Conceptualizing treatment of uncomplicated type B dissection using the IDEAL framework

Area of Science:

• Medical device development
• Interventional cardiology
• Health technology assessment

Background:

• Physicians, investigators, and regulatory agencies require structured guidance for medical device development.
• The life cycle of device development and procedural refinement necessitates a standardized approach.

Purpose of the Study:

• To introduce the IDEAL (idea, development, exploration, assessment, and long-term study) framework.
• To provide a structured guide for the entire life cycle of medical device development and procedural refinement.

Main Methods:

• The IDEAL framework's components are described.
• The framework's application is illustrated using the treatment of uncomplicated type B dissection (uTBD).

Main Results:

• The IDEAL framework guides the stages from initial idea to long-term study.
• Treatment of uTBD is currently in the exploration phase, supported by registries for assessment and long-term study.

Conclusions:

• Applying the IDEAL framework to technology development and monitoring standardizes nomenclature.
• The IDEAL framework facilitates evidence-based practice and enhances the innovation process for medical devices.