Journal o f Medical Engine ering & Techno logy, Vo lum e 24, N umbe r 2, ( March/ April 2000) , page s 53 ± 62
G o o d d e s ig n p ra c tic e f o r m e d ic a l d e vic e s a n d
e q u ip m e n t, P a rt I I: d e s ig n f o r va lid a tio n
K. Ale x and e r and P. J. C larkso n*
Cambridge En gineering Design Centre at the Departmen t of Engin eerin g,
Un iversity of Cambridge, T ru mpin gton Street, Cambridge CB2 1PZ, UK
M edical devices an d their associated process equ ipmen t mu st be
reliable an d ® t for pu rpose. In light of the recent chan ges to the
medical device regu lation s, man u facturers mu st n ow take an
in tegrated approach to design , developmen t an d validation .
Good design practice en cou rages this in tegrated approach while
en su rin g ® tn ess for pu rpose within commercial reality. A review
of cu rrent literature related to good design practice carried ou t
in Part I of this paper showed that there is in adequ ate gu idan ce
regardin g the in tegration of validation with design . T his paper
proposes a practical approach to design for validation aimed at
makin g devices easier an d more econ om ic to validate. T he
approach comes in the form of a model of design for validation
that illu strates the basic relation ship between design, develop-
men t an d validation an d a series of design tactics that were
formu lated in order to help design ers take a more proactiv e
approach to validation du rin g design .
Intro ductio n
G o o d d esign p r actice can p ro vid e m e th o d s an d
gu id an ce to th e m e d ica l d evice in d u str y to e n ab le an
in te gr ate d ap p ro ach to d e sign , d e ve lo p m en t an d
p ro d u ctio n . At its sim p lest:
`Go o d d e sign p ractice en su re s fitn ess fo r p u r p o se
with in co m m er cial r eality.’
Valid atio n e n su r es a d evice is ® t fo r p u r p o se th ro u gh -
o u t th e e vo lu tio n ary p ro ce ss o f p ro d u ct d e ve lo p m e n t
an d is con ce r n e d with d e m on stratin g th e co n siste n cy
an d co m p lete n e ss o f a d e sign with r esp e ct to th e in itial
id e as o f wh at th e syste m sh o u ld d o . T h is is o fte n
co n fu se d with ve ri® catio n wh ich is co n ce rn e d with
e n su rin g th at, as th e d e sign an d im p lem e n ta tio n
d e ve lo p , th e o u tp u t fro m e ach p h ase fu l® ls th e
r eq u ir em e n ts sp e ci® e d in th e o u tp u t o f th e p re vio u s
p h ase . Part o f th e re aso n fo r th e co n fu sion b e twe e n
va lid ation an d ve r i® catio n is th e u n cle ar o f® cial
d e ® n itio n s, sh o wn in tab le 1, p u t for th b y th e re gu lato r y
b o d ie s. As a re su lt, m an y h ealth car e o rga n izatio n s h ave
d e ve lo p e d th e ir o wn d e ® n itio n s fo r va lid atio n an d
ve r i® catio n th at are d iffere n t to th e o f® cial te r m s.
In o rd e r to p r ese n t m o re p r actical d e ® n itio n s, ve ri® ca-
tio n an d valid atio n will b e vie we d fo r th e p u r p o se s o f
th is p ap er as a m ean s o f an swe rin g th e fo llo win g
q u e stio n s:
*Au thor for correspon den ce: e-mail: pjc10@en g.cam.ac.u k
Jou rnal of M edical En gineerin g & T echn ology
ISSN 0309-1902 p r in t/ ISSN 1464-522X on lin e Ó 2000 T aylo r & Fran cis L td
h ttp :/ / www.tan d f.co .u k/ jo u r n als
Ve ri® catio n : `Are we b u ild in g th e th in g r igh t?’
Va lid atio n : `H ave we b u ilt th e righ t th in g?’
Past m e d ical d e vic e r egu latio n s fo cu se d o n p r od u ctio n
an d n o t d e sign . T h u s, va lid atio n wa s fre q u e n tly vie we d
as an ad d -o n p h ase at th e e n d o f p ro d u ctio n th at o n ly
ap p lie d to th e m an u factu rin g p r o cesse s. Re gu latio n in
b o th th e EU [ 4] an d U SA [ 2] h as ch an ged sign i® can tly
in th e p ast twe n ty ye ars fro m a m an u factu rin g p r o ce ss
fo cu s to a d e vice d esign an d m an u factu rin g p r o ce ss
fo cu s. In p articu lar , th er e is a n ew fo cu s o n in te gr atin g
d esign co n tro ls an d risk an alysis in to th e d e vice an d
co rr esp o n d in g p ro ce ss e q u ip m e n t d e ve lo p m e n t p ro -
ce sse s.
G u id an ce d o cu m en ts r e latin g to go o d d esign p r actice
are b e co m in g m or e p re d o m in an t. H o we ve r , m u ch o f
th e gu id an ce still d e scrib es what m u st be d o n e rath e r
th an how it can b e d o n e an d is th e re fo re o f lim ite d
va lu e . Part I of th is p ap e r co n tain ed a re vie w o f cu rr en t
m e d ical d e vice re gu latio n s, stan d ar d s, gu id an ce d o cu -
m e n ts an d d esign fo r X m e th o d s. It wa s sh o wn th at,
with th e e xce p tio n of stan d ar d s re latin g sp e ci® cally to
risk an a lysis, th e m ajo r ity of re gu latio n s an d stan d ard s
p ro vid e d little gu id an ce o n go od d esign p ractice. T h e
re vie w also sh o we d th at gu id an ce d o cu m e n ts an d DFX
te ch n iq u e s we re m o r e u se fu l th an th e re gu latio n s an d
stan d ard s, b u t th e y te n d e d to b e ve r y sp e ci® c an d we re
lackin g th e co n te xt o f d e sign an d d eve lo p ed wh e re th e y
sh o u ld b e u se d .
O ve rall, n o n e o f th e re vie we d d o cu m en ts p ro vid ed an
o ve rall vie w of th e in te gr atio n o f va lid atio n with d e vice
d esign , p ro ce ss d esign an d p ro d u ctio n . O f th e d o cu -
m e n ts th at we re sp e ci® cally aim e d at th e in te gr atio n o f
va lid atio n with d e sign , n o n e p r ovid e d p ractical gu i-
d an ce o n th e in d ivid u al ste p s o f d esign an d va lid atio n
in wh ich th is co u ld o ccu r . T h is le d to th e co n clu sion
th at cu rr en t gu id an ce o n va lid atio n , as it ap p lie s to
d esign , is in ad e q u ate .
C urrent practice o bse rvations
T h e latest ® gu re s fr o m th e Fo o d an d D ru g Ad m in istra-
tio n ( FD A) in th e U SA su gge st th at cu r re n t d e sign
p ractice is go o d an d a lo w p e rce n tage o f d e vice s are
re fu sed at th e ® r st attem p t [ 5] . H o we ve r , th e ® gu re s
give n o in d icatio n o f th e co m m e r cial effe ctive n e ss o f
d evice d eve lop m e n t. D iscu ssion s with d e vice d e ve lo p e rs
su gge st th at cu r r en t p ractice is far fr om go o d . M ost
b e lie ve th at d evice d e ve lo p m en t tim es, an d h e n ce co st,
co u ld b e d r am atically re d u ced [ 6] . Figu re 1 su m m ar izes
so m e co m m o n o b se rvatio n s o f cu rre n t p ractice.
53
K. Alexande r and P. J. C larkso n G ood d e sign p r actice fo r m ed ical d e vices an d equ ip m en t, Pa r t II
T able 1. Of® cial de® n ition s of v alidation an d veri® cation .
O f® cial EU D e® nitions
`Valid a tion is th e e xe rcise o f car ryin g o u t a
p ro gr am m e to d e m o n strate th at a p r o ce ss o p e r atin g
with in sp e ci® e d lim its, will co n siste n tly p r o d u ce
p ro d u ct o r se rvice s co m p lyin g with p re d e te r m in e d
r e q u ire m e n ts’ [ 1] .
`Ve r i® cat io n is co n ® r m atio n b y e xa m in atio n an d
p ro visio n o f o b jective e vid e n ce th at sp e ci® e d
r e q u ire m e n ts h a ve b e e n fu l® lle d ’ [ 3] .
Figu re 1. Com mon observation s of cu rrent design practice.
