5 Psychology Principles That Strengthen Design Research
Design research derives its identity from several larger disciplines, including anthropology, human factors, and sociology. Perhaps lesser-known, and surprising to me, was how embedded psychology is in this discipline. Shortly after I changed careers from clinical psychology to research, a colleague asked me to collaborate on a research activity designed for teens and adults. The exercise invited participants to choose cards labeled with emotions to describe their experience with an at-home medical procedure. Drawing on my background as a psychologist, I realized the emotions initially selected—like frustration or insecurity—were too complex for that age group. I recommended using simpler, primary emotions such as fear, happiness, and anger instead. This collaboration gave me confidence my psychology background could enrich design research in ways I had not imagined.
Psychology adds another layer to our multidisciplinary approach, enriching and deepening our user-centered research. Below are five key principles we regularly use to enrich our research.
1. Listen More, Learn More. In psychology, Carl Rogers’ Person-Centered Therapy emphasizes that people are the experts in their own lives. The therapist’s role is not to steer the conversation, but to listen and create space for the client to share openly.
Design research works the same way. When I interview a user, my job is not to tell them what I think matters. The best insights come when users guide the conversation. This approach can uncover needs that users may not think to share until given the space to do so.
2. EmpathyBuilds Insight. Empathy is a cornerstone of both psychology and design research. In psychology, empathy allows therapists to understand a client’s perspective without judgment, building trust and deeper insight. In design research, empathy serves a similar role—helping us see products and experiences through the user’s eyes. By setting aside assumptions and genuinely connecting with users, we uncover not just what they do, but how they feel, which leads to more human-centered and meaningful designs.
3. From Insight to Impact.In both psychology and design research, the real value lies not just in understanding people, but in using that understanding to create meaningful change. Psychologists study behaviors and goals to design interventions that improve well-being. Similarly, design researchers uncover what users are trying to achieve, along with the barriers they face, and then translate those insights into design decisions. This process ensures that our research doesn’t stop at knowledge—it shapes products and experiences that truly support people in reaching their goals.
4. What People Do vs. What They Say. Psychology is the study of human behavior and mental processes. In practice, that often means observing how people behave in real settings rather than relying only on what they say. Someone may claim they get plenty of exercise, but observed behavior might show long periods of sitting broken up by short periods of movement. Observation reveals the gap between perception and reality.
Design research depends on observation. Watching how people interact with a device, tool, or environment often uncovers workarounds or struggles they may never mention in an interview. These small details—hesitations, repeated errors, improvised fixes—are often the very clues that point us toward better design solutions.
5. Making the Invisible Visible. Psychologists study conceptslike hope, motivation, or attitudes that cannot be observed directly. To understand them, we design questions and experiments that reveal underlying patterns.
Design researchers face a similar challenge when studying products that do not yet exist. How do you understand a user’s reaction to a future product? You construct thoughtful questions, scenarios, and prototypes that invite users to imagine and respond. By treating these unseen elements seriously, we can design not just for what people do now, but for what they might need tomorrow.
Equally important, we dig below the surface of what people say or do to uncover the why—the possible sources of problems and motivations driving behavior. Often the frustrations or workarounds we observe are symptoms of deeper issues. By identifying those underlying drivers, we create solutions that address not only the immediate challenge but also the broader needs shaping user behavior.
WHY IT MATTERS
Blending psychology and design research creates a powerful lens for innovation. It helps us:
Put users at the center of product development.
Discover needs and challenges that are not immediately obvious.
Design products that do not just function but resonate with real human experiences.
At Kaleidoscope, this cross-disciplinary thinking is part of how we approach research and design. Research thrives when we bring multiple disciplines together – psychology included. When we approach design research with a multidisciplinary lens, we create solutions that are more intuitive, empathetic, and impactful.
If you are a designer, researcher, or product developer curious about how psychology can strengthen design, let’s connect. The more we share perspectives across disciplines, the better we can design products that truly serve the people who use them.Let’s start something, together.
Rachael brings over 10 years of research experience to her role at Kaleidoscope Innovation. She has advanced training in clinical psychology and mixed methods research methodology. Guided by the principles of positive psychology, Rachael uses a human-centered lens for deeply understanding the user experience. Her work at Kaleidoscope focuses on human-machine interaction and identifying design changes capable of positively impacting well-being at the individual and institutional levels.
How to Build Smarter Products with Global + Onshore Teams
In today’s rapidly evolving business environment, speed, talent, and cost-efficiency are top of mind for companies seeking competitive advantage. Many global organizations—Microsoft, Google, Johnson & Johnson, Pfizer, and countless others—are turning to India, Czech Republic, and other talent-rich regions to build Global Capability Centers (GCCs), also known as Global Delivery Centers or formerly “captives.” These hubs offer access to specialized expertise, scalable teams, and reduced overhead.
But there’s one crucial element that often gets overlooked in the rush to globalize: how to seamlessly integrate these offshore capabilities with effective, real-time collaboration, regulatory alignment, and product accountability.
That’s where the partnership between Kaleidoscope Innovation and Infosys comes in.
The GCC Boom: Why Global Companies Are Investing in India
India has become a hotspot for companies building internal hubs for IT, R&D, and technology innovation. GCCs allow organizations to “own” their operations abroad, hiring top-tier talent while reducing long-term cost. With more than 1,700 GCCs already established in India and an expected $100B+ market by 2030, this model has become a proven strategy for scaling operations.
