Hybrid multi-component frameworks and qualitative integration characterize best practices in medical device risk managementReview Identifies Best Practices for Medical Device Risk Management

Frontiers in Medicine Published June 25, 2026 Study authors: Rosario Luxardo, Arkeliana Tase, Florence Leong, Massimo Micocci, Martina Tognini, Peter Buckle, Mel… DOI ↗ Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

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Key Takeaway

Note that hybrid multi-component frameworks and stakeholder engagement are key components of medical device risk management.

This scoping review synthesized evidence from 12 documents, including 1 regulatory document and 11 peer-reviewed studies, to identify best practices in medical device risk management (RM). The analysis focused on identifying current methodologies, existing knowledge gaps, and priorities for future research.

Key findings indicate that ISO 14971 is the only regulatory document providing a structured RM process. Among the identified best practices, hybrid or multi-component frameworks were common, appearing in 5 instances. Additionally, 3 cases showed an integration of qualitative and structured quantitative approaches, while 2 included patient preferences. Only 1 instance specifically highlighted stakeholder and end-user engagement. The review noted that addressing system-level challenges, such as cybersecurity, remains limited.

The authors concluded that no single best practice was identified across the reviewed literature. There is a recognized need for greater end-user involvement to identify unknown hazards and improve medical technology safety. These findings suggest that while current frameworks are diverse, more robust integration of user perspectives may be necessary to address evolving risks in the medical device landscape.

This scoping review looked at 12 different documents, including one regulatory document and 11 peer-reviewed studies. The goal was to find the best ways to manage risks when making and using medical devices. Because this is a scoping review of existing literature rather than a clinical trial, it identifies trends in current practices rather than testing a new treatment.

The review found that most successful risk management uses hybrid or multi-component frameworks. These systems often combine qualitative information with structured quantitative data. While some processes include patient preferences and stakeholder engagement, the study noted these are not always standard. Only one specific regulatory document provided a fully structured process for managing risks.

One important finding is that current methods may struggle with new challenges like cybersecurity. The review suggests that involving more end-users can help find hidden hazards. Because no single best practice was identified, experts recommend looking at these various components to improve overall safety in medical technology.

What this means for you:

Better risk management for medical devices involves using mixed methods and including more patient feedback.

Common questions

What are the best practices for managing risks in medical devices?

The study found that many effective systems use hybrid or multi-component frameworks. These often combine qualitative and structured quantitative approaches. While some include patient preferences and stakeholder engagement, the review did not find one single best practice that applies to every situation.

How does involving patients help with medical device safety?

Including end-users and patients helps identify unknown hazards that might be missed during standard testing. The study suggests that more involvement from these groups can improve the overall safety of medical technology.

Are there any gaps in current risk management for medical devices?

The review noted that some modern challenges, such as cybersecurity, have limited attention in current risk management processes. Additionally, only one regulatory document currently provides a fully structured process for managing these risks.

Study Details

Study typeSystematic review

EvidenceLevel 1

PublishedJun 2026

View Original Abstract ↓

Risk management (RM) is an essential element for developing safe technologies and frequently a requirement by the regulators. The practice of RM spans from pre-to-post market stages, starting from product development and continuing after product launch. Technological advancements and shifting demands in healthcare led to rapid growth of new technologies such as AI, robotics and point of care diagnostics, presenting many unknowns to the RM process. This study aims to review best practices in medical device RM, highlight gaps and ambiguities in knowledge and identify priorities for future research. A thorough literature review was conducted in June 2025 in two parts: (A) assessment of official updated regulatory documents and guidelines for Medical Devices (MDs), and (B) review published literature for reported best practices in RM of MDs. Part A of the search focused on official regulatory agencies, and Part B of the search was conducted on OVID, Embase, Medline, PubMed, Engineering Village, Scopus, and Google Scholar. A 10-year and English as language limit was applied only for part B. Our search found 147 publications (16 were guidelines from regulatory agencies and 131 were from peer reviewed literature). A total of one regulatory document and 11 studies met the inclusion criteria. Step (A) ISO 14971 was the only regulatory document that explicitly described a structured process for RM. Step (B) Although no single best practice was identified, several recurring themes emerged. Significant best practices suggest the use of hybrid or multi-component frameworks (n = 5), the integration of qualitative and structured quantitative approaches (n = 3), incorporation of patient preferences (n = 2), inclusion stakeholder and end-user engagement (n = 1), and considerations of emerging system-level challenges, such as cybersecurity, was limited. Based on our findings, we advise targeted recommendations to strengthen current practices. In conclusion, many challenges exist in conducting an efficient RM process for medical devices, driven by variability in technology and specifications, which will increase as these technologies continue to evolve. Greater end-user involvement throughout all stages can help identify unknown hazards and improve medical technology safety.

Hybrid multi-component frameworks and qualitative integration characterize best practices in medical device risk managementReview Identifies Best Practices for Medical Device Risk Management

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Hybrid multi-component frameworks and qualitative integration characterize best practices in medical device risk managementReview Identifies Best Practices for Medical Device Risk Management

Common questions

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