The Tao of Excellence survey
Welcome to the Tao of Excellence survey on the impact of Regulation on Innovation. We thank you for agreeing to take part in this important survey at this juncture, when the European market for medical devices is undergoing a sea of change in the regulatory environment. Your valuable feedback backed by years of experience will help in aptly re-defining the medical industry landscape. The survey should take only 5 - 6 minutes to complete. We recognise that protecting your personal information is critical and will never sell your personal information to third parties.
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Which of the following industries best fits the organisation that you are employed by ?
What type of manufacturer are you ?
Clear selection
Where is the headquarter of your organisation located ?
How old is your organisation (in years) ?
Which of the following best defines the size of your company ?
Clear selection
What class of medical devices does your company manufacture ?
What is your current role in the organisation ?
Which of the following describes closely the percentage of spend on research / innovation compared to the annual financial turnover ?
Clear selection
Please rank the 6 steps in the "Innovation cycle" with respect to time taken for each process ? (1) for the lowest time taken and (6) for the highest time taken.
1
2
3
4
5
6
Concept development
Product development
Clinical trial
Regulatory approval
Reimbursement approval
Time to market
Clear selection
How many patents has your Organisation received in the last five years ?
Clear selection
Does your organisation have a dedicated research team for innovating new products ?
Clear selection
What is the size of your research / product development team ?
Clear selection
Please rank the following with respect to the difficulty in meeting the regulation (1) for the lowest difficulty and (5) for the most difficult.
1
2
3
4
5
Readiness of the Quality System
Availability of the Technical file / dossier
Adequate clinical data
Availability of the notified body
Adequate understanding of the regulation
Clear selection
According to your opinion, are there any other hindrances to innovation in medical device industry ?
What according to you accelerates the process of innovation ?
Has the need for clinical data helped to improve your product design ?
Clear selection
Please rank the aspects of Regulation that you think help your business needs ? (1) for most helpful, (5) for least helpful
1
2
3
4
5
Tougher regulation avoids easy copying of the product technology
Entry barrier to competition due to tighter regulation
Increases job safety due to highly trained regulatory people
The regulatory approval cycle is reliable
Higher product margins due to the highly regulated environment
Clear selection
What drives innovation in your organisation ?
Next
Clear form
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