There’s a Map for That: Using Mapping Techniques to Support Human-Centered Product Development
At Kaleidoscope, we often find that the biggest barriers to innovation aren’t a lack of ideas or supporting information, but a lack of shared understanding. Mapping helps us transform complex processes and research data into clear directions for design.
A cornerstone of human-centered design is deeply understanding the people you’re designing for and the context in which your solutions will live. Mapping is one of the foundational methods our design researchers use to analyze and visualize the systems, processes, and experiences that shape design outcomes.
BENEFITS OF MAPPING For product development efforts of all sizes and budgets, dedicating time to mapping early in the process pays dividends throughout the project.
In the early stages – when a team is defining and framing the problem – visual maps serve as alignment tools, establishing a shared understanding of the current state. This is especially valuable for multidisciplinary teams, where each member brings unique expertise and often differing ideas about what users experience today and what an ideal future should look like.
Once research is conducted with users and other stakeholders, maps serve as a framework for visualizing research data and formulating actionable insights. They help teams convey large amounts of sometimes complex information both clearly and concisely.
Many teams believe they have a solid understanding of users’ needs and workflows. But when research findings are laid out visually, misconceptions, assumptions, and knowledge gaps often reveal themselves.
Finally, as a pivot point between research and ideation, mapping is a catalyst for uncovering opportunities and ultimately conceptualizing and visualizing new solutions and strategies.
MAPPING TECHNIQUES
At Kaleidoscope, we rely most often on three mapping techniques. Distinguishing between each isn’t critical; techniques can overlap or evolve depending on context. What matters is selecting the approach that best fits the project: the number of actors involved, the type of process, and how the map will ultimately be used.
Process Mapping visualizes a workflow that typically involves several people or entities. It highlights interconnected systems and the handoffs between individuals or teams. Often, several smaller workflows are nested within a larger process. Examples include a company’s onboarding process, a hospital’s medication management process, or a clinical team’s workflow for triaging, treating, and discharging patients.
Procedure Mapping is a more focused form of process mapping used to illustrate the workflow for a single event. At Kaleidoscope, this often means a medical procedure (e.g., a surgery or the use of a medical device), but non-medical examples include the check-in procedure at a hotel or the exact sequence a barista follows to prepare a drink.
Journey or Experience Mapping captures a user’s experience from their perspective. This could be a single event (like a shopping trip) or a longer arc (such as a product experience from initial interest through adoption and ongoing use).
DESIGNING THE MAP TO FIT THE NEED
Regardless of the type, these maps all communicate what actually happens, as revealed through primary research—whether direct observation, in-depth interviews, or both. Even before formal data collection begins, defining the tasks or steps along the map’s x-axis provides a framework for systematic data gathering. Collaborating on this early version with the project team is valuable not only for orienting researchers to the problem space but also for surfacing assumptions and gaps in knowledge.
Once a draft sequence is defined, the map’s y-axis structure is shaped by its intended purpose. If the goal is to understand how various actors work together to achieve a common outcome, representing each individual’s actions in parallel makes sense. If the objective is to compare multiple users or events to identify differences in behavior or duration, separating by instance or user is more appropriate.
There are numerous possibilities – and often, layering multiple perspectives reveals deeper meaning and greater insight.
THE IMPACT OF MAPPING
When thoughtfully constructed, maps become enduring tools, not only for communicating research findings but for supporting UX and product development teams throughout the design cycle. Our team has used maps in the following ways, just to name a few:
Procedure maps focused on surgical instrument usage sequencing and duration helped inform user needs, product requirements, training materials, and instructions for use (IFUs)
Process maps highlighting gaps and pain points in the process of teaching optometry patients to use contact lenses informed prioritization of R&D and marketing workstreams across service, physical, and digital solutions
Journey maps of competitive shopping experiences helped our client define opportunities for differentiation and competitive advantage
Ultimately, mapping strengthens alignment, sharpens insight, and creates a foundation for more informed and intentional design.
Charlotte is a design research manager at Kaleidoscope, with 20+ years of experience in user-centered design and research. She leverages multi-dimensional, immersive research to uncover unmet user needs and to inform the development of solutions for clients ranging from medical and pharmaceutical companies to consumer product manufacturers and global technology companies.
Usability Check: The Bandage Battle You Didn’t Know You Needed
Everyone has used an adhesive bandage, but which one is your favorite? Have you ever stopped to think about why? Bandage usability has real implications for patient care, safety, and user satisfaction. In this article, we examine how packaging, adhesive, and design choices impact the experience for end users.
