[HTML][HTML] Osteochondral tissue engineering: perspectives for clinical application and preclinical development

C Ai, YHD Lee, XH Tan, SHS Tan, JHP Hui… - Journal of Orthopaedic …, 2021 - Elsevier
The treatment of osteochondral defects (OCD) remains challenging. Among currently
available surgical treatments for OCDs, scaffold-based treatments are promising to …

Gap analysis in manufacturing, innovation and marketing of medical devices in the Asia-Pacific region

B Sapkota, S Palaian, S Shrestha, A Ozaki… - Expert Review of …, 2022 - Taylor & Francis
Introduction Although similar in many aspects of manufacturing and regulatory provisions to
medicines, medical devices have their provisions and attract considerable investments in …

Medical device product innovation choices in Asia: an empirical analysis based on product space

F Hu, L Qiu, H Zhou - Frontiers in Public Health, 2022 - frontiersin.org
Due to the increasing demand for health care, identifying and evaluating the feasibility of
local medical device innovation and production is an important guarantee for the long-term …

Commercializing Covid-19 diagnostic technologies: a review of challenges, success factors, and insights from the profiting from innovation framework

J Soltanzadeh, N Sahebjamnia, EM Khosroshahi… - Technovation, 2024 - Elsevier
Evidence shows that only a few newly developed diagnostic technologies to control and
mitigate the recent health crisis-Covid-19 pandemic, have been successfully …

[HTML][HTML] Patient-Centric product development: a summary of select regulatory CMC and device considerations

M Algorri, NS Cauchon, T Christian, C O'Connell… - Journal of …, 2023 - Elsevier
Patient-centric drug development describes the systematic approach to incorporating the
patient's perspectives and preferences into the design, assessment, and production of a …

A review of lean methodology application and its integration in medical device new product introduction processes

O Slattery, A Trubetskaya, S Moore, O McDermott - Processes, 2022 - mdpi.com
The purpose of this study is to review the Lean tool application and its utilisation in medical
device design and the new product introduction process to establish the benefits and best …

In Vitro System for Evaluation of Biosensors in Controlled Dynamic Environmental Conditions

B Ko, AT Zavareh, MJ McShane - IEEE Transactions on …, 2023 - ieeexplore.ieee.org
Rapid in vitro evaluation of sensors and biosensors in conditions replicating in vivo
physiological environments is desirable for improved preclinical evaluation. A two-part …

Multi-dimensional readiness assessment of medical devices

RR Seva, ALS Tan, LMS Tejero… - Theoretical Issues in …, 2023 - Taylor & Francis
Medical device (MD) developers currently use the Technology Readiness Levels (TRLs) to
determine the status of technology. However, the broad definition of each level makes it …

Proposal of an FFE model with a high degree of innovation integrating TRIZ and design thinking methodologies, specific for the personal health equipment sector

J Uribe Ocampo, PC Kaminski - Cogent Engineering, 2023 - Taylor & Francis
The literature identifies incremental and radical innovation. In product design and
development with a High Degree of Innovation (HDI), different authors identify the difficulties …

[HTML][HTML] Critical elements in the design, development and use of medical devices. A systemic perspective of orthopedic devices landscape in low-and middle-income …

T Saidi, TS Douglas - Health Policy and Technology, 2022 - Elsevier
Objectives The paper reviews the critical elements in the design and development of
medical devices in general and orthopedic devices in particular as well as illustrates by …