How can we ensure Regulators and Innovators speak the same language?
by Rita Hendricusdottir on 15 Jul 2024
Reading time: 1 minute
We recently invited regulators, funders, tech transfer officers, academics and startup founders to discuss the challenges of understanding and implementing Medical Device Regulation (MDR).
With the support of University College London (UCL) and the Accelerating Medical Technology Regulatory Science Innovation (AMRI) network, RegMetrics held a two-day workshop series staging expert presentations, round table and panel discussions.
The purpose of the workshops was to work with the AMRI network to improve patient safety and access to innovative products by delivering a programme of regulatory education, training and mentoring for early stage innovators.
At the conclusion of the workshops, it was clear that:
- Regulatory knowledge is often obtained very late in the device development process.
- Innovators find the regulatory information difficult to understand and implement.
- Funders and regulators would like innovators/academics to be empowered in understanding the regulatory process so that they have a better chance of receiving funding and bringing their device to market in the hands of the patients.
One solution is to ensure that Regulators and Innovators harmonise to educate students and academics on the regulatory concepts early in their studies and careers.
The workshops would not have been possible without the support from Farhad Gilani, Clinical Trials Operations Manager from UCL's Joint Research Office, Helen Cooksley, Senior Translational Research Manager from UCL's Translational Research Office and Micheal Kipping, President of the Organisation for Professionals in Regulatory Affairs (TOPRA).
Let us know what other solutions there might be to bridge the regulatory knowledge gap?