Designing with empathy.
Delivering with confidence.
We help MedTech teams avoid costly mistakes and late-stage changes. With our expert support, complex decisions become clear — helping you go beyond compliance and deliver products that succeed in the real world.
We help MedTech teams avoid costly mistakes and late-stage changes. With our expert support, complex decisions become clear — helping you go beyond compliance and deliver products that succeed in the real world.
Trusted by medtech businesses worldwide
Trusted by medtech businesses worldwide
Trusted by medtech businesses worldwide
Human Factors expertise that goes beyond compliance
Real Partnerships
We work alongside your team.
Not over the fence.
Experts Who Do the Work
When we say senior, we mean it — seasoned experts, working directly with you from day one.
Insights That Matter
Research that’s practical, usable, and designed to improve your product.
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.
We help you succeed, not just comply
You’re not looking for a test house or a report factory. You need senior human factors experts who work alongside your team to simplify complex challenges. By applying scientific rigour at every step, we help you make confident decisions that lead to safer, more effective products.
· True senior experts. Doing the work, not just selling it
· We join early and make an impact. Not just validate at the end.
· Research is made to be used. Not filed away.
· You get real-world, regulatory-aligned guidance.
· We partner with your team. Not just pass over reports
Hear from our happy clients
- Reece and I worked together on one of Smith & Nephew's largest investment NPD programme RENASYS EDGE. As EDGE has now sucessfully landed on patient's hands around the world, 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. Reece has a true passion for Human factors with previous experience in other sector like automotive which has served him well throughout his career. Personally, Reece has been a great colleague to work alongside with, he is a very personable and approachable individual.
Maximilien Czech
Program Manager
- A big thank you to Reece and his team for their support on our project. From the very beginning, they demonstrated a strong ability to quickly grasp our objectives and adapt their approach to meet our specific needs. Their responsiveness to feedback ensure a good progress of the process. Reece and his team were always kind, collaborative, and welcoming, which made working with them not only productive but as well enjoyable. I highly recommend Reece and his team for any Human Factors-related work—they bring both the competence and the human touch that make a real difference.
Pierre Bessot
Human Factors Engineer
- Reece is a highly knowledgeable, passionate, and hard working human factors professional who you will enjoy working with. He brings honesty, creative solutions, rigorous science, and a well-organized approach to all his work. He also keeps end users at the forefront of all project decisions. I’ve had the pleasure of knowing Reece for many years, and I highly recommend him for your human factors needs.
Melissa Lemke
Human Factors SME
- Each time we have partnered with Reece has been a great experience. Reece is professional, attentive, and worked with us to understand our needs and the overall goal of what we wanted to accomplish. He was thorough in ensuring we had updates throughout his work process as well as the materials we needed at any given time, including when we needed to submit an IRB. Reece is also very personable and creates a friendly and easy working environment. We continue to anticipate ways in which we can continue this partnership in the future.
Lauren Tokarewich
Senior Manager
- 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
Engineer Manager
- Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader. Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader.
Jessica Parry
Chartered Human Factors Specialist
- I worked with Reece when he was managing the Human Factors team at Smith and Nephew. During this time he cultivated a friendly, collaborative team culture, building the foundations of the teams vision. Reece is an exceptionally capable, thoughtful individual with a wholesome ‘can-do’ attitude that made him widely liked and respected. I would unreservedly recommend Reece for his leadership aptitude, positivity and ability to build meaningful work relationships with the people around him.
Alex Agis
Human Factors Specialist
- Reece and I worked together on one of Smith & Nephew's largest investment NPD programme RENASYS EDGE. As EDGE has now sucessfully landed on patient's hands around the world, 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. Reece has a true passion for Human factors with previous experience in other sector like automotive which has served him well throughout his career. Personally, Reece has been a great colleague to work alongside with, he is a very personable and approachable individual.
Maximilien Czech
Program Manager
- A big thank you to Reece and his team for their support on our project. From the very beginning, they demonstrated a strong ability to quickly grasp our objectives and adapt their approach to meet our specific needs. Their responsiveness to feedback ensure a good progress of the process. Reece and his team were always kind, collaborative, and welcoming, which made working with them not only productive but as well enjoyable. I highly recommend Reece and his team for any Human Factors-related work—they bring both the competence and the human touch that make a real difference.