It was o b se rve d th at cu rr en t d evice d e ve lo p m e n t h as a
te n d e n cy to b e p er fo rm e d in th e se r ial m an n e r o f
r eq u ir em e n ts cap tu re , d e sign an d th e n te st. With in th is
se rial ap p r o ach , it wa s o b se r ve d t h at th e cap tu re d
r eq u ir em e n ts we r e o fte n in ad e q u ate , th e re we re
fr eq u e n t d if® cu ltie s o ve r d ecid in g wh at to te st o r h o w
to test an d th er e was co n fu sion o ve r d evice an d p ro ce ss
va lid ation .
Se rio u s d esign e rr o rs can arise fro m a se r ial re q u ire -
m en ts cap tu r e , d e sign an d te st ap p r oach . Co n sid e r an
e xa m p le [ 7] wh e r e a sm o o th co n tin u o u s co n tro l kn o b
r otatio n wa s u se d to ad ju st th e o xyge n ¯ o w to a p atie n t.
Ph ysician s co u ld se le ct a ¯ o w o f 2.5 ( b etwe e n 2 an d 3)
e xp e ctin g 25% o f fu ll ¯ o w. Wh at th e p atie n t actu ally
r ece ive d wa s n o o xyge n ! A re q u ire m en t fo r d iscr ete
¯ o w rate s h ad b e en in co rp o r ate d in to th e d esign so th at
o n ly in teger ¯ o w va lu e s, sele cte d via a co n tin u o u s d ial,
r esu lte d in o xyg en b e in g su p p lie d . H o we ve r , th e re al
r eq u ir em e n t o f su p p o r tin g th e p atien t an d h o w th e
d e vice m igh t b e u se d in th e re al wo r ld h ad b e e n
fo rgo tte n wh en th e d e vic e wa s te sted an d su b seq u e n tly
ap p ro ve d fo r sale .
Exa m p le s e ch oin g th e ab ove o b ser va tio n s can b e fo u n d
in th e late st FD A n o tice s o f p ro d u ct re calls. In ju st o n e
we e k at th e en d o f 199 8, th e r e we r e 15 p ro d u ct re calls
in clu d in g 32 au to m atic im p lan tab le car d io va scu lar
d e ® b r illato rs with th e wa rn in g th at `th e p ace m ake r s
m ay ce ase fu n ctio n in g with o u t wa rn in g d u e to a
co m p r o m ise d h er m etic seal o n a ch ip car rier co m p o -
n e n t p ar t’ an d 74 000 d isp o sab le p r essu re m o n ito rin g
kits wh e r e `th e r e m ay be p in h o le s in th e ® lm o f th e
b liste r p acka ge , th e re b y co m p r o m isin g th e ste r ility o f
54
O f® cial FD A D e® nitions
`Valid a tion m e an s co n ® r m atio n b y e xa m in atio n
a n d p r o visio n o f o b je ctive e vid e n ce th a t th e
p a rticu lar r e q u ire m e n ts fo r a sp e ci® c in te n d e d u se
can b e co n siste n tly fu l® lled ’ [ 2] .
`Ve r i® cat io n m e a n s co n ® r m atio n b y e xa m in a tion
a n d p r o visio n o f o b je ctive e vid e n ce th a t sp e ci® e d
r e q u ire m e n ts h ave b e e n fu l® lle d ’ [ 2] .
th e d e vic e s’ [ 8] . In b o th case s, in ad e q u ate sp e ci® catio n ,
d esign or te stin g o f th e p ro d u ct o r its asso ciate d
m an u factu rin g p ro cesses wa s to b lam e fo r th e re call.
It wa s also fou n d in cu rre n t p ractice th at alth o u gh th e
m ajo rity o f m e d ical d e vice d e sign e rs u n d e rsto o d th e
activitie s with in th e ir d evice d e ve lo p m e n t p ro gram m e s,
alb e it a se rial ap p ro ach , m o st we re co n fu sed o ve r h o w
va lid atio n ® tte d in to th e o ve rall d eve lo p m e n t. T h e
co n fu sio n e xists b e cau se d e sign an d va lid atio n h ave in
th e p ast b e e n co n sid e re d as two se p arate activities
with in a p ro je ct life cycle . Mo st d e vice d e sign e rs r e ly o n
th e `va lid atio n d e p artm e n t’ to p e rfo r m in d ep e n d en t
va lid atio n afte r th e p ro d u ct h as b e e n d e sign e d . T h is is
n o t an o p tim al situ atio n be cau se it is cle ar th at d e vice
d eve lo p m e n t m an age r s an d d e sign e r s n ee d to b e m o re
awa r e o f, an d in ¯ u e n ced b y, va lid atio n issu es.
Backgro un d o f de sign fo r validatio n
D esign fo r valid atio n is aim e d at d e sign in g m e d ical
d evice s to m ake th e m easie r an d m o r e e co n o m ic to
va lid ate . In o r d er to e n su r e th at a d e vice an d its
asso ciat ed m an u factu rin g an d te st e q u ip m e n t are
re liab le an d ® t fo r p u rp o se , d e sign m u st affe ct
va lid atio n an d va lid atio n m u st affe ct d esign . T h e go al
o f d esign fo r va lid atio n is to p ro vid e gu id an ce in o rd e r
to h elp d e sign e r s ach ie ve in te gr ated d e sign , d e ve lo p -
m e n t an d valid atio n . It fo rm s p art o f a wid e r d e® n itio n
o f go o d d e sign p r actice wh ich aim s to e n co u r age ® tn e ss
fo r p u rp o se with in co m m er cial r eality.
Re sear ch h as be e n carr ie d o u t at th e Cam b r id ge
En gin e e rin g D esign Ce n tre in th e ® e ld o f d e sign fo r
va lid atio n in re co gn itio n of th e n e e d fo r m o re p r actical
gu id an ce th at e n co u rage s in te gr ate d d esign an d
va lid atio n . Rese arch wa s carr ie d o u t in th e fo rm o f
stu d yin g cu r re n t p ractice in o r d e r to id en tify th e facto rs
th at co n tribu te to in tegr ate d d e sign , d e ve lop m en t an d
va lid atio n . Case stu d ie s we re an alysed an d in te rvie ws
we r e car r ie d o u t with va r io u s m e d ical d e vice d e sign e rs
an d p ro je ct m an age rs. Fr o m th e in fo rm atio n ga th er e d ,
a p ractical ap p r o ach to d e sign fo r va lid atio n wa s
fo rm u late d with th e u se o f a m o d e l o f d esign fo r
va lid atio n an d a se ries o f d e sign tactics [ 6] .
K. Alexande r and P. J. C larkso n G ood d e sign p r actice fo r m ed ical d e vices an d equ ip m en t, Pa r t II
T h e o ve r all ap p r o ach to d esign fo r va lid ation can b e
co m bin e d with o th e r go o d p r actice te ch n iq u es su ch as
d e sign fo r m an u factu r e an d assem b ly [ 9] , d e sign fo r
r eliab ility [ 10 ] an d d e sign fo r u sab ility [ 7, 11] . D u e to
th e d ive rse n atu r e o f th e m e d ical d e vice in d u stry in
b o th th e r an ge o f p ro d u cts an d sizes of co m p an ie s, D FV
h e lp s d e sign e rs ach ie ve go o d d esign p ractice th r o u gh
th e e n h an ce m e n t o f cu rre n t ISO 9001 [ 12] / U S Q u ality
Syste m Re gu latio n [ 2] ap p r oach e s an d is ad ap tab le to
b o th d evice an d p r o ce ss d e sign . De sign fo r va lid a tio n
was d e ve lo p e d in o rd e r to b e u n d e rsto od an d accessible
to a d ive r se au d ien ce o f d e vice d eve lo p e rs, p r o je ct
m an age r s an d q u ality m an age rs, all o f wh o m n e ed to
u n d e rstan d an d ap p ly go o d p ractice te ch n iq u e s.
T h e ap p ro a ch wa s e va lu ate d b y se n d in g q u e stio n n air e s
to in d u str y. T h e fe ed b ack wa s ve ry p ositive an d , b ased
o n th e e va lu atio n , re visio n s we re m ad e to th e d e sign fo r
va lid ation m od e l an d d e sign tactics. T h is p ap e r will
d e scr ib e th e ap p r o ach co n sistin g o f a m o d e l o f d esign
fo r va lid atio n an d a ser ie s o f d e sign tactics [ 13] . T h e
ap p ro ach p ro vid e s a fram e wo rk fo r m o r e sp e ci® c D FV
p ro jects, su ch as th e d e ve lo p m e n t o f tech n iq u e s to
su p p o rt m e d ical d e vice d e sign an d ve ri® catio n [ 14] an d
th e d e ve lo p m e n t o f a tech n iq u e to aid re q u ir em e n ts
cap tu re fo r m e d ical d e vice s [ 15 , 16 ] .
