UX/HF/Regulatory

Question 1

What does ISO 9241 cover?

Answer 1

International Organization for Standardization (ISO) covering ergonomics of human-computer interaction

Question 2

6 principles of user-centered design (ISO 9241)

Answer 2

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.

Question 3

User centered evaluation includes the extent to which….(ISO 9241)

Answer 3

A product can be used by specified users to achieve specific goals with effectiveness, efficiency, and satisfaction in a specified context of use.

Question 4

Neilson’s 10 broad areas of interface design (heuristic evaluations)

Answer 4

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

Question 5

1 user will find ___% of problems. 5 will find ____.

Answer 5

1 user will find 1/3

5 will find 3/4

Question 6

Card sorts tell you

Answer 6

how people mentally group information. Will help you decide how to display information.

Question 7

Cognitive walk thru tells you

Answer 7

If users know what to do at each step and if they did the right thing, will they know they did it

Question 8

Goal is for interface designs to be (3 things)

Answer 8

Predictable, understandable and learnable

Question 9

app.expimetrics, dscout, indeemo are apps that can be used for…

Answer 9

Diary studies

Question 10

ISO 14971 is for

Answer 10

the application of risk management to medical devices

Question 11

Amendment to Medical Device Directive (MDD) 2007/47/EC clarified what in terms of software?

Answer 11

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

Question 12

ISO 13485:2003 and its harmonization with MDD define requirements for what

Answer 12

A QMS (quality mgmt system) that ensures processes used during development and production of a medical device are defined and monitored.

Question 13

IEC 62304:2006 provides guidance for what

Answer 13

Medical device software - software life cycle processes to be performed. Clause 7 describes software risk managment process.

Question 14

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.

Answer 14

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

Question 15

6 phases of risk management process per ISO 14971

Answer 15

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

Question 16

ISO 13485 states what with regards to hiring contractors

Answer 16

That manufacturer is responsible for safety of medical device irrespective of whether they did the work themselves or outsourced.

Question 17

FMEA means and does what

Answer 17

Fault mode and effect analysis

An approach for risk identification

Question 18

Roadmap to ISO 14971 compliance includes how many milestones and goals?

Answer 18

14 milestones

44 goals

Question 19

Devices are regulated by what group at FDA?

Answer 19

CDRH - center for devices and radiological health

Question 20

IDE
PMA
PMN

Answer 20

Investigational device exemption
Pre-market approval
Pre-market notification

Question 21

Explain what a predicate device is

Answer 21

Class III device that have only minor differences from an already approved device may be reclassified as Class I or II.

Question 22

What does exempt status mean?

Answer 22

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

Question 23

Most class II devices must

Answer 23

Demonstrate they will perform as expected and will go through a PMN (aka 501k) clearance will will likely not require stringent evidence.

Question 24

Class III - which approval is required?

Answer 24

Typically require pre-market approval (PMA) and require clinical evidence to support application.
Sponsor can petition for reclassification via 513(g) application.

Question 25

In order to conduct pre-market clinical trials you must first obtain what?

Answer 25

IDE (investigation device exemption)

Question 26

Philips mentioned some things to keep in mind when thinking about patient data but these are good/relevant for other places.

Answer 26

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.

Question 27

What is the difference between clinical informatics and health informatics?

Answer 27

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.

Question 28

What is contextual inquire?

Answer 28

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.

Question 29

Group feedback = focus groups (when do you use them)?

Answer 29

To collect information from multiple people at one time and reach a group consensus.

Question 30

Describe a solid approach to UI design

Answer 30

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

Question 31

SaMD

Answer 31

Software as a medical device

Question 32

IEC

Answer 32

International electro-technical commission

Question 33

IEC 62366

Answer 33

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

Question 34

IEC 62366 specifies formative evaluations as….

Answer 34

Occurring iteratively during design phase to explore unintended use errors

Question 35

IEC 62366 specifies summative evaluations as….

Answer 35

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

Question 36

In a task analysis, consider PCA for each critical step. What does this stand for and what does it mean?

Answer 36

Perception, cognition and action. What they are thinking/doing when they are handling the device.

Question 37

3 ways to mitigate use errors

Answer 37

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.