Strategies for Derisking Translational Processes for Biomedical Technologies.

Area of Science:

• Biomedical Engineering
• Translational Science
• Medical Technology Development

Background:

• Inefficient translation of biomedical research leads to drug and medical device development failures.
• These failures result in patient harm and product withdrawals, highlighting a critical need for process improvement.
• Academic settings particularly require streamlined resource utilization for early-stage research.

Purpose of the Study:

• To identify a structured guideline for de-risking early-stage biomedical technology translation.
• To propose a 12-step process to enhance the efficiency of moving medical concepts toward clinical applications.
• To improve the cultivation, evaluation, and refinement of academic biomedical innovations.

Main Methods:

• This opinion article outlines a 12-step guideline.
• The guideline focuses on reducing risks in the translation of medical technologies.
• The process addresses stages from prototyping to preclinical proof of concept and clinical testing.

Main Results:

• A 12-step guideline is presented for de-risking early-stage biomedical research translation.
• The proposed process aims to mitigate common failures in drug and medical device development.
• Implementation is expected to improve the pathway from concept to clinical application.

Conclusions:

• Adopting the 12-step guideline can significantly enhance translational efficiency in academic biomedical research.
• This structured approach aids in the successful development of medical technologies.
• The process supports better cultivation and refinement of early-stage biomedical concepts for clinical use.