fda impact u.s. medical technology innovation

8/8/2019 FDA Impact U.S. Medical Technology Innovation

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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


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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.


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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 .


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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.


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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 .


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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).


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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 .


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9


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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.


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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.


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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).


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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.


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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 .


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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


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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.


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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


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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.


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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.


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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).


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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.


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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


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


23/44


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)


wIth pmA revIew


In eUrope (ce)


24/44


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.


25/44


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 .


26/44


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


27/44


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


28/44


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.


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)




DollArS In thoUS

AnDS (000S)

DollArS In thoUSAnDS (000S) FDA-DepenDent/relAteD

FIgUre 10 AverAge totAl eXpenDItUre By StAge For 510(k) proDUct

monthS


30/44


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





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


DollArS In thoUSAnDS (000S)

DollArS In thoUSAnDS (000S)

monthS


31/44


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 .


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.


33/44


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 .


34/44


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.


35/44


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


36/44


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 .


37/44


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


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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.


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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 .

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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.


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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


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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.


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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 .

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fda impact u.s. medical technology innovation

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