Why it works:
Access to highly skilled technical talent
Cost efficiency and predictable budgets
Ability to operate across time zones
Speed to build and scale capabilities
MedTech, in particular, is driving this shift. As India’s medical technology market expands from $12B in 2023 to a projected $50B by 2030, more companies are embracing hybrid development models that combine offshore scale with onshore regulatory and clinical expertise. India is no longer just a back-office location—it’s emerging as a global innovation hub for digital health, diagnostics, and device R&D.
The “Follow the Sun” Model: Speed and Continuity Without Compromise
As GCCs rise, the “follow the sun” development model has become a powerful advantage—enabling teams to work in multiple time zones so product progress continues 24/7.
But making this model work isn’t just about time zones—it’s about alignment, accountability, and protecting design intent from dilution.
That’s where many companies stumble.
The Role of Onshore and Nearshore Partners in a GCC Strategy
To maximize your investment in a GCC, you need more than offshore bandwidth—you need strategic integration. Onshore and nearshore partners like Kaleidoscope Innovation and Infosys provide critical functions that cannot (and should not) be offloaded entirely:
Real-Time Collaboration with U.S. Stakeholders When your design team needs live feedback from U.S.-based clients, regulators, or clinical users, having a partner in the same time zone is invaluable.
Regulatory and Quality Expertise Especially in MedTechd other regulated industries, onshore teams bring a deep understanding of U.S. FDA requirements, ISO standards, and risk management frameworks. That nuance is hard to replicate in global teams unfamiliar with regional constraints.
Ownership, Engineering Integrity, and Design Intent Offshore teams often provide executional muscle, but design and engineering intent can get diluted without close product ownership. Kaleidoscope maintains continuity from concept to completion, protecting the integrity of the design, maintaining alignment with user needs and technical requirements, and ensuring your product vision never gets lost in translation.
The Kaleidoscope + Infosys Advantage: A Hybrid Model That Works
As a subsidiary of Infosys, Kaleidoscope Innovation is uniquely positioned to bridge the gap between global delivery and onshore expertise. Together, we offer a hybrid development approach that blends scale, speed, and specialization.
What this means for your business:
Round-the-clock productivity without loss of design fidelity
Cost-effective scalability paired with deep domain knowledge
Seamless communication across time zones and disciplines
Access to more than 3,000 Infosys professionals in India
A U.S.-based team of engineers, designers, and regulatory experts ready to integrate
“As we look ahead to 2030, we expect that 70% of Fortune 500 companies will be expanding their presence to India. The writing is on the wall–India is no longer just participating in the global tech narrative–we're authoring it.”
— Pari Natarajan, CEO of Zinnov (source: Economic Times)
At Kaleidoscope, we don’t just collaborate with global teams—we elevate them. Our role is to challenge assumptions, contribute domain expertise, and ensure each phase of your product development journey aligns with business outcomes and regulatory standards.
As product lifecycles shrink and markets become more interconnected, hybrid development models will become the norm. Organizations that master the art of synchronized, multi-region execution will outpace competitors still relying on siloed teams and linear workflows. In the near future, we expect to see more AI-assisted collaboration, automated quality validation, and near-real-time prototyping across continents. But speed alone isn’t enough. The next evolution in R&D will demand more: smarter integration of global talent, robust IP protection, and seamless alignment with converging regulatory frameworks.
That’s where Kaleidoscope and Infosys stand apart. Together, we offer a rare blend of scale and specialization, pairing continuous global delivery with deep, domain expertise in design, human factors, engineering, and regulatory affairs. The companies that win won’t just move fast–they’ll move with clarity, confidence, and a partner built for what’s next.
Global Capability Centers are unlocking new levels of scalability and productivity. As your strategic partner, we embed where it matters, bridge time zones, and bring clarity to complexity. Let’s start something, together.
This thought leadership piece was written in collaboration with Infosys Engineering Services.
Matt has always loved interacting with clients to find solutions for their challenges. He was drawn to business development at Kaleidoscope Innovation because of the great potential he saw. After graduating from the Lindner College of Business at the University of Cincinnati, he worked with two startups, a marketing consultancy, a financial services company and the non-profit 3CDC. He believes that listening is the most important part of sales. In his free time, Matt enjoys movies, trying new foods, traveling and the great outdoors.
Envisioning the Impossible: What Would It Take to Develop a Wearable Biomarker Sensor for Cancer Patients?
Hindsight may always be 20/20, but imagining tomorrow’s advanced technologies is the work of the present. Think of the Apple Watch. For many consumers today, it’s an indispensable device, but back in 2012, it was merely the audacious spark of an idea to create a wrist-worn iPhone.
It’s that kind of progressive mindset that drives Kaleidoscope Innovation to nurture a team of blue-sky thinkers who take on the big “What if?” questions, not just to imagine what’s possible but also to understand what the path forward entails. One such recent exploration focused on the potential development of a wearable biomarker sensor tailored for subjects volunteering for clinical research.
What’s the Current Biomarker Landscape
While traditional, large-molecule hormones like insulin and testosterone have been known and studied since the early twentieth century, we now realize there are many other “dark” hormones circulating in human serum. Some estimates assert that there are as many as 10,000 unknown physiologically active nano-proteins. (Blume, Nature Comm, 11, Article 3662 (2020))
Between the well-known and the dark unknown, an ever-increasing number of microprotein biomarkers are being characterized and evaluated as disease markers, drug targets, and indicators of therapy effectiveness. Studying and sampling these biological indicators is a principal activity of modern clinical research. New technologies using mass and infrared spectroscopy are bringing these proteins into the clinical light.
