present In me at Atoka, in the Choctaw
nation, in 1867. and here he has since resided. He is practically the
father of the town, for there were hut two families on its site when
he came here, and he wrote the petition for the first postoffke. Until
twelve years ago he performed his missionary labors in connection
with the missionary hoard of the Southern Baptist church, but in
1889 he changed his relationship to the Baptist Home Missionary
Society, of Xew York, under whose auspices he is now working.
Although he still does personal missionary work among the Indians
his position has been advanced until at the present time lie has
general supervision of all the Indian missionarv work of the Baptist
denomination in the entire territory. He inaugurated and established
the missionary work among the Blanket Indians of Oklahoma, which
is now in a very flourishing condition. He has organized seventy
Baptist churches in the Indian Territory, and with his own hand- and
money has assisted in building about that number of meeting
houses. Nearly all of these churches have been for the Indians
exclusively. He has aided in ordaining about sixty preachers, most of
them Indians, and has baptized nearly eighteen hundred persons,
most i
The text on this page is estimated to be only 21.99%
accurate

23S HISTORY OF INDIAN TERRITORY. has taken all the

degrees of the Scottish Kite in the consistory except the thirty-third.
It can be truthfully said that every member of the fraternity in the
Indian Territory knows Mr. Murrow and loves him, and the same
regard is entertained by all who have made his acquaintance in
other walks of life. Rev. Mr. Murrow was united in marriage, in 1850.
to Miss Clara Burns, a daughter of a Baptist missionary. She died in
1S68. leaving one child, Mrs. William A. McBride, now of Atoka. His
present wife bore the maiden name of Katrina Lois Ellen and was
horn near Cleveland. Ohio. She came to the territory as a missionary
to the Indians, and was married to Rev. Murrow in 1S88. Their fine
home in Atoka is a mecca for all who appreciate generosity, kindness
and sympathy. Mr. Murrow has a splendid library, "a literary
workshop," and in his voluminous correspondence and clerical work
he receives valuable assistance from his wife, a lady of broad charity
and earnest Christian character. The degree of doctor of divinity was
conferred upon him by the Indian University at Muskogee. He is a
veritable "good lather" to every cue who is fortunate enough to get
within the range of his acquaintance. The gi 1 d that Ik- has
accomplished in the Territory cannot he measured by any known
standard, but his influence has been widely felt and is acknowledged
by all with whom he has come in contact. His life has been a blessed
benediction to all who know him, and of him it may justly lie -aid as
of Brutus : "His life was noble, ami the elements So mixed in him
that nature might stand up And sav to all the world. This was a
man." LODERICK MATTHEW'S. Loderick Matthews, who is engaged
in the drug business in Miami, was born in Arkansas on the 13th of
May. 1855. ^'s .grandfather. Loderick Matthews, was born in
Georgia, but his father was a Scotch-Irishman and became the
founder of the family in America. His father. Captain Benjamin R.
Matthews, was a native of Georgia, horn in the year 1821, and his
death occurred in El Dorado. Union count}', Arkansas, June 7. 1894.
He was one of the pioneers of Union county, having emigrated
westward from Georgia in the year 1842. lie cleared the ground on
which the town of El Dorado now stands, and in many other ways
took an active part in the substantial improvement and development
of that section of the country. He served as clerk of the county for a
number of years before the war and was a leadingspirit in public
affair-, doing all in his power to advance the general welfare along
material, social, intellectual and moral lines. He served throughout
the period of hostilities between the north and the south a- captain
of a Confederate company and won distinction by many act- of
braverv. He was the
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HISTORY OF INDIAN TERRITORY. 239 soul of honor,

