The Six Challenges Defining Clinical Product Right Now

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This is Clinical Product Thinking 🧠, a weekly newsletter featuring practical tips, frameworks and strategies from the frontlines of clinical product.

Welcome, friends, this is issue No. 016 of Clinical Product Thinking. This week we’re diving into the six core challenges faced by clinical product managers today.

Over the past few months, I’ve spoken with over 100+ people working across the clinical product ecosystem, Clinical Product Managers, founders, Clinical Safety Officers, product leaders and regulators.

I asked a simple question:

What are the biggest challenges faced by Clinical Product Managers today?

While the specifics varied by organisation and market, the underlying patterns were remarkably consistent.

This week’s issue distils those responses into six core challenges that are shaping day-to-day clinical product work right now.

1. Regulation vs innovation (the dominant tension)

This is the single most consistent theme.

CPMs are struggling with:

• Balancing regulatory compliance with speed and experimentation

• Building AI or data-heavy products within the evolving regulatory landscape

• Translating regulatory requirements into practical product decisions, not just documentation

This shows up as:

• ‘Regulation vs innovation’

• ‘AI as a medical device, performance vs explainability’

• ‘Engineering approaches to facilitate regulation’

Signal: CPMs respect regulation but currently sometimes lack product-native ways of working within it.

2. Influence without authority

A close second.

Many CPMs describe difficulty:

• Getting buy-in from engineering, commercial or leadership

• Advocating for clinical safety, evidence, or quality when it’s not immediately revenue-generating

• Being listened to without being perceived as the blocker

• Operating in ambiguous roles where decision rights are unclear

This includes:

• ‘Communicating clinical needs to other stakeholders’

• ‘Influencing roadmap decisions’

• ‘Getting clinical considerations taken seriously early, not at sign-off’

Signal: CPMs are often senior in responsibility but junior in formal power.

3. Translating clinical reality into product systems

Another strong theme.

CPMs struggle with:

• Turning messy, contextual clinical practice into clean product logic

• Designing workflows that work across multiple clinician types and care settings

• Avoiding over-simplification without building unusable complexity

• Making products safe and usable in the real world

This often shows up as:

• ‘Product touches many clinicians’

• ‘How to represent clinical nuance in software’

• ‘Bridging the gap between clinical needs and technical implementation’

Signal: This is not a ‘requirements gathering’ problem; it’s a sensemaking problem.

4. Clinical safety integration (too late, too bolted-on)

Another frequently described challenge is clinical safety and how it’s integrated into teams.

Challenges include:

• Safety being treated as a checklist or gate rather than a design input

• Unclear ownership between product, clinical and governance teams

• Difficulty embedding safety thinking into agile development

• Friction between delivery timelines and safety assurance processes

Signal: Teams want safety by design, but many currently lack shared language, tools and rhythms.

5. Evidence, outcomes and ‘what’s enough?’

A quieter but important thread.

CPMs raised:

• Uncertainty around what level of evidence is proportionate

• Tension between real-world evidence and formal validation

• Pressure to ‘prove impact’ without being clear on the standards

• Confusion over how evidence expectations differ by market (UK / EU / US)

Signal: Evidence strategy is becoming a product strategy, but many CPMs feel a lack of clarity.

6. Role ambiguity and career uncertainty (implicit but real)

Present underneath many responses is uncertainty about what clinical product actually is.

CPMs are operating in:

• Poorly defined roles

• Organisations that don’t yet understand ‘clinical product’

• Career paths without clear progression or peer benchmarks

Signal: The discipline is still forming and people feel that.

The underlying pattern

Across all responses, the core issue is not lack of skill or expertise.

Clinical Product Managers are often:

• Holding risk, safety, evidence and user impact

• Moving at startup speed

• Operating without shared frameworks, organisational backing or clear authority

In short:

Many Clinical Product Managers are carrying systemic responsibility in organisations that have not yet built systems to support them.

Closing this gap will require organisational design changes, not better individual performance.

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Your Turn

If you work in or around clinical product:

👉 Which challenges feel most pressing in your work right now?
👉 Where do you think the discipline needs to go next?

I’d love to hear from you - just hit reply.

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That’s all for this week. See you next time! 👋

🤝 Work with me | 📅 Attend an event | | ✍️ Send a message

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Written by Dr.Louise Rix, Head of Clinical Product, doctor and ex-VC. Passionate about all things healthcare, healthtech and clinical product (…obviously). Based in London. You can find me on Linkedin.

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