fda impact u.s. medical technology innovation
TRANSCRIPT
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
1/44
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
2/44
prepAreD by J s ma , mD c s P fess f me e, S f u e sCEO, ExploraMed Development, LLC; Venture Partner, NEA Aa d m md-mBaCandidate, Stanford University l D d rese ass e, S f u e s
wIth SUpport From m di a D i ma u a u s Ass ia i (mDmA) na i av u ca i a Ass ia i (nvcA) A d u i S a di a i dus a iza i s
InDepenDent DAtA AnAlySIS AnD verIFIcAtIon by p i a us c s llp
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
3/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
3
tAble oF contentS
ExEcutivE Summary 5Background 11Study mEthodology 16Study limitationS 19Study rESultS 20diScuSSion 33diScloSurES 43
lISt oF tAbleS
taBlE 1 c p s f i s ve s s P p de p s 18
lISt oF FIgUreS
FigurE 1 510( ) c e es Pma app s (1999-2009) 15FigurE 2 510( ) cE m re t e es 22FigurE 3 Pma cE m re t e es 23FigurE 4 Fda ve s s Eu P e b 26FigurE 5 Fda ve s s Eu re s b e ess 26
FigurE 6 Fda ve s s Eu t sp e 27FigurE 7 Fda ve s s Eu o e E pe e e 27FigurE 8 a e e t e b S e f 510( ) P 29FigurE 9 a e e pe m E pe e b S e f 510( ) P 29FigurE 10 a e e t E pe e b S e f 510( ) P 29FigurE 11 a e e t e b S e f Pma P 30FigurE 12 a e e pe m E pe e b S e f Pma P 30FigurE 13 a e e t E pe e b S e f Pma P 30
n : A f u s a d a s a i d au s su da a u ss is i d.
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
4/44
U di a , i i i ,a d si u a
ss s a j a diziA i as ad s i si ii d i a i .
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
5/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
5
execUtIve SUmmAry
Over the past few years, the manner in which the U.S. Foodand Drug Administration (FDA) is executing its authorityover the regulation of medical devices in the U.S. has beencalled into question. While some have claimed that currentregulatory requirements are lax and harming patients,independent analysis has demonstrated that the currentsystem does an exceptional job of protecting patients. 1However, with regard to the agencys objective of promoting
the public health through new innovations, there areincreasing concerns from patients, physicians, and innovatorsthat the FDA is falling short. Until now, little (if any) data hasbeen produced to either validate or refute these concerns.
ovErviEw
t e p p se f s s s ess e ee f be se e e ep f u.S. e e e e p e s. t e s e e
s s e 2010 s e es s be se f s ss s e e Fda e i s e f me e (iom).
t e u.S. e s s e ses b f p esses bef e p s b e p e s ( efe e s e p e e pe ) f e p s bee e e /
pp e f e ( efe e s e p s e pe ) e s e p e s fe p effe e ess. t e s , e f f s e , f se e s e
ssess p e e e p esses. i s se e p e e e f e s be eff e f e u.S. e p esses e e s e esp e ss e
e e ( e e ) s . i s s es e e f e e e e es
e e e s e s u.S. p e e e p esses e s s( e s) ese ss es p e u.S. e e p es. t s ep s zese es s f e s e p es e p s f e p e s, s,e u.S. e e s , e e e.
1 Ralph Hall, Using Recall Data to Assess the 510(k) Process, Public Health E ectiveness o the FDA 510(k) Clearance Process:Workshop #2, Institute o Medicine, Washington, D.C., July 2010.
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
6/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
6
resp ses f 204 q e p es e ef e e e s . t s beep ese s pp e 20 pe e f p b e e-b e e
f e s e u.S. e f se b e e e p e e p b e (e. ., e es se e pe e s , bes ).
p p s e e s e b e e pe e es e Fda, s ee pe e es E pe e es s p sbe ee spe s f e e s s e s ss e e s fe f
e e b e p e.
rESultS
i e e , s e esp e s e e e u.S. e p esses f b e p e s ( e p e e p ess) s p e b e e z
e s. F e p e, 44 pe e f p p s e p - p e e e p ess e e pe e e e es e pe s
e e e e e / b ef esp s b e f e p s e . pe e f esp e s s ep e pp p e Fda s ff / p s
e Fda e e p ese e ee s be ee e Fda e p . F ss ese e e u.S. p e e e p ess eff e es e e
t e b e f s s b e s f e s Fda ep esses. S e esp e s ep e e p e e p ess f 510( ) p
e es ( f - e e- s ) e e f 10 s f f s f
F se sp e e Fda b s f e e e- s e e bef e e s b ss , e p e e p
e e f 31 s f f s be e e e i s , esp e s s e e e f 7 s E pe f
be b e e e s e ( eq e ) e e.
F e s e es see p e e pp s ( e Pma p ), espp es e e e f 54 s e Fda f
be pp e e e e e. i E pe, f 11 s f f s pp .
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
7/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
7
2 The term exit re ers to a liquidity event (usually an acquisition or initial public o ering) that potentially allows investors to realize areturn on their invested capital.
3 In this context, availability re ers to having achieved regulatory clearance/approval to legally market the device; i t does includecommercialization activities, such as reimbursement or distribution.
t e Fda p e f b E pe e es e s, s e :
Predictability 85 percent o respondents considered EU authorities to be highly ormostly predictable, while only 22 percent gave the FDA the same ratings.
reasonableness 91 percent o respondents rated EU authorities as highly or mostlyreasonable compared to just 25 percent or the FDA.
transParency 85 percent ound the processes and decisions o the EU authorities to behighly or mostly transparent compared to 27 percent or the FDA.
overall exPerience 75 percent o respondents rated their regulatory experience inthe EU excellent or very good. Only 16 percent gave the same ratings to the FDA.
t e s e s s e e e e s f p p s b - e e- s 510( ) p f ep e e s pp e $31 ,
$24 spe Fda epe e / e e es. F e - s Pmap , e e e s f ep pp s pp e $94 ,
$75 spe s es e e Fda. (t ese es es e e sf b e b se e s es/ e - e e es.) S e esp e s
f e e e b e e e p s b e p e s f s e s f e s e s s s E pe. F u.S. p es, ese s s
e s s b e e e-b e s e e ess e f f e e s -ps s ee , 50 pe e f ep e e s2 e ess $100 , e p f
b e es e p s s .
Pe ps s p , e s e e e e e s b p e e f Fdap e e e p esses s s f , e s e b e s u.S. p e s ef f e e . resp e s ep e e e es e e b e u.S. ze s
e e f f e s e p e s e es, e e s eFda / p e s s p s e e s s e e u.S. bef e e-
s , e pe s e e p esses e .3 i s e ses, s e e e e p 70 s ( e s e s).
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
8/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
8
imPlicationS
u p e b e, eff e , e pe s e e p esses p e u.S. s b e e s p p s e e . d f e s e
E pe e p esses s e e e eb e p e s e q e s . t e e s b e q es
se e e e e e eff e e Eu s bee e e ep e s fe . h e e , f s e b e s es
E pe s bee p se . if e s e e es be e b e u.S. fe E pe pp f e e e s e e s s s e s e e e e u.S. p e e e p esses e b
e e p f e p b e , f e e es
u e e Fda p esses, s f u.S. p e s e be e e e e e e e es e f s ( e s e ) b e
Fe e e e e s - ps e be e e u.S. s es e ps es e e se s. a , s e e
e e e es e e be s, b e j bs e . re s s s e e e e se ese b
p e e p b e , e Fda s p se e s b e e eq e s, p e e e b e eq e e s f p e e p s
, b e e e f es e e e e es e p e s. o e e s effe e es e
e e pe p e p p a e p e s; e e p e be bes se e .