Mo de l o f de sign f o r valid atio n
Alth o u gh valid atio n p h ilo so p h ie s fo r p r o ce ss eq u ip -
m en t h ave b ee n in p lace fo r so m e tim e , cu rr e n t
m eth o d s fo r d evice va lid atio n are re lative ly n e w an d
n o t we ll u n d er sto o d . A m o d e l of d e sign fo r va lid a tio n
was d e ve lo p e d in an atte m p t to cle arly re p re se n t th e
stage s o f va lid atio n , in clu d in g ve ri® catio n an d q u ali® ca-
tio n , as th e y ap p ly to th e d e sign an d d e ve lo p m e n t
activitie s o f a typ ical m e d ical d evice p r o je ct. T h e m o d e l
in clu d es th e b asic p h ilo so p h ie s o f d esign co n tro l an d
p ro ce ss d e ve lo p m en t va lid atio n , b u t sh o ws th e activit ie s
in th e co n te xt o f th e e n tire p r o je ct. In d o in g so , th is
p ro vid e s a clear p ictu r e to m e m b e rs o f th e p r o je ct
te am , su ch as a d e vic e o r p ro ce ss d esign e r , o f h o w th e
activitie s in vo lve d in h is o r h e r p articu lar are a o f th e
p ro ject will im p act o th e r ar e as an d u ltim ate ly fo rm p art
o f th e o ve r all va lid atio n o f th e d e vice.
Valid atio n h as b e e n re p re sen te d in p re vio u s lite ratu r e
in th e fo r m o f th e wa te r fall m o d e l [ 17] an d th e
p ro d u ctio n d e ve lo p m e n t va lid a tio n V-m o d e l [ 18] . Part
I o f th is p ap e r sh o we d t h at th e m o d els p re se n t a cle ar
p ictu re of va lid atio n , b u t o n ly in re latio n sh ip to sp e ci® c
asp e cts o f a m e d ical d e vic e p ro je ct. T h e wa ter fall m o d e l
sh o ws va lid atio n an d ve r i® catio n as th e y re late to th e
m ajo r ste p s o f d e sign , b u t n o t as th ey re late to p ro ce ss
e q u ip m e n t d e ve lo p m e n t. T h e p r od u ctio n d e ve lo p m e n t
va lid ation V-m o d e l sh o ws a m o d e l o f va lid atio n th r o u gh
a se ries o f p ro d u ctio n eq u ip m e n t q u ali® catio n s an d
d o e s n o t ad d re ss an y ste p s o f d e vice o r p ro ce ss
e q u ip m e n t d e sign .
T h e wa te rfall m o d el an d p r o ce ss d eve lo p m e n t V-m o d e l
b o th r ep r ese n t sp e ci® c asp e cts o f va lid ation , b u t b o th
are lackin g th e o ve r all p ictu re o f va lid atio n as it ap p lie s
to d e vice d esign , p ro cess d e sign an d p ro d u ctio n
d eve lo p m e n t. Ba se d o n th e se re p re se n tatio n s, it is n o
su r p rise th at d e sign e r s co n sid e r d e vice va lid atio n to b e
co m p lete ly d iffer e n t th an p ro cess d eve lo p m e n t va lid a-
tio n . G o o d p ractice p ro p o ses th at th e o ve rall p h ilo so -
p h y o f va lid atio n is th e sam e wh e th e r it b e fo r a d e vice
o r its asso ciate d m an u factu r in g p ro cess e q u ip m e n t.
Va lid a tio n an swe rs th e q u e stio n : h ave we bu ilt th e righ t
th in g? Fo r a d e vice, th is is u ltim ate ly ach ie ve d b y
sh o win g th at th e ® n al d e vice m e e ts th e o rigin al u se r
n ee d s an d in te n d ed u se s. Pro ce ss va lid atio n re p re sen ts
th e sam e co n ce p t an d sh o ws th at th e p ro ce ss e q u ip -
m e n t m e e ts th e o rigin al u ser n e e d s an d in te n d e d u se s.
Figu r e 2 sh o ws va lid atio n as it ap p lies to th e d e sign an d
d eve lo p m e n t o f a m e d ical d evice . T h e m ajo r ste p s in
tran sfo r m in g u se r n e ed s to th e ® n a l m e d ical d e vice are
sh o wn as sh a d o we d b o xe s o n th e le ft h an d sid e o f th e
d iagr a m in te r m s o f `d e vice d e sign ’ , `p ro ce ss d e sign ’
an d `p ro d u ctio n d e ve lop m en t’ . It can b e se e n in th is
d iagr a m th at th e d e ve lo p m en t o f va lid atio n re q u ire -
m e n ts sh o u ld co m m e n ce as so on as th e u se r n ee d s are
kn o wn .
Wh ile d evice va lid a tio n e n co m p asse s all activitie s with in
th e lar ge `D evice Va lid atio n V’ o n th e d iagr am , p r o ce ss
va lid atio n in vo lve s all o f th e activitie s with in th e
`Pro ce ss Va lid atio n V’ in clu d in g th o se asso ciat ed with
p ro ce ss d e sign an d p ro d u ctio n d e ve lo p m e n t. Alth o u gh
`p ro ce ss d esign ’ an d `p r o d u ctio n d e ve lo p m e n t’ are
sh o wn se rially to sim p lify th e d iagr am , in actu al fact,
th ese two activitie s o ve r lap . Pro d u ctio n d e ve lo p m e n t is
u su ally in te gr ate d with p ro ce ss d e sign . Fo r in stan ce , th e
p ro to typ e m an u factu rin g e q u ip m e n t u se d for ve ri® ca-
tio n d u r in g p r oce ss d e sign u ltim ate ly b e co m e s th e ® n al
m an u factu rin g e q u ip m e n t at th e e n d o f p r od u ctio n
d eve lo p m e n t. Be fo re th e m e d ical d e vice re gu lat io n s
fo cu se d o n d e sign co n tr o l, p r oce ss va lid atio n wa s o ften
vie we d b y d esign e r s as o n ly b e in g ap p licab le to
p ro d u ctio n d e ve lo p m e n t an d n o t p ro ce ss d e sign .
T h e ® n al step o f va lid ation , wh e th e r fo r th e d e vice o r
p ro ce ss e q u ip m e n t, is p e rfo r m e d aga in st u se r n e e d s.
Figu re 2. T ypical medical device design an d developm en t
phases.
55
K. Alexande r and P. J. C larkso n G ood d e sign p r actice fo r m ed ical d e vices an d equ ip m en t, Pa r t II
`Pro ce ss u se r n e e d s’ e sse n tially co n sist o f th e d e vic e
d e sign sp e ci® cat io n an d p r o ce ss e q u ip m e n t re q u ire -
m en ts th at are o fte n d er ive d d u rin g th e d e vice d esign
p ro ce ss. `De vice u ser n e ed s’ are n o t so cle arly d e ® n e d .
D e vice u se r n e ed s m u st b e d er ive d fr o m a m u ltitu d e o f
d iffere n t so u rce s an d th e ir d er iva tio n is b y n o m ean s a
straigh tfo r wa rd p ro cess. T h u s, d evice va lid ation can b e
m u ch m or e co m p licate d th an p ro ce ss va lid atio n .
Valid atio n , o r p ro vin g ® tn ess fo r p u r p o se, in vo lve s an
e vid e n ce b u ild in g p ro ce ss th r o u gh all o f th e activitie s o f
th e d e sign an d d e ve lo p m e n t p ro cess. T h e last stage o f
va lid ation , p e rfo r m e d afte r p ro d u ctio n an d ve ri® cation
o f th e ® n al d e vice , u su ally in vo lve s clin ical tr ials o r
e va lu atio n s to en su r e th at th e ® n al p ro d u ct m e e ts th e
o rigin al u se r n ee d s an d in te n d e d u ses. Ve ri® catio n is a
p ro ce ss th at o ccu rs with in e ach o f th e d evice d e sign ,
p ro ce ss d e sign an d p r o d u ctio n d eve lo p m e n t activit ie s
an d p r o vid e s a m e an s fo r an swe r in g th e q u e stio n : are
we b u ild in g th e th in g righ t? Ve r i® catio n can b e
illu str ate d u sin g a m o re d e taile d r ep re se n tatio n o f th e
d e sign an d d eve lo p m e n t activitie s. Figu re 3 sh o ws an
e xa m p le of th e activitie s associate d with d e sign ve r i® ca-
tio n .
