DIGITAL HEALTH ADVISORY

BUILT TO
BE USED

We help medtech companies build digital health products that reach patients, meet regulators, and grow with the business. Senior expertise, without the overhead.

Søren Pedersen and Søren Thorup at a medical conference
At work at a medical conference where we earned our nickname the Sørens
Products that get adopted
We've shipped digital health products with retention rates 10× the industry average. We know what separates products patients actually use from ones they abandon after day one.
Regulatory without the slowdown
ISO 13485, CE-marking, SaMD classification. We've navigated all of it. We build compliance in from the start, so it doesn't derail you at launch.
Teams that scale
We build the capability behind it. Process design and knowledge transfer, so your team keeps executing after we're gone.
Where we fit
Every phase.
One team.
We work across the full product lifecycle. Hover a phase to see how we could help.
01
Product
shaping
02
Product
development
03
Product
growth
04
Product
pivot
Phase 01: Product shaping
You have an idea.
Now make it defensible.
You have a product concept — or a therapy area and a mandate to build something digital. But you're not yet certain what to build, for whom, or whether the regulatory and commercial conditions are actually in your favour. We help you pressure-test the idea against clinical reality, define a product direction grounded in real user evidence, and map the regulatory path before you commit to building anything.
Example engagement
A 4-week Discovery sprint with the main output being a product strategy specifying the exact target audience, core value drivers, business metrics and success criteria, regulatory classification and pathway, and a prioritised roadmap for the first build cycle.
Fractional product leadership
We can lead the discovery sprint as fractional CPO, embedded in your team from the start.
Built-in organisational transfer
The strategy we define becomes yours. We document decisions and assumptions so your team can own the direction after we leave.
Phase 02: Product development
You're building.
Make sure it survives launch.
Strategy is validated and it's time to build. Whether it's a standalone digital therapeutic, a companion app for a connected device, or a clinical decision support tool — the challenge is the same: stay compliant, design for real users, and ship without accumulating technical or regulatory debt. We've launched CE-marked SaMD platforms and connected device ecosystems across 40+ markets.
Example engagement
An end-to-end build engagement covering UX research and design, engineering oversight, ISO 13485-compliant quality system setup, regulatory submission preparation, and go-live readiness. Structured as iterative sprints with defined clinical and commercial milestones at each stage.
Fractional product leadership
We can step in as fractional VP Product for the build, accountable to the clinical and commercial milestones we set together.
Built-in organisational transfer
Every process we put in place, we document for your team: quality systems, sprint structure, review gates. It runs without us.
Phase 03: Product growth
You've launched.
Now make it stick.
The product is live but clinical adoption is slow, engagement falls off after the first week, or pharma partners are asking questions about outcomes data you don't yet have. Growth in digital health is harder than in consumer tech. We bring the behavioural science frameworks, usage data analysis, and product iteration capability to turn a launched product into one that earns its place in a clinical workflow.
Example engagement
A 6-week product audit and growth sprint: analysis of live usage and drop-off data, identification of the top three behavioural barriers to engagement, redesign of critical user flows applying JITAI and COM-B frameworks, and a defined measurement plan with 30/60/90-day retention targets.
Fractional product leadership
We can run the growth sprint as embedded fractional CPO, working directly with your product and clinical teams.
Built-in organisational transfer
The behavioural frameworks and measurement systems we introduce stay with your team. We make sure they know how to run them.
Phase 04: Product pivot
Something isn't working.
Find out what before it costs more.
The product isn't getting traction. The market shifted, the regulatory environment changed, or the organisation that built it has outgrown the way it makes decisions. Digital health is moving faster than most companies can absorb right now — AI is reshaping what products can do and pharma partners want measurable clinical outcomes, not engagement metrics. We help you diagnose what's actually broken — product, process, team, or all three — and reorient without losing what's working.
Example engagement
A 3-week diagnostic engagement covering product-market fit reassessment, leadership and user interviews, technical and regulatory debt audit, and team capability mapping. The output is a prioritised pivot recommendation with a phased execution plan and clear go/no-go criteria.
Fractional product leadership
If the pivot needs interim leadership while you rebuild direction, we can step in as fractional CPO or CTO.
Built-in organisational transfer
The diagnostic and the recommendations are yours to own. We make sure the thinking is transferable, not consultant-dependent.
Our mindset

OUR
APPROACH

Regulated digital products fail at the intersections. Where clinical rigor meets commercial reality. Where a validated strategy meets a team that can’t execute. Where a strong product hits a regulatory wall it could have avoided.

We cover all three, from two people who have done it before.

Between us, we have built digital health products that outperform industry retention benchmarks by 10×, operated inside ISO 13485-certified quality systems, taken products through MDR classification and CE-marking across 40+ markets, and scaled product and engineering organizations from under ten people to 65. Across oncology, neurology, endocrinology, rare diseases, and chronic conditions.

That experience spans two disciplines that rarely sit together: deep user and commercial insight, knowing what patients and clinicians will actually do rather than what the brief says they should, and the regulatory and delivery rigor to get a product to market without accumulating debt you pay for later.

We also have a clear view on AI. Where it speeds up delivery, where it introduces compliance risk, and how to build guardrails that let teams use it without creating problems downstream.

If you need clinical, commercial, and regulatory thinking in one place rather than three, that is the conversation we are here for.

