Constraints of Service Development within the Medical Device Industry: A Preliminary Study

2012 ◽  
Vol 433-440 ◽  
pp. 733-739
Author(s):  
Linda Ryan ◽  
David Tormey ◽  
Perry Share

Cost, quality and technology leadership are no longer sufficient for businesses to secure critical advantage. Instead, differentiations are being provided through the supply of innovative services, which can rapidly develop into a firm’s unique selling proposition. However, although services can provide additional competitive advantage, the inherent differences between product and service can cause difficulty in the effective integration of the two processes. Services are dominated by intangible elements which can be difficult to perceive and quantify. Within the medical device industry, the growing focus on usability, patient safety and increasing regulatory requirements has further complicated the already complex development process. In order to meet regulations, development is undertaken within strict boundaries to produce tightly controlled outputs. It can be seen that there is an incongruity between the nature of medical device development and the service development processes. This paper explores the constraints and inhibitors of service creation within the context of the medical device industry. Service innovation and its application is discussed. Difficulties in the addition of a service element and their potential solution within a medical device context are explored.

2009 ◽  
Vol 3 (2) ◽  
Author(s):  
Jan B. Pietzsch ◽  
Lauren A. Shluzas ◽  
M. Elisabeth Paté-Cornell ◽  
Paul G. Yock ◽  
John H. Linehan

The medical device development process has become increasingly complex in recent years. The advent of new technology concepts, stricter regulatory requirements, and the ever increasing importance of reimbursement decisions for successful device commercialization require careful planning and strategy-setting, coordinated decisions, and consistent, rigorous business processes. The design and implementation of such processes, often captured in development models and accompanying standard operating procedures, have become a key determinant of the success of device commercialization. While various models may exist in the device industry, no comprehensive development model has been published. This paper reviews existing model representations and presents a new comprehensive development model that captures all aspects of device development and commercialization from early-concept selection to postmarket surveillance. This model was constructed based on best-practice analysis and in-depth interviews with more than 80 seasoned experts actively involved in the development, commercialization, and regulation of medical devices. The stage-gate process includes the following five phases: (1) initiation - opportunity and risk analysis, (2) formulation - concept and feasibility, (3) design and development - verification and validation, (4) final validation - product launch preparation, and (5) product launch and postlaunch assessment. The study results suggest that stage-gate processes are the predominant development model used in the medical device industry and that regulatory requirements such as the food and drug adminstration (FDA’s) Quality Systems Regulation play a substantive role in shaping activities and decisions in the process. The results also underline the significant differences between medical device innovation and drug discovery and development, and underscore current challenges associated with the successful development of the increasing number of combination products.


Author(s):  
YASH LALWANI ◽  
VASANTI SUVARNA

Medical devices assume a significant job in providing various healthcare services. The purpose of this article is tantamount to bring about the highlight key insights of the medical device industry and current innovative developments taking place, unique insights, and expectations for coming years from medical device industry professionals around the world. Global markets expect from the sturdiest growth, biggest regulatory challenges. The rising occurrence of acute diseases, regulatory requirements, and consistency in innovation is central point driving the medical device business sector development, later it is significant for the medical device industry to regularize and enhance the method to take into account the requirements of patients.


1997 ◽  
Vol 11 (2) ◽  
pp. 116-119 ◽  
Author(s):  
Patrick J. Prendergast

The author assesses the results of the Bioengineering Design Forum – a collaboration between university researchers, clinicians and industry in Ireland. The aim of the Forum is to initiate, develop and bring to a successful conclusion R&D collaborations that lead to new or improved medical devices. By laying down certain operating procedures for the Forum, an effective ‘meeting ground’ has been developed which serves the objectives of both university engineering departments and the medical device industry in a unique way. The purpose of this paper is to relate our experiences of the Forum; they may be useful to others who would like to attempt similar initiatives in other fields. The author also describes the results that may be expected from this kind of university–industry collaboration in practice.


Sign in / Sign up

Export Citation Format

Share Document