Medical device manufacturers have a mission. Their goal is to deliver quality products that improve health outcomes for patients. Healthcare providers need to feel confident about using these products, which calls for high quality standards when designing and manufacturing medical devices.

Medical device manufacturers can achieve this high level of quality by designing and implementing a thorough risk management process.

The ISO 14971 framework is a great starting point for creating a risk management process. This voluntary standard outlines the best practices to adopt to mitigate risks when designing and distributing medical devices.

Types of Risks Faced by Medical Device Manufacturers

Before developing a risk management plan, medical device manufacturers need to understand that different types of risks can threaten their organization.

Regulatory Risks

From properly labeling a medical product to choosing materials cleared by the U.S. Food and Drug Administration (FDA), medical device manufacturers have to comply with strict guidelines at every step of the way.

Regulatory frameworks can also determine how a manufacturer should market their product, how they should disclose potential risks, and how healthcare providers should use these products.

Regulatory risks include facing fines and penalties if a manufacturer fails to meet the standards set by the FDA, European Union, or the International Organization for Standardization (ISO). Medical device manufacturers can even lose access to a market if they fail to comply.

Managing regulatory risks is challenging because the regulatory environment keeps changing. For instance, the Canadian market is currently replacing the Canadian Medical Devices Conformity Assessment System with the Medical Device Single Audit Program.

Product Liability Risks and Safety Risks

A medical device that doesn’t work as intended can cause harm to a patient. Medical device manufacturers can become liable for additional medical costs, loss of quality of life, or even death.

Risk management goes beyond product quality. It encompasses the way the manufacturer markets the product since making inaccurate claims about how a product works can result in harm to a patient.

Packaging is another important aspect of risk management. The right packaging should protect the integrity and quality of the medical device.

The first barrier against product liability risks is to develop a comprehensive process that ensures product quality. This process can include studies and testing before releasing a new product and monitoring patient outcomes once the product is on the market.

Medical device manufacturers should aim for continuous improvement. With new materials and manufacturing techniques available, it’s possible to keep improving product designs to reduce risks.

ISO 14971 is a comprehensive risk mitigation framework that can help assess product liability risks at different stages.

Business Continuity Risks

Business continuity can refer to a number of threats that could interrupt key business processes.

Cyber-attacks are a common example. With cyber-attacks up 42% in 2022 compared to 2021, your risk assessment team can’t overlook this threat.

With IT products being such an important tool for many business processes, a network or power outage can also be a business continuity risk.

Terrorist attacks, fires, floods, pandemics, and other natural disasters can also result in disruption. The risk management process can be challenging for organizations that outsource product assembly or production abroad.

Business continuity risks can impact your organization directly or indirectly. For instance, a pandemic or natural disaster can disrupt your supply chain.

Identifying and Assessing Risks

Now that you have a better understanding of the risks medical device manufacturers typically face, it’s time to evaluate the unique risks your organization faces.

Methods for Identifying Risks

You can implement different risk assessment strategies to identify your unique risks. We have collected six varying approaches, such as:

  1. Learn from your past mistakes. If you encountered an issue with a product or experienced business continuity challenges, approach the incident as a risk you need to mitigate.
  2. Listen to legal and compliance experts. These experts can use the ISO 14971 framework and other tools to assess your risks.
  3. Consider getting help from an outside consultant. Someone with extensive experience and knowledge of your industry can help spot regulatory risks or product liability risks you had overlooked.
  4. Conduct a thorough IT risk analysis. Look at risks such as data breaches, network outages, cyber-attacks, and more.
  5. Keep up with the latest industry trends. Look at the risk affecting your competitors and partners. These trends can help you predict the risks you will face in the near future.
  6. Listen to employees and stakeholders. The people who design and manufacture your products might be aware of flaws, and the healthcare professionals or patients who use your products can also help with risk management.

Assessing the Likelihood and Impact of Risks

Medical device manufacturers need to adapt their risk management strategy to each individual risk based on two factors:

  • The likelihood of a risk. How likely is the event to happen? For product liability risks, the percentage of patients affected by an issue can be a helpful risk assessment tool.
  • The potential impact of the risk. A risk can result in a loss of revenue, a loss of reputation, or a fine from the FDA. Assess the extent of this impact on the organization.

While medical device manufacturers shouldn’t overlook any existing risks, looking at the likelihood and potential impact of risk will help prioritize risk mitigation. It can also support the decision to allocate resources to the risk mitigation plan.

Mitigating Risks

After completing a thorough risk assessment, medical device manufacturers can create a risk management plan with strategies that will prevent or reduce the impact of known risks.

Risk Prevention and Control Measures

Risk prevention strategies include quality control, improving the design of a product to prevent failure, or replacing problematic materials.

Medical device manufacturers can also develop a compliance process to follow ISO and FDA guidelines, or offer training to healthcare providers to help improve patient outcomes with a device.

Control measures are another way to prevent risks. Examples include restricting access to sensitive data or replacing a high-risk supplier with a reliable partner.

Risk Acceptance and Transfer

Medical device manufacturers can take steps to reduce risks, but risks will always exist to some degree. Organizations need to determine the level of risks they are comfortable with.

Risk transfer is another core component of a successful risk management strategy. A common way to transfer risks is to purchase insurance coverage. For instance, an insurance policy can protect medical device manufacturers from product liability claims or cyber-attacks.

Your insurance company can become a valuable partner for helping you understand and assess risks. Your insurer can help uncover risks you hadn’t considered or recommend a tailored policy based on the likelihood of different events.

You can also transfer risk by having healthcare providers and patients can also sign waivers to indicate they understand the potential risks of using a medical device. A waiver can, for instance, eliminate liability risks in case the healthcare provider or patient doesn’t use the medical device as intended.

Best Practices for Risk Management

Successful medical device manufacturers have turned risk management into a well-documented process.

Developing and Implementing a Risk Management Plan

After assessing risks and identifying relevant strategies, you should develop a written plan. This plan will act as a framework you can refer to when a new risk arises. It ensures a consistent response to risks across your organization and will improve your response time since you’ll have a go-to solution when a risk threatens your organization.

Plus, your written plan shows that you are taking an active role in preventing risks. It can help in the context of an audit by the FDA or a lawsuit for negligence.

Regularly Reviewing and Updating the Risk Management Process

Risk management is an ongoing project. Risks aren’t set in stone and can change over time.

Ideally, you should have a multidisciplinary team that is in charge of reviewing and updating your plan regularly. You might want to update your plan when you release a new product or when regulatory frameworks change.

Involving All Stakeholders in the Risk Management Process

Risk management shouldn’t be an isolated process. You’ll get a much better understanding of the risks your organization faces by involving several stakeholders.

Product designers, marketing employees, suppliers, and executives can help you identify risks across several processes. Your IT team also has a crucial role to play in identifying risks linked to protecting intellectual property and sensitive data.

You should also involve healthcare providers and patients. Studies and interviews can help improve your product and reduce product liability risks.

Take the Next Step in Your Risk Management Journey

Medical device manufacturers face a wide range of risks in different areas, including product liability claims, compliance, and business continuity. Manufacturers need to build a process that allows them to identify new risks and implement the right strategies to either remove or reduce the impact of these risks.

The ISO 14971 framework is a great place to start for medical device manufacturers looking for a set of risk management best practices developed by industry experts. Working with the right partners can also help reduce risks. If you’re in need of a trustworthy medical product assembly and packaging vendor, MDI could be a great match. Contact our team today to tell us about your project and request a quote.