Medical device innovation is accelerating at a dizzying pace — from AI-powered diagnostic tools to implantable biosensors. But as these devices grow in complexity, so do the risks they pose to patient safety. Risk management is not just a regulatory hurdle — it’s a cornerstone of quality, innovation, and trust. While FMEA remains a favorite in the industry, the study reveals that it’s not the silver bullet many assume it to be.
In the world of medical device development, risk is an ever-present companion. Whether it’s an infusion pump, a pacemaker, or a surgical robot, the consequences of failure can be catastrophic. To manage this risk, the industry has long turned to a tool that has stood the test of time: Failure Modes and Effects Analysis (FMEA).
FMEA enjoys a stellar reputation among engineers, quality professionals, and regulators alike. It is widely taught, broadly applied, and almost universally recognized. But while its strengths are many, so are its limitations. As the complexity of medical technology evolves, the industry is beginning to ask hard questions: Is FMEA enough? Should we be relying on it as heavily as we do?
Let’s take a closer look at why FMEA became the tool of choice, its strengths, why it remains so prevalent, and why — despite all of this — it might not be sufficient for the challenges of today and tomorrow.
At its core, FMEA is a structured, proactive technique used to identify and mitigate potential failure points in a system, product, or process. It was originally developed by the U.S. military in the 1940s and later adopted by industries such as aerospace, automotive, and eventually, medical devices.
The process is simple in theory but powerful in practice:
This structured approach gives design and manufacturing teams a tangible way to prioritize risks and drive mitigation strategies early in the development lifecycle. It’s especially useful during design validation, where failure to address potential issues could result in costly rework or worse — patient harm.
Additionally, FMEA is:
One reason FMEA has become the default risk tool is simply because it’s familiar. Professionals across engineering, manufacturing, and quality control are trained in it. Templates are readily available. Tools like Excel, FMEA software, and enterprise PLM systems all support it. When a company needs to show its risk management plan to a regulator, pulling out a comprehensive FMEA is an easy, recognizable win.
This familiarity has led to what some experts describe as “FMEA inertia.” Organizations are reluctant to adopt alternative methods — even when those methods might be better suited for the situation — because FMEA feels safe and proven.
In their 2025 study, Nolan and McDermott describe this phenomenon in the medical device space, noting that auditors and notified bodies often expect to see FMEA. As one interviewee said bluntly: Auditors will ask for it.
This creates a feedback loop:
In essence, FMEA has become not just a risk tool, but a compliance ritual.
Let’s talk regulation. In the medical device world, ISO 14971 is the gold standard for risk management. It provides a framework for identifying hazards, estimating and evaluating risks, controlling those risks, and monitoring the effectiveness of those controls.
FMEA aligns well with parts of ISO 14971, particularly in identifying failure modes and their consequences. It also integrates neatly into the documentation-heavy environment required by regulators. Risk management plans, design controls, CAPA systems, post-market surveillance — all of these can tie into a well-constructed FMEA.
However, this is where we hit a snag: ISO 14971 is a hazard-based standard, not a failure-based one. And that’s a crucial difference.
FMEA looks for failures in components or processes. But ISO 14971 asks a different question: What hazards might the device pose, even when it’s functioning correctly? This includes:
These scenarios might never show up in a traditional FMEA because they don’t stem from a component failure. A device might work exactly as intended—and still harm the patient.
Despite its strengths, FMEA has critical blind spots. And relying on it exclusively can lead to gaps in your risk management process. Let’s explore a few of the most important:
FMEA has earned its place in the risk management toolbox. It’s intuitive, systematic, and effective in the right context. But it’s not — and never was — meant to be the only tool used.
To truly align with ISO 14971 and ensure comprehensive patient safety, companies must think beyond compliance checklists and embrace risk thinking:
The regulators of tomorrow may no longer be satisfied with an FMEA-for-everything approach. And neither should we. The goal isn’t to check a box. The goal is to design devices that work safely, even in the messy, unpredictable real world.