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
9/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
9
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
10/44
t U.S. d i duss i s $123 i i i du s,
a s $21.5 i i i sa a i s4,a d di s
a 357,000 i di idua s 5.
4 State Impacts o the Medical Technology Industry, The Lewin Group, 2007, http://www.ihi .org/f les/State%20Impacts%20o %20the%20Medical%20Technology%20Industry_%23436092%20_3_.pd (October 26, 2010), p. 1.
5 Ibid., p. 12.
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
11/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
11
bAckgroUnD
In 1976, when the U.S. Congress passed the Medical DeviceAmendments to the Federal Food, Drug, and Cosmetic Act,it established a new organization with the FDA that is knowntoday as the Center for Devices and Radiological Health(CDRH). The Center has a two-fold mission to both protectand promote the public health when it comes to the use of medical technologies. However, over the last two years,representatives from the medtech industry have reported
that the FDA is becoming less predictable, transparent, andreasonable while, at the same time, its requirements fordemonstrating the safety and effectiveness of new devicescontinue to increase. To better understand if CDRHs currentapproach toward device regulation effectively balances thetwo imperatives reflected in its mission, or if the Center hasbecome so cautious that its policies are denying patientstimely access to the latest technologies and negatively
affecting innovation in the industry, a systematic evaluation of the regulatory oversight process was needed. These factorsmotivated the initiation of the study described in this report.
thE induStry
t e e e s p s p e e es f p e s e . i se , e e efe s e e es e e f se f e pe s
p p ses. t e e e se e s f e e e e se , e e p ese b e p e e s e . F e p e, f 1980 2000, e
s e e p s e pe e e se u.S. fe e pe f e ee e s, 16 pe e e e se es, 25 pe e e e
s b es f e e e .6 d s pe , f e s s e f. m s e e b e 30 pe e f s e p e s b e 20
pe e f se b e s e .7
6 The Value o Investment in Healthcare, MEDTAP International, 2004, www.aha.org/aha/content/2004/PowerPoint/ValuePresentation.ppt (October 2, 2010).
7 Ibid.
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
12/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
12
t e u.S. e e s s s esse e e u.S. e . i 2006, e f e s ppe p s e $123 b p $21.5 b s8 t e
s e e p e e 357,000 s e 1.6 j bs (e e e e p s e e es 4.47 j bs e ).9 E p ees e e e f e e b e e e es pp e$60,000 pe e be se e s eq es s s e
f e.10 ne e e es s e e p e e sf es e e e pe es.
i e , e u.S. s e es b s e f e e es. he s e p e . t e e e s e e s p p s
f s , s s e es e s ese e e p e (r&d) b u.S. ep es e e e p b s e . as es , e
s e be f s es e u.S. s e s pi 2007, e e e e s p s s es e $5.4 b .11
t , e e e s s bee e b s , ep es p ss f s e s fe , e effe e s se
p e s. a be f j e e f e s e s , e 80 pee e p es e fe e 50 e p ees.12 t ese s s s- ps e e e
f e s e e e p e f e e e es, e f e q e bp es s e e. t e b e eff s f b s e p es e, r&d es e e s e b e e 1
es p e e r&d es e f p es e u.S. fb e e f e s .13
thE Fda
w e Fda, cdrh s p e p s e e es e e . t e ce e ses e p e e pp (Pma) p e
pp e e es e e p se p e s e . F e s e es, e p s e p e e f
re ess f e e e e s f e 510( ) Pma p , e Fda s
b eq es p p e s pp e e f e eq es e b e Fda pe f s e u
s es e e e e p (idE).
8 State Impacts o the Medical Technology Industry, The Lewin Group, 2007, http://www.ihi .org/fles/State%20Impacts%20o %20the%20Medical%20Technology%20Industry_%23436092%20_3_.pd (October 26, 2010), p. 1.
9 Ibid., p. 12.10 Ibid., p. 4.11 Medical Technology and Venture Capital: A Fruit ul Yet Fragile Ecosystem, MDMA and NVCA, June 2009,
http://www.medicaldevices.org/node/656 (October 2, 2010).12 Ibid.13 Medical Devices Industry Assessment, International Trade Administration, 2009, http://www.ita.doc.gov/td/health/Medical%20De-
vice%20Industry%20Assessment%20FINAL%20II%203-24-10.pd (October 2, 2010).
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
13/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
13
E e p e e f se 510( ) f e me de e a e e s, s ee ze e 510( ) p e eff e f e e b f e es e e s e e e se s e e e e es e
e e b e . t s pp s e p es b pes b s e s e f e e e f s fe effe e ess e p e e
p e e s b e p e s. n s p s , e 510( ) p ess s ee se e Pma p . i 2009, f e p e, cdrh pp e j s 15
Pma s b ss s e e e pp e 3,000 p s e 510( ).14
as s ep e s e es ese p s, e Fda s b e epe e f ss e s fe , effe e ess, q f e b e e
e es s ss f f s e b p p es e ,p e b e e e . i e e e s, s e p s, e be s f e p ess,
s e ps e ze e Fda f eq e ess e s fe f e e es, p se e e e 510( ) p . d e b e
e p es ep e e e , ese e s e pe s s e esp e pe e e e b e 510( ) Pma p s e f f e e e p p se p e
p e s. F e p e, e e e s e s e 99.6 pe e f 510( ) Pma e es e e / pp e b e Fda be ee 2004 2009 e e e c ss i15 e .16 (re s e f j e e p b e s e e p e
e e ffe p e s fe / e e effe e ess.) S es s e s e se s e e- e e s fe p b e s e e e e e. a s , e s e
j f ese e p s e e e s s e f ss es e q s s e s
f p esses ss es e bee s effe e e e e e e p s e p e e eq e e s.
14 Calculated rom FDA data available at http://www.accessdata. da.gov/scripts/cdrh/c docs/c PMN/pmn.c m andhttp://www.accessdata. da.gov/scripts/cdrh/c docs/c PMA/pma.c m (October 22, 2010).
15 A Class I recall is the most serious type o FDA recall because the problem or which the device has been recalled may result in majorinjuries or death.
16 Hall, op. cit.
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
14/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
14
desp e s e e e, e Fdas eq e e s e se. we s se e p s e pe e e
s fe effe e ess ( e e e e e e e f es e s e s f e-s e be p
p e e pe . w e es p e e eq es s f e p s, es s e f e e e e e Fdas e pe s,
, es eq e e s e e j s fE e e b e e s be f e p es f s ep ese
Fda e e e s e eq es es e s e f es , p s q ese s b s e b e, s e es e e pe se e e e e
effe e ess. m e e , e e s e ep e e Fda s bep e b e e s eff e s p e e e e e. S e
e cdrh, e e s se e e s, s be e e e ess sp e
e s s, s e s s e esp q es e s b ss ese ep s ep ese s e e s e s s e e e s e p e f s s .
a e e p es, ese es e e e e s b e e e u.S., pp e ff-se p b e be
e e e e s p e f s - p s p e e e , be se f e e
as es , e s b ss s f e e e e es e bee e u.S. e e s se e e s. c e es/ pp s e s e
s F e 1). i e f e e s e f e e e e e s , e s q es f es e e
e e e .
