All work Develop an AI product function for an imaging CRO Healthcare

Setting up a
product function

How opportunities get found, how one becomes a decision, where the capacity comes from, how it turns into revenue, and what runs in the first ninety days.

Contents

Overview
  • 0.1   Core principles
  • 0.2   Two ways a product develops
  • 0.3   Where the business is heading
  • 0.4   The order the function gets set up in
Part 1 — Product development
  • 1.1   Understand the business
  • 1.2   Find the opportunities
  • 1.3   Frame one
  • 1.4   Shape it with Technology and Science
  • 1.5   Prioritise
  • 1.6   Build it
  • 1.7   Decide what stays human
  • 1.8   Automate, augment, amplify
  • 1.9   Evaluate it
  • 1.10   Turn it into revenue
  • 1.11   Build the product unit
  • 1.12   Scientific product leads
  • 1.13   The product agent system
Part 2 — Governance
  • 2.1   Five demands, one pool, three bands
  • 2.2   Two lanes, four forums, one log
  • 2.3   Gated evaluation
  • 2.4   Making the split real
  • 2.5   Product-to-revenue assessment
  • 2.6   Benchmarks and traction
Part 3 — The first ninety days
  • 3.1   Seven streams, three phases
  • 3.2   What depends on what
  • 3.3   Committed outputs
  • 3.4   Anticipated resistance
  • 3.5   The model in one page
Appendix
  • A.1   Non-linear development
  • A.2   Finding the idea
  • A.3   Six questions for this business
  • A.4   Validating it
  • A.5   Governing it: the fourth band
  • A.6   What a shaping session sounds like
  • A.7   Signals that the model is working

Overview

The funding covers platform work, partner work and a regulatory path at once. Each has different customers, different clocks and different ways of failing, and they draw on the same scientists and engineers. This paper sets out how the product function would be built, in the order the work happens.

0.1Core principles

PrincipleWhat it means here
A lean functionOne role to start with. Stewardship spread across people who already work here, and product literacy taught rather than hired.
Diversified revenueMore than one way to be paid for work already being done. The layers inside a single delivery get priced separately before anything new is invented.
Growth-focused developmentStrengthen what already earns, extend it into new offers, raise the value at each payer tier, and sell what the work leaves behind.
Smart allocationOne pool, three bands, set against measured capacity, published, and reversible with the reasoning written down.
A staged progressionService with technology, technology-enabled service, technology-led service. Each one is a position that can be measured.
Product as the connectionEvery material item carries a named owner in Commercial, Operations, Science and Technology. Product brings the four together and makes the trade-off visible.
Frameworks that runEach framework has stated inputs, criteria and output. The same inputs give the same answer whoever runs it, which is also what lets an agent prepare it.

0.2Two ways a product develops

VALUE TIME LINEAR — THE FOCUS OF THIS PAPER every step knowable from the start NON-LINEAR appendix Linear doesn't mean small. It means the path can be planned, dated and held to account, which is what makes it fundable.
The same period, developed two ways.

Linear development means the path is knowable at the start. Each step follows from the last, dates can be attached, and the result can be forecast.

Non-linear development means the destination isn't knowable at the start. A capability throws up something odd, the odd thing gets followed, and the end point is somewhere nobody was aiming. It's managed on cost per learning cycle rather than progress against a plan, and most of the time it ends without a product.

Everything that follows is the linear path. The appendix covers how a non-linear one would be spotted and governed, and the one rule that stops it eating the capacity the plan depends on.

0.3Where the business is heading

TODAYExpert service Imaging and analysisdelivered by experts NEXTConsistent service The same work made fasterand easier to deliver THENPackaged capability Repeatable pieces boughtwith less involvement THENExposed capability Mature capabilities reachedthrough partners SELECTIVELYRegulated software Only where a capability cancarry a claim Each step is paid for by the evidence produced at the step before it.
The trajectory, and the position each step describes.
StageWhere expertise sitsWhat improves the economics
Service with technologyExperts do the work. Technology holds the data and helps the person doing it.Price, and the mix of work taken on. Quality depends on who was assigned.
Technology-enabled serviceTechnology runs the routine path. Experts set the rules, clear the exceptions and sign the result.A falling exception rate. Margin improves without a price change, and delivery becomes predictable enough to quote.
Technology-led serviceThe service runs on the platform. Experts set acceptance criteria, watch the results and audit a sample.Volume grows faster than expert hours. A capability here can be configured by a customer or called by a partner.

0.4The order the function gets set up in

The rest of this paper follows the order the work would actually happen in. Each step needs the one before it.

1Understand the business Blueprint the delivery lifecycle. One shared picture. 2Find the opportunities Four routes in, one intake record, one short review. 3Frame one A one-page thesis, written by whoever raised it. 4Shape it Product, Technology and Science on one proposition. 5Prioritise Admissible first, then five lenses, then sequence. 6Build it Five phases, and a decision on what stays human. 7Evaluate it Repeatability position, and the right to the next step. 8Turn it into revenue Trace it, package it, price it, and sell what data allows. 9Govern it Three bands, two lanes, one log, seven gates. 10Build the unit Stewards, cells, and scientists with a product role. 11Make it survivable An assessment step before every forum that exists. 12Install it in ninety days Seven streams, in the order above. STEPS 1 TO 3 PRODUCE THE CANDIDATES · 4 TO 8 TURN ONE INTO REVENUE · 9 TO 11 MAKE IT REPEAT WITHOUT A DEPARTMENT Nothing here needs a new team. It needs a shared picture of the work, one written route from an idea to a decision, and somewhere the reasoning is kept.
Twelve steps, and the order they depend on each other in.

Part 1 — Product development

1.1Understand the business

The first job is a shared picture of how a study actually gets delivered. Not a process document — a blueprint drawn with Operations, Science and Technology in the room, showing who does what at each phase and where the handovers are. It takes a few sessions in the first month and it becomes the source everyone argues from afterwards.

The value of drawing it is that three separate things become visible at once: where expert time goes, where the work fails, and what the work leaves behind.

DESIGN & QUALIFY ACQUIRE INGEST & QC ANALYSE READ & ADJUDICATE LOCK SPONSOR AND SITE Agrees the protocol, scans the participant, uploads, answers queries, receives the result LINE OF VISIBILITYCROSSING UP = AMPLIFY OPERATIONS Onboarding, chasing, query handling, scheduling, blinding, reconciliation — no doctorate required LINE OF EXPERTISECROSSING UP = AUGMENT SCIENCE Acceptance criteria, every exception, adjudication, sign-off — the constrained resource LINE OF AUTOMATIONCROSSING DOWN = AUTOMATE PLATFORM, UNATTENDED Config, transfer, de-identification, tag checks, processing, provenance, export, audit trail WHERE THE OPPORTUNITY SITS, PHASE BY PHASE Setup and feasibilitymade less manual Feedback to the sitewhile they can still act Obvious checks run,unclear cases routed Routine analysis run,provenance recorded Better tools for experts,hard calls stay human Reporting, traceability,partner integration Drawn from public information. In the role it would be redrawn in the first month with Operations, Science and Technology present. The middle band is the constraint: almost every phase touches a scientist, and in several of them only some of the work needs one.
The delivery blueprint, and the opportunity sitting in each phase.

Three readings of the same map

Read it forWhat to look atWhat it produces
Expert timeWhich phases touch Science, and how much of that work needs a doctorateThe automation and augmentation candidates
FailureWhere work comes back, gets queried, gets redone, or waitsThe exception clusters, ranked by frequency
By-productsWhat the workflow records along the way and nobody countsThe data assets, and what could be sold from them

Every candidate on the roadmap should come from one of those three readings, or from a customer asking. Anything else is someone's preference.

The questions each function asks of the same capability

FunctionAsks
ProductWhat outcome matters here — faster turnaround, lower cost, more capacity, or an earlier decision
ScienceWhat accuracy and reproducibility is needed, and which cases still need judgement
TechnologyWhether it runs consistently across the data that turns up, and what reusable layer that needs
OperationsWhat it does to delivery load, turnaround and the exception queue
CommercialWho buys the outcome, how it's packaged, and whether a fixed-scope entry point makes sense

1.2Find the opportunities

Candidates arrive all the time, informally. Each route knows one thing well and is blind to another, so the route points at the missing evidence rather than whether the idea is any good.

RouteArrives asBringsMissing
OperationsFriction in deliveryFrequency, hours consumed, where it failsWhether anyone would pay, and reuse beyond this study
ScienceA capability that now existsValidity, reproducibility, what can be measuredWho has the problem, and what it's worth to them
CommercialA request, or a lost dealNamed demand, whether budget existsReuse, and cost to serve
PartnerAn integration askReach, and the workflow the customer already usesMargin, and who owns the customer

Two mechanisms turn this into something workable. One intake record: what was raised, by whom, when, and what was said back. One short review every fortnight, where a few items get twenty minutes each, presented by whoever raised them. The output is a test to run with an owner and a date, not a decision to build.

Repetition matters more than enthusiasm. The same ask from unrelated accounts, or the same failure across unconnected studies, points at a problem that exists whether or not the person describing it is persuasive.

InputsIntake record, exception data, won and lost reasons, partner requests, scientific proposals.
CriteriaProblem stated with no solution in it; route named; repetition count from unrelated sources; blueprint phase identified; evidence gap named.
OutputA candidate with its route, its repetition count, its missing evidence, and the cheapest test that would close the gap.

