Practical Guide -

1

Practical guide to using post-market safety

data to target medical device innovation

How you can use DeviceMatters data to understand safety

issues and market needs for targeted quality improvements

April 2012

http://www.devicematters.com/

2

Terms of use

The materials and information within this presentation are for your information only. Acelly LLC does not

practice medicine or provide medical services or advice, and the information in this presentation should not be

considered medical advice. The information in this report is provided "as is" and should not be relied upon for

any specific purpose. Further, there are limitations inherent in electronic data indexing, and this report might

not have captured all relevant data through the coverage date indicated. Acelly LLC, Qmed (a UBM brand)

and its affiliates do not make, and hereby disclaim, any representation or warranty as to this presentation's

accuracy, completeness, merchantability, or fitness for a particular purpose. Acelly LLC, Qmed (a UBM brand)

and its affiliates shall not be liable to you for any losses suffered (including, without limitation, damages for

any consequential loss or loss of business opportunities or projects, or loss of profits), whether in contract, tort

or otherwise from your use of this presentation or its contents, or from any action or omission taken as a result

of using this report or its contents.

www.devicematters.com


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Increasing public concern around medical device safety

Quality is an increasing concern within the public’s eye and

we have been lacking objective metrics for post-market safety

High profile recent recalls

– Hip implants: Metal-on-metal hip implant

recalls (Depuy ASR hip class 2 recalls

2010/2011)

– Pacemaker leads: Lead fracture & insulation

failure (Medtronic Fidelis lead class 1 recall

2007, St. Jude Riata lead class 1 recall 2012)

– Vaginal mesh: FDA Public Health Notification*

in 2008

Increased publicity – count of media mentions

of “medical device safety” has grown significantly

in recent years (see examples on right)

Lack of objective metrics of post-market

safety makes it difficult to discuss clean facts; we

lack good quality and broadly accepted industry-

wide data to monitor post-market device safety

* FDA Publich Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and

Stress Urinary Incontinence



4

With good post-market quality metrics, we could achieve a lot

Spot quality

trends

Identify quality

gaps

Track and

compare safety

performance

Understand

risk factors

Early alert for potential quality and safety issues

Identify opportunities for safer next generation

solutions

Learn when & why things go wrong post-market

to design an improved next generation product

Help strategy teams identify patient needs

Drive product strategy to help differentiate

products based on post-market quality & safety

Refine marketing messages for existing products

Refine target populations and corresponding

marketing messages based on typical device

failure modes



5

DeviceMatters has chosen to look at adverse event data to

help decipher post-market quality performance

How can quality information drive innovation?

Why we have chosen to look at adverse events as the metric for

post-market quality performance?

DeviceMatters Solution

What are the pros/cons and biases inherent in adverse event data

and how can our data help?

Pros/Cons & Biases

How to drive innovation

How can DeviceMatters data help you spot quality trends and

potential safety issues?

How to spot trends



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Quiz

200,000

100,00050,000

How many adverse event reports do you believe

were filed for medical devices in 2011?

400,000B.

A.

D.

C.



7

Quiz

200,000

100,00050,000

How many adverse event reports do you believe

were filed for medical devices in 2011?

400,000B.

A.

D.

C.



8

Adverse event reporting has been increasing rapidly …

Note: Device safety changes for the same class of devices used in the same circumstances cannot be deduced from the data given above trends

1,93,355

2,40,352

3,01,720

4,07,308

2008 2009 2010 2011

Adverse Event Reports Submitted to the FDA

+28% p.a.

Why are adverse events increasing so rapidly?

Drivers of the rapid growth in

adverse events

Improved reporting due to greater

awareness and compliance

Device prevalence that is growing

much faster than the 6-9% industry

growth rate due to increasing use of

implants “for life”

Increased device complexity

(e.g., greater use of software)

Increased use of devices by high-risk

populations (e.g., the elderly)



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… yet, little attention has been paid to what it means or how it

could be used

Issues with current adverse

event database

Dataset is difficult to manage

(millions of data points require

specialized database skills just to

load the data)

“Dirty” data with prevalent

company and product mis-

spellings, and misclassifications

“Keys” are not always used or are

sometimes overlapping &

confusing

Multiple reports are sometimes

recorded for the same event

DeviceMatters has

cleaned up the adverse

event data & provides

analytics on unique

patient and device

outcomes



10

Adverse Event Patient Outcomes

155,838

343,094

2008 2009 2010 2011

Serious Adverse Event Patient Outcomes

(Hospitalization or worse)

18,028

54,816

2008 2009 2010 2011

DeviceMatters has cleaned up the adverse event data &

provides analytics on unique patient and device outcomes

+30% p.a.+45% p.a.

