We will optimize your medical device’s usability

Ensuring your device or product undergoes thorough usability testing and validation is imperative to ensure it has a successful debut on the market. In a nutshell, usability testing looks at how your users interact with your device or product. It involves observing users' interactions with your product or service and assessing their response to it. Whilst it may seem simple, it is one of the key components of the FDA's requirements - usability testing is a crucial in ensuring you build a product that is safe, efficient, and effective for your intended users.

With years of experience in usability testing, we are able to identify design flaws that may have otherwise been overlooked. We employ a variety of methods to do this, including contextual research and formative studies. These methods enable us to uncover information that you may have been unaware of, especially in comparison to other qualitative research methods. If we find any usability issues, we will offer solutions, advising you on how to leverage these issues and ensure you make the improvements that will successfully bring your product or design to the market. We use statistics to aid our usability testing, using risk analysis to evaluate factors that could impact the success of your product or design.

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How Contextual Inquiry dictates the design process

The best way to gain a deep understanding of end users and usability challenges is to observe them in the actual environment. Nectar utilizes contextual inquiries as a crucial part of the design process by observing users in context, which enables designers to understand and empathize with their needs. This process can take place in an operating room or in the comfort of a home depending upon the device. Information gathered directly feeds into the design requirements and user needs. We are experts at identifying even the smallest details, and asking the right questions that lead to outstanding user experiences.

Generating powerful insights with
Critical Task Analysis

We take risk assessment to the next level by conducting a critical task analysis. Simply put, this involves analyzing the results of the contextual inquiries, documenting workflows, and generating a known use related risk assessment to identify critical tasks. Critical tasks identify crucial moments in the use of the device in which serious harm or injury can occur to the user or patient if the task is preformed incorrectly or not at all. This step in the medical design process can be the difference between life and death. Nectar is dedicated to creating devices that are easy to use, but above all else safe and effective.

Medical device Risk Analysis

We specialize in medical device Risk Analysis, Assessment, and Management

Medical devices can literally decide between life or death. If a device is used frequently on many different patients in a hospital setting, the risk of causing harm to a patient or healthcare practitioner is elevated. For this reason, a lot of the medical device development process revolves around risk reduction.

Risk reduction is an important tool that involves the identification of potential hazards, as well as understanding how these hazards can be prevented in users. Thorough analysis is required to enable designers to identify any possible flaws associated with the design - both in normal and fault conditions.

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We are ISO 13485 Compliant through every step of the way

The International Organization for Standardization (ISO) and The International Electrotechnical Commission (IEC) has a framework commonly used for risk analysis, and the core steps are:

  • Identifying the risk and the reason for its occurrence
  • Identifying the consequences if the risk occurs
  • Identifying the probability of the risk occurring once more
  • Identifying factors that reduce the consequences or probability of the risk

As an ISO 13485:2016-certified company, risk reduction is what Nectar excels at. We work closely with our clients to conduct high-quality risk analysis and ensure your medical device is safe and reliable.

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Formative Usability Testing in medical device development

Studies are a huge part of evaluating usability - they enable us to understand how a product is performing and how well-received it is by users. Here at Nectar we are big on formative studies as they help us identify and resolve usability issues, enabling us to make the design process as smooth as possible.

Used during the early stages of the design process, formative studies analyze the UI to identify any potential issues with the UI early in the design process. This in turn enables us to rectify any issues early in the design and development process. Formative studies guide the rest of the design process, as they enable you to filter out different design features until only ones that will benefit end-users can be chosen. As they are formative, these studies combine to move the iterative process forward; as the team discover more potential issues, they can collate these findings to guide further development.

Summative Usability Testing in medical device development

Summative evaluation is specified by the International Electrotechnical Commission (IEC) 62366 for the evaluation of the usability of medical devices. In a nutshell, it is a methodology that ensures designers implement a user-first perspective. Once the design for a medical device has been concluded, summative testing is conducted to validate the safety of the product.

Not only are we at Nectar experts in summative evaluation, we can also do it well under pressure. The Covid-19 pandemic resulted in a desperate need for ventilators. We worked with BreathDirect to create the BDR-19™ Critical-Care Ventilator - an easy to use, mass produced, full featured critical care ventilator that was created in 10 months. In less than a year, we conducted summative evaluation studies to ensure the ventilator met the high bar for performance, quality, and safety.

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