Kari KiviniemiAalto 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 MEDICALDEVICE 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 + 2007/47/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 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

QUALITY SYSTEMS

• ISO 9001 - Quality Management System

• ISO 13485 - 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 623661. 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 1981

• 50 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?