The team device makers need before the FDA asks
Gen UX Consulting is a human factors, UX research and UX design firm for medical devices. It takes device teams from early user research through formative and summative validation, and builds the usability engineering file the FDA actually reviews.
Senior only
Every researcher holds a Master's or a PhD. No juniors learning on a client's device.
One roof
Research and interface design in the same team, so findings turn into design changes without a handoff.
Formative to file
Formative studies, summative validation, use specification and URRA, through to a clean submission.
Great work, discovered after the deficiency letter
Most device teams treat human factors as a checkbox at the end. They go looking for a partner when the summative report is due or when the FDA sends questions back. By then the work is remediation, the budget is spent and the buyer is shopping on price. Gen UX's best work happens months earlier, and nobody was calling it then.
New work arrived after a problem surfaced, when the value Gen UX protects early was already gone.
The pipeline moved at the speed of the network. Quiet months had no second source of new work.
No way to see which device teams had just raised, opened a trial or cleared a device, so no way to arrive early.
From waiting to be found, to arriving on time
The fix was not more volume. It was timing: reach each device team at the moment its program made human factors a live question, with a reason it could see in its own news. Flip the switch to see each layer before and after the build.
The sending layer, as built
Four principles, one rule: meet the program where it is
This is not cold email. Cold email starts from a list; signal-based outreach starts from a reason. A device program leaves public traces at every stage. We read where each team sat on the regulatory clock, decided whether it deserved an email at all, chose the angle its signal earned, and opened with a free audit instead of a pitch.
Read the regulatory clock
Every account was placed on its device program's timeline using public FDA, trial and funding data. Earlier means cheaper human factors.
See the clockSix gates before a send
An account had to be an FDA-regulated, human-use device in active development before it earned a score, a tier and an email.
Try the gatesSignal times it, role frames it
The signal decided why we were writing now. The reader's role decided which human factors risk they would recognise.
See the angle gridValue before a pitch
Every first conversation was a free audit of the team's human factors plan. The findings made the case for the work.
See the auditEvery account was placed on its program's clock
A usability finding costs little in design and a lot after submission. So the question for every account was simple: where is this device program right now? Five public signals answered it, each pulled into Clay with its source kept on the row. Pick a signal to see where it lands.
Money just landed and the clock on clearance started. Design decisions are being made now, which is when human factors is cheapest.
Runway to clearance. Spend the round on a file that clears the first time.
Two segments, one shared clock
The device makers were the buyers. The firms around them, CROs, regulatory and quality consultancies and contract engineering shops, meet those buyers at exactly the moments that matter. They became a second segment with their own angle.
US device and healthtech companies, mostly under 200 people, Seed to Series D. Founders, CTOs, regulatory and clinical leads. Split into a Priority and a Secondary tier by the six gates.
CROs, regulatory and quality consultancies, contract engineering and design firms across 477 companies. Principals, partners and heads of business development.
A signal earned attention. Six gates earned an email.
A funding round at a software company is noise for a human factors firm. Before any account was contacted, it passed six gates. Three were knockouts. The other three set the score, and the score set the tier and the effort. Switch the gates on the example account and watch it move.
Up to two contacts per account, each framed for their role. 960 prospects reached in this tier.
Example account with simplified rules. Real scores ran as an ICP prompt in each segment's Clay table, with the evidence for every gate kept on the row.
The signal chose the moment. The role chose the risk.
A founder, a regulatory lead and a head of product fear different things about the same device. So every angle had two parts: a reason to talk now, taken from the account's own signal, and the human factors risk that particular reader already carries. Select any cell to see how the two combine.
The round set the clock on clearance.
The submission window.
Runway to clearance, framed around the date.
Simplified view of the routing logic. Partner firms received one angle for every reader, built on the client programs they already support.
Every first conversation was a free audit
Device leaders hear vendor pitches every week. Gen UX opened with something useful instead: a free audit of the team's human factors plan, read against where the program sat on the clock. The findings made the case for the work, not a sales deck.
