scholarly journals The role of the user within the medical device design and development process: medical device manufacturers' perspectives

2011 ◽  
Vol 11 (1) ◽  
Author(s):  
Arthur G Money ◽  
Julie Barnett ◽  
Jasna Kuljis ◽  
Michael P Craven ◽  
Jennifer L Martin ◽  
...  
Keyword(s):  
Medical Device ◽  
Development Process ◽  
Device Design ◽  
Design And Development ◽  
Medical Device Design ◽  
Medical Device Manufacturers

scholarly journals Exploring the role of Design in the context of Medical Device Innovation

2019 ◽  
Vol 2 (1) ◽  
Author(s):  
Keum Hee Kimmi KO ◽  
Jessica Lea DUNN ◽  
David LAHOUD ◽  
Erez NUSEM ◽  
Karla STRAKER ◽  
...  
Keyword(s):  
Medical Device ◽  
Development Process ◽  
Product Development Process ◽  
Health Issues ◽  
Device Design ◽  
Medical Problems ◽  
Medical Device Design ◽  
Commercial Viability ◽  
Design Innovation

Technology is the leading driving force in healthcare and medical device design, however, innovations which emerge from these practices are often driven by clinical requirements. Such innovations are focused on developing products that addresses current health issues, diseases or medical problems – often lacking consideration of the end users’ needs. Design innovation advocates that user-centred design happens much earlier in the product development process so that the patient needs are prioritised. However, this emerging field is yet to be defined and explored in a medical context. This paper therefore proposes a framework of Medical Device Design Innovation to explore the role of design in medical device innovation through two medical device case studies. The proposed framework suggests a way to navigate the nuances and complexities of the medical device industry in order to put the patient first while ensuring commercial viability.

Integrated Fuzzy-Based Modular Architecture for Medical Device Design and Development

2010 ◽  
Vol 4 (3) ◽  
Author(s):  
Celestine C. Aguwa ◽  
Leslie Monplaisir ◽  
Prasanth Achuthamenon Sylajakumari ◽  
Ram Kumar Muni
Keyword(s):  
Medical Device ◽  
Programming Model ◽  
Optimal Number ◽  
Product Cycle ◽  
Device Design ◽  
Modular Architecture ◽  
Design And Development ◽  
Medical Device Design ◽  
Goal Programming Model ◽  
Medical Device Manufacturers

In this paper, we present an integrated collaborative modular architecture method for medical device design and development. The methodology is focused on analyzing the input of stakeholder data from existing products and components to achieve an optimal number of modules. The methodology starts by defining a product’s functional and physical decompositions. Product parameters are selected such as quality, reliability, ease of development, and cost. These are prioritized using analytical hierarchy process (AHP) to determine the medical device manufacturers’ focus area. The parameters’ subsequent metrics are selected for performance requirements. Next, we evaluate the candidate modules by acquiring stakeholder data and converting them to crisp values by applying the Sugeno fuzzy-based method. Finally, we determine the subsequent optimal module values using a multi-optimization goal programming model. We present here a proof of concept using a typical glucometer. The implication of this work is the determination of the optimal number of product modules based on stakeholder constraints. Hence, an original equipment manufacturer (OEM) can work on fewer components per module without adversely affecting the integrity, quality, and reliability of the final product. Next is the improved quality of patient care by enabling cost reductions in product design and development, thereby improving patient safety. This methodology helps reduce product cycle time, thereby improving market competitiveness among other factors.

scholarly journals A Limb Hypothermia Wearable for Chemotherapy-Induced Peripheral Neuropathy: A Mixed-Methods Approach in Medical Product Development

2020 ◽  
Vol 2 ◽  
Author(s):  
Jonathan Binder ◽  
Ertu Unver ◽  
Jane Clayton ◽  
Patrick Burke ◽  
Richard Paxman ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Peripheral Neuropathy ◽  
Medical Device ◽  
Development Process ◽  
Central Component ◽  
Evidence Based ◽  
Device Design ◽  
Mixed Methods Approach ◽  
Medical Device Design ◽  
Hands And Feet

Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a common dose-limiting side-effect of taxane-based chemotherapy, causing progressive and often irreversible pain/sensitivity in the hands and feet. Prevention/treatments for CIPN are not well-developed and urgently needed. Limb cryocompression during chemotherapy has demonstrated promising early data of preventing/reducing CIPN severity. Currently there are no medical devices available that are dedicated to the specific requirements of CIPN prevention. As part of our ongoing development of a dedicated CIPN-prevention limb cryocompression system, this study documents the design & development of the wearable arm wrap, a central component of the system, from initial concept to a trial-ready prototype. A collaborative and multidisciplinary approach was adopted to address the complex and high-risk nature of this SME (Small Medium Enterprise)-centered medical device design & development process. The complementary collaboration unites multidisciplinary expertise spanning the scope of the project. Alongside the clinical, academic, and design & development expertise, the integration of commercial expertise is imperative to promote the market viability, and ultimate success, of the development. As the global leading experts in scalp cooling specializing in the prevention of chemotherapy-induced alopecia, UK-based SME Paxman Coolers Ltd is optimally positioned to support the commercial and regulatory dimensions. Development and adoption of a novel mixed-methodology (HudPAX) facilitated the integration of evidence-based and user-centered techniques to optimize the design & development approach and ensure integration of all critical design inputs. Alpha prototypes were designed through evidence-based approaches, with data from existing clinical trials utilized to determine the preliminary design inputs, alongside 3D ergonomic data. Investigations utilized computer-aided design, rapid prototyping, additive manufacturing, sketch modeling, and fast ideation. User-based approaches facilitated stakeholder-feedback through expert focus groups, informing further design & development and projecting the design into the next stage, Beta prototyping, for use in large-scale efficacy trials and upscaling manufacturing. This paper demonstrates a novel mixed-methods approach, which promotes cross-sector multidisciplinary collaboration, to address the complex multi-layered challenges posed by an early-stage medical device design & development process.

scholarly journals Effect of Rating Modification on a Fuzzy-Based Modular Architecture for Medical Device Design and Development

2012 ◽  
Vol 2012 ◽  
pp. 1-14 ◽  
Author(s):  
Celestine C. Aguwa ◽  
Leslie Monplaisir ◽  
Prasanth A. Sylajakumari
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Optimal Number ◽  
Device Design ◽  
Modular Architecture ◽  
Design And Development ◽  
Medical Device Design ◽  
Potential Failure ◽  
International Testing ◽  
The Impact

The goal of this research is to determine the effect of customer ratings on the optimal number of modules for medical device design. Medical devices have a 90% failure rate in their first prototype tests according to the international testing body, Intertek. To address this key issue of quality, we present an integrated, collaborative, modular architecture method for medical device design and development. A typical glucometer is used as proof of concept to demonstrate the methodology and analyze the impact of changing the customer ratings on the optimal number of modules and minimum deviation. The implication of this research is to generate scholarly work and to reduce the number of potential failure points in medical devices by determining the optimal number of modules.

Sign in / Sign up

Export Citation Format

Share Document