A wearable biomarker sensor like the one the Kaleidoscope team was exploring would feature advanced technology that could collect information and monitor health biomarkers known to be significant in treatment monitoring. In the case of the theoretical wearable, the device would be designed specifically for cancer patients undergoing chemotherapy. The premise behind such a device would be to gather key data about biomarkers circulating in the body fluids of cancer patients to identify early warning signs and inform treatment adjustments with the ultimate goal of improving outcomes and saving lives.
Where to Start
Yes, the Apple Watch can monitor heart and respiratory rate, wrist temperature, blood oxygen levels, and sleep duration; it can also provide irregular rhythm notifications, ECG recordings, and fall detection. It would be easy to imagine that this established technology provides a baseline on which to build our concept. That thinking would be wrong for many reasons. First and foremost, today’s small mass spectrometers used in cancer research are benchtop models that are roughly 40 square feet, while the larger ones with the highest degree of sensitivity and accuracy can be over 100 square feet. Compressing that amount of technology into something you can strap to your wrist is simply not currently feasible.
But that’s not even the first consideration. The questions that need to be asked are much more elemental to the project.
What Are We Measuring?
In developing a cancer and chemotherapy monitoring system like this, first and foremost, you need to know what to look at—these are the biomarkers (cytokine molecules) that circulate in the blood. Any given cytokine can be a marker for any number of issues, for example, different types of inflammation in the body. In developing a tool for cancer patients, it will be essential to monitor more than one type of cytokine to be able to see a comprehensive picture.
Measuring cytokine levels in cancer patients is not commonly done, as home-based measurement capability does not exist, and lab-based measurement requires invasive blood draw and wet chemistry analysis using liquid chemistry mass spectrometry techniques and highly skilled technicians. The advantages of a wearable, home-based system lie in developing immunoassay techniques that automate sample collection and analysis using a miniaturized sweat-based aptamer sensor.
Aptamers are synthetic, single-stranded DNA or RNA molecules that can specifically bind to a target cytokines. Think of the cytokine as a lock, and an aptamer as a key. When these two get together, they connect in a one-to-one correspondence. When the aptamers lock onto a cytokine, they can release or change state in a way that we can measure electronically and thus make some kind of analysis.
But identifying the relevant cytokines and aptamers is just the beginning. Because every person’s body chemistry is different, the normal state baseline will be unique to each patient. You also need to determine the normal concentration levels of cytokines in an individual patient.
To determine the baseline, patients would need to wear the device for a period, and the doctor would need to review the incoming data collected. Once they have the baseline, the doctor can set customized alert levels that trigger notification when sensor readings are high or low. All this amounts to the device needing to be a highly tailored treatment scenario, not a one-sensor-does-it-all.
The Collection Mechanism
The analytic subsystems of the biomarker sensor will require liquid chromatography (a form of liquid chemistry). In other words, we would need to get a liquid from the patient in the form of either sweat or blood.
Most of the wearables in development today use sweat because it can be conveniently generated and collected from the wearer’s skin. The wearable biomarker sensor would need to generate sweat by electrically stimulating the skin in the presence of a certain kind of chemical. Cancer patients are generally not able to generate sufficient sweat by exercising without stimulation.
The challenge with this approach is that the concentration of key biomarkers in sweat is significantly lower than in blood. Direct blood sampling would be ideal, but highly impractical. For that, the device would need to employ a microneedle jab periodically throughout the day to produce a tiny blood sample that could be used for analysis.
In either the sweat or blood testing scenario, the system would need a mechanism for collecting that sample in a collection wafer, so it can be transmitted to a chemical sensor element that has the aptamers on it. This way, aptamers trigger or don’t trigger based on the concentration levels found in the sample. As previously mentioned, each wafer would likely need to be customized to the patient and/or the type of cancer that they have.
Now we must consider aspects of the sensor. It will need to be disposable. What other issues would we possibly encounter? Would sunblock interfere? Would a particular kind of body wash affect the pH of the chemistry and therefore undermine the system?
All these scenarios need to be figured out by a resource team that includes experts in material science, bioengineering, electronics, and data analytics.
What Happens to the Data?
Once the sample is collected and the data has been generated, it will likely have to be transmitted either to a phone app or a base station in the patient's house. Not only would the base station need to be set to contact the doctor's office every day, but the doctor would need to be able to communicate back.
Here’s an example of how the communications would work: A patient’s physician sets alarm levels for a range of biomarkers. When those fall outside the acceptable baseline, the doctor’s office is notified, and they, in turn, alert the patient and say, “Ms. Jones, we’re concerned about your numbers in this area and would like you to call and schedule an appointment for tomorrow.”
In another scenario, the doctor might simply want to keep tabs on how a patient reacts to a particular type of chemotherapy, or what the recovery cycle looks like, so they know at what rate to advance treatment.
Even still, logistics must be considered. If it’s an app that's on a patient’s phone, where does the data go from there? What if the patient doesn’t have or know how to use a smartphone? How does a doctor treating 200 patients manage the volume of incoming data? What are the HIPAA implications? What if someone illegally accesses the data? These are issues that would have to be considered and addressed well in advance. That means inventing the entire universe of the product, of which the patient experience is only one.
Anticipating the Hurdles
As a medical device, the wearable sensor would be regulated by the FDA. When Apple sought FDA permission and approval just to put a heart monitoring app onto the iPhone, they spent in excess of 1 billion dollars on this simple, noninvasive capability.
