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.

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.

MEDICAL DEVICES EARLY ASSESSMENT METHODS: SYSTEMATIC LITERATURE REVIEW

2014 ◽  
Vol 30 (2) ◽  
pp. 137-146 ◽  
Author(s):  
Katarzyna Markiewicz ◽  
Janine A. van Til ◽  
Maarten J. IJzerman
Keyword(s):  
Literature Review ◽  
Medical Device ◽  
Systematic Literature Review ◽  
Medical Devices ◽  
Quantitative Methods ◽  
Assessment Methods ◽  
Theory And Practice ◽  
Early Assessment ◽  
Medical Device Development ◽  
Device Development

Objectives: The aim of this study was to get an overview of current theory and practice in early assessments of medical devices, and to identify aims and uses of early assessment methods used in practice.Methods: A systematic literature review was conducted in September 2013, using computerized databases (PubMed, Science Direct, and Scopus), and references list search. Selected articles were categorized based on their type, objective, and main target audience. The methods used in the application studies were extracted and mapped throughout the early stages of development and for their particular aims.Results: Of 1,961 articles identified, eighty-three studies passed the inclusion criteria, and thirty were included by searching reference lists. There were thirty-one theoretical papers, and eighty-two application papers included. Most studies investigated potential applications/possible improvement of medical devices, developed early assessment framework or included stakeholder perspective in early development stages. Among multiple qualitative and quantitative methods identified, only few were used more than once. The methods aim to inform strategic considerations (e.g., literature review), economic evaluation (e.g., cost-effectiveness analysis), and clinical effectiveness (e.g., clinical trials). Medical devices were often in the prototype product development stage, and the results were usually aimed at informing manufacturers.Conclusions: This study showed converging aims yet widely diverging methods for early assessment during medical device development. For early assessment to become an integral part of activities in the development of medical devices, methods need to be clarified and standardized, and the aims and value of assessment itself must be demonstrated to the main stakeholders for assuring effective and efficient medical device development.

scholarly journals Tailor-Made Design Guidelines for Human Factors and Usability for Medical Device Application: A Proposed Methodology

2019 ◽  
Vol 1 (1) ◽  
pp. 995-1004 ◽  
Author(s):  
Kamya Nagarajan ◽  
Arlindo Silva
Keyword(s):  
Human Factors ◽  
Medical Device ◽  
Medical Devices ◽  
Development Process ◽  
Design Guidelines ◽  
Device Application ◽  
Medical Device Development ◽  
Device Development ◽  
Tools And Techniques

AbstractWith increasing level of advancement and complexity in medical devices, there is a need for methodology, tools and techniques in practice to integrate Human Factors and Usability (HF/U) elements in design due to its increasing diversity of users and rapidly changing interface types. This paper proposes a methodology to develop a tailor-made HF/U design guidelines for medical device development with various sources and to develop heuristics for evaluation and score the product usability throughout the development process.

Enabling Reuse of Documentation in New Medical Device Development: A Systematic Architecting Approach

2015 ◽  
Author(s):  
Troels Victor Jensen ◽  
Jakob Filippson Parslov ◽  
Niels Henrik Mortensen
Keyword(s):  
Medical Device ◽  
Product Family ◽  
New Product ◽  
Time To Market ◽  
Product Families ◽  
Arterial Blood Gas ◽  
Medical Device Development ◽  
Device Development ◽  
Arterial Blood ◽  
Carry Over

Medical device companies are continuously challenged with the ability to prove compliance with increasingly complex regulatory frameworks. Operating under heavy regulatory requirements may therefore cause significant delays to the lead time of new medical devices and thus contribute significantly to time-to-market for even simple medical device development projects. In this paper we illustrate how medical device companies can reduce their research and development (R&D) efforts needed to prove compliance when developing new product families by means of platforming and modularization. The results presented in this paper are based on a two-year empirical case study of a European manufacturer of arterial blood gas (ABG) sampling devices. The core contribution of this paper is a systematic architecting approach that applies the concept of a delta-multi-domain matrix (ΔMDM) to support companies in justifying the reuse of verification and validation (V&V) test documentation packages across new product family designs. The paper introduces an approach to aligning product and documentation architectures by architecture mirroring, and emphasizes the need for having a one-to-one mapping between the product and V&V test view. This will allow for V&V-related documentation to follow the product platform, and thereby enable carry-over of test documentation packages from one product family to another. Hence, this approach can provide significant competitive advantages to companies as it increases R&D efficiency while reducing time-to-market for new medical device development.

Making Human Factors Affordable for Medical Device and Global Health Startups

2018 ◽  
Vol 7 (1) ◽  
pp. 140-147
Author(s):  
Elizabeth Johansen
Keyword(s):  
Global Health ◽  
Human Factors ◽  
Case Studies ◽  
Medical Device ◽  
Medical Devices ◽  
International Electrotechnical Commission ◽  
Medical Device Development ◽  
Device Development ◽  
Multiple Levels ◽  
The U.S

Including human factors during medical device development leads to better outcomes as recognized by the U.S. Food and Drug Administration (FDA) and the International Electrotechnical Commission (IEC). Startup companies have historically been a major source of medical device innovation. However, many startups are unaware of the field of human factors or do not know the value it can bring in creating safe and effective medical devices that are well-adopted in the market. In this paper, there are four ideas for including human factors during medical device development at startups: demonstrating the value of human factors to startups; collaborating on early funding proposals; delivering value on multiple levels simultaneously; and using resources creatively and judicially. These ideas are illustrated in 3 case studies.

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.

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