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Related Concept Videos

Design Consideration01:22

Design Consideration

634
Designing a structure involves a series of considerations, primarily the material's ultimate strength, calculated through tests that measure changes under increased force until the material reaches its breaking point or limit. The ultimate load, where the material breaks, is divided by its original cross-sectional area, resulting in the ultimate normal stress or strength. The ultimate shearing stress is another significant factor taken into account.
The factor of safety is another key...
634

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HEADROOM APPROACH TO DEVICE DEVELOPMENT: CURRENT AND FUTURE DIRECTIONS.

Alan Girling1, Richard Lilford2, Amanda Cole3

  • 1Institute for Applied Health Research,University of BirminghamA.J.Girling@bham.ac.uk.

International Journal of Technology Assessment in Health Care
|December 24, 2015
PubMed
Summary
This summary is machine-generated.

The headroom approach provides a value-based price ceiling to assess medical device viability and guide development decisions. This method aids in navigating market opportunities and pricing strategies throughout the product lifecycle.

Keywords:
Development decisionsHeadroom analysisMedical devices

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Area of Science:

  • Health economics
  • Medical device development
  • Business strategy

Background:

  • The headroom approach estimates value-based price ceilings for medical devices during development.
  • These price ceilings define commercial opportunities within healthcare systems.
  • Understanding market potential is crucial for successful medical device innovation.

Purpose of the Study:

  • To apply a model for obtaining critical business information during medical device development.
  • To explore future directions for the headroom approach.
  • To provide a framework for decision-making in medical device commercialization.

Main Methods:

  • Health economic modeling applied to the supply-side development cycle.
  • Utilizing a simple model to derive business insights.
  • Analyzing the product development pathway.

Main Results:

  • Headroom serves as an initial viability check for devices in the healthcare market.
  • It supports product development decisions through a real options approach.
  • Headroom assists in creating pricing policies that account for reimbursement uncertainties.

Conclusions:

  • The headroom approach unifies business decisions throughout a new product's development cycle.
  • It helps justify the costs of clinical trials and evidence gathering by quantifying the value of new information.
  • Headroom acts as a shared tool for commercial negotiations and promotes rational service planning.