Because a biomarker sensor is a true medical device, a wearable version would be highly regulated by the FDA, which requires a series of clinical trials, initially done in very small numbers of patients, before advancing to efficacy trials. These would be analogous in scope to the pharmacology trials that big pharma companies undergo for drug development. They involve hundreds or thousands of patients. In the biomarker sensor example, you would need to physically manage the trial process, enlisting a mass of patients, drawing blood from them 24/7, and comparing the aptamer-based sensor data to the analytical lab data. Figuring out what the data means would be the final step.
Furthermore, the wearable biomarker sensor with electrochemical sweat generation would likely be considered a combination device, meaning it is partially drug and partially device. In this case, the FDA would decide the primary mode of action and assign it to the most appropriate division within the agency. From there, a complex regulatory path dictates a specific sequence and process. The first phase would establish requirements, and for medical devices, the FDA demands proof through data. It’s not just the data that is regulated, but also the mechanisms for obtaining that data that are regulated, and that means validating the tests in a controlled, well-documented process.
The Kaleidoscope team concluded that yes, the list of hurdles is extensive, but they’re not insurmountable. Yes, it would be a massive, complicated, and extremely expensive effort, but one that could feasibly be undertaken by the government or a giant corporation. For context, a simple drug-eluting stent, roughly eight years ago, cost $600 million from conception to launch. A device like the wearable biomarker sensor could easily be a $1 billion development activity.
What’s Here and What Could Be Ahead
There are some development efforts currently in the works aimed at miniaturizing such a system, most notably at Purdue University. The institution’s R&D team has taken many elements of a biomarker sensor and miniaturized them down to a 55-pound unit, which is at least a factor of 10 to 20 higher than what a wearable system would require. The unit uses a finger-prick test to draw blood into a small capillary tube. The patient then inserts their blood sample into the spectrometer base station, which is roughly the size of a toaster oven. There is no built-in data transfer system yet, and there are some other missing elements, but it’s a beginning.
There is also research being done on sweat-based systems in college labs around the country (and likely also in commercial labs, but their work isn’t available to the public).
So, what is realistically possible in 10 years? It seems feasible that there will be some kind of wearable device that features a removable sweat sensor. The user would wear the sensor for a set time, remove it, and plug it into a base station where the sample is analyzed in a unit that has enough physical space to do the analytic chemistry that's involved.
In this scenario, the patient doesn't have to be tethered to the monitoring device. Once they put the wafer in, they're free to go about their day, just as they did while wearing the device to collect the sample. While this kind of system would be a step down from the full-blown “set-it-and-forget-it” device a patient puts on in the morning and takes off at night, it is an essential step toward that ideal.
Anticipating the Future Today
This internal “blue sky” thought exercise was designed to share findings with Kaleidoscope Innovation’s management team so that we’re prepared to understand the scope when a client or other entity asks what it would take to make a wearable cancer sensor. The work we completed examined at the highest level what would be required not just to anticipate the development of this transformative medical device but also to imagine what we could be doing right now…or if we should even be doing it.
The missing parts of this exploration are business-related. An undertaking of this magnitude would require the attention of a federal researcher who could request a government research grant to start work on the essential elements. At the same time, a large medical device company would likely want to conduct an in-depth analysis to determine the market potential and what a system like this would cost to develop. Armed with a more complete picture, it would then be time to look for investors.
A Future-Forward Partner
The wearable mass spectrometer project is one of many transformative ideas being explored at Kaleidoscope Innovation headquarters in Cincinnati, some of them are being conducted in collaboration with our parent company Infosys, which exponentially expands our digital expertise and resources.
If your organization has a big idea that needs visionary horsepower to explore, assess, and develop, get in touch. We’re ready to dive in.
Engineering fellow at Kaleidoscope Innovation with a demonstrated history of IP generation and Medical Device development. Skilled in Verification and Validation (V&V), DMAIC, Computer-Aided Design (CAD), Mechanism Design, and Failure Mode and Effects Analysis (FMEA).
Your Guide to Sustainable Product Development
Designing for Impact. Developing for the Future.
Here’s your go to guide for sustainable product development > download here.
At Kaleidoscope Innovation, we help companies create smarter, more sustainable products through a proven, intentional approach to Design for Environment (DfE). Whether you're building something new or rethinking an existing product, our process helps reduce environmental impact across the entire product lifecycle.
Step 1: Identify Environmental Impact Hotspots
We begin by identifying which stages of your product’s lifecycle carry the greatest environmental burden. This helps prioritize design decisions that yield the most sustainable outcomes.
Consider the full product lifecycle:
Raw Material Extraction – What’s required to source and process your materials?
Production – How energy-intensive is manufacturing?
Distribution – What’s the transportation footprint?
Use Phase – Does your product consume energy or resources during use?
End-of-Life – What happens when the product is no longer needed? Landfill, recycling, or reuse?
Key metrics: CO₂e emissions, energy use, resource depletion, water usage, waste, and pollution.
Step 2: Sustainability-Focused Brainstorming
With impact areas identified, we guide teams through targeted ideation. Example prompts include:
How might we reduce plastic usage?
How might we design this for disassembly and recycling?
How might we extend the product’s usable life?
How might we minimize energy consumption in use?
These focused prompts keep environmental responsibility front and center during early concept exploration.
Step 3: Concept Development with Sustainability in Mind
We embed sustainability criteria into concept selection and evaluation—both qualitatively and quantitatively.
Best practices include:
Clearly identifying and communicating sustainability benefits in each concept.
Including lifecycle impact assessments in selection criteria.
Step 4: Sustainable Design & Engineering
Our designers and engineers apply DfE principles to reduce environmental impact without sacrificing performance.
We consider the following nine sustainable design strategies:
Longevity – Design for durability and long-term performance.
