Regulatory managers face a wide range of daily challenges, from tracking updates across multiple countries to resolving errors under tight deadlines. These responsibilities are not only present in day-to-day operations but can also potentially threaten a company's international growth. Let's look at the five most common pain points in a regulatory intelligence department, and how they can slow down a company's growth.
- Information overload
- Regulatory surveillance with Excel
- Time pressure is a constant factor
- Am I alone in this world?
- How do I prove my value within the organization?
Information overload
In your daily work in regulatory intelligence processes, you are constantly dealing with the effects of rapid growth, technological innovation, and strict regulations. And often in multiple markets at the same time. This means that information and updates are coming in from all sides, and you can't afford to miss any important details. MDR/IVDR updates, FDA guidelines, updates from ISO standards, Q&As from notified bodies, safety notices. Not only is the volume large (could be a thousand documents per month in global outlook), but the pace is also high, and the impact is potentially crucial. In addition, it seems that the complexity of laws and regulations is only increasing. Cybersecurity and AI are topics that have already taken an indispensable place within this domain, and that will only increase in the coming years. Data legislation and environmental laws are next to knock on your door.
The technical details and legal complexity of laws and regulations make it increasingly difficult to separate relevant details from side issues or to find the legal nuances that do have an impact.
Regulatory surveillance with Excel
Yes, Excel... the powerhouse of many office workers. It can do just about anything. From creating simple tables and overviews to building complete databases with 500,000 rows. Whatever job you need to do, Excel is often high on the list of solutions. This is also true as a regulatory surveillance instrument. Just think about it: it's fast and flexible, it costs almost nothing, and you don't need to train anyone. Yes, as a MedTech company just starting out with regulatory surveillance processes, Excel appears to be an easy choice.
But in the meantime, your company is growing rapidly, and staying up to date with all laws and regulations is no longer a Friday afternoon task. Add the increased regulatory complexity, the expanding product portfolio and market approval scheme, and regulatory surveillance by Excel can become a risk and a bottleneck. An Excel database is difficult to scale up as your product portfolio grows or you need to monitor more markets.
If more people become involved in regulatory surveillance and need to work in the same file, clear version management suddenly becomes a huge challenge introducing serious risks. “Reg-Intel-Database_v8.5_final_FINAL_FINAL2b” is obviously not a suitable method for a crucial part of the business.
And by the time an audit is conducted, this is obviously not a good reflection on the company. An auditor may see this as a of lack of control in regulatory knowledge and compliance, and expect a company to have organized this in a professional manner. Consistency, rationality, and data lineage are important criteria, which is difficult to achieve with a system such as Excel.
Time pressure is a constant
You work for a fast-growing company with sky-high ambitions. To achieve all your goals, it is important to keep product development moving at a fast pace and enter new markets. But at the same time, this means you have to be aware of and monitor more and more regulations and updates. Changes to these occur continuously and are not always predictable. Processing this information simply takes a lot of time (interpretation → analysis → risk assessment → decision-making → implementation → documentation), and in the meantime, the company just wants to move forward. With channels like social media blooming, it might well be that hierarchy is reading up on something just released, and expect you to have answers on their questions of impact on the business right away.
This creates a constant feeling of time pressure and, with it, adds risks to the careful execution of your work. It becomes difficult to set priorities, which in turn creates the risk of information overload. You start missing deadlines, or you miss essential regulatory changes, which can have negative consequences for product development or market entry. Time pressure seems to be a structural part of the work of a regulatory intelligence manager.
Am I alone in this world?
Regulatory affairs is already a specialized field. Within that field, regulatory intelligence (RI) is even more specific. And in many companies, there is no RI department or even a sparring partner with whom you can discuss the substance of your work. This can sometimes make you feel like you are the only one who has to keep all the balls in the air.
You know better than anyone that information and updates can come from dozens of sources. Think of regulations, guidance documents, standards, best practice documents, etc. This happens often all at once! For the rest of the organization, this sometimes feels abstract, complex, and “just your job.” This crucial thinking takes place behind the scenes, which can make this role feel lonely. On top of that, you are the one who has to tell the organization that it needs to slow down. “Compliance is not yet complete” or “the regulations do not allow this” is not a pleasant message in an organization that mainly wants to accelerate.
How can you turn this around? That depends on many factors, of course. But in any case, it helps if a clear regulatory intelligence process has been implemented, and this process is also made visible within the organization. This can be done, for example, by using dashboards and sharing stakeholder updates. Alignment meetings with other departments also promote understanding and coordination.
How do I prove my value in the organization?
In a growing organization, you are always working to strengthen your own position. Perhaps you are in the process of building your own regulatory team. One of the important points to focus on is how you can prove your value and make it visible. This role has a huge impact, but much of it is invisible, preventive in nature, and difficult to quantify. At the end, the results are not always recognized and appreciated.
How can you make your work visible? Here are three tips!
Monthly updates
A relatively simple step with high visibility is to send out a monthly update internally. This could be done via intranet, Slack, or email. A short informative message about the most important regulatory changes and their impact on products or markets is enough to significantly increase the visibility of the work.
Link regulatory intelligence activities to business goals.
If one of the business goals indicates that market entry in the US will take place in Q3 and the RI department signals that an FDA guidance update will be released in Q1, this is an opportunity to demonstrate that timely and accurate analysis of this guidance directly contributes to keeping the market launch on schedule. Seize this opportunity and demonstrate the direct link between regulatory surveillance and business objectives.
Without preventive tasks, catastrophes would occur.
“If we hadn't investigated this MDR guidance update immediately, we could have faced a delay of up to six months in the NB review.” If you can demonstrate that you prevented significant delays in market entry by acting in a timely manner, that is obviously worth its weight in gold. One of the most important tasks of regulatory surveillance is to prevent things from going terribly wrong.
The regulatory surveillance function is one with many challenges, but also with enormous potential strategic value. Due to the nature of the function (laws and regulations, preventive work, sometimes having to put on the brakes), it may not be the cool kid on the organizational chart. But no medical technology company can do without it. Due to the growing complexity of products, the risks are also increasing. Implementing the right processes and tooling is essential in professionalizing the regulatory surveillance organization. And when you can demonstrate its value, your regulatory surveillance function will be seen more often as a strategic advantage, rather than overhead and bureaucratic burden. That is exactly where you want it to be in the organization.
Do you want to know how Regulatory Intelligence solutions can help you save time and reduce risks? Keep an eye on our blog section for more or try out Qserve InSight!