Planning Human Factors Engineering for Development of Implantable Medical Devices

2018 ◽  
Vol 7 (1) ◽  
pp. 156-160
Author(s):  
Maria Lund Jensen ◽  
Jayme Coates
Keyword(s):  
Human Factors ◽  
Medical Devices ◽  
User Interfaces ◽  
Implantable Devices ◽  
Human Factors Engineering ◽  
Implantable Medical Devices ◽  
Life Cycle Stages ◽  
User Groups ◽  
The Right ◽  
High Level

Development of implantable medical devices is becoming increasingly interesting for manufacturers, but identifying the right Human Factors Engineering (HFE) approach to ensure safe use and effectiveness is challenging. Most active implantable devices are highly complex; they are built on extremely advanced, compact technology, often comprise systems of several device elements and accessories, and they span various types of user interfaces which must facilitate diverse interaction performed by several different user groups throughout the lifetime of the device. Furthermore, since treatment with implantable devices is often vital and by definition involves surgical procedures, potential risks related to use error can be severe. A systematic mapping of Product System Elements and Life Cycle Stages can help early identification of Use Cases, and for example user groups and high-level use risks, to be accounted for via HFE throughout development to optimize Human Factors processes and patient outcomes. This paper presents a concrete matrix tool which can facilitate an early systematic approach to planning and frontloading of Human Factors Engineering activities in complex medical device development.

scholarly journals Wireless Technologies for Implantable Devices

Sensors ◽  
2020 ◽  
Vol 20 (16) ◽  
pp. 4604
Author(s):  
Bradley D. Nelson ◽  
Salil Sidharthan Karipott ◽  
Yvonne Wang ◽  
Keat Ghee Ong
Keyword(s):  
Data Collection ◽  
Medical Devices ◽  
Implantable Devices ◽  
Implantable Medical Devices ◽  
Medical Treatments ◽  
Good Opportunity ◽  
Wireless Technologies ◽  
Technical Challenges ◽  
The 1950S ◽  
And Control

Wireless technologies are incorporated in implantable devices since at least the 1950s. With remote data collection and control of implantable devices, these wireless technologies help researchers and clinicians to better understand diseases and to improve medical treatments. Today, wireless technologies are still more commonly used for research, with limited applications in a number of clinical implantable devices. Recent development and standardization of wireless technologies present a good opportunity for their wider use in other types of implantable devices, which will significantly improve the outcomes of many diseases or injuries. This review briefly describes some common wireless technologies and modern advancements, as well as their strengths and suitability for use in implantable medical devices. The applications of these wireless technologies in treatments of orthopedic and cardiovascular injuries and disorders are described. This review then concludes with a discussion on the technical challenges and potential solutions of implementing wireless technologies in implantable devices.

A Pre-Prototyping Framework to Explore Human-Centered Prototyping Strategies During Early Design

2020 ◽  
Author(s):  
Salman Ahmed ◽  
H. Onan Demirel
Keyword(s):  
Human Factors ◽  
Product Development Process ◽  
Extensive Literature ◽  
Human Factors Engineering ◽  
Design Strategies ◽  
Key Factors ◽  
Hands On ◽  
The Right

Abstract Current prototyping frameworks are often prompt-based and heavily rely on designers’ experience. The lack of systematic guidelines in prototyping activities causes unwanted variation in the quality of the prototype. Notably, there is limited, or no prototyping framework exists that enables human factors engineering (HFE) guidelines be part of the early product development process. In this paper, a pre-prototyping framework is proposed to render human-centered design strategies to guide designers before the hands-on prototyping activity starts. The methodology consists of extracting key factors related to prototyping and human factors engineering principles based on an extensive literature review. The key elements are then combined to form the prototyping categories, dimensions (theory), and tools (practice). The resulting prototyping framework can be used to develop prototyping strategies consist of theoretical guidelines and practical tools that are needed during the prototyping of human-centered products. The framework provides systematic guidance to designers in the early stages of the design process so that designers, in particular novices in ergonomics and human factors, can have a head start in building the prototypes in the right direction. Finally, a case study is presented to demonstrate a walk-through and efficacy of the proposed pre-prototyping framework.

Interaction of Environmental Conditions: Role in the Reliability of Active Implantable Devices

2007 ◽  
Author(s):  
Elizabeth S. Drexler ◽  
Andrew J. Slifka ◽  
Nicholas Barbosa ◽  
John W. Drexler
Keyword(s):  
Cochlear Implants ◽  
Medical Devices ◽  
Environmental Conditions ◽  
Implantable Devices ◽  
Major Influence ◽  
Implantable Medical Devices ◽  
The Third ◽  
Actual Operation ◽  
And Storage ◽  
Cardioverter Defibrillators

Environmental conditions can have major influence on the lifetimes and reliability of active implantable medical devices (e.g., neurostimulators, cochlear implants, internal cardioverter defibrillators). These environmental conditions can range from those encountered by the device in processing and production to transportation and storage to actual operation. Although one might argue that the environmental conditions found in the first two situations are harsher than those of the third, failures that result from those situations are screened before implantation. If we assume that the active medical device is in perfect operational form at the time it is implanted, it will still experience a host of environmental conditions that can affect reliability. In fact, the ultimate goal of these medical devices is to restore the patient, wherever they may reside, to normal activities. A list of some environmental conditions that may be experienced by a device implanted in a representative patient is found in Table 1.