Materiality – Use recycled, recyclable*, compostable, or low-energy materials.
Dematerialization – Minimize the amount of material used.
Repairability – Use accessible fasteners, avoid adhesives.
Modularity – Design swappable components to extend product life.
Component Reduction – Fewer parts = less waste and simpler assembly.
Energy Efficiency – Optimize for low power use and renewable energy compatibility.
Disassembly – Ensure components can be separated for recycling*.
Remanufacturing – Enable re-use of containers or product components.
*Keep in mind: most users won’t recycle unless it’s easy and intuitive.
Step 5: Testing & Iteration
We simulate real-world conditions, including worst-case scenarios, using lean, repeatable methods. We aim to reduce material waste by reusing test samples and limiting sample size with engineering rationale.
Let’s Build Smarter, Cleaner Products
Kaleidoscope is your partner in eco-conscious product development. From concept to commercialization, we combine innovation with sustainability to future-proof your product and brand.
Ready to design with the planet in mind? Let’s talk about your project.
Choosing the right evaluation method depends on your specific needs and constraints. Heuristic evaluations offer quick, cost-effective insights, while usability studies provide in-depth user feedback. Task analysis enhances both methods by focusing on user tasks and uncovering challenges. By integrating these approaches, you can achieve a comprehensive and user-centric evaluation of your product.
When Do You Need a Usability Study vs. a Heuristic Evaluation? Where Does Task Analysis Fit In?
Understanding when to use a usability study versus a heuristic evaluation can significantly impact the effectiveness of your product development process. Here’s a breakdown of each method, how task analysis fits in, and examples of how these methods have been applied in our day-to-day work.
HEURISTIC EVALUATION
What is it? A heuristic evaluation involves usability experts assessing a design based on established “rules of thumb.” Historically used for human-computer interaction systems, this method evaluates software interfaces for usability. Building on well-established guidelines, experts have tailored 14 Usability Heuristics specifically for medical devices. We apply these 14 heuristics to conduct thorough heuristic evaluations, ensuring usability excellence in client projects.
Why Use It? Heuristic evaluations are quick and cost-effective, making them ideal when time and resources are limited. They provide valuable insights early in the product development process, even before a fully-fledged prototype is available. Our approach includes:
Expert Reviews: Conducted by seasoned usability experts.
Tailored Heuristics: Using our custom heuristics for medical devices.
Comprehensive Analysis: Identifying potential areas for improvement and their impacts.
FORMATIVE USABILITY STUDY
What is it? At a high level, a usability study typically involves simulated use testing of a product to observe how users interact with it. Usability studies inform product design, identify use-related risks, and can help engineers and designers discover the root cause of use errors to include risk mitigations in the product’s design. This evaluation method uses representative users in a representative environment to gather user feedback on specific product components, or the product as a whole.
Why Use It? For medical devices and combination products, FDA requirements necessitate usability studies to ensure device safety and effectiveness. These studies help iterate through device design and thoroughly evaluate components. Compared to heuristic evaluations, usability studies show how end users interact with the device and reveal more opportunities for design improvements.
Our approach includes:
Simulated Use Testing: Observing real users in a controlled environment.
FDA Compliance: Ensuring all regulatory requirements are met.
Comprehensive Study Design: Simulating a representative use environment, recruiting representative users, and applying study findings to design recommendations.
TASK ANALYSIS
What is it? Task analysis goes hand in hand with both heuristic evaluations and usability studies. It involves breaking down the tasks users will perform with the device to understand their needs and challenges.
Why Use It? It provides a deeper understanding of user interactions, enhancing the effectiveness of heuristic evaluations by ensuring that the heuristics are applied in a context that reflects real user behavior. It also enriches usability studies by identifying specific tasks that need to be tested, ensuring comprehensive coverage of user interactions. Our task analysis process includes:
User-Centric Focus: Understanding user needs and challenges.
Ethnographic Methods: Observing users in their natural environment.
Detailed Task Breakdown: Analyzing each step users take with the product.
How These Methods Work Together By combining heuristic evaluations, usability studies, and task analysis, you can ensure a thorough and user-centric design of your product. These evaluation methods complement each other, providing a comprehensive understanding of both potential usability issues and real-world user interactions.
For more detailed examples and insights, check out our case studies on heuristic evaluations and usability studies. These case studies illustrate how Kaleidoscope Innovation has successfully applied these methods to improve product design and usability.
For over 7 years, Kaleidoscope Innovation has been a trusted partner to industry leaders like Eli Lilly, Pfizer, and Baxter, helping bring safer, smarter medical products to market. Our integrated Human Factors expertise ensures that the right evaluation methods—whether heuristic, usability-focused, or task-based—are applied at the right time. Whether you're developing a new device or improving an existing one, we’re here to guide your team with insights that reduce risk, streamline development, and enhance user experience. Let’s talk about how we can help you choose and apply the best evaluation methods for your product.
Taylor is a Human Factors Engineer at Kaleidoscope Innovation. She brings experience from roles in Human Factors, Research and Design, and Clinical Research. Her background in Human Factors Engineering, combined with her collaborative approach, ensures that user-centered design is seamlessly integrated into every project.
Formative Human Factors Studies Elevate the Design Process and Ultimately Drive Market Success
A formative human factors study plays a pivotal role in the design process, particularly in industries where usability directly impacts safety, efficiency, and regulatory compliance. This research method, typically conducted during the early to mid-stages of the design process, provides actionable insights to align the product with real-world user needs and workflows. Beyond improving usability, formative studies deliver significant business value by reducing costly redesigns and enhancing a product's competitive edge.
