Empower Organizational Capability

The process of product commercialization, also known as the product life cycle management process, defines the stages a product goes through from market opportunity or concept to market research, business analysis, feasibility study, design and development, verification and validation, design transfer, clinical trials, regulatory registration, and after product launch, it will then experience phases of introduction, growth, maturity, and decline. Throughout this process, the participants, activities, and deliveries of each stage are defined to ensure the smooth launch and commercial success of the product. For medical device products, due to strict national regulations, manufacturers are required to complete design and production tasks according to the ISO 13485 quality system and strictly follow the design change process. Therefore, any subsequent changes have a significant impact on the project. Early identification of critical activities, deliveries, and risks during the product commercialization and design phases can minimize the cost of unnecessary design changes later in the project, helping companies save time and costs. In addition, by identifying critical paths and resources through preliminary project planning, start-up companies can plan ahead and accelerate the launch of new products.

What we can do for you?

 Introduce typical commercialization models of medical devices to give you a basic understanding of product commercialization.

Based on your product and system characteristics and the current stage of product commercialization, we will conduct preliminary project planning and identify some key activities, deliveries, and potential risks to help you obtain critical information and be prepared in the early stages of the project.

Provide you with relevant consultation and training in areas such as project management, quality systems, regulatory registration, clinical trials, human factors engineering/usability, network security, and risk analysis based on your current needs or areas of interest.

During the model introduction, we will introduce basic knowledge and processes such as the V&V model, production validation preparation process, medical software and equipment commercialization comparison, and quality management practices.

 Identify critical paths through preliminary planning and provide you with optimization recommendations and potential risk mitigation measures.

All of the above services will be provided free of charge, and we hope to establish a long-term relationship of trust and cooperation with you. Please feel free to contact us if you have any questions, as we are happy to share our knowledge and experience.

In the process of commercializing a product, a startup's high-level project management ability is the guarantee of the product's success in reaching the market and achieving commercial success. Generally speaking, there is a difference between "large projects" and "small projects" in the process of product commercialization. "Large projects" refer to the entire product life cycle from concept to market launch and eventual discontinuation. "Small projects" refer to product development projects within the R&D department. The "large project manager" or "project manager" and the "small project manager" or "technical manager", together with the "product manager", are known as the "three drivers" of product commercialization, and all three are indispensable. In addition to basic project management skills, both "large and small" project managers need to have a background in the medical industry and basic knowledge in various fields in order to better plan, execute, and monitor projects.

What we can do for you?

We can provide project management training courses that cover the ten knowledge areas and five process groups of project management, which will quickly improve your company's project management skills.

We offer project risk management training, conducting risk assessment and analysis at various stages of product commercialization and providing feasible mitigation measures and action plans. Our consultants can also directly participate in the risk analysis of a project and deliver a project risk register.

We can provide guidance in project planning, and our consultants can also serve as project managers to directly participate in a project and complete project planning, including work breakdown structure and workload estimation, Gantt chart, and identification of project critical path and risks.

Through the above services, we can help you quickly improve your company's project management skills, whether it is in product commercialization management or internal product development management. You will be able to quickly gain advanced management experience from multinational 

During the process of product commercialization, start-up companies often face challenges such as frequent staff turnover and a shortage of human resources. It is crucial to establish an adaptive and efficient project team organizational structure that aligns with the company's development. Additionally, effective communication becomes highly important as the project team grows in size and involves members from different teams within the commercialization process. It serves as a vital guarantee for the smooth progress of the project.

What we can do for you?

Help start-up companies establish appropriate project organizational structures and provide effective communication management training to improve interdepartmental communication efficiency.

Assist the research and development departments of start-up companies in establishing suitable organizational structures and introduce the PCMM (People Capability Maturity Model) assessment tool to enhance human resources management proficiency.

Through the above services, we can help you establish an efficient project team organizational structure and enhance communication efficiency within departments or across departments. Additionally, by introducing the PCMM assessment tool, department managers can comprehensively assess team capabilities and implement effective talent management strategies to address challenges related to employee turnover and shortages.