Mölnlycke is a world-leading company in medical technology products and services and has since the summer of 2022 used Hoodin for its regulatory intelligence needs. Christina Kultje is the project owner and the person who set up architecture and surveillance for their project in Hoodin. We had a chat to listen to Christina's experiences from using Hoodin and how it affected her and their Regulatory Affairs team's work around regulatory intelligence.
You have been using Hoodin for your Regulatory Intelligence needs for some time now. How would you describe a before / after picture of how you and your team work with Regulatory Intelligence?
“In the past, I have been completely dependent on my colleagues in various local markets to catch up on new and changed regulations for product registrations. This has worked relatively well as my colleagues have a good grasp, but there are a number of markets where Mölnlycke does not have the same local anchoring (usually less regulated or unregulated) and there is a risk of missing essential information.
With Hoodin, I feel more secure that we won't miss anything important. As we work with Hoodin, it also means a more efficient way to scan various different news sources, both more global but also more local sources. If we were to try to do it the same way we worked before... well, there aren't that many hours in the day.”
What do you see as the main benefits for you of using Hoodin?
“We have looked at other systems and what is striking is that Hoodin is modern, user-friendly, neat and clear; you get a wow feeling! Value for money is very good. Some of the other systems were prohibitively expensive.”
Do you think that you as an RA team are perceived differently within Mölnlycke after you started using Hoodin?
"Yes, I think so. Traditionally, RA teams are often seen as a bit old-fashioned and complicated. With Hoodin, I hope and believe that we are now considered more modern and progressive. This is in line with Mölnlycke's entire approach to digitization and we want to be at the forefront and show that an RA team can be pioneers in digitization."
How do you think systems like Hoodin will change the work within RA teams?
"When we got up to speed on e.g. monthly reports and to more interactively use the possibility to comment on an article, I see that Hoodin will be an excellent addition to our internal RA Intelligence library, where we collect Mölnlycke's own evaluations of new and changed regulatory requirements related to product registrations, and how this affects our daily work.
In our Hoodin project, we monitor information partly based on so-called regulatory updates, which is news from local authorities and ministries regarding changes in regulations, and partly via regulatory insights, which is information about how different experts interpret regulatory changes. The articles in Hoodin will give a broader picture, but also how different experts interpret and guide in relation to the authority requirements.
RA as a team will feel even greater certainty that "we are in control" and can provide even better support to the various business areas within Mölnlycke, through a clear RA strategy, which increases speed to market for Mölnlycke to be able to equip healthcare personnel to achieve best patient, clinical and financial outcomes”
Is there anything else you would like to share about your experience working with Hoodin for regulatory intelligence?
"For us, it is important to use a system that we can trust and that we have a good relationship with the supplier. Therefore, I would like to highlight that the support we received from Hoodin when we had questions, or when something happened that we needed help with, has been very fast and efficient."
Leran more about Hoodin for Medtech here: https://www.hoodin.com/medtech