Human replies to a signal-led email
Free audits of the human factors plan, one per program
Audits whose findings became a scoped engagement
One audit, read against the clock
The audit covered the same six parts of the file for every device team. What changed was what counted as a gap, because a team in design and a team that just cleared are missing different things. Switch the stage to see an example readout change.
Finding: start formative work now, while design changes are still cheap.
The audit stood on its own. Teams kept the readout whether or not they worked with Gen UX.
The signal that started the conversation told the audit where to look first.
Each gap the audit surfaced was a piece of work the team could already see it needed.
Public records in, audits out
Every source fed the same two Clay tables, one per segment. Each row kept its source, its signal count and the evidence behind every gate, so every account contacted could be traced back to the record that justified it.
- FDA 510(k) database
- ClinicalTrials.gov
- Crunchbase funding and leadership
- Apollo and Sales Navigator for people
- Source column and signal count
- Dedup across sources
- Enrichment waterfall
- Six-gate ICP prompt, then tier
- Every address verified first
- Three campaigns: two tiers, one partner segment
- Angle routed by signal and role
- Short, plain-text sequences
- Replies routed same day
- Free audit of the human factors plan
- Findings scoped into a proposal
- Notes back to the account row
$1.05M in pipeline from 2,311 prospects
Everything here happened inside the 90-day build. Each dot below is one prospect. Switch segments to see where replies and opportunities came from, and select a number to light up just those dots.
Every email was triggered by a signal and sent to a verified address. No ads and no cold calls.
The funnel, step by step
Earlier on the clock, warmer the reply
The Priority tier, funded teams in active development, replied at more than twice the rate of the partner firms and produced nine of the fourteen opportunities. The Secondary tier, larger sponsors with trials and clearances, replied almost as often but sat further along the clock. Partner firms replied least, and every partner audit opens a door to many device teams.
What carried the result
Timing is the signal
In a regulated market, the best reason to write is the moment a program makes your work urgent. Funding, trials and clearances are public, dated and specific to one company. Reaching device teams at those moments put Gen UX in the room at formative, when its work is worth the most, instead of after the deficiency letter.
Priority tier: 3.65% reply rate, 9 of 14 opportunitiesGates before volume
Six gates kept software-only, idea-stage and fully staffed teams out of the campaigns. Fewer emails, and every one of them to a team that could buy.
3 knockouts, 3 scored gates, 3 tiersValue before a pitch
No first conversation was a sales call. Each one was a free audit that left the team with a readout of its own file. Nearly half of all replies became an audit.
29 audits from 62 repliesVerified or not sent
Two secondary domains, six warmed inboxes, plain text, no tracking pixels and no unverified address. The floor that keeps the sending domains out of spam.
1.0% bounce ratePartners compound
Partner firms replied least, but each one sits beside dozens of device programs. Their audits looked at human factors gaps across their client work: slower to convert, wider in reach.
7 partner audits
Gen UX stopped waiting for the deficiency letter. It now arrives at formative.
Gen UX already had what device teams need: senior researchers, design in the same room, and files that clear. What it lacked was a way to reach teams before the problem was visible to them. The engine reads the regulatory clock every week and writes to the teams for whom human factors just became a live question. The expertise is unchanged. What changed is when buyers meet it.
The same engine, pointed at a second regulated market
The 90-day build ended with the engine handed over and live. Because the method runs on public regulatory records rather than on a list, it transferred. As part of our ongoing work with Gen UX, the same system was rebuilt for nicotine and tobacco-alternative companies facing FDA premarket review, and went live in October 2026.
New clearances and newly recruiting trials are pulled every quarter, so the device list never goes stale.
The nicotine build swapped device gates for public FDA decisions on tobacco products. Scoring and tiers did not change.
A free audit first, a scoped proposal after. The conversion model moved over untouched.
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