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
15/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
FIgUre 1 510( ) cleArAnceS AnD pmA ApprovAlS (1999-2009)
SOURCE: Calculated rom FDA PMA approval and 510(k) clearance data. 17
i 2009, cdrh e ps e e: (1) e 510( ) p , (2) e ce e ses s e f s pp s e e s . S , e iom
e e ee e Fdas eq es ssess e effe e ess f e 510( ) p ess.as ese ps e f , f e e e s, s p b e ,
bje e s be s e e be s e e f e Fda p e e p be e eq f e e s e p esses ( s e b e). u ,
e e s bee e s s e f e sp e e e ep sf e e e e s effe s Fda e s u.S. p e ess e ee , e e e , a e s e e e e s p p s
e .
t e p p se f s s s e q e q e f ep ese es bse f e e p es e e e p f e Fdas e e p es
e e e e e f p b e s c ess, eFda, e iom e e f s e e e s.
15
4000
3500
3000
2500
2000
1500
1000
5000
60
50
40
30
20
10
01999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
510( )s
pmAs
17 Calculated rom FDA data available at http://www.accessdata. da.gov/scripts/cdrh/c docs/c PMN/pmn.c m andhttp://www.accessdata. da.gov/scripts/cdrh/c docs/c PMA/pma.c m (October 22, 2010). It was not possible to calculate thepercentage change in clearances/approvals rom year to year because data regarding the total number o 510(k) and PMAsubmissions is not made publicly available by the FDA.
nUmb e r oF or I gI nAl p mA S Ub m
I S S I onS
nUmber oF 510(k) cleArAnceS
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
16/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
16
StUDy methoDology
t b e s s e e s f e pe ep s e pe e es f p es e e Fda, e s s es e s e . t s s
e e e f f e e s e e es b e E pe p e e e p esses p e, e s e ep e e e p esses, spe s f e u.S. p e e e
e s e s.
i p e q es s s eq es e f mdma, nvca, e f e e sss s e c f he e i s e (chi), m Bio, m ss
l fe S e e a e (m es ), me te (ny), c B s e e ass , F
me m f e s c s , w s B . Fee b s s se Fda, se e cdrh e e s p p .
o e e q es e s e e pe , p p s e e e e e s. mdma se e s e s 260 e be s. nvca s s b e e
q es e 211 f s e be s e e p f s p ese e f e . t ese f s e e e s e p ss e e e p es
es e p f s. if f e e e p f p es bee se e e e pp e 750 p e p p s.
me e p es e e e p s f p p e s e : eesp e q es s -pe s e ep e-b se e e ; e
p e e s e s e e b e e e eb-b se f . tf e s s e s bse f e s e e s e q es s, sq e p e e.
d e e pe , 100 p e e e s e e e , pmdma e be s. i , 95 mdma e be s e p esse e es e s e , b
80 be s e e f p e e e (f 31 pe e mdma p pa e 20 p es e b e s e e e s s (e. ., e s
ss s s e b e) s p p e p e.
P p s e e nvca esp e e e s e . i , 17p e e e eb-b se q es e, b 131 p e b e ( e
e epe e e f f e e es q f s e s).750 p f p es, s es e 17 pe e nvca esp se e.
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
17/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
17
d p e e es f mdma nvca e be s e e e e , e esp ses ep ese e e pe e es f 213 q e p s f 204 p es. a s be f
p es e e pe e e e esp se f e e e pe e es es f f ffe e p s, f e e ep e esp e
e e e z . h e e , e s j f e p es e s e e es , e -s e e es, f se s e p f .
i e s f e z e esp e s, 90 pe e e e p e p es; 10 pe ee e p b - e . t e j e e e e-b e s e e be s s ze
( e = 33 e p ees). w e e e Fda, 55 pe e p e e 510( ) f - e e- s e e; 32 pe e e e Pma
p ess f e - s e e; 13 pe e e e e p s (spe510( )s, e 510( )s, f se e es). a p s f e s e
p p s u.S. e e s p b s e E s & y s 2010 P se f ei s : me te rep , s s t b e 1.
tAble 1 compArISon oF InDUStry verSUS pArtIcIpAnt DemogrAphIcS
SOURCE: U.S. industry data drawn rom Ernst & Youngs Pulse of the Industry: Medical Technology Report , 2010.
U.S. InDUStry
1,023 p b e e-b ee e p es
>50 pe e f p es c f ,m es , m ss se s
l es spe es e ee s , pe s,
se se-spe f
pArtIcIpAntS
204 p b e e-b ee e p es
>50 pe e f p es c f ,m es , m ss se s
l es s e s f p p s e fpe s, s , e e
p s s e
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
18/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
18
w e e e e e 16,000 e e e p es e s e e ef e es s s f z s s pp p e s e e s e z se e p es, b es, e -pe e p ses. of e , 4,776 e e ze s e e e f e s
be e ef e e p e p s. l e p es s e p e e s s pe e . i , e e p s fe
f ese p es f e p e e s b ss s e Fda. t s, s e s e e p es ep ese e s b e e ssess e s
i s , e e e p es e e E s & y p f e e pe e e e f e s e b
e es e ( .e., se s e p es ep ese e e ee e). t s s bse e se s e p p e s s es e
if e s e s ese 1,023 e e p es s e e p p f e spp e 20 pe e f u.S. e e s s esp e e s
q e p es).
af e e s s e , e s e , s e b se, s ses es b e P e e sec pe s llP e s e e e e f
e s s es s e e e . P e e sec pe s ssese , b f se s e ss e e s
e es s e e e p ese e p pe . t e s ze sef e s ese e f e s es s.
a f e e e p es p p e e s e e ss e be ep f e . F s e s , e p ese s es s
e e f s p -spe f f s e e e . E p s ep ef e e e pe e es f spe f e e p es
p se e f e f p p s.
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
19/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
19
StUDy lImItAtIonS
w e e f e 200 p es p e pe e u.S.e p es e effe e e e e s , e e e
s e p e s e s .
F s , e e be se e b ses e s p e. mdma, nvca, s e sse be s e e e p es f e p p e e s . P b e e-b e e e p es e e e e e p e e es
be s p e b e e Fda e e .
a , p p s . t s e p es ss es ep be e e e s esp e s e ; e e , e s s ep es p s e e p p e. a be f p es e
e esp e fe f e b f e Fda ( esp e ss es e e f e ). o e s s e e e b s . t e e p es
e e s s f p p e e s.
Be s, e s es f p e b s e s . Spe f , s e f e s se e e e e s ff s. m e e , s e p p s e se es be s bje e b ses b se e pe s e pe e es e Fda e
b s ess e es s e s be s e .
l s , e ep ese e f e q es es ss e s e f se e e s s:
Some questions were designed to apply only to certain subsets of the survey respondents(e.g., speci ic questions were asked only o those companies that had pursued a 510(k), orrequired an IDE, or sought a CE mark, etc.).
Survey responses collected via the 100 telephone interviews used a more expansive, detailedquestionnaire, whereas the online survey was shorter and more ocused.
