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.

scholarly journals Evaluating Medical Devices Remotely: Current Methods and Potential Innovations

2020 ◽  
Vol 62 (7) ◽  
pp. 1041-1060
Author(s):  
Anne Collins McLaughlin ◽  
Patricia R. DeLucia ◽  
Frank A. Drews ◽  
Monifa Vaughn-Cooke ◽  
Anil Kumar ◽  
...  
Keyword(s):  
Data Collection ◽  
Medical Device ◽  
Medical Devices ◽  
Class Iii ◽  
Participant Recruitment ◽  
Medical Device Design ◽  
Remote Testing ◽  
Behavioral Studies ◽  
3D Printed ◽  
Remote Evaluation

Objective We present examples of laboratory and remote studies, with a focus on studies appropriate for medical device design and evaluation. From this review and description of extant options for remote testing, we provide methods and tools to achieve research goals remotely. Background The FDA mandates human factors evaluation of medical devices. Studies show similarities and differences in results collected in laboratories compared to data collected remotely in non-laboratory settings. Remote studies show promise, though many of these are behavioral studies related to cognitive or experimental psychology. Remote usability studies are rare but increasing, as technologies allow for synchronous and asynchronous data collection. Method We reviewed methods of remote evaluation of medical devices, from testing labels and instruction to usability testing and simulated use. Each method was coded for the attributes (e.g., supported media) that need consideration in usability studies. Results We present examples of how published usability studies of medical devices could be moved to remote data collection. We also present novel systems for creating such tests, such as the use of 3D printed or virtual prototypes. Finally, we advise on targeted participant recruitment. Conclusion Remote testing will bring opportunities and challenges to the field of medical device testing. Current methods are adequate for most purposes, excepting the validation of Class III devices. Application The tools we provide enable the remote evaluation of medical devices. Evaluations have specific research goals, and our framework of attributes helps to select or combine tools for valid testing of medical devices.

scholarly journals Study for development of a patient-specific 3D printed craniofacial medical device: Design based on 3D virtual biomodels/ CAD/ RP

Procedia CIRP ◽  
2018 ◽  
Vol 70 ◽  
pp. 235-240 ◽  
Author(s):  
Cristian C. Ardila ◽  
Clara Isabel López ◽  
Javier Mauricio Martínez ◽  
Genny Liliana Meléndez ◽  
Diana Carolina Navarro ◽  
...  
Keyword(s):  
Medical Device ◽  
Patient Specific ◽  
Device Design ◽  
Medical Device Design ◽  
3D Printed

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.

scholarly journals Digital process chains for patient specific medical devices

2020 ◽  
Vol 6 (3) ◽  
pp. 357-359
Author(s):  
Michael Wehmöller ◽  
Michael Utz ◽  
Valentine Gesche
Keyword(s):  
Advisory Committee ◽  
Medical Device ◽  
Medical Devices ◽  
Medical Technology ◽  
Patient Specific ◽  
Medical Technology Advisory Committee ◽  
Development Framework ◽  
Process Chains

AbstractThe Medical Technology Advisory Committee of the VDI Society develops a guideline for the implementation of digital process chains for patient-specific medical devices. The underlying medical device constitutes the basis for each individualized medical device. It serves as the development framework for manufacturing.

scholarly journals The Characteristics of Innovative, Medical Devices

2010 ◽  
Vol 4 (2) ◽  
Author(s):  
Katja Holtta-Otto ◽  
Matthew Saunders ◽  
Carolyn Seepersad
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Design Methods ◽  
User Interactions ◽  
Additional Function ◽  
Medical Device Design ◽  
Award Winning ◽  
Environmental Interactions ◽  
Engineering Level ◽  
Current Engineering

It is not easy to design an innovative and successful product in any field of engineering. Medical device design is further complicated by strict regulations. Current engineering design methods provide help in designing a good product, but the designer lacks tools that help him or her create an innovative, commercially successful product. In this study, we analyzed 51 innovative, award-winning medical devices against their competition to identify what made those products stand out from the competition. The method was focused on finding engineering-level characteristics that made the products successful and whether the characteristics of success in the medical device industry are similar to those of other industries. We used a set of innovation categories that have been shown to apply to mechanical engineering products. The results show that the most innovative medical devices were innovative in at least three categories. Overall, a majority (greater than 60%) of the award-winning medical devices exhibited enhanced user interactions, with a similar percentage displaying enhanced environmental interactions and architectural changes, compared with only 20% of devices offering an additional function. We conclude that designers of innovative medical devices need better design methods that extend beyond the functionality of the products.

