In the complex field of medical device development, risk management is often perceived as a mountain of paperwork and regulatory hurdles. However, a shift is occurring. ISO 14971, the globally recognised standard for medical device risk management, is evolving into a powerful catalyst for innovation and enhanced patient safety, particularly within the specialised field of orthopaedics. In this article, author Dr Stuart Grant, principle consultant at Archetype Medtech, discusses the potential of ISO 14971 in orthopaedic device development
The unique challenges of orthopaedic devices
Orthopaedics stands apart from other medical device sectors due to its focus on the skeletal system. Unlike soft tissues, bones present unique engineering challenges. The interaction between implants (made of metal or plastic), instruments, and the bone is a critical consideration, as are the associated risks.
Orthopaedic implants, such as hip or knee replacements, are typically designed for longevity, often exceeding 15 years. This extended lifespan within the body presents specific clinical risks. Unlike some surgical devices that can be removed without replacement, orthopaedic implants, once removed, usually necessitate replacement to maintain the structural integrity of the skeletal system. The bone cannot regenerate to fulfil the function of a removed hip or knee joint, for instance. This need for long-term compatibility and durability significantly influences the design and risk assessment of orthopaedic implants.
ISO 14971: A catalyst for innovation in orthopaedics
ISO 14971 provides a structured approach to systematically identify, assess, and control risks associated with medical devices. By proactively addressing potential hazards throughout the product lifecycle, companies can not only achieve compliance but also gain a competitive edge. The standard fosters innovation by encouraging a deep understanding of the device’s intended use, its potential interactions with users, patients, and the environment, and the possible harms that could arise.
This knowledge empowers design and engineering teams to develop creative solutions that mitigate risks, enhance safety features, and improve the overall user experience. For instance, in orthopaedics, where the forces exerted on the implant are significant, engineers might innovate materials or surface textures to enhance the bone-implant interface and reduce the risk of loosening or stress shielding.
Empowering engineers: Informed decision-making
ISO 14971 equips engineers with a robust framework for making informed design decisions. By clearly defining risk acceptability criteria and providing tools for risk analysis and evaluation, the standard guides engineers in prioritising safety and performance throughout the development process.
In addition, the standard emphasises the importance of considering both clinical and engineering risks. While clinical risks primarily focus on patient safety, engineering risks encompass factors such as device reliability, manufacturability, and serviceability. A comprehensive understanding of both types of risks enables engineers to optimise designs, identify potential failure modes, and implement effective control measures.
Usability engineering and risk management
Usability engineering, as outlined in IEC 62366-1, plays a crucial role in risk management. By considering the device’s interaction with users, including healthcare professionals and patients, engineers can identify and address potential use errors, thereby enhancing the overall user experience and further improving patient safety.
Making products more accessible and more intuitive for users to interact with leads to higher user satisfaction, increased efficiency, and fewer errors during use. When products are designed with the user in mind, they become more enjoyable and accessible, which can lead to better adoption rates and customer loyalty.
Lifecycle integration: Ensuring safety and effectiveness
ISO 14971 advocates for the integration of risk management into every phase of the product lifecycle, from concept to post-market surveillance. This proactive approach ensures that potential risks are identified and addressed early in the development process, reducing the likelihood of costly design changes or product recalls later on.
Lifecycle integration facilitates continuous improvement. By actively monitoring and evaluating device performance in the real world, companies can gather valuable feedback and identify emerging risks. This information can be used to refine risk control measures, update product labelling, and inform future product development efforts, ensuring the device remains safe and effective throughout its lifespan.
Crucially, the standard also recognises that the risk landscape can evolve over time. New technologies, changes in clinical practice, or the emergence of unforeseen hazards can necessitate a re-evaluation of existing risk control measures. By embracing a lifecycle approach, companies can adapt to these changes and proactively manage risks, even for devices that have been on the market for years.
Beyond documentation: Strategic value and knowledge transfer
While documentation is a critical component of ISO 14971 compliance, it should not be viewed solely as a regulatory burden. Robust documentation provides a valuable record of the risk management process, demonstrating a company’s commitment to safety and efficacy. This can streamline regulatory approvals and instil confidence in healthcare professionals and patients.
Furthermore, documentation serves as a powerful tool for knowledge transfer and continuous improvement. By capturing design decisions, risk assessments, and lessons learned, companies can build a repository of valuable information that can inform future product development efforts and facilitate effective communication across teams and departments.
