Medical device development, from technical design to integrated product development.

Area of Science:

• Biomedical Engineering
• Product Development
• Small and Medium-sized Enterprises (SMEs)

Background:

• Medical device (MD) development integrates medicine and engineering, facing challenges like communication barriers and differing priorities.
• MD development is complex due to high regulations, concurrent technologies, diverse user needs, and risk classification (low, medium, high).
• Existing product development process (PDP) models are often ill-suited for SMEs in the mechanical and electronic sectors developing low-to-medium risk physical MDs.

Purpose of the Study:

• To synthesize a tailored PDP model for SMEs in the medical device sector.
• To integrate best practices from engineering with the specific requirements of the medical field.
• To address the complexities faced by SMEs developing low-to-medium risk physical MDs.

Main Methods:

• Extensive bibliographic analysis of existing PDP models and medical device development literature.
• Field research conducted with Small and Medium-sized Enterprises (SMEs) in the medical device industry.
• Synthesis of findings to create a new, integrated PDP model.

Main Results:

• Identification of key challenges in current PDP models for SMEs in the medical device sector.
• Determination of essential engineering practices and medical sector particularities for effective MD development.
• Development of a synthesized PDP model designed for SMEs producing low-to-medium risk medical devices.

Conclusions:

• A synthesized PDP model can enhance the development process for SMEs in the medical device industry.
• Integrating engineering and medical best practices is crucial for overcoming MD development complexities.
• The proposed model offers a more suitable framework for SMEs facing specific regulatory and market demands.