universally beloved for his kindly trait-; of character. Xot very lung
before President Lincoln issued his emancipation proclamation,
freeing the negro slaves of the south, Captain Matthew.-, bought a
slave woman, for whom he paid fifteen hundred dollars, giving five
hundred dollars in cash and assuming an obligation for the balance.
After the war was over, when he returned to his home almost broken
in fortune, he began freighting in order to make the money with
which to pay the balance due on the slave woman who had then
enjoyed her freedom for several years. His honesty and honor were
unimpeachable and he did all that he believed to be right at any cost
to himself, and was a devoted, sincere Christian gentleman, holding
membership in the Baptist church. In the days before the war he
was the owner of a large plantation and carried on an extensive
business. Before attaining his majority he became a Mason,
obtaining a special dispensation tor this unusual transaction, on
account of the fact that he was going to Arkansas, where he would
have no opportunity of becoming a member of the order at that
early da} . Captain Matthew.-, was united in marriage to Miss Sarah
E. Wright, whose father. Edward W. Wright, was lorn in Xew York
and was of English descent. Mrs. Matthews was a native of Alabama
and died in 1884, in Camden. Arkansas, where she was laid to rest.
Her husband's remains were also taken for burial to Camden. Mrs.
Matthews was one of the famous Crowed family of Alabama,
celebrated for the line horses and other stock which they raised.
Both she and her husband had several brothers who were
Confederate soldiers in the Civil war. The subject of this review was
a cousin of Lieutenant Commander Stokely Morgan, of the United
States navy, whose recent death has brought again to mind his
splendid service in the Spanish-American war. He was in. the forward
turret of the Olympia in the battle of Manila on the 1st of May. 1898,
and responded to Admiral Dewey's famous order. "You may fire
when ready. Cridley," tiring the first gun in that memorable
engagement. Loderick Matthews, whose name introduces this
record, prepared for the pharmaceutical profession in Hampton,
Calhoun county, Arkansas. He profession for some time in Little
Rock, whence he came to the ory, having now for five years been
engaged in business in Miami stor of a drug store. He is thoroughly
proficient in the line of lling and has added to his knowledge of
medicine and their uses tudy in the Little Rock Medical College. He
now ha. a large and well appointed store, in which is found
everything carried in a firstclass establishment of the kind, lie has
been a member of the Arkansas Association of Pharmacy since [884,
and at a meeting of the Indian Territory Pharmaceutical Association
at Muskogee, in May. 1900. he was unanimously elected first vice-
president. At the seventh annual meeting of the Indian Territory
Pharmaceutical Association, which convened at South McAlester, nn
the [Link] of May, loot. Mr. Matthew-, the accredited' delegate to the
meeting of the Arkansas Association of the past year, was chosen as
president followed the In. Han Te xriti as the pre iprk his chosei 1 cal
by a year 's si
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24© HISTORY OF INDIAN TERRITORY. of the association

by acclamation. IK made a verbal and glowing report of the last
meeting and the work that was dune there, and also presented a
most interesting paper npon the relation of the clerk and employer.
The following is taken from the .Mian;, Herald, which copies from
the South McAlester Daily Capital: "The election of officers for the
ensuing year was taken up and Dr. L. Matthews, of .Miami, was
chosen by acclamation, and to him Dr. fohnson gracefully
surrendered the gavel. In assuming the chair the new president
thanked the members for the honor and promised 'to do his hest to
till the position as well as his predecessor, declaring that it thus well
done he would be satisfied. He also said that he had something else
to be thankful for, and that was that he was from Arkansas. This
raised a laugh, and when the election of officers was concluded it
was discovered that every mother's son of them was from the same
blessed state, and about half of the remainder pleaded guilty to the
same indictment. "At the close of the operetta of Snow White and
the Seven Dwarfs, which was given at the meeting". Mr. Matthews
presented the queen of the fairies, who was the daughter of his
predecessor, Dr. Johnson, a beautiful bouquet of flowers, with the
following well chosen words: 'Miss Lavinia. in behalf of the Indian
Territory Pharmaceutical Association, of which vour father. Mr. C.
Johnson, has been president for the year just ended, which position
he filled with credit to himself and honor to the association. I
present to you this bouquet, and as the fragrance of these flowers is
so much enjoyed by all who come near them, may many kind words
and sweet songs from you and all these little girls go far towards
making manv people happv in this life.' •' Mr. Matthews was united
in marriage to Miss Alice E. Greer, who was born in Prairie count}-,
Arkansas, in 1S65. and is a daughter of Harvey Greer. They now
have three children, — William Benjamin, Wylie Carl Hudgepeth and
Virgil Dale, aged, respectively, eight, six and three years. In his
political affiliations Mr. Matthews is a stalwart Democrat and is a
devoted member and active worker in the Miami Baptist church, to
which his wife also belongs. He is truly consistent in his religious
principle-, which he applies to his every day business life raid he is
uniformly respected for his high sense of honor and for his purity of
purpose in all business transactions. lie is a broad -minded, liberal
man. kindlv in action, courteous in manner. He has a large
acquaintance throughout Arkansas and the Indian Territory, and
wherever he goes his genial manner and winning personality make
him welcome and win for him many strong friends. DRURY II.
MIDDLETOX. Ann lg the residei ts 0 the Indi; 11 Tei ritory vho lis ve
c Dme t 1 this ccti on 0 the country from the Lone Star >tate i Drur
• II. Mid, leton, vho was )orn near Gra lbun . 11 1 Co l'exas. .11 the
25th 01 Oc tober,
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• / M/^c/ceU^z
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HISTORY OF INDIAN TERRITORY. 241 1S62. His parents,

