scholarly journals A Practical Guide to Class IIa Medical Device Development

2020 ◽  
Vol 10 (10) ◽  
pp. 3638 ◽  
Author(s):  
Adél Hinsenkamp ◽  
Dorottya Kardos ◽  
Zsombor Lacza ◽  
István Hornyák
Keyword(s):  
Quality Management ◽  
Medical Device ◽  
Musculoskeletal Diseases ◽  
Laboratory Research ◽  
Platelet Rich Fibrin ◽  
Medical Device Development ◽  
Device Development ◽  
Blood Drawing ◽  
Development Procedure ◽  
One Step

There are many beneficial medical device ideas based on clinical needs and laboratory research, but medical device development is an expensive, time-consuming and complex challenge. Research and quality management, which are both needed to develop a medical device, are two distinct fields, initiated by a researcher or a clinician having a concept for a medical device, and it is often challenging to find and achieve the proper steps to create a licensed product. Thus, in this paper, we demonstrate the required mindset and main steps of the medical device development procedure through an existing example, a Class IIa medical device, called hypACT Inject Auto. HypACT is a specific syringe, which is capable of blood drawing and serum from platelet-rich fibrin (SPRF) isolation in one step in a closed system. SPRF is intended to be used to improve joint functions in the case of musculoskeletal diseases, specifically osteoarthritis.

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.

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