Most biotech and pharma product teams import SaaS playbooks into a world with REMS obligations, HCP adoption cycles, and legal/medical/regulatory review gates. We build product operations that account for those constraints from the start, so patient support programs and digital health tools actually ship and get used.
The Problem
Roadmaps built like SaaS, reviewed like pharma
Product teams sprint-plan features and commit to launch dates before regulatory and medical, legal, and regulatory review has even seen the concept. The review board sends it back, the date slips, and the team relearns the same lesson next quarter. The roadmap was never built around the review cycle it has to pass through.
Patient support programs run by whoever owns the vendor contract
Copay assistance programs and patient hubs often get built by procurement and ops, not product. Nobody owns enrollment friction, drop-off, or the support-hub user experience end to end. The result is a program that technically exists but nobody is accountable for whether patients actually complete enrollment.
Product-market fit measured against the wrong signal
Internal launch dates and feature counts get treated as success metrics. Physician adoption and patient enrollment – the numbers that actually indicate the product works – go unmeasured or get reviewed once a quarter, long after the window to fix onboarding friction has closed.
Product, medical affairs, and regulatory fight over decisions instead of sequencing them
Product wants speed, medical affairs wants clinical accuracy, regulatory wants a documented review trail. Without a shared operating rhythm, every decision becomes a standalone negotiation. Teams burn weeks re-litigating the same category of question – claims language, data collection scope, consent flows – because there is no standing process for it.
How We Help
We start with an assessment of the actual product operation, not the org chart. That means sitting in on regulatory and medical affairs review meetings, reading the last two quarters of product decisions that got delayed or reversed, and mapping where patient enrollment or HCP adoption data disappears between systems. Within the first two weeks we can usually point to three or four specific decisions that are stuck for the same underlying reason – not lack of effort, but a missing gate in the process.
From there we build the strategy layer: a product roadmap that is sequenced around your actual review calendar, not an idealized one. If a claims-adjacent feature needs medical, legal, and regulatory sign-off, that gate is in the roadmap as a named step with an owner and a expected turnaround, not an afterthought discovered two days before launch. For patient support hubs and copay assistance programs, we rebuild the enrollment funnel around what patients and caregivers actually experience – identity verification, eligibility checks, benefit verification calls – and treat drop-off at each step as a product problem, not a call-center problem.
Execution runs in parallel with your existing team. We do not hand off a strategy deck and disappear. We embed with product, work directly with medical affairs and regulatory stakeholders on specific initiatives, and build the artifacts your team needs to keep moving after we leave: decision logs, review-gate checklists, a backlog prioritized against both patient impact and regulatory risk.
For digital therapeutics and companion apps tied to a REMS program, we build the product roadmap around the REMS requirements directly – what data has to be collected, what has to be reportable to FDA, what triggers a program modification – instead of treating REMS compliance as a separate workstream that gets bolted onto the product late. This is the difference between a digital health roadmap that survives an FDA inspection and one that generates a corrective action plan.
Measurement is where most biotech product teams are weakest, and where we spend real time. We build dashboards around physician adoption (prescriptions written, portal logins, repeat usage) and patient enrollment and retention (program starts, time-to-first-fill, adherence over 90 and 180 days) instead of ship dates and story points. These are the numbers that tell you if the product is actually working in the field, and they are the numbers commercial and medical affairs leadership actually want to see.
Throughout, we act as the connective tissue between product, medical affairs, regulatory, and commercial. We are not trying to make regulatory move faster than it should, or make medical affairs rubber-stamp things. We are building the operating rhythm so those functions engage with product decisions at the right time, with the right information, instead of being a surprise gate at the end.
What differentiates Winston Francois here is that we have run growth and product functions inside operating companies, not just advised them. We know what it looks like when a patient hub enrollment flow quietly loses forty percent of patients at benefit verification, and we know how to fix that without waiting for a full replatform.
What we deliver
- Product roadmap re-sequenced around your actual regulatory and medical affairs review calendar
- Patient support hub / copay assistance program audit with a rebuilt enrollment funnel
- Physician adoption and patient enrollment measurement framework with live dashboards
- Cross-functional operating model connecting product, medical affairs, regulatory, and commercial
- REMS-aligned digital health and companion app roadmap
- Prioritized backlog mapped to patient impact and regulatory risk, with named owners per item
If your patient support hub's enrollment metric is 'program launched' instead of 'patients enrolled and refilling at day 90,' you don't have a product – you have a vendor contract.