Drury L. and Mary W. (Odell) Middleton, are now residents of
Abilene, Texas. In the public schools of Granbury Mr. Middleton
acquired his education and remained at that place until twenty year-
of age, when he removed to Abilene and became interested in the
cattle busi■ness. He there remained until 1S90, when he took up his
abode in Tulsa, Indian Territory, where he continued the raising and
herding of cattle for two years. Since that time he has made his
home in Muskogee and is numbered among the leading cattle-raisers
of this portion of the country. Ikis now extensively engaged in
breeding Hereford cattle and in connection with C. W. Turner is
doing an enormous business, handling about ten thousand head of
cattle annually. Raising fine grades of stock, their cattle have found a
ready sale on the market, and the profit of their business annually
augments their income. Mr. Middleton is a man of resourceful
business ability, determined purpose and much energy, and his
efforts have not been confined alone to one line, for he has
judiciously invested in the Turner Hardware Company, in the
Muskogee Telephone Company and in other industries and
enterprises. In 1893 occurred the marriage of Mr. Middleton and
Miss Fannie Wainwright. a daughter of Thomas Wainw right, of
Eayetteville, Arkansas. They have two children, Audrey and Drury \\
., aged three years and one year, respectively. Mr. Middleton is a
member of the Masonic fraternity and has taken the Knight Templar
degree in the commandery. His political views accord with the
principles of the Democracy. Mr. Middleton is recognized as one of
the very representative business men of the territory. WILLIAM
CLAUDE MITCHEXER, M. D. Although one of the younger
representatives of the medical fraternity in the Indian Territory Dr.
Mitchener has attained prestige bv reason of his ability and is
regarded as a very popular physician. He was born in Saltillo,
Mississippi. December S. 1S75. bis parents being McW'illiam Carroll
and Sarah (Nelson) Mitchener. His father now resides in Tupelo,
Mississippi, but the mother has passed away. The Doctor obtained
his early education in Christian College in northern Mississippi and in
the high school of his locality. After putting aside his text-book-; he
clerked for two years in the mercantile business and then began the
study of medicine with Dr. L. A. Ellison, of Saltillo, Mississippi. In
order to further perfect himself in his chosen calling he matriculated
in the Memphis .Medical Hospital College and was graduated with
the class of 1S97. He began practice in Mississippi StateYharitv
Hospital, at Vicksburg. entering upon bis work there between his
college courses. After his graduation lie came to Okmulgee, where
he opened an office and is still making his home. He has secured a
large and constantly -rowing practice and is now the leading
physician of the district. The cures he lias effected demonstrate his -
kill and ability and he is widely known for a leader in his
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2 42 HISTORY OF INDIAN TERRITORY. chosen field of