Ergonomics Implementation, the Right Way and the Wrong Way

2005 ◽  
Vol 49 (8) ◽  
pp. 837-840
Author(s):  
Boris Povlotsky
Keyword(s):  
Human Factors ◽  
Product Design ◽  
End Users ◽  
Human Factors Engineering ◽  
Implementation Challenges ◽  
The Right ◽  
Office Environments

This paper illustrates some of author's views of the ergonomics implementation challenges within diverse industries, manufacturing, office environments, and machinery/product design. We intend to analyze and review the roots of problems from different perspectives and recommend which ergonomics approaches are likely to succeed or fail. Most importantly it is imperative to find the actual cause(s) of obstacle(s) - problem(s) before looking for appropriate ergonomics solution(s) and acceptance of ergonomics innovations by end users. The presented material is based on the substantial authors' experiences in human factors engineering and ergonomics, in industry and academia and in various countries. Our objective is to present an integrated view of ergonomics within corporate bureaucracy in the contexts of favorable and unfavorable environments - factors that lead to success or failure.

scholarly journals An Ultra-Low Power Implantable Medical Devices: An Engineering Perspective

2021 ◽  
Vol 23 (12) ◽  
pp. 46-59
Author(s):  
B. Sathyabhama ◽  
◽  
B. Siva Shankari ◽  
Keyword(s):  
Low Power ◽  
Medical Devices ◽  
Neurological Disorders ◽  
Heart Diseases ◽  
Implantable Devices ◽  
Implantable Medical Device ◽  
Implantable Medical Devices ◽  
Ultra Low Power ◽  
Device Integration ◽  
History Of

Implantable Medical Devices (IMDs) reside within human bodies either temporarily or permanently, for diagnostic, monitoring, or therapeutic purposes. IMDs have a history of outstanding success in the treatment of many diseases, including heart diseases, neurological disorders, and deafness etc.,With the ever-increasing clinical need for implantable devices comes along with the continuous flow of technical challenges. Comparing with the commercial portable products, implantable devices share the same need to reduce size, weight and power. Thus, the need for device integration becomes very much imperative. There are many challenges faced when creating an implantable medical device. While this paper focuses on various techniques adapted to design a reliable device and also focus on the key electronic features of designing an ultra-low power implantable medical circuits for devices and systems.

scholarly journals Medical Device Human Factors Standards: Finding Them and What They Contain

2019 ◽  
Vol 63 (1) ◽  
pp. 592-596
Author(s):  
Molly Follette Story
Keyword(s):  
Human Factors ◽  
Medical Device ◽  
Medical Devices ◽  
Task Force ◽  
Technical Information ◽  
Engineering Practice ◽  
Human Factors Engineering ◽  
Development Organizations ◽  
Working Groups ◽  
Technical Specifications

An HFES Task Force is considering if, when, which, and how HFES research publications should require the citation of relevant standards, policies, and practices. To support Task Force activities, papers are being written about how to find relevant standards produced by various development organizations (such as ISO, IEC and AAMI) and the content of those standards. This paper describes ISO’s, IEC’s, and AAMI’s standards programs and their technical committees and working groups that produce standards, recommended practices, technical specifications, technical information reports, guides and other publications for medical devices. This paper focuses on those medical device publications that are relevant to human factors engineering practice and explains where and how to find them.

Implantable Medical Devices and Tissue Engineering: An Overview of Manufacturing Processes and the Use of Polymeric Matrices for Manufacturing and Coating their Surfaces

2020 ◽  
Vol 27 (10) ◽  
pp. 1580-1599 ◽  
Author(s):  
Gabriel Victor Simões Dutra ◽  
Weslany Silvério Neto ◽  
João Paulo Simões Dutra ◽  
Fabricio Machado
Keyword(s):  
Tissue Engineering ◽  
Medical Devices ◽  
New Technologies ◽  
Implantable Devices ◽  
Manufacturing Processes ◽  
New Materials ◽  
Implantable Medical Devices ◽  
Technological Advances ◽  
Wide Range ◽  
Modified Surface

Medical devices are important diagnosis and therapy tools for several diseases which include a wide range of products. Technological advances in this area have been proposed to reduce adverse complication incidences. New technologies and manufacturing processes, as well as the development of new materials or medical devices with modified surface and the use of biodegradable polymeric devices such as a substrate for cell culture in the field of tissue engineering, have attracted considerable attention in recent years by the scientific community intended to produce medical devices with superior properties and morphology. This review article focused on implantable devices, addresses the major advances in the biomedical field related to the devices manufacture processes such as 3D printing and hot melting extrusion, and the use of polymer matrices composed of copolymers, blends, nanocomposites or grafted with antiproliferative drugs for manufacturing and/or coating the devices surface.

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