Our Methodology
We run this as a 90-day sprint, structured in three phases. Days 1-30 are assessment and diagnosis: we review the product roadmap, sit in on regulatory and medical affairs meetings, audit the patient support hub or HCP portal end to end, and identify the two or three decisions that are actually blocking momentum. You get a written diagnosis with specific, named issues – not a generic maturity model score.
Days 31-60 are strategy and initial build: we re-sequence the roadmap around your review gates, redesign the highest-drop-off step in the patient enrollment funnel, and stand up the physician adoption and enrollment dashboards. We work directly with your product, medical affairs, and regulatory leads to pressure-test the new process on a live decision, not a hypothetical one.
Days 61-90 are execution and handoff: we ship the redesigned funnel or portal change, validate it against the new measurement framework, and document the operating model so your team can run it without us. By day 90 you should have at least one measurable improvement in physician adoption or patient enrollment, plus a repeatable process for the next one.
How We Work
The first 30 days are diagnostic and involve our team directly, usually two to three people, embedded with your product, medical affairs, and regulatory stakeholders. We meet weekly with your leadership and daily with the working team. This is not a survey-and-report engagement – we are in your systems and your meetings.
Days 31-60 shift to build mode. We work inside your existing tools and workflows rather than standing up parallel infrastructure. If you use a particular ticketing system, review tracker, or CRM for HCP or patient data, we work in it. The goal is a process your team owns by the end, not a dependency on us.
Days 61-90 are about proving the change holds. We track the specific metrics we set in phase one – enrollment completion rate, time-to-first-fill, portal adoption among target HCPs – and adjust based on what the data shows. Cadence drops to a weekly check-in as your team takes over day-to-day ownership.
After the initial 90 days, most clients keep us on a lighter fractional cadence – typically one to two days a week – to keep the product operating model intact as new regulatory requirements or program changes come in. If your biotech or pharma company needs growth product management that actually accounts for how your organization is regulated, we should talk.
- Faster time from product concept to regulatory-cleared launch
- Higher patient support program enrollment and completion rates
- Improved HCP portal adoption and repeat usage among targeted prescribers
- Fewer late-stage rebuilds caused by missed regulatory or medical affairs input
- A measurement framework leadership actually trusts and uses in review meetings
- A documented, repeatable cross-functional decision process for future product launches
If your biotech & pharma company needs growth product management leadership, we should talk.
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Frequently asked questions
How is growth product management different from regular product management in biotech and pharma?
Regular product management in this industry often gets treated as a technical execution function – build what commercial or medical asks for. Growth product management means the product decisions are made with adoption and enrollment outcomes as the target, not just feature delivery. It also means the roadmap is built with regulatory and medical affairs review as a designed-in step, not a surprise gate at the end.
Do you need to have worked with our specific therapeutic area before?
No. The product operating problems we fix – roadmaps that ignore review cycles, patient hubs with no enrollment ownership, adoption metrics nobody tracks – show up across therapeutic areas and company sizes. We do need your medical affairs and regulatory teams to walk us through the specific review requirements for your programs in week one, and we build the roadmap around what we learn.
Can you work on a REMS-related digital health product without slowing down our regulatory timeline?
Yes, and that is usually the point. When REMS requirements are built into the product roadmap from the start – what has to be collected, what has to be reportable, what triggers a modification – you avoid the late-stage rework that actually slows programs down. We work directly with your regulatory team so nothing we build creates a new compliance question.
What does success look like at the end of the 90 days?
A measurable change in at least one adoption or enrollment metric, a working measurement dashboard your leadership actually checks, and a documented cross-functional process your team can run without us. We agree on the specific metric targets during the first two weeks based on what your current baseline actually is.
Who on our team needs to be involved for this to work?
At minimum, a product lead, someone from medical affairs, and someone from regulatory who can speak to review requirements. If a patient support hub or copay program is in scope, we also need whoever owns that vendor relationship. Commercial input is useful but not required for the first 30 days.