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45% of Class I medical device recalls in the U.S. in 2023 were related to software failures or connectivity issues. Source: U.S. Food & Drug Administration (FDA) Recall Data, 2023
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The volume of post-market safety data for medical devices has increased by 250% over the past 10 years, creating significant challenges for manual analysis. Source: McKinsey & Company (2023), Medical Device Post-Market Trends
Failure Modes and Effects Analysis (FMEA) is one of the most widely used tools in medical device risk management. It’s praised for its structured format, accessibility, and long-standing reputation as a robust tool across industries. But popularity isn’t perfection. As the complexity of medical devices grows — incorporating software, AI, connectivity, and use in diverse clinical environments — FMEA is being pushed beyond its limits.
A recent study by Nolan and McDermott (2025), based on qualitative interviews with industry experts, exposes the limitations of FMEA in modern medical device risk management. While FMEA still serves a valuable role, its hidden gaps could undermine safety, compliance, and innovation if not addressed through complementary tools and methods.
Let’s explore the four most critical gaps in FMEA: its single-fault focus, failure to address normal use risks, subjectivity in scoring, and its fundamentally bottom-up approach.
One of the most significant criticisms of FMEA is that it evaluates only single-point failures. In a traditional FMEA, each component or process step is analyzed in isolation. The tool does not account for how multiple failures might interact — or how a common-cause failure could simultaneously impact multiple parts of a system.
This limitation is especially problematic in complex, integrated systems, such as software-enabled medical devices, implantable sensors, and combination products. For instance:
None of these scenarios are easily handled within the scope of a traditional FMEA. As one expert in the study noted, FMEA looks at specific failure modes one at a time — and it’s that limitation that creates a problem, because the risk of harm is not dependent only on one line item in an FMEA.
In contrast, Fault Tree Analysis (FTA) or Event Tree Analysis (ETA) offer a more suitable top-down perspective for analyzing combinations of failures and their cascading effects. These tools are underutilized in MedTech but offer crucial insights where FMEA falls short.
FMEA is rooted in engineering logic: it asks what happens if a component or process fails. But what if the device works exactly as designed — and still causes harm?
That’s not a rhetorical question. In healthcare, many adverse events don’t arise from failure, but from normal operation under complex conditions:
These are examples of normal condition hazards, which are central to the expectations of ISO 14971. This international standard doesn’t just focus on failures — it emphasizes comprehensive hazard identification, including:
Unfortunately, these types of hazards are invisible to FMEA. One interviewee in the study bluntly summarized: The obvious limitation—as the name implies — is that it’s a Failure Modes and Effects Analysis, not every hazard is the result of a failure… most people fail to realize that sometimes the device is not broken — it’s working just as it should — and it still creates a hazard.
This is why ISO 14971 encourages broader risk thinking, such as:
Ignoring normal-use risks creates a significant compliance gap and, more importantly, a potential threat to patient safety.
FMEA depends heavily on scoring: severity (S), occurrence (O), and detection (D). These scores are multiplied to calculate a Risk Priority Number (RPN), which is used to rank and prioritize risks.
The math is straightforward. The reality is anything but.
Each rating — S, O, and D — is highly subjective. Teams often assign values based on intuition, inconsistent historical data, or even internal politics. Worse still, two very different risk profiles can result in the same RPN:
This undermines the credibility and effectiveness of FMEA as a prioritization tool. As Nolan and McDermott report, participants agreed that RPNs often fail to reflect true clinical risk. Severity is way more important, one expert said, but the RPN gives it equal weight with occurrence and detection.
Regulators and safety professionals increasingly recommend avoiding sole reliance on RPNs and instead using risk matrices, qualitative risk narratives, and clinical judgment to evaluate hazards. ISO/TR 24971:2020, the companion guidance to ISO 14971, even suggests redefining harm severity levels to improve consistency — e.g., replacing vague terms like serious with major or fatal.
FMEA is a classic bottom-up method. It begins at the component level — analyzing screws, circuits, software modules — and builds upward to subassemblies and the finished product.
