Do You Still Believe These 7 Common Risk Management Myths?
Risk management is an integral part of life science product development, and there are a lot of opinions out there about it. Among organizations, regulatory bodies, and other industry stakeholders, there’s no clear consensus on many aspects of risk management. As a result, a number of myths have evolved which can negatively impact product development activities. Dispelling these myths is important for incorporating a more dynamic and nuanced approach to risk management for life science products.
1. Risk management should be done toward the end of product development
Many life science organizations put off risk management activities, and this can be problematic. It’s very easy for issues to compound and seriously impact your product’s design, project timelines, and more, and if they aren’t found until late-stage risk analysis, your entire product could fail. Taking an approach to risk early on during the development process, perhaps even during initial innovation/design stages, can identify and control issues that would otherwise force backpedaling and lost time due to remediation.
2. Users are the only stakeholders that should factor into my risk analyses
Users and patients are the priority stakeholders when it comes to risk management related to human factors. In reality, however, they are not the only people working with your product. While you want to make sure risks related to use and user-product interaction are prioritized, evaluating stakeholders involved in all stages of the product life cycle for risk is important. From the personnel manufacturing your product to those providing support, supplies, servicing, and so on, all these human interactions with your product can ultimately expose your users and patients to hazards and harms.
3. I should only care about the intended use environment
Unless your life science product is stationary, chances are that it’s going to move in and out of its intended use environment. While the product might be used primarily in a hospital setting, for example, it could transition to homes, clinics, mobile use environments, and so on. It won’t be possible to predict and scope out every single environment your product may be used in, but you can attempt to evaluate risk as thoroughly as possible and incorporate mitigations and controls that can better account for this variation.
4. One risk tool is good enough for all my risk management work
There is no single tool that acts as a panacea when it comes to life science product development risk analysis. It’s precisely for this reason that FDA, other regulatory bodies, and international standards recommend a number of context-based tools organizations can implement. Some risk management teams might find preliminary hazard analyses more productive than others who leverage FMEAs or human factors risk activities. Each tool offers certain benefits that others do not, and finding a balance between them is critical for you to address before design and development work even begins.
5. Risk management is just for meeting regulatory compliance
It is true that risk management can be beneficial in providing evidence of safety and effectiveness for regulators to review during premarket submission. However, it’s also about quality. By reducing, controlling, and mitigating design risks, you can deliver a higher-fidelity life science product to patients and consumers. With greater assurances of safety and consistent treatment, the value of your product is boosted—ultimately making robust risk management worthwhile.
6. Design and risk management are separate development processes
It’s too easy in life science organizations to create silos for the teams involved in product development. Design work and risk management are often considered as distinct, individualized aspects of the process, but this isn’t the case. Risk is inherently tied to design, and vice versa; therefore, partitioning teams and their work is problematic. By fostering interdisciplinary cooperation between working groups and their processes, you can align design principles across your teams and encourage greater understanding and advancements.
7. Risk management doesn’t allow for innovation
This last myth is perhaps the most difficult of all to dispel. Risk management is, by nature, a restrictive and controlling aspect of product development. As a result, it’s easy to conclude that it stifles creativity rather than promotes it. But while risk management can be restrictive, it can actually be a powerful force in product innovation. When done in an iterative fashion and linked with your design activities, risk management can generate insights that lead to more dynamic products that take care of your user needs.
Risk management can be a time-consuming aspect of life science product development, and it’s easy to treat risk as static and routine. However, falling back on the long-standing myths associated with risk management as a result can negatively impact your product. Understanding risk as a dynamic part of the process can help your team work toward greater safety and quality for users and patients.
About Nick Schofield
Nick Schofield is a content creator for Cognition Corporation. A graduate of the University of Massachusetts Lowell, he has written for newspapers, the IT industry, and cybersecurity firms. In his spare time, he is writing, hanging out with his girlfriend and his cats, or geeking out over craft beer. He can be reached at firstname.lastname@example.org.