scholarly journals Introduction of Medical Device Development through Industry–Academia Collaboration by the Hamamatsu Method

2020 ◽  
Vol 9 (0) ◽  
pp. 112-116
Author(s):  
Yuko Amano-Ito
Keyword(s):  
Medical Device ◽  
Medical Device Development ◽  
Device Development

Recent Statistical Contributions to Medical Device Development

2014 ◽  
Vol 48 (1) ◽  
pp. 90-97 ◽  
Author(s):  
Brian L. Wiens ◽  
Theodore C. Lystig ◽  
Scott M. Berry
Keyword(s):  
Medical Device ◽  
Medical Device Development ◽  
Device Development

scholarly journals The medical device development landscape in South Africa: Institutions, sectors and collaboration

2017 ◽  
Vol 113 (5/6) ◽  
Author(s):  
Kylie de Jager ◽  
Chipo Chimhundu ◽  
Trust Saidi ◽  
Tania S. Douglas ◽  
◽  
...  
Keyword(s):  
South Africa ◽  
Medical Device ◽  
Centrality Measures ◽  
Collaboration Network ◽  
Medical Device Development ◽  
Device Development ◽  
Healthcare Needs ◽  
Scientific Papers ◽  
Future Policy ◽  
Local Healthcare

A characterisation of the medical device development landscape in South Africa would be beneficial for future policy developments that encourage locally developed devices to address local healthcare needs. The landscape was explored through a bibliometric analysis (2000–2013) of relevant scientific papers using co-authorship as an indicator of collaboration. Collaborating institutions thus found were divided into four sectors: academia (A); healthcare (H); industry (I); and science and support (S). A collaboration network was drawn to show the links between the institutions and analysed using network analysis metrics. Centrality measures identified seven dominant local institutions from three sectors. Group densities were used to quantify the extent of collaboration: the A sector collaborated the most extensively both within and between sectors; local collaborations were more prevalent than international collaborations. Translational collaborations (AHI, HIS or AHIS) are considered to be pivotal in fostering medical device innovation that is both relevant and likely to be commercialised. Few such collaborations were found, suggesting room for increased collaboration of these types in South Africa.

Engineering Design Controls for Efficient Medical Device Development

2008 ◽  
Author(s):  
Lisa Henn
Keyword(s):  
Medical Device ◽  
Early Stage ◽  
Design Team ◽  
Medical Device Development ◽  
Device Development ◽  
Development Teams ◽  
Final Design ◽  
Design Proposal ◽  
Effective Design ◽  
University Setting

Early stage medical device development teams investigate many alternatives before selecting a final design proposal. The team must be able to retrace and reproduce successful designs and understand factors that underpin decisions that came before. This is especially important in a university setting due to the natural turnover on the team that is inherent in a successful research group. Effective design control provides this support to the design team.

Using Value Stream Mapping to Improve Medical Device Development

2013 ◽  
Vol 7 (2) ◽  
Author(s):  
Christopher Sweem ◽  
Stan Crossett ◽  
Lori Lucke
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Development Process ◽  
Value Stream Mapping ◽  
Medical Device Development ◽  
Value Stream ◽  
Device Development

In this paper a method is presented for using value stream mapping for improving the development process of medical devices. Two examples are shown to demonstrate the utility of this approach.

scholarly journals Spinal dura mater: biophysical characteristics relevant to medical device development

2018 ◽  
Vol 42 (2) ◽  
pp. 128-139 ◽  
Author(s):  
Sean J. Nagel ◽  
Chandan G. Reddy ◽  
Leonardo A. Frizon ◽  
Matthieu K. Chardon ◽  
Marshall Holland ◽  
...  
Keyword(s):  
Medical Device ◽  
Dura Mater ◽  
Medical Device Development ◽  
Device Development

scholarly journals Complexity Stage Model of the Medical Device Development Based on Economic Evaluation—MedDee

2020 ◽  
Vol 12 (5) ◽  
pp. 1755 ◽  
Author(s):  
Petra Marešová ◽  
Lukáš Peter ◽  
Jan Honegr ◽  
Lukáš Režný ◽  
Marek Penhaker ◽  
...  
Keyword(s):  
Economic Evaluation ◽  
Medical Device ◽  
Stage Model ◽  
Concept Design ◽  
Development Stages ◽  
Medical Device Development ◽  
Device Development ◽  
Economic Methods ◽  
Financial Expenditure ◽  
Investment Process