Note: Increased reporting rates does not necessarily mean less safe devices.



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The key question remains: Is adverse event data reliable

enough to make product-critical decisions?

110

7869

35

59

50-100 101-200 201-500 501-1000 1001+

Number of product codes by number of adverse event patient outcomes in 2011

Range of adverse event

patient outcomes reported in 2011

Nu

mb

er

of

pro

du

ct

co

de

s

Data characteristics

Data is plenty for a large number of

product codes

Biases exist (as for most data), but

provides unique insights with smart &

cautious interpretations

– Product bias – Limit comparisons

to similar devices

– Manufacturer bias – More

emphasis should be given to serious

adverse events & trends

Normalization factor overall is lacking

– For individual areas where product

sales or numbers are known, the

data can be normalized

Historically, we have been able to

“spot” major issues before major

recalls



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What We Knew Before: Medtronic Fidelis Leads

Event history

Leads approved as 510k and started

selling in Sept 2004

FDA was alerted in February of 2007

(2.5 years post launch) that there were

some issues

FDA/Medtronic issued a class I recall

8 months later (10/17/2007)

268,000 leads sold, an estimated

2.3% of leads fractured leading to

~6160 lead fractures and at least 5

deaths

1646 15211294

1774

2840

4703

2002 2003 2004 2005 2006 2007

Adverse event patient outcomesAll Medtronic pacemaker and defibrillator pulse generators & leads

37% 60% 66%Y-o-y growth:

Note: Medtronic’s CRDM sales growth in the

mean time for Medtronic was 9%, 13%, -6%

Could we have seen there was a potential issue with Medtronic leads earlier?



13

What We Knew Before: DePuy Metal-on-Metal Hip Implants

Event history

Aug 2005 first Depuy ASR cup system

approved

Mid-2009 FDA notifies DePuy of

issues with metal-on-metal hip early

failures and sends a non-approvable

letter to a J&J 510k application

August 2010, DePuy ASR metal-on-

metal hip recall was issued (1/8 found

to fail within five years, >93,000 of the

ASR components implanted)

Note: Depuy’s hip implant sales have been

noted to show strong sales prior to 2010

218 269

1,053

1,805

1,348 1,639

2,576

5,256

2003 2004 2005 2006 2007 2008 2009 2010

Adverse event patient outcomesAll J&J hip implants

Could we have seen there was a potential issue with DePuy hip implants?



14

`

Could management or quality have spotted these trends

earlier based on DeviceMatters analytics?

J&J adverse event patient outcome trend

* Some product codes showed a decline during this period.

J&J adverse event patient outcome trend

19854 18874

2765133726

55414

2007 2008 2009 2010 2011

+47%

2008-09 adverse event growth & drivers of growth

Code Name Abs. growth % growth

NBW Over the Counter Blood Glucose Test Systems 4307 148%

GCJ General & Plastic Surgery Laparoscopes 269 80%

KWB Metal Cemented Acetabular Hemi- Hip Prostheses 229 83%

KWA Metal Uncemented Acetabular Component Semi-Constrained Hip Pros. 146 54%

LPH Metal/Polymer Porous Uncemented Semi-Constrained Hip Prostheses 317 90%

FZP Implantable Clips 817 121%

GDW Implantable Staples 1117 106%

GEI Electrosurgical Cutting & Coagulation & Accessories 176 35%

LFL Ultrasonic Surgical Instruments 1268 111%

Quick drill-down yields 9 product codes

responsible for 8,646 out of 8,777* of the increase

Clinical Chemistry & Toxicology > Clinical Chemistry

> Sugar Test Systems > NBW

Gastroenterology & Urology > GU Diagnostic

Devices > Other Scopes > GCJ

Orthopedics > Orthopedic implants > Partial &

Complete Hip Implants > KWA, KWB, LPH

General & Plastic Surgery > Surgical Tools >

– Staples, Surgical Tapes, & Access. > FZP, GDW

– Powered Surgical Instruments > GEI, LFL



15

`

Could management or quality have spotted these trends even

earlier based on DeviceMatters analytics?

