Design Method to Structure Orthosis Design: Camptocormia Postural Brace Case Study.

Area of Science:

• Biomedical Engineering
• Rehabilitation Engineering
• Medical Device Design

Background:

• Orthoses, classified as Class 1 medical devices, often lack structured development, leading to user-unmet needs and abandonment.
• Small- and medium-sized enterprises dominate orthosis development without standardized research methods, resulting in suboptimal device adaptation.
• Existing design methodologies are not fully applied in orthosis development due to field-specific challenges and knowledge integration difficulties.

Purpose of the Study:

• To develop a structured methodology for orthosis design.
• To integrate the device life cycle and stakeholder involvement into the orthosis development process.
• To address the empiricism in orthosis design by establishing standard rules and procedures.

Main Methods:

• A novel methodology was developed to structure the orthosis design process.
• The methodology was validated through a case study.
• The methodology was applied to the development of an orthosis for camptocormia (bent spine syndrome).

Main Results:

• The proposed methodology provides a structured framework for orthosis development.
• The case study demonstrated the successful application of the methodology in designing a camptocormia orthosis.
• The structured approach aims to enhance device efficacy and user adherence.

Conclusions:

• A structured methodology is crucial for effective orthosis design, considering the entire device life cycle and stakeholder input.
• The developed methodology offers a systematic approach to overcome challenges in the orthosis field.
• This structured process can lead to better-adapted orthotic devices, improving patient outcomes, particularly for conditions like camptocormia.