The field of Human Factors is changing rapidly, and the quality standards expected by regulators are high.
Our human factors specialists regularly keep their knowledge and skills up-to-date. From ANSI/AAMI courses to the BHBIA guidelines for ethical research. All our HF work complies with the relevant Standards, and our work closely follows the latest guidelines, including:
- AAMI/ANSI HE-75: Human Factors Engineering – Design of Medical Devices.
- ANSI/AAMI/IEC 62366 Medical Devices: – Application of usability engineering to medical devices
- UCM259760 ‘Applying Human Factors and Usability Engineering to Medical Devices’, FDA Guidance February 2016
All the projects we work on and the data we collect is kept to global industry level data protection standards and we always guarantee total confidentiality. For the same reason, we cannot name our clients or their devices, but they are some of the most successful pharmaceutical and medical device companies in the world.
Our protocols and human factors reports are regularly reviewed by FDA and so we can bring this experience to bear on your device development plan.
Our protocols and Human Factors reports are regularly reviewed by the Food and Drugs Administration (FDA). We keep updated with the latest thinking from the FDA so we can advise clients appropriately about their plans, studies and next steps. The FDA has a wide scope but part of their remit is responsibility for protecting public health and in the USA and assuring the security, safety and efficacy of the drugs for human use and medical devices. They also ensure that the public get accurate information about how best to use medicines.
We have worked with many companies on the Human Factors aspects of their medical devices in order to attain their CE Marking. This marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation.
We have worked on Human Factors studies for companies seeking approval for their products from the Therapeutic Goods Administration (TGA) in Australia. The TGA carry out a wide range of tasks and one of their remits is carrying out assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard.
Performing HF studies safely
When you start testing your medical devices with the intended users, you will need to be sure that you have done everything you can to reduce the risk of harm to study participants.
Not only that, but you have a reputation for quality and safety that must be upheld. In common with clinical studies, human factors studies need careful preparation and management to ensure that your professional standards are not compromised.
Most of our team have worked in the pharmaceutical and medical device industries and the healthcare system. We understand the importance of standards, quality management and professional integrity.
We have ISO13485:2012 and ISO9001:2008 accreditation and have standard operating procedures in place that guide all aspects of our human factors testing programmes.
Our process for managing study-related risk
We identify all potential hazards in your proposed study; we design them out where possible in the protocol and reduce them to a minimum, for example by replacing drug with placebo, or using our own bespoke skin pads.
We can advise you as to whether your study protocol needs prior review by an ethics committee (in Europe) or Institutional Review Board (in the US). If so, we follow a tried and tested process:
Health and safety
We take full responsibility for the health and safety of participants during the testing, providing a safe test environment with adequate first aid facilities. All our study staff are first aid trained.