medical device companies: opportunities in 2010

Medical Device Companies: Opportunities in 2010

October 21, 2009

Presented by Goodwin Procter LLP


Panel I: Medical Device Investment Market

Rakesh Mehta, JP MorganKirk Nielsen, Versant VenturesRay Zemlin, Goodwin Procter LLP

Medical Device Companies: Opportunities in 2010Medical Device Investment Market

Rakesh J. Mehta

October 2009

Agenda

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Medtech Market Update

Medtech M&A Update 5

M E D T E C H O V E R V I E W

30%

40%

50%

60%

70%

80%

90%

100%

110%

120%

130%

140%

1/3/07 5/10/07 9/14/07 1/19/08 5/25/08 9/29/08 2/3/09 6/10/09 10/16/09

Relative stock price performanceRelative stock price performance

Note: Market data as of 10/16/091 Large cap universe includes ABT, ACL, BAX, BCR, BDX, BSX, COV, JNJ, MDT, SNN, STJ, SYK, ZMH2 Mid cap universe includes AMMD, BEC, BLUD, COO, EW, EYE, GPRO, HAE, HOLX, HSP, IART, IMA, ISRG, KCI, MASI, MNT, NUVA, RMD, SIRO, STE, VAR, XRAY3 Small cap universe includes ABMD, ALGN, ANGO, ARAY, ARTC, CPTS, CYBX, DSCP, ELOS, EVVV, GB, GIVN, HNSN, ICUI, MMSI, OFIX, PODD, SMA, SONO, THOR,

TOMO, VNUS, VOLC, WMGI, ZOLL4 Micro cap universe includes ANPI, ASPM, ATEC, ATRC, ATSI, BMTI, CAMH, CMN, CRDC, CRY, CSCX, CUTR, CYNO, DRAD, DXCM, ELGX, ETRM, EXAC, HDIX, IFLO,

KNSY, LMAT, MAKO, MEND, NMTI, NSPH, NXTM, OMRI, PMII, RTIX, SNCI, SPNC, STXS, TSON, VASC, VTAL, XTNT

Small cap3

(23.7%)

Mid cap2

13.7%

Large cap1

(7.5%)

Micro cap4

(31.9%)

S&P 500(23.2%)

Returns S&P 500 Large cap Mid cap Small cap Micro cap

1-week 1.5% (0.4%) 1.2% (2.0%) 2.6%1-month 1.8% 1.1% 2.8% 0.9% 3.7%3-months 15.6% 6.8% 24.4% 18.0% 21.8%6-months 25.7% 18.6% 35.5% 35.1% 60.4%2009 YTD 20.4% 8.5% 50.2% 17.7% 50.1%LTM 14.9% (4.4%) 27.8% 11.2% 20.2%Since 1/3/07 (23.2%) (7.5%) 13.7% (23.7%) (31.9%)

Medtech sector performance

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1.0x

1.3x

1.5x

1.8x

2.0x

2.3x

2.5x

2.8x

3.0x

3.3x

3.5x

3.8x

4.0x

1/3/06 6/24/06 12/14/06 6/5/07 11/25/07 5/15/08 11/4/08 4/26/09 10/16/09

Medtech forward revenue multiples

Historical FV / NTM revenue multiplesHistorical FV / NTM revenue multiples

Small cap3

1.9x

Large cap Mid cap Small cap

EV / NTM revenue Mean Median Mean Median Mean Median

Current 2.8x 2.6x 2.9x 2.6x 2.1x 1.9x Average 3.4x 3.1x 3.3x 2.8x 2.8x 2.4x % change (31%) (20%) (25%) (19%) (36%) (29%)

Source: FactSet as of 10/16/091 Large cap universe includes ABT, ACL, BAX, BCR, BDX, BSX, COV, JNJ, MDT, SNN, STJ, SYK, ZMH2 Mid cap universe includes AMMD, BEC, BLUD, COO, EW, EYE, GPRO, HAE, HOLX, HSP, IART, IMA, ISRG, KCI, MASI, MNT, NUVA, RMD, SIRO, STE, VAR, XRAY3 Small cap universe includes ABMD, ALGN, ARAY, ARTC, CPTS, CYBX, DSCP, ELOS, EVVV, GB, GIVN, HNSN, ICUI, MMSI, OFIX, PODD, SMA, SONO, THOR, TOMO, VOLC, WMGI, ZOLL

