Question 1

What is human factors?

Accepted Answer

Human factors, sometimes referred to as usability engineering, is there to ensure that your device is being used as intended. It is a multidisciplinary field, incorporating aspects of psychology, engineering, industrial design, statistics, operations research, and anthropometry. It is the science of understanding human capability and human errors, and the application of this understanding to the design, development, and deployment of systems and services; and the art of ensuring successful integration into the using environment.

Question 2

What is human factors in healthcare?

Accepted Answer

In the healthcare industry, human factors is essential in improving healthcare delivery and the safety of systems and devices. This is done by looking at the interaction between a user, the machine, and the use environment. This can be broken down further to end users, equipment, workspace (a clinical or home environment), use procedures, work practices, and training for healthcare professionals and patients. Human factors ensures that the entire use interaction runs as smoothly and safely as possible.

Question 3

Why human factors is important in healthcare?

Accepted Answer

For medical devices and products, the most important goal of the human factors is to minimize use-related errors and risks, injuries and accidents, so that your device can be used safely, effectively, and efficiently. Applying human factors allows devices and procedures to be designed with the user in mind, by considering users’ capabilities and limitations while they interact with the devices and use environment.
The importance of human interaction cannot be understated, and indeed, in the UK more than 11,000 people deaths per year are due to use-related errors. Several individual factors can impact on human performance and predispose a person to error, and it is a failure to apply human factors principles to validate interaction that is a key aspect of many adverse events in health care.
An example where interaction can go wrong is given by the FDA. A patient was using an infusion pump to administer their medication. After finishing their current medication cassette they changed to a new one, but they forgot to remove a cap from the infusion line, blocking the flow of medication. The pump had no alarm for high pressure and there was no warning that the medication was not being administered and as a result, the patient was hospitalised. Effective human factors would have encountered this situation in testing and the risk would have likely been mitigated.
Safety can seem expensive, but it is far cheaper than having an incident. Managing human failures is essential to prevent major accidents, use errors, injury, and death, all of which can cost businesses money, reputation and potentially their continued existence. Successful businesses achieve high productivity and quality while ensuring their devices can be used safely and effectively by end users.

Question 4

How long has the company been in business?

Accepted Answer

Auxergo was founded in Cambridge in 2016. 2022 marks our 6th year. Thank you to our customers, past and present.

Question 5

Why Auxergo?

Accepted Answer

With a dedicated team of specialists and researchers, we provide solutions-driven, flexible, and cost-effective human factors projects on time and within budget. 
Furthermore, we have received 100% client satisfaction; 100% study participant satisfaction; 100% on time project delivery; and 92% impactful outcomes. We have worked with more than 340 healthcare professionals; more than 3000 patients; and carried out more than 90 documentation and regulatory reviews in over 8 countries so far.
All our work is conducted in accordance with human factors regulations and guidelines. Please see our MARKETS for more details.

Question 6

What are our human factors capabilities?

Accepted Answer

We can provide comprehensive human factors services all the way through the development process, ranging from participant recruitment for studies to final reports. We can also provide all usability engineering files including writing and reviewing user specifications and conducting your summative study. Please see our HUMAN FACTORS AND USABILITY for more details.

Question 7

What type of medical devices do you work with?

Accepted Answer

We work with all types of medical devices from Class I to Class III. Specific examples are clinical use and home use medical devices, in vitro diagnostic devices, surgery equipment, monitoring devices, drug delivery devices or combination products. Please see OUR FOCUS for more details. We also work with digital devices, telehealthcare devices, software systems, and hospital systems. 
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Question 8

Could you keep the project information confidential?

Accepted Answer

Yes, absolutely. For all the projects we work on, and all the data we collect and analyse, we keep global industry level data protection standards and we always guarantee total confidentiality. Data will be stored securely, and any published information will be kept anonymous. In addition, we always ensure our projects are carried out in accordance with the Declaration of Helsinki and are available to be reviewed by Research Ethics Committee in the UK.

Question 9

How do you recruit the end-users needed for a formative or summative study?

Accepted Answer

We have our own user database under different hospital trusts and socioeconomic regions. We also have an established working relationship with several market research companies. Therefore, we can recruit all manner of clinicians (such as physicians, nurses, pharmacists) and patients (such as diabetics, COPD patients, general consumers) in different geographic regions. For more details, please see PARTICIPATE.

Question 10

Do you help with concept design or prototype building?

Accepted Answer

Yes. We can be involved in any of the design and development stages. We can work with your design team to co-design your products to deliver comprehensive and elegant solutions that offer a positive user experience. Please see CO-DESIGN page for more details. We also can work together with your R&D staff to integrate human factors into your process to test and develop your products to maximally avoid potential use error.

Question 11

Do you take on small projects?

Accepted Answer

Certainly. We have worked on projects lasting a few hours to projects spanning multiple months to a year.
Every client, from the largest pharmaceutical companies to the smallest start up medical device companies, receives the same excellent level of customer service.

Question 12

Do you work on non-medical products?

Accepted Answer

No. Auxergo has worked exclusively for medical device companies and pharmaceutical companies, as well as digital technology companies in the healthcare industry.

Question 13

Where are you located?

Accepted Answer

We are based in Cambridge, UK and Shanghai, China. While we have clients in Europe, Asia, USA and Canada, the majority of our clients are based in the UK and China. See ABOUT US for more details.

Question 14

How many people are on your team?

Accepted Answer

In the UK, we have a core team of four specialists, and in China, our core team is also composed of four specialists. We also have associates that we depend upon to round-out the expertise we bring to specific projects. Our goal is to create a project team with the skills and experience you need to reach a successful outcome.

Question 15

Who do I contact about our project needs?

Accepted Answer

You can complete the form on our CONTACT page, or you can email us at info@auxergo.com, and we will get back to you ASAP.

Question 16

Do you have a usability lab?

Accepted Answer

We are building our usability labs in China this year; we plan to finish them at the end of 2022. For more details, please see USABILITY LAB, or the article: Chinese Medical Device Multi-testing Centre including Human Factors Laboratory. In the UK, currently, we conduct testing in different locations, depending upon the needs of the project. For some medical devices, taking home haemodialysis as an example, it is better to test in a real home use environment, rather than a lab environment, so we have carried out testing in a patient’s home. We have also conducted testing at client facilities (for example, many clients have demonstration labs that simulate the clinical environment), market research centres, and hospital simulation labs. We find locations that ensure we can recruit the required number of test participants, ideally near our client and participants, so that they have the option of observing evaluation sessions.

Question 17

Do you provide guidance on other regulatory jurisdictions, aside from the UK, EU and FDA?

Accepted Answer

Yes. We are well versed in Chinese requirements for Usability Engineering for NMPA approval in China. What is more, health Canada has no explicit requirements for human factors, but in our experience Health Canada’s expectations for human factors are similar to the FDAs.

FAQS

Frequently asked questions