1.3Frame one

One page, written by whoever raised it, with Product filling the gaps their route is weak on. It replaces the business case, which takes longer, gets read by fewer people, and asks about investment before the problem is settled.

FieldQuestion
CustomerWho has the problem
ProblemWhat they're trying to do, and what's in the way
DecisionWhich decision the platform would improve
ValueWhat improving that decision is worth
Business impactWhat changes here: revenue, margin, retention, strategic capability, market position or risk
Why usWhat differentiated capability this leans on
EvidenceWhat's already known
UnknownsWhat could still make it wrong
DeliveryWhat human and technology workflow would deliver it
EconomicsWhat it costs to deliver, including the exception path
Commercial modelHow the customer might pay, and against which budget line
ReuseHow many studies, customers or partners could use it unchanged
Next testThe cheapest credible way to learn the next thing
Stop or pivotThe result that would change the plan

Business impact is a required field. Without it, an item that frees expert hours can't be weighed against one that wins a customer, and the argument defaults to whichever is easier to count.

The hypothesis in one sentence

Investment hypothesisThis customer has this problem. This capability creates this value. They pay for it through this model. It will be clear it worked when this measure reaches this threshold.

Written before the test, not after. Fixing the threshold in advance ends the conversation about whether something sort of worked, and it makes a negative result respectable.

1.4Shape it with Technology and Science

The gap that matters sits before a feature becomes a roadmap item: what exactly is being built, and whether Product, Technology and Science are shaping the same thing. Bring Technology in after the decision and architecture follows the roadmap instead of informing it, which is where the reuse and cost trade-offs get lost.

Where it goes wrongWhat replaces it
Requirements written, then estimatedThe product boundary shaped together
The technical answer is yes or noAlternative designs proposed, reusable pieces identified
Architecture follows the roadmapArchitecture helps set the roadmap
Technical trade-offs appear after launchTrade-offs visible while shaping
The feature gets built onceWhat makes customer two easier is designed in
Technology measured on deliveryTechnology also measured on reuse and cost to serve
CUSTOMER AND MARKET Demand, budget, route to market SCIENCE What must be true, where judgement stays OPERATIONS Whether it can run for real SHAPING SESSION One page, one short session, no standing committee ONE PROPOSITION Clear enough to test, specificenough to cost and to stop Product owns the outcome and the trade-off. Technology owns the design. Science owns what has to be true. USED FOR MATERIAL THESES ONLY · NOT FOR EVERY TICKET OR SMALL CHANGE
Three sources of truth, one session, one proposition.

The canvas

SectionProduct drivesTechnology and Science bring
OutcomeThe outcome and how success is definedWhether it's technically and scientifically meaningful
WorkflowUsers, friction, the experience aimed atSystem boundaries, integration points, dependencies
Scientific truthThe scientific need turned into a requirementScience sets validity and evidence; Technology says what that implies
BoundaryWhat's owned, what's partnered, what's left to the customerReusable platform boundaries and interfaces
Technical shapeBusiness-level requirements and the trade-offs acceptedArchitecture, data, integration, security, how it runs
Automation boundaryThe intended split between human and machineValidation, failure detectability, the controls that follow
EconomicsThe value hypothesis and the commercial modelBuild and run cost, and expert effort retained
RiskWhat could stop adoption or scaleDomain risks and the controls available
ReuseWhat must be reusable from customer two onwardShared components, and what constrains sharing them
Next testWhich uncertainty gets resolved nextThe cheapest technical or scientific experiment

Six questions asked together

  1. What outcome is being changed — the customer or business outcome, not the feature.
  2. What has to be scientifically true, and what evidence proves it.
  3. What the workflow becomes, and for whom.
  4. The simplest technical shape that could deliver it.
  5. Where the human stays, resolved through the boundary test in 1.7.
  6. What would make it reusable. If it only works once, it's a service project.

The shaping loop

Six stages. The point isn't passing a committee, it's reducing uncertainty in the right order. Every stage ends in the same four words.

DISCOVER Customer problemScientific signalOperational pain SHAPE Product outcomeTechnical architectureAutomation boundary PROVE Small experimentCustomer valueScientific and technical evidence PRODUCTISE Repeatable workflowStable data and interfacesLess expert effort COMMERCIALISE Package and priceAdoptionSecond customer SCALE Reusable revenuePartner leverageReliability and risk PRODUCT DECISION Advance · Hold · Pivot · Stop
StageThe decision it ends onWhat has to exist to move on
DiscoverIs this worth shapingThe problem stated with no solution attached, and who has it
ShapeIs this a credible propositionProduct outcome, technical shape and automation boundary agreed together
ProveAdvance, pivot or stopA test against a threshold written before the test
ProductiseCan customer two be deliveredRepeatable workflow, measured exception rate, less expert effort per unit
CommercialiseWill people use it and payA named offer with a price, a contract route and someone selling it
ScaleDoes this deserve more capacityA second customer with no bespoke engineering, and margin that holds

Who decides what

DecisionProductScienceTechnologyCommercialOperations
Customer problem and outcomeAccountableContributesContributesContributesContributes
Scientific validity and claimContributesAccountable, hard stopContributesInformedInformed
Architecture and feasibilityContributesContributesAccountable, hard stopInformedContributes
Automation boundaryAccountableContributesContributesInformedContributes
Commercial propositionContributesInformedInformedAccountableInformed
Delivery feasibility and loadContributesContributesContributesInformedAccountable
Investment recommendationAccountableContributesContributesContributesContributes

Science and Technology don't need to win every debate. They need a way to stop something that crosses their boundary. Product needs a way to make the trade-off when no boundary has been crossed. Consensus does neither: the loudest function gets an informal veto, or a generalist rules on questions they aren't qualified to rule on.

1.5Prioritise

Two different questions get confused here. Where capacity goes is a portfolio question, answered by the three bands in Part 2. Which item inside a band goes first is a product question, answered here.

First, is it admissible

Six inputs have to be present before an item competes at all. If they can't be answered it goes back for evidence. That alone removes most of the volume without anyone having to say no.

InputQuestionFrom
DemandWhich named accounts or partners, what value, repeat or one-offCommercial
ReuseHow many studies, customers or partners use it unchangedProduct
Scientific basisWhether it uses a real edge, and whether the validation path is knownScience
Regulatory claimWhat intended use it creates, and what holding that claim costsQuality and regulatory
Delivery leverageExpert hours and quality hours removed per studyOperations
Cost to serveCompute, storage and exception handling per scan and per studyFinance and Technology

Then, five lenses

BUSINESS IMPACT What changes if thisgets solved Revenue, margin,retention, option value CUSTOMER PULL Whether the demand isreal and repeated Interviews, repeat asks,design partner, paid pilot SCIENTIFIC VALUE Whether it's credibleand hard to copy Validation, performance,reproducibility DELIVERY LEVERAGE Whether delivery getsmaterially easier Expert hours, exceptionrate, configuration, reuse TECHNOLOGY & RISK Whether it can be builtand exposed safely Architecture, data, intendeduse, failure detectability RECORDED AS: WHAT'S STRONG · WHAT'S WEAK · WHAT'S STILL UNKNOWN · WHAT THE NEXT TEST SETTLES No composite score. Two lenses carry a hard stop — scientific validity, and architecture and exposure. Where one is hit, the item gets redesigned or dropped. Where none is hit, the trade-off belongs to Product.
Five lenses, applied to anything competing for capacity.

A single number that ranks everything looks decisive and isn't. The estimates underneath don't carry that precision, people learn to move the weights, and the argument shifts from the decision to the arithmetic.

Where business impact comes from

SourceWhat to askEvidence
Revenue growthDoes this create new revenue or raise the chance of winningNamed opportunity, pipeline demand, a pricing hypothesis
Margin and costDoes it improve the economics of work already being doneCost to serve, expert hours removed, less rework
RetentionDoes it protect or deepen an existing relationshipStated customer pain, support burden, turnaround, repeat use
Strategic capabilityDoes it unlock something elseWhat becomes possible afterwards that isn't possible now
Market positionDoes it create something defensibleWhat a competitor would need in order to match it
RiskDoes it reduce a real operational or regulatory exposureFailure rate, traceability, dependency on individuals

Not every item needs a revenue forecast. Early ones can carry option value instead, as long as that's said out loud and the evidence that would make the option worth taking is written down.

Then, which one first

HOW MUCHIT UNBLOCKS highlow fastslow TIME TO KNOW WHETHER IT WORKED DO THIS NOW Frees the constraint, a lot depends on it, and the answer arrives inside a quarter. Take it into the current quarter whole. FUND IT, BUT STAGE IT Important and slow. Break it into pieces that each produce evidence on their own. Each piece carries its own stop condition. TEST IT CHEAPLY Fast to learn, doesn't unblock much. Fast-lane material. No gate, no committee, just a posted result. SAY NO OUT LOUD Slow to learn and unblocks nothing. Goes on a visible declined list with the reason, so it stops being re-raised. TIE-BREAK: WHEN TWO LAND IN THE SAME BOX, THE ONE CLOSEST TO MONEY WINS
Sequencing by what a thing unblocks and how fast the answer arrives.

The unblocking axis does most of the work. Something that frees ten expert days a month is worth less than something that makes four other things possible. Ordering by value delivered builds a pile of good things that don't compound. Ordering by constraint removed builds a platform.

