Winston Francois runs product design and research for biotech and pharma companies where the product is a combination device, a patient support app tied to a therapy, or an HCP tool that has to survive fair-balance review. We build research operations that hold up under FDA human factors scrutiny and still ship faster than a traditional consultancy.
The Problem
Usability Testing Gets Treated Like a Software Sprint Instead of an FDA Submission Requirement
If your product includes a combination device, an autoinjector, or any component evaluated under IEC 62366-1, usability testing is not a nice-to-have discovery exercise, it is a formal use-related risk analysis with formative and summative studies that regulators will read line by line. Most product teams run one quick round of think-aloud sessions and call it usability testing, then discover during submission prep that the study design, the participant criteria, and the documentation do not meet human factors engineering standards.
You Cannot A/B Test a Therapy or a Device the Way You A/B Test a Landing Page
When the product under research is an injectable, a diagnostic, or the therapy itself, standard product research methods do not transfer. There is no live production environment to run a controlled experiment in, no shipping a v2 to half your users overnight, and every session involving a real patient runs through informed consent and often an IRB.
Clinical Trial PRO Data Sits in Biostatistics and Never Reaches the Product Team
Your clinical trials are collecting patient-reported outcome data through validated instruments, and that data describes exactly what patients struggle with day to day. Almost none of it ever becomes a product requirement, because the PRO data lives with biostatistics and clinical operations, formatted for an endpoint analysis, not for a design brief.
Patient-Facing Tools Get Designed for a Patient Who Does Not Exist
The people using your patient support app or companion tool skew older, sicker, and more cognitively taxed than the persona in most design decks, and health literacy in the general population is lower than product teams assume.
HCP Research Gets Blocked by the Same Legal Review That Governs a Sales Deck
Research sessions with physicians and other prescribers have to clear medical, legal, and regulatory review before a single question gets asked, because anything that touches fair balance or looks like off-label discussion creates exposure.
Research Insight Dies in a Deck Nobody Opens Again
Most biotech and pharma product teams run research only when a submission or a board deck demands it, then the findings live in a slide file that never becomes a tracked requirement. The next product cycle starts from scratch, repeats the same recruitment and IRB overhead, and rediscovers half of what the last study already found. Without a repeatable research operation, every study is a one-time cost instead of a compounding asset.
How We Help
We start with a two-week audit of what research actually exists versus what your last submission or board deck implied exists.
From that audit we build a research roadmap scoped against three things: what needs formal IEC 62366-1 formative and summative validation before submission, what can move on lighter-weight discovery research because it never touches a regulated use-error pathway, and what PRO or clinical data already exists that we can translate into requirements without running a new study at all.
Then we run the studies. For device and combination product work, that means task-based simulated-use sessions with participants who match your actual use population, not a convenience sample of employees, and documentation built to the standard a reviewer expects to see.
For PRO translation, we work directly with your clinical or biostatistics team to pull the patient-reported outcome data that already exists and turn it into a traceable requirements backlog: this symptom cluster from the PRO data maps to this feature gap, this adherence pattern maps to this onboarding flow change.
For HCP-facing tools, we build research scripts and prototypes that clear medical and legal review before the session is scheduled, not after a rejection forces a rewrite.
We embed as a fractional research and design team, not a vendor running one study and disappearing. The person who ran your formative usability study is the same person available when a summative study question comes up during submission prep three months later.
What we deliver
- Research audit mapping existing studies against IEC 62366-1 formative and summative standards
- Use-related risk analysis and task-based usability study design for device or combination product components
- PRO-to-requirements translation pipeline connecting clinical trial data to product backlog items
- Health literacy and accessibility testing built into every patient-facing digital tool study
- HCP research protocols and prototypes pre-cleared through medical, legal, and regulatory review
- Recruitment plan for real patient and HCP populations respecting IRB and informed consent constraints
- Documented research repository so findings carry forward instead of resetting every product cycle
A usability study built to satisfy an FDA submission and a usability study built to make the product genuinely easier to use are not the same study, and most biotech and pharma teams only budget time and money for one of them.
Our Methodology
We run in 90-day sprints, structured around whatever regulatory or clinical milestone is actually driving the timeline rather than a generic product cadence. Days 1-15 are the audit: what research exists, what meets human factors standards, what PRO or clinical data is sitting unused. Days 16-45 are study design and recruitment, which for device and patient research means working through IRB and informed consent lead times honestly instead of assuming a two-week turnaround that never happens. Days 46-75 are the studies themselves, run as formative or summative depending on where the product sits in its lifecycle, with documentation built for the reviewer, not just the product team. Days 76-90 are translation: turning findings into a requirements backlog with clear traceability back to the data that generated them.