J&J adverse event patient outcome trendJ&J adverse event patient outcome trend

19854 18874

2765133726

55414

2007 2008 2009 2010 2011

-5%

2007-08 adverse event growth & drivers of growth

Code Name Abs. growth % growth

NBW Over the Counter Blood Glucose Test Systems 1471 102%

LTI Intragastric Implants for Morbid Obesity 205 1708%

KWA Metal Uncemented Acetabular Component Semi-Constrained Hip Pros. 198 268%

NIM Carotid Stents 196 700%

MLR Chemical Sterilizers 159 130%

NJL Metal/Polymer Mobile Bearing Semi-Constrained Patellofemorotibial Knee Pros. 153 62%

HET Gynecologic Laparoscopes & Accessories 144 127%

Using the same threshold

for cutoff as on the earlier

slide, 7 product codes added

2,526 adverse event patient

outcome reports between

2007 and 2008



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Assuming metal-on-metal hip implants did emerge on top,

how do we know if it is a concern or artifact?

74 272 418

2,031

251277

506

350

2007 2008 2009 2010

Adverse event patient outcomes (KWA+KWB, J&J.)

1. Implant removed

2. Metal shedding debris (emerged later)

3. Loose, dislodged, dislocated, mallocated

4. Loss of osteointegration (emerged later)

5. Naturally worn

Specific failure reasons reported for KWA

and KWB

What is the call for action?

Should we recall? Stop selling?

Notify users about the potential risk?

Acceptable risk. Queue up

improvements or do nothing

How can this drive innovation?

Can the design/material/etc be tweaked

to achieve higher safety?

Is there a radically new way to avoid

the type of problem seen?

325549

924

2,381

What does the data for KWA and KWB look like exactly?

Is the increase real or artifact?

Was there increased media attention (e.g., recalls)?

Is it a combination of sales trends and expected

timing of implant failure?

What is the root cause of adverse events?

Is it a design, manufacturing, procedure, etc impact?

How broad is the impact?

Is it a product code-wide issue?

Is it specific to a specific model?

Is it specific to a specific batch?

69%

68%

158%



17

With good post-market quality metrics, we could achieve a lot

Spot quality

trends

Identify quality

gaps

Track and

compare safety

performance

Understand

risk factors

Early alert for potential quality and safety issues

Identify opportunities for safer next generation

solutions

Learn when & why things go wrong post-market

to design an improved next generation product

Help strategy teams identify patient needs

Drive product strategy to help differentiate

products based on post-market quality & safety

Refine marketing messages for existing products

Refine target populations and corresponding

marketing messages based on typical device

failure modes



18

How do I find and access this information?

Visit www.devicematters.com

Sign in and download the Basic

Report FREE to learn more and

find out what the Comprehensive

Report offers

Find the device category, product

code or manufacturer you want to

learn about

Download or request the

Comprehensive Report




19

Contact Us

TERMS OF USE

The materials and information within this presentation are for your information only. Acelly LLC does not practice medicine or provide

medical services or advice, and the information in this presentation should not be considered medical advice. The information in this

report is provided "as is" and should not be relied upon for any specific purpose. Further, there are limitations inherent in electronic

data indexing, and this report might not have captured all relevant data through the coverage date indicated. Acelly LLC, Qmed (a

UBM brand) and its affiliates do not make, and hereby disclaim, any representation or warranty as to this presentation's accuracy,

completeness, merchantability, or fitness for a particular purpose. Acelly LLC, Qmed (a UBM brand) and its affiliates shall not be liable

to you for any losses suffered (including, without limitation, damages for any consequential loss or loss of business opportunities or

projects, or loss of profits), whether in contract, tort or otherwise from your use of this presentation or its contents, or from any action or

omission taken as a result of using this report or its contents.

Clarimed & DeviceMatters


Qmed, a UBM Canon brand

www.qmed.com

http://www.qmed.com/contact-us



http://www.qmed.com/






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Practical Guide -