In some cases, respondents could not reply to all questions due to a lack of information. Inother cases (particularly with the online survey), they may not have completed all ields andno explanation was provided. When this occurred, missing responses were excluded romthe sample or those questions.
desp e ese p e s, s s s e f s e p p e ep ese e e f e e e s s e pe e es e e Fda e e . i
s f es e b e be se e p ssess e p e u.S. e e e s e b f u.S. p es e
p ess ff a e ze s ess e bes e e se s. i s s e f s e eff b mdma, nvca, j f
e e e s e ss s.
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
20/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
20
StUDy reSUltS
res s f e s e e s ze be f p se s: (1) eff ee p esses e p e e Eu, (2) pe ep s f Fda pe fe e E pe e es, (3) s e e p es,
u.S. p e s.
EFFiciEncy oF u.S. rEgulatory ProcESSES andhow thEy comParE to thE Eu
t e Fda E pe e es b e s e f e s fe effe e ess f e e es e e b e
h e e , s e esp e s ep e e Fdas e p es e ess effe e s E pe e p s. t e e e eff e f e p es
e s e b e e es p s e es es, s e s e p esef p ess s p s.
i e s f p ess s p s, e s e e p e p b e s beff e es e s. F e p e, 44 pe e f p p s e
e e p ess e e pe e e e es e pe se e e e e / b ef esp s b e f e p s e . ses, p es e pe e e s f se b e e
bee e e . i e e s se b f ee e e s e ffe e e pe s, e s s e es, f es e e s.
a f 34 pe e f esp e s s ep e pp p e Fda s ff /s s e Fda e e p ese e ee s. F s e, ep ese e
se e p es ep e -p p s s e e b s s e e Fda e e e s e e e es. t e e
s e p s s e e f e e e p s spe e s ss e e e e s e f e . d ffe e e
p s s e pp p e b e e ss e (e. ., p s e ssess s e e).
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
21/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
21
F pe spe e, e cdrhs off e f de e E (odE) ep e sFy2009 f s e pe f e ep e e e Fda e e e f 510( )
s j s e s (63 s). t e e e e pse e f e e p fe s s e 3 s (98 s).18 h e e , ese Fda- ep e e es
e e es e e e eq e e e 510( ) e e f se e e s s.F s , e Fy2009 s s p e e e be f e s s 2009s b ss s e s pe e e . Se , e Fda s es b s e
f e e f e p ess f p p s es e e / p ess; e e s p ep s e e e e
f e s pe s ff es f p pe f eq es (idE, 510( ), Pma, e .). t s p e p e be s e . w Fda e be f e p s p ese e s e s bs eq e e e f es f s e 510( ), eq es
510( )s be , e e 510( )s b se e p ss e f e, e e
e e es e e e. F e , e e e e e f p e s es s es f e p e e e e e p ess
s e e pp e f e . t e s e e q f s eu.S. p es E pe.
w e e s p e e e es f e Fda E pe e es s e esp e s, s p s e e s e e . if e f f f
s b ss f e e pp s e e e f e f s e be ee p e b , e e f f s f s se s e e e. F
s s p e, - s p s (e. ., 510( )s), p es e e
s b ss p e e e b . h e e , j f ses,p es e e e e e b es / f e e e s
e e b (e. ., eq es p e-idE ee s ss e es f p ss b e , f idE). i s ses, e e f f s s se s
e e . i ses, p s e eq e s e e e e e e b f f . E e , e
e es e be ee p e b s se s e s p fe u.S. E pe e e e es e e e e .
18 Annual Per ormance Report, O fce o Device Evaluation, Fiscal Year 2009,http://www. da.gov/downloads/AboutFDA/CentersO fces/CDRH/CDRHReports/UCM223893.pd (October 4, 2010), pp.8-9.
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
22/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
According to the survey, U.S. companies that navigated the 510(k) pathway stated that it tookthem an average of 10 months from first filing to clearance. 19 Responses from those whohad communicated with the FDA prior to making a 510(k) submission indicated that the totalelapsed time from first communication to clearance (including any pre-IDE 20 or IDE relatedinteractions) was an average of 31 months. (Note that a relatively small subset of respondents(n = 15) is reflected in this data point because most companies do not have contact withthe FDA prior to making a 510(k) submission.) In contrast, survey participants found theirinteractions with regulatory officials in Europe to be much more timely. On average, theysaid it took 7 months from first communication to the time that CE mark certification wasawarded. 21 A comparison of U.S. and EU timelines is shown in Figure 2.
FIgUre 2 510( ) AnD ce mArk regUlAtory tImelIneS
Survey respondents reported similar experiences with the PMA pathway. In its fiscal year2009 annual performance report, the ODE stated that its average total elapsed time fromfiling to approval for all original PMAs was just over 9 months (284 days). 22 However, surveyparticipants indicated that it actually took them an average of 54 months to work with the FDAfrom first communication to approval (or until the time of the survey, if the review was still inprogress). In Europe, an equivalent product review took an average of 11 months from firstcommunication to CE mark certification (as shown in Figure 3).
22
19 First fling re ers to the point at which a ormal submission is made to the FDA.20 The pre-IDE program includes pre-submission meetings used to discuss premarket requirements that are not related to clinical
studies and IDE requirements.21 In the European Union, a CE mark is awarded to indicate regulatory approval.22 Annual per ormance Report, op. cit., p. 5
FDA reporteD 510( )revIew tIme
(Office of Device Evaluation, AnnualPerformance Report, 2009)
US compAnIeSexperIence
wIth 510( ) revIew
US compAnIeSexperIence
In eUrope (ce)
3 monthS
average total elapsedtime rom receipt to
inal decision
7 monthS
rom irstcommunication to
certi icate
10 monthS
rom irst iling to clearance
31 monthS
rom irstcommunication to
clearance
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
23/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
23
FIgUre 3 pmA AnD ce mArk regUlAtory tImelIneS
F p s eq idE, e odE ep e e e e e e e s27 s f s e 2009 99 pe e f idE e s s e e ss e 30 s.23 h e e , p p s e s e , e e e e eq e
b idE s e 14 s. t e Fdas es j s 56 pe e f idEs b ss s e pp e e f s e e e. i e e 44 pe e f ses,
e e eq es s f f e s b p es, e esse e e e e es.24 t e Fda s pp s s idE pp s,e e s es e e be se f e s eFda p ses. S , e Fda pp s f fe s b s es s idE pp s,e e f fe s b s s p p se . F , s e idEs e e Fdass es , e e e e p e-idEs. a odE , e e e e e
e f p e-idE s b ss s s 92 s Fy2008 b j pe 156 s ( e f es) Fy2009.25
9 monthSaverage total elapsed
time rom iling toapproval or all
original PMAs
54 monthSrom irst
communication toapproval
(or to present)
11 monthSrom irst
communication tocerti icate
23 Annual per ormance Report, op. cit., p. 10.24 Ibid.25 Ibid., p. 12.
FDA reporteDpmA revIew tIme
(off e f de e E , aPe f e rep , 2009)
US compAnIeSexperIence
wIth pmA revIew
US compAnIeSexperIence
In eUrope (ce)
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
24/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
24
S e esp e s s e s e e e - e e e Fda e e ef f p eff e p s (27 pe e
f p s fe e p s (15 pe e ), e f s s s e se f ss (8 pe e ), s ze f e (12 pe e ), s s e q es (6 pe
e ee f z (5 pe e ). o e idE s b e , esp e e f 21 s p s es e s sf
eq e e s ss e f e eq f e Fda- e s es
PErcEPtionS oF Fda PErFormancE rElativE to EuroPEanrEgulatory authoritiES
i ss es e e e eff e f e e e e p essesp e s pe e e e e e e e p ffe e es be ee e Fd
E pe e es e e f , e ee , sp e b , e s b e ess, sp e . o e , e Fda s pe e eeff e pe f p e e e e s e e s E pe e p
w e s e b e e e f e e e s, s e p p s f 88 pe ee e e s be s pe e eclinical competence p e j s 47
pe e f u.S. e e e s. S , 91 pe e f Eu e e e s e e s e e s p f e e s f eengineering competence p e 52 pe e
u.S. a , 79 pe e f Eu e e e s e e be e e be scompetent in statistics e s s 60 pe e e u.S.
