What is DFM (Design for Manufacturability) ?
The process of designing a medical device can be exceedingly difficult, expensive, and time-consuming. The approach known as “design for manufacture,” or DFM, can cut down on the time spent trying to solve manufacturing problems by taking into account the simplicity of manufacture at the outset of your design process before tooling.
Basic Principles of DFM:
The five areas that are taken into consideration while setting up DFM principles are as follows:
- Process
- Design
- Material
- Environment
- Testing and Compliance
DFM involves jointly challenging the design with stakeholders, manufacturers, and designers in order to foresee potential future issues the original design may have created. Whether it is a brand-new product or an improved version of a previous model, every design feature needs to be carefully examined. When earlier ideas are reviewed without revision, several design errors are made. Examining the original sketches, looking at comparable items already on the market, and speaking with other manufacturers or your own who may have addressed related problems on different devices are all appropriate ways to properly investigate the design’s downsides.
Why does Gesco Healthcare follow DFM principles when designing medical devices?
There are several distinct areas in which DFM has the potential to assist in lowering costs and improving the end product. Considering that design decisions can account for up to 70% of manufacturing expenses, using best practices will always result in the highest-quality final product. Before the design is finalized, successful DFM examines every aspect of producing a device, which can be useful in the following ways.
- Reduces the time it takes to bring a product to market.
- Reduces overall costs to design and develop the product.
- Ensures the product can be made profitably.
- Get a higher quality product.
A product’s assembly labour and material requirements are reduced by reducing the number of components needed to create it. Manufacturers can offer feedback on your product’s features and suggestions for methods to cut the costs of engineering, production, labour, shipping, and testing through the use of DFM.
Three Reasons Why We Care About Manufacturability Design
- Assures that we can manufacture the Medical Device
DFM begins with one of the most critical aspects of a medical device manufacturing project: gathering all design inputs.
Design inputs are your product’s mechanical, and environmental requirements, which will serve as the foundation for device design and product qualification. Aside from mechanical, and environmental specifications, it is critical to understand how the surgical implants or surgical instruments will be used.
After finalizing the design inputs into the design drawings (which also serves as the foundation for tool design), basic 3D-printed (or machined) prototypes can be created to validate the design concept prior to full tooling production. It allows us to simulate how the product would be built in a production environment at our facility.
In medical device manufacturing, it can be difficult to achieve the desired features of a part or the performance of a system on the first try. Prototyped parts allow us to quickly pivot if necessary, allowing us to return to the drawing board to make changes before production tooling is built.
2 – DFM influences the finished medical device’s aesthetics, feel, and functionality.
All designs for bill of materials (BOM) items and final assembly, such as mould layouts/tooling design and manufacturing process design, are included in DFM.
Achieving the desired aesthetic, tactile, dimensional, and functional properties of your product requires the use of appropriately designed tools. The fundamental design requirements while manufacturing a medical device might include:
- Flexibility: In addition to allowing for greater adaptability, strain reliefs also help to preserve the structural integrity, flexibility, and overall robustness of the connection between the cable material and the connector or grommet.
- Gripping: Non-slip finger grips built into the connector overmold for convenience.
- Security: Latching features that lock connectors in place and prevent disconnection during use.
- Handling: Specially designed handles for maneuverability, which is often desirable in surgical applications.
These kinds of decisions are made and approved as part of the process by both the Gesco Healthcare Design team and our customer.
3 – It determines the overall timeline
Allowing time for good DFM practices should always be included when creating a project timeline. Depending on the quality requirements and complexity of the medical device environment, it may take several weeks and iterations between our teams to arrive at a solid manufacturing path.
During frequent communications and design reviews, every detail of medical cable assembly projects must be verified and confirmed with both Gesco Healthcare’s design team and our customer’s team. Gesco Healthcare will participate in design reviews in accordance with design control requirements throughout the development process.
We share CAD 3D models, 3D printed samples, or machined prototypes for approval during design reviews before beginning tool fabrication. This establishes a certain level of confidence in ‘freezing’ the design in order to begin production steps. It helps to eliminate potential mistakes that could cost a lot of time and money to fix later on. While it may appear that scheduling time for adjustments is contradictory and may slow down the overall project, DFM best practices are the tortoise that wins the race in medical device manufacturing.
