Myth 1: It Takes a Lot of Expertise
Fact: The reality is that you probably already employ regulatory intelligence in your daily work. For example, when you look up product approvals or guidance documents to assess the regulatory landscape, that’s part of RI. When you track a competitor’s recall to learn from others’ experience—also RI. True RI is gathering the most complete information available, analyzing it to develop in-depth insight, and determining the most effective strategy to address a need in the regulated environment.
You may be doing this every day to some extent. The key is to elevate your process and skills to the highest levels of proficiency and success. You can accomplish this by developing methods and acquiring tools that help reduce the amount of time spent researching and organizing information and allow more quality time for developing analyses, insights and strategies.
RI can help you minimize risk and maximize effectiveness, and should be an essential tool in every regulatory professional’s toolbox. Mastering the use of RI advances your abilities and your career as a regulatory professional.
Myth 2: It’s Only for Large Companies
Fact: While large companies have the advantage of bigger staffs to investigate the regulatory landscape, when you take into account the greater number of products they have to maintain, the difference is not as large as it may seem. For smaller companies, there are a number of emerging tools for document management, analytics and intelligence that can serve as an equalizer, or even provide a leg up. These tools are helping to improve and automate time-consuming, low-value work like document search and document management, allowing regulatory professionals to focus more time and energy on analysis, insight and strategy—in other words, regulatory intelligence. These same tools make activities like competitive intelligence more accessible to small groups that can’t devote the number of hours needed for manual approaches.
Myth 3: It’s Too Expensive
Fact: The key is that, in the regulatory world, good RI provides a very high return on investment—whether it’s an investment of your own time or an investment in some critical tools. To use an analogy, you can do very involved home improvement projects with a hammer, a hand saw and other simple tools. However, making an investment in some power tools can save tremendous amounts of valuable time and allow you to do a much better job.
As an example in the regulatory world, finding the right document that provides you with a superior predicate device can bring a huge return in the form of a shorter, lower-cost pathway to clearance. Being able to provide an analysis of adverse events to your R&D group that will result in a better product design can yield greater product sales and fewer adverse events. The ability to quickly analyze how the US Food and Drug Administration (FDA) is shifting in its submission requirements can save months of extra work. Good RI with the right tools more than pays for itself.
Myth 4: You Have to Have a Dedicated Staff to Perform it
Fact: While a few large companies do have a staff to do RI work, the overwhelming majority of companies do not. The bulk of RI is performed by a full range of specialists, associates, managers, directors and vice presidents as an integral part of their daily work, whether they think of it as RI or not. The question is how to elevate it to a higher level of effectiveness and how to free up more time for everyone to be able to focus on it—whether it is general RI work, such as surveillance of the environment, or specific work related to a particular project or task. It’s important to note that RI is steadily becoming a more essential part of the profession.
Myth 5: It’s Too Laborious and Complex
The processes required for ongoing, high quality regulatory intelligence are laborious and complex when using traditional methods of finding information. Effective RI cannot be performed at a high level with yesterday’s methods. To be effective, you have to develop the ability to reduce the laborious work at the front end of the process from hours into minutes. You need to have the ability to quickly see the big picture and connect the dots between pieces of information housed in disparate documents or datasets. You have to find efficient ways to capture and analyze trends. You need quick, reliable methods to monitor the increasingly dynamic environment. And you must develop the analytics that will provide you insights that result in superior strategies.
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