How much evidence to ask for

A discovery experiment shouldn't have to prove what a mature product proves. Asking for the whole case at the start kills work before it's had the chance to produce anything.

StageThe decisionWhat carries the weight
DiscoveryIs this a real problem worth learning aboutCustomer pull, strategic relevance, scientific plausibility
ProofIs there enough value to justify more workCustomer value, scientific acceptance, feasibility, willingness to pay
ProductisationCan the workflow be made repeatableConfiguration share, exception rate, expert hours, cost to serve
CommercialisationWill customers use it and payConversion, activation, repeat use, margin
ScaleDoes this deserve real capacityRepeatability past the first customer, reusable revenue, reliability

The decision card

One card per item, carried into the review and updated as evidence arrives. It's also the artefact the assessment step in 1.13 reads.

FieldContent
ProblemThe customer, operational or scientific problem
Business impactWhich source above, and by what mechanism
Customer evidenceWho has confirmed it, and how strong the pull is
Scientific evidenceWhat's established, what's still uncertain
Technical evidenceWhat's feasible, what's expensive or dependent
Delivery leverageEffect on expert hours, exception rate, turnaround, reuse, cost to serve
Commercial modelWho pays, for what outcome, packaged how
StageDiscovery, proof, productisation, commercialisation or scale
Biggest uncertaintyThe one question that could kill it
Next testThe smallest experiment that answers it
Capacity askPeople, time, and what gets displaced
DecisionAdvance, hold, pivot or stop
Next gateWhat evidence is needed before the next investment
InputsThesis, six admissibility answers, decision card, current band allocation, capacity already committed.
CriteriaSix inputs present; five lenses recorded with evidence; no unresolved hard stop; stage identified and evidence weighted for it; position on the sequencing matrix.
OutputAdmissible or returned with named gaps and owners. If admissible: a position in the band, the capacity released, and what it displaces.

1.6Build it

Inside a single product the work runs in five phases. Each one has a question and an exit condition, and skipping one usually shows up later as a number nobody trusts or a workflow nobody can hand over.

0INSTRUMENT Can it be seen? Measure the thingbefore changing it. Exit: a baseline nobody 1RELIEVE Does it free thescarce person? Take load off the constraint. Exit: hours back 2STANDARDISE Is it the sameevery time? Same inputs, same outputs, Exit: a service level 3EXTERNALISE Can someoneoutside run it? No expert watching it. Exit: first outside use 4PACKAGE Will someone payfor it separately? Named, priced, sellable. Exit: first sale disputes known exception rate Phase zero is the one under pressure to skip. Without a baseline, every later claim about improvement is an argument rather than a measurement.
Five phases inside one product, each with an exit condition.

Writing a feature

A brief describes outcomes and constraints. Technical solutions stay out of it, because writing them in takes away the decision the technical owner is accountable for. Four things get stated before build.

Four kinds of feature

Only two of them carry a price. Classifying at entry decides whether the item is expected to earn or to be budgeted as cost.

ClassWhat it doesPricedTraced to
ProtectHolds existing revenue. Reliability, compliance, the reasons a customer stays.NoRetention of named revenue
EnableMakes something else sellable. Provenance, versioning, automation, standardisation.NoThe offers it unlocks
CreateA new thing a new buyer pays for, with its own line on an invoice.YesIts own stream
ExpandAn existing customer pays more. Extensions, extra modalities, more sites.YesExtension value on the account

Enablers get traced, not priced. Charging for the piece that makes the sellable thing possible raises the price of the thing being sold and blocks the channel it was built for. The revenue it unlocks gets counted against it instead.

The balance across the four is a health check. Mostly protect means the business is holding position. Mostly create with no enable underneath means shipping things that can't be delivered at a sensible cost.

1.7Decide what stays human

This usually gets argued on whether the technology can do it. In a regulated science business that's the wrong test. If a wrong answer comes out quietly, automating it moves risk rather than cost, however good the method. The question worth asking is where automation increases the leverage of scarce expertise without giving up quality or safety.

Q1 A validated method exists that agrees with an expert not yet EXPERT-LED Q2 The input can be checked against a known envelope unbounded EXPERT-LED, OR REDESIGN THE PROCESS Q3 A wrong answer shows up rather than passing quietly fails silently EXPERT-VERIFIED Q4 The judgement needs nothing beyond what's in front of it needs context EXPERT-VERIFIED Q5 Volume repays validating it, and revalidating it later it doesn't EXPERT-LED, ON PURPOSE THEN THE EXCEPTION RATE SETS THE MODE High, every case reviewed  ·  moderate, exceptions worked as a queue  ·  low, audit sampling The boundaries between the three come from measured data, not from a guess, and get reviewed at each gate.
Five questions, four service modes.
ModeWhat it meansWhat it does to the economics
Expert-ledAn expert does the work.Good margin per unit, no leverage. A choice, reviewed at each gate.
Expert-verifiedAutomated, every case reviewed before release.Leverage on speed and consistency, not on headcount.
Exception-onlyAutomated, people work a queue.The first mode where volume grows faster than headcount.
Audit-sampledAutomated, quality held by sampling and monitoring.The only mode that can be licensed or embedded.

The mode isn't fixed for the life of a capability. As the exception rate falls it moves down the list and margin improves without a price change. That gives the leverage band something concrete to aim at instead of a general instruction to automate. It also gives Science a way to say no that isn't about protecting territory, and Commercial a way to explain why one analysis costs more than another.

Classify the work before deciding what to do with it

Break each step of the delivery workflow into sub-tasks, then classify the behaviour each one demands. The classification picks the move; nobody has to argue about it.

SKILL-BASED Practised, automatic, done withoutconscious attention. Checking, routine processing,standard runs, reconciliation. RULE-BASED If this, then that. The rule existsand an expert applies it. Is this usable? Does this deviationmatter? Which prior do I compare to? KNOWLEDGE-BASED No rule exists. The expert reasonsfrom first principles. Novel design. First-in-kind analysis.Something nobody has seen before. AUTOMATE AUGMENT — encode the rule, keep the person AMPLIFY the output, not the task One pass generates the backlog for all three moves at once, and it settles which move an idea belongs to before anyone argues. It also protects the knowledge-based column, which is the part nobody should be trying to remove.

Asking whether a whole capability can be automated usually gets the answer no, and the conversation stops. Split the task into four stages and the answer becomes specific.

1. Gathering Collecting the input, themetadata, the prior records 2. Analysing Running the method, measuring,comparing over time 3. Deciding Is this usable? Is this real?Does this hold? 4. Acting Releasing the value,exporting, locking AUTOMATE FULLY AUTOMATE FULLY KEEP THE HUMAN ONLY IF FAILURE IS VISIBLE
Automate stages one and two completely. Present stage three to a person who is now much faster at it. Automate stage four only where a wrong answer would be caught.

Where expertise stays, and why

DimensionQuestionA high score means
JudgementHow much interpretation is neededKeep expertise close
RiskWhat a wrong output costsMore human control, earlier
VolumeHow often it happensBetter economics for automating
StandardisationWhether it can be made consistentAutomation is feasible
LeverageWhether automating creates reusable capabilityWorth more than the hours saved

What a designed loop produces

A loop that's designed gives four things back: the exception record that sequences the next piece of automation, the evidence behind the claim, the audit trail the regulated setting needs, and the data that lets the mode move. A loop that exists as a fallback gives none of them, because nothing gets recorded in a usable form.

ElementSettled before build
TriggerWhat sends a case to a person instead of through
PresentationWhat they see: the proposed answer, where it came from, where confidence is low
Decision setA closed set of responses, so outcomes can be counted
RecordWhat gets written down, in a shape that supports analysis later
FeedbackWhere the outcome goes, and what it changes
Role around the workflowHolds
OperatorRuns it, handles routine exceptions inside the rules
ReviewerResolves what the rules don't cover, and classifies it
AuditorSamples released output, watches failure rates, raises a validation event on a shift
Accountable expertOwns the acceptance criteria and the claim, signs any change of mode

Splitting these roles is what lets work cross the expertise line. When one person holds all four, every case costs the most expensive role in the set.

1.8Automate, augment, amplify

Automation is the narrowest of the three, and the one most platform strategies start and stop at. The other two change different things and get measured differently, which is what makes this a progression rather than three similar words.

MoveWhat changesWhere the value shows up
AutomateThe machine does repeatable work without a person doing it each timeExpert hours per unit, and turnaround
AugmentA person does better work than they could alone, or a different person can now do it at allWho can perform the step, and consistency between people
AmplifyThe same expertise reaches people who will never meet a scientist hereCustomers served per capability, and partner-originated revenue

On the blueprint these are directions of travel: down across the automation line, up across the expertise line, up across the visibility line. A roadmap becomes work crossing a line rather than a list of features.

The obvious fourth step is autonomy. It's left out. In a regulated imaging business it contradicts everything worth saying about failure detectability and audit sampling, and it tells the science team their expertise is on a countdown.

Different moves, different measures

Each move needs its own measures. Judging an augmentation feature on cost per scan makes it look like a failure. Judging automation on user satisfaction makes it look like a success when it isn't.