Mid cap2

2.6x

Large cap1

2.6x

Large cap median since 1/3/06 - 3.1x

Mid cap median since 1/3/06 – 2.8x

Small cap median since 1/3/06 – 2.4x

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0.0

1.0

2.0

3.0

4.0

5.0

05/01/00 07/06/01 09/11/02 11/17/03 01/22/05 03/30/06 06/05/07 08/10/08 10/16/09

Historical FV / NTM revenue multiples since 5/1/00Historical FV / NTM revenue multiples since 5/1/00

Source: FactSet as of 10/16/09; recession data from National Bureau of Economic Research1 Large cap universe includes: ABT, ACL, BAX, BCR, BDX, BSX, COV, JNJ, MDT, STJ, SYK, ZMH2 Mid cap universe includes: AMMD, BEC, COO, EW, HAE, IART, ISRG, MNT, RMD ,SIRO, BLUD, STE, VAR, XRAY3 Small cap universe includes: ABMD, ALGN, ARTC, CPTS, CYBX, DSCP, GB, ICUI, MMSI, OFIX, SONO, THOR, VITL, WMGI, ZOLL4 Micro cap universe includes: ASPM, ATSI, CAMH, CMN, CRY, ELGX, EXAC, IFLO, KNSY, NMTI, RTIX, SNCI, SPNC, VASC, VTAL

Small cap3

1.9x

Mid cap2

2.6x

Large cap1

2.6x

Micro cap4

1.6x

Large cap mean 3.4x

Mid cap mean 2.7x

Small cap mean 2.3xMicro cap mean

2.0x

Recession:March 2001-Nov.2001 (8-

months)

Valuation Trough: Jan. 2002 - Jul.2003 (18 months)

Valuation Trough: Oct. 2007 - Current (23 months)

Current Multiples

Recession: Dec.2007 –

current (22 months)

Medtech forward revenue multiples: historical macro perspective

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Agenda


Agenda

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Medtech Market Update

Medtech M&A Update 5


EV / Revenue

Target Acquirer Date Trans. value LTM FTM Commentary / Rationale

Sept-09

Sept-09

$450

$400

na

na

na

na

The acquisitions of Evalve and Visiogen provide Abbott with next-generation technologies to broaden its existing product portfolio in the cardiovascular and ophthalmic device spaces, respectively

Large commercial infrastructure and global footprint enable Abbott to quickly gain share in emerging patient care markets that utili ze newly-acquired technologies

Jan-09 $2,744

2.4x 2.3x Acquisition moves Abbott into the global ophthalmology marketplace 149% premium to previous day’s close, but only 88% of the 52-week high AMO had been negatively affected by economic downturn and high leverage

Sept-09

May-09

$194

$425

1.9x

4.3x

1.9x

3.8x

Adds BIS brain monitoring technology and $100 million+ in sales to Covidien’s $1,370 million respiratory and monitoring solutions business

Expands presence in vascular market (complements 3/09 Bacchus Vascular acquisition) and fits in with its strategy of becoming a leading partner with vascular surgeons and interventional radiologists while adding $100 million+ of sales and 15%+ top-line growth to Covidien’s $530 million vascular business (growing ~6%)

Jun-09

$150 na na Broadens ev3's neurovascular portfolio for the treatment of cerebral aneurysms Chestnut’s Pipeline Embolization Device (PED) is one of 2 marketed flow-diversion devices;

will immediately contribute to revenue and allow ev3 to capture market share and fuel growth

Feb-09 Blocked

$261 na 22.1x Structured as a 50% cash / 50% stock transaction designed to leverage the strength of Thoratec’s balance sheet, while preserving capital for Heartware’s future programs

Strong research and development engine will significantly bolster Thoratec’s pipeline

Feb-09

Feb-09

$700

$325

14.0x

na

7.4x

na

Acquisitions give Medtronic a strong head start into the transcatheter aortic valve market

Together, the CoreValve and Ventor acquisitions may block other consolidators from entering the market in a meaningful way over the next 5 years

Jan-09

Sep-08

$225

$380

na

11.0x

na

7.9x

Made two acquisitions in the AFib space within 6 months; provides Medtronic with the ability to offer both RF and Cryo balloon-based technologies

Leapfrogged leaders with best-in-class next generation technology

Dec-08

Dec-08

$250

$300

3.1x

na

na

na

Radi added products to bolster vascular closure business and provided a key pipeline growth driver with the pressure measurement guidewire, PressureWire Certus

