Digital readiness in 3D bioprinting: software, governance and hospitals' proto-clinical interfaces.

Aim: To understand the process through which some hospitals have become ready to assimilate the digital technologies required for 3D bioprinting. By enhancing their digital readiness, hospitals will be able to develop the current proto-clinical potentialities of bioprinting. Materials & methods: We conducted interviews with bioprinting researchers, entrepreneurs and regulators in three countries (United Kingdom, Italy and Brazil). We analyzed bioprinting papers in which hospital-based researchers participated. We also analyzed the international bioprinting market. Result s: Digital readiness is more advanced in some hospitals and countries, which have noticed the strategic relevance of bioprinting. Furthermore, it is strengthened by the reformulation of the relations between hospitals and other institutions, a phenomenon that is here interpreted with the concept of interfaces.

[1]  Edison Bicudo,et al.  Software, risks, and liabilities: ongoing and emergent issues in 3D bioprinting , 2020, Journal of Risk Research.

[2]  Peter Laux,et al.  Artificial Intelligence and Machine Learning Empower Advanced Biomedical Material Design to Toxicity Prediction , 2020, Adv. Intell. Syst..

[3]  Tim R. Dargaville,et al.  Emulating Human Tissues and Organs: A Bioprinting Perspective Toward Personalized Medicine , 2020, Chemical reviews.

[4]  V. Mak,et al.  When Does Stand-Alone Software Qualify as A Medical Device in the European Union?-The Cjeu's Decision in Snitem and What it Implies for the Next Generation of Medical Devices. , 2020, Medical law review.

[5]  Vincenzo Salvatore.  Exploring Solutions to Foster ATMP Development and Access to Patients in Europe. , 2020, European journal of health law.

[6]  P. Kluger,et al.  Advanced gelatin-based vascularization bioinks for extrusion-based bioprinting of vascularized bone equivalents , 2020, Scientific Reports.

[7]  Phoebe Li,et al.  3D bioprinting in a 2D regulatory landscape: gaps, uncertainties, and problems , 2020 .

[8]  A. Bosserhoff,et al.  Tumor Cells Develop Defined Cellular Phenotypes After 3D-Bioprinting in Different Bioinks , 2019, Cells.

[9]  Andrew Webster,et al.  Aligning technology and institutional readiness: the adoption of innovation , 2019, Technol. Anal. Strateg. Manag..

[10]  Ana Luiza Garcia Massaguer Millás,et al.  The Brazilian sectoral innovation system in the field of Tissue Engineering and Bioprinting: actors, challenges and perspectives , 2019, International Journal of Advances in Medical Biotechnology - IJAMB.

[11]  Amit Kumar,et al.  The Adoption of Three-Dimensional Additive Manufacturing from Biomedical Material Design to 3D Organ Printing , 2019, Applied Sciences.

[12]  Zhichao Ma,et al.  Towards the Digital Hospital: From Implant Design to In-Clinic Bio Fabrication , 2018, IFMBE Proceedings.

[13]  Ali Khademhosseini,et al.  A perspective on 3D bioprinting in tissue regeneration , 2018, Bio-design and manufacturing.

[14]  Marisela Rodríguez-Salvador,et al.  Uncovering 3D bioprinting research trends: A keyword network mapping analysis , 2018, International journal of bioprinting.

[15]  Deepak Choudhury,et al.  The arrival of commercial bioprinters – Towards 3D bioprinting revolution! , 2018, International journal of bioprinting.

[16]  A. Meyer,et al.  Printing of Patterned, Engineered E. coli Biofilms with a Low-Cost 3D Printer. , 2018, ACS synthetic biology.

[17]  Craig A. Simmons,et al.  Generating vascular channels within hydrogel constructs using an economical open-source 3D bioprinter and thermoreversible gels , 2018 .

[18]  Le Jin,et al.  Clinically Relevant Bioprinting Workflow and Imaging Process for Tissue Construct Design and Validation , 2017 .

[19]  Phoebe Li,et al.  3D Bioprinting Regulations: a UK/EU Perspective , 2017, European Journal of Risk Regulation.

[20]  Andy Wen Loong Liew,et al.  In vitro pre-vascularization strategies for tissue engineered constructs – Bioprinting and others , 2017 .

[21]  Liu Yang,et al.  Engineering zonal cartilage through bioprinting collagen type II hydrogel constructs with biomimetic chondrocyte density gradient , 2016, BMC Musculoskeletal Disorders.

[22]  Keekyoung Kim,et al.  3D bioprinting for engineering complex tissues. , 2016, Biotechnology advances.

[23]  Charlotte Salter,et al.  Bioinformatics and the Politics of Innovation in the Life Sciences , 2016, Science, technology & human values.

[24]  Martin Heller,et al.  Social and legal frame conditions for 3D (and) bioprinting in medicine. , 2016, International journal of computerized dentistry.

[25]  David J. Williams,et al.  A 3D bioprinting exemplar of the consequences of the regulatory requirements on customized processes. , 2015, Regenerative medicine.

[26]  Emmanuel C. Alozie,et al.  Promises and Challenges , 2015 .

[27]  Jasper L. Tran,et al.  To Bioprint or Not to Bioprint , 2014 .

[28]  Geoffrey K. Aguirre,et al.  FIASCO, VoxBo, and MEDx: Behind the code , 2012, NeuroImage.

[29]  Bärbel Bohr,et al.  A Review of “The Computer Boys Take Over: Computers, Programmers, and the Politics of Technical Expertise” , 2011, Inf. Soc..

[30]  Nathan Ensmenger,et al.  The Computer Boys Take Over: Computers, Programmers, and the Politics of Technical Expertise , 2010 .

[31]  Alex Faulkner,et al.  Regulatory policy as innovation: Constructing rules of engagement for a technological zone of tissue engineering in the European Union , 2009 .

[32]  Richard B Gunderman,et al.  The adoption of innovation. , 2008, Radiology.

[33]  Vladimir Mironov,et al.  Organ printing: promises and challenges. , 2008, Regenerative medicine.

[34]  R. Brayley,et al.  Institutional readiness and grant success among public recreation agencies , 2006 .

[35]  Steven Weber,et al.  The Success of Open Source , 2004 .

[36]  D. L. Parnas,et al.  On the criteria to be used in decomposing systems into modules , 1972, Software Pioneers.

[37]  James Davis,et al.  A brief history of programming languages , 1998 .

[38]  Linda Weiser Friedman,et al.  From Babbage to Babel and Beyond: A Brief History of Programming Languages , 1992, Comput. Lang..

[39]  David Lorge Parnas,et al.  A rational design process: How and why to fake it , 1985, IEEE Transactions on Software Engineering.

[40]  Robert C. Wolpert,et al.  A Review of the , 1985 .

[41]  W. Brinegar.  Experiment Perilous: Physicians and Patients Facing the Unknown , 1975 .

[42]  R. Fox.  Experiment Perilous: Physicians and Patients Facing the Unknown , 1974 .

[43]  David Lorge Parnas,et al.  Information Distribution Aspects of Design Methodology , 1971, IFIP Congress.

[44]  Michael Schwenk,et al.  Tumor , 1828, The London medical and physical journal.