Safety of medical devices is closely linked to the notion of usability. Usability includes such factors as ease of learning how to repeatedly use the device in an efficient and effective manner. Consideration of such factors results in a safer product due to less user error.
Based on the ISO norms in the medical industry today, it is clear that regulations are quickly aligning with the idea of usability to increase safety. For example, ISO/IEC 62366 is a process-based standard that aims to help manufacturers of medical devices 'design in' usability. Manufacturers following this standard must adopt a user-centered design process delivering on actual end-user requirements instead of perceived requirements.
The end-user interaction with the device, as well as his/her perception of quality and efficiency, must be considered.
In summary, the medical devices have to:
- work efficiently and effectively
- be comfortable and safe to use
- be ergonomic and aesthetically pleasing
As designers and manufacturers in the medical device industry, you face challenging requirements, as devices should be highly performant, precise, ergonomic and easy to use. You also have to deal with challenges of efficiency, size, and thermal performance vs. cost in an environment where there is a clear gap between user expectations and device manufacturer requirements. User expectations such as efficient, safe and ergonomic devices are closely linked to the design, weight and thermal management performance.
These challenges highlight the need for new features to consider user experience attributes like:
- Aesthetic
- Comfort
- Reliability
- Performance
- Ease of use
- Durability
- Safety
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The performance and durability expected from medical devices is closely linked to heat dissipation, and
generation of heat is systematic in devices which often contain advanced electronics.
Indeed, in some technologies like magnetic resonance imaging (MRI) or computerized axial tomography (CAT) scans, cooling is critical, and this effect is amplified in devices with
multiple heat sources. The performance of the device is not the only feature affected, as
temperature fluctuations can also impact calibration and results. The use of fans in such devices may not be the best solution as they
collect dust and harbor bacteria that might be part of the
spread of hospital-acquired infections.
Heat dissipation can be provided via different manners, but the most optimized route seems to be thermally conductive plastics (TCP) containing Boron Nitride.