Lessons learned

 

Follow-up

 

Devices

 

Timelines

 

Discussion

 

User experience

• Improve connectivity
• Omit smart phone in the process
• Variations in questions / topics

Study experience

• Licensing 'Quality of Life' questionnaire
• Study or not (Regulatory aspect)
• More extensive testing needed

FU study III:

Commercial driven

FU study II:

Real-life experience

 

INTEGR8:

2-way communication

Patient population

• Internal & external patients
• Broaden age range
• Global
• Multi-language

Study design

• Data entry / answer questions
• Extended functionality (metrics)
• Provide support community
• Data correlation
• edc2go (vs. e-capture)

Study names

• Fusion
• Mesh
• Unify
• Ittaika
• Ikkan

Define study

• Device
• Protocol
• CRF
• Consent Form
• Participants
• Sign-off

Development

• Mockups
• Engineering
• Testing
• Validation

Communication

• Internal
• External

Study conduct

Publication