Pierre Bessot
Human Factors Engineer
- Reece is a highly knowledgeable, passionate, and hard working human factors professional who you will enjoy working with. He brings honesty, creative solutions, rigorous science, and a well-organized approach to all his work. He also keeps end users at the forefront of all project decisions. I’ve had the pleasure of knowing Reece for many years, and I highly recommend him for your human factors needs.
Melissa Lemke
Human Factors SME
- Each time we have partnered with Reece has been a great experience. Reece is professional, attentive, and worked with us to understand our needs and the overall goal of what we wanted to accomplish. He was thorough in ensuring we had updates throughout his work process as well as the materials we needed at any given time, including when we needed to submit an IRB. Reece is also very personable and creates a friendly and easy working environment. We continue to anticipate ways in which we can continue this partnership in the future.
Lauren Tokarewich
Senior Manager
- 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
Engineer Manager
- Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader. Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader.
Jessica Parry
Chartered Human Factors Specialist
- I worked with Reece when he was managing the Human Factors team at Smith and Nephew. During this time he cultivated a friendly, collaborative team culture, building the foundations of the teams vision. Reece is an exceptionally capable, thoughtful individual with a wholesome ‘can-do’ attitude that made him widely liked and respected. I would unreservedly recommend Reece for his leadership aptitude, positivity and ability to build meaningful work relationships with the people around him.
Alex Agis
Human Factors Specialist
- Reece and I worked together on one of Smith & Nephew's largest investment NPD programme RENASYS EDGE. As EDGE has now sucessfully landed on patient's hands around the world, 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. Reece has a true passion for Human factors with previous experience in other sector like automotive which has served him well throughout his career. Personally, Reece has been a great colleague to work alongside with, he is a very personable and approachable individual.
Maximilien Czech
Program Manager
- A big thank you to Reece and his team for their support on our project. From the very beginning, they demonstrated a strong ability to quickly grasp our objectives and adapt their approach to meet our specific needs. Their responsiveness to feedback ensure a good progress of the process. Reece and his team were always kind, collaborative, and welcoming, which made working with them not only productive but as well enjoyable. I highly recommend Reece and his team for any Human Factors-related work—they bring both the competence and the human touch that make a real difference.
Pierre Bessot
Human Factors Engineer
- Reece is a highly knowledgeable, passionate, and hard working human factors professional who you will enjoy working with. He brings honesty, creative solutions, rigorous science, and a well-organized approach to all his work. He also keeps end users at the forefront of all project decisions. I’ve had the pleasure of knowing Reece for many years, and I highly recommend him for your human factors needs.
Melissa Lemke
Human Factors SME
- Each time we have partnered with Reece has been a great experience. Reece is professional, attentive, and worked with us to understand our needs and the overall goal of what we wanted to accomplish. He was thorough in ensuring we had updates throughout his work process as well as the materials we needed at any given time, including when we needed to submit an IRB. Reece is also very personable and creates a friendly and easy working environment. We continue to anticipate ways in which we can continue this partnership in the future.
Lauren Tokarewich
Senior Manager
- 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
Engineer Manager
- Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader. Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader.
Jessica Parry
Chartered Human Factors Specialist
- I worked with Reece when he was managing the Human Factors team at Smith and Nephew. During this time he cultivated a friendly, collaborative team culture, building the foundations of the teams vision. Reece is an exceptionally capable, thoughtful individual with a wholesome ‘can-do’ attitude that made him widely liked and respected. I would unreservedly recommend Reece for his leadership aptitude, positivity and ability to build meaningful work relationships with the people around him.
Alex Agis
Human Factors Specialist
- Reece and I worked together on one of Smith & Nephew's largest investment NPD programme RENASYS EDGE. As EDGE has now sucessfully landed on patient's hands around the world, 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. Reece has a true passion for Human factors with previous experience in other sector like automotive which has served him well throughout his career. Personally, Reece has been a great colleague to work alongside with, he is a very personable and approachable individual.