MediGuide provided innovative navigation system technology platform with applications across the AFib and Cardiology divisions

Dec-08 $1,120 2.9x 3.1x Allowed J&J to strengthen presence in aesthetic and reconstructive medicine at a time when

the overall market for aesthetic procedures, including breast augmentation, was weakening Mentor expected to operate as stand-alone business unit through Ethicon

$ millions$ millions

Source: Company filings, equity research

Consolidators have aggressively been using acquisitions to enhance their growth profile

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Strategic acquirors evaluate a variety of value drivers

Sustainable business model

Current pre-revenue deals

Sales ramp

Novel technology

Profitability

IP protection

Pipeline

Robust clinical trials

Blockbuster markets ($1bn+)

Blockbuster markets ($1bn+)

Sustainable business model

Current pre-revenue deals

Sales ramp

Novel technology

Profitability

IP protection

Pipeline

Robust clinical trials

Typical device markets

($500mm - $1bn)

Typical device markets

($500mm - $1bn)

Buyers are looking for home run opportunities

Buyers are looking for scale businesses or opportunities that fit into their current distribution while quickly adding growth to the top-line and profit to the bottom line

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$450

$400

$150

$325$300

$250 $240

$725

$333

$246

$166

$260

$160$200

$850

$237

$300

$225 $240

$215

Abbot t/ Eval ve Abbot t /V i s i ogen

ev3/ ChestnutM edi cal

M edt r oni c/Ventor

Technol ogies

M edtr oni c /Cor eVal ve

M edt r oni c/Abl at i onFr ont i ers

St . JudeM edi cal /

M edi Gui de

St . JudeMedi cal / Radi

M edi cal

Systems

J&J/ Sur gRx M edi ci s/Li poSonix

Bausch & Lomb/ eyeoni cs

Cytyc/ Adi ana

Kyphon/ Di sc-O-T ech

Kyphon/ St .Fr anci sM edi cal

Technol ogi es

Or thof i x /B l ackstone

M edi cal

T ycoHeal thcare/

Conf l uent

Sur gi cal

Hol ogi c / R2T echnol ogy

Hol ogi c / Sur os C.R. Bar d/V enetec

T er umo/Mi cr oV ent i on

M edt r oni c/T r ansneur oni x

Cytyc/P r ox i ma

T her apeut i cs

Private medtech M&A transactions ($mm)Private medtech M&A transactions ($mm)

Total median: $246

Note: Excludes asset sales, acquisitions by sponsors, transactions with total deal value <$100mm and diagnostics transactions; Figures represent total deal value; indicates upfront portion of total deal value

Source: Company filings and press releases1 Milestone payments undisclosed

$350

2009 2008 2006 2005

Summary of private medtech M&A activity

$75

$700

$155 $150$100

$525

Upfront median: $239

1

1

NA $60NA

2007

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Notes:IPOs include NYSE/Nasdaq medtech IPOs with gross proceeds >$15mm; excludes in-vitro diagnostics, life science tools and contract manufacturing;M&A includes all announced medtech transactions >$50mm; excludes in-vitro diagnostics, life science tools and contract manufacturing

Source: SDC, Dealogic, and J.P. Morgan

14

2 1

57

20

16

10

13

10

10

22

25

21

17

20

10

2830

37

25

29

22

14

0

5

10

15

20

25

30

35

40

45

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009YTD

IPOs M&A

Medtech IPO and M&A activity since 1997Medtech IPO and M&A activity since 1997

Market conditions are expected to continue to drive M&A activity

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An noun ce Offer price pre mium to Date Acq uiror Target 1 da y 1 mo nth 52-wk h ig h

1 0/09 /09 Kimb erle y-C lark

I-Flow 7.6 % 35.4 % 1.6%

0 9/28 /09 Covidien Aspect Med ical

56.5 % 84.6 % 4 9.8%

0 9/09 /09 Syn ero n Ca ndela 51.1 % 130.9 % (6.6 %)

0 7/29 /09 Covidien Power Med ical

2 58.6 % 246.7 % (66.4 %)

0 5/08 /09 Covidien VNUS 36.0 % 40.6 % 2 3.4%

0 2/12 /09 Tho ra tec He artW are 93.6 % 109.7 % 2 3.1%

0 1/12 /09 Ab bott AMO 1 48.6 % 274.1 % (11.6 %)

