Develop the Application Specification

Pattern Attributes

Intervention {Organization, Management, Governance {Decision_Structures, Controls, Metrics}, Process, Infrastructure {Communication, SCCS, Knowledge_Management}, Product {Architecture, Language}
Domain Medical
Work Programme SPRTMDRC
Research Area any
Evidence Type Standard
Evidence Source Standard
Evidence Strength Hypothetical
Trigger product_domain == medical, doing_usability_engineering == true

Problem

You are executing a usability engineering process on a new medical device in line with IEC 62366. You need to produce an application specification so that all team members know what the device will do, who will use the device and in what context the device will be used. To do this you need to produce an application specification.

Analysis

The usability of medical device can have a substantial impact on the safety of the safety of the device. In order to ensure that adequate usability is incorporated in the device, it is essential to understand not just what the device is to do, but also who is going to be using the device (e.g. an experienced medical professional or a casual end user) and the context in which the device is going to be used. The application specification is used to identify and document all of these factors as they can each impact the usability of the medical device.

Solution

  1. Define the medical intention of the device to ensure the development team members know what the device should accomplish. This will aid with the prioritisation of tasks, which is a necessary component of usability engineering
  2. Define the intended patient population so that the development team know who the device will be used and can incorporate this in the design. This may affect the ergonomic design of the device.
  3. Define the intended part of the body or type of tissue applied to or interacted with. This may impact the ergonomic design of the device
  4. Define intended user profile(s) by identifying characteristics of the user(s) that may impact device design. This affects all aspects of the device (ergonomics, User Interface, dialog design, etc.).
  5. Define intended condition(s) of use as this can limit the potential user interface components that can be used.
  6. Define the operating principle to all development team understand how the device is intended to function to achieve the medical intention of the device.
  7. Document the application specification so that it can be distributed to all team members and maintained for future reference.

References

  1. IEC 62366:2007 “Medical Devices - Application of usability engineering to medical devices”

  2. Flood, D., Mc Caffery, F., Casey, V., Regan, G.,(2013) “A Methodology for Software Process Improvement Roadmaps for Regulated Domains - Example with ISO 62366”, European System, Software & Service Process Improvement & Innovation (EuroSPI 2013)

  3. Flood, D., Mc Caffery, F., Casey, V., Regan, G.,(2013) “MeD UD - A Process Reference Model for Usability Design in Medical Devices”, South CHI 2013 International Conference on Human Factors in Computing & Informatics, Maribor, Slovenia.