Maximilien Czech
Program Manager
- A big thank you to Reece and his team for their support on our project. From the very beginning, they demonstrated a strong ability to quickly grasp our objectives and adapt their approach to meet our specific needs. Their responsiveness to feedback ensure a good progress of the process. Reece and his team were always kind, collaborative, and welcoming, which made working with them not only productive but as well enjoyable. I highly recommend Reece and his team for any Human Factors-related work—they bring both the competence and the human touch that make a real difference.
Pierre Bessot
Human Factors Engineer
- Reece is a highly knowledgeable, passionate, and hard working human factors professional who you will enjoy working with. He brings honesty, creative solutions, rigorous science, and a well-organized approach to all his work. He also keeps end users at the forefront of all project decisions. I’ve had the pleasure of knowing Reece for many years, and I highly recommend him for your human factors needs.
Melissa Lemke
Human Factors SME
- Each time we have partnered with Reece has been a great experience. Reece is professional, attentive, and worked with us to understand our needs and the overall goal of what we wanted to accomplish. He was thorough in ensuring we had updates throughout his work process as well as the materials we needed at any given time, including when we needed to submit an IRB. Reece is also very personable and creates a friendly and easy working environment. We continue to anticipate ways in which we can continue this partnership in the future.
Lauren Tokarewich
Senior Manager
- 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
Engineer Manager
- Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader. Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader.
Jessica Parry
Chartered Human Factors Specialist
- I worked with Reece when he was managing the Human Factors team at Smith and Nephew. During this time he cultivated a friendly, collaborative team culture, building the foundations of the teams vision. Reece is an exceptionally capable, thoughtful individual with a wholesome ‘can-do’ attitude that made him widely liked and respected. I would unreservedly recommend Reece for his leadership aptitude, positivity and ability to build meaningful work relationships with the people around him.
Alex Agis
Human Factors Specialist
- Reece and I worked together on one of Smith & Nephew's largest investment NPD programme RENASYS EDGE. As EDGE has now sucessfully landed on patient's hands around the world, 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. Reece has a true passion for Human factors with previous experience in other sector like automotive which has served him well throughout his career. Personally, Reece has been a great colleague to work alongside with, he is a very personable and approachable individual.
Maximilien Czech
Program Manager
- A big thank you to Reece and his team for their support on our project. From the very beginning, they demonstrated a strong ability to quickly grasp our objectives and adapt their approach to meet our specific needs. Their responsiveness to feedback ensure a good progress of the process. Reece and his team were always kind, collaborative, and welcoming, which made working with them not only productive but as well enjoyable. I highly recommend Reece and his team for any Human Factors-related work—they bring both the competence and the human touch that make a real difference.
Pierre Bessot
Human Factors Engineer
- Reece is a highly knowledgeable, passionate, and hard working human factors professional who you will enjoy working with. He brings honesty, creative solutions, rigorous science, and a well-organized approach to all his work. He also keeps end users at the forefront of all project decisions. I’ve had the pleasure of knowing Reece for many years, and I highly recommend him for your human factors needs.
Melissa Lemke
Human Factors SME
- Each time we have partnered with Reece has been a great experience. Reece is professional, attentive, and worked with us to understand our needs and the overall goal of what we wanted to accomplish. He was thorough in ensuring we had updates throughout his work process as well as the materials we needed at any given time, including when we needed to submit an IRB. Reece is also very personable and creates a friendly and easy working environment. We continue to anticipate ways in which we can continue this partnership in the future.
Lauren Tokarewich
Senior Manager
- 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
Engineer Manager
- Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader. Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader.
Jessica Parry
Chartered Human Factors Specialist
- I worked with Reece when he was managing the Human Factors team at Smith and Nephew. During this time he cultivated a friendly, collaborative team culture, building the foundations of the teams vision. Reece is an exceptionally capable, thoughtful individual with a wholesome ‘can-do’ attitude that made him widely liked and respected. I would unreservedly recommend Reece for his leadership aptitude, positivity and ability to build meaningful work relationships with the people around him.
