Purpose <p>Precision medicine (PM) represents a transformative shift in healthcare from population-average decisions to individualized prevention, diagnosis, and therapy. This approach uses individual biological, environmental, and lifestyle information rather than “one-size-fits-all” model often encapsulated as P4 medicine—predictive, preventive, participatory, and personalized. The stratification in PM is based on distinct subgroups unique characteristics to enable data-driven, evidence-based clinical decisions that improve efficacy and safety. Similarly, this concept can be applied to medical technology (MedTech). At the heart of this transformation paradigm, we coin here <i>personalized/precision medical devices</i> (PMD™) in MedTech.</p> Methods <p>We included articles cited by PubMed, Science Direct and Google Scholar published in peer-reviewed journals or these that include terms like ‘precision medicine, personalized medicine / MedTech’ or related concepts in the title or abstract. We performed literature survey of databases with a particular focus on PM and medical technology devices. Utilized framework techniques to develop overarching scheme and sets of principles.</p> Results <p>The convergence of PM, and cutting-edge technologies with advance medical technologies integration in this field will drive personalized/precision medical devices. We affirm that the next decade will be defined by PMD™. Miniaturized or portable, smart PMD™ devices like—wearables, implantables, diagnostics, delivery systems, and digital therapeutics that generate patient-specific data and deliver adaptive interventions in real time will become commonplace. Finally, provide framework components for the link between PM and MedTech vis-à-vis PMD™.</p> Conclusions <p>This research paper analysis explored the scientific foundations, enabling technologies, clinical applications, regulatory considerations, challenges, and outlook of personalized medical devices. It also argued that these PMD™ are essential for realizing the promise of individualized care, improving outcomes, and making healthcare proactive, data-driven, and equitable. The developed framework acts as a guide and ensures overall consistency and alignment with health care.</p>

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Precision medicine in medical technology-medtech: the future of healthcare through personalized devices

  • M. Walid Qoronfleh

摘要

Purpose

Precision medicine (PM) represents a transformative shift in healthcare from population-average decisions to individualized prevention, diagnosis, and therapy. This approach uses individual biological, environmental, and lifestyle information rather than “one-size-fits-all” model often encapsulated as P4 medicine—predictive, preventive, participatory, and personalized. The stratification in PM is based on distinct subgroups unique characteristics to enable data-driven, evidence-based clinical decisions that improve efficacy and safety. Similarly, this concept can be applied to medical technology (MedTech). At the heart of this transformation paradigm, we coin here personalized/precision medical devices (PMD™) in MedTech.

Methods

We included articles cited by PubMed, Science Direct and Google Scholar published in peer-reviewed journals or these that include terms like ‘precision medicine, personalized medicine / MedTech’ or related concepts in the title or abstract. We performed literature survey of databases with a particular focus on PM and medical technology devices. Utilized framework techniques to develop overarching scheme and sets of principles.

Results

The convergence of PM, and cutting-edge technologies with advance medical technologies integration in this field will drive personalized/precision medical devices. We affirm that the next decade will be defined by PMD™. Miniaturized or portable, smart PMD™ devices like—wearables, implantables, diagnostics, delivery systems, and digital therapeutics that generate patient-specific data and deliver adaptive interventions in real time will become commonplace. Finally, provide framework components for the link between PM and MedTech vis-à-vis PMD™.

Conclusions

This research paper analysis explored the scientific foundations, enabling technologies, clinical applications, regulatory considerations, challenges, and outlook of personalized medical devices. It also argued that these PMD™ are essential for realizing the promise of individualized care, improving outcomes, and making healthcare proactive, data-driven, and equitable. The developed framework acts as a guide and ensures overall consistency and alignment with health care.