AUTOMATE Exception rate per volume Cost per unit and per study Throughput per pipeline Turnaround, arrival to value Rework rate Failure detection rate what share of wrong answersget caught before release AUGMENT Expert hours per study Time on task, per decision Agreement between reviewers,before and after Workload, measured properly Time for a new starter to reachcompetence Trust calibration override rate when the machine iswrong, and when it is right AMPLIFY Task success for an untrainedexternal user Time to first result, new study Support contacts per study Self-service completion rate Studies served per capability Integration two versus one the test of whether the patternis a product or a project The three highlighted are the ones nobody usually measures, and they decide whether this is safe Automation that's right most of the time and silent about the rest is worse than automation that's right less often and says so. Trust calibration catches over-reliance and under-reliance, and both cost money. The integration comparison is the only honest test of the partner thesis.

Depth inside automation

LayerWhat runs without a personWhat has to exist firstWhat it changes
Task executionA defined step on defined inputsA validated method, a bounded inputTime per unit, consistency between operators
Flow controlRouting, sequencing, retries, queues, notificationA stable definition of done and of failedElapsed time and coordination effort, usually bigger than processing time
Judgement supportA proposed decision with its evidence, confirmed by a personProvenance on every value, and a record of the confirmationWho can do the step. It moves to a wider group.
Assured operationThe whole path, with quality held by sampling and monitoringDetectable failure, a watched population of results, a defined response to driftThe capability becomes licensable, and cost separates from headcount

Sequencing follows how often something fails, not how interesting it is to build. The layer that removes the most frequent failure pays back faster and also produces the data the next layer needs.

1.9Evaluate it

0Bespoke Built for oneengagement 1Repeatable Repeatable by thepeople who built it 2Standardised Defined procedure,any qualified person 3Configurable Set up withoutengineering 4Customer-run Runs with no expertwatching 5System-run Consumed insideanother platform Three to four is the whole platform question A partner can only sell something that runs without a scientist in the loop. Scored per capability, with Science and Technology. The roadmap becomes a set of named moves up this scale, which Science, Technology, Commercial and the board can all read at once. Position also sets what's possible commercially: below three it's a service, at four and above distribution opens up.
Where a capability sits, and what that position allows.

Moving a capability up the index

ScoreWhat it meansWhat becomes possibleWhat has to change to move up one
0Bespoke expert workExpert-led delivery onlyWrite down what was done, so it can be done again
1Repeatable internallyA standard operating procedureMake the inputs and outputs the same every time
2Standardised serviceA fixed-scope package with a priceTurn build steps into configuration steps
3Configurable, productisedLower-touch delivery, quotable in advanceGet the exception rate low enough that nobody has to watch it
4Low-touch external useRecurring or usage-based revenueA stable contract, a permissions model and a support model
5Embedded or partner-distributedAn ecosystem model
Position also sets what's commercially possible. Below three it's a service. At four and above, distribution opens up. Scoring is done jointly with Science and Technology, and re-scored at each quarterly gate.

Earning the next investment

A thesis doesn't have to prove the whole business before getting capacity. It has to show why the next unit of capacity is rational.

StageGets enough capacity to proveReleased by
ProblemThe problem is real and sharedUnrelated accounts describing the same thing
ProofValue and feasibilityA test against a threshold set in advance
RepeatableDelivery is consistentA defined procedure, a measured exception rate, delivery by someone else
ViableCustomers use it and payConversion from a proof of value, and margin against cost to serve
ScalableThe first success wasn't a one-offA second customer delivered with no bespoke engineering

The scorecard

DimensionLeadingProductOutcome
Customer pullQualified signals, interview evidence, design partnersProof-of-value conversion, onboarding, repeat useExpansion, retention, referenceability
Scientific qualityEvidence maturity, validation planPerformance against a comparator, reproducibilityScientific acceptance, reuse across studies
DeliveryTime-to-value plan, workflow mapTurnaround, configuration share, exception rate, human hoursFaster deployment, lower support burden
EconomicsUnit-cost model, price hypothesisCost to serve, revenue per expert hourGross margin, payback, reusable revenue
DistributionPipeline and partner interestActive customers, usage, readiness for customer twoPartner-sourced revenue, multi-customer adoption
Platform and riskArchitecture readiness, intended-use assessmentReliability, traceability, version controlRegulatory readiness, sustainable operating risk

1.10Turn it into revenue

A feature isn't a revenue stream. Two things sit between them, and both get skipped: the operational change the feature causes, and the economic change that follows from it. Naming them is what makes the claim checkable.

THE FEATURE OPERATIONAL CHANGE ECONOMIC CHANGE REVENUE STREAM What gets built What people stop doing,or can now do What that does to cost,price or win rate Which stream it lands in,and how it's measured An item with no operational change is a preference. An item with no economic change is hygiene, and gets budgeted as such. A stream that can't be walked back to named features is an aspiration. Cheaper to say so early. Every roadmap item names all four. Walked forward it says what the build earns; walked backward it says what has to exist before an invoice.
Four links, walked both ways.

The longer form of the same chain gets used when an item is being written up rather than checked: problem, who has it, what changes if it's solved, which capability creates that, how the capability is delivered, how it's charged for, what it costs to serve, and what measurable result says it worked.

Unbundle before inventing

A study gets delivered as one item and invoiced as one item, but it contains several services with different buyers, different cost structures and different ceilings: site access and qualification, capture and harmonisation, computation, expert interpretation, evidence assembly, comparison against a wider population, and delivery into someone else's workflow. Pricing them separately, internally at first, shows which layer carries the margin and which is subsidising the rest. Most new revenue in an analytics business comes from selling one layer to a buyer who'd never buy the whole thing.

Making an offer out of a capability

ElementQuestionWhat happens without it
NameWhat it's called, in the customer's wordsSold as some analysis work, priced by argument each time
BuyerWho signs, and whether a budget line already existsEnthusiasm from someone who can't purchase
Value unitWhat they're countingEvery deal quoted from scratch
PromiseWhat's guaranteed, and what happens if it's missedScope arguments after delivery
BoundaryWhat's explicitly not includedMargin leaking into unpaid extras
Price and floorWhat it costs at the margin, and the lowest acceptable priceDiscounting below cost, invisibly
Contract pathWhether it can be sold without a full study agreementA small package carrying a large package's paperwork
SellerWhose target it lands onA real offer nobody is paid to sell

Contract path and seller are the two that get forgotten, and both are product decisions even though neither is software. They belong on the roadmap next to the build.

How much of the work the customer does

1Expert-led Project and study fees 2Productised Fixed scope, fixed price.The way in. 3Assisted Customer runs most of it,support on exceptions 4Self-service Only where the workflowis provably standard 5Embedded The partner already ownsthe customer workflow 6Licensed Inside someone else'sproposition Involvement falls left to right. Recurring and licence revenue only becomes possible once a capability reaches repeatability level four. True self-service for trial imaging isn't credible near term — the compliance and procurement path puts a person in the loop by design. Level two is the practical entry point: a fixed-price package bought without a full study agreement, which converts into larger work.
Six levels of customer independence, each with a different revenue shape.

Matching the model to the customer

The point isn't to push everyone to self-service. It's to stop expensive expert delivery being applied to every customer regardless of what they're worth.

Customer positionModelWhy
Lower value, lower complexityFixed package or self-serviceLow cost to serve, low friction to buy
Medium value, repeatable needProductised service, pooled supportKeeps expertise while cutting bespoke work
High value, complex needManaged service with named scientific supportThe value justifies the expert involvement
Strategic or ecosystem partnerIntegration and a strategic relationshipMulti-study, distribution and embedded potential

Selling what the work leaves behind

Data doesn't become revenue in one step. Each level needs the one below it, and the bottom two earn nothing directly.

LevelWhat happensRevenue
Use itFix the exceptions, find the clusters, bring the failure rate downNone. Everything above depends on it.
Reflect itGive it back to whoever generated it, against the wider networkNone directly. Buys retention and better inputs.
Compare itShow how one site, protocol or cohort sits against everything else seenFirst sellable level
Predict with itSay in advance what a given design will produceSold before a contract exists, which is also when it helps win the work
Price the riskGuarantee an outcome instead of selling the effortA different margin structure, set by the buyer's risk rather than by cost

Rights position gets stated before any of this is proposed, because it's the first question anyone asks. Operational and process metadata usually sits in a different position from patient-level data, and that difference decides which candidates are product work and which are legal projects. The cheap move is a contract template that seeks aggregate-use rights in exchange for giving the customer access to the resulting comparison. It costs nothing today and it compounds with every study signed afterwards.

Testing a stream before pricing it

  1. Does the buyer have a budget line for this kind of thing today.
  2. What's the unit, and does it grow with their activity or with selling effort.
  3. What does one more unit cost to serve, including the expert exception path.
  4. Does it displace revenue that would have been earned anyway, and in what proportion.
  5. What has to be true before an invoice can go out: capability maturity, a price, a contract route, and someone whose job it is to sell it.

The fourth is the one people skip. Where a channel reaches segments not sold to directly, the volume is new. Where the segments overlap, a written channel rule is easier to enforce than a price floor and settles the question before the first conflict rather than after it.

InputsRoadmap item, feature class, the capability it creates, the operational and economic change, offer elements, target stream, rights position where data is involved.
CriteriaForward walk reaches a named stream; backward walk reaches named features; feature class matches the price position; route-to-market level matches the repeatability position.
OutputTraced or untraced, with the broken link named and one of five diagnoses applied.

1.11Build the product unit

The function starts as one role, supported by people who already have day jobs. A director who tries to be the product manager for everything becomes the bottleneck the role exists to remove, so what the function refuses matters as much as what it owns.