D e sign ve r i® catio n is th e p ro cess o f p ro vin g th at d esign
o u tp u ts m e e t d e sign in p u ts. Sin ce th e ve r i® catio n ste p s
o ccu r se q u e n tially d u r in g th e ite ratio n s o f th e d esign
an d d eve lo p m e n t activitie s, a cir cle is sh o wn in th e
ce n tre o f th e d iagr am . Sim ilar to th e va lid atio n
r eq u ir em e n ts, ve ri® catio n r e qu ir e m en ts can b e d e ve l-
o p e d as th e d e sign in p u ts are d e ve lo p e d . Pro ce ss
q u ali® catio n , sim ilar to d e sign ve ri® cation , is a m e an s
o f p r o vin g th at p ro ce ss d e ve lo p m e n t ou tp u t m e e ts
p ro ce ss d e ve lo p m e n t in p u t d u r in g th e d eve lo p m e n t o f
all th e m an u factu rin g an d te st e q u ip m e n t. T h e
se q u e n ce o f ste p s asso ciat ed with th is activit y, m ain ly
in stallatio n q u ali® catio n ( IQ ) , o p e r atio n al q u ali® catio n
( O Q ) an d p e rfo r m an ce q u ali® catio n ( PQ ) , fo rm p art
o f wh at is kn o wn as p ro ce ss valid atio n .
T h e ve r i® catio n p r o ce ss sh o wn in ® gu re 3 is co n tain ed
with in th e d e vice d e sign , p r o ce ss d e sign an d p r o d u c-
tio n d eve lop m e n t activitie s o f ® gu r e 2. T h e r esu lt is th e
d e sign fo r va lid a tio n V-m o d el sh o wn in ® gu r e 4. T h e
D FV V-m o d e l re p r e sen ts th e va lid atio n o f a m e d ical
d e vice as an e vid e n ce gath e r in g p r o cess, fro m u se r
n e ed s to th e ® n al p ro d u ct, to sh o w th at th e d e vice is ® t
fo r p u r p o se. T h e lar ge `d e vice va lid atio n V’ , re p re sen t-
in g th e o ve rall p ro ce ss o f va lid a tio n , co n tain s sm alle r
ve r i® catio n an d q u ali® catio n V’ s wh ich e n su r e th at
o u tp u t m e e ts in p u t d u rin g th e d e sign an d p ro d u ctio n
d e ve lo p m e n t activit ie s.
T h e activitie s o f ® n al p r o cess q u ali® catio n , ® n al p ro ce ss
d e sign ve ri® ca tio n an d ® n al d e vice d e sign ve ri® cation
are sh o wn exp licitly alo n g th e righ t h an d sid e o f th e
D FV V-m o d e l. T h e se activitie s sh o u ld b e p e r fo r m ed
with th e sam e d e vice s an d p ro ce ss e q u ip m e n t th at will
b e u sed fo r o n go in g p ro d u ctio n . O f n o te in th e m o d e l
is th at ite r atio n s sh o u ld take p lace with in th e d esign
an d d eve lo p m e n t activities, p re fe rab ly b e fo re th e
p ro d u ctio n o f th e ® n al d evice s. Iter atio n s re q u ire d
afte r th e p ro d u ctio n o f th e ® n al d e vice s, su ch as wh e n
56
d esign o r va lid ation p r o b le m s ar e d isco ve r e d d u r in g
u se r or clin ical tr ials, can b e e xtr em e ly co stly an d tim e
co n su m in g.
Pro ce ss q u ali® catio n o ccu rr in g with in th e p r od u ctio n
d eve lo p m e n t lo o p wo u ld in vo lve IQ an d O Q activities
o n site wh ich ar e r elate d to p r o vin g th e p r o cess
e q u ip m e n t m e e ts th e fu n ctio n al an d d esign sp e ci® ca-
tio n s. Fin al p ro ce ss q u a li® catio n , co m m o n ly kn o wn as
facto ry IQ an d O Q , in vo lve s p ro vin g th at th e ® n al
p ro d u ctio n e q u ip m e n t m e ets th e fu n ction al an d d e sign
sp e ci® cation wh e n th e e q u ip m e n t is in stalle d an d
o p er ated in th e factor y. Pr o ce ss e q u ip m e n t p er fo r-
m an ce q u ali® catio n ( PQ ) is r ep r e se n ted b y two
d iffere n t activities in th e DFV V-m o d el. `Fin al p r o ce ss
d esign ve ri® catio n ’ p r o ve s th at th e p r o ce ss eq u ip m e n t
p er fo rm s to th e p r o ce ss u ser re q u ir em en ts sp e ci® ca-
tio n . T h e ® n al ste p o f p r oce ss va lid atio n , also co n sid -
e re d p ar t o f PQ , p r o ve s th at th e d evice p r o d u ce d
co n siste n tly m e ets th e d evice d e sign sp e ci® catio n . T h is
step can n o t take p lace with o u t th e p ro o f o f all th e o th e r
ve ri® catio n an d qu ali® catio n activitie s asso ciate d with
p ro ce ss d e sign an d p ro d u ctio n d e ve lo p m e n t.
Fin al d e vice d esign ve ri® catio n p r o ve s th e p e r fo rm an ce
o f th e d e vice b y sh o win g th at it m e ets th e d e vice
re q u ire m en ts sp e ci® catio n . T h e ® n al ste p o f d e vice
va lid atio n , wh ich re q u ire s th e p ro o f o f all th e activities
alo n g th e le ft an d r igh t h an d sid e o f th e D FV V-m o d el,
in vo lve s clin ical tr ials o r e va lu atio n s to p ro ve th e ® n al
d evice m e e ts th e in itial u se r n ee d s an d in ten d e d u se s.
T h e DFV V-m o d el p ro m ote s th in kin g ah e ad to va lid a-
tio n an d ve ri® catio n re q u ire m e n ts wh ile at th e in p u t
stage s o f th e d e sign an d d e ve lo p m e n t activities, as
illu strate d b y th e d ash e d lin e s in th e m o d e l. Fo r
in stan ce , d u r in g th e in itial stage s o f th e p r o je ct, th e
te am n e e d s to th in k ah e ad to th e typ e o f clin ical trials
o r e va lu atio n s th at will b e r eq u ire d fo r th e ® n al stage o f
d evice va lid atio n . Wh ile at th e d esign in p u t stage s,
d esign e r s n ee d to th in k ah ead to th e d e sign ve ri® catio n
an d p r o ce ss q u ali® catio n th at will b e re q u ire d . Go o d
d esign p ractice te ch n iq u e s, su ch as d e sign fo r u sability,
sh o u ld b e co n sid e re d wh e n p lan n in g th e ap p r o p riate
ve ri® catio n an d va lid atio n activit ie s.
Figu re 3. A ctivities associated with design veri® cation .
K. Alexande r and P. J. C larkso n G ood d e sign p r actice fo r m ed ical d e vices an d equ ip m en t, Pa r t II

Figu re 4. T he design for validation (DFV) V-model.

D e sign tactics

By e n co u r agin g d e sign er s to th in k ah e ad to va lid a tio n

an d ve ri® catio n , th e D FV V-m o d e l p r ovid e s a fram e-
wo r k fo r d e sign e rs to take a p ro active ro le to wa r d s
va lid ation . H o we ve r , ad d itio n al gu id an ce is n ecessary in
o rd e r to h e lp d e sign er s fo cu s th e ir p ro active e ffo r ts o n
sp eci® c activitie s d u r in g d e sign . D e sign tactics ar e u sed
fo r th is p u r p o se b e cau se th e y ar e ap p licab le to a wid e
r an ge o f d e vice s, e n h an ce e xistin g d esign m e th o d s,
e xte n d th e cu rr e n t m e d ical d e vic e r egu la tio n gu id an ce ,
p ro vid e p ractical gu id an ce to h e lp d e sign e rs ach ie ve
go o d p ractice an d ar e ad ap tab le to d e vic e an d p ro ce ss
d e sign . At th e h e art o f th e d e sign tactics lie s a ge n e ric
ve r i® catio n m o d el, wh ich is a sim p le d e riva tive o f th e
D FV V-m o d e l. T h e gen e ric ve r i® catio n m o d e l will b e
d e rive d in th e fo llo win g se ctio n . O n ce fo rm u late d , th e
m o d e l is u sed to p re se n t e ach o f th e six d e sign tactics.