In contrast, ISO 14971 requires a top-down approach. It starts with identifying:
FMEA doesn’t naturally align with this flow. It doesn’t begin with harms or hazardous situations. Instead, it starts with parts or processes, which may or may not be tied to meaningful clinical risks. As one study participant explained, There is no reference to failure modes, effects, and other FMEA terminology as part of ISO 14971.
This misalignment can create blind spots:
Modern best practices recommend mapping FMEA elements to ISO 14971 elements or developing hybrid tools that combine FMEA structure with top-down hazard analysis. Some companies use risk management platforms that generate traceability between hazards, hazardous situations, and controls — far beyond the linear structure of a spreadsheet-based FMEA.
FMEA is not obsolete. It remains an important tool for design, manufacturing, and reliability risk analysis. But it’s only one piece of the puzzle. Treating FMEA as the only risk management tool is no longer tenable in the evolving landscape of medical device regulation and real-world clinical complexity.
To close the gaps, companies should:
A robust risk management process is not about using one tool well — it’s about using the right combination of tools, with the right mindset, and with patient safety always as the north star.
Risk management in the medical device industry is undergoing a quiet revolution. As devices grow more complex — integrating software, artificial intelligence, and connectivity across a range of user environments — the methods used to ensure their safety are evolving as well. No longer is a single tool sufficient to capture the diverse range of risks that can emerge throughout a product’s lifecycle.
Traditionally, Failure Modes and Effects Analysis (FMEA) has dominated the risk management landscape. But recent research, particularly the 2025 study by Nolan and McDermott, reveals that the industry is shifting toward hybridized risk management approaches. These approaches blend FMEA with other analytical tools, each contributing a unique perspective to more comprehensively address clinical and regulatory requirements — particularly those outlined in ISO 14971 and its companion guidance, ISO/TR 24971:2020.
Hybridized FMEAs are not an entirely new invention but rather an evolution. They integrate the traditional structure of an FMEA — breaking down failure modes, effects, and causes — with top-down hazard-based thinking. This shift is crucial for aligning risk assessments with ISO 14971, which requires manufacturers to begin with hazards, hazardous situations, and harms, rather than simply focusing on failures.
In Nolan and McDermott’s interviews, several industry experts reported moving toward custom risk spreadsheets or risk management platforms that merge FMEA logic with:
These “hybrid FMEAs” enable teams to evaluate not only what happens when a part fails, but also what risks arise during normal use, misuse, or under environmental stress — all while preserving the familiar structure engineers are comfortable with.
This shift toward hybridization is strongly supported by regulatory guidance. ISO/TR 24971:2020, the companion document to ISO 14971, clearly states that no single risk analysis method is sufficient. Instead, it recommends using a suite of complementary tools, selected based on the device’s intended use, complexity, technology, and maturity.
Each tool brings unique strengths and compensates for the blind spots of others. The challenge — and the opportunity — is knowing when and how to combine them. Here are four critical tools increasingly paired with FMEA in hybridized risk management frameworks:
PHA is often the first step in a comprehensive risk management process. Unlike FMEA, which is reactive to component-level failures, PHA is proactive and top-down. It identifies:
PHA’s strength lies in setting the scope of risk analysis. It helps teams brainstorm broadly before diving into the component-level details of an FMEA. For example, a team designing an insulin pump might use PHA to identify systemic hazards such as over-delivery, under-delivery, battery depletion, or wireless interference — some of which may not originate from a single component failure.
In the study, several participants reported using PHA as a precursor to FMEA, feeding its results into a structured downstream analysis that covers both system-level hazards and component-level failure modes.
HAZOP originated in the chemical industry but has found application in MedTech due to its structured scenario-based analysis. It focuses on deviations from intended operation by asking “What if?” questions for each part of a process or function:
HAZOP is particularly useful for process-driven devices and systems with multiple states or transitions. For example, HAZOP can be applied to drug-delivery processes, dialysis machines, or complex user interfaces where usability errors or environmental influences can cause hazards.
