medical device design

Designing Medical Devices For Manufacturability: A Complete Guide

The medical device design process can be incredibly complex, expensive and time-consuming. Design for manufacture, or DFM, is a process that can overcome these issues. It might also be referred to as Design for manufacturing and Assembly (DFMA). By considering the ease of manufacture at the beginning of your design process before tooling, you can significantly reduce the time spent on figuring out manufacturing difficulties.

Principles of Design for Manufacture

There are five areas that are examined during DFM, which are:
1. Process
2. Design
3. Material
4. Environment
5. Compliance and Testing

It’s a process of challenging the design collaboratively, including stakeholders, manufacturers and designers, in order to pre-empt later challenges the original design may have caused. Every design element should be scrutinised, whether the product is new or an iteration of an earlier model.

Many design mistakes are made when older designs are revisited without revision. Properly investigating the drawbacks of the design could include looking at original drawings, similar products on the market, and talking to other manufacturers, or your own, who may have solved similar issues on different devices.

What are the benefits of DFM in medical device design?

There are clear areas in which DFM can help cut costs and improve the finished product. Where up to 70 per cent of manufacturing costs are derived from design choices, following best practices is guaranteed to deliver you the best end product. Successful DFM looks at every part of making a device before the design is finalised, which can help in the following ways.

Reducing the number of elements needed to make a product reduces assembly labour and materials required. DFM can engender this where manufacturers can comment on the elements of your product and suggest ways to reduce engineering, production, labour, shipping and testing costs.

You can identify parts of your design that can incorporate standardised parts. This eliminates customisation costs, which includes testing, material working and design. Standardised parts are easier to find and produce, they are tooled and tested to quality metrics, so passing inspection isn’t a worry. Modular designs simplify the assembly process and means that standard parts are easier to incorporate into future projects, as are multi-functional parts. Multi-use products capitalise on this benefit even further, so consider whether your product could draw from other, on the market devices.

Designing products for ease of fabrication means ascertaining the right combination of material and manufacture which reduces production costs. For example, reducing the number of fasteners and joinings, which add significant costs to the assembly process, is a good start. If fasteners are needed, consider using standard, easy-to-apply fasteners.

Symmetrical devices reduce handling during assembly, as less positioning, orienting and fastening reduces lead times. Assembly direction is another element to this; if parts assemble in a downward direction, gravity aids with speed. Design your device with compliance in mind by building in part-protecting design such as tapers, chamfers or radius sizes that guide how equipment is assembled.

Each of these areas of DFM focuses on a different element to manufacture, promoting ease of assembly or production. Inevitably this brings down costs by reducing labour and lead times, as well as complying with later quality standards.

Questions to have in mind when designing for manufacturability

Clearly, DFM should be built into your design process, but here are some questions to keep in mind to ensure that you spend your time meaningfully:

• Are you starting with a clear, understandable, complete design?
• Have you considered all parts of the manufacturing process? This includes: Process, Material, Assembly, Tooling, Compliance, Use.
• Are any design changes you are making cost-effective?
• Is your design functional?
• Have you reduced unnecessary, cost-adding finishes and fastenings?

This is not an exhaustive list, but it does include many of the ways in which we look at designs whilst consulting on them for our clients. If you want to find out more about how Europlaz uses design for manufacture (DFM) to support the medical device designing process then, contact us today.

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