Regulatory Support for MedTech Innovators with Wagtail CMS
RegMetrics is a regulatory navigation tool, designed to make it easier for medical device innovators to understand and fulfil their legal requirements regarding medical device regulations.
Dr Rita Hendricusdottir, CEO of RegMetrics, assembled an international team of researchers and data scientists to develop the tool, before bringing us on board to provide design and development expertise.
We’re delighted to be joined by Rita, to hear more about their journey so far.
Can you tell us a little bit about where the idea for RegMetrics came from?
The technology was initially developed by the Natural Interaction Lab (NIL) at the University of Oxford, as a solution for a need that was observed within the community of innovators.
Complying to the medical device regulations is essential for every MedTech company bringing a medical device to the market. Currently, one of the key challenges for MedTech companies is access to regulatory expertise and the cost for regulatory support is very high. Our own research showed that innovators also struggle with the regulatory language, finding the right supporting documents and knowing what to do next.
Therefore, we developed the digital tool RegMetrics in order to help as many innovators as possible. The tool is developed to be easy to use and provides personalised regulatory support to MedTech innovators, where no prior knowledge is required. The software guides innovators through the regulatory requirements step by step, breaks up long workflows and sets expectations for what’s ahead. It provides an objective and trustworthy approach with all its content referencing official documents, whilst using data driven technologies to cater to all types of medical devices from software to hardware as well as in-vitro diagnostics.
You came to us with a challenge to extend your existing MVP for scalability and with more complex prediction features. Can you tell us more about what you wanted to achieve, and why you chose us?
Torchbox came highly recommended by colleagues, for your expertise with the Django framework we’d already started to build with and with the expertise in Wagtail. One of our objectives was to ensure the content could be managed by our content developers in the future to make sure the tool is always up to date.
Next to adding on multiple complex modules and including Wagtail, we also required some design input, how to integrate complex regulatory pathways to make it easy for users to follow.
We’ve now got a strong technical foundation with great branding and designs. We can now continue extending the service to the next steps in the regulatory journey, and to other regulations internationally.
As part of this work, we’ve incorporated Wagtail into the backend of RegMetrics - how have you found this?
We were drawn to Torchbox by the Django expertise in the first instance, but one great advantage was also your expertise with Wagtail content management system. Incorporating content management across the service has enabled us to be really responsive to changes in the regulation, so that we’re always giving our users the most relevant and timely guidance.
Regulations around medical devices are complex and fast moving, so it’s critically important for us to keep the tool up to date. Being able to do that directly and easily through Wagtail has made a big difference, and helps us make sure we are a trusted source of regulatory information.Dr Rita Hendricusdottir, CEO of RegMetrics
RegMetrics has some complex data models to drive the logic that navigates users through the regulation, and enable the predictions that help users identify their next steps. We’ve been really impressed with the flexibility of Wagtail to fit our data model and page structure without compromising usability of the CMS or the user-facing service.
RegMetrics has some really cutting edge functionality driven by data science techniques - how have we supported your work to make these features useful to a wider audience?
RegMetrics exists to help medical device innovators understand and fulfil their regulatory requirements, so that they can safely develop and place their product onto the market.
In several cases, that means choosing the most relevant or appropriate option from hundreds, or possibly tens of thousands, of items in a list. To help users through this process, the RegMetrics team used data science techniques to predict and suggest the most relevant options based on the information a user has already provided.
The Torchbox team were excellent in translating our proofs of concept into functioning parts of the service, and thinking through how to make these performant and usable for everyone. It was a major milestone in the project to implement suggestions for Test Houses and Standards, and we’re excited to extend this functionality to other areas of the regulatory pathway in the near future.
Looking to the future
RegMetrics is at a really exciting point in its development and growth - what have been the biggest lessons from the past 6 months that you’re taking forward into this next phase?
One big lesson for us has been that developing a tool with a CMS like Wagtail ensures that you can keep it up to date without delay. For RegMetrics, that has meant that the site can keep up with the pace of change and we can be really responsive to user feedback.
We were able to work as a single, combined team with Torchbox. Feeling entirely integrated with the work of the team, helped us to be really responsive to things we were learning about our users, and really agile in our decision-making. That helped reduce delays, and also meant we could solve problems really effectively with perspectives from the different disciplines and a clear understanding of the value RegMetrics offers to its users. This way of working also meant that we identified opportunities to improve things as we worked - we may not have been able to do that so effectively if we’d worked in a more siloed way, or to a strict upfront specification.
What’s next for RegMetrics?
There are more elements of the European medical device regulations that we will cover, and we have exciting concepts in development for predicting and recommending next steps based on user inputs.
These plans will enable medical device innovators and developers across industry and academia to better understand the risk profile and compliance requirements they need to adhere to, as well as making it easier and more efficient for medical devices to reach the patients and healthcare professionals who really need them.
In the longer term, we’ve got ambitious plans to scale the service to other legislative jurisdictions around the world, so that the service can be used to give (medical) device developers a global picture of their path to market, and ensure that as many patients as possible can benefit from the latest innovations.