OwnedConvened, not ownedNot done
The portfolio and the band splitScientific validity and biomarker strategySprint management and delivery coordination
Gate decisions and the decision logArchitecture and technical designWriting technical solutions into briefs
The interfaces between componentsPricing, which Commercial ownsOwning day-to-day backlogs
Reuse, cost to serve, packaging inputCustomer relationships, which Commercial and Operations ownAttending every delivery meeting
The productisation measure and its baselineRegulatory strategy, which quality and regulatory ownsBeing the only person who knows things

Cells, not squads

A squad model needs a product manager per squad. Instead, a small cell forms around a live thesis, made of people already here, and ends when the question is answered. Nobody leaves their day job for it.

PRODUCT FUNCTION · portfolio · band split · interfaces · gates · decision log CELL · around one thesis Product lead — whoever is closest tothe problem, often not Product Science lead — validity and evidence Technology lead — architecture, reuse Commercial owner — demand, pricing COMPONENT · a standing area A steward drawn from existing businessanalysts, product owners, scientists and project managers Keeps the repeatability position honestand brings items to the review FOUR NAMED OWNERS Science — hard stop on the claim Technology — hard stop on exposure Commercial — demand and price Operations — delivery reality NOTHING PASSES A GATE WITHOUT ALL FOUR PRESENT · A CELL IS A ROLE, NOT A POST · IT ENDS WHEN THE THESIS IS ANSWERED Stewardship also spreads context on purpose, which is the mitigation for deep knowledge sitting with a few people.
One function, standing components, temporary cells.

In a specialist business the real fight is rarely about priorities. It's about whose expertise counts as authoritative. Naming four owners and giving two of them a hard stop settles that up front, and it costs the product function very little in practice.

Components, not squads

A squad model needs a product manager per squad. The alternative is a component model with stewardship spread across people who already work here.

PRODUCT FUNCTION — portfolio · capacity split · component interfaces · gates · decision log 1Ingest andsite access Upload, checks,site onboarding 2Data andharmonisation Canonical model,normalisation 3Analytics andmeasurement Methods,validation 4Reads andadjudication Expert workflow,blinding, audit 5Setup andconfiguration The productisationbottleneck 6Reporting anddelivery Exports, schemas,sponsor systems 7Partnerinterfaces Contract, tenancy,permissions 8Regulatedproduct Intended-useboundary, claims S T C O S T C O S T C O S T C O S T C O S T C O S T C O S T C O S — Scientific ownerValidity, evidence, performance. Hard stop on the scientific claim. T — Technical ownerArchitecture, feasibility, engineering standards. Hard stop on exposure and design. C — Commercial ownerDemand evidence, pricing input, customer access, positioning. O — Delivery ownerWhether it runs in the real world: exception load, turnaround, support. Every component and every growth item carries four named people. Nothing passes a gate without all four. A steward is a role, not a job.
Components five and seven are where the platform strategy is won or lost. Setup and configuration is the productisation bottleneck; partner interfaces is the first place a stable external contract has to exist.

Build, buy, partner or decline

ChoiceUsed whenEffect
BuildDifferentiated scientific capability and intellectual propertyProtects and compounds what's already an advantage
BuyCommodity or regulated-standard capabilityKeeps scarce engineering off non-differentiating infrastructure
PartnerSomeone else has the distribution, workflow or complementary capabilityEcosystem leverage instead of rebuilding the stack
DeclineLow demand, low reuse, weak economics or poor fitProtects capacity, and lets the organisation say publicly what it isn't doing

The decline column is the most useful one. A lean organisation has to be able to state what it isn't doing, so people stop asking.

1.12Scientific product leads

The aim isn't to turn scientists into junior product managers. It's to make them better at turning a scientific insight into a product decision, while Product absorbs the commercial and delivery mechanics. That distinction is what makes the path acceptable to the people asked to walk it.

SCIENTIST Scientific truth anddomain judgement Default state CONTRIBUTOR Joins a discovery session,reviews a thesis Early signal, limited time SCIENTIFIC PRODUCT LEAD Owns one bounded thesisthrough a defined gate Where a capability has real potential PRINCIPAL / MENTOR Leads a capability portfolio,coaches the next lead Only after the first one works What Product supplies, stage by stage: the commercial questions, then discovery and method, then coaching, economics and documentation. In a company where a quarter of people hold doctorates, the only senior path is usually management. This makes a second one, at no cost to headcount.
Four stages, each with a different contribution and a different level of support.

Making the time real

This falls over when the time is notional. One of four mechanisms gets chosen for each person, explicitly, rather than assumed.

MechanismUsed when
Protect time inside the bandThe thesis matters strategically, and the allocation sits in the split rather than on top of it
Remove workThere's lower-value work that can stop
Business analyst or product owner supportThe expertise is there but the bandwidth isn't
A short external burstA specialised skill is missing for a while

Learning it by doing it

ModuleWorked onWhat it builds
1From science to problemOne capability rewritten as a customer problemProblem framing
2Customer discoveryInterviews with sponsor, diagnostics or partner peopleCustomer evidence
3The product thesisThe one page, writtenProduct judgement
4Value and economicsValue, cost to serve, a commercial hypothesisCommercial thinking
5Experiment designThe smallest credible test, threshold set firstLearning discipline
6ProductisationThe boundary test and the route-to-market optionsDelivery-model thinking
7Risk and intended useBoundaries set with quality, regulatory and TechnologyRisk-aware product thinking
8Portfolio decisionA thesis presented for advance, hold, pivot or stopExecutive communication

Sessions on validity, architecture and regulatory claim are led by those functions rather than by Product. Two run the other way, with scientists teaching Product and Commercial the underlying science. That buys more credibility than anything Product could deliver on its own. Everything worked on is live; there are no case studies.

1.13The product agent system

Every framework here has stated inputs, criteria and output. That's what makes an assessment come out the same whoever runs it, and it's also what lets part of it be prepared automatically. What follows is a check that runs before meetings that already exist. Not a decision engine, and not a new platform.

Whoever is about to submit something runs it first. They get a verdict and a list of what's missing, and they fix what they can before anyone else's time is spent. Then the same assessment travels with the item into the review, so everyone reads the same page.

1 · Draft Whoever raised it writeswhat they've got 2 · ASSESS Runs in minutes. Verdictplus a gap list. 3 · Close The submitter fixes whatcan be fixed 4 · SUBMIT WITH THE PACK Everyone reads the samepage before the meeting re-run until the gaps are closed or explained THREE VERDICTS, AND NOTHING ELSE Ready — inputs present, precedent found, no unresolved conflict.  ·  Not ready — named gaps, named owners.  ·  Escalate — contractual or regulatory urgency that shouldn't wait for the next meeting.
The same pattern at every checkpoint, run before submission rather than after.

The value is in what never reaches the meeting. A lot of what gets deferred today is deferred for a missing number the person who raised it could have found in twenty minutes, if anyone had told them it was needed.

What each check applies

FrameworkThe question it settles
AdmissibilityWhether an item is formed enough to compete for capacity
Five lenses and the decision cardWhether the evidence supports the next unit of investment
Sequencing matrixWhich of the admissible items goes first
Boundary test and service modesHow much human review is needed
Repeatability scaleHow close it is to running without an expert watching
GatesWhat evidence has to exist before more gets invested
Route-to-market ladderHow much involvement delivery still needs
Feature-to-revenue traceWhether it connects to a stream in both directions

Where the checks sit in the workflow

Something arrivesClient ask, delivery pain,scientific idea, partner CHECK 1Intake — is this evenadmissible? Thesis writtenOne page, by whoeverraised it CHECK 2Pre-review — thefive-lens pack MONTHLY REVIEWAdvance, hold, pivot, stop CHECK 3Pre-gate portfolio pack QUARTERLY GATECapacity, stop dates, roadmap Work gets builtPlatform and Science CHECK 4Release readiness RELEASE DECISIONTechnology, quality, Operations CHECK 5Pre-board summary BOARD PAPERSQuarterly

What each one reads and hands over

CheckpointRuns beforeReadsProduces
IntakeAnything reaching the monthly agendaIntake record, decision log, past theses, contract summariesAn admissibility card: which inputs are present, who has asked before, proposed band
Pre-reviewThe monthly portfolio reviewThesis and decision card, validation records, exception telemetry, contracts, pipelineOne page per item against the five lenses, plus a gap block with owners
Pre-gateThe quarterly capacity gateThe quarter's decision log, band status, trace statusBand adherence, untraced items, untraced streams, stop conditions coming due
Release readinessA platform releaseThe change set, active study list, method versions in use, intended-use registerWhich live studies are affected, whether comparability is at risk, whether a claim changes
ReportingBoard papersThe quarter's decisions and measures, what shipped and what stoppedA draft summary in the language the board already uses

Specifying one

ElementDefinition
TriggerWhat makes it run, and who runs it
SourcesThe records it reads, and the access needed
CriteriaThe framework applied, by version
OutputA fixed structure: verdict, gaps with owners, precedent found, conflicts
Verdict setClosed, so results compare across items and over time
ReviewerThe person accountable, who stays accountable whether or not it was assisted

Build order follows the records. A check that reads a decision log, a version register and a contract summary becomes possible as soon as those exist in a consistent shape, which makes the record-keeping in the first ninety days the thing that unlocks this layer rather than a separate project. The release check is the one with real money behind it, because a method change inside a running study affects comparability across the whole study rather than one result.

