General Risks of CRM&N Product Development Process: A Case Study of a Medical Device Manufacturing Company

Research Article
Open access

General Risks of CRM&N Product Development Process: A Case Study of a Medical Device Manufacturing Company

Zechu Ren 1 , Shiyang Su 2* , Wanqi Yang 3
  • 1 University of British Columbia, Canada    
  • 2 St. Cloud State University, United States    
  • 3 South China Agricultural University, China    
  • *corresponding author shiyang.su@go.stcloudstate.edu
Published on 13 September 2023 | https://doi.org/10.54254/2754-1169/20/20230191
AEMPS Vol.20
ISSN (Print): 2754-1177
ISSN (Online): 2754-1169
ISBN (Print): 978-1-915371-83-6
ISBN (Online): 978-1-915371-84-3

Abstract

Nowadays, every new product development process is bound to have certain risks. This study will analyze the identification and control risks in the Cardiac Rhythm Management & Neuromodulation (CRM&N) product development process of a medical device manu-facturing company in the United States and summarize and analyze the common risks dur-ing New Product Development Process (PDP). CRM&N system of medical industry prod-uct and service institutions, namely the CRM&N system used by medical devices, medical equipment, medical consumables, biotechnology and other medical products/services en-terprises. The medical industry is facing many problems in transportation and terminal sales. This study adopts the case analysis method, through the analysis of a new product development case of a company, the research results of this study are obtained: (1) Risk should be controlled at every step of a new product from the preparation before production to the end of production. Therefore, the company needs to establish a complete risk man-agement system to reduce the existence of some risks as far as possible. (2) Large sample size and heavy testing workload in the process of new product development led to in-creased costs. Therefore, companies need to use new statistical methods to analyze large sample data and reduce development costs. This study makes an in-depth analysis of the risks that may occur in the process of the company's new product development and draws some useful conclusions and strategies.

Keywords:

cardiac rhythm management & neuromodulation (CRM&N), product development process (PDP), medical device manufacturing, risk analysis

Ren,Z.;Su,S.;Yang,W. (2023). General Risks of CRM&N Product Development Process: A Case Study of a Medical Device Manufacturing Company. Advances in Economics, Management and Political Sciences,20,176-184.
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References

[1]. de Vasconcelos Gomes, L. A,. et al.: Design principles of hybrid approaches in new product development: a systematic literature review. R&D Management 52(1), 79-92 (2022).

[2]. Cooper, R. G,. Sommer, A. F,.: Agile–Stage-Gate for Manufacturers: Changing the Way New Products Are Developed Integrating Agile project management methods into a Stage-Gate system offers both opportunities and challenges. Research-Technology Management 61(2), 17-26 (2018).

[3]. Weissenberger‐Eibl, M. A,. Teufel, B,.: Organizational politics in new product development project selection: a review of the current literature. European Journal of Innovation Management Vol. 14, 51-73 (2011).

[4]. Marodin, G,. et al.: Lean product development and lean manufacturing: Testing moderation effects. International Journal of Production Economics 203, 301-310 (2018).

[5]. Hartwig, S,. Mathews, S,.: Innovation Project Risk Analytics: A preliminary finding. Research-Technology Management 63(3), 19–23 (2020).

[6]. Björnsdóttir, S.H,. et al.: The importance of risk management: What is missing in ISO standards. Risk Analysis 42(4), 659–691 (2021).

[7]. Subramanian, V,. et al.: Approaches to implement safe by design in early product design through combining risk assessment and life cycle assessment. Chemosphere 311, 137080 (2023).

[8]. Ewing, R,. Cudney, E,.: Critical Success Factors Tied to Risk Mitigation Methodology in New Product Development. Missouri University of Science and Technology, Missouri (2020).

[9]. Huang, K,. Hong, Y,.: Risk Analysis and Control in new product development process. Machinery Manufacturing 2011(07),43-46 (2011).

[10]. Yao, C,.: Risk analysis and control of new product development. An economist 2004 (02), 249-250 (2004).

[11]. Zhang, J,.: Research on technical risk management of A Company's new product project development. Small and Medium Enterprise Management and Technology (China) 2016(02),12-14 (2016).

[12]. Maropoulos, P. G,. Ceglarek, D,.: Design verification and validation in product lifecycle. CIRP annals 59(2), 740-759 (2010).


Cite this article

Ren,Z.;Su,S.;Yang,W. (2023). General Risks of CRM&N Product Development Process: A Case Study of a Medical Device Manufacturing Company. Advances in Economics, Management and Political Sciences,20,176-184.

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About volume

Volume title: Proceedings of the 2023 International Conference on Management Research and Economic Development

ISBN:978-1-915371-83-6(Print) / 978-1-915371-84-3(Online)
Editor:Canh Thien Dang, Javier Cifuentes-Faura
Conference website: https://2023.icmred.org/
Conference date: 28 April 2023
Series: Advances in Economics, Management and Political Sciences
Volume number: Vol.20
ISSN:2754-1169(Print) / 2754-1177(Online)

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References

[1]. de Vasconcelos Gomes, L. A,. et al.: Design principles of hybrid approaches in new product development: a systematic literature review. R&D Management 52(1), 79-92 (2022).

[2]. Cooper, R. G,. Sommer, A. F,.: Agile–Stage-Gate for Manufacturers: Changing the Way New Products Are Developed Integrating Agile project management methods into a Stage-Gate system offers both opportunities and challenges. Research-Technology Management 61(2), 17-26 (2018).

[3]. Weissenberger‐Eibl, M. A,. Teufel, B,.: Organizational politics in new product development project selection: a review of the current literature. European Journal of Innovation Management Vol. 14, 51-73 (2011).

[4]. Marodin, G,. et al.: Lean product development and lean manufacturing: Testing moderation effects. International Journal of Production Economics 203, 301-310 (2018).

[5]. Hartwig, S,. Mathews, S,.: Innovation Project Risk Analytics: A preliminary finding. Research-Technology Management 63(3), 19–23 (2020).

[6]. Björnsdóttir, S.H,. et al.: The importance of risk management: What is missing in ISO standards. Risk Analysis 42(4), 659–691 (2021).

[7]. Subramanian, V,. et al.: Approaches to implement safe by design in early product design through combining risk assessment and life cycle assessment. Chemosphere 311, 137080 (2023).

[8]. Ewing, R,. Cudney, E,.: Critical Success Factors Tied to Risk Mitigation Methodology in New Product Development. Missouri University of Science and Technology, Missouri (2020).

[9]. Huang, K,. Hong, Y,.: Risk Analysis and Control in new product development process. Machinery Manufacturing 2011(07),43-46 (2011).

[10]. Yao, C,.: Risk analysis and control of new product development. An economist 2004 (02), 249-250 (2004).

[11]. Zhang, J,.: Research on technical risk management of A Company's new product project development. Small and Medium Enterprise Management and Technology (China) 2016(02),12-14 (2016).

[12]. Maropoulos, P. G,. Ceglarek, D,.: Design verification and validation in product lifecycle. CIRP annals 59(2), 740-759 (2010).