scholarly journals The Role of Soft Robotic Micromachines in the Future of Medical Devices and Personalized Medicine

Micromachines ◽  
2021 ◽  
Vol 13 (1) ◽  
pp. 28
Author(s):  
Lourdes Garcia ◽  
Genevieve Kerns ◽  
Kaitlin O’Reilley ◽  
Omolola Okesanjo ◽  
Jacob Lozano ◽  
...  
Keyword(s):  
Medical Device ◽  
Spatial Scales ◽  
Surgical Techniques ◽  
Patient Specific ◽  
Device Design ◽  
Healthcare Applications ◽  
Medical Device Design ◽  
Material Chemistry ◽  
Minimally Invasive Surgical ◽  
The Future

Developments in medical device design result in advances in wearable technologies, minimally invasive surgical techniques, and patient-specific approaches to medicine. In this review, we analyze the trajectory of biomedical and engineering approaches to soft robotics for healthcare applications. We review current literature across spatial scales and biocompatibility, focusing on engineering done at the biotic-abiotic interface. From traditional techniques for robot design to advances in tunable material chemistry, we look broadly at the field for opportunities to advance healthcare solutions in the future. We present an extracellular matrix-based robotic actuator and propose how biomaterials and proteins may influence the future of medical device design.

Physician-Developer Interaction in Medical Device Design

2010 ◽  
Author(s):  
Lauren A. Shluzas ◽  
Larry J. Leifer
Keyword(s):  
High Risk ◽  
Medical Device ◽  
Medical Devices ◽  
Early Stage ◽  
End Users ◽  
Device Design ◽  
Financial Outcomes ◽  
Medical Device Design ◽  
Medical Products

Industry-physician relationships have been widely reported throughout the medical device community. However, there is limited research that describes how device developers effectively interact with physicians throughout the development of new medical products. There is also limited research regarding how the process of physician-developer interaction influences the clinical and financial outcomes of early stage companies. Knowledge of such interaction is particularly relevant to the large and growing number of complex and high-risk medical devices, in which physicians are the primary end users and patients are the recipients of care.

Standardizing the patient-specific medical device design process via a paper-based pro-forma

2020 ◽  
Vol 6 (2) ◽  
pp. 233-258 ◽  
Author(s):  
Sean Peel ◽  
Dominic Eggbeer ◽  
Peter Dorrington
Keyword(s):  
Medical Device ◽  
Design Process ◽  
Quality Management System ◽  
Regulatory Compliance ◽  
Patient Specific ◽  
Device Design ◽  
Structured Interviews ◽  
Medical Device Design ◽  
Starting Point ◽  
Pro Forma

Purpose/audience: this study targets designers, clinicians and biomedical engineers who are involved in digital surgical planning and patient-specific medical device design, either in hospitals, universities or companies. A commonly accepted, standardized design process does not exist in this specialized but highly variable field, and this can make regulatory compliance via the implementation of quality standards more difficult. Methodology/approach: an article-based design pro-forma was created based on needs identified in previous work. It was structured in order to broadly standardize the design process; consolidate planning and modelling behaviours into discrete clusters; anticipate decision-making on key product requirements; facilitate focused discussion with clients (surgeons); create a pleasurable experience for the designer; and encourage detailed reporting of design decisions and therefore to lower barriers to Quality Management System (QMS) implementation and adherence. The performance of the pro-forma was verified using observation, simultaneous verbalization and semi-structured interviews. Three participants across two contexts were observed designing without and then with the pro-forma. Their behaviours and comments were recorded, their designed outcomes evaluated and their quality compliance assessed. Findings: The design workflow was shown to be segmented and contained within distinct and repeatable steps when using the pro-forma. Reported participant confidence increased and stress decreased. Contact time between participants and clients was consolidated. Designed outputs and documented records successfully complied with generalizable aspects of the International Organization for Standardization (ISO) 13485 standard. However, it did not, and by definition could never, wholly implement a complete certifiable QMS, which must be tailored to a specific organization. Implications for practice, society or research: as demand for patient-specific devices continues to rise, and as regulatory requirements about QMS adherence extend to cover all contexts, organizations will need to react accordingly. This pro-forma offers a clear direction for how to introduce evidence-based best practices, and a starting point for full QMS certification. Originality/value: this research marks the first attempt to standardize this highly specialized design process across users, tools and contexts.