1 2/01 /08 J&J Men tor 92.0 % 83.4 % (24.1 %)

0 9/25 /08 M edtronic CryoC ath 97.1 % 94.4 % 1.2%

0 9/16 /08 Ge tinge Da tascope 11.7 % 12.5 % 5.3%

0 7/24 /08 Ge neral Ele ct ric

Vital Signs

28.4 % 29.2 % 1.9%

0 4/7/0 8 KC I LifeCell 18.2 % 26.3 % 1.1%

0 1/15 /08 W arb urg Pin cu s

LifeCore BioMe dica l

32.4 % 29.2 % (13.9 %)

1 2/21 /07 Ph ilips Re sp ironics 24.3 % 30.7 % 1.0%

0 7/23 /07 Teleflex Arrow 20.4 % 19.3 % 3.2%

0 7/16 /07 Bla ckston e DJ Ort hope dics

19.4 % 25.1 % 0.3%

0 6/03 /07 Qia gen Dig ene 37.6 % 38.4 % 1 4.9%

0 5/20 /07 Hologic Cytyc 32.8 % 32.7 % 2 6.8%

0 5/16 /07 W arb urg Pin cu s

Bausch & Lom b

5.7 % 13.4 % (3.7 %)

0 5/14 /07 Cardinal Viasys 35.5 % 30.1 % (1.0 %)

0 4/04 /07 I nverness Biosite 9.7 % 52.1 % 9.7%

0 2/12 /07 Cytyc Adeza 54.5 % 60.9 % 0.9%

0 1/05 /07 AM O IntraL ase 11.1 % 14.3 % 7.6%

0 6/05 /06 A merican M edical Syste ms

Lase rscope 44.8 % 44.1 % (28.3 %)

0 4/12 /06 Dana her Sybron 12.6 % 18.5 % 0.4%

1 2/16 /05 J&J Animas 34.6 % 44.1 % 2.0%

1 0/16 /05 St . Jude ANSI 34.3 % 24.7 % 1 6.7%

M ean 48. 5% 60. 9% 1.3 %

M edian 34. 3% 35. 4% 1.2 %

US healthcare control premiums1US healthcare control premiums1

Precedent premiums

Precedent premiums – Medtech dealsPrecedent premiums – Medtech deals

Selected transactions2Selected transactions2

Public medtechM&A activity

post-credit crisis

34%

41%

26%

43%

25% 27

%

34%

48%

24%

28% 29

%

36%

34%

30% 32

%

2005 2006 2007 2008 1H09

One-day One-week One-m onth

Source: J.P. Morgan; Dealogic Enterprise static data as of June 30, 2009Premiums deal list source: Dealogic Enterprise Static as of June 30, 2009Note: US target rank eligible deals greater than $10mm1 Premiums based on one-day, one-week and one-month prior to announcement. Includes public deals where initial

stake is <50% and final stake is >51%2 As of 10/16/09

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This presentation was prepared exclusively for the benefit and internal use of the JPMorgan client to whom it is directly addressed and delivered (including such client’s subsidiaries, the “Company”) in order to assist the Company in evaluating, on a preliminary basis, the feasibility of a possible transaction or transactions and does not carry any right of publication or disclosure, in whole or in part, to any other party. This presentation is for discussion purposes only and is incomplete without reference to, and should be viewed solely in conjunction with, the oral briefing provided by JPMorgan. Neither this presentation nor any of its contents may be disclosed or used for any other purpose without the prior written consent of JPMorgan.

The information in this presentation is based upon any management forecasts supplied to us and reflects prevailing conditions and our views as of this date, all of which are accordingly subject to change. JPMorgan’s opinions and estimates constitute JPMorgan’s judgment and should be regarded as indicative, preliminary and for illustrative purposes only. In preparing this presentation, we have relied upon and assumed, without independent verification, the accuracy and completeness of all information available from public sources or which was provided to us by or on behalf of the Company or which was otherwise reviewed by us. In addition, our analyses are not and do not purport to be appraisals of the assets, stock, or business of the Company or any other entity. JPMorgan makes no representations as to the actual value which may be received in connection with a transaction nor the legal, tax or accounting effects of consummating a transaction. Unless expressly contemplated hereby, the information in this presentation does not take into account the effects of a possible transaction or transactions involving an actual or potential change of control, which may have significant valuation and other effects.

