For readers who is interested in listening Podcast delivered in Mandarin, you may listend to the podcasat- Biomeder’s Life Journey-Science, Engineering and Life , EP116- Design Challenges in Mnufacturing?DFM vital for CDMOs. How to implement it efficiently .
Rarely do we write articles discussing engineering technologies about product development. Such kind of content is relatively rare on Internet.Expressing engineering technology precisely in a simple and understandable language requires in-depth knowledge and experience.However,it’s time to start write one. After all,I’ve never written articles in this kind of topics seriously over these years as an engineer. This article would serve as a good record.
Therefore, we don’t talk about biomedicine in this article. Come with us, let’s go toward product development together.
Well designed but not manufacturable
Is a Well-Designed Product Always Manufacturable? I remember during the COVID-19 pandemic, there was a global shortage of vaccines, and governments around the world were registering on the COVAX platform to purchase vaccines, but there were also frequent reports of delivery delays. In fact, during that period, there was a global shortage of vaccines. On one hand, there was a huge demand, and on the other hand, problems arose when factories ramped up their production, which is what we call scale-up manufacturing. Some issues that were not present during smaller-scale production gradually emerged.
I often explain those issues with the example-“making dumplings”.It is easy to handmade 30 dumplings, however,if 100 thousand dumplings were put in order, then you may need more resources, such as equipments, manpower to make it.Due to the large quantity, there may be some minor or major issues arising in managing those resources.Thus, you may think that just duplicate what we prepared while making 30 dumplings, and make multiple copies of it to “manufacture” 100 thousand dumplings.For sure, this might be doable. However, the cost would be high and it takes long time to complete it. A company seeking manufacturing partners as CDMOs may hesitate to collaborate with you, as there are other vendors more capable of mass production and reducing costs, while maintaining the same high manufacturing quality.The key element here is the capability of DFM(Design for Manufacturing) for manufactures.
What is DFM?
DFM, short for Design for Manufacturing, refers to the practice of designing products with the ultimate goal of efficient manufacturing. It is a crucial part of the product development process, occurring roughly one-third of the way through from mid-design to entering the engineering phase. The aim is to smoothly transition from design to manufacturing, ensuring that products can be produced smoothly and at the highest quality with minimal cost. Therefore, all manufacturing requirements and elements need to be considered during the design phase. In essence, DFM addresses the gap between design and manufacturing, ensuring successful product realization. Consequently, effective DFM can be key for manufacturers to secure CDMO contracts and achieve substantial profitability. Variants such as DFA, DFMA, DFX, and DFT are commonly seen in various industries, each representing a specific type of DFM practice.
Manufacturing requirements and elements
What we refer to as “manufacturing requirements and elements” encompasses a broad perspective across the entire product development process. After designing a product, there are numerous steps before it hits the market or is sold. CDMO firms, apart from not needing to sell directly to consumers, handle nearly all other aspects, including manufacturing and, notably in the pharmaceutical industry, adhering to regulations to obtain product licenses. Indeed, DFM can scale to encompass such considerations. From an engineering standpoint, typical DFM planning involves mold development, component manufacturing, product assembly, packaging, testing, and scaling up production. Thus, during the design to engineering phases of product development, these issues must be carefully considered in advance.
Taking plastic parts as an example, when designing plastic components for injection molding, one must consider mold development to ensure the feasibility of manufacturing through injection molding. This process can be divided into two stages: the first stage focuses on the design of the part itself, while the second stage incorporates details of mold development. It’s essential to understand that regardless of what product you design, it must be manufacturable to be profitable.
I’ve encountered instances where engineers unfamiliar with injection molding processes fail to consider mold development challenges when drawing CAD diagrams. Consequently, when the product enters engineering phases, numerous issues arise such as part breakage, flow inconsistencies due to thickness variations, or inadequate structural integrity due to improper joint designs in critical areas. These are all fundamental engineering knowledge that should be known during mechanical design.
However, not every research and development team or organizational structure comprehensively understands these engineering principles, nor does every team member possess this expertise. Early in my engineering career, I remember having to visit injection molding factories to observe mold trials firsthand, learning how specific designs and mold combinations minimize issues during molding. Additionally, I had to conduct manual tests on finished products.
Conversely, I’ve encountered organizations where from engineers to managers, no one has visited the factory floor to understand mold trials or lacks this crucial knowledge. Despite this, they proceed with operations, only to encounter a plethora of issues during the engineering phase, all passed down to engineers to solve one by one, consuming time and resources. This process often leads to poor inter-departmental communication and argues between teams.
The implementation
So how should DFM be implemented? Let’s answer this question from the necessary elements of people and tools. For addressing details, we need to know the organizational structure of the company, especially departments for the development process and their expertise as well as reponsibilities. In principle, the work and connecting the design and engineering stages mentioned in the previous paragraph should be completed by various departments in accordance with the time sequence and duties. This requires hard skills of engineers, but also relies heavily on the soft skills, like team communication and coordination. However, in the med-pharma field, all work in the development process needs to be recorded. Thus it’s good to have a formal DFM document to record it (of course there are other ways, which we will not go into in this article to avoid losing focus).
You can imagine that this is a very large company with many projects underway at the same time. If the team needs to communicate through a document, how should this document be designed? In addition to documents as a communication tool, hard skills in engineering is very critical when it comes to DFM work. If you have DFM documents and fully understand what DFM is , but the engineering team has very little engineering skills and experience, DFM execution will be very hard, like dragging a car forward with stuck wheels. The car itself is very poor, and no one would ask it to go far. However, engineering knowledge we need will be different depending on your products. In this way, appropriate tools, such as software and hardware to predict or solve engineering problems, can accelerate the progress of DFM. In a broad sense, DFM considers not only the manufacturabilities of parts, but also the issues might occur at assembly, testing, packaging and even mass manufacturing and transportation. Let’s take testing as an example. When planning DFM, you need to prepare for DFT (Design for Testing). Firstly,you need to know what kind of test the product needs to pass in the end. Then you design your product for this test. In particular for med-pharma products , there are testing standards, so you must consider the challenges you may encounter in the early stages of design. Many people will ask how to use software to make predictions or solve problems? Should we use ChatGPT? After all, what we need is a scientific method. You can use analytical solutions or numerical analysis to find answers, or you can design experiments, use AI and other tools, as long as it can solve problems scientifically.
Cost Reduction
Can DFM reduce the cost of product development? According to the spirit of DFM, if it is executed well, we are confident that the cost can be reduced, or the cost of product development can be stabilized. So you can see that DFM has become a professional, but its actual implementation is very flexible. We should not think about it on reducing the cost only, but what is more worthy of investing in design is to produce high-quality products while maximizing production capacity. If DFM is used in accessing cost, an experienced engineering team can evaluate the relative costs of sovling problems that may be encountered based on the concepts of DFM. In short, it is whether the product is easy to develop and how much it will cost to overcome the difficulties. Then, we can know how much it will cost. It is mentioned here that “experienced engineering team” means that the factor of “people” is relatively important. If the team has no experience or poor execution capabilities, the cost of product development will be high naturally . In Taiwan, perhaps due to cultural and industrial factors, local employers prefer to hire novices. Without good organization and manpower planning, you may not save any money, but instead pay the price in product development costs.
Once the concept is in place, the next step is to select the suitable talants and tools to implement DFM. In summary, well-executed DFM can definitely reduce costs and increase CDMO opportunities. DFM is not only a professional, but its execution is actually very flexible, and good talents are absolutely crucial.
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