Fo rm ulation o f a ge ne ric ve ri® catio n mo del
T h e se q u e n ce o f ve r i® catio n activitie s p re sen te d in
® gu re 3 co n tain s a m ixtu r e o f o b je cts an d activit ie s. In
o rd e r to aid in th e p r ese n tatio n o f th e d esign tactics, a
m o d e l can b e fo r m u late d wh ich re p re se n ts all activit ie s
as b o xe s an d all o b je cts as ar ro ws. Figu r e 5 sh o ws th at
th e d e sign ve ri® catio n m o d el can b e co lle cte d an d
r en am e d in to a gen e ric ve ri® catio n m o d e l.
T h e ge n e r ic ve ri® catio n m o d e l d e ® n es th e we ll
kn o wn r eq u ire m e n ts cap tu r e , d e sign an d ve r ify
Figu re 5. Creation of a gen eric veri® cation model from design
veri® cation .
seq u e n ce fo u n d in m o st p ro d u ct d e ve lo p m e n t m o d e ls
an d is a sim p li® e d ve rsio n o f th e lar ge r m o d el fo u n d
in so ftwa re e n gin e er in g te xts [ 19] . T h e se q u e n ce o f
activitie s con tain e d in th e ge n e ric ve r i® catio n m o d e l
will o ccu r re p e ated ly as th e d e vice an d p r o cess
d esign s p ro gr e ss fr o m in itial re q u ir em en ts th ro u gh
to d e tailed d e sign .

57
K. Alexande r and P. J. C larkso n G ood d e sign p r actice fo r m ed ical d e vices an d equ ip m en t, Pa r t II

T h e id eal e xe cu tio n se qu e n ce fo r th e m o d e l is: can b e in eith e r im p licit o r exp licit fo rm . Exp licit
re q u ire m en ts ar e th o se wh ich ar e cle arly e xp re ssed
( i) r e q u ire m e n ts cap tu r e; wh ile im p licit re q u ire m e n ts are th o se wh ich are
in d ire ctly e xp r e sse d . U n id e n ti® e d o r in co rr e ct re q u ire -
( ii) d e® n e ve ri® catio n re q u ire m e n ts; m e n ts can le ad to e xce ssive d e ve lo p m e n t co sts o r , in th e
wo r st case , th e d e ve lo p m e n t o f a p ro d u ct th at is n o t ® t
( iii) d e sign ; fo r p u r p o se. T h u s, a syste m a tic ap p ro ach sh o u ld b e
u se d to e n su r e th e im p licit an d e xp licit re q u ire m en ts
( iv) ve rify. fo r a d evice an d its p ro ce ss e q u ip m en t are cap tu r ed . In
e sse n ce , th e r eal n ee d fo r a p r o d u ct m u st b e id en ti® e d .
O n e ke y elem e n t in a ge n e ric m o d e l, wh ich is n o t
fo rm ally re p re se n te d in p ro d u ct d e ve lo p m e n t m o d e ls,
is th e activity o f d e ® n in g ve r i® catio n re q u ire m en ts.
Ve r i® cation re q u ire m e n ts n e e d to b e d e rive d , as far as
it is p ossible, fr o m th e p r o d u ct r eq u ire m e n ts b e fo re
startin g th e d esign . In p ractice , th e ve ri® cation re q u ire -
m en ts, wh ich ar e p ar t o f th e ve ri® cation an d va lid a tio n
p ro ce ss, will b e re ® n e d as th e d e sign p r o gr esse s.

A se r ie s o f six d e sign tactics will b e p r ese n te d in th e

fo llo win g se ctio n s u sin g th e co m m o n fram ewo r k o f th e
ge n er ic ve ri® catio n m o d e l. T actics 1 to 4 ar e sh o wn in
® gu re 6 wh ile tactics 5 an d 6 are illu str ate d in ® gu r e 7.
T h e tactics we re fo r m u late d b ase d o n th e p rin cip le s o f
go o d p ractice an d ar e aim e d at sp e ci® c are as o f th e
d e sign an d d e ve lo p m en t p ro ce ss wh e re d esign fo r
va lid ation can b e p ar ticu larly e ffe ctive .

T actic 1: captu re implicit an d explicit requ iremen ts

Valid atio n in vo lve s p ro vin g th at a p r o d u ct m e e ts its u se r Figu re 6. Illustration of tactics 1 to 4 u sin g the gen eric
n e ed s an d in te n d ed u se s. Re qu ire m e n ts fo r a p r od u ct veri® cation model.

Figu re 7. Illustration of tactics 5 an d 6 u sin g the gen eric veri® cation model.

58
K. Alexande r and P. J. C larkso n G ood d e sign p r actice fo r m ed ical d e vices an d equ ip m en t, Pa r t II
Re q u ire m e n ts cap tu re is th e id en ti® catio n an d d o cu -
m en tatio n o f th e r eq u ir em e n ts th at th e d e sign m u st
satisfy. T h e re q u ire m e n ts lay th e fou n d at io n fo r th e r e st
o f th e d e sign . T h e re fo re , it is esse n tial th at th e y are
co rr e ct. A go o d re q u ir em e n ts sp e ci® catio n m ay in -
cr ease q u ality o f th e p r od u ct an d re d u ce d e sign tim e
an d co sts. A b ad r eq u ir e m e n ts sp e ci® catio n m ay r esu lt
in d e lays, ad d itio n al co sts, o r at wo rst, th e wr o n g
p ro d u ct [ 15] .
T h e ab o ve state m en t can b e u n d e rsco r e d u sin g th e case
o f N ASA’ s d e sir e to d e ve lo p a pen fo r u se in sp ace .
U sin g th e r eq u ir em e n t fo r a p en to u se in sp ace , N ASA
sp en t seve r al m illion U S d o llar s to d eve lo p a d e vic e
cap ab le o f wr itin g u n d e r ze ro -gravity co n d itio n s. Wh e n
th e Ru ssian s we re faced with th e sam e task, th eir
r eq u ir em e n t wa s fo r a m e an s to write in sp ace. As a
r esu lt, th e y to o k a p e n cil.
Re q u ire m e n ts sh o u ld b e co rr ect, co m p lete , clear an d
r ep re se n t th e n e e d s of all u se rs o f th e p r od u ct
th ro u gh ou t its e n tire life cycle . Su ch u se r s in clu d e n o t
o n ly th e p atie n t, b u t also d o cto r s, n u rse s, in stallation
an d se r vice p e rso n n e l, p ro d u ctio n an d va lid atio n
e xp e rts, m arke tin g an d b u sin e ss m an age rs an d m an y
o th er s. T h e re q u ire m en ts, wh ich can b e wr itte n in th e
fo rm of d e m an d s o r wish e s, sh o u ld b e ke p t in so lu tion
n e u tr al te rm s th at sp e cify what th e d e sign m u st ach ie ve ,
b u t n o t how it will b e ach ieve d . D e m an d s ar e th e
r eq u ir em e n ts th at th e p r o d u ct m u st satisfy. Wish e s are
r eq u ir em e n ts th at are d esir ab le fo r th e d e sign to satisfy,
b u t are n o t e sse n tial.
A th r e e-p art m eth o d fo r cap tu rin g im p licit an d exp licit
r eq u ir em e n ts fo r m e d ical d e vices h as b e e n p r o p o se d in
a wo r kb o o k b y Sh e fe lb in e et al. [ 16] . T h e m e th o d to
cap tu re re q u ire m e n ts co n sists o f a fu n ctio n al an alysis to
d e ter m in e fu n ctio n al an d p er fo r m an ce ch ara cter istics,
a m atrix ch e cklist to d ete r m in e ge n e ral re q u ir em e n ts
th at ap p ly to th e en tir e p ro d u ct an d re gu lato r y
r eq u ir em e n ts gu id e lin e s to p ro vid e in fo rm atio n o n
r egu latio n s an d stan d ard s fo r th e EU an d U n ite d State s.
T h e re q u ir em e n ts cap tu re d u sin g th e th re e -p art m e th -
o d are th e n d r afte d in to a re q u ire m en ts sp eci® catio n
u sin g a b asic te m p late with stan d ard h e ad in gs. A
stru ctu re d m e th o d can b e u sed in co n ju n ctio n with
d e sign fo r u sab ility [ 8, 11 ] tech n iq u e s to h e lp th e
d e sign e r take a life -cycle ap p r oach to re q u ir em e n ts
ge n er atio n in o rd e r to p ro d u ce a re q u ir em e n ts
sp eci® catio n th at is b ro ad b ase d wh ile r e m ain in g
co n cise an d cle ar.
