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How to Design MedTech Equipment for Mass Manufacturing

EmilyNewton
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Medtech equipment - Blood pressure Cuff

As health care becomes increasingly complex, the developers of medical devices face new challenges — like how to innovate while ensuring designs remain practical and cost-effective if used for mass manufacturing.

Effective medical devices and other medtech products can be difficult to manufacture at scale due to the complexity of new devices, and how factors like material choice can influence the manufacturing process.

The right design practices can help businesses plan for mass manufacturing and ensure their designs are not cost-prohibitive or too complex for manufacturers to handle.

Why Design for Manufacturability

When developing a new medical device or component, many medtech designers centre the fabrication process, making the design of parts that meet manufacturing constraints a high priority. Typically, this means embracing a design philosophy called “design for manufacturability,” or DFM.

DFM allows businesses to pre-empt issues that can emerge during the manufacturing process — like design decisions that introduce variability into finished products or material choices that may be cost-prohibitive in practice.

For example, manufacturers often don’t have a choice between hard and soft tooling — meaning they may have to accept the significantly higher prices that can come with hard tooling.

DFM can enable a business to reduce costs by making design decisions that allow a product to be manufactured primarily or exclusively with soft tooling. The designer may also use certain manufacturing processes that allow them to further reduce costs by taking advantage of the tool library a particular manufacturer already has on hand. This requires communication with a manufacturer during the design process and early consideration of how certain designs may render certain manufacturing strategies impossible to use.

Typically, manufacturers that utilize DFM will consider manufacturing constraints at every stage in the design process. DFM, as a result, must become a consideration at the earliest stages of the design process — typically during concept development or CAD modelling of early prototypes.

The application of DFM strategies and considerations will continue to be relevant through the end of the manufacturing process — including during prototyping, testing, and the other later design stages performed in preparation for mass manufacturing.

This attention to detail will help ensure desired features or structural decisions in a prototype won’t make the device harder or impossible to manufacture at scale.

Key Benefits of DFM in Medtech Design

Thinking about manufacturability early on also allows designers to consider innovative manufacturing techniques, and how the product’s design may enable the business to take advantage of these techniques during the fabrication process.

For example, additive manufacturing techniques like 3D printing are becoming increasingly popular among medical device manufacturers. Recent innovations in 3D printing technology have enabled the printing of materials like metal and fabric. Considering the possibilities these new technologies enable could help guide a medtech developer during the design process.

DFM may also mean reviewing and improving the information that is provided to process engineers who will oversee the actual manufacturing process of the part.

CAD models of a component, along with 3D images and scans of prototype parts, can provide engineers with information — like internal wall thickness of a component, or a full view of what the part should look like — that may not be available with more conventional manufacturing specifications.

In addition to minimizing costs, key benefits of DFM also include improving speed-to-market and streamlining quality assurance processes. By planning for manufacturing from the start, many issues that would arise during the manufacturing process can be effectively avoided.

This helps simplify quality control, potentially reducing the number of errors that may be introduced by the manufacturing process.

The manufacturing speed of products can also be accelerated by reducing their complexity. Design strategies like part count reduction can help significantly streamline the assembly process of a new product, for example, helping to reduce manufacturing time and cost.

DFM Strategies for Medtech Designers

Certain DFM strategies can be useful, regardless of the niche a medtech manufacturer resides in. These strategies are often a good place to start when determining what DFM should mean for a particular product or component.

For example, designing with the intention to use certain high-productivity manufacturing machines, like four-slide metal stamping machines, can help improve manufacturing throughput and reduce the risk of quality control issues.

Manufacturers may also want to consider the application of other design strategies — like concurrent engineering — that can help further streamline the design process and ensure a product is ready for mass manufacturing as soon as possible.

Other Design Considerations for MedTech Manufacturers

Certain medtech niches may also face specific risks that will require unique strategies. Manufacturers of micro-sized implantable devices, for example, like sensors, guidewire assemblies, and slow-release point-of-use drug-delivery devices, often face significant challenges in the moulding and machining processes.

Micro details can have a major impact on a device, and even small deviations in a design can cause major performance issues. Parting line shut-offs and venting channels in a mould, if not designed with extreme precision and care for the small scale of the device being moulded, can cause these deviations.

These risks can be mitigated during the design process — moulding design, material choice, and material processing will all have a significant impact on the frequency of errors in the manufacturing process. Structured analytical approaches, like a Process Failure Mode Effects Analysis (PFMEA) method, will also help a manufacturer design effective tools that can help minimize errors during the manufacturing process.

Preparing Medtech Designs for Mass Manufacturing

MedTech equipment is increasingly complex but still needs to be designed for mass manufacturing. Making manufacturability a top consideration during the design process can help medtech developers ensure that products can be manufactured in a way that is both practical and cost-effective.

The right combination of techniques and novel manufacturing technology can help. Businesses in certain medtech niches may also benefit from field manufacturing knowledge that can help them to avoid common pitfalls — like design errors that may cause manufacturing deviations.

Emily Newton is the Editor-in-Chief of Revolutionized Magazine. She has over three years experience writing articles for the tech and industrial sectors. Subscribe to the Revolutionized newsletter for more content from Emily at https://revolutionized.com/subscribe/

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