Product & Process improvement
“Efficiency is doing things right; effectiveness is doing the right things.”
Applying Human Factors Engineering (HFE) principles to your Design & Development process makes a lot of sense for Medical Device (MD) manufacturers. Designing for safe usability matters for Patient Safety which is directly related to the (long term) success of your product on the market. The necessity of applying at least a basic set of HFE principles is clearly defined in European and USA (FDA) standards and regulations relevant to Medical Devices (MDD, MDR, IVDR, IEC-62366, MHRA and FDA) who all stipulate the need to show evidence of use centered design for all devices where use errors may result in harm to the patient.
To apply those rules correctly, effortlessly and consistently they should be linked to, or preferably be embedded into, your Research&Development, Risk Management and post market surveillance processes and procedures.
Weaver Human Factors Engineering can help you with improving your processes by reviewing, strategy consulting, training, writing or change management support. It will allow you to transition to more efficient and predictable design and development phases, while developing a more safe and more effective product that stands a good chance of receiving regulatory approval.
The number of medical devices used for critical patient monitoring are ever increasing, and use errors leading to patient harm have progressively become a main cause for concern for regulators, manufacturers and patients. The cause of those errors is often due to poorly designed device user interfaces, in particularly where a complex user system is involved. Medical devices, used in busy environments with many distractions, have become more and more diverse in their capabilities and complexity. As patient care evolves and is transferred to private homes or public environments, often less skilled or even unskilled users including patients and caretakers must be enabled to safely use these complex devices.
UI design plays and important role in causing use error and/or preventing it. Use errors are to be expected and should be identified as part of overall device risk which necessitates specific ”human factors” considerations. — Ron Kaye, FDA
You should be aware of the fact that the design effort that you invest into your product and in particular your User Interface, cannot only be focused on the look and feel and desirability for your users. Good, medical device design needs to support safe and effective use as well. Needless to say that a desirable design and a safe design go hand in hand in achieving an overall good Use experience and a marketable product.
Achieving a good quality product with regards to a safe User Interface design can only be done if you apply Human Factor Engineering principles that help you identify anticipated and, otherwise missed, unanticipated use errors and a process that helps you handle those observations and transform them into safe and proven design solutions which will help you be successful.
Weaver Human Factors Engineering can help you with improving your product by offering support throughout all phases of product conception, design, development, launch and post-market surveillance. No matter which stage of development you are in, I can add value. See the services overview to get a feel for the diversity of services I can provide.