In su m m a ry, it is go o d p ractice to id en tify as m an y
r eq u ir em e n ts as p o ssible b e fo re startin g th e d esign
p ro ce ss. Alth ou gh e xp licit r eq u ir em e n ts are o fte n easy
to id e n tify an d d o cu m e n t, d e sign e r s m u st also be awa re
o f th e n e ed to cap tu r e im p licit re q u ire m en ts. T h e se
m ay n o t b e o b vio u s, b u t are o f e q u al im p o r tan ce to th e
d e sign . System atic m e th o d s can b e e xtre m e ly u se fu l in
h e lp in g to cap tu r e all typ e s of re q u ire m e n ts b e cau se
th ey e n co u rage d e sign e rs to e xa m in e th e u se r n e e d s
an d in ten d ed u se s o f a p r o d u ct th r o u gh o u t its life cycle .
T actic 2: requ iremen ts shou ld be veri® able
All re q u ire m en ts are d e® n ed in o rd e r to b e fu l® lle d .
T h is is p ar t o f th e p ro ce ss o f sh o win g th at th e d e vic e is
® t fo r p u rp o se . T h u s, e ach re q u ire m e n t sh o u ld h ave an
asso ciat ed p e r fo rm an ce targe t th at can be m e asu re d in
o rd e r to ve rify th at th e r eq u ir em e n t h as b e e n m e t. Su ch
targe ts sh o u ld , wh e re p o ssible , b e q u an titative with
n u m e rical lim its. Wh er e r eq u ire m e n ts can n o t b e
d e® n ed q u an tita tive ly, e va lu atio n again st q u alitative
criter ia sh o u ld b e co n sid e r e d . Fo r e xa m p le , d e sign fo r
u sab ility p ro vid es gu id an ce o n asse ssin g ae sth e tic an d
u sab ility r e q u ir e m e n ts via u se r tr ials.
Co n sid er th e case o f an in fu sio n p u m p . In itially, a
re q u ire m en t state d th at `th e d e vice sh o u ld m ain tain th e
p atie n t’ s b o d y te m p e r atu r e d u rin g in fu sio n ’ . H o we ve r ,
is it p ractical to e xp e ct an in fu sio n p u m p to m easu re
an d co n tr o l b o d y te m p e ratu re o r wo u ld it b e b e tte r fo r
th e re q u ir em e n t to re ad `¯ u id sh ou ld b e tran sfu se d at
n o rm al b o d y tem p e ratu re ’ ? T h in kin g ah e ad to ve ri® ca-
tio n d u r in g th e d e ve lo p m en t o f th e in itial re q u ire m en ts
wo u ld h ave h igh ligh ted th e d if® cu lty in p r o vin g th e
d evice m ain tain e d b od y te m p er atu re d u r in g in fu sio n .
Re q u ire m e n ts co n tain e d in all sp e ci® catio n s th r o u gh -
o u t th e d e sign an d d e ve lo p m e n t p r oce ss n e ed to b e
ve ri® ab le. Sp e ci® catio n s se rve as a d e sign in p u t d u r in g
th e sp ir allin g n atu r e o f d e sign . De sign co n tro l re gu la-
tio n s sp e cify th at d e sign o u tp u t m u st b e ve ri® e d aga in st
d esign in p u t. T h u s, e ve ry d e sign in p u t m u st b e ve ri® e d
to sh o w th at it h as b e e n fu l® lled .
O n e o f th e ke ys to go o d d e sign an d va lid a tio n is th e
p ro d u ctio n o f str aigh tfo rwa rd an d ve ri® ab le sp e ci® ca-
tio n s b e fo re th e wo rk is co m m e n ce d at each stage o f th e
d esign an d d e ve lo p m e n t p ro ce ss. D e® n in g ve ri® catio n
re q u ire m en ts in p aralle l with all d e sign re q u ire m en ts
allo ws n o n -te stab le re q u ire m en ts to b e id e n ti® e d an d at
a ve r y e arly stage . T h u s, fo r e ve ry d esign re q u ire m en t
co n tain ed in a d e sign sp eci® catio n , th e r e sh o u ld be a
co rr esp o n d in g ve r i® ca tio n re q u ire m e n t with acce p -
tan ce crite ria co n tain e d in a ve ri® catio n sp e ci® catio n .
As a re su lt, q u alitative re q u ire m e n ts can be ad d re ssed
u p fr o n t b e fo r e fu rth e r d e sign is car r ied o u t an d
alte rn ative ve ri® catio n m e th o d s o r eve n a ch an ge in
re q u ire m en t can b e im p le m e n te d .
In su m m ar y, d e sign er s m u st th in k ah e ad an d p lan th e
ve ri® catio n of each d e sign re q u ire m e n t. It is go o d
p ractice to d e ve lo p ve r i® catio n sp e ci® catio n s in p ar alle l
with th e fo rm u latio n o f r e q u ire m en ts sp e ci® catio n s.
T h is h e lp s d esign e r s to id en tify re q u ir em e n ts n ee d in g
sp e cial q u alitative ve r i® catio n p r o ced u re s th at cou ld b e
co stly an d tim e co n su m in g if n o t id en ti® e d e ar ly in th e
d esign p r oce ss.
T actic 3: u se a risk based approach to design an d veri® cation
Risk an alysis sh o u ld p lay an im p o rtan t ro le in b o th th e
d esign an d ve ri® catio n o f m e d ical d evice s. Bo th th e EU
an d th e U S r e qu ir e risk an alysis as p art o f d e sign
co n tr o l. T h e cycle of risk id e n t i® catio n , r isk asse ssm e n t
an d r isk re d u ctio n fo rm s th e p r oce ss o f risk m an age -
59
K. Alexande r and P. J. C larkso n G ood d e sign p r actice fo r m ed ical d e vices an d equ ip m en t, Pa r t II
m en t. A r isk m an age m en t p ro gram m e sh o u ld star t with
a p r elim in ar y h aza rd an alysis p e rfo r m e d o n th e u se r
n e ed s an d co n tin u e th r o u gh th e life cycle o f th e d e vic e
u n til it is re m o ve d fro m se r vice . An in tegrate d ap p r o ach
to r isk m an age m e n t in clu d in g d evice d e sign , p ro ce ss
d e sign an d p r od u ctio n d e ve lo p m e n t will d rive th e
ve r i® catio n of th e d esign , th e q u ali® catio n o f th e
p ro d u ctio n e q u ip m e n t an d co n trib u te to valid atio n o f
th e ® n al d e vice .
Risk id en ti® catio n an d r isk asse ssm e n t can b e ach ieve d
th ro u gh th e u se o f to o ls su ch as fau lt tr ee an alysis
( FT A) [ 20 ] , failu re m o d e an d e ffe ct an alysis ( FMEA)
[ 21 ] , failu r e m o d e e ffe ct an d criticality an alysis ( FM E-
CA) [ 10] , h azar d an alysis cr itical co n tr o l p oin ts
( H ACC P) [ 22, 23] an d h azard an d o p er ability stu d y
( H AZO P) [ 24] . T h e se to o ls can also b e u se d to id e n tify
th e failu r e m o d e s an d r isks as we ll as critical d e vice ±
u ser in te ract io n s. D ru g d e live ry d evice s, su ch as p e n
in je cto rs, o fte n re q u ir e as m an y as twe n ty se p ar ate
actio n s to e n su r e p r o p e r u se. O f th e se actio n s, p o ssibly
® ve are critical fo r safe o p e ratio n . Su ch cr itical actio n s
d e m an d sp ecial care d u r in g d esign eith e r to e n su re
fo o lp ro o f o p er atio n th ro u gh sou n d e rgon om ic d esign
o r to r ed u ce th e ir criticality.
Alth o u gh risk r ed u ctio n is cr itical b e cau se it in ¯ u e n ces
ve r i® catio n re q u ir em e n ts an d d e sign , re se arch sh o we d
th at th is is cu rre n tly n o t we ll im p lem e n te d [ 6] . Risk
r ed u ctio n , ad d re sse d in stan d ard s su ch as EN 1441 [ 25]
an d EN 6060 1-1-4 [ 26] , sh o u ld fo cu s o n r ed u cin g a
r isk’ s seve rity an d / o r like lih oo d u n t il th e r isk is d ee m ed
acce p tab le . If it is n o t p o ssible to re d u ce th e r isk to
acce p tab le le ve ls b y d esign m e asu r es, th en r isks sh o u ld
b e b ro u gh t to an acce p tab le leve l th r o u gh m itiga tio n
e ffo rts su ch as ve ri® catio n an d q u ali® catio n .
