By Tiina Tyni
Regulatory complexity has increased significantly for everyone in the medtech industry. If regulatory professionals want to keep up to speed in a constantly changing environment, they need to think how they track regulatory intelligence.
How to stay current with regulatory demands
Manual monitoring
Manual monitoring means you go to different sources, enter search queries or scroll pages to find relevant information. Once you have it, you copy paste or download it to your repository.
Although manual monitoring is simple and free, it’s also time-consuming. For example, if you’re trying to stay up to date with the MDR implementation drama and the release of new guidances and standards, or attempting to take all the proactive and systematic steps required by the MDR for your devices, you’re going to have a handful with hand searching.
Especially if you need to repeat the searches in several sources. It’s easy (and human) to make mistakes when you’re manually repeating routine tasks. Source confusion may strike you if you keep running into the same publication in different sources. You may end up going back and forth to verify the information trail.
Manual monitoring is hard to scale, especially if the number of monitored sources grows. Assuring your conformity assessment reviewer you’re compliant and have an accurate audit trail can be tricky if you’re using only a manual process.
Semi-automated monitoring
You can step up manual monitoring by adding some automation. For example, you might follow relevant hashtags and industry experts on LinkedIn to not lose track of the maturing MDR interpretations. Or sign up for newsletters, join email alert lists or create an RSS feed for search to receive important MDR news and updates without delay.
Semi-automated monitoring is usually free and simple, just like manual tracking. However, the added benefit of semi-automation is that it saves your time. Most of the information you monitor will be delivered to you. You’ll get notified when the automation picks it up. This way you’ll have more time to focus on other tasks on your full plate.
It’s easier to scale semi-automated monitoring than manual tracking. You just follow, sign up for or join to monitor new sources as they emerge, without needing more resources to do the actual work. Semi-automated monitoring can help you make your audit trail more reliable and impress your auditor by meeting the compliance requirements with less human errors.
Automated monitoring
With automated monitoring, technology does the heavy lifting for you and brings the insights to a centralised system.
A regulatory intelligence tool monitors regulatory information and data from verified industry websites and databases for you. While you’re busy preparing technical files or firefighting urgent issues, robots cut through the noise and find key regulatory insights for you. You may not be able to follow every source (for example social media) with an automated tool though. And there are costs involved in using automated monitoring.
However, automation saves your time as it’s collecting data 24/7 in a centralised place.
There are several medtech regulatory intelligence solutions on the market. One of them is Hoodin. I had a chance to try it out recently. It was easy to create monitoring feeds for essential regulatory intelligence use cases, such as for regulation changes, PMS data and industry trends. Each feed has lots of trusted sources to choose from. I could pick those that were
relevant for me to follow. And if something I want to monitor wasn’t on the list, I could request a source to be added, which is nice. For a bigger organisation scenario, I appreciated that with Hoodin one could comment and tag the findings, as well as share them with colleagues (who
can use the tool for free by the way). That way one could easily loop in others impacted by the information and turn the regulatory intelligence into an action point.
To conclude, regulatory changes are likely to continue and regulatory professionals need to keep up. There are pros and cons with each regulatory intelligence monitoring method. Finding the right way for you depends on your resources, budget, how many devices you have and how many sources you need to keep an eye on. Automation can support you in making the regulatory intelligence process faster and more efficient.
This article was written by Tiina Tyni. She is a medical device regulatory expert, writer & marketer. She has a long and international experience from regulatory affairs within the medical device industry. Heading roles such as regulatory manager. Learn more about Tiina here.
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Book an insight call with one of our experts here.
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