Advanced Assessment of Medical Devices

Dear Colleagues,

The preclinical assessment of implantable medical devices is essential for enhancing both their safety and efficacy before reaching the patient. In light of recent high-profile clinical failures, preclinical testing regimes which previously used simplified or averaged conditions and ex situ analysis have faced increased scrutiny. This fails to capture clinically relevant failure modes and provides limited actionable or predictive data on the long-term performance of devices, hindering the effective translation and adoption of emerging technologies. An increase in the popularity of and demand for implants in younger patients, or those with complex healthcare needs, means that current preclinical testing domains are not representative. Furthermore, new and disruptive technologies often necessitate the need for advanced testing. This burgeoning calls for in silico models that drive innovation, offering great potential to address the growing and varied challenges in medical device development, but this is challenged by appropriate experimentally derived inputs and verification/validation frameworks.

This Special Issue of Bioengineering on Advanced Assessment of Medical Devices aims to showcase device development and assessment that goes beyond the current state of the art by inviting contributions from the community in the following areas (among others):

• Advanced preclinical testing;
• Device–biology interaction;
• Co-creation with patients, clinicians, regulators, and industrial partners;
• Machine learning and in silico digital twin methodologies;
• Predictive models for device behaviour in vitro and in vivo;
• High-throughput methodologies for biomaterial characterisation;
• Regulatory science.

Dr. Andrew Robert Beadling
Prof. Dr. Michael Bryant
Prof. Dr. Richard M. Hall
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Bioengineering is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

• medical devices
• preclinical assessment
• biomaterials
• bioengineering
• regulatory science
• digital twins