Alex Agis
Human Factors Specialist
- Reece and I worked together on one of Smith & Nephew's largest investment NPD programme RENASYS EDGE. As EDGE has now sucessfully landed on patient's hands around the world, 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. Reece has a true passion for Human factors with previous experience in other sector like automotive which has served him well throughout his career. Personally, Reece has been a great colleague to work alongside with, he is a very personable and approachable individual.
Maximilien Czech
Program Manager
- A big thank you to Reece and his team for their support on our project. From the very beginning, they demonstrated a strong ability to quickly grasp our objectives and adapt their approach to meet our specific needs. Their responsiveness to feedback ensure a good progress of the process. Reece and his team were always kind, collaborative, and welcoming, which made working with them not only productive but as well enjoyable. I highly recommend Reece and his team for any Human Factors-related work—they bring both the competence and the human touch that make a real difference.
Pierre Bessot
Human Factors Engineer
- Reece is a highly knowledgeable, passionate, and hard working human factors professional who you will enjoy working with. He brings honesty, creative solutions, rigorous science, and a well-organized approach to all his work. He also keeps end users at the forefront of all project decisions. I’ve had the pleasure of knowing Reece for many years, and I highly recommend him for your human factors needs.
Melissa Lemke
Human Factors SME
- Each time we have partnered with Reece has been a great experience. Reece is professional, attentive, and worked with us to understand our needs and the overall goal of what we wanted to accomplish. He was thorough in ensuring we had updates throughout his work process as well as the materials we needed at any given time, including when we needed to submit an IRB. Reece is also very personable and creates a friendly and easy working environment. We continue to anticipate ways in which we can continue this partnership in the future.
Lauren Tokarewich
Senior Manager
- 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
Engineer Manager
- Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader. Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader.
Jessica Parry
Chartered Human Factors Specialist
- I worked with Reece when he was managing the Human Factors team at Smith and Nephew. During this time he cultivated a friendly, collaborative team culture, building the foundations of the teams vision. Reece is an exceptionally capable, thoughtful individual with a wholesome ‘can-do’ attitude that made him widely liked and respected. I would unreservedly recommend Reece for his leadership aptitude, positivity and ability to build meaningful work relationships with the people around him.
Alex Agis
Human Factors Specialist
- Reece and I worked together on one of Smith & Nephew's largest investment NPD programme RENASYS EDGE. As EDGE has now sucessfully landed on patient's hands around the world, 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. Reece has a true passion for Human factors with previous experience in other sector like automotive which has served him well throughout his career. Personally, Reece has been a great colleague to work alongside with, he is a very personable and approachable individual.
Maximilien Czech
Program Manager
- A big thank you to Reece and his team for their support on our project. From the very beginning, they demonstrated a strong ability to quickly grasp our objectives and adapt their approach to meet our specific needs. Their responsiveness to feedback ensure a good progress of the process. Reece and his team were always kind, collaborative, and welcoming, which made working with them not only productive but as well enjoyable. I highly recommend Reece and his team for any Human Factors-related work—they bring both the competence and the human touch that make a real difference.
Pierre Bessot
Human Factors Engineer
- Reece is a highly knowledgeable, passionate, and hard working human factors professional who you will enjoy working with. He brings honesty, creative solutions, rigorous science, and a well-organized approach to all his work. He also keeps end users at the forefront of all project decisions. I’ve had the pleasure of knowing Reece for many years, and I highly recommend him for your human factors needs.
Melissa Lemke
Human Factors SME
- Each time we have partnered with Reece has been a great experience. Reece is professional, attentive, and worked with us to understand our needs and the overall goal of what we wanted to accomplish. He was thorough in ensuring we had updates throughout his work process as well as the materials we needed at any given time, including when we needed to submit an IRB. Reece is also very personable and creates a friendly and easy working environment. We continue to anticipate ways in which we can continue this partnership in the future.
Lauren Tokarewich
Senior Manager
- 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
Engineer Manager
- Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader. Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader.
