Medical device founders: Here is where you are potentially losing hundreds of thousands of dollars

The FDA has explicitly stated that HF (human factors) validation is required for specific medical devices. Only after this approval can you launch your product and start generating revenue!

A major portion of FDA documentation consists of human factors documentation. This is where usability tests, user research, data synthesis, task analysis, and final study reports, best known as formative reports, are important. Yet, HF teams struggle to align these into continuous feedback loops. As a result, there is not a clear history of how you iterated your device over time and why you made the design decisions you made!

In modern day practice, user studies are recorded with the participant's permission onto recording platforms like Teams or Zoom. One engineer typically interviews and observes the user, and 1 or 2 engineers are responsible for filling out the matrix, taught to do fast...

• How much do you pay this panel of recording your observations?
• How much do you pay your team's HF human?
• How much time do these HF events add format?
• Most crucially delays, delay.

So, let's do the math here:

1. Contact HF participants (Usability room): $15,000 - $30,000
2. User Recruiting, daily allowances, participants: $1,500/participant × 15 = $15,000 - $20,000
3. Observational Panel Travel: boarding, weekly allowance: engineer - $2000 x 3 = $6,000
4. License Recording, licensed: $10,000
5. Data Analyst and engineers, freelancer/outsourced: $5,000
6. Pay for an entire Device engineering team/month: $50,000 - $70,000

We're already at approx: $83,000 and we haven't even added the tax, prototyping costs, shipping costs and other extra numbers

But wait, there's more... After a study, engineers get to work and analyze these word charts and tracks and start hunting around identifying use behaviors, comments, and use scenarios. The FDA is very strict about how transcribing these reports are to the way. The average engineering team depends on 1 to 2 members on this research, usually mandating 1 to 2 months as they juggle other tasks. That's an average of about $4000 a day per engineering team per report...

What if you could cut the reporting requirement off from the list above?

You save $32,000 per study AND you're a month/two months natively into the future. The average medical device produces undergoes 4-7 studies before FDA submission.

The math is simple to state as an exact record!

• Hardware engineers creating usability protocols and observations, that you save on mixed costs but still pay a salary
• Use Submitta; Just upload the auto-generated meeting transcript and you'll have a populated base structured report in minutes... As you sit around!

Please reach out to info@submitta.ai to get on our beta wait-list!