Upon completion of the risk assessment, a comprehensive benefit-risk analysis is carried out. This vital step establishes the acceptability of product risk, carefully weighing the potential benefits against the identified risks. All of these critical measures culminate in the creation of a detailed risk management report, effectively summarizing the full range of risk management activities undertaken.
Benefit-Risk Analysis
After determining the residual risk of the product (Risk Evaluation) a Benefit-Risk Analysis can be completed to determine if the benefits of the product outweigh its residual risks.
General
In circumstances where certain product risks are determined as unacceptable, ISO 14971 provides manufacturers with a framework to undertake a benefit-risk analysis. This analysis enables the potential release of the product if the benefits significantly outweigh the associated risks.
- This should be the last resort when trying to reduce risk; benefit-risk analysis is only undertaken after determining that further risk controls are not practicable per the accepted product state of the art.
- Benefits regarding financial or monetary issues are not in scope of this analysis; as for anything regarding ISO 14971 risk management, the only benefits concerned are to the patients’ well-being as a result of the use of the medical device in question.
- While the risks of the product are detailed in the risk evaluation, the benefits of using the product are generally a judgment by qualified individuals, usually medical or clinical affairs personnel or others well-versed in how the product will be used.
Benefit Estimation
The benefit of using a medical device is correlated to the improvement of the patient’s health after using the device.
There are several ways to gain the knowledge needed to estimate the product benefit:
- Clinical performance
- Clinical outcomes
- Comparison to similar existing medical devices
- Known benefits of similar types of treatment for the diseases to be treated
It is expected that, for devices not yet on the market, some assumptions will need to be made to simplify the analysis in the absence of unequivocal data. When doing so, take the following into account:
- What are the expected benefits (i.e. life-saving or essential for health)
- What is the magnitude of the expected benefits (symptom relief vs. cure of the condition, and to what extent of either)
- What is the probability that the patient will actually experience the benefits
- What is the anticipated duration that the patient will experience the benefits (i.e. temporary relief or long-term effects)
Although it is expected that not all information will be known to some extent, a large degree of uncertainty about the benefits of the product may require the company to conduct targeted testing to physically demonstrate the benefit, especially if high risk levels are inherent when using the product.
Criteria for Benefit-Risk Analysis
The risks and benefits of a particular medical device are highly specific to that device. When benefit decisions are considered, an understanding of the various standards and regulations is required to determine whether the benefits are in line with what the markets expect from that type of device. Again, clinical testing may be necessary to demonstrate such benefits relative to the product expectations.
Benefit-Risk Comparison
Once the benefits are determined along with the evaluated risk, a comparison between the two is possible. Given the complexities of the product design, and the relative uncertainty of the data involved (as explained above), such a comparison is hardly simple or straightforward, and requires a considerable amount of interpretation and qualitative analysis on the part of the product experts. The judgment of whether the benefits outweigh the risks should consider the following:
- The condition of the disease and/or the patient receiving treatment
- The amount of uncertainty of the available data
- Information about similar devices on the market
- The generally acknowledged state of the art
- Benefits and risks of the device in question against those of similar devices on the market
Examples of Benefit-Risk Analysis
There are many examples of medical devices where the benefits are judged to exceed the risks of using the product:
- X-ray machines
- Heat lamps
- Cochlear implants
- Pacemakers
- Artificial limbs
- Stents and other implants
For the products with inherently higher risk, the benefit-risk analysis offers an opportunity to justify releasing a beneficial product to the market despite relatively high risk.
Risk Management Report
After completion of all risk management activities, the manufacturer needs to demonstrate that those activities satisfied the requirements of the risk management plan. A formal review of the following should be sufficient:
- All tasks outlined in the risk management plan have been executed
- The overall risk has been demonstrated to be acceptable
- Appropriate methods are in place for production and post-production review of product issues
The contents of this review are commonly contained in a risk management report. The report summarizes the completion of the risk management plan activities, summarizes the residual risk and its acceptability, and confirms that post-market surveillance measures are in place.
- Note that the acceptability of the residual risk may involve the need for a benefit-risk analysis as noted above. This analysis may be included within the risk management report, or in a separate document referenced by the report; either is an acceptable method.
The risk management report is generally authored at the conclusion of the product development process, just prior to market launch. That said, there may be circumstances throughout the life of the product that may require updates to the risk management plan, risk management report, or other facets of the product’s risk analysis. The manufacturer’s risk management process should allow for periodic or ad hoc updates to the product risk management file as needed.
- Probably the most common reason to update the risk management report is for design changes that occur throughout the on-market life of the product. As the design changes, the risk may be raised or lowered, and the risk management report should reflect the new overall residual risk of the product.
- Product performance that differs from what was understood during development may or may not result in a change in the residual risk of the product. The manufacturer may decide to modify the product design to keep the residual risk at the same levels, or update its benefit-risk analysis to ensure that the risk remains acceptable. Either way, the risk management report should be updated to acknowledge the new learnings about the product.
The risk management reports for different products will likely follow the same format; a template for the risk management report document can be included in the manufacturer’s risk management process.
It is very important to make sure that information in the risk management report is summary in nature; it is not intended to be a repeat of the risk analysis process, nor as a way to introduce new information into the product risk file.
Similarly, the risk management report is specific to a single product (or product family). The report is not supposed to include the periodic reviews of the risk management process that the manufacturer is expected to perform from time to time per the quality system procedures. The risk management review detailed in ISO 14971 is not the same as the process review that is specified in the quality system standards; the company needs to keep the various standard and regulatory requirements separate in their system.
Conclusion
The process of benefit-risk analysis and creating a comprehensive risk management report is a critical path in the lifecycle of a medical device. It establishes the line between the inherent risks of the product and the benefits it brings to the patients. The careful orchestration of this balance is not merely a regulatory necessity but also a moral responsibility toward ensuring patient safety and well-being.
As manufacturers of medical devices, it is paramount that we constantly engage in this cycle of analysis and reporting. This involves first identifying and evaluating the risks, followed by an estimation and analysis of the product’s benefits. Only then can we confidently determine whether the benefits of our product outweigh its risks.
Remember, our role does not end with the creation of the risk management report. It is an ongoing process that demands constant vigilance and updates. Whether it’s a change in the product’s design or a shift in its on-market performance, the risk management report should reflect the latest picture of the product’s overall residual risk.
Finally, while the process may seem complex and demanding, we must not lose sight of our ultimate goal: to create medical devices that are safe, effective, and beneficial for the patients they serve. We are not merely complying with regulations – we are making a difference in people’s lives. The detailed risk management report is not merely a document – it is a testament to our commitment to patient safety and efficacy.
As we navigate the intricate world of risk management in medical devices, let us keep these guiding principles in mind. In doing so, we create not only successful devices but also contribute positively to global health outcomes.
Let’s not forget that every benefit-risk analysis we conduct, every risk management report we draft, isn’t just about the device, but about the patients whose lives we strive to improve.
At Ventura Solutions, we are dedicated to assisting you in navigating the creation and management of risk management files. As a rapidly growing medical device and pharmaceutical staffing, consulting, and training firm, we possess extensive industry expertise in medical device, pharmaceutical, and combination products. Whether you require seamless integration into your team to manage small to complex projects, or assistance in sourcing, screening, and onboarding reputable employees, our commitment to excellence makes us a top choice for a wide range of projects.
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