The difference from a traditional human factors consultancy or a generic UX research agency is that we do not hand off a findings report and move to the next client. We stay embedded through the design decisions that follow the research, because a study that identifies a use error and then sits in a PDF while the next release ships the same error unfixed was never worth running.
How We Work
The first 30 days are diagnostic and protocol design. We review existing research, meet with your clinical, regulatory, and product teams, and come back with a study plan scoped to what your submission or product timeline actually requires, not a generic research package.
Days 31-60 are recruitment and execution. Patient and HCP recruitment for regulated research takes longer than consumer product recruitment, and we plan for that honestly rather than compressing a schedule that then slips. Sessions run moderated, task-based, and documented to a standard that holds up under both product review and regulatory review.
Days 61-90 are synthesis and handoff. Findings become a prioritized, traceable requirements backlog, not a slide deck. For submission-track work, documentation is packaged in the format your regulatory affairs team needs. For product-track work, findings go straight into your design and engineering backlog with the evidence attached.
Most engagements continue past the initial 90 days as a fractional research function, cadence set by your release and submission calendar rather than a fixed weekly call. If your biotech or pharma company needs product design and research built for real patients and real regulatory constraints, we should talk.
- Usability studies that meet IEC 62366-1 formative and summative documentation standards
- PRO and clinical data translated into a traceable product requirements backlog
- Patient-facing tools tested for health literacy and accessibility before launch, not after adoption drops
- HCP research protocols that clear medical-legal-regulatory review on the first pass
- A research repository that compounds across product cycles instead of resetting each time
- Faster submission timelines because human factors documentation is built correctly the first time
If your biotech & pharma company needs product design & research leadership, we should talk.
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Frequently asked questions
How do you handle FDA human factors requirements when researching a combination product or device?
We scope every study against IEC 62366-1 from the start, distinguishing formative research meant to inform design from summative research meant to validate it for submission. Participant criteria, task design, and documentation are built to the standard a human factors reviewer expects to see, not retrofitted after an informal study runs short of what submission requires.
What if our product is a therapy or physical device rather than software – how does research work?
Research methods shift to simulated-use sessions, physical prototypes or representative mock-ups, and task-based observation instead of live A/B testing, since there is no production environment to experiment inside. Recruitment respects IRB approval and informed consent timelines, which typically run longer than a standard product research schedule, and we plan the study calendar around that reality instead of around a generic sprint length.
Can you turn our clinical trial patient-reported outcome data into actual product requirements?
Yes, that is one of the most underused assets we see in biotech and pharma product teams. We work with your clinical or biostatistics team to pull PRO data collected for endpoint purposes and translate specific patient-reported patterns into design and feature requirements, with documented traceability from the clinical data to the product decision it informed.
How do you address health literacy and accessibility for patient-facing digital tools?
We build health literacy testing and accessibility review into the same research sessions as usability testing, rather than treating them as separate workstreams added late. That means testing plain-language content with participants who reflect your actual patient population's literacy range, not a tech-savvy persona, and checking that the tool works for lower vision, limited dexterity, and lower digital fluency users.
How do you research HCP-facing tools without running into fair balance or compliance problems?
We build research scripts and prototypes through your medical, legal, and regulatory review process before scheduling any HCP session, using templates and a reviewer relationship that carry forward to future studies. That upfront step is slower for the first study and considerably faster for every one after it, since the review pathway already exists.
What does a product design and research engagement cost?
Engagements are scoped fractional, typically in the range of $15K-$35K per month depending on whether the work includes formal human factors validation studies, which carry more recruitment and documentation overhead than discovery-stage research. That covers an embedded research and design team, not a fixed number of sessions, because the highest-value work is often deciding which studies matter most.
What type of biotech or pharma company is the right fit for this service?
Companies at Series A through growth stage with a combination product, a patient support tool tied to an approved or in-development therapy, or an HCP-facing digital product are the clearest fit, especially if a submission deadline or a stalled adoption metric is forcing the research question. The first step is the two-week audit, which tells you exactly what research exists, what is missing, and what the realistic timeline looks like before you commit to a full engagement.
