Module 18 2021

First page Table of contents Previous page 249 Next page Last page

2/9/2021

So how do I demonstrate I am ‘State of the Art’?

Have you considered non- medical options?

Have you considered competitive devices? How will you collect that data? Have you considered similar devices or alternative technology?

Have you considered Pharmacological options as part of your assessment?

How can you measure patient outcomes?

How will you obtain this data?

So how do I demonstrate I am ‘State of the Art’?

International Guidance or National Guidance (EU) Documents

European Medical Societies/National Medical Organisations

Literature Searches

PMS Data – Non-Inferior Model (Statistical analysis)

Physician Surveys/Usage Data

Real World Evidence e.g. Registry Data

Made with FlippingBook flipbook maker