Designing a manufacturable medical device requires careful attention to detail, creativity, and a deep understanding of the manufacturing process. Senior Design Engineer, Phil, shares some top tips for designing manufacturable medical devices:

From the earliest stages of product development, designers must consider a wide range of factors, from regulatory compliance to the intricacies of production, to create a successful device that can be produced efficiently and cost-effectively;

1. Begin with a clear design brief:

A clear design brief is essential for developing a manufacturable medical device. The design brief should include information about the device’s intended use, performance requirements, target market, and budget. By establishing clear goals and objectives at the outset, designers can create a more effective and efficient medical device that ticks all the boxes.

2. Design for manufacturability:

Design for manufacturability (DFM) is a critical consideration when designing a medical device. DFM involves designing a product that is easy to manufacture, assemble, test and disassemble. By considering manufacturing processes during the design phase, designers can reduce manufacturing costs, improve product quality, and reduce the time-to-market.

3. Consider regulatory compliance:

Medical devices are subject to rigorous regulatory requirements that vary by country or region. Designers must consider regulatory compliance throughout the design process to ensure that the device meets all relevant regulations. Early engagement with regulatory agencies can help identify potential compliance issues before they become major obstacles.

4. Choose appropriate materials:

Material selection is one of the most important aspects of medical device design, as the chosen materials can have an impact at every stage of the device development. Designers must select materials that are safe, reliable, and appropriate for the device’s intended use. Materials must also be cost-effective and readily available. Material selection must be balanced with the device’s performance requirements, manufacturing processes, regulatory compliance and considerations given to the type of environment for intended use.

5. Test early and often:

Early testing can help identify potential design flaws, manufacturing issues, and regulatory compliance concerns. Designers should test prototypes frequently throughout the design process to ensure that the device meets performance requirements and is manufacturable.

6. Consider usability:

Usability is one of the top considerations in medical device design. The device should be easy to use and operate, even for users with limited training or experience. Designers should consider user feedback during the design process to ensure that the device meets usability requirements. If the device is difficult to use, then it’ll never last, and will always be superseded by a simpler, easier to use device!

7. Use design controls:

Design controls are a set of procedures and processes that ensure the consistency and quality of a product’s design. Design controls can help ensure that the device meets regulatory requirements, performs as intended, and is manufacturable. Design controls should be implemented early in the design process to ensure that all design activities are performed in a controlled and documented manner.

8. Implement risk management:

Risk management is a crucial aspect of medical device design. Designers must identify and manage potential risks throughout the design process to ensure that the device is safe and effective. Risk management should be an ongoing process, with risks assessed at each stage of the design process.

9. Engage with manufacturing partners early:

Manufacturing partners play a critical role in the design and production of medical devices. Designers should engage with manufacturing partners early in the design process to ensure that the device is manufacturable and meets regulatory requirements. Early engagement can help identify potential manufacturing issues, reduce costs, and improve time-to-market.

10. Consider sustainability:

In the current climate of medical technology and product development, sustainability is an increasingly important buzzword in medical device design. Designers must consider the environmental impact of the device throughout its lifecycle, from material selection to disposal. Sustainable design can reduce waste, conserve resources, and reduce costs. The more sustainable medical devices out there in the world the better. Us as designers hold the key to reducing the amount of difficult to recycle single use devices there are out there in the world! Hopefully there will be some big regulatory changes in the near future that will lead to a simpler and more efficient device recycling infrastructure being implemented across the industry.

In conclusion, designing a manufacturable medical device requires careful consideration of a wide range of factors, from regulatory compliance to manufacturing processes. By following the tips discussed in this blog, you can create effective, efficient, and successful medical devices that meet the needs of patients, healthcare providers, and regulatory agencies. If you have any further questions or would like to discuss a project, please get in touch.

Phil Sampey 15 May 2023


Get in Touch with Phil Sampey

Senior Design Development Engineer

Phil graduated from Staffordshire University with a degree in Automotive Technology. Since joining HD, Phil has primarily been working on a number of medical device projects, supported by his wide range of experience from prototype manufacturing, plastic injection moulding and CNC machined parts, to designing bespoke gearbox systems for various industries. Phil also assists with the management of our ISO 13485 & ISO 9001 QMS and network of approved manufacturing suppliers.

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