labor. Dr. Mitchener is extremely popular both as a citizen and
physician and has the confidence of the entire community. lie was
elected mayor of Okmulgee April _\ 1901. and is acting United
State.- commissioner. He was married, Apr;] 3, igoi. to -Miss
Margaret LaRue, of Warrensburg, Missouri, who was a teacher in the
national schools for several years. The Doctor is a member of the
Modern Woodmen and A. O. I". \Y. Dr. MARION E. TARVIN. Dr.
Marion Elisha Tan-in was born in Baldwin county, Alabama, January
15, 1837, and is a son of Elisha Tarvin. who also was born in that
state, in 1800. His grandfather, William Tarvin, was a native of
England, who on crossing the Atlantic to America took up his abode
at Harper's Ferry. Virginia. The mother of our subject bore the
maiden name of Theresa Tate, and was a daughter of David Tate,
who was sent by Mr. Panton. a rich merchant of Pensacola, Florida,
to Inverness College, Scotland, where he completed his education,
after which he returned to his home at Little Talise, on the Coosa
river, Alabama, and in 1800 married Miss Mary Random of French
and Creek blond. They had three daughters. — Louisa, Betsey and
Theresa. The latter married Elisha Tarvin, 111 1825, and became the
mother of our subject. David Tate was a half-brother of the
renowned William Weatherford. or Red Eac;ie. war chief of the
Creeks in Alabama from 1812 to 1814, when he voluntarily
surrendered to General Andrew Jackson. Our subject's mother was
also a granddaughter of Colonel John Tate, of England, a member of
the British army, whose wife was Sehoye McGiilivrav. a sister of the
noted General Alexander McGillivray, who was the principal chief of
the Creeks from 1770 to 1793, when he died, but his family history
is very closely interwoven with that of Alabama. The subject of this
review remained in Baldwin county until twenty-one years of age.
during which, time he attended the private schools of that locality,
afterward pursuing the academic course in Wilkes Academy, in
Maury comity. Tennessee. Subsequently he pursued a course of
private study in the languages under the direction of Professor
Brooks and Miss Thurston, of Quitman, Mississippi, studying French,
Latin and the English branches. His desire to become a member of
the medical fraternity led him to enter the office of Dr. J. G. Foster,
of Mount Sterling, Alabama, with whom he remained as a student
from 185S until 1861. During that time he purchased an extensive
medical library and mastered much of its contents. In 1S61 Dr.
Tarvin was commissioned a lieutenant c ilonel in the Alabama militia
by Governor A. B. Moore, and in March. 1862. he enlisted for -ervice
with Company E. of the Fortieth Alabama Volunteers and made
second lieutenant. He served throughout the Civil war. participating
in the siege of Vicksburg and the battle- of Shelbyville. Lookout
Mountain. Missionary Ridge. Atlanta and other noted engagements,
lie was wounded in the arm, but still remained at the front ami
loyally defended the principles in winch he
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HISTORY OF INDIAN TERRITORY. 243 believed. After being

mustered out he resumed the study of dentistry, under the direction
of Dr. B. B. Seals, of Sumter county, Alabama, and later he pursued
two full courses in the Baltimore School of Dentistry, being
graduated in that institution in March, 181
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HISTORY OF LXDIAN TERRITORY. New Yoi ■k, an ;.l ' tvas i

ean :d in Cii icinna ti. He was ; l Si HI of ( ie irgt ■ Cha rters, a
native at S cot fend an. 1 ; i re; ifesenta tive of one o f the ol d f:
uni' lies 1 if the Covenant ers. En nigra tine ; t o the new worli 1, lie
res ded f or son ie t ime i n the eastern metro pol is ai id t lie n rem
overt to C incinnati . Ohi whe ■re he ei -ected the first 1 librai build
ing in the c itv. The maternal grar Lit ather . t 0111 • sttbject. Dr.
Dun i Ch; arte: rs. marr ie'd M iss . \ngeline Isaac s. win 1 w as hi irn
in Brothertc JWIl, Xt :\v V ork, a daugl iter (i f Th imas Isaacs. SI ie
b< don gad to the Six Xati ons t ril ie of Xe Vi irk India ns. In 1847 ,
afte r i ■esitl ling ■ for some time in Dam ■ill. .\ 111 inoi s. Dr. :
Dunca n c harters 1 ■emov ed wil :h : hi- £ amily to Missouri, taking
up his abode on the site of Kansas City. There he engaged in
merchandising, his patrons being the Peoria In. Hans. He afterward
went to Maryville. Missouri, where his skill and fame as a medical
practitioner brought to him an extensive patronage. His death there
occurred, and his family afterward resided in Ohio. Indiana and in
Miami county, Kansas. His wife died in Paola, Kansas, in August.
1864. She was a most highly educated lady and for many years
acted as teacher in the southwest. One of her daughters, Mrs.
Isabella McKensie, an aunt of our subject, is a remarkably intelligent
iady, aristocratic in appearance and possessed of many superior
qualities and characteristics. She was afforded splendid educational
privileges, which she diligently improved, and her intellectual
attainments give her prominence in the community in which she
resides, making her a social leader. She now resides with her
nephew, Charles Geboe, whose name introduces this review. The
mother of our subject was twice married. After the father's death
she became the wife of Edward Eichhorn. and her own death
occurred in 1879. James Edward Geboe belonged to the Miami tribe
of Indians, but the subject of this review is now a "citizen Miami."
having withdrawn from the tribe, becoming a citizen of the United
States under the congressional act of 1873. He pursued his
education in St. Mary's mission, which is located northwest of
Topeka, Kansas. He married Miss Elma Chandler, a white iady, and a
daughter of Eli and Minerva 1 Botkin ) Chandler. Their children are
as follows: Charles C. the eldest, is a graduate of Haskell Institute,
and is now preparing for the profession of law as a student in the
Kansas State University, at Lawrence. He is a splendid musician,
talented in many other ways, and an intelligent and fine looking
young man of much promise, undoubtedly having before him a
successful future. He is now a Ouapaw by adoption. Clifford C, the
second of the family, has charge of the g >vernment machine shop
in Darlington. Oklahoma. He obtained Ids education in the Haskell
Institute, and. like his brother, is a voting man of abilitv and worth.
Mr. and Mrs. Geboe reside in Peoria. He his been a resident of the
Territory since 1887. and i~ n"w tbe ownei of two hundred and forty
acres of valuable land, his farm being located in the Ouapaw
reservation a mile and a half north of the city in which he makes his
home. His father was a Catholic, but he belongs to no church.
Widely recognized as a political leader, he takes an active part in the.
work of the Republican organiza 
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th th s e. ucs itional of t ler le ! 1"' igress have • the res lie.