t e s e es s e e s e e f predictability , 85 pe e f esp e ss e Eu e es be s p e b e. B
22 pe e e e Fda e s e s (see F e 4). t e j f s e pbe e e e e be s e p e b e (25 pe e ), s p e bpe e ), e p e b e (31 pe e ).
resp e s s f Eu e es be ereasonable . a f 91pe e f esp e s e e s s e s b e p e j spe e f e Fda (see F e 5).
i e s f transparency , 85 pe e f e p esses e s s f e Eu be s sp e p e 27 pe e f e Fda (see F e
F , s e p p s e Eu e es be eoverall , s s F e7. a f 75 pe e e e e e e pe e e e Eu e e e
e 16 pe e e e s e s es e Fda.
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
25/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
25
Be ese e p s s, 93 pe e f p p s e s ee see Fda s be e e s - e se e p s e s e e.
Spe f , e e e e es e ep e e s s e p es / e es e e p ess e e 1990s e 2000s s e e
e see s be e s e se es e e s s, e ee s e e p ess ess p e b e e s . a , 81 pe e f esp e s ee s ee e Fda s p ff e e
e e es (e. ., / e e b s e s Pma p s).F , 66 pe e e p esse f s es e Fda s e e e p
s e e p e p ess f e p es e e .
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
26/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
SurvEy rESPondEnt ratingS oF Fda andEu rEgulatory PErFormancE
26
FIgUre 5 FDA verSUS eU reASonAbleneSS FDA ( =124) ce ( =86)
50%
45%
40%
35%
30%
25%
20%
15%
10%
5%
0%
hi m s S a m s vr as a r as a r as a U as a U as a
FIgUre 4 FDA verSUS eU preDIctAbIlIty FDA ( =120) ce ( =83)
60%
50%
40%
30%
20%
10%
0%
hi m s S a m s vp di a p di a p di a U di a U di a
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
27/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
27
FIgUre 7 - FDA verSUS eU overAll experIencec p e pe e e e e
FIgUre 6 FDA verSUS eU trAnSpArency FDA ( =119) ce ( =81)
FDA ( =119) ce ( =83)
50%
45%
40%
35%
30%
25%
20%
15%
10%
5%
0%
e v g d Fai Dissa i i vDissa i i
60%
50%
40%
30%
20%
10%
0%
hi m s S a m s vt a s a t a s a t a s a U a s a U a s a
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
28/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey o Over 200 Medical Technology Companies November 2010
28
thE coSt to mEdtEch comPaniES
i eff e e p esses be e s e e p es be sf e e s e s - ps e s f s ese es e e s
s e , p p s e e s e e e f e ( s) e sps es e e e p e e p e e f p s e 510( ) ps F e 8. t e , e e e s e es e e e e e pe
e s e, s s F e 9. d f e s e esp e s s e e e e e e pe e e e e e e e p
s F e 10). t e s e ee q es s e e s e f p s e Pma ps s F es 11 13.
w e e s e s b eq e e p esses p es s ss e ese s s s e f ess e . h e e , f
s s e e e Fda eff e es / e s b e e s, p sbe e p b e e e pe s e b e e u.S. F e p e,
e s e , e e p spe s e p b e $400,000 pe f 510( ) p e $750,000 f Pma p
E e e 510( ) Pma p ess se f s s $520,000 $740,000 pe , espe e . t ese e pe e e e s e
e p es f e e es e e f e e e . t s,e s e b e e se e e s s e u e S es.
t e s e s e e e e e e s f p p s bp f ep e e s pp e $31 , $24 Fda epe e / e e es. F Pma, e e e s f
pp s $94 , $75 spe s es e e Fda. ese es es e e s f b e b se e pp
e - e e es.) t e e f ese f es f s e ep es se f-se e e p p e e s e e e s e se
e, e e e es eq e e Fda e se see e e s p e e e s s - s , b q
es e e s e e.
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
29/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey of Over 200 Medical Technology Companies November 2010
$12,000
$10,000
$8,000
$6,000
$4,000
$2,000
$0
29
iMPaCT oF FDa DelaYs in TeRMs oF TiMe anD CosT
FIgUre 8 AverAge tIme By StAge For 510(k) proDUct
25
20
15
10
5
0
FDA-DepenDent/relAteD
FIgUre 9 AverAge per month eXpenDItUre By StAge For 510(k) proDUct
$800
$700
$600
$500
$400
$300
$200
$100$0
c D c i i a U i p ss f Saf /F asibi i pi a p ss f a d p f f c D ob ai i IDe c i i a S ud c i i a S ud ob ai i 510(k)
c D c i i a U i p ss f Saf /F asibi i pi a p ss f a d p f f c D ob ai i IDe c i i a S ud c i i a S ud ob ai i 510(k)
c D c i i a U i p ss f Saf /F asibi i pi a p ss f a d p f f c D ob ai i IDe c i i a S ud c i i a S ud ob ai i 510(k)
FDA-DepenDent/relAteD
DollArS In thoUS
AnDS (000S)
DollArS In thoUSAnDS (000S) FDA-DepenDent/relAteD
FIgUre 10 AverAge totAl eXpenDItUre By StAge For 510(k) proDUct
monthS
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
30/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey of Over 200 Medical Technology Companies November 2010
30
FIgUre 11 AverAge tIme By StAge For pmA proDUct
3530
25
20
15
10
5
0
c D c i i a U i p ss f Saf /F asibi i pi a p ss fa d p f f c D ob ai i IDe c i i a S ud c i i a S ud ob ai i pmA
c D c i i a U i p ss f Saf /F asibi i pi a p ss fa d p f f c D ob ai i IDe c i i a S ud c i i a S ud ob ai i pmA
c D c i i a U i p ss f Saf /F asibi i pi a p ss fa d p f f c D ob ai i IDe c i i a S ud c i i a S ud ob ai i pmA
FDA-DepenDent/relAteD
FDA-DepenDent/relAteD
FIgUre 12 AverAge per month eXpenDItUre By StAge For pmA proDUct
$1,600
$1,400
$1,200
$1,000
$800
$600
$400
$200$0
FIgUre 13 AverAge totAl eXpenDItUre By StAge For pmA proDUct
$45,000$40,000
$35,000
$30,000$25,000
$20,000$15,000
$10,000$5,000
$0
FDA-DepenDent/relAteD
DollArS In thoUSAnDS (000S)
DollArS In thoUSAnDS (000S)
monthS
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
31/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey of Over 200 Medical Technology Companies November 2010
31
The CosT To U.s. PaTienTs
imp rt t y, ub pt m r u t ry pr c c v c t t p t t t t mucm r f c t t t dd t d r c mp mu t p d t t t r pr duct tm r t. W U.s. c t z u d t b t f r t t cc t v t v w t c ,t y w f c d v c . st t d t r w y, U.s. c t z cc t w U.s.-m dm d c t c t r t p t t t r c u tr .
o v r , t pr duct r pr t d t urv y w r v b t p t t t U.s. fu tw y r ft r t y w r v b t p t t eur p (r = 3 t 70 m t t r). i
m c , r p d t d t y t t d t r r u t ry pr c w t d ut d tU.s. t t m t m , but r c v d c r c / ppr v t U.s. muc t r. i t c p t
f , xp v FDa r v w , t r d t y d c d d t r bt eur pppr v f r t ff rt t r t v r t t c u d p fu d t r U.s. r u t ryff rt . a t r t v y, m c mp r p rt d t t t y w r w tt up p r tv r d d v p tr t t t d t r y t U.s. m r t, d p t t f ct t t t
r m t w r d r t d m t c mm rc y ucr t v d v c m r t.