Part 2 — Governance

Part 1 covers how something becomes a product. This part covers who decides, on what evidence, and where the capacity comes from. The aim is to take decisions off the calendar rather than add meetings to it.

2.1Five demands, one pool, three bands

Two roadmaps already exist: a platform roadmap owned by Technology and driven by operational requests and near-term client work, and a science roadmap owned by Science and split between long-term clinical strategy and near-term client needs. The growth agenda doesn't add a third stream. It adds three — partner integration, automation and standardisation, and the regulatory path — each with its own clock, buyer and way of failing.

Merging the two roadmaps would remove what makes each of them work: scientific judgement, architectural coherence, contractual awareness. What unifies is the decision framework and the capacity view. Ownership stays where it is.

DEMAND CAPACITY BANDS Contracted deliveryOperations, client commitments Platform roadmapTechnology Science roadmapScience Partner integrationCommercial and Technology Regulatory pathQuality and regulatory ONE POOL Expert weeks andengineering weeks,counted separately RUN What has to be delivered because the current business depends on it Ring-fenced first. Never traded down mid-quarter. LEVERAGE What makes today's business more scalable or profitable Has a floor. Client pressure can't eat it. GROW What could create new reusable revenue or strategic capability Evidence-gated on entry. Every item has a stop condition. Set quarterly against measured capacity, and published. Inside a band, the owner sequences without convening a committee.
Five demands, one pool, three bands.
BandPurposeRulePrioritised on
RUNKeeps the current business runningRing-fenced first, never traded down mid-quarter. Changes belong to Operations and Commercial.Delivery obligation. Inefficient run work can be challenged, but not deprioritised.
LEVERAGEMakes today's business cheaper and more scalableProtected floor. This is the first thing sacrificed to client pressure, and the only route to structural margin without a price rise.Measurable leverage — expert hours, exception rate, turnaround, configuration share, cost to serve — weighted by how important the workflow is.
GROWCreates future revenue and optionsEvidence-gated on entry, reviewed at each quarterly gate against a written stop condition.Strength of customer pull, business impact, scientific and technical credibility, and a route to market.

What each function brings and holds

FunctionBringsHolds
CommercialDemand evidence, whether budget exists, pricing, channel positionPrice and packaging
OperationsDelivery feasibility, exception load, hours consumed, turnaroundChanges to contracted delivery
ScienceValidity, evidence, the validation path, acceptance criteriaA hard stop on the scientific claim
TechnologyFeasibility, architecture, exposure, cost of running itA hard stop on architecture and exposure
Quality and regulatoryIntended use, claims, change controlThe regulatory boundary
ProductThe portfolio view, sequence, reuse, cost-to-serve logic, the trace to revenueThe trade-off, and the gate record

Decision rights

One accountable owner per decision. Hard stops sit with whoever carries the professional risk, and get used at gate entry rather than at launch review. Consensus does one of two things in a specialist business: the loudest function gets an informal veto anyway, or a generalist ends up ruling on questions they aren't qualified to rule on.

DecisionAccountableHard stopRatified
Problem, proposition, who it's forProductExecutive
Build, configure, partner or declineProductTechnology on architecture; Science on validity; quality and regulatory on the claim
Moving something from bespoke to reusableProductScience, TechnologyExecutive
The capacity splitExecutive forumFinance on the envelopeExecutive
Order of work inside a bandBand ownerProduct
Advancing through a gateProduct and Science togetherScience on validity
Scale, pivot or stopProduct proposesScience, TechnologyExecutive
Changes to contracted deliveryOperations and Commercial
Pricing and packagingCommercialProduct on reuse and cost to serve; Finance on the margin floorExecutive

2.2Two lanes, four forums, one log

Gates protect against expensive mistakes. They also make small experiments impossible, because nobody convenes a committee to spend three days finding something out. So there are two lanes with different rules, and most of the volume goes through the fast one.

FAST LANE Contracted delivery, protocol changes, site support, and small changes with no claim and no exposure Operations and Commercial decide. A written plan and a posted result, no approval step. A published limit runs from raised to decided, so speed is a commitment rather than a claim. SLOW LANE Anything that eats growth or leverage capacity, changes a claim, or creates an external commitment Enters through admissibility, gets the five lenses, and passes a gate with four owners present. Volume here is small by design. If it grows, the admissibility criteria are what to look at. The lane gets decided at intake, not negotiated afterwards.
Two lanes, one criterion for which applies.
ForumPurposeCadenceQuestion
Discovery reviewDecides which signals deserve a thesisFortnightly, shortIs this worth investigating
Portfolio reviewAdvances, holds, pivots or stops live thesesMonthlyWhat did the evidence show
Capacity gateSets the band split, confirms stop conditions, approves the next two quartersQuarterlyWhere does the next unit of capacity go
Delivery reviewUnblocks live work. No roadmap decisions here.Weekly, shortWhat's stopping delivery
Scientific and regulatory gateProtects scientific and regulatory authorityAt gates, or on triggerIs the claim acceptable

The weekly one matters most for what it doesn't do. Delivery meetings are where roadmaps quietly get rewritten by whoever is under the most pressure that week.

One artefact

Each entry in the decision log records the decision, the date, the owner, the band, the evidence relied on, the capacity committed, what would change the decision, and when it gets looked at again. The last two are the ones that matter. They make reversing a decision cheap and unembarrassing, which is what placing bets in a moving market requires. A decision reversed on new evidence is the system working. A decision reopened with no new evidence means the decision rights aren't real.

2.3Gated evaluation

Ideas earn capacity as they earn evidence. Promotion is joint between Product and Science; validity stays a single function's call. The decision at every gate is one of four words.

G0 SIGNAL Something pointsat a realopportunity G1 PROBLEM Big enough tochange whatpeople do G2 FEASIBLE Science andTechnology cancredibly solve it G3 VALUABLE Someone pays,or it saves realmoney G4 REPEATABLE Delivered thesame way twice,at a known cost G5 SCALABLE Works past thefirst customer G6 REGULATED Only where aclinical claim isneeded EVIDENCE RISES LEFT TO RIGHT, AND SO DOES THE INVESTMENT RELEASED FOUR WORDS AT EVERY GATE · ADVANCE · HOLD · PIVOT · STOP Seven gates isn't seven meetings. Most items die at G1 in a fifteen-minute conversation, and the ones past G4 are decisions already being taken. Naming them lets a scientist see what evidence unlocks the next slice of investment instead of guessing what would persuade someone.
Seven gates, each releasing the investment the evidence has earned.
GateEvidenceSigned by
G0 SignalCustomer request, scientific insight, operational pain or partner interest, with the repetition recordedProduct
G1 ProblemInterviews, won and lost reasons, workflow observationProduct and Commercial
G2 FeasibleValidation data, prototype, technical spikeScience and Technology
G3 ValuableA paid proof of value, willingness to pay, or time and cost demonstrably savedCommercial
G4 RepeatableStandard inputs and outputs, quality control, measured exception rate and cost to serveOperations and Science
G5 ScalableA second or third customer, a repeatable integration, margin that holdsProduct and Technology
G6 RegulatedIntended use, clinical evaluation, quality system, submission planQuality and regulatory, with Science

2.4Making the split real

In a lean organisation, scarce scientific and engineering capacity behaves like capital. Governance should show not just what the company wants to build but what capacity each intention consumes.

2.5Product-to-revenue assessment

The trace from 1.10 shows up in governance as two extra columns on the portfolio view — the value unit and the stream — and one question at the gate: which stream does this touch, and can the walk down to named features be made. If neither direction survives, the item goes back rather than in.

What shows upHow it looksWhat happens
Untraced itemOn the roadmap, traces to no stream, and isn't classified as protectReclassified as hygiene with an explicit budget, or dropped
Untraced streamIn the plan, and the backward walk finds no featuresCalled an aspiration, with the gap named and dated
Mispriced enablerSomebody wants to charge for the thing that makes the sellable thing possibleTrace it to what it unlocks, count that revenue against it, leave it free at the point of use
Uncaptured creatorSomething with its own buyer is being delivered inside a bundled feeName it, price it, give it a contract path and an owner
Unsold offerA real package exists and lands on nobody's targetAssign a seller, or withdraw it

2.6Benchmarks and traction

Benchmark against ourselves first. Generic software benchmarks describe a business with a different cost structure, a different buyer and no validation obligation, and importing them produces targets nobody can act on. The first quarter sets a baseline. Direction of travel comes after that.

The one number

Configuration share of new-study setup — how much of a new study can be stood up without engineering. If it's rising, licensing gets cheaper to deliver, onboarding speeds up, margin improves structurally, and the regulatory conversation gets less expensive because the validated surface is smaller. If it's flat, features are shipping and the platform position isn't moving.