Jessica Parry
Chartered Human Factors Specialist
- I worked with Reece when he was managing the Human Factors team at Smith and Nephew. During this time he cultivated a friendly, collaborative team culture, building the foundations of the teams vision. Reece is an exceptionally capable, thoughtful individual with a wholesome ‘can-do’ attitude that made him widely liked and respected. I would unreservedly recommend Reece for his leadership aptitude, positivity and ability to build meaningful work relationships with the people around him.
Alex Agis
Human Factors Specialist
- Reece and I worked together on one of Smith & Nephew's largest investment NPD programme RENASYS EDGE. As EDGE has now sucessfully landed on patient's hands around the world, 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. Reece has a true passion for Human factors with previous experience in other sector like automotive which has served him well throughout his career. Personally, Reece has been a great colleague to work alongside with, he is a very personable and approachable individual.
Maximilien Czech
Program Manager
- A big thank you to Reece and his team for their support on our project. From the very beginning, they demonstrated a strong ability to quickly grasp our objectives and adapt their approach to meet our specific needs. Their responsiveness to feedback ensure a good progress of the process. Reece and his team were always kind, collaborative, and welcoming, which made working with them not only productive but as well enjoyable. I highly recommend Reece and his team for any Human Factors-related work—they bring both the competence and the human touch that make a real difference.
Pierre Bessot
Human Factors Engineer
- Reece is a highly knowledgeable, passionate, and hard working human factors professional who you will enjoy working with. He brings honesty, creative solutions, rigorous science, and a well-organized approach to all his work. He also keeps end users at the forefront of all project decisions. I’ve had the pleasure of knowing Reece for many years, and I highly recommend him for your human factors needs.
Melissa Lemke
Human Factors SME
- Each time we have partnered with Reece has been a great experience. Reece is professional, attentive, and worked with us to understand our needs and the overall goal of what we wanted to accomplish. He was thorough in ensuring we had updates throughout his work process as well as the materials we needed at any given time, including when we needed to submit an IRB. Reece is also very personable and creates a friendly and easy working environment. We continue to anticipate ways in which we can continue this partnership in the future.
Lauren Tokarewich
Senior Manager
- 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
Engineer Manager
- Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader. Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader.
Jessica Parry
Chartered Human Factors Specialist
- I worked with Reece when he was managing the Human Factors team at Smith and Nephew. During this time he cultivated a friendly, collaborative team culture, building the foundations of the teams vision. Reece is an exceptionally capable, thoughtful individual with a wholesome ‘can-do’ attitude that made him widely liked and respected. I would unreservedly recommend Reece for his leadership aptitude, positivity and ability to build meaningful work relationships with the people around him.
Alex Agis
Human Factors Specialist
- Reece and I worked together on one of Smith & Nephew's largest investment NPD programme RENASYS EDGE. As EDGE has now sucessfully landed on patient's hands around the world, 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. Reece has a true passion for Human factors with previous experience in other sector like automotive which has served him well throughout his career. Personally, Reece has been a great colleague to work alongside with, he is a very personable and approachable individual.
Maximilien Czech
Program Manager
- A big thank you to Reece and his team for their support on our project. From the very beginning, they demonstrated a strong ability to quickly grasp our objectives and adapt their approach to meet our specific needs. Their responsiveness to feedback ensure a good progress of the process. Reece and his team were always kind, collaborative, and welcoming, which made working with them not only productive but as well enjoyable. I highly recommend Reece and his team for any Human Factors-related work—they bring both the competence and the human touch that make a real difference.
Pierre Bessot
Human Factors Engineer
- Reece is a highly knowledgeable, passionate, and hard working human factors professional who you will enjoy working with. He brings honesty, creative solutions, rigorous science, and a well-organized approach to all his work. He also keeps end users at the forefront of all project decisions. I’ve had the pleasure of knowing Reece for many years, and I highly recommend him for your human factors needs.
Melissa Lemke
Human Factors SME
- Each time we have partnered with Reece has been a great experience. Reece is professional, attentive, and worked with us to understand our needs and the overall goal of what we wanted to accomplish. He was thorough in ensuring we had updates throughout his work process as well as the materials we needed at any given time, including when we needed to submit an IRB. Reece is also very personable and creates a friendly and easy working environment. We continue to anticipate ways in which we can continue this partnership in the future.