In th e e arly stage s o f a p ro je ct, risk m an age m e n t is u sed
to id e n tify we akn e sses in th e d e sign . In th e latte r stage s
o f a p r o je ct as th e d e sign b eco m e s m o re d e taile d , risk
m an age m e n t is u se d to sh o w ro b u stn ess an d safe ty o f
th e p ro d u ct o r p ro ce ss. Ad d re ssin g r isks at a d esign
le ve l is m u ch m o r e co st e ffective th an ad d re ssin g th e
r isks at th e valid atio n stage wh e re th e p ro d u ct an d
p ro ce sse s h ave b ee n ® n alized . Risk m an age m e n t is
p articu la rly u se fu l fo r in n o va tive p ro d u cts an d p ro -
ce sse s as it p ro vid e s d e sign e rs with an e xce lle n t b asis fo r
m akin g th e ir d e sign an d ve ri® catio n d ecision s.
In su m m ar y, it is goo d p ractice to u se risk m an age m e n t
th ro u gh ou t a m e d ical d e vic e p ro ject. Syste m atic m e th -
o d s su ch as FT A an d FM EA can b e u se d to id e n tify an d
asse ss p ote n tial risks fr o m th e re q u ir e m e n ts ca p tu re
stage th ro u gh to d e taile d d e sign . Alth o u gh it is
p re fe rab le to r ed u ce u n acce p tab le risks th r ou gh d esign
m easu re s, it m ay also b e p o ssible to u se ve r i® catio n as a
fo rm of m itiga tio n . T h u s, a r isk b ased ap p ro ach can b e
u sed to d rive bo th th e d esign an d ve ri® catio n o f a
d e vice an d its r elate d p ro ce ss e q u ip m en t.
T actic 4: con sider the effects of redesign on requ iremen ts
Wh e n r e d e sign is r e qu ire d as a re su lt o f ve ri® cation
o r th e id en ti® catio n o f er ro r s in d e sign , th e e ffe cts o f
60
th e re d e sign o n th e ab ility o f th e d e vice o r p ro cess to
m e e t th e re q u ir em e n ts sh o u ld b e co n sid e re d . In
so m e case s, th is m ay le ad to re q u ire m en ts b e in g
clari® e d o r ch an ge d an d in all case s, th e re vise d
d esign will re q u ire re -ve ri® catio n . T h is latte r p o in t is
p articu larly tru e in so ftwa re d e sign . It is all to o e asy
to `® x’ so ftwa r e fau lts with th e m in im u m of re -
ve ri® catio n . H o we ve r , in m o st case s th is in e vitably
le ad s to th e in tro d u ctio n o f fu rth e r fau lts. It is a
so b er in g th o u gh t th at in th e so ftwa re d esign in d u stry,
it is wid e ly accep te d th at as m an y fau lts, wh ich are
d isco ve re d d u r in g ve ri® catio n , are left u n d ete cte d in
th e ® n al co d e [ 27] .
D esign is a p r o ce ss co n sistin g o f d iffer e n t p h ase s.
T h u s, th er e will b e r eq u ire m e n ts fo r e ach p h ase o f
th e d e sign su ch as u se r re q u ire m e n ts, fu n ctio n al
re q u ire m en ts, em b o d im e n t re q u ire m en ts o r d e taile d
d esign re q u ire m en ts. T h e e ffe cts o f a re d e sign will
h ave to b e e xp lo r e d , ve ri® ed an d p o ssibly va lid ate d
with th e ap p ro p r iate r eq u ire m e n ts. Fo r in stan ce , a
d etaile d d esign ch an ge m igh t o n ly re q u ir e ve ri® ca-
tio n again st th e d e taile d d esign re q u ir em e n ts. H o w-
e ve r, a d eta ile d d e sign ch an ge co u ld also br in g
ab o u t th e ge n e r atio n o f an en tire ly n ew re q u ire -
m e n t. T h e e ffo rt re q u ire d to im p le m en t a n e w
re q u ire m en t m igh t be su b stan tial as th e d e sign e r
m u st track b ack to th e b e gin n in g o f th e d e sign
p ro ce ss to im p le m e n t th e ch an ge alo n g with th e
ap p r o p riate ve ri® catio n an d va lid ation m e asu r es to
e n su re th at th e n e w re q u ire m en t h as b e e n p ro p e r ly
ad d r e sse d .
O n e o f th e ke ys to re d e sign is to u n d e r stan d th e
im p licatio n s o f th e ch an ge o n ot h e r are as o f d esign an d
va lid atio n . T h is r eq u ire s an accu rate se t o f d e sign
re q u ire m en ts an d a we ll d o cu m en te d an d u n d e rsto o d
d esign . Fu n ctio n al m o d e ls are p ar ticu larly u sefu l fo r
h elp in g visu alize th e im p licatio n s o f a r ed e sign . T h e
im p acts o f a d e sign ch an ge can b e tracke d u p th ro u gh
th e h ie rar ch ical laye r s o f th e m o d e l.
Activities su ch as d esign r e vie ws an d re visitin g th e
h azard an d fau lt an alysis will also aid th e d e sign e r in
u n d e rstan d in g th e fu ll im p licatio n s o f th e re q u ir ed
ch an ge . O ve rall, a p lan sh o u ld b e p u t to ge th er at th e
b e gin n in g o f a p ro ject wh ich o u tlin es th e stru ctu re d
activitie s to b e im p le m e n te d if a r ed e sign is r e qu ire d .
All to o o fte n , p lan n in g d o es n o t take p lace u n til afte r
th e n e e d fo r a re d e sign h as b ee n d isco ve r e d . T h is can
le ad to th e situ ation wh e re p r o je ct te am s scr am b le to
im p lem e n t a q u ick-® x so lu tio n with o u t p ro p er ve ri® ca-
tio n o r va lid a tio n .
In su m m ary, it is im p er ative th at d e sign e rs e xp lo r e an d
asse ss th e im p act o f re d e sign o n th e wh o le o f th e d e sign
p ro ce ss.
T actic 5: con sider the effects of device requ iremen ts, design an d
veri® cation on process requ iremen ts an d validation
D ecision s m ad e d u r in g th e d e vic e r e qu ir e m e n ts cap -
tu re , d e sign an d ve ri® catio n activities m u st be e xp lo r ed
to u n d e rstan d th e ir im p act o n th e r eq u ir em e n ts fo r th e
K. Alexande r and P. J. C larkso n G ood d e sign p r actice fo r m ed ical d e vices an d equ ip m en t, Pa r t II
r elate d p ro ce ss e q u ip m e n t. T h is re vie w m u st also
co n sid e r th e va lid atio n re q u ir em e n ts o f su ch eq u ip -
m en t. T h is is p ar ticu lar ly tru e for n o ve l d evice s wh e re
little is kn o wn in itially ab o u t th e r o b u stn e ss o f th e
d e vice d e sign .
T h e p ro d u ct an d m an u factu rin g p ro ce ss can b e
d e ® n e d in p aralle l. D u rin g th e ear ly stage s o f d e vic e
d e sign , wh e th e r it b e at th e u ser re q u ir em e n ts
sp eci® catio n o r at th e in itial d e vice co n cep t stage ,
d e sign e r s m u st th in k ah e ad to wh at p ro ce sses will b e
r eq u ir ed to m an u fa ctu r e th e p r o d u ct. As a ste p fu r th e r ,
th e d e sign e r m u st also e xp lo r e th e re q u ir ed p ro ce ss
ve r i® catio n an d qu ali® catio n . Pro ce sse s an d m ater ials
h ave lim itatio n s an d a d e sign e r m u st b e awa r e o f th o se
lim itatio n s d u r in g th e d e sign o f th e d evice . Pro cesses
su ch as ster ilizatio n can p lace co n strain ts o n th e d esign
an d p o te n tially cau se d e vic e q u ality p ro b lem s. Risk
an alysis can p lay a ke y ro le in h igh ligh tin g p ro ce ss
d e sign , ve r i® catio n an d va lid atio n r e qu ire m e n ts d u rin g
d e vice d e sign .
T h is tactic m ay ap p e ar to be a statem e n t o f th e o b vio u s.
H o we ve r , n u m e ro u s FD A wa rn in g n otice s r e late th e
failu r e to ve r ify cr itical d e vice fu n ctio n s d u rin g m an u -
factu re o r to va lid ate th e asso ciate d m an u factu rin g
p ro ce sse s. Co n sid e r, fo r e xa m p le , th e fo llo win g FD A
war n in g n o tice: `T h e re is in su f® cie n t evid e n ce to
su p p o rt th at th e ster ilizatio n d o se is cap ab le to ach ie ve
th e sp e ci® e d ste rility assu r an ce le ve l.’ Co n sid er atio n o f
m an u factu rin g p r o ce ss va lid atio n d u r in g d e vice d esign
wo u ld h ave m ad e th is p articu lar p r o d u ct re call u n likely.
