Biotech and pharma companies building a genuinely new therapeutic approach, platform, or care delivery model face a real choice: define the problem and the category on your terms, or get filed under an existing framework that undersells what you built.
The Problem
Novel science gets forced into an existing category that doesn't fit
Payers, health systems, and analysts default to evaluating new entrants against the closest existing framework, because that's how coverage decisions and comparative research get built. A genuinely novel modality or care delivery model gets assessed against criteria built for a different kind of product, and it either looks like an inferior version of the old category or gets dismissed as not fitting the evaluation framework at all, when the real issue is that the framework itself doesn't apply.
The company talks mechanism while the market needs a name for the problem
Category design starts with defining a problem in a way stakeholders recognize as real and urgent, not with explaining a mechanism of action. Most biotech and pharma companies attempting to create a new category lead with the science, when the more effective sequence names the clinical or care-delivery gap first, in language payers and clinicians already relate to, before introducing the specific approach that closes it.
First-mover advantage erodes fast without proactive category ownership
Being first with a novel approach creates a window to define how the category gets evaluated, categorized by analysts, and covered by payers, but that window closes as fast followers enter and the market starts forming its own consensus definition. Companies that stay heads-down on clinical execution without a parallel category definition effort often watch a competitor with a similar but later approach capture the framing advantage instead.
Internal teams disagree on category definition, so external messaging never lands consistently
Without a clear, agreed category definition, clinical, commercial, and investor-facing teams each describe the company differently depending on the audience and the moment, and that inconsistency reads as confusion to analysts, payers, and investors who are actively trying to figure out where you fit. A company that can't consistently answer "what category are you in" internally has no chance of establishing that definition externally.
How We Help
We start by defining the specific problem your approach solves in language stakeholders already recognize as real – a care gap, an unmet clinical need, an economic burden on the health system – before introducing the mechanism or platform that addresses it. This sequencing matters: category design succeeds when the market agrees the problem is real and significant first, then meets your solution as the answer to a problem they already believed in.
From there we build the evaluation framework your category actually deserves, working with your medical and commercial teams to define the criteria payers, health systems, and analysts should use to assess something like this, rather than letting an ill-fitting existing framework define you by default. This includes identifying which existing category boundaries genuinely don't apply and building the evidence and language to make that case credibly, not just assert it.
We move on the proactive window while it's open. That means aligning analyst relations, KOL engagement, and investor narrative around the same category definition simultaneously, so the market forms a consensus view shaped by your framing rather than reverse-engineering a definition after fast followers have entered and started shaping perception themselves. Timing matters more in category design than almost any other positioning work, because the advantage is real but temporary.
We align your internal teams first, before pushing category language externally. Clinical leadership, commercial, and investor relations get a shared, specific definition of the category and the problem it addresses, tested against how each function actually talks to its own stakeholders, so external messaging lands as a consistent, deliberate position instead of three different descriptions of the same company.
What we deliver
- Problem-first category framework – the unmet need or care gap defined in language stakeholders already recognize, sequenced before mechanism
- Evaluation criteria design – the assessment framework payers, health systems, and analysts should use, built with medical and commercial input
- Coordinated proactive rollout – analyst relations, KOL engagement, and investor narrative aligned around the same category definition simultaneously
- Internal alignment – a shared category definition tested and adopted across clinical, commercial, and investor-facing teams before external rollout
Category design doesn't start with explaining what you built – it starts with naming a problem the market already believes is real. The company that names the problem first usually gets to define how its solution gets evaluated.
Our Methodology
We run this as a 90-day sprint built around the two dynamics that determine whether a biotech or pharma company successfully defines a new category or gets absorbed into an ill-fitting existing one: sequencing the problem before the mechanism, and moving proactively while the first-mover window is still open. The first 30 days are diagnostic – defining the specific problem and evaluation gap in stakeholder language, auditing how internal teams currently describe the company to identify inconsistency, and mapping which existing category frameworks are actively misclassifying you. Days 30 to 60 build the category framework and evaluation criteria, align internal teams around a shared definition, and prepare coordinated materials for analyst relations, KOL engagement, and investor narrative. The final 30 days launch the coordinated external rollout across those channels simultaneously.
