Product meetings, HF decisions and documentation.Your lead joins product meetings, completes company training and can have a company email address. They assess use-related risks, write and review HF/QMS documents, and plan the HF evidence for FDA submission.
Up to four small formatives each year.Included in the service. You cover study expenses only.
Need more than four studies? That’s great.Your HF lead will work with in-network HFaaS specialists to deliver additional or larger formatives, pre-summative and validation studies at half the typical external vendor cost, and start them in half the typical time.
In-network HFaaS specialists cover vacations and departures.Product meetings, HF documentation and studies continue when your usual contact is away.
A service agreement. No new employee headcount.
You want one of them.→
This is the way to do HF. An embedded expert who knows your product, has good judgment and likes their job. And they are backed up by more experts like themselves, for them to think with, run your studies, and handle the logistics.
For experienced HF specialists
$120,000/ year
An average 20-hour week, including study work.
The remaining time is yours.Take on other work if you choose.
Coworking membership and business-class travel.Business class on all flights (even domestic!) for study conduct.
Required experience.At least seven years in medical-device HF, including consulting. FDA submission experience, independent study moderation, and a history of leadership and independent judgment. Admission requires passing a rigorous interview.
A Ph.D. or HF publication record strongly preferred.Relevant consulting backgrounds include Core Human Factors, Bold Insight, Design Science, Exponent, Human Factors MD, Research Collective and ClariMed.
Ready to moderate and champion HF.Good at taking feedback and navigating ambiguous situations.
←You want a position like this.
This is the way to work in HF. A continuing role with a reasonable schedule, colleagues who value you and products you get to know. And other HF experts to think with, run studies with and share the logistics.
One lead slot for one or two products.
Our recommended starting point. Add coverage for more products or more day-to-day presence.
For companies outside the U.S.
Your U.S.-based HF lead supports product decisions, prepares HF documentation for FDA submissions and runs U.S. studies.
The same experts conduct your studies.
Your HF contact already knows the product. They and in-network HFaaS specialists run studies, with agency support for recruitment, IRB coordination, consent forms and logistics. External testing documentation is issued on the agency’s letterhead. Your HF contact can also obtain proposals from other vendors and oversee them, if the team prefers.
Small formatives and additional studies.
The included formatives typically involve 5–8 participants in hour-long sessions. Expenses include recruitment, participant incentives and travel when needed. Your quote for an additional study shows the comparable market price for the same scope, including lab space, and the HFaaS price at half that amount.
Compare your HF options.
In the conventional model, internal HF staff guide the product and oversee studies. External vendors supply researchers, recruiting, participant payments and lab space. Studies enter the vendor’s backlog and typically wait months, even with several HF staff in-house.
HF coverage options, illustrative U.S. costs, study delivery and work left with your team.
Approach
Cost
Expertise & studies
No dedicated HF expert
$0dedicated payroll
No internal HF expertise. Your team must buy and oversee it, with exposure to missed risks, submission delays or rejection. Studies wait in vendor queues.
Junior HF employee
~$10,000/ month, fully loaded
Full-time support, with senior supervision still needed for HF risks and submission evidence. Studies are outsourced at vendor prices and wait for vendor availability.
Principal HF employee
~$22,000/ month, fully loaded
Experienced judgment and product continuity. Your HF hire oversees external studies; you still pay vendor fees and wait for vendor capacity. You cover absences and departures.
Part-time agency contractor
~$10,400/ month at 20 hours/week
Embedded expertise without employee headcount. Part-time income makes retention harder; replacement takes time. Studies still require external vendors, separate budgets and a wait for capacity.
External HF consultancy
$40k–$200kper study
A study project buys no continuing internal HF guidance. Your team briefs the vendor, manages handoffs and corrects misunderstandings. Book months ahead and risk cancellation fees if the product isn’t ready, or wait in the backlog.
HFaaS
$15,000/ month
Principal-level guidance, in-network backup and study delivery together. Up to four small formatives/year, expenses only. Additional studies: half the comparable external vendor fee and half the startup time.
Illustrative U.S. costs. Employee budgets include benefits, overhead and office space; vendor study fees are additional. Study fees vary with scope, participants and logistics.
Cost assumptions and sources
Employee figures are illustrative U.S. employer budgets: junior salary of $80,000 plus 40% employment costs and $8,000/year workplace and operating overhead; principal salary of $180,000 plus 40% employment costs and $12,000/year workplace and operating overhead. These produce $10,000 and $22,000 per month. Salary anchors: Nemera HF Engineer 1 and Medtronic Principal HF Design Engineer.
The contractor example assumes $80/hour paid to the contractor and a one-third agency share of client revenue: $120/hour billed × 20 hours/week × 52 weeks ÷ 12. Agency arrangements vary.
Small formative example: 5–8 participants in hour-long sessions. An included HFaaS formative has no additional labor fee; recruitment at $250 plus an incentive of $200 per participant totals $2,250–$3,600. Travel and other applicable study expenses are additional.