B d t pr v c f t d ddr d by t c mp t tudy, tm t t m f am r c d t v cc t t t t, m t v t v m d ct c . R p d c mp r p rt d d y f r U.s. ppr v r t v teur p f r pr duct ff r f c t dv c f r tr t r d y pr v tc d t uc rt d , u d , b ty, d rt r t . T tudy d t c r y
p t r m p ctur f r p t t , w m dt c v t r r t v t t c t yf c t y ppr c t r u t ry t ( ) f t r pr duct d v pm t pr c tU t d st t .
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
32/44
U.S. a i s wai d aa a f w a s
a s i eu
ai a ss w di ai s f su a i s.
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
33/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey of Over 200 Medical Technology Companies November 2010
33
DIScUSSIon
s c t M d c D v c am dm t w r ct d r y 35 y r , m dt c r u t ft b d cr b d p du um t t w b tw r -t r t d r - v r
r u t ry v r t. ov r t t tw y r , t FDa m t b t m d t f y t t rw t w rd m r r - v r pr ct c . T f rc t t dr v t c t r p w rfu
d d p y r t d t cu tur f FDa, w t ft xp ct t mp d t cy by t dm tr t c r t y p rt cu r t m . P t t , t pub c, tm d , m dt c mp y , t c t f c c mmu ty, pr ct c p y c , d p t c f r b tt r r f r w r p y r f u c t FDa p t .
T cy c c r y t c r t p c t p t t t b t rv t
pub c t d d v d f f c t ft fr m p t c f u c . T FDa t r t tb c t ct v t t m p t b tw t tw xtr m . h w v r, b c u m f t t d r t d b v ft v m t d r f rm t b ut t r t d r
ct v t , tr ppr pr t b c c b d ff cu tp rt cu r y w pr v t b fd b v r r b d p rc pt , d , d cd t r t r t ctu d t .
T urv y tt mpt t br f rw rd d t t t c b u d t p f rm t d cucurr t y u d rw y t t FDa d w t t ioM r rd t b t p t f rw rd f rm d c d v c r u t . W t c w f c t d y r c mp x d mu t v r t ,
d m y qu t t r m , ur p t t t r u t f t tudy w p r u t rd v t r w r t t r t c v b c t t u t m t y rv t b t t r t f
p t t d t U.s. c my t r .
o f t pr m ry bj ct v f t urv y w t d t rm f t c c r r d byr pr t t v f t m dt c du try r rd t c v r m t t t FDaw r r t v y w d pr d, r mp y t c mp t f v c m r ty. T r u t c r yd m tr t t t ff c c , d y , d t m u t c t f t U.s. r u t ry pr c
r b f t w d y cr v t r t du try.
T r u t tudy, w p d t d t w r t r t t pr b m x t.T d t p t t tr ub ff c c c u d by r v w r tur v r, c t t qu ty
d p rt c p t f xp rt dv r , d xc v d y , p rt cu r y c mp r d t tFDa eur p r u t ry c u t rp rt . P rt c p t w r d b ut t r xp r cw t eur p r u t ry ut r t t t c mp r c u d b m d b tw p ct
f t tw d m t r u t ry y t m t t ur t f ty f v t v t c y tb m r tp c .
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
34/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey of Over 200 Medical Technology Companies November 2010
34
T tudy r v d t t t t f c t y r t v t U.s. r u t ry prt d t c mp t eur p ppr v f r t m pr duct . R p d t
r t v y w d pr d p rc pt t t t FDa b c m r b , tr ppr d ct b c mp r d t eur p r u t ry ut r t . i c mb t , t f
d f c t ff ct r p d t v r xp r c w t t FDa. M r t urv y p rt c p t d t y f u d t r t r ct w t t cy t b d
r v ry d pp t . T r u t u t t t t cy t ct v y p rtm dt c mp y t w r t w rd mutu y t f ct ry r u t d t b f t f c r t U.s.
F y, t tudy u t t qu t fy t c t f r u t ry ff c c d t p t t d c mp t m dt c du try. W t w r d t t t r
d v c v t v w m d c t c r b c m v b t U.
v r f tw y r t r t p t t eur p ( m c , t d v c m t x y r ).26 T tru c t f t d ff cu t t t m t , but c yp t
t t m f p t t m y t b ff rd d t pp rtu ty t b f t fr m t bc r t y w t b tt r r d ff r t tr tm t t t r c mm y b u d tc u tr . W t v b v d c t u t t t t f ty f t d v c
ub t t y mpr v d t y v t t U.s. r u t ry pr c (r t v t eurr b t qu t w t r t t y d xp v FDa pr c tru y prp t t t , r m r mp y d y p t t cc t w t r p t t r y r r r t r r p .
T tudy d cum t d, t m d d r , w t t t t v t t c r t p r u t ry pr c t w y t m r t t U.s. obt iDe, 510( ), d/ r PMa b t xp v d t m c um . h w v r, t t m d c t c t dc duct t typ f p v t c c tr cr y r qu r d by t FDa
rm . a d t r qu r m t fr m t FDa v r , t c mp x ty f t r qutud , w t umb r f p t t f r w c d t r r qu r d, pr v t
pr b t v t m dt c v t r d v t r .
T p u b tt r u d r t d t mp c t f t urv y d t t U.s. p t t , v t r , m dt c mp y , d t c my t r , w r d t f d w
p t t (M rt C r), t r v t r (R b rt F c , R d y P r , d P um dt c v t r (Ry Dr t, R J ff , d h P ), d m dt c du try (D v d C ). T r p r p ct v r r f ct d t d cu b w.