Lauren Tokarewich
Senior Manager
- 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
Engineer Manager
- Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader. Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader.
Jessica Parry
Chartered Human Factors Specialist
- I worked with Reece when he was managing the Human Factors team at Smith and Nephew. During this time he cultivated a friendly, collaborative team culture, building the foundations of the teams vision. Reece is an exceptionally capable, thoughtful individual with a wholesome ‘can-do’ attitude that made him widely liked and respected. I would unreservedly recommend Reece for his leadership aptitude, positivity and ability to build meaningful work relationships with the people around him.
Alex Agis
Human Factors Specialist
- Reece and I worked together on one of Smith & Nephew's largest investment NPD programme RENASYS EDGE. As EDGE has now sucessfully landed on patient's hands around the world, 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. Reece has a true passion for Human factors with previous experience in other sector like automotive which has served him well throughout his career. Personally, Reece has been a great colleague to work alongside with, he is a very personable and approachable individual.
Maximilien Czech
Program Manager
- A big thank you to Reece and his team for their support on our project. From the very beginning, they demonstrated a strong ability to quickly grasp our objectives and adapt their approach to meet our specific needs. Their responsiveness to feedback ensure a good progress of the process. Reece and his team were always kind, collaborative, and welcoming, which made working with them not only productive but as well enjoyable. I highly recommend Reece and his team for any Human Factors-related work—they bring both the competence and the human touch that make a real difference.
Pierre Bessot
Human Factors Engineer
- Reece is a highly knowledgeable, passionate, and hard working human factors professional who you will enjoy working with. He brings honesty, creative solutions, rigorous science, and a well-organized approach to all his work. He also keeps end users at the forefront of all project decisions. I’ve had the pleasure of knowing Reece for many years, and I highly recommend him for your human factors needs.
Melissa Lemke
Human Factors SME
- Each time we have partnered with Reece has been a great experience. Reece is professional, attentive, and worked with us to understand our needs and the overall goal of what we wanted to accomplish. He was thorough in ensuring we had updates throughout his work process as well as the materials we needed at any given time, including when we needed to submit an IRB. Reece is also very personable and creates a friendly and easy working environment. We continue to anticipate ways in which we can continue this partnership in the future.
Lauren Tokarewich
Senior Manager
- 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
Engineer Manager
- Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader. Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader.
Jessica Parry
Chartered Human Factors Specialist
- I worked with Reece when he was managing the Human Factors team at Smith and Nephew. During this time he cultivated a friendly, collaborative team culture, building the foundations of the teams vision. Reece is an exceptionally capable, thoughtful individual with a wholesome ‘can-do’ attitude that made him widely liked and respected. I would unreservedly recommend Reece for his leadership aptitude, positivity and ability to build meaningful work relationships with the people around him.
Alex Agis
Human Factors Specialist
- Reece and I worked together on one of Smith & Nephew's largest investment NPD programme RENASYS EDGE. As EDGE has now sucessfully landed on patient's hands around the world, 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. Reece has a true passion for Human factors with previous experience in other sector like automotive which has served him well throughout his career. Personally, Reece has been a great colleague to work alongside with, he is a very personable and approachable individual.
Maximilien Czech
Program Manager
- A big thank you to Reece and his team for their support on our project. From the very beginning, they demonstrated a strong ability to quickly grasp our objectives and adapt their approach to meet our specific needs. Their responsiveness to feedback ensure a good progress of the process. Reece and his team were always kind, collaborative, and welcoming, which made working with them not only productive but as well enjoyable. I highly recommend Reece and his team for any Human Factors-related work—they bring both the competence and the human touch that make a real difference.
Pierre Bessot
Human Factors Engineer
- Reece is a highly knowledgeable, passionate, and hard working human factors professional who you will enjoy working with. He brings honesty, creative solutions, rigorous science, and a well-organized approach to all his work. He also keeps end users at the forefront of all project decisions. I’ve had the pleasure of knowing Reece for many years, and I highly recommend him for your human factors needs.
