Regulatory Open Forum

How should our usability engineering file, including the Standard Operating Procedure (SOP), be structured given that our device is based on well-established technology and similar devices have been available on the market for many years? We believe a usability study is unnecessary and all user-related risks and errors are addressed in our risk management activities. What are the expectations in this scenario?"

How should our usability engineering file, including the Standard Operating Procedure (SOP), be structured given that our device is based on well-established technology and similar devices have been available on the market for many years? We believe a usability study is unnecessary and all user-related risks and errors are addressed in our risk management activities. What are the expectations in this scenario?"

A simple design validation exercise, demonstrating no unexpected problems with the device, the packaging, the labeling, etc, could be sufficient in a case like that. A full-blown formative to summative usability process only adds value where there are more potential unknowns.

How should our usability engineering file, including the Standard Operating Procedure (SOP), be structured given that our device is based on well-established technology and similar devices have been available on the market for many years? We believe a usability study is unnecessary and all user-related risks and errors are addressed in our risk management activities. What are the expectations in this scenario?"

Anon,

There are number of different formats and structures which can be used generating a usability document for an existing product.  While an HFE factors assessment or Usability Study does not necessarily need to be performed - an "assessment" from a usability perspective is quite helpful to generate a usability file.  This is looking at risk management, the instructions for use, design and development, design inputs, and design outputs which can be summarised and referenced in a usability file.  Answering your question: what you want to create is a document which gives the reader an understanding of how usability aspects have been considered and evaluated - sort of a high level summary overview document which then references or points to location of more detailed information.  Review IEC 62366 and more particular the US FDA guidance document to get some ideas of what this content would look like and how a reader can understand these considerations have been taken into account.

A simple design validation exercise, demonstrating no unexpected problems with the device, the packaging, the labeling, etc, could be sufficient in a case like that. A full-blown formative to summative usability process only adds value where there are more potential unknowns.

How should our usability engineering file, including the Standard Operating Procedure (SOP), be structured given that our device is based on well-established technology and similar devices have been available on the market for many years? We believe a usability study is unnecessary and all user-related risks and errors are addressed in our risk management activities. What are the expectations in this scenario?"

IEC 62366-1 / EN 62366-1 (as amended, hereinafter "62366-1") represents the generally recognized state of the art; thus, conformity is often required (yet this ultimately depends on the particular jurisdictions in which the subject device will be marketed). 62366-1 normatively requires a certain approach rather than one based on whatever we might invent or reimagine. Specifically, in a nutshell for a UOUP scenario (see my preceding post), 62366-1 prescribes that we:

• Create a Use Specification (see clause 3.23 definition)
• Review "post-production" information (officially defined as the part of the life-cycle of the medical device after the design has been completed and the medical device has been manufactured) (62366-1 incorporation by reference from ISO 14971). Note that expending resources to randomly involve, invoke, or evaluate design and development data (e.g., inputs, outputs, verification, validation, etc.) would not meet this 62366-1 requirement and is not required by 62366-1 for UOUP except within the scope of the next bullet below.
• Risk management related to usability. The best way for this is to apply a proper ISO / EN ISO 14971 (as amended, hereinafter "14971") paradigm or similar. Specifically, 62366-1 literally requires identification of corresponding 14971 hazards, hazardous situations, risk control, and residual risk evaluation.

Anon,

There are number of different formats and structures which can be used generating a usability document for an existing product.  While an HFE factors assessment or Usability Study does not necessarily need to be performed - an "assessment" from a usability perspective is quite helpful to generate a usability file.  This is looking at risk management, the instructions for use, design and development, design inputs, and design outputs which can be summarised and referenced in a usability file.  Answering your question: what you want to create is a document which gives the reader an understanding of how usability aspects have been considered and evaluated - sort of a high level summary overview document which then references or points to location of more detailed information.  Review IEC 62366 and more particular the US FDA guidance document to get some ideas of what this content would look like and how a reader can understand these considerations have been taken into account.

A simple design validation exercise, demonstrating no unexpected problems with the device, the packaging, the labeling, etc, could be sufficient in a case like that. A full-blown formative to summative usability process only adds value where there are more potential unknowns.

How should our usability engineering file, including the Standard Operating Procedure (SOP), be structured given that our device is based on well-established technology and similar devices have been available on the market for many years? We believe a usability study is unnecessary and all user-related risks and errors are addressed in our risk management activities. What are the expectations in this scenario?"