26 As noted, availability refers to having achieved regulatory clearance/approval to legally market a device.
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
35/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey of Over 200 Medical Technology Companies November 2010
iMPliCaTions To PaTienTs
a t d, f t m t tr ub utc m f t urv y t t U.s. p t t rcr y y t b t f r t t v cc t v t v w m d c t c ,
v w t d v c r v t d t U.s. a m dt c v t r d mp yt c p t t m -c um , xp v FDa r u t ry pr c , r w umb r r t
t r d v c w r b f r m t m v b t am r c p t t . o ff ct f ttr d t t t U.s. t p t t d pr v d r f m d c c r . our w r df m u U.s. p t r t r c v m y p t t fr m v r t w r d b c u tm t dv c d t c r t b pr ct c d t U t d st t b c u f t FDa,
t t d Dr. R b rt F c , r v t r d f u d r f mu t p m d c d v c c mp .
a t r ff ct t t U.s. p t t r b f rc d t pur u d - d d v c d t rc t d pr c dur v r . a Ry Dr t, r p rt r w t v tur c p t f rm
nea, put t:
Fr y, t tr dy. s m f t d v c r f y d ff ct v y t m r t eur p f r f v y r b f r t FDa w v w
t m t b u d U.s. c c tr . T t u t t t p p vt d c d w t r t f r m p t t y f v t c y rf y t eur p d f ur ut m w y t p y f r t ut f p c t,i f d v ry tr ub . RYan DRanT, geneRal PaRTneR, nea
M rt C r b c m p t t ct v t, bby t FDa f r c t r u t rypr ct c , ft r f c d m r tu t . C r, w w v r y d b t t d by c rv cd c d , w f rc d t tr v t e d t r c v t tr tm t d r d ct rb v d w u d pr v d t b t r u t . i c u d t b v i c u d t t t b t tr tm t
my w c u try, d. F y, i d c d d my y ut w t f d f rur w t xp rt mp t t d v c my p y c d i d m d m t ppr pr t v t u t d v c w r m d 40 m fr m my U.s. m . C r p d f r rur ry w t m y fr m r m v , w ft d .
35
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
36/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey of Over 200 Medical Technology Companies November 2010
36
C r c d r d r f v c f r m f U.s. p t t w , r w rd ,d y uff r , d t r r t , d m t m dy w t y w t f r t
t u t pr duct t y d r m t m w d y v b ut- f-c u try d wtr c r c rd . s b r t d:
i ppr c t [t FDa ] d t pr t ct p t t . h w v r, b utur c t r b xp ct t , tw b d r
m . V r fy t t t pr duct f d w fu ct dt t t p t t d d ct r m t d c .
MaRTi CongeR, PaTienT aCTiVisT
C r bby t FDa t cc pt t r u t ry f d f t r, tru t d ttr f ty tr c r c rd ( . ., eur p , au tr , d J p ) r, t m mum, t f
tr c pr duct t t v b c r d/ ppr v d t c u tr d t m t r t r u p tm r t tud .
R J ff , m d r ct r f V r t V tur , r d mp rt t qu t f ri try t pr t ct u fr m t t t m t t b f , r w m ut pr dt t c u d b v ry ff ct v ? d. By tt mpt t m t f ty r t p
p b t t t cy dv rt t y m t t p t t b f t t t c d v r. T tru y ct t b t t r t f p t t d t pub c t , m
t c p r p ct v d d. s f ty mp rt t c d r t , but t r rqu y cr t c f ct r t c d r. F r t c , r u t r mu t t t cc u
c t d w t pr v d v t v tr tm t t p t t w t rw m tr m , cc pt b pt .
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
37/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey of Over 200 Medical Technology Companies November 2010
iMPliCaTions To U.s. MeDTeCh innoVaToRs, inVesToRs,anD eMPloYees
s c 2008, t t u v tur v tm t t m dt c f d d c d by $1 b .27 o r f r t dr m t c d cr t b c m c d w tur , w c b 2008
d t f d 2009. h w v r, v t r d m dt c v t r r p rt t t t r rt r f ct r c tr but t t d c , c ud t c t t v ccurr d t U.s.
r u t ry v r m t v r t t v r y r .
l tr p r t d pr d ct b r u t ry pr c d c ur v t r fr m puttt r m y t m dt c c mp . T ff ct mp f d dur c m c d w turw v r c p t v b t m dt c v tur c p t t d t t rt-up t yfu d. Dr. P u Y c , r w d v t r d t d r ct r f st f rd U v r ty Pr r m B d , xp d t p m :
T d v pm t f w t c y f y typ d ff cu td fr pr c , d t d v pm t f m d c t c y m r fr pr c t . a m j r r f r t t r u t .
T r b c t t w v tt r b y r t v r ty r w t b c r fu b ut v t but t t f t w tr u t . But w w v muc m r c rv t v ppr vpr c , c mb d w t c m c cru c . U f rtu t y f r
v t r , t tw f ct r c c m t t r t t t ut f v t .
PaUl YoCk, MD, PRoFessoR oF MeDiCine, sTanFoRD UniVeRsiTY
Mu t p v t r c f rm d t t t c t c t f br m d c d v c t m r t c u fu d t f w ut f t m dt c ct r d t t r du tr w r r u t
p t t y d t x t ( r t p rc v d uc f c t b rr r). a t urv yw d, t v r c t f t pr duct t r u 510( ) c r c $31 m , d
t v r c t f tt pr duct t r u PMa ppr v $94 m ( xc ud
r mbur m t d /m r t ct v t ). h P , p rt r w t M r t rV tur , p t d ut w muc t c t v cr d:
27 According to data provided by NVCA.
37
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
38/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey of Over 200 Medical Technology Companies November 2010
38
W i f r t t rt d tr pr ur t r y 1990 , t mt t t t pr duct t w y t r u PMa w $30-40 m
d r , w c w w t t t t d 510( ). s w r d ub f t c t t t r c m c v r m t d w tm y v b v tur c p t .
hank Plain, PaRTneR, MoRgenThaleR VenTURes
h t r c y, v tm t r tur t d v c du try r r t v y m c mpx mp , t t t b t c d p rm c ut c du tr . acc rd t d t f
W d v r str t c Tr ct d t b , ppr x m t y 50 p rc t f m d c d(f r w c v u w r r p rt d) r u d r $100 m ; 75 p rc t r u d r $150 m28
i c w r t c t f tt t m r t ppr c t v r x t v u , d f ct t t y f ur ut f v ry 10 m d c t c y v tm t c d r d u29 t m dt c fu d qu t u d r t r u t ry c d t cr t t t r v b .
imp rt t y, t urv y qu t f d, FDa-d p d t pr duct d v pm t t ccf r fu 77 p rc t f t c t f br 510( ) pr duct t m r t d 79 p rc t fPMa, t ff ct f r u t t u u d t b u d r t m t d. a D vm d r ct r f W d v r i f rm t , d cr b d:
W v r dy t t t p t w r v t r d v t r t t r u t ry p t w y d y, T w t c y c u d b
m fu d c u d b pfu t p t t , but w ju t c t vt c c t.
DaViD Cassak, Managing DiReCToR, WinDhoVeR inFoRMaTion
st t d t r w y, t burd f cr y d ff cu t d c t y r u t ry p tju t f t by t c mp t t r u t m t y b t br t r t c t mburd c ctu y rv d t rr t t t p v t r fr m d v p t
d t c mp y-b c d pr duct . a t r t f FDa ubm c t u t dp t t r b t v y mp ct d t y r d d t pp rtu ty t xp r
f - c b f t f t c t t r v r d v p d t pr duct tbr u t t m r t.
28 Data provided by David Cassak, managing director of Windhover Information.29 According to data provided by NVCA.
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
39/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey of Over 200 Medical Technology Companies November 2010
at t m t m t t p t t r w rd t du try v d m d w t r r u t ryc t d ppr v t m , m dt c r v cr d. U c rt ty b ut FDa
xp ct t b c m r t t t t r u t ry pr c ft c r ct r z d m v t r t. i ur bu , w t w t d try t m r , xp d Dr t.if y ur w r f w t r , y u c ft t m m t d qu t y d ppr pr t y.But f t FDa p m v t p t, t cr d b y rd t m t t r .