When to Conduct a Formative Human Factors Study
Formative studies are most effective during the early stages of the design process, when prototypes or workflows remain flexible. By iterating on the design based on user feedback, teams can identify and resolve usability issues before they escalate into expensive fixes later in development. Repeating formative studies at key points throughout the design process ensures that the product evolves in step with user expectations and emerging requirements.
Why Conduct a Formative Study?
The primary goal of formative studies is to proactively identify potential user challenges, especially those that could lead to errors, frustration, or inefficiency. In high-stakes industries like healthcare, addressing these challenges early helps mitigate risks, enhance safety, and ensure compliance with standards such as the FDA’s human factors guidance for medical devices.
From a business perspective, formative studies create products that resonate more effectively with users, driving customer satisfaction and market adoption. They also streamline regulatory approval by ensuring the product design adheres to usability and safety standards, reducing delays and associated costs.
Ethnographic Methods in Formative Studies
Ethnographic research is a cornerstone of formative human factors studies, offering deep insights into how users interact with products in real-world settings. Methods such as observational studies, contextual inquiries, and think-aloud protocols help uncover hidden pain points and inefficiencies that might not emerge in controlled environments. For example, observing medical professionals using a device in a clinical setting can reveal critical workflow issues that may be overlooked in a simulated lab.
These methods allow designers and engineers to empathize with users, enabling them to create products that better accommodate user environments, limitations, and preferences. This user-centered approach enhances product usability and builds a reputation for intuitive, high-quality solutions—key drivers of customer loyalty.
FDA Guidance and Compliance
In regulated industries, following FDA human factors guidelines is essential. The FDA emphasizes that human factors studies, including formative testing, must demonstrate that users can safely and effectively operate the product under real-world conditions. Formative studies aligned with these guidelines provide evidence of due diligence and risk mitigation, paving the way for smoother regulatory submissions.
The Business Value of Formative Studies
Beyond usability and safety improvements, formative studies deliver significant business benefits. By identifying usability issues early in the design process, these studies help minimize development costs and prevent expensive late-stage redesigns. Products created with a strong focus on user needs are more likely to succeed in the marketplace, driving customer satisfaction and loyalty. Additionally, addressing regulatory requirements early reduces the risk of delays or setbacks in bringing products to market.
Conclusion
Formative human factors studies are more than a tool for improving usability—they are a strategic investment in product success. By integrating ethnographic methods and adhering to FDA guidelines, these studies enhance safety, usability, and user satisfaction while providing measurable business advantages. Incorporating formative studies at the right points in the design process enables companies to create products that are safer, more effective, and better aligned with user needs, all while optimizing costs and time to market.
For over 7 years, Kaleidoscope Innovation has been a trusted partner for industry leaders like Eli Lilly, Pfizer, and Baxter to bring safer, smarter medical products to life. Our integrated Human Factors expertise ensures that usability is built in, helping you reduce risk, accelerate development, and deliver intuitive, high-performing solutions.Whether you're launching a new product or refining an existing one, we’re here to support every step of the process. Let’s talk about how we can help elevate your design through formative research.
Human Factors Engineering Process for Medical Devices
In the medical product industry, ensuring the safety, efficacy, and usability of products is paramount. One of the key methods for achieving this goal is through the proper implementation of a robust Human Factors engineering (also known as usability engineering or ergonomics) process. Human Factors engineering (HFE) focuses on optimizing the interaction between people and technology to prevent errors, enhance performance, and improve the overall user experience.
Because of the risks involved, medical device development demands an especially thorough Human Factors process. They often require precise operation under conditions where an error can result in reduced clinical effectiveness, harm, or even death. Whether these products are used by health care providers, caregivers, or even the patients themselves, medical products that are not designed with the capabilities of the end user in mind can increase the chance of errors. To mitigate these risks, regulatory bodies such as the U.S. Food and Drug Administration (FDA) mandate that Human Factors principles be integrated into the design and development of medical products.
The HFE process for medical products is a structured, iterative approach that aims to identify potential use-related risks early in the design process and systematically reduce those risks throughout product development. This process incorporates both user needs and environmental considerations to create intuitive, safe, and effective products.
User Research and Task Analysis
The first step in the HFE process is to develop a deep understanding of the intended users and the tasks they will perform with the product. It is important to recognize that there may be distinct types of users (user groups) that have varying tasks, capabilities, and responsibilities. This step involves the following activities:
User needs: Identify the specific requirements and expectations of users that the product needs to fulfill to be used safely and effectively. These needs generate testable design requirements.
User characteristics: Understand the characteristics of the intended users that could impact product use. Common characteristics include age range, experience, education, physical abilities, cognitive capabilities, and any disabilities. These characteristics may drive segmentation of the intended users into separate user groups for usability testing.
Use environment: Identify factors such as lighting, noise, and other products in the intended use environment that may impact use of the product, keeping in mind there may be multiple environments in which the product is used, such as a clinic or a home setting.
Task Analysis: Based on the intended use of the product, identify and break down the tasks that users must accomplish to safely and effectively use the product. Read about Task Analysis here.
Identifying and Analyzing Risks
Once the user characteristics, environments, and tasks are understood, the next step is to conduct a use-related risk analysis (URRA). This process involves:
identification of what and how use errors may occur
assessment of the potential consequences and severity of those errors
identification of potential mitigations
validation plans for those mitigations
By systematically analyzing use-related risks, the design team can prioritize which potential issues are most critical to address based on severity, likelihood, and impact on patient safety. Additionally, this is the step in which critical tasks are identified. According to the FDA guidance document “Applying Human Factors and Usability Engineering to Medical Devices,” critical tasks are those which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care. Identification of critical tasks drives creation of the usability validation protocol, to ensure that any critical use error mitigations are properly validated.
