Table 3:

Limitations to health-economic modeling and analyses in the development process and product life cycle.

	Limitation	Stage
Implementati on	Level of health economic expertise Resources (cost, time) Interdisciplinary cooperation (all relevant stakeholders)	Development process
Intervention	Innovation in medical devices is often a process of continuous incremental improvement. Short life cycle compared to drugs	Any stage
Comparator	Treatment standards are very often not established	Any stage
Model inputs	Manufacturer's access to national databases (cost, epidemiology) Resilient outcome measures	Product life cycle
Decision	Based on analyses that contain the best knowledge available at the time.	Any stage
Optimum price setting	Interaction of all stakeholders Patient potential (revenue) Estimated cost-effectiveness in daily practice	Early stage
Investment	Estimates per one health-economic study published by a manufacturer range from €50,000 to €100,000 (US$60,000 to US$120,000), depending on external and internal expert involvement and model input data processing	Product life cycle