Special Issue "Translational Bioengineering—Process Primer and Real World Applications"
A special issue of Bioengineering (ISSN 2306-5354).
Deadline for manuscript submissions: closed (30 November 2016).
The term Translational Research is an often used and abused vernacular, describing the aspirational application of any scientific discovery to the development of technology/products intended to solve clinical problems. Self-identification of projects as translational is unfettered and finds many disciples masking basic research as translational research for the purpose of funding justification.
Engineering by its very nature is an application science and the rightful owner of term translational process.
For the purpose of clarity, we are recognizing a pure form of Translational Bioengineering as the application of engineering principles for the systematic development of products targeted at solving specific clinical problems. These problems must be rooted in a clear understanding of user needs and desired clinical outcome.
As an integral part of the translational (development process), the innovator must understand and follow a regulated path documenting design, testing, quality assurance, usability and clinical safety and efficacy. In the United States, the FDA Medical Device regulations govern this process. Academic engineers are generally not well equipped to navigate this translational process. We intend to change that. In this Special Issue, we will provide a primer to the FDA Medical Device regulations, application of design controls, quality engineering principle, human factor and usability studies and preclinical/clinical testing requirements using didactic and experiential articles. Most importantly, we will share real world experiences and lessons learned of translators pursuing their novel product innovations.
We are seeking both didactic articles related to the regulatory and development process and experiential articles covering any form of product-oriented bioengineering including global directed projects.
Prof. Dr. Arthur Rosenthal
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 papers will be 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 quarterly 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 1000 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.
- FDA Medical Device Regulations
- Human Factors
- Customer Usability
- Product Development Process
- Medical Product Development