What is risk-based thinking in the medical device industry? Why is it essential? Around 4,500 drugs and medical devices are pulled from shelves across the United States each year. This alarming statistic highlights the importance of controlling and mitigating risk in the medical device industry. For years regulatory guidance and standards like ISO 14971 have encouraged MedTech companies to infuse risk-based thinking into their entire quality ecosystem. You’ve probably read a lot about “risk-based” this and that, but really, what is it?
First, let’s focus on something else: the role of the Food and Drug Administration and other regulatory agencies. Above all, such agencies exist to keep the public safe. So these organizations have a key responsibility to make sure design, production, and post-market activities all work together to keep devices from harming users and patients. Notice that their priority is the human being or user/patient, not your company’s ROI or time-to-market. In short, regulatory bodies evaluate risk across the whole product lifecycle, not just during any one phase.
Above all, risk-based thinking means your team spends their time identifying uncertainties in the company’s processes. Then, you apply controls within the relevant processes to minimize any negative effects. In addition, the same controls (or similar ones) can help to maximize the positive effects as well. In short, the identified controls help to drive preventive action, prioritize existing resources against the risk of non-conformances, and make sure conforming devices are the only devices that reach your customers and their patients. As such, risk-based thinking is good for the business!
In order to fully integrate these principles into a company culture, you need a plan, a risk management plan. A management plan involves employing a systematic, data-driven approach to identify which processes need to be monitored for negative trends (and they are not only “quality control” processes—any process can be studied and improved this way), and how you will identify and eliminate those trends before they produce costly delays, product rework, or recalls. Avoid focusing on individual events (such as a single out of specifications batch) or minor deviations. Keep the team’s eye on trend-identification.
As such, your plan is not a document. Therefore, you need more of an organic process where team members integrate the idea of risk-based thinking into all levels of decision-making throughout the organization. If you are doing it well, risk-based thinking becomes part of the company culture.
Conclusions and Next Steps
In short, company culture is influenced most by the leadership. And leadership exists at many levels, of course, and all those leaders can use these principles—the search for trends that can have a negative effect on products, patients, and profits! If your company’s leaders (at any level) want to learn more about how to implement risk-based thinking into their teams, contact MAE Group.