scholarly journals The Case for Qualifying More Than One Sterilization Modality

2020 ◽  
Vol 54 (s1) ◽  
pp. 15-21
Author(s):  
Vu Le ◽  
Andre Tuggles
Keyword(s):  
Product Development ◽  
Medical Device ◽  
Development Process ◽  
Development Stage ◽  
Product Development Process ◽  
Subject Matter Experts ◽  
Sustainable Business ◽  
Chain Flexibility ◽  
Supply Chain Flexibility ◽  
Medical Device Manufacturers

Abstract Due to its complexity, sterilization has been perceived by some professionals who lack sterility assurance expertise as a “black box” process. Historically, medical device manufacturers have selected one of the available industrial sterilization options: dry heat, moist heat, gamma, or ethylene oxide (EO). The preselection of a sterilization modality (method) typically is made without understanding its impact based on qualified sterilization processes for existing products, capability, or resources required for the specific processes. Early engagement with sterilization subject matter experts (SMEs) can redirect the decision to preselect a legacy modality and help foster innovation and operational agility. Recent focus on supply chain flexibility and sustainability by the medical device industry has been affected by concerns surrounding cobalt-60 shortages and EO emissions. These factors drive the need for early involvement with sterility assurance SMEs in the product development process and the exploration of multiple sterilization modalities. This article highlights the importance of exploring multiple sterilization modalities during the product development stage to support sustainable business continuity plans.

Is Collaboration Important at All Stages of the Biotechnology Product Development Process?

2017 ◽  
pp. 130-176
Author(s):  
Catherine Beaudry
Keyword(s):  
Clinical Trials ◽  
Product Development ◽  
Research And Development ◽  
Small Firms ◽  
Development Process ◽  
Development Stage ◽  
Product Development Process ◽  
Innovation Activities ◽  
Stage Of Development ◽  
Statistics Canada

Using the four Biotechnology Uses and Development surveys of Statistics Canada, the chapter examine the importance of collaborating with firms and public institutions at various stages of product development, from research and development to clinical trials and then on to production and commercialization. The models examine the propensity to have products at a particular stage of development using instrumental variables probit regressions. This chapter finds that while small firms do not benefit from collaborating with firms at the research and development stage, during the clinical trials and in the production phases, collaborating with firms has a strong positive effect. The factors that affect the R&D phase are R&D expenditures, an important IP strategy, revenues from contracts and to some extent contracting out some innovation activities. In later stages of the development process, the number of patents and the diversity of the biotechnology employment team play a more crucial role.

Is Collaboration Important at All Stages of the Biotechnology Product Development Process?

Biotechnology ◽  
2019 ◽  
pp. 1759-1794
Author(s):  
Catherine Beaudry
Keyword(s):  
Clinical Trials ◽  
Product Development ◽  
Research And Development ◽  
Small Firms ◽  
Development Process ◽  
Development Stage ◽  
Product Development Process ◽  
Innovation Activities ◽  
Stage Of Development ◽  
Statistics Canada

Using the four Biotechnology Uses and Development surveys of Statistics Canada, the chapter examine the importance of collaborating with firms and public institutions at various stages of product development, from research and development to clinical trials and then on to production and commercialization. The models examine the propensity to have products at a particular stage of development using instrumental variables probit regressions. This chapter finds that while small firms do not benefit from collaborating with firms at the research and development stage, during the clinical trials and in the production phases, collaborating with firms has a strong positive effect. The factors that affect the R&D phase are R&D expenditures, an important IP strategy, revenues from contracts and to some extent contracting out some innovation activities. In later stages of the development process, the number of patents and the diversity of the biotechnology employment team play a more crucial role.

Applying P-Diagram in Product Development Process: An Approach towards Design for Six Sigma

2015 ◽  
Vol 789-790 ◽  
pp. 1187-1191
Author(s):  
Olalere Folasayo Enoch ◽  
Ab. Aziz Shuaib ◽  
Abu Hassan bin Hasbullah
Keyword(s):  
Product Development ◽  
Six Sigma ◽  
Development Process ◽  
Development Stage ◽  
Product Development Process ◽  
Basic Unit ◽  
Operational Cost ◽  
Business World ◽  
Design For Six Sigma ◽  
Successful Business

Successful business enterprises are to a great extent determined by strong sales and overall low operational cost; as a result, improving quality and reducing cost have been one of the important tasks for any business enterprise. These will help in achieving high quality products at reasonable price. Thus, due to the effectiveness ofSix Sigmain improving quality and reducing cost, it has become an excellent initiative that is gaining momentum in the business world. However, academics have conducted little research regarding this phenomenon, especially on it applicability in manufacturing industries. Therefore, this paper seeks the knowledge regarding howP-Diagram Model(Taguchi Method) can be applied in product development stage to achieve Design for Six Sigma (DFSS). The paper illuminates on “Process” as the basic unit for Six Sigma and how production process can be enhanced usingP-diagram. Following this understanding, the paper demonstrates how P-diagram can be applied in conceptualizing and developing product ideas that put into consideration users intent (User-centred design), reduce variations and thus, lower the risk of product failing.

Experience Design Applied to Research

2019 ◽  
Vol 2 (1) ◽  
Author(s):  
Andrea CAPRA ◽  
Ana BERGER ◽  
Daniela SZABLUK ◽  
Manuela OLIVEIRA
Keyword(s):  
Information Technology ◽  
Product Development ◽  
Design Process ◽  
Development Process ◽  
Product Development Process ◽  
Experience Design ◽  
Low Resolution ◽  
Design Concepts ◽  
Innovative Products ◽  
Technological Products

An accurate understanding of users' needs is essential for the development of innovative products. This article presents an exploratory method of user centered research in the context of the design process of technological products, conceived from the demands of a large information technology company. The method is oriented - but not restricted - to the initial stages of the product development process, and uses low-resolution prototypes and simulations of interactions, allowing users to imagine themselves in a future context through fictitious environments and scenarios in the ambit of ideation. The method is effective in identifying the requirements of the experience related to the product’s usage and allows rapid iteration on existing assumptions and greater exploration of design concepts that emerge throughout the investigation.

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