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Nectar Product Development

ISO 13485:2016
DEVICE DEVELOPMENT
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ISO 13485:2016
DEVICE DEVELOPMENT

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Usability

We will optimize your medical device’s  usability
Ensuring your device or product undergoes usability testing and validation is imperative to ensure it has a successful debut on the market. In a nutshell, usability testing involves observing users’ interactions with your product or service and assessing their response to it. While it may seem simple, this is a key FDA requirement and is crucial for ensuring that you are building 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 pertinent information that you may have been unaware of, taking your understanding beyond what qualitative research methods provide. If we find any usability issues, we will offer solutions and advise you on how to remedy these issues and make the improvements that will bring your product successfully to the market. We also pair statistics and risk analysis with our usability testing to evaluate factors that could impact the success of your product or design.
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

At Nectar, we believe that a diverse team with vast skillsets is key to tackling any challenge in medical device development. As we continue to grow, so does our global presence. Our team of 25+ people around the world, spanning across the United States, the United Kingdom, and Kosovo. At Nectar we have embraced the remote work revolution, which allows us to bring together the best people from around the world to create exceptional outcomes. Our team is committed to pushing the boundaries of what’s possible in medical device development, and we are proud to have a global team that reflects our commitment to diversity, innovation, and excellence.

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

Medical devices can make the difference between life and 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 mitigated for users. Thorough analysis is required to enable designers to identify any possible flaws associated with the design – in both normal and fault conditions.

We are ISO 13485 Compliant through every step of the way
The International Organization for Standardization (ISO) and The International Electrotechnical Commission (IEC) have frameworks commonly used for risk analysis, for which the core steps are:
  • Identifying the risk and the reason for its occurrence
  • Identifying the consequences if the risk occurs
  • Identifying the probable frequency of the risk occurring
  • Identifying factors that reduce both the consequences or probability of the risk
As an ISO 13485:2016 Certified company, risk reduction is something 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 an essential 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 user experience (UX) to identify any potential issues early in the design process. Formative studies guide the rest of the design process, as they enable you to filter out different design features until only the ones that will benefit the end-users remain. As they are formative, these studies combine to move the iterative process forward; as the team discovers 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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