In hybrid risk frameworks, HAZOP complements FMEA by adding depth to operational and use-related risks, especially those involving human-machine interaction — an area where traditional FMEA often falls short.
Where FMEA is bottom-up, Fault Tree Analysis (FTA) is distinctly top-down. It begins with a specific undesirable event (e.g., overdose, infection, device shutdown) and works backward to identify all the contributing causes. These can include:
FTA uses Boolean logic (AND, OR gates) to model how combinations of events lead to failure. This makes it extremely effective in analyzing complex interdependencies and common cause failures that FMEA alone cannot handle.
As medical devices increasingly rely on software, AI, and connectivity, the need to assess interactions and fault propagation has grown. Interview participants in the study noted that while FTA is underused in MedTech, it offers significant value when analyzing critical clinical outcomes, particularly in life-sustaining systems.
HACCP is a well-established methodology from food and pharmaceutical manufacturing. In MedTech, it is increasingly used in production and process risk management. It identifies:
Unlike FMEA, which is focused on what could go wrong, HACCP ensures that known hazards are systematically prevented or mitigated at specific checkpoints. This makes it ideal for managing process reliability, especially in contract manufacturing, where consistent quality and traceability are essential.
In hybrid risk models, HACCP often pairs with Process FMEA (PFMEA) to provide a dual perspective — FMEA handles theoretical failure modes, while HACCP ensures active control of known hazards in real time.
One of the key takeaways from Nolan and McDermott’s study — and the wider risk management literature — is that there is no one-size-fits-all solution. Instead, organizations must develop risk management strategies tailored to their devices, incorporating:
For a wearable monitoring device, the hybrid approach may lean on usability testing, FMEA, and fault tree analysis. For an implantable pacemaker, it might include detailed PHAs, FTAs, and in-depth reliability modeling.
ISO/TR 24971 emphasizes this point: use Annex B as a reference for choosing the right combination of tools based on context. This modular strategy ensures coverage from multiple angles — engineering, clinical, regulatory, and operational.
The transition toward hybrid risk tools marks a cultural shift as much as a technical one. It reflects an evolving understanding that risk is not just about mechanical failure — it’s about human behavior, software unpredictability, system integration, and the ever-changing clinical landscape.
By combining FMEA with PHA, HAZOP, FTA, HACCP, and others, MedTech companies are building a multi-dimensional view of risk. This leads to smarter design, better documentation, enhanced compliance with ISO 14971, and—most importantly—safer outcomes for patients.
In the words of one study participant: There isn’t one single risk analysis tool. You need a suite of tools, each with its own lens, to fully see the picture.
And in today’s complex medical world, that’s exactly the toolbox we need.
A striking insight from the study was the competency gap in risk management. Many companies rely solely on training records to demonstrate compliance. But risk management is a skill — it requires judgment, domain knowledge, and cross-functional collaboration.
Some larger firms like Medtronic and Abbott have internal training academies. But smaller companies often rely on self-training, peer mentorship, or one-off external workshops.
This raises an important question: Are we training checkbox compliance, or real risk thinkers?
In the ever-evolving world of medical technology, the tools used to design, assess, and monitor devices are undergoing a seismic transformation. For decades, risk management in the MedTech space has relied heavily on traditional tools like Failure Modes and Effects Analysis (FMEA), process audits, and human-driven data review. But the rise of digital technologies — particularly artificial intelligence (AI), the Internet of Things (IoT), and predictive analytics — is opening up a new frontier for how risk is identified, measured, and mitigated.
As highlighted in Nolan and McDermott’s 2025 study on medical device risk management, while frameworks like ISO 14971 provide the foundation, the future lies in leveraging intelligent systems that can anticipate problems before they happen. This shift is not just a technological upgrade — it’s a philosophical reorientation, moving from reactive risk control to proactive risk prediction.
Traditionally, risk management has been about identifying hazards, estimating risk based on historical data, and applying mitigation strategies. The process is structured and thorough — but inherently retrospective. It looks at what has gone wrong in the past to inform future prevention.
The digital frontier flips this script.