What separates this from a standard positioning engagement is that most positioning work assumes the category already exists and focuses on differentiating within it. Category design assumes the category doesn't exist yet in a form that fits, and the work is defining it before someone else does. We sequence problem before mechanism and internal alignment before external rollout, because for most biotech and pharma companies attempting this, the biggest risk isn't a bad category definition – it's a good one that arrives too late, after fast followers and analyst frameworks have already filled the vacuum.
How We Work
The first 30 days are audit and framework development. We define the core problem in stakeholder-recognizable language, audit current internal descriptions of the company for inconsistency, and map which existing category frameworks are misclassifying your approach. Days 30 through 60 build the evaluation criteria and category definition, working with medical and commercial teams to align internally before anything goes external, and prepare coordinated materials across analyst relations, KOL engagement, and investor communications. By day 90 we're executing the coordinated external rollout.
On our side, the team is a category design and positioning lead who coordinates directly across your clinical, commercial, and investor relations functions, since category design fails when it's run as a single-department project. From your side, we need executive sponsorship to align cross-functional teams around a shared definition, medical and clinical input to build a defensible evaluation framework, and coordination capacity across the analyst relations and KOL functions during rollout.
Cadence is weekly during the first 90 days, covering framework development and internal alignment progress, with more intensive coordination during the rollout phase as analyst, KOL, and investor materials launch together. Typical engagement length is 4 to 6 months given the internal alignment work required before external rollout, with many companies continuing on an advisory basis to sustain category ownership as fast followers enter.
What to expect at each phase: month one often surfaces real inconsistency in how different internal teams currently describe the company, which needs resolving before external work starts. Month two is intensive cross-functional framework development. Month three onward is coordinated external rollout, where category definition begins showing up consistently across analyst conversations, KOL engagement, and investor materials.
- A defensible category and evaluation framework replacing an ill-fitting existing classification
- Internal consistency in how the company describes itself across functions
- Coordinated first-mover positioning across analyst, KOL, and investor channels
- Reduced risk of fast followers capturing the category framing advantage
If your biotech & pharma company needs category design leadership, we should talk.
Expand your marketing team output with our experts
Let us take a custom approach to your growth goals by assembling and leading the best-in-class marketing team to support your next stage.
Frequently asked questions
How much does a category design engagement cost for a biotech or pharma company?
Most category design engagements with us run $15K-30K monthly given the cross-functional coordination required across clinical, commercial, and investor stakeholders. That's typically less than the cost of a dedicated internal strategy function attempting this alone, and it reflects the intensive nature of aligning multiple groups around a shared definition before external rollout. Companies with more complex organizational structures sit toward the higher end.
How long before we see results from a category design engagement?
Internal framework development and alignment typically take the first 60 days, since getting clinical leadership, commercial, and investor relations to agree on a shared definition is genuinely the hardest and most important part. Coordinated external rollout begins around day 90, and category adoption in analyst reports, payer conversations, and market perception typically builds over 6-12 months as the definition takes hold.
How does the category design team integrate with our existing staff?
We coordinate directly across your medical, commercial, and investor-facing functions to build and align a shared category definition, rather than working with a single department in isolation. Weekly working sessions during buildout cover framework development and cross-functional alignment. Executive sponsorship is required given the coordination this work demands across teams that don't always naturally collaborate.
What makes Winston Francois different from a traditional strategy or brand consultancy?
Most positioning consultancies assume the category already exists and focus on differentiation within it. We treat category design as its own discipline – defining the problem before the mechanism, and building internal alignment before external rollout – specifically for companies whose approach doesn't fit existing evaluation frameworks. We operate as an embedded team accountable to consistent category adoption across analyst, payer, and investor perception, not a positioning deck.
How do you measure ROI from a category design engagement?
We track internal consistency – whether clinical, commercial, and investor teams describe the company the same way – as a leading indicator, since that has to happen before external adoption is possible. Externally, we track category language adoption in analyst reports, media coverage, and investor commentary, along with whether payer and health system evaluation criteria begin reflecting the framework you defined rather than an ill-fitting existing one.
What type of biotech or pharma company is the right fit for this service?
Companies with a genuinely novel therapeutic modality, platform technology, or care delivery model that doesn't fit cleanly into existing evaluation categories are the best fit. Companies early enough in commercialization that a first-mover category window is still open, rather than already several fast followers behind, see the highest-leverage impact. The first step is auditing how existing category frameworks are currently misclassifying your approach.