The URRA can be considered a “living document,” since it should be continuously updated throughout the product development process when new hazards are identified through usability testing and existing hazards are mitigated through design.
Design and Prototyping
Human Factors specialists collaborate closely with designers and engineers—and and at Kaleidoscope, that means working under the same roof—to create prototypes that align with user needs and risk mitigation strategies. This integrated approach streamlines communication, accelerates iteration, and results in more effective, user-centered designs. Multiple prototypes may be developed that can be evaluated with representative users in the next phase.
Formative Usability Testing and Evaluation
Once prototypes are developed, formative evaluation is conducted to preliminarily assess the use-related risk mitigations as well as the degree to which the product is effective and easy to use. This is an iterative process, where feedback may be used to update user needs, user requirements, and the use-related risk analysis. This stage will often result in updates to the product user interface and labeling, as well as a determination whether and to what degree user training will be required.
Heuristic or Expert Reviews: “Quick and dirty” evaluations involving the assessment of a design by usability experts based on established Human Factors heuristics (rules of thumb).
Formative Usability Testing: Usability testing with representative users by simulating product use in realistic scenarios. Formative testing can be performed either with a subset of tasks or the entire system, and with everything from early-stage prototypes to near validation-ready products. Read about Formative Studies here.
Summative Usability Validation
Once formative evaluations have demonstrated that the use-related risk mitigations are adequate and the product is sufficiently usable, usability validation testing (also referred to as summative evaluation) can be conducted.
The usability validation process involves formally validating that the intended users can safely and effectively use the product to perform all critical tasks, that all identified risks are adequately mitigated, and that the product performs as expected under (usually simulated) real-world conditions. Testing should simulate actual use conditions as closely as possible, with a sufficient sample size of representative users of all intended user groups.
For example, when Tandem Diabetes Care developed the world’s smallest insulin pump—Tandem Mobi—they partnered with Kaleidoscope to support formative and summative studies for FDA submission (learn more here).
Once usability validation is complete, a comprehensive Human Factors report is created as part of the regulatory submission for product approval.
Conclusion
The Human Factors engineering process for a medical product is complex and requires the expertise of experienced professionals to fully realize the potential of the product concept. But the result of a properly scoped and applied Human Factors process is a product that is safe, effective, and easy to use, making it more likely to result in a successful regulatory submission and ultimate success in the market.
For over 7 years, Kaleidoscope Innovation has been a trusted partner in Human Factors engineering, supporting industry leaders like Eli Lilly, Pfizer, and Baxter. Whether you're bringing a new device to market or refining an existing product, our team brings deep expertise and real-world insight to every stage of development. Let’s talk about how we can help you design safer, smarter, and more user-friendly medical products.
Unlock Hidden Productivity with Time & Motion Studies
A Time & Motion (T&M) study can be a valuable addition to a user-centered design process. Time & Motion studies are usually conducted to identify potential bottlenecks in productivity but can also identify physiological risks associated with working in a warehouse environment, factory, health care environment or lab setting. Significant enhancements in productivity have been linked to ergonomically designed workspaces, leading to better worker morale and increased revenue due to reduced cycle times and fewer repetitive stress injuries.
At Kaleidoscope, we perform several time & motion studies for our clients every year. One of the advantages of this research technique are the insights gained by observing actual users performing the workflow in context and in real time. Our process for conducting a T&M study usually follows this sequence:
Meet with stakeholders to define the targetusers and workflow, and to determine if user experience and motion data will be in scope. If motion data is required, collaborate with ergonomic engineers to coordinate efforts.
Schedule onsite data collection. Send enough researchers to collect observational data, operate recording equipment, and conduct contextual interviews with participants.
Extract data from video footage throughframe-by-frame video manipulation. Analyze data, conduct descriptive statistical analysis and inferential analysis when appropriate. Identify insights and themes relevant to the research question(s).
Synthesize and present results to stakeholders. When possible, compare current results with historical data to view changes in time requirements that could be related to workspace/workstation design improvements. Incorporate user experience findings to give research participants a voice in future workstation design changes and continue Kaleidoscope’s commitment to human-centered design and research.
WHAT IS NOT MEASURED IN A TIME & MOTION STUDY
Time and motion studies are ideal for identifyingproductivityobstructions and potentially unsafe body movements. Not all the important factors related to employees’ work experiences are measured, however. As technology and infrastructure become more robust and complex, we have responded by expanding our capabilities to provide value for our clients. We share one challenge here to illustrate the complexity of studying modern warehouse environments.
Challenge
Time studies often target one piece of a complex system.
When only one component of a facility/system is studied, external factors that influence time requirements may not be observable or included in data collection.
Changes made to the target component may create unanticipated changes elsewhere in a facility or system.
Factors out of employees’ control may be misinterpreted as inefficiency.
Potential Solutions
It may be helpful to apply systems thinking near the beginning of a time & motion project.
Consider the larger system structure within which the T&M study is taking place.
Document who may be influenced by the design or redesign of the target component.
Discuss what stakeholders prioritize that could be influenced by the redesign of the target component.
Consider whether there are opportunities to change the system structure.
At what points can we intervene?
If possible, design interventions that benefit the entire system.
Map the system, even parts outside the area of focus. Create a visualization that allows stakeholders to envision how the system might react to changes in its structure (e.g., process map, schematic illustration, storyboard, animation).