Baselines to establish

AreaBaselineDirection
ActivationTime from contract or onboarding to first useful outputDown
Workflow efficiencyExpert hours per study or per analysisDown
AutomationShare of eligible workflow steps automatedUp
ExceptionsException rate and resolution timeDown
AdoptionShare of eligible studies or capabilities using platform functionalityUp
CommercialisationProof-of-value conversion, and expansion revenueUp
ReuseReusable capability ratio, and position on the repeatability scaleUp
Roadmap healthPlanned against unplanned workMore planned
Decision velocityTime from raised to decidedDown
Portfolio economicsExpected value against scarce capacity consumedUp

The formulas

MeasureHow it's worked outWhat it shows
Configuration shareSetup done by configuration ÷ total new-study setupMovement from platform to product
Expert leverageOutput volume ÷ expert hoursWhether automation is actually freeing specialists
Exception rateCases needing intervention ÷ total casesHow scalable an automated workflow really is
Time to valueAccepted work to first usable outputCustomer experience and operational friction
Proof-of-value conversionConverted to paid ÷ completed proofs of valueWhether learning turns into revenue
Second-customer repeatabilitySecond customers with no bespoke engineering ÷ second customersWhether the first success was a one-off
Revenue per expert hourRevenue supported ÷ expert hours consumedScientific leverage in commercial terms
Integration leverageSecond integration effort ÷ first integration effortWhether the pattern is becoming reusable
Decision latencyMedian days from raised to decidedWhether governance is faster than what it replaced
Re-litigation rateDecisions reopened with no new evidence ÷ total decisionsWhether the decision rights are accepted

Two families

Does the market value what was builtIs the operating model working
Partner-originated revenue and pipeline
Live integrations on the repeatable pattern
Recurring and licence share of revenue
Reuse — customers per shipped capability
Time to first result for a new study
Customer extension rate and value
Gross margin by offer type
Order book concentration by indication
Band adherence — actual against planned
Exception rate and queue age
Expert hours per study
Share of growth items with all six inputs at entry
Decision latency, and decisions reopened with no new evidence
Share of capacity eaten by unplanned work
Rework and impairment on platform assets
Gate throughput — promoted against stalled
Stewards trained, and theses authored outside Product

Reporting only the first family is how a company finds out too late that its process was theatre. Decisions reopened with no new evidence is the one to watch hardest — it points at a relationship to repair rather than a forum to redesign.

Part 3 — The first ninety days

All of it has to go in alongside live delivery. Seven streams run at once rather than three phases in a row, because they depend on each other: records before agents, a measured denominator before any split, cost to serve before any price. Contracted delivery is where care is needed, and nothing in it moves in the first month. Most of what the growth agenda needs isn't in flight at all, which is where the work goes first.

3.1Seven streams, three phases

DAYS 1–30 — find out what's true DAYS 31–60 — try it on something real DAYS 61–90 — make it the way things work
Learn the product Map how a study actually gets delivered, with Operations, Science and Technology. Sit with the people doing the work. Watch one setup end to end. Score every significant capability on the repeatability index, jointly. Agree which ones are worth moving. The map and the scores become the thing the roadmap is written against.
Collect ideas properly One list of everything anyone has asked for, with who asked and when. Pull in delivery problems and lost deals. Run a short review every fortnight. Whoever raised it presents it. The output is a small test, not a build decision. The best ideas arrive with evidence attached, and the same argument stops being had three times.
Improve one thing that already earns Find where the work fails most often and measure it, so there's a number nobody disputes. Fix the biggest cause at source. Move one capability one step up the index. A two-quarter roadmap written as named moves up the index, each with an owner and a stop condition.
Find out what people would pay for Work out what one study actually costs to deliver, layer by layer. Publish it with the assumptions visible. Define one small thing that can be bought on its own: name, buyer, price, what's included, what isn't, who sells it. That offer is approved and quotable, and the price has a floor underneath it.
Get the first new invoice moving Take each revenue ambition and work backwards to what has to exist first. Most of what's missing won't be software. Fix the contract route, and the rights position on the data the work produces. The offer goes to a real customer, or the reason it didn't is written down.
Sort out how decisions get made One list of everything in flight and what it's consuming. Draft who decides what. Run the monthly review on real live items. Start writing decisions down. Publish how capacity is split. First quarterly gate held on real numbers. Fewer standing meetings than before.
Bring scientists into product Pick the group. Agree with each one where the time comes from, in writing. Start the sessions, using live capabilities. First theses written by people outside Product. Named scientific product leads, with protected time visible in the split.
Build the pre-meeting checks Get the records into a consistent shape, because the checks read them. Write the first check and run it by hand before the review, to test whether the criteria work. The first checks run automatically. The rest are specified.
What exists at day ninety: a map of the work everyone agrees on · one list of everything in flight · a cost per study that can be defended · a repeatability score for every capability · a published capacity split · two months of written decisions, including at least one thing stopped · one new thing that can be quoted · named stewards and scientific product leads · a two-quarter roadmap · the first automated checks running.
What has to come first, and why. Three things get established in month one and nothing downstream can be defended without them. How much capacity actually exists, or any claim about splitting it is a guess. What a study costs to deliver, or no price or partner deal can be judged. And records kept in a consistent shape, or none of the checks can be built.

3.2What depends on what

CAPACITY BASELINE COST TO SERVE STRUCTURED RECORDS The band split, and any claimabout allocation Any price, floor, offer orpartner evaluation Every assessment check andthe agent layer THE FIRST GATE Held on real numbers, not proposals Three things get established before anything downstream of them can be defended. All three are month-one work. Nothing about the split, the pricing or the assessment layer gets presented earlier than the measurement behind it. A number produced before its denominator exists will get defended as though it were a decision.
Three dependencies that set the order.
StreamWhat it establishesNeeds
Product discoveryThat candidates arrive through a known route and get recorded, so repetition becomes visible and the same argument isn't had three timesAccess to exception data and to won and lost reasons
Product developmentThat the roadmap is a set of named moves between stages, each with a service mode and a stop conditionJoint scoring with Science and Technology, and a measured exception rate
Revenue testingThat the layers get priced separately, so it's known which one carries the margin and which offer can be quotedThe cost-to-serve baseline, and a week of finance time
Revenue generationThat every stream walks back to named features, and that contract route, price floor and ownership of the sale sit on the roadmapCommercial ownership of the sale, and legal review of templates
Governance setupThat capacity is explicit, decisions carry their evidence, and reversal is cheapThe portfolio view, and the executive forum setting the split
UpskillingThat product literacy spreads, so one role is enough and context isn't held by a few peopleTime allocated inside the band rather than on top of it
Product agentsThat checks run consistently before submission, and the records they read exist in a consistent shapeThe decision log and version registers from the governance stream

3.3Committed outputs at day ninety

The commitment that goes with it: nothing in flight moves in month one. Governance that arrives by breaking delivery doesn't survive contact with a live study, and it spends the trust needed for the quarter after.

3.4Anticipated resistance

ChallengeWhy it happensHow it's held
Product reads as overheadA new function producing documents instead of throughput is a fair thing to resentThe first thing produced is the portfolio view, and it's useful to delivery before it's useful to Product
Governance reads as losing scientific autonomyProduct functions accumulate authority over scientific judgement by defaultThe hard stop given publicly and early, gates co-signed, and something stopped visibly in the first quarter
Commercial fears slower dealsEvery gate looks like a delay from outsideThe fast lane carries most of the volume, with a published limit from raised to decided
Architecture reads as dictatedBriefs with technical solutions in them take away the technical owner's decisionA hard stop on architecture, and briefs that describe outcomes and constraints only
Cost to serve doesn't existNobody has needed it, and the allocation choices are genuinely arguablePublish a first version with the assumptions visible and invite people to argue
Scientists have no spare timeThey're billable, and product work is being asked for on topOne of the four capacity mechanisms chosen per person, and visible in the split
Pressure to show activity fastThe market watches quarterlyA published split makes deliberate underspend defensible, and the second integration pattern gets sequenced early so there's a pattern rather than a pilot
The first integration is also the reference caseA bespoke success distorts as much as a failureThe repeatable integration pattern is an explicit deliverable, separate from the first build
The financial year boundaryAn autumn start puts the diagnosis straight into next year's planningSequence so the first capacity split feeds the budget rather than arriving after it

3.5The model in one page

QuestionAnswer
What is being builtA service made easier to deliver, buy and scale — through consistency, then packaging, then partner distribution, and regulated software only where a capability can carry a claim
What stays humanWork where failure isn't detectable, input variance is unbounded, context sits outside the artefact, or volume doesn't repay validation
What gets automatedRepeatable work where errors show up, sequenced by how often something fails rather than by what's interesting to build
How scientists are helpedBetter tools, a defined product role with real capacity behind it, and a senior path that isn't people management
How improvement is knownConfiguration share, exception rate, expert hours, proof-of-value conversion, and whether the second customer is easier than the first
How what to build gets decidedA thesis, six admissibility inputs, five lenses, a sequencing rule, and a decision log
How it gets soldThe least involvement that still delivers the value safely and profitably, matched to what the customer is worth
How it stays safeNamed intended use, provenance, version pinning, audit trail, and hard stops held by the people carrying the risk
Six linesStart with an outcome. Shape it together. Make the boundary explicit. Test the biggest uncertainty. Earn the next investment. Scale what repeats.

Appendix

A.1Non-linear development

The plan is linear and should be judged that way. This exists because unplanned products usually turn up inside companies that then talk themselves out of them, and because the mechanisms that make the linear plan accountable are the same ones that would kill an exploration before it produced anything.

