Trusted by medtech businesses worldwide

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?

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?

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.