Module 17 2024

03/12/2024

MedTech vs. Drug - regulatory and economic differences

Intellectual property

Patents are easier to work around – multiple competitors

Intellectual property protection

Level of evidence

Efficacy evidence from RCTs required for licensing

The level of evidence is usually lower although this is changing under MDR

Reimbursement

Reimbursement prices that reflect cost of development (value)

Pricing is often cost-based rather than value based

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How value is defined

Fit with health system priorities

Incremental benefit for patients

Impact on health system resources

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