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TRANSCRIPT
Reed Tech Navigator™ for Medical Devices A Modern Approach to Analyzing Medical Device Data
December 11, 2018
Rachel Benway - Presenter Product Manager, Life Sciences
© Reed Tech 2018
Presenters
Joe Hage - Host MedicalDevicesGroup.net
Agenda
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Why the current process is frustrating
A Modern Approach Reed Tech Navigator™
Becoming Proactive instead of Reactive Product Alerts
Multiple Use Cases for Medical Device Data
Questions?
Searching the FDA’s web-based databases can be frustrating and takes too much time
0% 10% 20% 30% 40% 50% 60% 70%
No pain points
Cost
Lack of analytics expertise / personnel
Lack of analytics tools
Too many data sources
Data sources not clean
Time required
Difficult to search & retrieve meaningful results
Major Pain Points with Existing Methods
% of survey respondents who indicated FDA web-search is their primary method of researching medical device safety and quality risks (Nov 2016 Reed Tech survey of medical device mfrs)
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Despite a large volume of available data about medical
devices, there are significant barriers to using it effectively
for risk analysis and safety monitoring
1. Time-intensive process requires combing through multiple sources
2. Difficult to search & retrieve meaningful results
3. Data is not normalized or standardized, making trending & benchmarking difficult
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© Reed Tech 2018
Navigator connects over a dozen sources to create a comprehensive database of companies and their devices, as well as their regulatory, safety & quality information
GoodMed NexKnee Coated Knee
Femur Prosthesis
Adverse Event Reports Recalls
PMAs
De Novos
HDEs
510(k)s
Establishment Registrations
Device Listings
Warning Letters
UDIs
Safety Communications
MedSun Reports
GMDN
LexisNexis Corporate Affiliations
Navigator has extracted and standardized safety & quality metrics from text descriptions to enable quantitative analyses
It was reported that the patient is having swelling in her right knee and shows some posterior femoral lucency. The surgeon is concerned about osteolysis behind the femur and patella.
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0.0% 5.0% 10.0% 15.0% 20.0% 25.0%
Joint DislocationFracture(s)
Muscle Spasm(s)Pain
InflammationInfection
Nerve DamageDiscomfortOsteolysis
Joint Swelling
Top Patient Problems Reported
Navigator has made over 60,000 510(k)s PDFs searchable by intended use, indications for use, and device description
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Frustrated with search FDA sites?
There is a better way!
© Reed Tech 2018
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Reed Tech Navigator™ for Medical Devices
• Regulatory Intelligence • Predicate Searching • Guidance Documents
• Risk Management
• Adverse Event Research • Possible Failure Modes • Frequency & Severity
How to become Proactive instead of Reactive
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Never again miss a new product risk for your product or a competitor’s product with Navigator’s in-app alerts
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New voluntary report added to the FDA database within 30 days
Voluntary – submitted directly to the FDA— i.e. Not submitted through the manufacturer, user facility, or distributer)
Value: Currently can only find out about these Adverse Event Reports by manually checking the FDAs MAUDE Database
Voluntary Adverse Event
First instance of this device problem to be reported for this product
Value: A new device problem can indicate a new failure mode or hazard
Device Problem
First individual recall for this recall event
Value: Most valuable for competitive intelligence
Recall Event
What can all of this data tell us?
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Properly prepared data can support multiple use cases Clinical
Evaluations
Risk Analysis Competitive Intelligence
Post Market Surveillance
Failure Mode Analysis
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Adverse Event - Device Problems
Adverse Event – Patient Problems
Recall Reasons
Recall Unit Counts
510(k) Successors
FDA Guidance Documents
Warning Letter CFR References
Reed Tech Navigator™ for Medical Devices
www.reedtech.com/navigator
Fast and easy search
Trending and benchmarking of safety and quality metrics
Head-to-head product comparisons
In-depth research across multiple sources in one place
15 © Reed Tech 2018
“Navigator is a one-stop shop”
“Much simpler and a lot of time saving” compared to using FDA sources directly
“Very useful and very easy to navigate through”
For more information, contact:
Reed Tech Life Sciences Team
(215) 682-8269
Follow Reed Tech Life Sciences for new content and events
@ReedTechLifeSci
© Reed Tech 2018