Navigating the regulatory pathway for an innovative bionic vision system
Abstract
Bionic vision restoration systems incorporating an implantable device belong to the highest regulatory risk class in the USA and Europe (i.e Class III). As such, their release to the market or their use in clinical trials is subject to authorization by the competent authorities. These authorizations are based on thorough evaluation procedures which impose on the manufacturer the highest level of evidence of compliance with regulatory requirements. In order to obtain these authorizations in the shortest possible time, it is necessary to understand, in detail, the requirements specified in the regulations and their interpretation by the competent authorities. The means of demonstration of conformity and the criteria for acceptance must also be defined to ensure that they meet the expectations of the competent authorities. In the case of breakthrough innovation, these different aspects are even more difficult to determine as there is no predicate or state of the art on which the manufacturer and the competent authorities can rely. It is therefore necessary to deploy a regulatory strategy very early on incorporating as much input as possible from the competent authorities, in order to increase the probability of approval and thus streamline the regulatory pathway. We will present, as an example, the method we developed for the Prima Bionic Vision System and discuss the specificities of medical devices; including incremental development and short development cycles versus regulatory time and how to manage this particularity for breakthrough devices.
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Companies have had to face economic problems related to limited market size, cost of research and development, regulatory approval, and low acceptance of the device by clinicians and patients.
“Companies have had to face economic problems related to limited market size, cost of research and development, regulatory approval, and low acceptance of the device by clinicians and patients [229].”
From Advances in visual prostheses: engineering and biological challenges (2022) · cites this paper as [229]
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Advances in visual prostheses: engineering and biological challenges
Borda, E., & Ghezzi, D. (2022) · Progress in Biomedical Engineering · doi:10.1088/2516-1091/ac812c · Cited by 44 · see citing works
- Authors
- Chevrie, K.
- Affiliations
- Pixium Vision (France) (FR)
- Corresponding author
- Chevrie, Karine
- Venue
- Advanced Biomedical and Clinical Diagnostic and Surgical Guidance Systems XVIII
- Publisher
- SPIE
- Published
- 2020-02-21
- Pages
- 70
- OpenAlex
- W3007193082
- Cited by
- 1
- References
- 14
- Citations by year
- 2022: 1
- FWCI
- 0.19
- Type
- conference paper
- Language
- en
- Open access
- closed
- Locations
- Advanced Biomedical and Clinical Diagnostic and Surgical Guidance Systems (publishedVersion)
- Topics
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neuroscience and Neural Engineering
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Keywords
- biomedical implants, regulatory approval, Class III medical devices, regulatory strategy, regulatory pathways, incremental development, clinical trials, regulatory risk
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