Toward Sex-Specific Biomaterials Innovation: A Perspective

Area of Science:

• Biomaterials Science
• Translational Medicine
• Sex as a Biological Variable Research

Background:

• Biomaterials research historically overlooked sex-specific physiological differences.
• This oversight leads to inconsistent performance, reduced preclinical accuracy, and suboptimal clinical outcomes.
• Sex is a critical biological variable influencing tissue regeneration, immune response, and drug metabolism.

Purpose of the Study:

• To examine motivations and barriers to integrating sex-related differences into biomaterials research.
• To highlight biomaterials applications for female-specific conditions and sex-influenced diseases.
• To propose strategies for sex-specific biomaterials development aligned with precision medicine.

Main Methods:

• Review of current (pre)clinical study designs, data generation, and sharing practices.
• Analysis of funding realities and regulatory frameworks impacting sex-specific research.
• Exploration of biomaterials applications considering sex-related differences in disease and regeneration.

Main Results:

• Current biomaterials research often fails to account for sex-specific variability.
• Biomaterial performance is significantly impacted by sex-related differences in biological processes.
• Existing frameworks present barriers to sex-specific biomaterials integration.

Conclusions:

• A transition to sex-specific biomaterials research is necessary for advancing precision medicine.
• Standardized frameworks, integrated sex-specific data analysis, and AI are key strategies.
• Collaboration among researchers, funders, and regulators is vital for improved clinical applicability.