O n e m e th od th at can b e u sed to e xp lo r e th e
m an u factu rin g p r o ce ss is to co n stru ct a p r o ce ss ¯ o w
d iagr am b ase d o n th e d evice co n ce p t. T h e p ro ce ss ¯ o w
d iagr am sh o u ld in clu d e th e r eq u ire d m an u factu rin g
o p e ratio n s an d th e in p u ts an d o u tp u ts to e ach
o p e ratio n will fo r m th e b asic re q u ir em e n ts fo r e ach
p ro ce ss ste p . T h e re q u ire m e n ts will in itially b e ve ry
ge n er al, b u t will b e co m e m o re sp eci® c as th e d e vic e
d e sign an d p ro ce ss d e sign b e co m e m o r e d e tailed . By
th e en d o f th e d e vice d esign p ro ce ss, th e re sh ou ld b e a
d e taile d p ro ce ss ¯ o w d iagr am with th e r eq u ir ed states
o f all th e o p e ratio n s. T h u s, a d e taile d re q u ire m e n t
sp eci® catio n can b e wr itte n fo r e ach m ach in e o r
o p e ratio n .
In su m m ary, d esign e r s m u st u n d e rstan d th e re latio n -
sh ip s b e twe e n th e d e sign , ve r i® catio n an d va lid atio n o f
a d e vice an d its asso ciat ed p ro ce ss e q u ip m en t.
T actic 6: con sider the effects of process redesign on device
requ iremen ts
T h e effects o f re d e sign p e rfo r m e d d u r in g th e m an u -
factu rin g p r o ce ss d e sign an d d e ve lo p m e n t m u st b e
u n d e rsto o d an d , if n e cessary, re ¯ e cte d in th e d e vic e
r eq u ir em e n ts. In n o va tive d evice s o fte n d e m an d in n o -
va tive m an u factu rin g p ro ce sse s an d wh e re th e se p ro -
ce sse s fail to p e rfo r m ad e q u a tely, th e p er fo rm an ce o f
th e re su ltin g d e vice m ay also b e co m p r o m ise d . Pro ce ss
d e sign an d d e ve lo p m e n t m igh t b rin g to ligh t p ro b le m s
th at h ad n ot b ee n ad d r e sse d d u r in g d evice d esign . In
th e p ast, th e re h as b e e n a te n d e n cy to m ake d e sign
ch an ge s d u rin g th e p r o cess d e ve lo p m e n t stage with o u t
co n sid e r in g th e fu ll im p licatio n s o f th e ch an ge s o n
o th e r are as o f d e sign an d va lid atio n .
Fo r e xa m p le , d u rin g th e m an u factu r in g p ro ce ss o f a
p articu lar d e vice , th e th r e ad p itch o f th e d evice h an d le
wa s fo u n d cu t at an in co rre ct an gle . T h e e r ro r was
ju d ge d n o t to b e cr itical an d th e p r o cess sp e ci® cation
wa s su b se q u e n tly am e n d e d to re ¯ e ct th e ch an ge .
H o we ve r , it wa s late r d isco ve re d d u rin g clin ical e va lu a-
tio n s th at th e p r o d u ct was n o t fu n ctio n in g p r o p e r ly. An
in d e p th an alysis of th e p ro b le m sh owe d th at th e
o rigin al th re ad p itch wa s critical to th e p ro p er
fu n ctio n in g o f th e d e vice . T h e re fo r e, th e ch an ge in
p itch co n trib u te d to th e e n tir e d e vic e be in g u n ® t fo r its
in te n d e d p u rp o se . A m o r e th o ro u gh r e vie w fo llowin g
th e in itial e rro r co u ld h ave avo id e d fu rth e r co stly
re d e sign th at wa s d isco ve r ed late in th e d e ve lo p m en t
p ro ce ss.
In o r d e r to u n d er stan d th e in ¯ u e n ce s o f p r o ce ss
re d e sign o n th e d e vice , th e d e sign er m u st exp lo re th e
im p acts o n d e vice d e sign in p u t, d e sign o u tp u t, d e sign
ve ri® catio n an d th e en tire d e vice va lid atio n . Fo r
in stan ce , m akin g sligh t ch an ge s to th e p r o d u ct in o rd e r
fo r p ro ce ss eq u ip m e n t to o p e rate m o r e effe ctive ly
co u ld h ave m ajo r im p licatio n s as th e r e d e sign will
re su lt in a ch an ge to th e d e vice d esign . T h e wo rst case
m igh t b e th at th e r e is a n e ed to r ep e at all va lid atio n
in clu d in g clin ical trials. T h is is tr u e fo r d e vice d e sign
ch an ge s as we ll as th e u se o f n ew p ro ce sse s, m ater ials o r
p acka gin g o n an e xistin g d e sign .
In su m m ar y, d e sign er s m u st e xp lo r e th e im p acts o f
ch an ge s m ad e to th e d esign o f th e m an u factu rin g
e q u ip m e n t. T h is in clu d e s in ve stiga tin g th e im p acts o f
an y p ro ce ss e q u ip m e n t r ed e sign o n th e d e sign ,
ve ri® catio n an d o ve r all va lid atio n o f th e m e d ical d evice .
Sum mary
G o o d d e sign p ractice e n co u r age s th e in te gr atio n o f
d esign , d e ve lo p m e n t an d va lid ation o f m e d ical d e vices
an d asso ciate d m an u factu rin g e q u ip m e n t. Par t I o f th is
p ap e r co n tain e d a re vie w o f m e d ical d e vice re gu latio n s,
stan d ard s, gu id an ce d o cu m e n ts an d D FX te ch n iq u es
th at we re re late d to go o d d e sign p ractice. Sp e ci® c
atte n tio n wa s p aid to r evie win g d o cu m e n ts in th e ir
co n tr ib u tio n o f e n co u ragin g in te gr ate d d e sign an d
va lid atio n . It wa s sh o wn th at n o n e o f th e p re sen t
lite r atu r e p ro vid e d an o ve rall vie w o f th e in te gr atio n o f
va lid atio n with d e vice d esign , p ro ce ss d esign an d
p ro d u ctio n . O f th e d o cu m en ts th at we re sp eci® cally
aim ed at th e in te gr atio n o f va lid atio n with d e sign , n o n e
p ro vid e d p ractical gu id an ce o n th e in d ivid u al ste p s o f
d esign an d va lid atio n in wh ich th is co u ld o ccu r.
T h is p ap er d e scrib ed an ap p ro ach to d esign fo r
va lid atio n th at wa s fo r m u late d to p ro vid e go o d p r actice
gu id an ce fo r d e sign e rs to e n ab le in tegr ated d e sign ,
d eve lo p m e n t an d va lid atio n . T h e ap p ro ach to o k th e
fo rm o f a d e sign fo r va lid atio n V-m o d e l an d a ser ie s o f
61
K. Alexande r and P. J. C larkso n G ood d e sign p r actice fo r m ed ical d e vices an d equ ip m en t, Pa r t II

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p ractical ap p ro ach th at is ap p licab le to a wid e r an ge syst e m sÐ Mo d e l fo r q u ality assu ra n ce in d e sign / d e ve lo p -
o f d e vice s, e n h an ce s e xistin g d e sign m e th o d s, e xte n d s m e n t, p ro d u ctio n , in sta llatio n a n d se r vicin g, EN ISO 9001:
1994 ( Lo n d o n : British Stan d ar d s In stitu te) .
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13. ALEX AN D ER , K., C LARKSO N , P. J., an d B ISH O P , D., 1999, De sign
ad ap tab le to d e vice an d p ro cess d e sign .
fo r va lid atio n o f m e d ical d e vice s an d e q u ip m e n t. Workbook
( Ca m b rid ge , U K: Ca m b r id ge U n ive r sity En gin e e r in g De -
T h e d e sign fo r va lid atio n V-m o d e l wa s fo rm u late d to p a rtm e n t, Ca m b r id ge U n ive rsity) .
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b asic re lation sh ip b e twe e n d e sign , d e ve lo p m en t an d d e sign an d ve ri® catio n . First Year Report ( Cam b rid ge , U K:
va lid ation . In o rd e r to h e lp d e sign er s take a m o re Ca m b rid ge U n ive rsity En gin e e rin g De p a rtm e n t, Cam -
p ro active ap p ro ach to va lid atio n d u rin g d e sign , a se ries b rid ge U n ive rsity) .
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