UX/HF/Regulatory Flashcards
What does ISO 9241 cover?
International Organization for Standardization (ISO) covering ergonomics of human-computer interaction
6 principles of user-centered design (ISO 9241)
1: design is based upon explicit understanding of users, tasks, and environments.
2: Users are actively involved throughout design and development.
3: Design is driven and refined by user-centered evaluation.
4: Process is iterative.
5: Design addresses entire user experience (Peter Morville)
6: Design team includes multi-disciplinary skills and perspectives.
User centered evaluation includes the extent to which….(ISO 9241)
A product can be used by specified users to achieve specific goals with effectiveness, efficiency, and satisfaction in a specified context of use.
Neilson’s 10 broad areas of interface design (heuristic evaluations)
1: visibility of system status
2: messages displayed in understandable format
3: Aesthetic and minimalist design
4: user control and freedom
5: consistency (things work in familiar way)
6: recognition rather than recall
7: flexibility and efficiency for expert users
8: error prevention
9: help users diagnose problems
10: help documentation is useful
1 user will find ___% of problems. 5 will find ____.
1 user will find 1/3
5 will find 3/4
Card sorts tell you
how people mentally group information. Will help you decide how to display information.
Cognitive walk thru tells you
If users know what to do at each step and if they did the right thing, will they know they did it
Goal is for interface designs to be (3 things)
Predictable, understandable and learnable
app.expimetrics, dscout, indeemo are apps that can be used for…
Diary studies
ISO 14971 is for
the application of risk management to medical devices
Amendment to Medical Device Directive (MDD) 2007/47/EC clarified what in terms of software?
That in its own right, it can now be classified as a medical device.
E.g., insulin infusion devices that were not alerting as planned and were hard to understand
ISO 13485:2003 and its harmonization with MDD define requirements for what
A QMS (quality mgmt system) that ensures processes used during development and production of a medical device are defined and monitored.
IEC 62304:2006 provides guidance for what
Medical device software - software life cycle processes to be performed. Clause 7 describes software risk managment process.
What resource can an organization use when they wish to outsource or offshore part or all of their medical device software development to a 3rd party or remote division.
Medi SPICE assessment determines the state of an organizations software processes and practices
Med-Trace is a lightweight software traceability process asseessment and improvement method
Med Adept is an assessment for evaluating an organisations software development process and is inline with ISO 15504-5
6 phases of risk management process per ISO 14971
1: risk analysis
2: risk evaluation
3: risk control
4: evaluation of overall residual risk acceptability
5: risk mgmt report
6: production and post-production information
ISO 13485 states what with regards to hiring contractors
That manufacturer is responsible for safety of medical device irrespective of whether they did the work themselves or outsourced.
FMEA means and does what
Fault mode and effect analysis
An approach for risk identification
Roadmap to ISO 14971 compliance includes how many milestones and goals?
14 milestones
44 goals
Devices are regulated by what group at FDA?
CDRH - center for devices and radiological health
IDE
PMA
PMN
Investigational device exemption
Pre-market approval
Pre-market notification
Explain what a predicate device is
Class III device that have only minor differences from an already approved device may be reclassified as Class I or II.
What does exempt status mean?
No need for proof of safety or efficacy, nor for clinical trials. Do not need to undergo the standard pre-market notification process. Usually 3/4 of Class I devices qualify
Most class II devices must
Demonstrate they will perform as expected and will go through a PMN (aka 501k) clearance will will likely not require stringent evidence.
Class III - which approval is required?
Typically require pre-market approval (PMA) and require clinical evidence to support application.
Sponsor can petition for reclassification via 513(g) application.
In order to conduct pre-market clinical trials you must first obtain what?
IDE (investigation device exemption)
Philips mentioned some things to keep in mind when thinking about patient data but these are good/relevant for other places.
Figure out data-sharing models with healthcare providers so app developers can work together without violating patient rights or stepping on each other’s toes.
All players might have large repositories of clinical data, so it’s important to understand where that data comes from and how that information is shared.
Sometimes, there is a rush to market and to not have compliance thought processes built in. Figure out what you are giving up in terms of data, what are you getting in return and keep an eye on intellectual property rights.
What is the difference between clinical informatics and health informatics?
Clinical informatics focuses on the individual patient while public health informatics focuses on society and the population as a whole. Tissues and organs are the domain of imaging informatics, while bioinformatics deals with the processes of cells and molecules.
What is contextual inquire?
Collect feedback from individuals while they use your product (feedback collected in context). E.g., asking physicians about an electronic prescription pad as they write prescriptions.
Group feedback = focus groups (when do you use them)?
To collect information from multiple people at one time and reach a group consensus.
Describe a solid approach to UI design
1: conduct research and prepare vision statement
2: conduct hazard, task, and use-related risk analysis
3: develop design specifications
4: develop multiple design concepts
5: based on user input, down-select
6: develop detailed design and build prototype
7: conduct formative evaluations - eg cognitive walk-thru and formative usability test
8: Refine design and re-test
9: validate and document final design
SaMD
Software as a medical device
IEC
International electro-technical commission
IEC 62366
Medical devices — Part 1: Application of usability engineering to medical devices.
Does not apply to clinical decision making relating to use of a medical device
IEC 62366 specifies formative evaluations as….
Occurring iteratively during design phase to explore unintended use errors
IEC 62366 specifies summative evaluations as….
Occurring at the end of interface development as part of the verification and validation of the design to conclude the interface can be used safely.
Validation of product, determination if risk mitigation are effective, determines of users can complete critical tasks
In a task analysis, consider PCA for each critical step. What does this stand for and what does it mean?
Perception, cognition and action. What they are thinking/doing when they are handling the device.
3 ways to mitigate use errors
1: safety by design: e.g., can’t plug wrong cord in to incorrect outlet.
2: protective measures: incorporate safety mechanisms e.g., safety locks
3: information (warnings/cautions) in use manual.
