In the medical device industry, there are 3 ways to manage risk: avoidance, mitigation, and acceptance. Risk management does not occur on only the product design, but also on the product itself and its manufacturing process. Avoidance is the most favored method of risk management, but that is not always possible.
Of the product, product design, and manufacturing process, which project area is avoidance more easily incorporated and possible? Why?
Do you have experience with risk management application on one of the project areas? Explain.
Avoidance is more easily incorporated and possible in the product design phase of the product, product design, and manufacturing process. This is because the product design phase is in the earlier developmental stage of the product lifecycle. This means changes can be made during this phase quite easily and is cheaper than if the changes were to occur during any other phase. It is also easier to incorporate avoidance in this phase because of the flexibility and iterative nature of this phase.
I second to the fact that avoidance is easily incorporated in the product design phase due to multiple reasons, such as
1. During product design phase there are many changes to be made according to the practicality and feasibility of the product
2. It is often observed that after the initial draft of the design, the stakeholders, or the end users (clients) propose modifications, whether for cost-cutting considerations or additions to the product requirements.
3. Regulatory compliance and standards are often integrated into the product design phase, making it an opportune time to identify and mitigate risks associated with non-compliance.
Incorporating avoidance techniques in the product design phase is highly feasible and beneficial. This is mainly due to the fact that product design is the initial stage in the product development process, allowing for greater flexibility and cost-effectiveness in making changes compared to later stages like manufacturing. Designing a product requires the ability to envision and construct its structure, appearance, and purpose. This stage offers ample room for creative exploration, allowing for the consideration of various design options, potential challenges, and necessary adjustments without the pressure of financial or time limitations. A key aspect of product design entails an iterative process, where designs are continuously improved through feedback, testing, and validation. This approach facilitates early detection and resolution of any issues, reducing the risk of expensive mistakes or the need for significant revisions later on in the development process.
Of the three phases listed, avoidance is more effective and efficient in the product design phase. The main reason being is that product design decisions have the greatest significance on the overall outcome of the project. During the design phase, product ideas are developed into more refined concepts, therefore it's possible to address problems early on, which can prevent downstream complications in manufacturing and production. By identifying these issues early on, decisions can be made to mitigate or avoid them altogether. Another key aspect that the product design phase offers is a high degree of flexibility. As a result of its flexibility, designers are able to explore different design alternatives and solutions through given feedback. This, in turn, allows them to make adjustments to avoid potential pitfalls before finalizing the product specifications. Furthermore, addressing issues early on during the product design phase is generally more cost-effective than making changes later in the manufacturing process. Design modifications tend to be less expensive and disruptive compared to changes made during manufacturing, where tooling and production processes may need to be adjusted. Ultimately, while avoidance strategies can also be incorporated into the product and manufacturing processes, the product design phase offers the greatest opportunity to proactively address risks and avoid potential issues before they have a significant impact on the project.