scholarly journals Reducing medical device alarms by an order of magnitude: A human factors approach

2021 ◽  
Vol 49 (1) ◽  
pp. 52-61
Author(s):  
Erik Koomen ◽  
Craig S Webster ◽  
David Konrad ◽  
Johannes G van der Hoeven ◽  
Thomas Best ◽  
...  
Keyword(s):  
Human Factors ◽  
Medical Device ◽  
Medical Devices ◽  
Information Overload ◽  
Noise Pollution ◽  
Commercial Aviation ◽  
Alarm Fatigue ◽  
Medical Device Design ◽  
Information Displays ◽  
Order Of Magnitude

The intensive care unit (ICU) is one of the most technically advanced environments in healthcare, using a multitude of medical devices for drug administration, mechanical ventilation and patient monitoring. However, these technologies currently come with disadvantages, namely noise pollution, information overload and alarm fatigue—all caused by too many alarms. Individual medical devices currently generate alarms independently, without any coordination or prioritisation with other devices, leading to a cacophony where important alarms can be lost amongst trivial ones, occasionally with serious or even fatal consequences for patients. We have called this approach to the design of medical devices the single-device paradigm, and believe it is obsolete in modern hospitals where patients are typically connected to several devices simultaneously. Alarm rates of one alarm every four minutes for only the physiological monitors (as recorded in the ICUs of two hospitals contributing to this paper) degrades the quality of the patient’s healing environment and threatens patient safety by constantly distracting healthcare professionals. We outline a new approach to medical device design involving the application of human factors principles which have been successful in eliminating alarm fatigue in commercial aviation. Our approach comprises the networked-device paradigm, comprehensive alarms and humaniform information displays. Instead of each medical device alarming separately at the patient’s bedside, our proposed approach will integrate, prioritise and optimise alarms across all devices attached to each patient, display information more intuitively and hence increase alarm quality while reducing the number of alarms by an order of magnitude below current levels.

A Process for Design, Verification, Validation, and Manufacture of Medical Devices Using Immersive VR Environments

2010 ◽  
Vol 4 (4) ◽  
Author(s):  
Daniel F. Keefe ◽  
Fotis Sotiropoulos ◽  
Victoria Interrante ◽  
H. Birali Runesha ◽  
Dane Coffey ◽  
...  
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
System Level ◽  
Design Verification ◽  
Device Design ◽  
Product Cycles ◽  
Medical Device Design ◽  
Simulation Based ◽  
Device Engineering ◽  
The Impact

This paper presents a framework and detailed vision for using immersive virtual reality (VR) environments to improve the design, verification, validation, and manufacture of medical devices. Major advances in medical device design and manufacture currently require extensive and expensive product cycles that include animal and clinical trials. The current design process limits opportunities to thoroughly understand and refine current designs and to explore new high-risk, high-payoff designs. For the past 4 years, our interdisciplinary research group has been working toward developing strategies to dramatically increase the role of simulation in medical device engineering, including linking simulations with visualization and interactive design. Although this vision aligns nicely with the stated goals of the FDA and the increasingly important role that simulation plays in engineering, manufacturing, and science today, the interdisciplinary expertise needed to realize a simulation-based visual design environment for real-world medical device design problems makes implementing (and even generating a system-level design for) such a system extremely challenging. In this paper, we present our vision for a new process of simulation-based medical device engineering and the impact it can have within the field. We also present our experiences developing the initial components of a framework to realize this vision and applying them to improve the design of replacement mechanical heart valves. Relative to commercial software packages and other systems used in engineering research, the vision and framework described are unique in the combined emphasis on 3D user interfaces, ensemble visualization, and incorporating state-of-the-art custom computational fluid dynamics codes. We believe that this holistic conception of simulation-based engineering, including abilities to not just simulate with unprecedented accuracy but also to visualize and interact with simulation results, is critical to making simulation-based engineering practical as a tool for major innovation in medical devices. Beyond the medical device arena, the framework and strategies described may well generalize to simulation-based engineering processes in other domains that also involve simulating, visualizing, and interacting with data that describe spatially complex time-varying phenomena.

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