Guest Blog: Dr Rita Hendricusdottir & RegMetrics
RegMetrics is a digital tool to support health technology innovators in navigating the medical device regulations. The tool is 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.
By performing a need-led study, we found that there were many academics and start-up companies that needed to better conform to the regulation earlier on in the development. This would allow them to place their innovation onto the market and make the all-important patient impact within a short timeframe.
We interviewed 14 innovators and asked them ‘how can we help you with the medical device regulation?’. Interestingly, the majority struggled with the first step that forms their regulatory strategy, which was ‘How do I find out if my product is a medical device?’ as well as ‘Which class is my product?’. The innovators also found the language within the regulations difficult. They struggled with how to interpret the text and did not always understood what was expected of them. In addition, legislation is organised in a way that HealthTech innovators are not used to, with the important definitions at the start of the document, and the information on how to conform to the regulation located in the Annexes. This information needs to be seen next to each other in order to navigate the regulations. In addition, the innovators felt that they did not have access to simple guidance. Using the need-led, bottom up approach, we developed a free-to-use digital tool called RegMetrics to address this need, in order to support as many innovators as possible at a global scale.
The first phase of the RegMetrics development was to support health technology innovators in answering the initial crucial question, which aims to determine if their product is a medical device, and if so which class. When the innovators log in to RegMetrics they will be provided with tips for writing the intended use statement of their device. They will then be guided through the medical device definition and the classification rules, for both the medical device regulations (MDR) and in vitro diagnostic medical device regulations (IVDR), using simple ‘yes’ and ‘no’ questions. To accommodate for the difficulty in regulatory language we have included glossaries and parts of the approved guidance documents whenever relevant. This will allow the innovators to give informed answers to each question, which will finally lead to the anticipated classification of their product. The summary page does not only provide the user with the anticipated classification, but also recaps of all the answers, glossaries and relevant guidance. This information can be used to review the answers given and allow for comparison with members of the team that completed the questions for the same product. Empowering innovators to understand the classification will also lead to much better and informed conversations with regulatory experts.
The technology underpinning RegMetrics is a data-driven approach which enables user to better interpret complex regulations (JH Bergmann, 2019). RegMetrics applies a rule-based optimisation (Abdelhalim et al., 2016) based on the legal framework.
User testing of RegMetrics has been performed during workshops, whilst in-depth user research took place during scheduled interviews. The feedback showed that the usability of the tool was perceived to be excellent, with most participants agreeing that they would like to use this tool frequently during the development of a medical device.
The RegMetrics team is developing the next step on the regulatory journey, which consists of personalising the safety and performance requirements to the user needs. This module also follows the need-led research methodology and once completed it will empower the innovators in understanding which requirements are applicable to their device. They will gain information about which tests are required for their product in order to conform to the MDR or IVDR. A release of this update is expected before the end of the year.
Users can navigate and interpret the medical device regulations with the described online tool. It will save the users’ time, whilst creating opportunities to gain valuable insights and increase their understanding of the medical device regulations.
Rita Hendricusdottir, PhD Program Manager Regulatory Navigation, RegMetrics, Natural Interactions Lab (NIL), Department of Engineering Science, University Of Oxford
Abdelhalim, A., Traore, I., & Nakkabi, Y. (2016). Creating Decision Trees from Rules using RBDT-1. Computational Intelligence, 32(2), 216–239. https://doi.org/10.1111/COIN.12049
JH Bergmann, R. H. R. L. (2019). Regulatory navigation: a digital tool to understand medical device classification pathways. Comprehen Biotechnol, 5, 167–172.