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At CLEIO, years of designing and developing medical devices have taught us one crucial lesson: strong research is the foundation for innovation. While we may become well-versed in medical terminology with each project, our true strength lies in bridging the gap between theoretical knowledge and real-world needs.
Our cross-functional team of User Experience (UX), Human Factors Engineering, and Innovation Strategy specialists is essential in ensuring product viability by aligning their expertise with project risks and market objectives through a research-driven approach.
From comprehensive literature reviews and predicate assessments to in-depth Subject Matter Expert (SME) interviews and formative evaluations, let’s explore together how user-centered research prioritizes patient needs and enhances a safe user experience.
Leveraging Prior Knowledge
Every new project that lands on our desks brings a blend of discoveries and technologies. To make sure the final product is safe, efficient, and fits seamlessly into existing workflows, our Human Factors and UX teams become temporary specialists in the specific area involved. Their first step? A deep dive into research conducted by experts in the field.
Navigating Best Practices and Common Pitfalls
By analyzing past successes and failures of similar devices, we avoid reinventing the wheel and leverage valuable insights. This not only prevents us from repeating design mistakes but also saves time and resources.
Research shows that historical medical devices, such as the speculum, focused solely on clinical functionality, which compromised user safety and hindered device adoption. The discomfort associated with speculum use can lead to anxiety and avoidance of important screenings.
Unveiling Potential Risks
Literature reviews can be key to anticipating potential safety concerns specific to speculum use before they arise during the design process. For instance, reviewing the FDA’s adverse event reporting system (FAERS) might reveal documented cases of tissue pinching or discomfort associated with specific speculum designs.
Addressing Psychological Factors
Existing research on women’s health devices provides valuable insights into the psychological impact on both healthcare providers and patients. This knowledge allows us to create speculum designs that are user-centered and minimize potential risks during consultations.
For instance, studies have shown that proper visualization can be complex with certain anatomies when speculums are used on their own, leading to clinician frustration and potentially causing patient discomfort. By addressing these challenges, even though the overall risk is low, we can develop innovative designs, such as disposable sheaths or integrated lighting, to enhance visibility and streamline examinations.
Understanding the Psychological Impact of Medical History
Additionally, the speculum’s evolution reflects broader societal attitudes toward women’s bodies and reproductive health. This knowledge empowers us to address potential anxieties and misconceptions, fostering a more positive and supportive healthcare experience.
Harnessing the Power of Predicate Assessment
Before embarking on any design journey, we complement our documentary research with a thorough examination of the existing landscape. This includes a meticulous evaluation of equivalent devices, often referred to as predicates.
Applying Heuristics by Evaluating the Initial Prototype
This method evaluates the design against a set of established usability principles, or heuristics, such as user interface clarity, consistency, error prevention, and user control. Here, our Human Factors specialists act as meticulous inspectors, systematically examining the client’s speculum prototype against these heuristics.
Putting Insights to the Test
While literature reviews provide a valuable starting point, truly understanding user needs requires delving deeper. CLEIO’s Human Factors and UX specialists utilize a multidirectional approach to refine potential design through field studies and testing.
Examining the User Ecosystem
Directly observing healthcare professionals in their work environments provides invaluable insights into the practical challenges and opportunities within the clinical setting. By assessing factors such as lighting, noise, temperature, and physical space limitations, we can design products that seamlessly integrate into existing workflows. For instance, shadowing gynecologists might reveal limited storage space, prompting our team to explore collapsible or compact speculum designs. Although minor, this type of adjustment can significantly enhance the user experience without compromising performance.
Field studies further allow us to validate or refine insights gleaned from literature reviews done earlier on in the process. For example, while research highlights a variety of speculum brands and shapes, each offering unique benefits, observations from gynecological examinations reveal a distinct preference for a specific model among intended users. This trend provides crucial insights that can guide ergonomic choices in the design of the new speculum.
Interviewing the Potential End-Users
Engaging with Subject Matter Experts (SMEs) during interviews offers a unique opportunity to delve deeper into the complexities of the clinical environment. By discussing the needs, challenges, and workflow with gynecologists, nurses, and other healthcare professionals, we can uncover nuanced insights specific to their roles.
Verifying and Refining Our Work
Equipped with this user-centered understanding, our industrial designers can then begin sketching and iteratively refining potential speculum designs. As the first iterative design is underway, the Human Factors and UX experts take the lead to ensure the design aligns with user requirements and to identify usability issues early on.
With the latest prototype, they conduct formative evaluations with potential end-users. The feedback from these test sessions allows the team to identify and mitigate possible risks associated with the design before significant development resources are invested.
Charlotte Lachance
UX-UI Designer at CLEIO
Research is The Cornerstone of Successful Medical Device Innovation
A comprehensive and well-executed design process for medical devices hinges on a strong foundation built upon research. Literature reviews equip medical device designers and engineers with invaluable knowledge about existing technologies, potential user psychology, historical precedents, and, most importantly, unmet needs.