M dt c v t r r qu r r t r tr p r cy d pr d ct b ty fr m t FDa t pbr t r /r w rd qu t b c t m t. J ff c mm t d:
T y u my m d t v y t m t t c b m rff c t, c t t, d pr d ct b t r u t f d v c . T t
v v v b tt r tr f r v w r , b tt r, m r up-t -d tc c xp rt t t FDa w u d r t d t t t f t rt w t w t p c ty, d pr c f p d fr qu tc mmu c t b tw c mp d t FDa w c r v
u r b w y d m v pr duct f rw rd m r qu c y. Ross JaFFe, MD, Managing DiReCToR, VeRsanT VenTURes
i v t r xpr d t d r t b b t m t w t t FDa t t t rt f m dt cpr duct d v pm t pr j ct, r m fu c c tr tr t y, d t x cut
t t w t m r b ur c t t t cy w u d r t r m t. W t utuc c , t b t d br t t t t t f d w p t t y t rt m v t t r
t c y d m , v tur v t r r d , w c c u d u t m t y d t f w r f -c r f - v d v c b d v p d t m t p t t d .
39
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
40/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:
A Survey of Over 200 Medical Technology Companies November 2010
40
ImplIcatIons to the U.s. economy
U i r , d i i i rg b U.s. iw gi w r i d r , d r i izi g i iz b U.s.
w r d r gi . h w r, d urd i b d d i b u di g d i d, d i i r id ri g r gi r U.s.-d d . U r u , d rib d, i w gi r r i g U.s. i r i i r g gr
ugg U i d s i ri i g i r i r i i g b d i i . a i i r i , U.s.
g i i d j b r d r .
a rdi g p i , e r I i d wi w eur rt r g , i w u d b 100 r u d U.s. r ir i i ri d ir r du u . Bu w w w r i
r r deur i ir r u d, i , i a d i b b gi rg i g i d r u id U.s
u r du r du d j b r wi w. a p r i , i i r r urg r s rd U i r i d u d r ud i i , i d u :
I r i u d d , w i d u uri g j b r .n w w r i i g w dg w r r j b br d. o u
x r i i j b , j b w b . W d b d qu r gu r ru i wi r id i r ii i .
RoDney peRkIns, mD, clInIcal pRofessoR of sURGeRy, stanfoRD UnIveRsIty
D i U.s. i i i r i g r i r d i i d ig - r j b i d wi i i i du ri , ur r d ri i
d j b r i g r . f r i , r i i r
i d i d r u r r i , iri g 19 U.s. d iri g 12 i eur . n x , d u d w i U.s. r du
i i d r 30 40 u uri g j b eur . I i r i u r u ur gr w w d r . k i g i i d r dir
i i dir r ib r r 4.47 j b i i ,30 U.s. u d b iz b .
30 See State Impacts of the Medical Technology Industry, op. cit. , p. 12.
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
41/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey of Over 200 Medical Technology Companies November 2010
W t d f du try r t c my t r u d v r b pr r t z d v r p t tf ty, t t c r t t t curr t r u t ry b t c t U.s. m r t try tru y c tr but t
t pr t ct d pr m t f pub c t . g v t d r c m c c d t f t U.s.,t tr d t w rd cr t xc pt b rr r f r f t f w r m du tr w c
ur c u try t d r u d b f c t c u f r c c r .
41
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
42/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey of Over 200 Medical Technology Companies November 2010
42
looking FoRWaRD
our t curr t y f c u pr c d t d c m t v ry ct r f t h w v r, t d v du c t z , t m r mp rt t t t r w t
w t t d w f r f t r f m . R u t r d v t r mp rt t r p b ty t pr t ct d dv c pub c t , d t m t t
b tw r d b f t f r t p t t t y rv . i d , t p t t muf r t d f r m t ur m d t t m . P t t c b rm d f u f m dt c r c t m r t, but t y r rm d w mp rt t v t
v b t tr t t r m d c c d t .
T d t pr t d t r p rt pr t tr ub p ctur f t t t f m d c r u t ( d t ff ct v t d t dv c m t f pub c t ) u dFDa p c d pr ct c . T urv y r u t d c t t t t p du um m
wu t f r d r ct d b c d t b r t r d.
a t d, t c t t FDa t t v tr p r d v r t t v r y r (v cc r t d t t tw y r ) v r y b dr v by p rc v d f
Y t, t r t t d x mp d cd t , d f t v d t b prju t fy uc f c t d w p dju tm t . Dur t p r d, r u t ry
eur p v r m d r t v y c t t, m t m v u b c mp r t r fw r u t ry p rf rm c t U.s. it c r fr m t d t t t t eur p r u
pr c m r pr d ct b , r b , d tr p r t. T y t m w
t m f d ff ct v w m d c pr duct v b t p t t m r qu cw r c t. T r b qu t b r d ( d r qu r w r) w
r u t ry ff c cy t eU b c v d t t xp f p t t f ty. f rm t v b t d t t u t t t p t t f ty eur p b
c mpr m d. if t m d v c b c m v b U.s. f w t r eur pppr v y ft r xt v d y d dd t c t r ccru d, w mu t v
w t r t U.s. pr m r t r u t ry pr c tru y c tr but t t dv c mpr m t f t pub c t , r f t ctu y r tr t.
T d y, w f c ub t t c c r r rd t c t f t c r , w mu
c w d t t ub t t umb r f mp rt t p t t d t r m ua ut t b t f t pr b m c t b c v d by d y w v t
d c t- ff ct v tr tm t . T tru y pr m t t pub c t , t FDa mu t mpr b r u t ry r qu r m t w v t , mp m t m r b cr qu r m t f r pr m r t d p tm r t c c d t , d b c t v rf rc t r w rd t c y t t pr t t r t t v u t p t t . o y t wm t ff ct v dv c m d c c r b d v p d d d v r d pr mpt y t amp t t ; d y t w t pub c t d ur c my b b t rv d.
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
43/44
FDA ImpAct on U.S. meDIcAl technology InnovAtIon:A Survey of Over 200 Medical Technology Companies November 2010
DIScloSUreS
F c , t c , d t ctu upp rt f r t urv y d t r p rt w pr v d d by tM d c D v c M uf ctur r a c t (MDMa), t n t V tur C p t a c t(nVCa), exp r M d, C f r h t c r i t tut , adv M d, M c Bio, M Bio, Pa B ,l f sc c a y (M t ), M dT c (n w Y r ), C r d B c c a c t , F r dM d c M uf ctur r C rt um, W t B , nea, d T F u dry.
T tudy w c duct d by Dr. J M w r d a b d M r. M w r mp y d V tur P rt r t nea, t Ceo f exp r M d D v pm t, d C u t Pr f r tst f rd U v r ty. h rv t b rd r c u t t t v r m d c d v cc mp . a b d M r tud t t st f rd U v r ty pur u MD d MBa
c curr t y. h w r d umm r c t t c duct t tudy. ly D d, r rcc t t st f rd U v r ty, w r d t t d v p t r p rt.
Pr c w t r u C p r llP d p d t y v r f d t d t d y pr t d tr p rt. T v w xpr d t D cu ct r f ct t p r p ct v f t ut r ,t tudy p rt c p t , d ct m dt c du try r pr t t v w w r t rv w d byt ut r ft r r v w t tudy r u t .
43
-
8/8/2019 FDA Impact U.S. Medical Technology Innovation
44/44