In today’s competitive medical device market, with its demanding standards and swift time-to-market expectations, optimising development methods is more critical than ever. One of the pivotal stages in this process is the inspection phase during development, which, if executed effectively, ensures a seamless transition from design to mass production. However, misconceptions about inspection processes can lead to increased project costs, delays in timelines, and compromised product quality. This article aims to address and clarify three such common misconceptions, with insights particularly relevant to the expertise and approach of Bluefrog Design in medical device development.

It’s a common belief that more detailed component specifications, easily added through CAD and technical drawing software, lead to better quality. Designers often think that including numerous inspection notes will result in more accurately checked and refined parts. However, this approach can backfire in several ways:

Increased Inspection Time: More inspection points mean longer times to inspect each part. For components undergoing multiple revisions, this can significantly lengthen the development process.

Irrelevant Specification Changes: Initial component samples might not be accurate across all areas. Including unnecessary inspection points can lead to a focus on insignificant features, diverting attention and resources from more crucial aspects.

Specification Overload: An overly extensive specification can confuse manufacturers about priority areas, potentially leading to critical dimensions being overlooked.

Another common belief is that widening tolerances and reducing testing will accelerate development and reduce expenses. While this might lower initial costs, such as tooling for injection moulding, it often doesn’t lead to overall project cost savings due to potential compromises in part quality. Important factors to consider include:

Design Constraints: Performance and user requirements create design boundaries. Properly defined specifications from the outset mean fewer chances of needing later revisions.

Tolerance Stack-up: Loosening tolerances without considering the device’s function can increase the risk of device failures. Adequate tolerances should satisfy tolerance stack-up calculations, ensuring all components function together as intended.

Manufacturing and Material Limitations: Discussions with manufacturers and material suppliers can reveal where tolerances can impact costs and where they can be safely adjusted.

At Bluefrog Design, we understand the intricacies of defining component parameters that balance quality and cost, ensuring the medical device’s integrity and functionality are not compromised.

Relying solely on inspection methods for sample analysis can miss critical aspects of a component’s performance:

Unseen Imperfections: Components may have imperfections not visible to the naked eye, affecting their properties. These can include moulding issues or material inconsistencies that inspection alone may not detect.

Complex Interactions: While inspection is valuable for assessing individual components, testing actual interactions between parts can uncover potential issues.

Material Property Complexities: Theoretical properties of materials like plastics don’t always hold up in practice. For example, issues like creep or stress relaxation in a device with a long shelf-life might be identified through ageing studies but not through theoretical models.

Bluefrog Design advocates for a balanced use of inspection and testing methods. This comprehensive approach ensures that both theoretical and practical aspects of the device are thoroughly evaluated, enhancing the development process.