Notwithstanding anything herein to the contrary, the Company and each of its employees, representatives or other agents may disclose to any and all persons, without limitation of any kind, the U.S. federal and state income tax treatment and the U.S. federal and state income tax structure of the transactions contemplated hereby and all materials of any kind (including opinions or other tax analyses) that are provided to the Company relating to such tax treatment and tax structure insofar as such treatment and/or structure relates to a U.S. federal or state income tax strategy provided to the Company by JPMorgan.

JPMorgan’s policies prohibit employees from offering, directly or indirectly, a favorable research rating or specific price target, or offering to change a rating or price target, to a subject company as consideration or inducement for the receipt of business or for compensation. JPMorgan also prohibits its research analysts from being compensated for involvement in investment banking transactions except to the extent that such participation is intended to benefit investors.

IRS Circular 230 Disclosure: JPMorgan Chase & Co. and its affiliates do not provide tax advice. Accordingly, any discussion of U.S. tax matters included herein (including any attachments) is not intended or written to be used, and cannot be used, in connection with the promotion, marketing or recommendation by anyone not affiliated with JPMorgan Chase & Co. of any of the matters addressed herein or for the purpose of avoiding U.S. tax-related penalties.

JPMorgan is a marketing name for investment banking businesses of JPMorgan Chase & Co. and its subsidiaries worldwide. Securities, syndicated loan arranging, financial advisory and other investment banking activities are performed by a combination of J.P. Morgan Securities Inc., J.P. Morgan plc, J.P. Morgan Securities Ltd. and the appropriately licensed subsidiaries of JPMorgan Chase & Co. in Asia-Pacific, and lending, derivatives and other commercial banking activities are performed by JPMorgan Chase Bank, N.A. JPMorgan deal team members may be employees of any of the foregoing entities.

This presentation does not constitute a commitment by any JPMorgan entity to underwrite, subscribe for or place any securities or to extend or arrange credit or to provide any other services.

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Panel II: Regulatory Issues and Developments at the FDA

Lou Mazzarese, Edwards Life SciencesMark Heller, Goodwin Procter LLP

Recent 510(k) & Compliance Trendsby

Mark A. Heller

BIOCOM/Orange County Breakfast Meeting

October 21, 2009Newport Beach, CA

16

FDA COMMISSIONS IOM STUDY

• On September 23, 2009, FDA commissioned for $1.3 million IOM “to study the premarket notification program used to review and clear certain medical devices marketed in the United States.”

• The IOM Is a not for profit, non-governmental organization chartered as part of the National Academy of SciencesIts purpose is to provide national advice related to biomedical science, medicine, and health

• Claim 1976 Amendments established the 510(k) process with two goals:

Make safe and effective devices available to consumersPromote innovation in the medical industry

(CONT’D)

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• IOM Committee will answer two principal questions

Does the current 510(k) process optimally protect patients and promote innovation in support of public health?If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process?

• Problem with IOM assignment is that the principal substantive question regarding the adequacy of the program is based upon false premises

510(k) was not intended by Congress to be the method to optimally protect patientsIt was not intended by Congress to foster innovationIt was intended to sort devices into groups that would be subject to regulatory controls that would provide the right level of protection to achieve reasonable assurance of device safety and effectiveness and promote innovation by avoiding over regulation

18

September 24, 2009 Preliminary Report• Internal procedural errors that undermine the

integrity of decisionmaking• “[P]resence of widespread internal

disagreement and confusion about the legal standard for 510(K) review”

• Questions about “[FDA’s] authority to require clinical data in a 510(k) submission except to compare technology is unclear . . . .”

• No established procedures for Panel reviews of 510(k)s

• Need for an independent internal review

19

WHY IS 510(K) CURRENTLY A FOCAL POINT?