WHERE IT LANDS PRODUCTS THAT GET USED 01 USER & COMMERCIAL INSIGHT 02 REGULATORY MASTERY 03 EXECUTION
SHARED ETHOS

UNIFIED
PHILOSOPHY

WE KNOW WHAT GOOD LOOKS LIKE
We have bought consultancy ourselves. We know the difference between a repackaged deck and advice that actually changes something. We will never deliver work you could have produced with your own information and an AI. Every engagement starts by asking the questions that get to the root of the problem.
WE ARE IN IT FOR THE LONG TERM
The only way to build lasting partnerships is to produce value that is real and measurable, so that is the only kind we produce. We are not optimising for the next engagement. We are optimising for the kind of work that makes clients want to keep working with us.

The team

THE ARCHITECTS
Søren Thorup
TECHNOLOGY / DELIVERY
SØREN THORUP

I've spent 15+ years leading product and engineering in regulated, international technology businesses, the kind where getting it wrong has real consequences for patients.

Most recently I was VP of Technology and Platform at Dawn Health, where I scaled the engineering organisation from 10 to 65 people, launched an ISO 13485-certified SaMD platform, and led delivery of 10+ digital health products across 40+ markets for clients including Novartis, Merck, Novo Nordisk, GSK and Coloplast. Before that I built and led the EU programme management function at BrightInsight, running SaMD programmes with connected device and system integrations across multiple markets. Earlier in my career at ConvaTec, I led the end-to-end development and global launch of the Neria product line — and I'm a co-inventor on six patents from that period.

What I'm best at is the thing most consultants avoid: holding product direction, engineering delivery and commercial reality together in environments where all three are pulling in different directions. I hold a Master of Engineering from DTU.

Søren Pedersen
DESIGN / PRODUCT
SØREN PEDERSEN

I build research-driven product organisations in complex, regulated industries. Teams that make consistently better decisions from real user evidence and live product data.

Most recently VP of Product Strategy and Design at Dawn Health, where I scaled the product and design function from 3 to 24 people across a portfolio of patient-facing SaMD products. For much of that time, my team was also Dawn's product management function, owning vision, roadmaps, and strategy before we grew large enough to spin up a dedicated PM division.

The work was measurable. Products I helped define hit retention rates up to 10x the industry benchmark. Design cycle time dropped 50%. ARR grew 10x. I was part of the leadership team that secured €11.5M and then €21.5M in successive funding rounds.

Before Dawn, I ran large innovation programmes for global companies across pharma, medtech, fintech, and telecoms. Clients have included Novartis, Merck, Coloplast, GSK, Novo Nordisk, Johnson & Johnson, 3Shape, and Maersk.

I hold a Civil Engineering degree in Architecture and Design from AAU, with ongoing training in behavioural science and applied AI.

What I care most about: designing products people actually return to. That means understanding why they behave the way they do, not just what the data shows they clicked.

SELECTED WORK

CASES

A selection of engagements from across the product lifecycle: from early-stage discovery through CE-marked platform launches and international scale-up. All cases are anonymised.

FROM THERAPY AREA TO PRODUCT STRATEGY IN 4 WEEKS
A global pharma company needed to move fast on a digital companion for a newly approved oncology treatment. We ran a compressed discovery phase defining the target user, core value drivers, regulatory classification, and a prioritised build roadmap.
READ CASE
CE-MARKED SAMD PLATFORM FOR A CONNECTED INJECTION DEVICE
End-to-end delivery of a patient-facing companion app and HCP portal for a smart auto-injector. ISO 13485-compliant quality system, design system, and regulatory submission, launched across 40+ markets with an 8x ROI at full roll-out.
READ CASE
MOVING PATIENT ADHERENCE FROM 60% TO 94% IN A LIVE DTX
A launched digital therapeutic for chronic disease management was losing patients after week two. Applying COM-B and JITAI behavioural frameworks, we redesigned the critical user flows. 90-day retention reached 65% against an industry average below 5%.
READ CASE
SCALING A PRODUCT ORG FROM 3 TO 24 WITHOUT LOSING EXECUTION
Rapid headcount growth had created siloed product and design functions with no shared process. We defined the operating model, decision frameworks, OKR structure, and a design system that cut scoping time by 50%, while the team contributed to 10× ARR growth.
READ CASE
DIAGNOSING A STALLED PRODUCT: FINDING THE ACTUAL PROBLEM
A Series B medtech company had a CE-marked product with low clinical uptake. Our diagnostic identified that the adoption barrier was not the product itself but the absence of an HCP workflow integration. A targeted pivot and a new go-to-market model unlocked commercial traction within one quarter.
READ CASE
BUILDING AN AI-POWERED PATIENT COMPANION FOR AN ONCOLOGY TREATMENT
Designed and delivered a smart patient companion for a major pharma partner, integrating AI-driven symptom tracking, side-effect management, and treatment adherence support. The product significantly exceeded clinical engagement benchmarks at launch across multiple European markets.
READ CASE
GET IN TOUCH

TALK TO US.

We work with a small number of companies at a time. Reach out directly. We'll tell you honestly whether we can help.

TECHNOLOGY & DELIVERY
SØREN THORUP
Based in
Copenhagen, Denmark
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PRODUCT & DESIGN
SØREN PEDERSEN
Based in
Copenhagen, Denmark
DOWNLOAD CV