t and 5 rec ign Xi 1 a* a lg the 11 ►sit ion of HISTORY OF INDIAN
TERRITORY. 245 tion and i- chairman of the district executive
commutes for the Ouapaw agency. Ik- represents the most
progressive element in the Territory, and is a man of sterling worth,
of strong purpose and upright life and commands t'ne high regard,
confidence and respect of all with whom he is associated. PETER R.
EWIXG. The name of Mr. Ewing is inseparably interwoven
development of this portion of the c: tin try. America and
advancement to her school system, and the educati always been
men of prominence, generally commandi esteem of those among
whom they reside. Mr. Ewins leader of public thought in Eufaula,
where he is occup superintendent of the Eufaula high school, which
is a free institution controlled by the Creek nation. His father was
born in Alabama and came to this portion of the territory in the early
days, his mother being a Creek. Mr. Ewing acquired his education in
the old Asbury Mission, a school under the control of the Methodist
denomination, which was the first school in the Creek natii n and its
work was carried on by the Methodist Episcopal Missionary Si ciety.
the nation supporting the pupils and supplying the textbooks: Mr.
Ewing continued his studies there from 1874 until 1877. when lie
entered the Louisville Theological Seminary, in Louisville. Kentucky,
where he remained as a student until r8Sl. lie then entered the
William Jewell College, at Liberty, Missouri, but left that institution
when in the sophomore class in i88_\ The following year he retired
to his home in the Indian Territory ami engaged in farminp- until
1886. when he engaged in teaching in the public schools of the
nation, following that work for nine years. In 18(^4 he was
appointed by Chief L. C. Parryman as a commissioner to take the
names of all white people and their residences. There were three
commissioners: Mr. Ewing; Mr. Mcintosh, who is a resident of
Eufaula; while Mr. Anderson makes his home at Sapulpa, Indian
Territory. The appointment came to Mr. Ewing a- a pleasant surprise
and the work occupied his attention for an entire year. Before it was
completed, however, he received his commission to take charge of a
school at Coweta, where he remained for six months. He was then
appointed superintendent of the Creek Orphan School, at Okmulgee,
in winch there were about eighty children, ai^l for a year he
continued to superintend that institution. The superintendent is
elected bv a majoritv of the council members, and. in 1805 Mr.
Ewing and j. M. Parryman were the candidates, and Mr. Parryman
was elected by one vote. On Mr. Kwings defeat his friends desired
him to run for superintendent of the ( )rphau Asylum, and thus he
became the incumbent of thai position, llis opponent was I Ion. Xoty
Tuger, second chief of the Creek nation, lie was elected to the office
for a year, hut the term of his office has been increased to two
years. In [Sc/> the election >>\ chief occurred and lh n. 1'. Porter
became a candidate and, the opponent of Sper 
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