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 QUALITY, USABILITY, AND AGILITY OF MEDICAL DEVICE DEVELOPMENT

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

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

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

Standards and directives QUALITY

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

CONFORMITY ASSESSMENT - PATH

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

QUALITY SYSTEMS ISO Quality Management System ISO Medical Devices, Quality Management System

STANDARDS

SCRUM AGILE DEVELOPMENT

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

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

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

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

PROCESS

ARTIFACTS

ARTIFACTS 2

Standards USABILITY

USABILITY ENGINEERING PROCESS - IEC 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.

USER CENTERED DESIGN - ISO 13407

THE CASE

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

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

IMPROVEMENTS – PROJECT MANAGEMENT SCRUM Sprints Meetings & communication Product backlog

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

IMPROVEMENTS – USABILITY User interfaces Usability Engineering Process

QUESTIONS?