The role of ISO 14971 in mitigating orthopaedic-specific risks
ISO 14971 plays a crucial role in mitigating the unique clinical risks associated with orthopaedic devices. By requiring manufacturers to identify and assess potential hazards, the standard helps to ensure that devices are designed and manufactured with safety in mind. This includes considerations such as the long-term stability of implants, the risk of stress shielding, and the potential for wear and tear on materials.
The standard also promotes a proactive approach to risk management, encouraging manufacturers to continually monitor and evaluate the performance of their devices in the real world. This information can then be used to make improvements and reduce the likelihood of adverse events.
Quality and grade: There is a difference
Grade and Quality are distinct concepts that are often confused and merged in Orthopaedic device product development. Both are a crucial part of the innovation process, but they are different.
In essence, grade is about the level of performance or features the product offers, while quality is about conformance to requirements and how well the product performs according to its specifications.
So, a product can be high-grade or low-grade. A low-grade product is acceptable as long as it meets the specified engineering and quality standards and delivers what it promises. Both low-grade and high-grade products hold value for the patient and ISO 14971 helps engineers to bridge that gap safely. By providing a framework for risk management, it helps manufacturers develop safe and effective devices that meet the needs of patients and healthcare providers while adhering to regulatory requirements and allowing changes to grade for accessibility or commercial viability. Quality is non-negotiable, but grade must also be considered and stated from the start.
Engineering risks vs. clinical risks
One of the key challenges in implementing ISO 14971 in orthopaedics is ensuring that engineers understand the distinction between engineering risks and clinical risks. While engineering risks focus on the technical aspects of the device, clinical risks relate to how the device interacts with the patient and the potential for harm.
For example, stress shielding is an engineering problem that occurs when an implant is too stiff and doesn’t allow the bone to bear enough weight. This can lead to bone loss and implant loosening. However, the clinical risk is the potential for the patient to experience pain, instability, or even fracture.
By clearly distinguishing between these two types of risks, engineers can develop solutions that address both the technical and clinical challenges associated with orthopaedic devices.
Overcoming challenges: Practical implementation
Implementing ISO 14971 can be challenging, particularly for smaller companies or those new to the medical device industry. However, with careful planning and a focus on practicality, these challenges can be effectively addressed.
- Mindset: Some engineers may view ISO 14971 compliance as a bureaucratic burden that hinders innovation and slows down product development. This perception can lead to resistance and a lack of engagement with the risk management process. It is important to approach the process positively, emphasising its role in developing safe and effective devices.
- Training and Resource Allocation: Invest in comprehensive training for engineers and other team members involved in the risk management process. Start with fundamental concepts like Design Failure Modes and Effects Analysis (DFMEA) and build upon that foundation. Allocate resources effectively, ensuring that teams have the time and expertise needed to conduct thorough risk assessments and implement appropriate control measures.
- Tool Selection: Choose risk management tools and methodologies that match the complexity of your device. While basic tools like Word and Excel may suffice for simpler devices, more complex products may require dedicated software applications to manage the sheer volume of data and facilitate collaboration. Today, there are some outstanding requirements and risk management software tools available for managing both the interactions between engineering requirements and risks (e.g., Greenlight Guru, PTC Arena, Siemens Polarion, Aligned, etc.).
- Clear and Actionable Procedures: The standard is written in technical language, but that doesn’t mean your plan has to be. Develop clear, concise, and actionable steps that guide engineers through the risk management process. Avoid overly verbose or complex language that can create confusion and hinder implementation. Distil it into a To-Do list.
- Focus on the Essentials: Don’t overcomplicate the process or create unnecessary paperwork. Focus on the core principles of ISO 14971 and tailor your approach to the specific needs of your product and its intended use. Not everything will be relevant to you.
- Seek Expert Guidance: If needed, don’t hesitate to seek guidance from experienced consultants or regulatory experts who can provide valuable insights and support throughout the implementation process.
Conclusion
ISO 14971 is more than just a regulatory requirement. It’s a powerful tool that can drive innovation, improve patient safety, and enhance the overall user experience. By embracing a proactive and lifecycle-oriented approach to risk management, medical device companies, particularly those in the specialised field of orthopaedics, can develop safer, more effective products that truly benefit patients and contribute to the advancement of healthcare.
The standardised process provided by ISO 14971 helps create a level playing field for companies of all sizes. This enables startups and SMEs to compete by developing innovative solutions that address unmet clinical needs or improve upon existing technologies.