The development of a new product is essential for the progress and success of any company. The medical device market is very specific, which is challenging. Therefore, this paper assesses an economic model for medical device evaluation using the economic, health, technology regulatory, and present market knowledge to enable the cost–time conception for any applicant. The purpose of this study is to propose a comprehensive stage model of the medical device development to subsequently describe the financial expenditure of the entire development process. The identification of critical steps was based on the literature review, and analysis, and a comparison of the available medical device development stages and directives. Furthermore, a preliminary assessment of the medical device development steps and procedures on the basis of the interviews was performed. Six interviews were conducted with an average duration of one hour, focusing on areas: relevance and level of detail of the medical device development stages, involvement of economic methods, and applicability of the proposed model. Subsequently, the improvement and modification of the medical device investment process, based on respondents’ responses, were conducted. The authors have proposed the complexity model MedDee—Medical Devices Development by Economic Evaluation. This model is comprised of six phases: initiation, concept, design, production, final verification, and market disposition in which the economic methods are incorporated.

scholarly journals Harnessing Experience for Efficient Medical Device Product Development

2009 ◽  
Vol 3 (2) ◽  
Author(s):  
L. Lucke ◽  
D. Anderson ◽  
D. Smith
Keyword(s):  
Product Development ◽  
Medical Device ◽  
Clinical Application ◽  
Medical Devices ◽  
New Technology ◽  
Project Planning ◽  
Time To Market ◽  
Medical Device Development ◽  
Device Development ◽  
Development Times

Transitioning new research ideas into commercial products is difficult. For medical device design, the task is especially complicated because the commercialization of research ideas requires interdisciplinary teams that understand the nature of the clinical application as well as the abilities of the technology. Device development is complicated by the need to work within a regulated environment which requires well defined processes and significant testing to demonstrate the safety and efficacy of the device. An experienced development team, well versed in the design and manufacturing of medical devices, can greatly enhance the success of a commercialization program. A study of actual programs shows how experience can reduce development times. There are several factors that affect the success of new medical device development including the use of effective development tools and the innovativeness of the product concept. Successful product development may use a number of tools to assist with planning and control of the project. However it is difficult to measure the effect of experience on the success of new product development. In this work, several medical device development programs were studied to determine the role experience plays in improving the time to market for medical devices. Time to market is measured along several dimensions including complexity, technological invention, and uniqueness of clinical application. All designs were completed by the same company. As time progressed, the time to market improved even for complex designs with new technology. Over a ten year period of time, ten significant medical device development projects were executed. All required development of complex electromechanical systems with moderate to high complexity, and more than half developed products for new clinical applications or utilized new technology. After the development group had acquired at least five years of development experience, it was clear that the development times were improving by almost 50% over the predicted development times. Among the factors that contribute to this effect are the development of experts, the creation of design frameworks, and the optimization of processes which improve product development times while reducing project and regulatory risk. Experts with specific experience in systems engineering, program management, electromagnetic compatibility, manufacturability, and usability along with expertise in electronics, mechanical and software design can significantly reduce design times. Technology platforms central to medical devices such as blood and fluid pumps, sensor interfaces, real-time control systems, batteries and power systems are necessary for rapid development. Processes including project planning and tracking, requirements management, configuration management, risk analysis, and manufacturing design transfer are essential for streamlining development as well as ensuring support for regulatory submissions and audits. It has been challenging to demonstrate this effect, which has been anecdotally known for some time, in a quantitative manner. Doing so required studying an organization with not only significant experience over time, but breadth of experience in terms of program risk and complexity. The results of this study quantify the significant benefit of organizational experience in reducing time to market.

scholarly journals Pediatric medical device development by surgeons via capstone engineering design programs

2018 ◽  
Vol 53 (3) ◽  
pp. 493-498 ◽  
Author(s):  
Bryan S. Sack ◽  
Rodolfo A. Elizondo ◽  
Gene O. Huang ◽  
Nicolette Janzen ◽  
Jimmy Espinoza ◽  
...  
Keyword(s):  
Engineering Design ◽  
Medical Device ◽  
Medical Device Development ◽  
Device Development
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