Module 18 - Drug Device Combinations and Other Technologies

12/7/2023

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

• Think Indications!

• There may be some benefit to narrowing your indications in relation to demonstrating state of the art.

• State of the art should consider all alternative options.

• State of the art should consider what is acceptable in good clinical practice.

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So how do I demonstrate ‘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?

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