• Congressional Perceptions and Pressure• Public Interest Group Perceptions and Pressure• So-called Whistleblowers• The Media• Inconsistency within FDA• Common Criticisms

Can market if you are as good as the worst device on the market -- ?Can market if you are as good as a preamendment device, i.e., a 33+ year old device -- ?Very little transparency into decisionmaking

• Over-utilizationFailure to put in place class II controlsFailure to call for preamendment PMAs for Class III devices

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Premarket Notification/510(k): Creation • Medical Device Amendments of 1976

Premarket RegulationClass I Devices – General ControlsClass II Devices – Performance StandardsClass III Devices - PMA

Preamendments Devices Classification by RulemakingClass II Standards by RulemakingClass III PMAs by Rulemaking

Classification of Post-Amendments Devices Automatic classification/PMASENSENOT AN APPROVAL

Implementation Led to Regulatory Gap No standards Few PMA regulations

510(k) became the only premarket review for class IIs and preamendments class IIIs

(CONT’D)

21

Thoughts On 510(k) • 510(k) as a classification tool is effective, efficient and

necessary; significant change in this classification method for “new” devices will likely create large and uncertain resource demands

• Ultimately the real concern with the 510(k) process is its use as a surrogate for PMAs and performance standards/now special controls

• Currently, FDA is addressing the preamendments PMA issue to ensure either the reclassification or the submission of PMAs for preamendments Class IIIs

• Reclassified preamendments Class III devices will have special controls to qualify for Class II regulation

• For higher risk Class IIs, FDA could selectively reopen classification regulations and include special controlsfor each such type of device that requires them to provide

• In sum, effective implementation of FDA’s current authority can address the alleged major deficiencies of the 510(k) process; amendments to the FDCA will not achieve much

22

Regulatory Environment• More aggressive compliance effort

Dr. Hamburg’s speech to FDLIFDA must be quick and visible, i.e., publicize enforcement actions483 responses – as of 9/15/09 – 15 working days for response to ensure the timely decision to and issuance of warning lettersLimit Chief Counsel’s review of Warning letters to significant legal issues to expedite issuance FDA will not delay the issuance of a warning letter to review responses that are submitted more than 15 working days after receipt of a 483Prompter Enforcement – Enforcement action even prior to a WL in appropriate cases; discontinue the issuance of multiple WLs (CONT’D)

23

• Device compliance contextAggressive on recallsAggressive on press releasesLittle room for negotiations

L. J. Mazzarese

“The Perfect Storm”

Product Problems

Consumer Activism

FDA Turmoil

Political Oversight / Pressure

Legislative Initiatives

Product Problems

Vioxx

Defibrillator Lead Fractures

Heparin

Lead Contamination

Peanut Butter; Pistachios; etc

Consumer Activism

Media Coverage

Public Citizen – Sidney Wolfe

National Research Center for Women & Families– Diana Zuckerman, PhD

FDA Turmoil

New Administration

New Commissioner

CDRH Leadership Challenge

FDA’s “Disgruntled 8”

510(k): GAO Report; FDA and IOM Reviews

Political Oversight / PressureWaxman:

– Unseats Dingell as Chairman, Energy and Commerce– Anti 510(k); Anti PMA Pre-emption

Dingell – Stupak:– Calls for total FDA overhaul– “….sr. mgrs. coerced FDA experts to modify reviews…”– “…FDA employees are too close with industry…”

Pallone:– Committed to change 510(k)– Anti Pre-emption

Legislative

New Medical Device Bill: FDA OverhaulImport Safety

– Increased User Fees; Increased Facility Inspections Comparative Efficacy

– Influence on Reimbursement and FDA approval processPre-emption Challenge

Split FDA: Foods from Drugs and Devices

510(k) Attack

510(k) Attack

GAO Report; FDA and IOM Reviews

Likely Targets for reform:– Up-classification for higher risk Class II 510(k) products

to Class III (PMA) status.

– Restrictions to JTF process

– Significantly Increased Clinical Data requirements

Some New Faces

Joshua Sharfstein

Jeanne Ireland

Ann Witt

Peter Lurie

Meghan Scott

Some Past Affiliations

Waxman

Waxman

Waxman

Public Citizen

Amer. Assoc. for Justice– Trial Attorneys

“….The Past is Prologue…”

1962: Thalidomide

– Legislation: Kefauver Harris Amendments

» Drug Lag Legislative Reform

1976: Heart Valves, Tampons, Ventilators

– Legislation: Medical Device Amendments

» Device Lag Legislative Reform

Opportunities

Stay Alert: ……Strategic Awareness / Positioning

Don’t Go It Alone:…… D.C., AdvaMed, Consultants

Utilize Competitive Skills / Advantage

Engage: Become part of the solution.

Helping Patients is Our LifeHelping Patients is Our Life’’s Work, ands Work, and


Panel III: Intellectual Property Monetization

Josette Ferrer, Marsh Risk ConsultingPaul Davis, Goodwin Procter LLP

medical device companies: opportunities in 2010

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