Yesterday concluded the 2024 edition of the Regulatory Education for Industry Annual Conference Innovation in Medical Product Development held at the University of Maryland United States, and I would like to draw attention to a particular presentation by way of reviewing the conference, the presentation titled “Accelerating Device Innovation Through Regulatory Science” performed by the Director Office of Science and Engineering at FDA Edward Margerrison.
Specifically, the presentation outlined the significance of regulatory science tools (RSTs) in driving innovation and efficiency in the medical device industry.
Dr. Ed Margerrison emphasized the importance of RSTs for innovators, product development engineers, and regulatory reviewers, highlighting their role in standardizing the evaluation of safety and effectiveness.
The presentation underscored the public availability of CDRH (Centre for Devices and Radiological Health) Regulatory Science Tools, such as:
· Lab methods,
· AI training data sets,
· and computer models
which are utilised by innovators and reviewers to streamline the evaluation process.
It also discussed the proven link between regulatory process efficiency and stimulating upstream innovation, with active funding from NIH Institutes and NSF for tool development.
Furthermore, the impact of RSTs is demonstrated through the significant increase in the utilisation of tools, the addition of new tools at a rapid rate, and the effort to expand capacity.
The presentation provided examples of CDRH RSTs, including iMRMC for imaging and digital pathology, tools for evaluating AI-based algorithms and bias, as well as tools for early biocompatibility evaluation and anatomically correct whole-body models for simulations.
These tools have been cited in numerous premarket submissions, indicating their widespread adoption and impact across various product areas.
In addition, the presentation included a knowledge check section, highlighting the accessibility of RSTs to researchers in academia, industry product development teams, and CDRH reviewers, and emphasizing that RSTs do not guarantee FDA clearance or approval of medical device applications.
The summary of the presentation underscored the role of RSTs in aiding innovators to focus on the quality of their technology or product, facilitating benchmarking for product development teams, and enhancing the familiarity of CDRH reviewers with evaluation methods.
The call-to-action urged readers to explore the utilisation of RSTs and provide feedback on the needs for their application. Overall, the presentation emphasised the pivotal role of regulatory science tools in driving innovation, streamlining regulatory processes, and enhancing the evaluation of medical devices while highlighting their accessibility and potential impact across diverse product areas.
