Ginsbourg.com

Medical
Software
Validation
Challenges in
2014

1

Ginsbourg.com Medical
Software Validation 2014

12/23/13
Ginsbourg.com

• Formerly QA Manager of LoadRunner at Mercury Interactive
• M.Sc. cum laude in Bio-Medical Engineering
• M...
Ginsbourg.com

• Risks
• Costs

3

• Trends
• Challenges

Ginsbourg.com Medical
Software Validation 2014

12/23/13
Ginsbourg.com

4

Ginsbourg.com Medical
Software Validation 2014

12/23/13
Ginsbourg.com
1. Coding finished
2. Run a few tests
3. System approved
4. Release

← High Risk Approach

Result: Disaster ...
Ginsbourg.com

Catastrophic software failure
Therac-25 medical accelerator (1985-1987)
• Therac-25 was a therapy system th...
Ginsbourg.com

7

Ginsbourg.com Medical
Software Validation 2014

12/23/13
Ginsbourg.com

QC → Products
QA → Processes
ISO 13485:2003 Medical devices - Quality management
systems - Requirements for...
Ginsbourg.com
1.SW Lifecycle
2.Documentation
Low Risk Approach
3.Risk Analysis
4.Specifications (functional, performance, ...
Ginsbourg.com

• Risks
• Costs

10

• Trends
• Challenges

Ginsbourg.com Medical
Software Validation 2014

12/23/13
Ginsbourg.com

11

Ginsbourg.com Medical
Software Validation 2014

12/23/13
Ginsbourg.com

12

Ginsbourg.com Medical
Software Validation 2014

12/23/13
Ginsbourg.com

13

Ginsbourg.com Medical
Software Validation 2014

12/23/13
Ginsbourg.com

14

Ginsbourg.com Medical
Software Validation 2014

12/23/13
Ginsbourg.com

15

Ginsbourg.com Medical
Software Validation 2014

12/23/13
Ginsbourg.com

What are mobile medical apps?
Mobile apps are software programs that run on
smartphones and other mobile co...
Ginsbourg.com

Does the FDA regulate mobile devices and mobile app
stores?
FDA‟s mobile medical apps policy does not regul...
Ginsbourg.com
When is a mobile app classed as a medical device?

18

Ginsbourg.com Medical
Software Validation 2014

12/23...
Ginsbourg.com

• Currently available for iOS devices.
• Helps doctors calculate the percentage of a
patient‟s body surface...
Ginsbourg.com

20

Ginsbourg.com Medical
Software Validation 2014

12/23/13
Ginsbourg.com

21

Ginsbourg.com Medical
Software Validation 2014

12/23/13
Ginsbourg.com
THE DARIO PLATFORM
DarioTM is a state-of-the-art in diabetes management platform that
connects the user, car...
Ginsbourg.com

23

Ginsbourg.com Medical
Software Validation 2014

12/23/13
Ginsbourg.com

Meeting the Challenge:
1. Methods (V-model, Risk Manage)
2. Tools (Functional, Performance)

24

Ginsbourg....
Ginsbourg.com

25

Ginsbourg.com Medical
Software Validation 2014

12/23/13
Ginsbourg.com

26

Ginsbourg.com Medical
Software Validation 2014

12/23/13
Ginsbourg.com
Automated iPhone Testing using Open Source Tools:
This is a demonstration of how to automate the iOS platfor...
Ginsbourg.com

http://www.ibm.com

28

Ginsbourg.com Medical
Software Validation 2014

12/23/13
Ginsbourg.com

29

Ginsbourg.com Medical
Software Validation 2014

12/23/13
Ginsbourg.com

30

Ginsbourg.com Medical
Software Validation 2014

12/23/13
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Ginsbourg.com - Presentation of Medical Software Validation Challenges in 2014 ver 8 no video embedded

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Medical Software Validation Challenges in 2014
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* Risks * Costs * Trends * Challenges

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Ginsbourg.com - Presentation of Medical Software Validation Challenges in 2014 ver 8 no video embedded

  1. 1. Ginsbourg.com Medical Software Validation Challenges in 2014 1 Ginsbourg.com Medical Software Validation 2014 12/23/13
  2. 2. Ginsbourg.com • Formerly QA Manager of LoadRunner at Mercury Interactive • M.Sc. cum laude in Bio-Medical Engineering • M.Sc. in Mechanical Engineering 2 Ginsbourg.com Medical Software Validation 2014 12/23/13
  3. 3. Ginsbourg.com • Risks • Costs 3 • Trends • Challenges Ginsbourg.com Medical Software Validation 2014 12/23/13
  4. 4. Ginsbourg.com 4 Ginsbourg.com Medical Software Validation 2014 12/23/13
  5. 5. Ginsbourg.com 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! 5 Ginsbourg.com Medical Software Validation 2014 12/23/13
  6. 6. Ginsbourg.com 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. 6 Ginsbourg.com Medical Software Validation 2014 12/23/13
  7. 7. Ginsbourg.com 7 Ginsbourg.com Medical Software Validation 2014 12/23/13
  8. 8. Ginsbourg.com QC → Products QA → Processes ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes 8 Ginsbourg.com Medical Software Validation 2014 12/23/13
  9. 9. Ginsbourg.com 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 ← 9 Ginsbourg.com Medical Software Validation 2014 12/23/13
  10. 10. Ginsbourg.com • Risks • Costs 10 • Trends • Challenges Ginsbourg.com Medical Software Validation 2014 12/23/13
  11. 11. Ginsbourg.com 11 Ginsbourg.com Medical Software Validation 2014 12/23/13
  12. 12. Ginsbourg.com 12 Ginsbourg.com Medical Software Validation 2014 12/23/13
  13. 13. Ginsbourg.com 13 Ginsbourg.com Medical Software Validation 2014 12/23/13
  14. 14. Ginsbourg.com 14 Ginsbourg.com Medical Software Validation 2014 12/23/13
  15. 15. Ginsbourg.com 15 Ginsbourg.com Medical Software Validation 2014 12/23/13
  16. 16. Ginsbourg.com 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 16 Ginsbourg.com Medical Software Validation 2014 12/23/13
  17. 17. Ginsbourg.com 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 17 Ginsbourg.com Medical Software Validation 2014 12/23/13
  18. 18. Ginsbourg.com When is a mobile app classed as a medical device? 18 Ginsbourg.com Medical Software Validation 2014 12/23/13
  19. 19. Ginsbourg.com • 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. 19 Ginsbourg.com Medical Software Validation 2014 12/23/13
  20. 20. Ginsbourg.com 20 Ginsbourg.com Medical Software Validation 2014 12/23/13
  21. 21. Ginsbourg.com 21 Ginsbourg.com Medical Software Validation 2014 12/23/13
  22. 22. Ginsbourg.com 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. 22 Ginsbourg.com Medical Software Validation 2014 12/23/13
  23. 23. Ginsbourg.com 23 Ginsbourg.com Medical Software Validation 2014 12/23/13
  24. 24. Ginsbourg.com Meeting the Challenge: 1. Methods (V-model, Risk Manage) 2. Tools (Functional, Performance) 24 Ginsbourg.com Medical Software Validation 2014 12/23/13
  25. 25. Ginsbourg.com 25 Ginsbourg.com Medical Software Validation 2014 12/23/13
  26. 26. Ginsbourg.com 26 Ginsbourg.com Medical Software Validation 2014 12/23/13
  27. 27. Ginsbourg.com 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 27 Ginsbourg.com Medical Software Validation 2014 12/23/13
  28. 28. Ginsbourg.com http://www.ibm.com 28 Ginsbourg.com Medical Software Validation 2014 12/23/13
  29. 29. Ginsbourg.com 29 Ginsbourg.com Medical Software Validation 2014 12/23/13
  30. 30. Ginsbourg.com 30 Ginsbourg.com Medical Software Validation 2014 12/23/13

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