Scaffold translation: barriers between concept and clinic.

Area of Science:

• Biomaterials Science
• Regenerative Medicine
• Orthopedic Surgery

Background:

• Despite extensive research and funding, scaffold-based bone tissue engineering (BTE) therapies have not translated to clinical success.
• Over 25 years of BTE research, with thousands of publications, highlights a significant gap between laboratory findings and clinical application.

Purpose of the Study:

• To comprehensively review the technical, business, and philosophical barriers hindering the clinical translation of bone tissue engineering scaffolds.
• To propose a novel approach for overcoming these challenges and facilitating the transition of scaffolds from concept to clinic.

Main Methods:

• Review of existing literature on bone tissue engineering scaffolds.
• Analysis of technical challenges in scaffold design, manufacturing, and functionalization for bone defect repair.
• Examination of business and regulatory hurdles, including market needs, investment, and approval processes.
• Discussion of philosophical shifts in research and funding priorities.

Main Results:

• Identified key technical challenges related to scaffold form, fixation, function, and formation for specific clinical indications.
• Highlighted significant business challenges including regulatory approval, market viability, and securing investment.
• Recognized philosophical barriers in research paradigms, publishing, and funding models.

Conclusions:

• Clinical translation of BTE scaffolds requires addressing a multifaceted range of challenges beyond technical aspects.
• A modular systems approach, with adaptable complexity, is proposed as a strategic framework for overcoming translational barriers.
• This approach aims to bridge the gap between research and clinical application, enabling effective bone defect repair solutions.