SaMD: Metric for release frequency

Auxilium

Involved In Discussions
Dear community, I got a task from my boss to analyse our release frequency which we intended to increase a while ago in order to reduce the time to value for our customers. A while ago, our product versions were updated every 2-3 months and we targeted to develop and release our medical device every 2-4 weeks.
We are a SaMD (stand-alone) and since the last few releases of our new product versions, indeed the release frequency has been increased and the product updates have been smaller. Definitely did we optimise the process of compiling our Technical File acc. to MDR (EU) 2017/745 and have become more efficient.
However, I just can't come up with a metric that makes sense other than "Release Date Version A => Last day of use Version A".

If anyone has a suggestion whether there could be a more sophisticated metric that makes sense or with an overall rationale how to create such a metric, I'd be really grateful.

Thank you!
 

yodon

Leader
Super Moderator
What would be the purpose of collecting the data? Seems like just release frequency itself isn't all that interesting. I mean if you just determine that you make a release on average every 3.645 weeks, is that meaningful?

Why are you making releases? Bugs? New features? That might give some insight (potentially poor development process / unclear understanding of user needs, respectively).

What do your customers think of the release frequency? Updates are rarely completely painless. Maybe the frequency is too high for your customers' liking?

What's the rate of adoption for updates? (Or are users forced into the new release immediately after the release?)

What about the cost of releases? I presume there should be some amount of documentation and notification (regulatory bodies / customers). Are you losing money because of frequent releases?
 

Auxilium

Involved In Discussions
Let's say the release frequency makes sense and it's just about tracking whether we are reaching the goals, how would you do it?
 

yodon

Leader
Super Moderator
Let's say the release frequency makes sense and it's just about tracking whether we are reaching the goals, how would you do it?

Maybe I'm missing something but seems like actual -v- target?

To be honest, without knowing why you want to measure something, it's hard to say what you should measure.
 

milandy

Registered
Assuming you’re using something like Jira. I would gather just one metric, but several. The more the better. This is knowing you will be refining your metrics as they evolve. There unlikely only one number that will resolve your need and comparing several metrics with each other is always more informative.
1. Epics released / year
2. Cost / epic released
3. Releases / year
4. Cost / release
5. Medium priority bugs resolved / reported
 
Thread starter Similar threads Forum Replies Date
T SaMD expiry date IEC 62304 - Medical Device Software Life Cycle Processes 3
T Manufacturing flowchart SaMD IEC 62304 - Medical Device Software Life Cycle Processes 3
S Declaration of Conformance (SaMD) EU Medical Device Regulations 0
dgrainger Informational MHRA Guidance: Crafting an intended purpose in the context of Software as a Medical Device (SaMD) UK Medical Device Regulations 0
L Design Transfer Concept of cloud SaMD US Medical Device Regulations 2
C Can SaMD consist almost entirely of Software of Unknown Provenance (SOUP)? IEC 62304 - Medical Device Software Life Cycle Processes 4
B System lifetime for SaMD Medical Device and FDA Regulations and Standards News 8
T SaMD labeling requirements - MDR IEC 62304 - Medical Device Software Life Cycle Processes 3
R Declaration of Conformity for updated SaMD version EU Medical Device Regulations 2
Q MDDS Hardware upgrades impact on SaMD US Medical Device Regulations 3
V SaMD/MDSW - Class I - CE Mark CE Marking (Conformité Européene) / CB Scheme 1
T Relation between ISMS and QMS for a SaMD Medical Information Technology, Medical Software and Health Informatics 3
I SaMD Software bug and issue tracking. Manufacturing and Related Processes 3
D Do digitalised scoring forms and flowcharts qualify as SaMD? EU Medical Device Regulations 0
T SaMD or Software system? EU Medical Device Regulations 2
A SaMD: Post Market Surveillance after Decomissioning EU Medical Device Regulations 2
R SaMD Performance Testing US Medical Device Regulations 5
R Cloud-based SaMD Validation IEC 62304 - Medical Device Software Life Cycle Processes 8
Ed Panek Consultant Request SaMD AI "Expert" FDA US Food and Drug Administration (FDA) 2
K SaMD and Customer Integrations Medical Information Technology, Medical Software and Health Informatics 3
C How to place software version for SaMD product in HIBC secondary data structure (UDI-PI)? Other US Medical Device Regulations 4
R SaMD Verification & Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
T IEC 62304 : Risk control for SaMD IEC 62304 - Medical Device Software Life Cycle Processes 8
Z PMS Data collection for SAMD SaaS from clients EU Medical Device Regulations 3
L Essential Design Outputs for SAMD 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A SaaS SaMD - Impact QMS ISO 13485:2016 - Medical Device Quality Management Systems 2
I Software (SaMD) mobile application verification testing: objective evidence Medical Information Technology, Medical Software and Health Informatics 6
J Software as a Medical Device - SaMD IEC 62304 - Medical Device Software Life Cycle Processes 7
H ISO 13485-paragraphs for a SaaS SAMD needed or not? ISO 13485:2016 - Medical Device Quality Management Systems 3
H Customer Specific Change in a SaaS SAMD IEC 62304 - Medical Device Software Life Cycle Processes 1
I Multiple Indications in SaMD Other US Medical Device Regulations 8
Y SaMD Verification and Validation SOP and Plan IEC 62304 - Medical Device Software Life Cycle Processes 8
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
R SaMD - Placing on the Market before DoA EU Medical Device Regulations 2
D CE SaMD modular approach CE Marking (Conformité Européene) / CB Scheme 5
K Regulatory requirement of SaMD with machine learning component IEC 62304 - Medical Device Software Life Cycle Processes 3
Y Distributor for a SaMD Medical Information Technology, Medical Software and Health Informatics 3
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
Q Storing and developing SAMD (Software as a Medical Device) in the Cloud IEC 62304 - Medical Device Software Life Cycle Processes 3
A Demonstration of Equivalence - Need for comparing biological characteristics for an SamD EU Medical Device Regulations 1
N Servicing for SaMD ISO 13485:2016 - Medical Device Quality Management Systems 6
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 6
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 4
N Agile SOP for SaMD IEC 62304 - Medical Device Software Life Cycle Processes 3
M Informational TGA – Submissions received: Regulation of software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 1
D Not a SaMD - How to be submitted for marketing authorization in EU and USA CE Marking (Conformité Européene) / CB Scheme 5
T Medical device or not - SaMD Other Medical Device and Orthopedic Related Topics 3
M Informational TGA – Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
J Qualification of a Software as a Medical Device (SaMD) guidance under MDR EU Medical Device Regulations 9
M Informational TGA Consultation: Regulation of software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom