Take our ID audit at no cost and get access to an expert consultant for one hour. 1. Who are the users? Have all intended end-users such as healthcare professionals (physicians, nurses, med-techs), technical and service staff, patients, and lay caregivers, been identified? Have the end-users been prioritized into primary, secondary, and potentially tertiary groups? Does the design compensate for user limitations such as visual, strength, reach, dexterity, education and sociological considerations? Are potential mistakes addressed through interface design rather than documentation? Has the design addressed the needs of users with different levels of expertise or interaction? 2. What are the use-environments? Is the device suitable for highly challenging conditions such critical-care suites, poor or nocturnal lighting and excessive handling? Is the device sufficiently rugged to handle expected conditions? Is the device appearance, shape and interaction suitable for its intended-use environment, such as at-home (child and pet-safe), wearable and other uncontrolled environments? Has the UI and workflow been optimized to accommodate for power or interactive interruptions, third party involvement, and excessive motion? How will the user interact with the device? Does the device have an initial setup procedure such as data input and operational preference protocols? Does the device have calibration and other maintenance requirements to operate appropriately? If telemetry and data upload needs are a requirement, is the process streamlined and transmission protocols sufficiently robust? Does the design and its specified materials and finishes adequately consider cleaning/sanitation efficacy and service access? What are the critical tasks? Are there operational steps that could result in serious consequences if executed incorrectly or omitted? Are there safeguards or automated warnings to prevent or minimize errors during these crucial operations? If repeated sterilization and/or re-processing are required, is the design capable of reliably withstanding specified protocols? Does the intended workflow or the instructions-for-use (IFU) prevent cross-contamination? Do the disposal methods ensure safety and compliance for single-use items? 5. Aesthetics and user experience Well-designed medical equipment aesthetics can enhance the user's psychological comfort and create a more welcoming interactive setting. Does the clinician-facing device project hygiene, robustness and reliability? Does the patient-facing device project simplicity, friendliness and functional reassurance? Does device appearance project sophistication and technical excellence? If device appearance and setup convenience affect use-adherence and compliance, has sufficient effort been made to optimize these attributes? Does the design language communicate the function? (this can apply to the overall function or individual interfaces) 6. Safety and regulatory compliance Industrial design must incorporate risk mitigation strategies and ensure adherence to stringent regulatory guidelines and requirements. (FDA, ISO/IEC) Does the device address and minimize use-related hazards? Do the design specifications meet expected use-related requirements such as drop impacts, weatherproofing, electrical safety, thermal and vibrational protection? Does the development process thoroughly address and document risk assessment and management? Have the device design safety measures been informed and documented by human factors assessment and summative validation? Is the design history file (DHF) documentation and device master record (DMR) complete? 7. Business and lifecycle considerationsThe industrial design process must evaluate both product lifecycle and strategic business implications. Is the device design optimized for suitable manufacturing processes at the intended volumes? Are component supply chains reliable and multi-sourced wherever possible? Is there a ramp-up strategy in place and does the design reflect efficient manufacturing at both ends of the volume spectrum? Does the design integrate suitable corporate and sub-brand identities? Does the device consider long-term environmental impact and regional sustainability sensitivity? Does the device consider end-of-life disposal and recycling? Does the ID provide intellectual property protection? Your Name Your Email
