Design input requirements and standard gap assessments

[Chitchat]

I am interested in knowing how others manage design input requirements and standard gap assessments. I’m from the school of thought that the design input requirement is somewhat at a macro level and the standard gaps assessment is a follow-up activity to determine which clauses are applicable to your device, while others believe you need the gap assessment to establish the design inputs.

Design input => compliance to IEC 60601-1
Complete the gaps assessment – identify the applicable clauses.
Establish/create your design outputs.

Appreciate any input you can give.

 

[shimonv]

I am of the same school of thought. I Actually, I identify the applicable standards as part of the regulatory strategy. The RA input with marketing & business inputs becomes the design input.

The only incentive for the other approach is if you want to create a very detailed design input to begin with. In my opinion you should start with a high-level design requirement and go down to detailed design as the project develops.

Shimon

 

[DanMann]

I also put the standard in as the design input, then use gap assessments/checklists as design outputs and/or methods of verification (depending on the standard). For example, ISO 18113-1 can be verified by technical review of the IFU through a checklist, whereas IEC 60101-1 of course would need testing.

 

[Tidge]

I can describe my experiences with an employer, with comments.

One employer's process required that we do a formal, clause-by-clause assessment of relevant standards before preparing Design Input Requirements. Typically the applicable clauses ended up in a precursor feeder to the DIR; this had a predictable outcome of some clauses being turned verbatim into DIR.

This approach was IMO well-intentioned, but was (again IMO) a bad idea. The good intentions were this: We wanted a clear (1st) bookend for the Regulatory Affairs group to have primary ownership over a document that others (throughout development) could update with traceability to 'true' DIR... and when development finishes that traceability matrix could be leveraged by the RA group to speak to 'regulatory' concerns. In practice, I witnessed this approach fail for a variety of reasons... if I had to identify the largest contributing factor to the failure, it is probably that RA's "fire-and-forget" participation wasn't well-manifested in the actual development.

I am interested in knowing how others manage design input requirements and standard gap assessments. I’m from the school of thought that the design input requirement is somewhat at a macro level and the standard gaps assessment is a follow-up activity to determine which clauses are applicable to your device, while others believe you need the gap assessment to establish the design inputs.

Design input => compliance to IEC 60601-1
Complete the gaps assessment – identify the applicable clauses.
Establish/create your design outputs.

Appreciate any input you can give.

I disagree with the bolded part, and I dislike the proposed flow. I have a general disagreement and a specific disagreement.

The specific disagreement is that "compliance to 60601-1" is a good DIR. 60601-1 is a standard that if met, by consensus, the medical electrical device is both "safe" and "meets its essential performance".

The general disagreement is that 60601-1 applies to different medical electrical devices, and so the X-ray machine you intend to design could turn out to be an electric toothbrush. If the medical device didn't use electricity, then we would end up without any applicable design outputs.

More targeted DIR should be developed to make safe and effective medical devices without first appealing to consensus standards. The DIR should derive from things like a patient and user needs analysis, and the core technological concept intended to meet the user needs.