DURATION:

Medical Device Usability

50 min + 10 min. Question Time

Description:

Prerequisite:  starting level, no previous knowledge required

Contents:

• what is usability;
• use error and patient risk;
• references and standards;
• user profile and use environment as inputs for UX design;
• UX design techniques

Why You Should Attend:

Medical Device Usability has become a really hot topic for the medical device, pharma and combination products industries. Knowing about the main principles, best practices and applicable regulation of Medical Device Usability and Human Factor Engineering will help not only being compliant to regulation but also developing successful products that provide a better user experience and enhance inherent safety by minimizing user errors and prevent misuse.

Medical errors have been cited as the cause of nearly 100,000 deaths per year in the US healthcare system by the US Institute of Medicine in 1994.

According to the World Health Organization’s website, similar trends exist for European healthcare systems, with estimates that 8 to 12 per cent of hospitalizations involve adverse events and that as many as 18 per cent of patients report having experienced a medical error-induced problem. Costs in the UK alone for hospital infection Intervention is estimated at £1 million per year.

The term ‘usability engineering’, often used as a synonym for ‘human factors’, is also focused on creating qualities of  UIs that result in rapid learning, user satisfaction, and efficient interaction.

The term ‘usability’ is a multi-dimensional  quality that refers to the ability of a human to interact easily and relatively error-free with a system or product.

Terms  such as ‘user-friendly’ and ‘intuitive’ have emerged as descriptors of usability which translate to subjective attributes  regarding whether a system or device works and acts in the way the user expects, therefore avoiding frustration and  annoyance in carrying out an intention.

Poor design of medical devices and specifically poor user interface design can lead to errors that can deter patient treatment, diagnostic or monitoring and in some cases can result in harm or death; examples such as administration of incorrect medication or dose, incorrect interpretation of data resulting in misdiagnosis and also incorrect device setting for therapy are proofs of poor user interface design.

Usability Standards, IEC 62366-1:2015, define Usability as characteristic of the user Interface that establishes effectiveness, efficiency, and user satisfaction.

Who Will Benefit:

• Quality Manager
• Quality Engineers
• Design Quality
• Regulatory Affairs specialist
• Medical Affairs specialist
• Clinical Affair specialist
• R&D Engineers
• Marketing

Certification Requirements:

Students must view the entire program and successfully pass an online, multiple choice final assessment with >80% passing grade.Certificate will be printable in PDF format immediately after satisfying requirements.

Online Training Programs Includes:

• Answer to questions submitted during the webinar.
• An online final assessment with multiple choice questions.
• A Certificate of Completion.

Live Course Presented and Commented by:

Alice Ravizza is a Biomedical Engineer, graduated at Politecnico di Milano. She has great and extensive experience in R&D and QA / RA in the biomedical field. She is specialized in supporting Medical Device companies in building up and improve Quality System Management and assure Compliance through all the internal processs. She assist companies during the registration process for CE Mark making sure all the technical documentation is compliant to applicable standards and regulations. She is aswell an experienced Trainer and Lecturer.