Best Practices for Human-Centric Design of Medical Devices
Medical devices designed to accommodate human variability present a growing opportunity for the healthcare and life sciences industries. Historically, medicine has solved many of the âsimpleâ issues first: how to fix a broken leg has been known for centuries! But today we have treatments that didnât even exist a generation ago, such as the use of stents and replacement valves for heart disease. These devices address a more limited cohort of people and are most successful when designed to be patient-specific. The cohorts themselves must also be further defined to account for differences in things like age and gender.
Splinting broken bones reliably relieves suffering, but more sophisticated techniques are essential for delivering many of the advanced medical solutions available today. For the device manufacturer, the path to best practices has become smoother: computer-aided engineering and simulation are shortening product design and development cycles, enabling more precise patient customization and accelerating submission and approval.
FDA is now strongly supportive of applications that include simulation data documenting efficacy and durability, while the ASTM V&V 40 committee and ISO continue to fine-tune and align requirements to ease the path through verification and validation of computer models. Many of the medical devices that are currently being regulated, and particularly those with in-vivo durability questi...
Source: MDDI - Category: Medical Devices Authors: Kristian Debus Tags: Design Source Type: news
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