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Bioengineering
Special Issues
Translational Bioengineering—Process Primer and Real World Applications
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Translational Bioengineering—Process Primer and Real World Applications

A special issue of Bioengineering (ISSN 2306-5354).

Deadline for manuscript submissions: closed (30 November 2016)

Special Issue Editor

Prof. Dr. Arthur Rosenthal

E-Mail Website
Guest Editor
Department of Biomedical Engineering Boston University College of Engineering 44 Cummington St., Boston, MA 02215, USA

Special Issue Information

Dear Colleagues,

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
Guest Editor

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.

Keywords

  • FDA Medical Device Regulations
  • Human Factors
  • Customer Usability
  • Product Development Process
  • Medical Product Development

Published Papers (1 paper)

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Review
So, You Think You Have an Idea: A Practical Risk Reduction-Conceptual Model for Academic Translational Research
by John Schwartz and Christopher Macomber
Bioengineering 2017, 4(2), 29; https://doi.org/10.3390/bioengineering4020029 - 04 Apr 2017
Cited by 9 | Viewed by 8536
Abstract
Translational research for new drugs, medical devices, and diagnostics encompasses aspects of both basic science and clinical research, requiring multidisciplinary skills and resources that are not all readily available in either a basic laboratory or clinical setting alone. We propose that, to be [...] Read more.
Translational research for new drugs, medical devices, and diagnostics encompasses aspects of both basic science and clinical research, requiring multidisciplinary skills and resources that are not all readily available in either a basic laboratory or clinical setting alone. We propose that, to be successful, “translational” research ought to be understood as a defined process from basic science through manufacturing, regulatory, clinical testing all the way to market. The authors outline a process which has worked well for them to identify and commercialize academic innovation. The academic environment places a high value on novelty and less value on whether, among other things, data are reproducible, scalable, reimbursable, or have commercial freedom to operate. In other words, when investors, strategic companies, or other later stage stakeholders evaluate academic efforts at translational research the relative lack of attention to clinical, regulatory, reimbursement, and manufacturing and intellectual property freedom to operate almost universally results in more questions and doubts about the potential of the proposed product, thereby inhibiting further interest. This contrasts with industry-based R&D, which often emphasizes manufacturing, regulatory and commercial factors. Academics do not so much choose to ignore those necessary and standard elements of translation development, but rather, they are not built into the culture or incentive structure of the university environment. Acknowledging and addressing this mismatch of approach and lack of common language in a systematic way facilitates a more effective “translation” handoffs of academic project concepts into meaningful clinical solutions help translational researchers more efficiently develop and progress new and better medical products which address validated needs. The authors provide an overview and framework for academic researchers to use which will help them define the elements of a market-driven translational program (1) problem identification and validation; (2) defining the conceptual model of disease; and (3) risk evaluation and mitigation strategies. Full article
(This article belongs to the Special Issue Translational Bioengineering—Process Primer and Real World Applications)
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