Human Factors as a competitive edge in MedTech

Moving beyond box‑ticking to build safer, simpler devices — and stronger businesses.

Medical technology is only getting more complex. Reports indicate that about 33% of medical device incidents reported to the US FDA are due to use errors (Shaheen et al., 2020). Teams that integrate Human Factors early don’t just comply — they move faster, de‑risk decisions, and create products that people actively want to use. That’s the competitive edge: fewer surprises late in development, clearer evidence at stage gates, and better adoption in the real world.

The future I see

With earlier adoption of Human Factors, the future looks brighter for the whole MedTech ecosystem:

• Early evidence reduces costly rework later.

• Products match clinical workflows, not the other way round.

• Strong documentation that stands up to scrutiny — without slowing momentum.

• Confident, better equipped healthcare professionals.

• Better health outcomes for patients.

How Formara helps

Formara brings senior, hands‑on Human Factors expertise across research, design iteration and validation — from task analysis and formative testing to summative studies and IFU design. We work as an extension of your team: collaborative, practical and calm under pressure. Designing with empathy. Delivering with confidence.

The Formara Vision

I’ve always had the urge to build things that make a real difference. That curiosity became a career in Human Factors: I studied Ergonomics to apply ideas to the real world, then spent my early years inside complex, high‑stakes environments at Lockheed Martin and Jaguar Land Rover, where the question was always the same: how do we improve the system for it's users?

At Smith & Nephew, I spent seven years shifting an engineering‑first culture toward one that was user centred. It taught me that when you bring users’ realities into the room early, you not only change the product but the way teams think and decide.

I left Smith and Nephew with a clear objective; to help other companies adopt a user-centric approach and in doing so, make a bigger impact on the industry. Using my experience of working with many consultancies I wanted to prove there’s a better way to partner with MedTech teams: senior, collaborative, practical, and focused on outcomes over box‑ticking. That’s the consultancy I founded. That’s Formara.

The solution

Formara is my solution to a frustration I kept seeing: processes that slow people down and research that’s bolted on instead of built in. Formara exists to replace that with honest, senior thinking and hands‑on delivery that helps teams move faster with confidence. We’re a partner, not a vendor — creative when it matters, rigorous when it counts.

Underpinning it all are the values I started the company with: Human First, Expertly Curious, Brave Thinking, Built on Trust, Outcome Obsessed, and Thoughtfully Collaborative. Those aren’t slogans — they’re the way we show up day to day, so clients can make better decisions, sooner.

Formara is a place where good people do meaningful work and build meaningful relationships — where profit doesn’t come at the expense of integrity, and where “Designing with empathy. Delivering with confidence.” is more than a line on a slide; it’s how we operate with each other and with our clients.

My promise

You’ll get thoughtful, senior thinking and practical delivery — the kind that helps your team make confident decisions at pace. If that sounds like what you need, let’s talk about your next milestone.

— Reece Knight, Founder, Formara