VALUETIME LINEAR NON-LINEAR — THIS APPENDIX destination unknown at the start the reframe probes, dead ends, and knowledge that shows up in no revenue line
The same period, developed two ways.
LinearNon-linear
What's uncertainHow long, how much, how wellWhat is actually being made
What gets managedSequence, dependencies, capacityCost per learning cycle, and how fast being wrong happens
A good weekSomething shippedSomething ruled out
EstimatesMeaningful, and they improveMeaningless. Budget the exploring, not the outcome.
FailureLate, over budget, or unusedStill alive after a year with no new evidence
ReportingProgress against planWhat is now believed, and what has been ruled out
A surpriseManaged as a riskFollowed, because it might be the point
Who does itThe delivery organisationTwo or three people, part-time, never the ones delivery depends on

That last row matters more than it looks. The instinct is to put the best scientist on the interesting problem, and it's the fastest way to damage the business funding it.

A.2Finding the idea

Two mechanisms: one that generates candidates on purpose, and one that catches them when they arrive on their own.

Describe the capability more abstractly

Most descriptions sit at the level of what gets sold, which only ever surfaces adjacent markets. Climbing a couple of rungs surfaces problems that look unrelated. Run it over a few capabilities, with Science and Commercial in the room, a couple of times a year.

RungThe question
What gets soldHow the offer gets described today
What it does for themThe outcome they get, whatever the method
What makes that hardThe difficulty being absorbed on their behalf
What that makes the businessThe position occupied once that difficulty is solved repeatedly
What is really being doneThe most abstract true description, which usually names a different customer set

Catch the ones that arrive on their own

1. The stranger Someone outside the currentmarket asks whether thiscan be done for them 2. The off-label use A customer uses an outputfor something it wasn'tdesigned for 3. The mispriced favour Something regarded as trivialgets paid for, or thanked for,disproportionately 4. The valuable exhaust A by-product turns out to beworth more than the thingit came from THE ANOMALY LOG One shared list. What happened, who saw it, what they wanted, and what was said back. Nothing else. What gets looked for at the review The same anomaly arriving three times from unrelated directions. Three is a pattern. One is a good story. Signal three is the loudest one available and it's almost always dismissed. Somebody paying well for work regarded internally as trivial means the value sits somewhere other than where the effort is — which is where an unplanned product tends to hide. The log costs nothing and survives staff turnover.

They go in one shared log: what happened, who saw it, what they wanted, and what was said back. Nothing else. What gets looked for at review is the same thing arriving three times from unrelated directions. Three is a pattern. One is a good story. The log costs nothing and survives staff turnover, which a memory of a conversation doesn't.

A.3Six questions that produce candidates in this business

The abstraction ladder and the anomaly log are general mechanisms. They work better with a set of questions written for this specific position. Non-linear candidates here rarely come from the capability. They come from the position — sitting between sponsors, sites, scanner estates, readers, platforms, consortia and regulators, and seeing things none of those parties can see alone. So the useful question is not what else the technology could do. It is what can only be seen from here.

1Views only from the middle The same scanner across many sponsors. The same site across many indications. The same cohort across years. List the intersections, then ask who would pay to see one. 2The other side of the invoice Sponsors pay. Sites, scanner makers, readers, software vendors, consortia and payers do not. For each, ask what the position already knows that they want. 3Failure as a statement Every quality failure says something about another party's equipment, protocol or staff. Read the failure log as a product about whoever caused it. 4Where two experts disagree Adjudication produces disagreement data for free, and disagreement is where the tacit knowledge sits. Currently a by-product of a workflow step rather than an asset. 5What got declined last year Wrong therapy area, out of scope, no capacity, too small. Nobody keeps the list. Three declines of the same shape is a market signal. 6Who else has this problem Many instruments, untrained operators, and a need for numbers that can be compared. The abstraction ladder, asked concretely enough to answer. Questions three and five are highlighted because the material already exists and was generated as waste. Neither costs anything to start. Ninety minutes, twice a year. Three or four people, including someone from Science and someone from Commercial. Nothing gets built. THREE THINGS KILL A CANDIDATE HERE, AND CHECKING TAKES MINUTES RATHER THAN WEEKS Rights — anything needing patient-level or sponsor-owned data is a legal project rather than a product one. Budget line — does the buyer already spend money on this category of thing. Sites and imaging departments usually do not. Neutrality — does selling to this buyer compromise the independence the core business is bought for.
Six questions written for this position, and the three tests that end most candidates quickly.
QuestionWhy it produces something here
Views only from the middleEvery intersection the business sits across is a view no single party holds. Most product ideas in an analytics business are one of those intersections given a name.
The other side of the invoiceAn intermediary bills one side and serves several. The unbilled parties are where the strangers come from.
Failure as a statementThe failure record is usually treated as operational exhaust. Read as a product about the party who caused the failure, the buyer changes entirely and the data already exists.
Where two experts disagreeDisagreement data is the most valuable material in a specialist business — for standard-setting, for training, and for anyone proving their method matches expert judgement.
What got declinedThe declined list is the richest anomaly log available, and the one nobody keeps. Repeated declines of the same shape never reach anyone senior.
Who else has this problemMost answers will be wrong for reasons only an insider knows. The question still surfaces candidates that a capability-based question never reaches.
Five of the six produce nothing in most years. The sixth occasionally produces something that changes what the business is. The failure mode is not missing the insight — it is the insight arriving in somebody's inbox and never being written down, which is what the declined list and the anomaly log exist to prevent.

A.4Validating it

The gates in Part 2 assume the thing being made is known. The right ladder here is the one Science already uses for a finding, applied to a commercial question. It carries a standard people already respect, so the argument is about evidence rather than about who's more excited.

StageThe testStop if
ObservationIt can be described precisely, with no solution attachedIt's a preference or a hunch rather than an event
ReplicationThree independent instances, not three people repeating one storyAfter two review cycles it has still only happened once
MechanismWhy it happens can be stated, so its recurrence can be predictedThe explanation rests on luck or on knowing someone there
GeneralisationA second buyer, in a different setting, wants the same thingEvery instance needs a different version of the answer
ApplicationOne paid engagement at a real price, delivered without heroicsAt this point it joins the roadmap and Part 2 takes over

Stages one to three should cost days. Stage four costs weeks. Stage five is the first time anybody builds anything. Four of the five end with a written reason to stop, which is the only way a bet gets killed without it feeling like a defeat.

A.5Governing it: the fourth band

Exploration sits outside the three bands, with different rules. Roadmap discipline applied to an exploration kills it, because it asks for evidence of delivery that an exploration doesn't produce for a long time. Exploration language applied to the roadmap makes delivery unaccountable.

RUN, LEVERAGE, GROWEXPLORE
ForumMonthly review, quarterly gateOne agenda item, twice a year
CurrencyExpert weeks and engineering weeksA small cash budget, never borrowed capacity
Reported asProgress against the planWhat is now believed, and what has been ruled out
Decision wordsAdvance, hold, pivot, stopContinue, reframe, stop
Who can start oneAnyone, through the monthly reviewAnyone logs an observation; only the executive promotes one
LimitsThe capacity split, set quarterlyOne bet, a kill date agreed at the start, no full-time senior scientists
ProtectionThe ruleWhat it prevents
One betOne exploration at a time. A second means killing the first and saying why.Three half-explored ideas, none of which fails honestly
A kill dateAgreed at the start, in the decision log, with the evidence that would justify continuingThe permanent programme. A bet with no expiry is how a company this size quietly spends money it never decided to spend.
Cash, not capacityFunded with a budget, never with borrowed expert weeksThe roadmap slowing because of something nobody agreed to fund
Silence outsideNothing enters external material before the last stageA bet that can't be killed without embarrassment, and so survives on reputation rather than evidence

There's no hold. On the roadmap, holding something is sensible — the work is understood, it just isn't the priority. On an exploration, holding is how a bet becomes permanent: it stops producing evidence but keeps its claim on attention, and two years later nobody remembers why it's still open.

Existing mechanismWhat it carries
The fast laneStages one to three fit inside it. Desk work and ten calls need a written plan and a posted result, not an approval.
The test plan formatThe threshold gets written before the calls, so interesting conversations can't later be read as validation.
The quarterly gateWhere the stage transition and the kill date get confirmed in front of everyone.
The decision logWhere the kill date lives, so it survives enthusiasm and staff changes.
The observation logThe only new artefact, and a shared document rather than a process.

One rule holds the boundary: an exploration never draws capacity from the roadmap. If it needs people, it needs a decision, not a favour.

A.6What a shaping session sounds like

Instead ofAsk
Can this be builtWhat customer outcome does this buy, and what's the simplest technical shape that delivers it
The scientist says it's importantWhat decision does this improve, for whom, and what evidence says it matters
Engineering says six monthsWhich part actually needs six months, and what's the smallest test of the riskiest assumption
An interface is neededWhat external workflow needs it, and what contract would support customer two
Let's automate itWhich part is repeatable, how detectable are failures, and where does judgement stay
This is strategically importantWhat option does it create, and what evidence is needed before scaling it

A.7Signals that the model is working

SignalHealthyWarning
Product and TechnologyTechnology involved early, proposing reusable solutionsTechnology receives finished requirements, or gets pulled in only to estimate
ScienceScience challenges assumptions early and shapes boundariesScience consulted late, or only asked to approve
CommercialNamed customer evidence exists before meaningful buildRoadmap driven by internal enthusiasm
DeliveryNew capability reduces or contains delivery effortProduct work creates study delays
ReuseCustomer two is materially easier than customer oneEvery deployment becomes a custom project
Decision speedA clear owner decides once the evidence is inDecisions wait for consensus
PortfolioCapacity moves visibly when evidence changesProjects continue because nobody wants to stop them
Capability spreadNew scientists use the thesis format without helpEverything routes through one person