Melissa Lemke
Human Factors SME
- Each time we have partnered with Reece has been a great experience. Reece is professional, attentive, and worked with us to understand our needs and the overall goal of what we wanted to accomplish. He was thorough in ensuring we had updates throughout his work process as well as the materials we needed at any given time, including when we needed to submit an IRB. Reece is also very personable and creates a friendly and easy working environment. We continue to anticipate ways in which we can continue this partnership in the future.
Lauren Tokarewich
Senior Manager
- 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
Engineer Manager
- Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader. Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader.
Jessica Parry
Chartered Human Factors Specialist
- I worked with Reece when he was managing the Human Factors team at Smith and Nephew. During this time he cultivated a friendly, collaborative team culture, building the foundations of the teams vision. Reece is an exceptionally capable, thoughtful individual with a wholesome ‘can-do’ attitude that made him widely liked and respected. I would unreservedly recommend Reece for his leadership aptitude, positivity and ability to build meaningful work relationships with the people around him.
Alex Agis
Human Factors Specialist
- Reece and I worked together on one of Smith & Nephew's largest investment NPD programme RENASYS EDGE. As EDGE has now sucessfully landed on patient's hands around the world, 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. Reece has a true passion for Human factors with previous experience in other sector like automotive which has served him well throughout his career. Personally, Reece has been a great colleague to work alongside with, he is a very personable and approachable individual.
Maximilien Czech
Program Manager
- A big thank you to Reece and his team for their support on our project. From the very beginning, they demonstrated a strong ability to quickly grasp our objectives and adapt their approach to meet our specific needs. Their responsiveness to feedback ensure a good progress of the process. Reece and his team were always kind, collaborative, and welcoming, which made working with them not only productive but as well enjoyable. I highly recommend Reece and his team for any Human Factors-related work—they bring both the competence and the human touch that make a real difference.
Pierre Bessot
Human Factors Engineer
- Reece is a highly knowledgeable, passionate, and hard working human factors professional who you will enjoy working with. He brings honesty, creative solutions, rigorous science, and a well-organized approach to all his work. He also keeps end users at the forefront of all project decisions. I’ve had the pleasure of knowing Reece for many years, and I highly recommend him for your human factors needs.
Melissa Lemke
Human Factors SME
- Each time we have partnered with Reece has been a great experience. Reece is professional, attentive, and worked with us to understand our needs and the overall goal of what we wanted to accomplish. He was thorough in ensuring we had updates throughout his work process as well as the materials we needed at any given time, including when we needed to submit an IRB. Reece is also very personable and creates a friendly and easy working environment. We continue to anticipate ways in which we can continue this partnership in the future.
Lauren Tokarewich
Senior Manager
- 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
Engineer Manager
- Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader. Few people have the opportunity to report to a manager who is a mentor and Coach - I was one of those lucky few. I have worked with Reece for just over 3 years, 8 months of which were under his leadership. Reece's ability to manage multiple projects, take on added responsibility, cultivate a positive collaborative culture, whilst placing his team members at the forefront of his efforts is unparalleled. Reece is a genuine, kind and thoughtful leader who helped provide me with guidance and support to grow within my role. His hands-on approach to mentoring and career coaching, ingenuity, exceptional work ethic and insights made him a strong leader and a dream to work for. Any employee would be lucky to have Reece as their leader.
Jessica Parry
Chartered Human Factors Specialist
- I worked with Reece when he was managing the Human Factors team at Smith and Nephew. During this time he cultivated a friendly, collaborative team culture, building the foundations of the teams vision. Reece is an exceptionally capable, thoughtful individual with a wholesome ‘can-do’ attitude that made him widely liked and respected. I would unreservedly recommend Reece for his leadership aptitude, positivity and ability to build meaningful work relationships with the people around him.
Alex Agis
Human Factors Specialist
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.
Let’s speak about your project today
Reece Knight
Founder
Let’s speak about your project today
Reece Knight
Founder
Let’s speak about your project today
Reece Knight
Founder
Formara Consulting - All rights reserved
Formara Consulting - All rights reserved
Formara Consulting - All rights reserved