A Detailed Five-Year Review of Medical Device Additive Manufacturing Research and its Potential for Translation to Clinical Practice

2015 ◽  
Author(s):  
Katherine Stephenson
Keyword(s):  
Systematic Review ◽  
Clinical Practice ◽  
Additive Manufacturing ◽  
3D Printing ◽  
Medical Device ◽  
Development Stage ◽  
Medical Device Design ◽  
Device Development ◽  
Near Term ◽  
Common Clinical Practice

This paper provides a systematic review of over 350 publications that document specific medical device examples in which the design and manufacturing relied on additive manufacturing processes (more popularly referred to as “3d Printing”). Existing reviews on 3d printing for medical device design focus on the range of clinical applications and potential uses for this technology. However, existing work tends to omit key medical device development and regulatory requirements pertaining to the use of 3d printing for technology translation. These omissions often present a skewed view of each device’s potential for rapid translation to commercialization and common clinical practice. To fill gaps in existing literature, this review includes medical device journal articles and identifies each article’s country of origin, the product development stage in which 3d printing was used, and the device’s specific type and classification under the U.S. Food and Drug Administration. The findings from this systematic review provide a detailed international snapshot of current additive manufacturing research and its near term potential for changing clinical practice.

Design Process for a Birthing Bed, Based on User Hierarchy: Promoting Improvement in User Satisfaction

2021 ◽  
Vol 11 (20) ◽  
pp. 9430
Author(s):  
Fabiola Cortes-Chavez ◽  
Alberto Rossa-Sierra ◽  
Elvia Luz Gonzalez-Muñoz
Keyword(s):  
Medical Device ◽  
Design Process ◽  
User Satisfaction ◽  
Engineering Students ◽  
User Acceptance ◽  
Development Stage ◽  
Device Design ◽  
Design Processes ◽  
Medical Device Design ◽  
User Hierarchy

The medical device design process has a responsibility to define the characteristics of the object to ensure its correct interaction with users. This study presents a proposal to improve medical device design processes in order to increase user acceptance by considering two key factors: the user hierarchy and the relationship with the patient’s health status. The goal of this study is to address this research gap and to increase design factors with practical suggestions for the design of new medical devices. The results obtained here will help medical device designers make more informed decisions about the functions and features required in the final product during the development stage. In addition, we aim to help researchers with design process didactics that demonstrate the importance of the correct execution of the process and how the factors considered can have an impact on the final product. An experiment was conducted with 40 design engineering students who designed birthing beds via two design processes: the traditional product design process and the new design process based on hierarchies (proposed in this study). The results showed a significant increase in the user acceptance of the new birthing bed developed with the hierarchical-based design process.

scholarly journals Medical Device Development Process, and Associated Risks and Legislative Aspects-Systematic Review

2020 ◽  
Vol 8 ◽  
Author(s):  
Petra Marešová ◽  
Blanka Klímová ◽  
Jan Honegr ◽  
Kamil Kuča ◽  
Wan Nur Hidayah Ibrahim ◽  
...  
Keyword(s):  
Systematic Review ◽  
Medical Device ◽  
Development Process ◽  
Medical Device Development ◽  
Device Development

OP74 Stoma Cover Use By Fully Laryngectomized Patients

2019 ◽  
Vol 35 (S1) ◽  
pp. 18-18
Author(s):  
Simon Deblois ◽  
Sylvain L'Espérance ◽  
Martin Coulombe ◽  
Luigi Lepanto ◽  
Marc Rhainds
Keyword(s):  
Systematic Review ◽  
Clinical Practice ◽  
Methodological Quality ◽  
Conflicts Of Interest ◽  
Clinical Effectiveness ◽  
Conclusive Evidence ◽  
Future Research ◽  
Common Clinical Practice ◽  
Study Designs ◽  
Heat And Moisture

