Module 18 - Drug Device Combinations and Other Technologies

06/12/2023

Example 3

I need a prototype to do understand the effect of the steroid on the body when introduced by my proposed device at the intended site.

Physical?

Fidelity?

Cost?

Time?

Ability? Availability

No

NA

Med

Med

Yes

Third Party

Computer based modelling

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DDC prototypes: Late stage prototyping

DDC products can often not be fully manufactured in house.

There may be a CDMO involved for the manufacture of the drug or a contract manufacturer for the device component.

As we get into the later stages of prototyping there are challenges in working with workable prototypes that can be used for validation activities.

• Supplier sourcing and engagement • Scalability • Regulation

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