Medical device manufacturers are required to have a risk management process in their quality management system. This process should be implemented throughout the product lifecycle to address hazards resulting from interactions between the patient, user, environment, and devices and the device’s intended use. The FDA, Health Canada, the European Council, and other regulatory authorities evaluate the risk assessments performed by manufacturers for adequacy and to ensure that the devices do not pose any imminent, serious hazard to the patient, user, or environment. Before releasing a new product to the market, the risk management file, including the risk assessment, is always submitted to these regulatory agencies for any necessary clearances.
If medical device manufacturers are not careful, they can make critical mistakes when implementing a risk management strategy, which damages the company, its customers, and other stakeholders. That’s why it’s vital that every medical device manufacturer avoids the following 10 mistakes to ensure the safety of their devices.
Mistake #1: Assuming a reactive approach to risk management
Manufacturers sometimes assume a reactive approach to risk management. Taking a more proactive approach enables the identification of potential hazards and measures to prevent them before they arise. Administering user surveys, seeking customer feedback, researching the literature, conducting clinical studies, or even assessing and reviewing available information on competitors’ devices to incorporate lessons learned and ultimately assessing risks associated with the device are examples of proactive approaches. This is when production and postproduction, as well as feedback mechanisms, come into play, enabling manufacturers to implement continuous monitoring and assessment of data sources, allowing them to improve in areas where they fall short after reviewing those data sources.
Mistake #2: Failing to establish a schedule for frequent risk document review
Risk estimated is a snapshot in time. The lack of a method for a continuous evaluation of risk files may result in an outdated risk file. Instead, manufacturers can establish a predetermined schedule for monitoring the suitability of their risk files on an ongoing basis by reviewing the sources of quality data and the information gathered from them. A schedule can be created by assessing what works best for the organization.
Mistake #3: Not carefully considering product-related misuse
Failing to assess product misuse can be costly. Risk assessment should evaluate risks related to the device’s intended use and associated with “reasonably foreseeable misuse.” Devices are frequently susceptible to misuse situations as well as off-label use. The risks in these instances must be assessed and suitable risk controls implemented, including testing where necessary, with efforts made to limit the risks as much as possible. In case of residual risks associated with the misuse, considerations on effectively communicating it to the users should be made.
Mistake #4: Failing to evaluate hazards claim by claim
It’s essential for manufacturers to evaluate the hazards involved with each claim they make. Manufacturers can use any testing done to support of the claims made while assessing these hazards. First, determine what happens if the device fails to replicate or perform according to the claims made. For example, let’s say that a device contains a motor, and its manufacturer claims that it will perform as intended for 3,000 hours before requiring service. Does the manufacturer have testing and objective evidence to back up that claim? Claims and associated risks must be thoroughly analyzed, since they may expose manufacturers to a field action situation due to safety and efficacy or worse, legal liability issues.
Mistake #5: Not going beyond FMEA and fault situations
It is vital for manufacturers to go beyond failure mode and effects analysis (FMEA) and fault situations in monitoring risk management. The primary objective of FMEA is to identify product features that could result in product malfunctions or inadequate product life, for example. According to the standard, it is essential to review and recognize hazards throughout typical device or system operation, reasonably anticipated misuse situations, beyond marginal operation conditions, and during fault conditions, according to the standard. Hazard analysis and risk assessment provide information on risks that can affect patients, users, and the environment. FMEAs concentrate on risks associated with product design or process, whereas hazard analysis concentrates on product hazards affecting patient, user, or environmental safety.
Mistake #6: Neglecting to establish an escalation channel
Once a mechanism for collecting and reviewing production and post-production data is established, manufacturers can create an escalation path for incidents that exceed the established business criteria. This includes a plan for assessing the risks to patient and user safety associated with the use of the defective product, as well as a system to assess the issue itself. Based on the results of these assessments, manufacturers can make informed decisions and develop appropriate action plans.
Mistake #7: A lack of transparency and inadequate communication
When manufacturers see an increase in complaints or non-conformances related to production or even design and development, it’s imperative that they effectively investigate the impact of those failures or complaints on patient, user, and environmental safety. Even if the occurrence is low, the severity of the issue could be high, potentially causing harm to patients/users. Manufacturers must act quickly to make critical business decisions such as changing the process, design, containment, corrective actions, or even assessing the issue for a field action determination. Transparency and open channels of communication within their organization cannot be overstated.
Mistake #8: Not analyzing how change affects risk
It is critical to analyze the impact of any changes in design or process on the product and consider the hazards involved with any post-launch changes to a product. For example, whenever a manufacturer changes the manufacturing process, such as changed tooling, a mold cut, or new equipment, it is important for the manufacturer to assess if the change would impact the product’s safety or performance.
Mistake #9: Poor understanding of risk file coverage requirements
Risk management throughout the product’s lifecycle starts with design and development planning and progresses to launch, installation, use, decommissioning, and disposal. Manufacturers don’t pay much attention to risks when a device is discontinued, even when some devices are still in the field. Even after discontinuing a product, they are obligated to provide risk file coverage for the shelf life of the remaining units. If the products are complicated, higher classification, life-sustaining equipment, they need to review the data sources throughout the shelf life to verify that no new hazards have been introduced.
Mistake #10: Neglecting to assess risk throughout the product lifecycle
Medical device manufacturers are required to provide inherently safe and effective products. This is achieved by assessing risks associated with the use of the device to the patient, the user, and the environment throughout the product lifecycle. Risk management should begin as early as its initial concept phase. Identifying hazards and associated harms earlier enables more effective implementation of risk mitigation strategies.
Managing risk ensures success
Ultimately, ignoring risk management negatively influences a company’s reputation, can cause legal liability issues, and, most importantly, impact the patient, the user, and the environment. Businesses have spent millions on remediation that could have been spent on developing innovative products. When risk management is not done correctly, manufacturers are constantly catching up due to difficulties that arise after launch. Adopting the right mindset to prioritize risk management and devoting sufficient attention to risk management are smart business strategies.
Mruga Patel
Mruga Patel, MS, ASQ-CQE/CQA, is the manager of design quality engineering at a leading medical device manufacturer and has more than 10 years of experience in the medical device industry. Mruga is a subject matter expert on risk management and manages a team of engineers that oversees a wide variety of product portfolios. She has experience in the design and development of medical devices (class I, II and III implants and instruments), fielding notified bodies and FDA audits, supplier qualification and audits, and conducting internal audits. For more information, contact [email protected].