With access to vast amounts of real-time and historical data, machine learning algorithms and connected devices can spot patterns invisible to human reviewers. AI models can be trained on terabytes of post-market surveillance data, complaint logs, electronic health records, and even social media mentions to detect subtle early warning signs of potential failure or harm. Meanwhile, IoT-enabled medical devices can monitor themselves — continuously and autonomously — alerting manufacturers or clinicians when performance deviates from expected norms.
This move toward real-time risk intelligence offers the potential to revolutionize how we think about device safety.
Artificial intelligence — especially machine learning — has emerged as one of the most promising tools for advancing risk analysis in the medical device sector. The core power of AI lies in its ability to analyze massive datasets at scale, recognize complex patterns, and adapt its understanding over time.
In the context of medical devices, AI can be applied to:
By embedding AI into the risk management ecosystem, companies can move beyond the limitations of human analysis and anticipate risk before it escalates into harm or recall.
The Internet of Things (IoT) is another key technology reshaping the landscape. An IoT-enabled medical device is one that can collect, transmit, and often analyze data in real time. This connectivity enables a continuous feedback loop between the device, the manufacturer, the healthcare provider, and, in some cases, the patient.
Applications of IoT in medical device risk management include:
These smart devices act as living risk assessment platforms, constantly monitoring themselves and contributing to an adaptive safety ecosystem. Instead of relying solely on static risk assessments done pre-market, manufacturers can use real-world usage data to update their risk models dynamically.
Predictive analytics takes the vast data generated by AI and IoT and turns it into actionable foresight. Rather than simply describing what happened (descriptive analytics) or explaining why it happened (diagnostic analytics), predictive analytics focuses on what might happen next—and how to intervene.
In risk management, predictive analytics can be used to:
These insights allow companies to proactively mitigate risk, improve patient safety, and reduce the likelihood of costly product recalls or regulatory actions.
Though less mature in application, blockchain is beginning to show promise in the medical device space—particularly for supply chain traceability and regulatory compliance.
Blockchain offers a secure, immutable ledger that can track:
In risk management, this level of transparency provides a tamper-proof audit trail, which is invaluable in post-market investigations, regulatory submissions, and product recalls. It can also help ensure that changes to a device’s configuration or environment are properly logged and factored into updated risk assessments.
Despite the enormous promise of these technologies, integrating them into ISO 14971-compliant systems remains a work in progress.
ISO 14971 is a structured, document-driven standard. It emphasizes traceability, defined risk acceptability criteria, and formal review processes. Digital technologies, on the other hand, are dynamic, data-driven, and often based on probabilistic modeling rather than deterministic analysis.
This mismatch presents several challenges:
To close the gap, regulators and standards bodies are beginning to explore adaptive regulatory frameworks. For example, the FDA’s Digital Health Software Precertification Program and the European Commission’s focus on AI governance indicate that future versions of ISO 14971 may incorporate or harmonize with digital methodologies.
Until then, manufacturers must carefully map their digital tools onto existing risk management frameworks — treating AI insights as inputs into traditional risk documentation, rather than replacements for it.
The tech frontier in medical device risk management is rich with promise. AI, IoT, predictive analytics, and blockchain are not just buzzwords—they’re tools already reshaping how manufacturers monitor, anticipate, and mitigate risk.
But digital innovation must be paired with robust integration strategies, regulatory clarity, and a continued focus on patient safety. Companies that succeed in weaving these tools into ISO 14971-compliant systems will not only stay ahead of regulators — they will create safer, smarter, and more resilient products for the patients who depend on them.
As Nolan and McDermott’s study rightly implies: the future of risk management isn’t just about better checklists — it’s about intelligent ecosystems.
It’s time to move beyond FMEA as the default tool. While it has its place, true risk management requires a nuanced, multi-layered approach — one that blends engineering analysis, clinical insight, and human factors. Recommendations for MedTech Companies:
Improving risk management isn’t just about passing audits. It’s about protecting lives, enhancing product quality, and earning patient trust.
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