Early-Stage

We help MedTech teams uncover what matters—before it’s too late to change course. Our early-stage services are designed to reduce risk, clarify direction, and build confidence in your design decisions.

Contextual inquiry, Interviews & Surveys

Competitor analysis

Task analysis & Use environment definition

Early use risk identification

User needs generation

Concept ideation

Speak to an expert

Get it right from the start with research that brings clarity, not complexity.

Understand the problem you are solving, then flawlessly execute

Whether you're shaping a new concept or refining an existing idea, we bring empathy, rigour, and real-world insight to the earliest phases of development. By applying Human Factors Engineering from day one, we help you design the right thing—and design it right.Whether you're navigating human factors for the first time or are highly invested in getting it right first time, our research helps you move forward with confidence.

Speak to an expert

Reece's contribution in the early human factors's design considerations have made a long lasting impact on the product and the patients. The innovative product design has seduced many health care profesionals for its simplicity of use with built-in tutorials, its compact and quiet design. These were paramount early design considerations that Reece validated through Human factor studies.

Maximilien Czech

Project manager- Smith and Nephew

Our approach to
early-stage research & development

Contextual Inquiry, Interviews & Surveys

Get inside the world of your users.

We engage directly with users in their environments to uncover behaviours, needs, and pain points. Our methods include observational research, user interviews, and targeted surveys to build a rich understanding of user context. The research methodology should be decided based on objectives, current understanding and budget.

Competitor analysis

Learn from your competition.

We analyse existing products to identify usability strengths, weaknesses, and market gaps. We can do this either desk-based and/or hands-on. This helps you avoid known pitfalls, differentiate your offering, and build on proven design patterns.

Task Analysis & Use Environment Definition

Design for the real world, not the ideal one.

We break down how users interact with your product and where those interactions happen. This includes workflows, physical environments, and constraints—ensuring your design fits seamlessly into users’ lives.

Early Use Risk Identification

Spot potential problems before they become real ones.

We identify use-related risks early in development, helping you address them proactively. This feeds directly into your risk management file and supports safer, more intuitive design.

User Needs Generation

Turn insights into actionable users needs.

We translate user research into clear, well-defined user needs. These form the foundation for your design, usability goals, and regulatory alignment.

Concept Ideation

Explore ideas with creativity and evidence.

We support early-stage brainstorming and prototyping to test assumptions, refine concepts, and guide your team toward confident design decisions.

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.