A Practical Guide presentation created for DeviceMatters (www.devicematters.com) by vr4U Global Presentation Team

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
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2. www.devicematters.com
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.
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3. www.devicematters.com
Quality is an increasing concern within the public’s eye and
we have been lacking objective metrics for post-market safety
Increasing public concern around medical device 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 industrywide 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
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4. www.devicematters.com
With good post-market quality metrics, we could achieve a lot
Spot quality
trends
 Early alert for potential quality and safety issues
 Identify opportunities for safer next generation
solutions
Identify quality
gaps
 Learn when & why things go wrong post-market
to design an improved next generation product
 Help strategy teams identify patient needs
Track and
 Drive product strategy to help differentiate
compare safety
products based on post-market quality & safety
performance
 Refine marketing messages for existing products
Understand
risk factors
 Refine target populations and corresponding
marketing messages based on typical device
failure modes
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5. www.devicematters.com
DeviceMatters has chosen to look at adverse event data to
help decipher post-market quality performance
DeviceMatters Solution
 Why we have chosen to look at adverse events as the metric for
post-market quality performance?
Pros/Cons & Biases
 What are the pros/cons and biases inherent in adverse event data
and how can our data help?
How to spot trends
 How can DeviceMatters data help you spot quality trends and
potential safety issues?
How to drive innovation
 How can quality information drive innovation?
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6. www.devicematters.com
Quiz
How many adverse event reports do you believe
were filed for medical devices in 2011?
A.
50,000
C.
100,000
B.
200,000
D.
400,000
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7. www.devicematters.com
Quiz
How many adverse event reports do you believe
were filed for medical devices in 2011?
A.
50,000
C.
100,000
B.
200,000
D.
400,000
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8. www.devicematters.com
Adverse event reporting has been increasing rapidly …
Why are adverse events increasing so rapidly?
Drivers of the rapid growth in
adverse events
Adverse Event Reports Submitted
to the FDA
 Improved reporting due to greater
awareness and compliance
4,07,308
+28% p.a.
3,01,720
 Increased device complexity
(e.g., greater use of software)
2,40,352
 Increased use of devices by high-risk
populations (e.g., the elderly)
1,93,355
2008
 Device prevalence that is growing
much faster than the 6-9% industry
growth rate due to increasing use of
implants “for life”
2009
2010
2011
Note: Device safety changes for the same class of devices used in the same circumstances cannot be deduced from the data given above trends
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9. www.devicematters.com
… 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)
DeviceMatters has
cleaned up the adverse
 “Dirty” data with prevalent
company and product misspellings, and misclassifications
event data & provides
 “Keys” are not always used or are
sometimes overlapping &
confusing
patient and device
analytics on unique
outcomes
 Multiple reports are sometimes
recorded for the same event
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10. www.devicematters.com
DeviceMatters has cleaned up the adverse event data &
provides analytics on unique patient and device outcomes
Adverse Event Patient Outcomes
Serious Adverse Event Patient Outcomes
(Hospitalization or worse)
54,816
343,094
+30% p.a.
+45% p.a.
155,838
18,028
2008
2009
2010
2011
Note: Increased reporting rates does not necessarily mean less safe devices.
2008
2009
2010
2011
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11. www.devicematters.com
The key question remains: Is adverse event data reliable
enough to make product-critical decisions?
Data characteristics
Number of product codes
Number of product codes by number of
adverse event patient outcomes in 2011
 Data is plenty for a large number of
product codes
110
 Biases exist (as for most data), but
provides unique insights with smart &
cautious interpretations
– Product bias – Limit comparisons
to similar devices
78
69
59
35
50-100
101-200 201-500 501-1000 1001+
Range of adverse event
patient outcomes reported in 2011
– 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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12. www.devicematters.com
What We Knew Before: Medtronic Fidelis Leads
Could we have seen there was a potential issue with Medtronic leads earlier?
Event history
Adverse event patient outcomes
All Medtronic pacemaker and
defibrillator pulse generators & leads
4703
2840
1646
2002
1521
2003
 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
1774
 FDA/Medtronic issued a class I recall
8 months later (10/17/2007)
2005
 268,000 leads sold, an estimated
2.3% of leads fractured leading to
~6160 lead fractures and at least 5
deaths
1294
2004
2006
Y-o-y growth: 37% 60%
2007
66%
Note: Medtronic’s CRDM sales growth in the
mean time for Medtronic was 9%, 13%, -6%
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13. www.devicematters.com
What We Knew Before: DePuy Metal-on-Metal Hip Implants
Could we have seen there was a potential issue with DePuy hip implants?
