In the digital health sector, “fractional” roles are increasingly marketed as a flexible way for organisations to access specialist expertise, such as a Fractional Clinical Safety Officer (CSO).
However, when examined closely, fractional models are simply a modern rebrand of what Clinical Safety consultancies like DPM Digital Health have delivered for years.
DPM has long supported organisations with:
- Part-time CSO leadership
- Ongoing governance and risk oversight
- Safety documentation development and maintenance (DCB0129/DCB0160)
- Stand-by/ad-hoc advice and guidance
- Multi-month or continuous compliance support
- Training, Mentorship and Coaching for internal safety teams
- Incident support and regulatory alignment (MDR, ISO 14971, ISO 62304, ISO 42001, BS 30440, AMLAS)
This is, in essence, fractional CSO work, just delivered under the more accurate and established banner of consultancy.
Digital Clinical Safety consultancy has always been fractional in nature
A “Fractional CSO” is marketed as:
- Part-time
- Embedded
- Leadership-level
- Advisory and oversight-driven
- Non-employed
- Flexible
This is exactly how DPM has always operated.
For manufacturers, we provide ongoing safety documentation development, hazard workshops, governance structures, and iterative risk management support month after month.
For NHS Trusts, we deliver retained DCB0160 guidance, incident review, design authority support, and safety governance integration, all on a flexible, part-time basis.
Whether labelled “consultancy” or “fractional,” the function is identical, access to deep clinical safety expertise without hiring a full-time CSO.
“Fractional CSO” is simply a role-shaped wrapper for the same service DPM already provides
The term fractional suggests organisations are purchasing a “slice” of a senior leader.
In practice, they are engaging an external expert to:
- Lead or support Clinical Risk Management
- Chair or attend governance groups
- Oversee DCB0129/DCB0160 compliance
- Provide ongoing safety input across the lifecycle
- Support new releases, integrations, and incidents
- Mentor internal CSOs or digital teams
These activities are core consultancy services, not a new operating model.
DPM’s engagements naturally operate in a fractional style:
- We integrate into the client’s governance structures
- We hold an advisory leadership position
- We provide consistent oversight
- We support projects, BAU, and incidents
- We operate as a trusted extension of the internal team
This is consultancy, structured through a retained, flexible model, the same mechanics behind any “fractional” service.
| Value Delivered | Consultancy | “Fractional” |
| Expert Clinical Risk Management |  |
|
| DCB0129/DCB0160 compliance | |
|
| Safety Case/CSCR authorship | |
|
| Hazard workshops & risk analysis | |
|
| Ongoing governance membership | |
|
| Release/upgrade assessments | |
|
| Safety incident support | |
|
| CSO mentorship | |
|
| Continuous business-as-usual support | |
|
The service, impact, and responsibilities are indistinguishable.
The only difference is that fractional tries to package this as a leadership role rather than a consultancy engagement.
But DPM already performs leadership functions for its clients, including:
- Acting as the named CSO for manufacturers
- Supporting and guiding Trust CSOs
- Embedding governance processes that mirror internal leadership
- Advising at Board, Trust, and Programme levels
The “fractional” label adds spin, not capability
The rise of fractional titles in digital health is a trend, not a transformation.
Fractional CSO
Retained Clinical Safety Consultant embedded in governance.
There is no operational, regulatory, or methodological difference:
- Risk management models remain the same (DCB0129, DCB0160, ISO 14971).
- Governance processes remain the same (Clinical Safety Group, Incident Management, SOPs, CRMS).
- Advisory scope remains the same (design reviews, safety sign-off, incident support).
- Deliverables remain the same (CRMP, Hazard Logs, CSCRs).
In short, “fractional” is marketing language, consultancy wearing a leadership badge.
Why DPM prefers clarity over buzzwords
DPM Digital Health offers structured, mature, and standards-aligned Digital Clinical Safety consultancy, which already gives clients:
- Flexibility
- Leadership-level expertise
- Continuity
- Governance integration
- Long-term support
- Specialist capability on demand
Calling this “fractional” risks diluting the precision and regulatory credibility required for NHS safety standards.
We prefer terms that reflect reality:
“DPM provides dedicated Digital Clinical Safety consultancy that functions exactly like a fractional CSO model, but is grounded in formal, standards-aligned Clinical Risk Management practice.”
If a client is thinking, fractional CSO, the model is no different and the service they receive is the same robust, compliant, evidence-driven governance work that DPM has built its reputation on.
