1. Kari Kiviniemi Aalto University - School of Science and Technology Faculty of Electronics, Communications and Automation Department of Communications and Networking Supervisor: Prof. Jyri Hämäläinen Instructors: D.Sc. (Tech.) Timo Korhonen, M.Sc. (Tech.) Hannu Remahl 26.10.2010 QUALITY, USABILITY, AND AGILITY OF MEDICAL DEVICE DEVELOPMENT

2. AGENDA Scope of work New requirements for Medical devices Quality Agile Development Usability The case

3. SCOPE OF WORK Quality Documentation and standards Project Management To speed up the final stages Usability Usability engineering process

4. NEW REQUIREMENTS FOR MEDICAL DEVICES Medical Device Directive, 93/42/EEC + 2007/47/EC Usability Engineering Process Software Risk Management

5. Standards and directives QUALITY

6. CONFORMITY ASSESSMENT Meets MDD Demonstrated by using applicable standards CE-marking Notified body

7. CONFORMITY ASSESSMENT - PATH

8. APPLICABLE STANDARDS IEC 60601-1 - Medical Electrical Equipment ISO 14971 - Application of Risk Management to Medical Devices IEC 62366 - Application of usability engineering to medical devices IEC 62304 - Medical device software. Software life-cycle processes

9. QUALITY SYSTEMS ISO 9001 - Quality Management System ISO 13485 - Medical Devices, Quality Management System

10. STANDARDS

11. SCRUM AGILE DEVELOPMENT

12. SCRUM THEORY Transparency Who affect the results, must know If something is believed to be done, it must be done Inspection Frequent inspections to detect variances Adaptation Quick adaptation to changes

13. ROLES IN SCRUM - PRODUCT OWNER Scope What is to be done – Product Backlog Time At what time – Releases Money Resources Maximize the value The ultimate decisions on product matters

14. ROLES IN SCRUM – SCRUMMASTER Makes work possible Couches Herds the flock Buffer Leads, not manages Enforces Scrum rules Servant-Leader to the team

15. ROLES IN SCRUM – THE TEAM Do the job Self-managing No one tells how to do the job Self-organizing Who does what Cross-functional No specified roles

16. PROCESS

17. ARTIFACTS

18. ARTIFACTS 2

19. Standards USABILITY

20. USABILITY ENGINEERING PROCESS - IEC 62366 1.Specify the application of the medical device. 2.Identify the device's frequently used functions. 3.Identify hazards and hazardous situations related to usability. 4.Identify the device's primary operating functions. 5.Develop the usability specication. 6.Prepare the usability validation plan. 7.Design and implement the user interface. 8.Verify the user interface design. 9.Validate the usability of the medical device.

21. USER CENTERED DESIGN - ISO 13407

22. THE CASE

23. THE COMPANY Medium-sized production company Founded 1981 50 people in Finland, 50 in China Dental Treatment Chair & Unit

24. THE PROJECT Completely new product Design Electronics, analog → digital Mechanics Cheaper to manufacture Modular Started 2004 Late

25. IMPROVEMENTS – PROJECT MANAGEMENT SCRUM Sprints Meetings & communication Product backlog

26. IMPROVEMENTS – QUALITY Documentation requirements Standards Directives Documentation improvements Project plan, requirement specification, architecture specification Document templates Infomation system

27. IMPROVEMENTS – USABILITY User interfaces Usability Engineering Process

28. QUESTIONS?