Event history
Adverse event patient outcomes
All J&J hip implants
5,256
 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
2,576
1,805
1,053
218
1,348
1,639
 August 2010, DePuy ASR metal-onmetal hip recall was issued (1/8 found
to fail within five years, >93,000 of the
ASR components implanted)
269
2003 2004 2005 2006 2007 2008 2009 2010
Note: Depuy’s hip implant sales have been
noted to show strong sales prior to 2010
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14. www.devicematters.com
Could management or quality have spotted these trends
earlier based on DeviceMatters analytics?
J&J adverse event patient outcome trend
2008-09 adverse event growth & drivers of growth
55414
+47%
`
33726
27651
19854
18874
2007
2008
2009
2010
2011
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
Code
Name
NBW
GCJ
KWB
KWA
LPH
FZP
GDW
GEI
LFL
Over the Counter Blood Glucose Test Systems
General & Plastic Surgery Laparoscopes
Metal Cemented Acetabular Hemi- Hip Prostheses
Metal Uncemented Acetabular Component Semi-Constrained Hip Pros.
Metal/Polymer Porous Uncemented Semi-Constrained Hip Prostheses
Implantable Clips
Implantable Staples
Electrosurgical Cutting & Coagulation & Accessories
Ultrasonic Surgical Instruments
* Some product codes showed a decline during this period.
Abs. growth
4307
269
229
146
317
817
1117
176
1268
% growth
148%
80%
83%
54%
90%
121%
106%
35%
111%
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15. www.devicematters.com
Could management or quality have spotted these trends even
earlier based on DeviceMatters analytics?
J&J adverse event patient outcome trend
2007-08 adverse event growth & drivers of growth
55414
`
33726
-5%
27651
19854
18874
2007
2008
2009
2010
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
2011
Code
Name
NBW
LTI
KWA
NIM
MLR
NJL
HET
Over the Counter Blood Glucose Test Systems
Intragastric Implants for Morbid Obesity
Metal Uncemented Acetabular Component Semi-Constrained Hip Pros.
Carotid Stents
Chemical Sterilizers
Metal/Polymer Mobile Bearing Semi-Constrained Patellofemorotibial Knee Pros.
Gynecologic Laparoscopes & Accessories
Abs. growth
1471
205
198
196
159
153
144
% growth
102%
1708%
268%
700%
130%
62%
127%
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16. www.devicematters.com
Assuming metal-on-metal hip implants did emerge on top,
how do we know if it is a concern or artifact?
What does the data for KWA and KWB look like exactly?
Adverse event patient outcomes
(KWA+KWB, J&J.)
2,381
Specific failure reasons reported for KWA
and KWB
68%
69%
325
549
74 251
277
272
2007
2008
924
2,031
506
418
2009
2010
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?
Implant removed
Metal shedding debris (emerged later)
3.
Loose, dislodged, dislocated, mallocated
4.
350
1.
2.
158%
Loss of osteointegration (emerged later)
5.
Naturally worn
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?
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17. www.devicematters.com
With good post-market quality metrics, we could achieve a lot
Spot quality
trends
 Early alert for potential quality and safety issues
 Identify opportunities for safer next generation
solutions
Identify quality
gaps
 Learn when & why things go wrong post-market
to design an improved next generation product
 Help strategy teams identify patient needs
Track and
 Drive product strategy to help differentiate
compare safety
products based on post-market quality & safety
performance
 Refine marketing messages for existing products
Understand
risk factors
 Refine target populations and corresponding
marketing messages based on typical device
failure modes
17

18. www.devicematters.com
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Visit www.devicematters.com
Find the device category, product
code or manufacturer you want to
learn about
Sign in and download the Basic
Report FREE to learn more and
find out what the Comprehensive
Report offers
Download or request the
Comprehensive Report
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19. www.devicematters.com
Contact Us
Clarimed & DeviceMatters
Qmed, a UBM Canon brand
www.devicematters.com
www.qmed.com
http://www.qmed.com/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.
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