IntroductionThe use of stoma covers has been a common clinical practice for laryngectomized patients for several years. In the province of Québec, Canada, laryngectomized patients can obtain stoma covers through a dedicated program providing them with medical supplies and voice re-education services. For many years, the program's supply has included cloth and/or foam covers, but the supply of Heat and Moisture Exchangers (HME) has been limited. Two hospital-based HTA units joined their expertise to assess the opportunity of providing HMEs to more patients, depending on their clinical characteristics.MethodsTheir joined assessment rested on a systematic review (SR) and a field assessment. The systematic review aimed at assessing the efficacy, clinical effectiveness and safety of various types of stoma covers. The field inquiries intended to assess the perceptions of clinicians and managers towards stoma covers in clinical practice.ResultsWe included 27 studies in the SR. Most of them appraised the clinical effectiveness or safety of HME filters. Their methodological quality was very low with potential conflicts of interest whereas many studies were financed by the industry. The heterogeneity of study designs, expected outcomes and paucity of comparative studies prevented the pooling of results. Industry sponsorship appeared to be an important issue, since 17 of the included studies were sponsored. The SR did not provide conclusive evidence concerning the efficacy, clinical effectiveness and safety of the various types of stoma covers. The field inquiries intended to assess the perceptions of clinicians and managers towards stoma covers in clinical practice. It showed that industry representatives are quite active in clinical settings, promoting their products. Clinicians’ opinions and preferences were coherent with the systematic review main observations: in a context where the quality of the evidence is low, clinicians’ recommendations of stoma protectors for laryngectomies are mainly based on their professional experience and academic training.ConclusionsFuture research of high methodological quality would strengthen the evidence concerning the relative efficacy and safety of different stoma protectors. These studies would help define evidence-based allocation criteria and set parameters so that the choice of a stoma protector is best adapted to a laryngectomized patients’ condition.

scholarly journals An industrial oriented workflow for 3D printed, patient specific orthopedic cast

2021 ◽  
Vol 3 (11) ◽  
Author(s):  
Mario Formisano ◽  
Luigi Iuppariello ◽  
Antonio Casaburi ◽  
Pasquale Guida ◽  
Fabrizio Clemente
Keyword(s):  
Clinical Practice ◽  
Medical Device ◽  
Medical Devices ◽  
Quality Standards ◽  
Patient Specific ◽  
Clinical Use ◽  
Production Flow ◽  
Medical Device Design ◽  
Voluntary Standards ◽  
3D Printed

AbstractThe clinical use of 3D printed patient specific orthopaedic cast is of wide interest. However, design and production have problems such as production time, which can take up to 35 h, and standardized procedure considering that there are medical devices that must comply mandatory and/or voluntary standards. Moreover, the proposed procedures do not fully consider the traceability of this innovative medical device design to comply with standards and industrial proposes. The aim of this work is to propose a semi-automatic workflow for the production of the 3D printed orthopaedic casts. The procedure is oriented towards a reduction time in different phases (as scan setting, designing technique, printing orientation) of the production flow. The workflow is compliant with recognized quality standards for the production of additive manufactured medical devices. This approach offers the possibility to introduce new 3D printed medical devices in clinical practice as well as to design an optimized industrial workflow.

WikiRecs primary care: developing rapid recommendations for primary care through effective collaboration between systematic review and guideline teams

2018 ◽  
Vol 68 (suppl 1) ◽  
pp. bjgp18X697085
Author(s):  
Trudy Bekkering ◽  
Bert Aertgeerts ◽  
Ton Kuijpers ◽  
Mieke Vermandere ◽  
Jako Burgers ◽  
...  
Keyword(s):  
Systematic Review ◽  
Primary Care ◽  
Clinical Practice ◽  
Primary Care Physicians ◽  
Urinary Stones ◽  
Care Practice ◽  
Supporting Evidence ◽  
Supervised Exercise ◽  
Review Team ◽  
New Evidence

BackgroundThe WikiRecs evidence summaries and recommendations for clinical practice are developed using trustworthy methods. The process is triggered by studies that may potentially change practice, aiming at implementing new evidence into practice fast.AimTo share our first experiences developing WikiRecs for primary care and to reflect on the possibilities and pitfalls of this method.MethodIn March 2017, we started developing WikiRecs for primary health care to speed up the process of making potentially practice-changing evidence in clinical practice. Based on a well-structured question a systematic review team summarises the evidence using the GRADE approach. Subsequently, an international panel of primary care physicians, methodological experts and patients formulates recommendations for clinical practice. The patient representatives are involved as full guideline panel members. The final recommendations and supporting evidence are disseminated using various platforms, including MAGICapp and scientific journals.ResultsWe are developing WikiRecs on two topics: alpha-blockers for urinary stones and supervised exercise therapy for intermittent claudication. We did not face major problems but will reflect on issues we had to solve so far. We anticipate having the first WikiRecs for primary care available at the end of 2017.ConclusionThe WikiRecs process is a promising method — that is still evolving — to rapidly synthesise and bring new evidence into primary care practice, while adhering to high quality standards.

Sign in / Sign up

Export Citation Format

Share Document