Iterative Design & Usability

We design with people, not just for them. Our iterative approach—research, test, refine—keeps momentum high while reducing uncertainty and risk. You get senior thinking, practical delivery, and calm, collaborative support that turns insight into action and prepares you for validation with confidence.

Formative use testing

Risk management

Design workshops

Instructional design

Expert guidance

Industrial design

Speak to an expert

Design, test, evolve—deliver with confidence.

A tailored approach, from seasoned experts who have lived through projects from end-to-end

We want to make an impact and we do this through true partnership with our clients. We go that extra mile to understand your project and collaborate with your teams, so that we can deliver research and guidance that makes a difference to your patients and your healthcare professionals.

For more than 15 years each, our senior experts have helped some of the world’s largest manufacturers embed Human Factors effectively. That experience means we know how to make usability engineering work—on paper and in practice.

Speak to an expert

Reece was my Human Factors Specialist on my project for 4 years. He guided us immensely through design and testing and helped the project get to a full clinical trial. Reece was always diligent and would get involved with the Development team to set about making the product as usable and safe as possible. I enjoyed working with Reece and would definitely recommend him to others.

Bill Kelbie

Technical Lead- Smith & Nephew

How we help you acheive your goals

Formative Use Testing

Learn fast. Design smarter.

Observe real users with real tasks, uncover use risks early, and iterate with purpose. Every cycle delivers clear, practical improvements—while building the evidence you’ll need for validation.

Risk Management

Design out hazards, build in safety.

Our expert team applies principles and guidance from ISO 14971, IEC 62366, and the FDA to identify use-related risks and implement effective mitigations. This ensures your product is safe, compliant, and user-friendly from the outset.

Design Workshops

Collaborative creativity with purpose.

We facilitate hands-on workshops that bring stakeholders and user insights together to co-create solutions. These sessions accelerate innovation and align design decisions with real-world needs.

Instructional Design

Clear instructions. Confident users. Safer outcomes.

Great products deserve great instructions. Using our proprietary process, we design IFUs, quick‑start guides and packaging that make sense at first glance—reducing errors, boosting confidence and smoothing your path to market. Because when users feel informed, they feel in control.

Expert Guidance

Insights for strategy, documentation, design and compliance.

When you need clarity, we bring senior human factors expertise to your team. From shaping usability strategies and HF documentation to applying paper‑based methods like heuristic analysis, cognitive walkthroughs and literature reviews, we help you identify risks, strengthen design decisions and stay aligned with global regulatory expectations. Practical, adaptable and actionable guidance.

Industrial Design

Form that fits hands—function that fits life.

Our industrial design approach balances aesthetics, ergonomics, and usability. We create products that look great, feel right, and perform flawlessly in real-world contexts.

How we help

We integrate deep regulatory expertise with practical commercial insight, ensuring your products are not only approved but succeed in the real world.

Human Factors Expertise That Goes Beyond Compliance

Real insight, not generic reports

We don’t dump data on your desk. We help you use it to build something better.

A partner who brings clarity

We’re honest, human, and invested in your success.

Regulatory experience that translates

FDA, MDR, MHRA. We know the nuances and help you prepare for what’s ahead.

Answering your questions

Got more questions? Send us your enquiry below

1. What makes Formara different from other Human Factors consultancies?

We only assign truly senior specialists to your project — people with deep, hands-on experience across usability, risk management and medical device regulations. You won’t be passed to juniors or siloed experts. Our approach is collaborative, flexible, and grounded in real-world project constraints.

2. Do you only work with large companies, or do you support startups too?

We support both. While we regularly partner with leading MedTech and Pharma companies, we also help select startups build strong foundations and navigate early-stage development. Our flexible approach adapts to your size, budget and regulatory pathway.

3. Can you help with both formative and summative (validation) studies?

Yes. We offer end-to-end usability support, from early research and task analysis to validation studies for regulatory submission. We also support instructions for use (IFU) development, risk management files, and more.

4. Do you work internationally?

Yes. We’re based in the UK but frequently support clients across Europe and North America. We conduct in-person and remote research globally, and we’re experienced in aligning with regional regulatory expectations like FDA, MHRA, EU MDR and NMPA.

5. How early should we involve Human Factors in our project?

Ideally, from the beginning — but we can help at any stage. Early involvement maximises impact, helps avoid costly redesigns and ensures that usability and risk are considered proactively, not just reactively.

6. Can you work alongside our internal design or engineering teams?

Absolutely. We integrate closely with your teams, adapting to your workflow and tools. We're used to collaborating with R&D, regulatory, marketing, and more — and we make it easy to work with us.

7. How much does a typical project cost?

It depends on scope, but we’re happy to provide indicative pricing early on. Many formative studies range between £20,000 and £50,000. We also offer flexible day-rate consultancy and embedded resource options. Every proposal is bespoke and ultra transparent.

8. Can you support us with a tight deadline?

Often, yes. Because our team is experienced and lean, we can move quickly when needed. If you’re up against a deadline, reach out and we’ll let you know realistically what’s possible — and how to prioritise.

9. Do you provide facilities and recruit participants for usability studies?

Yes, we can manage the entire study logistics — including participant recruitment, facilities, equipment and moderation. We also offer hybrid and remote options where suitable.

10. Are you familiar with regulatory expectations like FDA guidance or IEC 62366?

Yes. Our team has extensive experience with FDA guidance, and IEC 62366 compliance. We know how to balance regulatory expectations with practical, commercial realities — helping you meet requirements without overcomplicating your process.

Answering your questions

Got more questions? Send us your enquiry below

1. What makes Formara different from other Human Factors consultancies?

2. Do you only work with large companies, or do you support startups too?

3. Can you help with both formative and summative (validation) studies?

4. Do you work internationally?

5. How early should we involve Human Factors in our project?

6. Can you work alongside our internal design or engineering teams?

Absolutely. We integrate closely with your teams, adapting to your workflow and tools. We're used to collaborating with R&D, regulatory, marketing, and more — and we make it easy to work with us.

7. How much does a typical project cost?

8. Can you support us with a tight deadline?

9. Do you provide facilities and recruit participants for usability studies?

Yes, we can manage the entire study logistics — including participant recruitment, facilities, equipment and moderation. We also offer hybrid and remote options where suitable.

10. Are you familiar with regulatory expectations like FDA guidance or IEC 62366?

Answering your questions

Got more questions? Send us your enquiry below

1. What makes Formara different from other Human Factors consultancies?

2. Do you only work with large companies, or do you support startups too?

3. Can you help with both formative and summative (validation) studies?

4. Do you work internationally?

5. How early should we involve Human Factors in our project?

6. Can you work alongside our internal design or engineering teams?

Absolutely. We integrate closely with your teams, adapting to your workflow and tools. We're used to collaborating with R&D, regulatory, marketing, and more — and we make it easy to work with us.

7. How much does a typical project cost?

8. Can you support us with a tight deadline?

9. Do you provide facilities and recruit participants for usability studies?

Yes, we can manage the entire study logistics — including participant recruitment, facilities, equipment and moderation. We also offer hybrid and remote options where suitable.