Collaboration between Human Factors Engineers and Designers is crucial for cultivating an understanding of individual goals and working together to meet those goals in product development.
Our team has researched users and developed products for markets all over the world. Learn more about our global perspective:
Learn how we utilize iterative prototyping to effectively push risk upstream and the value that each stage of prototyping provides as designs transition from engineering into manufacturing.
Sometimes it’s not all that easy to identify and prioritize user needs to ensure that they drive relevant decisions throughout development. Check out our latest Q&A with Insight’s Director of Research and Strategy, Carolyn Rose, to get some insights on this topic.
Craig Scherer and Carolyn Rose talk about the importance of effectively identifying, prioritizing, and translating user needs into design guidance in their latest Med Device Online article
Turning user needs into design guidance is a key component of developing a successful medical device. The primary goal of this process is to develop a device that not only meets the FDA’s criteria for safety and effectiveness, but also one that provides the best possible user experience for all stakeholders.
The successful application of user-centered design principles relies on iterative and frequent feedback from stakeholders throughout the entire development process. This research also provides the design team information with which to identify, document, and better manage risk throughout the design cycle.
Learn more about these six tools in the full article on MedDevice Online.
For a deeper dive in our user research activities, check out our user needs poster.
Effectively identifying, prioritizing and translating user needs into design guidance is critical to successfully developing a safe, effective and desirable medical device.
Sean Corrigan, Director of Engineering, and Carolyn Rose, Director of Research, discuss how to build a successful concept development framework in our latest Med Device Online article.
The definition of what constitutes “innovation” in the medical device industry has become enigmatic in recent years. While it’s still sometimes true that cracking the technology nut can be enough to result in market success, it’s typically more nuanced than that.
To drive commercial success in a crowded market, products need to address conflicting sets of user needs while simultaneously addressing market opportunities. This results in what can be a complex puzzle — but one that must be solved, if you wish to avoid pursuing technologies that don’t directly address primary user needs, incorrectly balancing or prioritizing user needs that inform development, or producing a product that meets all the specs on paper, but is not compelling or differentiated in the market.
The challenge can be distilled into three key dimensions that, weighed against one another, allow you to craft a successful development plan for a compelling product feature set.
To learn about these three dimensions, check out the full article on Med Device Online.
Craig Scherer talks about the importance of desirability when trying to achieve differentiation in a crowded marketplace in his latest Med Device Online article
Over the last few years, the term human factors engineering has become permanently and inextricably linked with any discussions on effective and appropriate medical device development. Human factors are used to optimize designs to users’ capabilities while minimizing the negative consequences of their limitations.
With the adoption of the AAMI HE75 guidance, the FDA’s expectations around how to utilize effective human factors for device development has become better understood and more widely embraced. Clinicians and lay users alike have specific and significant use-related challenges that need to be addressed by device developers. The FDA’s oversight helps to ensure that devices cannot be misused in ways that can cause accidental harm. Implementing a sound human factors plan offers device companies additional benefits, like lower training and in-service costs, minimized probability of recall, and diminished frequency of liability litigation.
However, the truth is that the FDA is not concerned with your devices’ sales numbers, adoption rates, or any other indicators of market success. It exists to ensure that your device is safe and clinically effective. Looking at the bright side, though, the FDA human factors guidelines require multiple rounds of formative research, and this research, if appropriately designed, can be leveraged to create more user-centric and appropriate solutions.
Consider these five things to delight users and deliver meaningful value with connected devices, says Abbe Kopra of Insight Product Development.
IoT is a buzzword these days, and the opportunities for product development are extensive.
McKinsey predicts “the impact of the Internet of Things on the global economy might be as high as $6.2 trillion by 2025,” and leaders like Google, Cisco, Oracle, and Intel are banding together to support smart object technology. Our medical device clients are confronted with seemingly endless possibilities and a need to “predict” that can overwhelm. How can we integrate connectivity to deliver benefits that end users really want?
While the individual solutions and strategies we’ve developed with our clients are diverse, here are some current trends in our latest QMED article to keep in mind.
Craig Scherer talks to Med Device Online about turning research into design inputs
Design innovation consultants are asked to help clients understand users holistically: Who they are, how they differ from each other, how they are influenced by their environments, and how they might change over time.
We must look to our core development process to focus around the user and all critical stakeholders. Designing optimal solutions means taking into consideration all of the influencers on the user, which might include technology strategies, market trends and opportunities, or outside influences, like regulatory and reimbursement systems.
Across medical device press, conferences, and other public forums one constantly hears organizations ask the question, “So…I have all of these user needs defined – what the heck do I do with them now?” What they really are asking is, “how do I translate user needs into specific and actionable design inputs?”
Check out the full article on Med Device Online to learn how.