Ginsbourg.com presentation of: Medical Software Validation Challenges in 2014 * no video embedded * Risks * Costs * Trends * Challenges

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Medical
Software
Validation
Challenges in
2014
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Software Validation 2014
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• Formerly QA Manager of LoadRunner at Mercury Interactive
• M.Sc. cum laude in Bio-Medical Engineering
• M.Sc. in Mechanical Engineering
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Software Validation 2014
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• Risks
• Costs
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• Trends
• Challenges
Ginsbourg.com Medical
Software Validation 2014
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1. Coding finished
2. Run a few tests
3. System approved
4. Release
← High Risk Approach
Result: Disaster !
 Inadequate design or
poor coding produces many
time bombs in the system!
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Catastrophic software failure
Therac-25 medical accelerator (1985-1987)
• Therac-25 was a therapy system that delivered two different kinds of radiation:
either a low-power electron beam or X-rays.
• The Therac-25's X-rays were generated by smashing high-power electrons into a
metal target positioned between the electron gun and the patient.
• An electromechanical safety interlock was replaced by a software control, because
software was perceived to be more reliable.
• The OS was compiled by a programmer with no formal training.
• Because of a “race condition” bug, the operator could accidentally configure the
Therac-25 so the electron beam would fire in high-power mode, but with the metal
X-ray target out of position.
• At least five patients died; others were seriously injured.
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Software Validation 2014
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QC → Products
QA → Processes
ISO 13485:2003 Medical devices - Quality management
systems - Requirements for regulatory purposes
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1.SW Lifecycle
2.Documentation
Low Risk Approach
3.Risk Analysis
4.Specifications (functional, performance, usability, etc.)
5.Requirements (marketing, technical, user expectations, etc.)
6.Code Review (manual, automatic)
7.Code Freeze
8.Version Management
9.Bug Base
10.Validation & Verification
←
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Software Validation 2014
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• Risks
• Costs
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• Trends
• Challenges
Ginsbourg.com Medical
Software Validation 2014
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What are mobile medical apps?
Mobile apps are software programs that run on
smartphones and other mobile communication
devices.
How will the FDA regulate mobile medical apps?
The FDA will apply the same risk-based approach the
agency uses to assure safety and effectiveness for
other medical devices.
Last Updated: 10/22/2013
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Software Validation 2014
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Does the FDA regulate mobile devices and mobile app
stores?
FDA‟s mobile medical apps policy does not regulate
the sale or general consumer use of smartphones or
tablets. FDA‟s mobile medical apps policy does not
consider entities that exclusively distribute mobile
apps, such as the owners and operators of the “iTunes
App store” or the “Google Play store,” to be medical
device manufacturers.
Last Updated: 10/22/2013
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When is a mobile app classed as a medical device?
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• Currently available for iOS devices.
• Helps doctors calculate the percentage of a
patient‟s body surface area that is burned.
• Calculates the amount of fluid to be
administered in the 24-hour period that
follows the burn injury.
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THE DARIO PLATFORM
DarioTM is a state-of-the-art in diabetes management platform that
connects the user, caregiver and healthcare professional anywhere
in the world.
Dario„s cloud-based software
provides you with an easy
seamless way to record, save,
track, analyze, manage & share
all your diabetes related
information in one lifestyle
management platform.
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Meeting the Challenge:
1. Methods (V-model, Risk Manage)
2. Tools (Functional, Performance)
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Automated iPhone Testing using Open Source Tools:
This is a demonstration of how to automate the iOS platform / iPhone
automation using Open Source tools; compatible with ANT and Maven
in any continuous environment.
In this demo we show you
how Open Source can
perform a basic test
in an iPhone app and run
through both positive and
negative testing.
Uploaded on Apr 7, 2011
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http://www.ibm.com
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