One recurring challenge in designing products for use directly by the patient is the difficulty in predicting long term aspects and the impact of a given medical device on a diverse group of users due to their varied characteristics and sensitivities, as most new medical technologies have limited information related to their long term results and side effects. Overcoming this challenge may be addressed by taking a holistic approach that considers issues like the following when designing and specifying components for the device:
Usability—Is the device easy to understand and intuitive to use? Is it comfortable to the senses? Does it do the job precisely, accurately, reliably, and safely?
Robustness—Will it continue to work and provide the needed functionality when subjected to the rigors of daily use and abuse, including impact, submersion, misuse, or overload; withstand anything a child could imagine to do?
Adaptability—Is the device portable, unobtrusive, and will it operate effectively for mixed conditions and environments?
Low Cost—Will the device be covered by insurance? Is it affordable for the end user?
Funding, Timing, and Testing—Are resources available for device and market development? Will the device introduction be timely and have the right features? What type of regulatory and compliance requirements exist, current and future?