Potential Add-Ons
To maximize the human potential embedded within workplaces, other research techniques may be added to time & motion studies for an even greater degree of comprehension.
Visual Aids: Diagrams of the facility the study is based on may help the audience better understand research findings.
Surveys: Surveys provide an inexpensive method of gathering large amounts of data quickly. Often, responses are provided in numeric format which allows for historical comparisons.
Interviews: 1:1 or group interviews may be added to a time & motion study to gain an understanding of time requirement results. Contextual information known to participants but not researchers may be shared in an interview to provide a deeper understanding of the “why” behind observed time requirements.
THE HUMAN COST OF EFFICIENCY IMPROVEMENTS
Any improvements to efficiency should be weighed against the human cost to the workers employed in the facilities we study. If efficiency improvements create a stressor where none was present, carefully consider whether the cost is worth the price. Constant time pressure and feeling hurried will take a toll on even the hardiest employees. Consider workarounds that value the worker, and which place them at the center of decision-making. The payoff in retention and increased job satisfaction will likely outweigh any efficiency improvements under consideration.
Rachael brings over 10 years of research experience to her role at Kaleidoscope Innovation. She has advanced training in clinical psychology and mixed methods research methodology. Guided by the principles of positive psychology, Rachael uses a human-centered lens for deeply understanding the user experience. Her work at Kaleidoscope focuses on human-machine interaction and identifying design changes capable of positively impacting well-being at the individual and institutional levels.
Breaking Down the FDA's New URRA Guidance: July 2024
The FDA has recently released a draft guidance on Use-Related Risk Analyses (URRAs) for drugs, biological products, and combination products. This new guidance consolidates previously available information into one comprehensive document, making it easier for industry stakeholders to access and apply the guidelines effectively.
KEY HIGHLIGHTS OF THE GUIDANCE:
Purpose: The guidance aims to explain identifying use-related hazards and implement measures to reduce associated risks. This is crucial for ensuring that medical products are safe and effective for their intended users.
Scope: The guidance is applicable to drugs, biological products, and combination products. This broad scope ensures that a wide range of products are covered, promoting consistency in risk management practices across different types of medical products.
Process: URRAs should be initiated early in product development and updated throughout the product lifecycle. This proactive approach helps in identifying potential risks early and allows for timely mitigation strategies.
Consolidation: This guidance combines previously available information into one comprehensive document, streamlining the process for stakeholders. This consolidation helps in reducing confusion and ensures that all relevant information is easily accessible.
WHY THIS MATTERS:
The new guidance ensures the safety and effectiveness of medical products by helping to determine the need for Human Factors (HF) study results in new marketing applications. By identifying and mitigating use-related risks early in the product development process, companies can enhance the overall safety and usability of their products. This not only protects end-users but also helps companies avoid costly recalls and redesigns.
KALEIDOSCOPE'S EXPERTISE:
At Kaleidoscope Innovation, we specialize in Human Factors for medical products, and have already integrated FDA guidance's into our process. Our team of experts interprets the guidance and applies it directly to your FDA submissions, ensuring you meet the latest requirements. Our HF team works closely with our regulatory team to help you understand the complexities of the regulatory landscape and provide tailored solutions to meet your specific needs.
HOW WE CAN HELP:
Interpretation: Our experts can help you understand the nuances of the new guidance. We provide detailed explanations and practical insights to ensure you fully grasp the requirements.
Application: We assist in applying the guidance to your product development and FDA submissions. Our team can help you develop comprehensive Use-Related Risk Analyses (URRAs) that meet FDA standards.
Compliance: Ensure your products meet the latest FDA requirements with our comprehensive consulting services. We offer ongoing support to help you stay compliant throughout the product lifecycle.
Taylor is a Human Factors Engineer at Kaleidoscope Innovation. She brings experience from roles in Human Factors, Research and Design, and Clinical Research. Her background in Human Factors Engineering, combined with her collaborative approach, ensures that user-centered design is seamlessly integrated into every project.
Eradicating Eye Disease
PulseSight (Formally Eyevensys) approached Kaleidoscope’s ID team with the following need:
“Help us develop and train ophthalmologists on how to perform our innovative electrotransfection gene therapy procedure.”
Unlike most pharmaceuticals that treat conditions of the eye, PulseSight’s non-viral gene therapy teaches the eye to heal itself. Very cool stuff!
So, Kaleidoscope’s designers got to work, collaborating with surgeons, practicing the procedure in situ, not only illustrating but also developing techniques for the procedure itself. The final procedure guide and accompanying trainer helped ensure PulseSight’s clinical trial progressed even more smoothly.
“Sunny” is the nickname for the anatomical model Kaleidoscope’s design and engineering team developed to train retinal surgeons on the innovative new Electrotransfection Gene Therapy pioneered by PulseSight.
To properly prepare surgeons for the novel obstacles experienced in the procedure, Kaleidoscope’s team of designers created this model to accurately simulate limited orbital access and the rotational effects of the rectus muscles of the human eye.
While Sunny doesn’t talk much, he definitely has seen a lot!
As experts in the field of Ophthalmic drug delivery devices, Kaleidoscope's team helped redesign the product from the ground up, improving the overall usability of the device and the efficacy and accuracy of the drug delivery.
Jake Schubert is a Senior Lead Industrial Designer at Kaleidoscope Innovation. His technical expertise and collaboration with our engineering team are instrumental in ensuring that user needs, design, and engineering intent converge seamlessly in our market-ready products.
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Design and Prototyping
Formative Usability Testing and Evaluation