Although adhesive bandages are typically classified as Class I medical devices by the Food and Drug Administration (FDA), that doesn't mean usability is unimportant. Think about the last time you used one: Were you in pain? In a rush? Maybe trying to open and apply it with one hand? These are the kinds of real-world conditions that highlight the importance of thoughtful design. To demonstrate that human factors can be applied to even the simplest of devices, we evaluated the usability of four different bandages that can be found in any local drugstore.
The Bandages
We chose four different adhesive bandages to compare. These bandages were chosen for their brand recognition and variability in shape, size, and material type.
Each bandage was evaluated based on key features and usability considerations, including the texture and flexibility of the fabric, the ease of removing the liner and applying the bandage, and the clarity of the instructions, labeling, and overall packaging design.
Methods and Results
In June 2025, 2 Human Factors Engineers (HFEs) from Kaleidoscope Innovation, Rebecca Chompff and Taylor Morgan, performed a systematic evaluation of 4 bandages and 10 key bandage features essential for successful and satisfactory use.
The usability of each bandage was discussed on a feature-by-feature basis. Each feature was subjectively rated on a scale from 0 to 4, where 0 = Not Applicable, 1 = Poor, 2 = Okay, 3 = Good, and 4 = Great.
The 10 key bandage features that were assessed included:
package labeling,
unboxing,
wrapper,
unwrapping,
material,
adhesive,
application,
a 72-hour leave-on test,
and removal post leave-on test.
The table below displays the subjective ratings for each bandage and bandage feature assessed during this evaluation:
The adhesive bandage(s) rated the highest and lowest for each key feature are discussed below:
Package Labeling refers to all text and visuals displayed on the bandage container and was evaluated for its usability. Nexcare earned the highest score (4) for its clear and informative labeling, featuring concise text, large graphics, well-organized layout, and user-friendly “Easy to Apply” instructions printed on the side of the box. In contrast, Niceful and Welly received the lowest score (1). Niceful was marked down for its lengthy paragraphs and the use of medical terminology, such as “absorb exudate quickly,” which could be important for healthcare professionals but may confuse lay users. Welly scored poorly due to minimal information and prioritization of kid-friendly colors over clarity. Most of the information was printed on a disposable paper wrapper around the tin container, which has to be removed, and likely discarded, before use.
Figure 1. Bandage Packages – Left to right: Band-Aid, Nexcare, Niceful, Welly
4Unboxing refers to the process of opening the new container to access the bandages inside. Niceful received the highest score (4) for its adhesive safety seal, which includes a pull tab sticker that aids the user in opening the box. Welly earned the lowest score (1) due to the absence of clear instructions or indicators on how to open the tin or identify its top side. Opening the Welly lid also required significant force, causing some bandages to fall out.
Wrapper refers to the sealed paper or plastic covering of each individual bandage. Band-Aid received the highest score (4) for its paper wrapper, which features a “peel here” label printed on a prominent red bar next to the pull tabs. In contrast, Niceful received the lowest score (1) due to its oversized plastic wrapper, which creates unnecessary waste and lacks clearly identifiable pull tabs.
Figure 2. Wrapped Bandages – Left to right: Band-Aid, Nexcare, Niceful, Welly
Unwrapping refers to the process of opening the sealed paper or plastic covering each bandage. Niceful and Welly received the highest score (4) for their user-friendly design, featuring large peel tabs and wrappers that separated easily. Nexcare received the lowest score (2) because its wrapper was somewhat difficult to pull apart and often tore irregularly during opening. No bandage received a score of 1 in this category.
Figure 3. Unwrapped Bandages – Left to right: Band-Aid, Nexcare, Niceful, Welly
Material refers to the surface of the bandage opposite the adhesive liner. Band-Aid earned the highest score (4) for its smooth, soft, and comfortable texture, along with the ability to stretch and conform to the body. Niceful received the lowest score (2) due to its slick plastic texture, which felt soft but less pleasant to the touch. No bandage received a score of 1 in this category.
Adhesive refers to the sticky side of the bandage that adheres to the skin and was assessed by fingertip touch. Niceful received the highest score (4) for its sticky adhesive, which continued across the absorbent pad, indicating that the bandage would stay securely in place for the duration of wear. Nexcare received the lowest score (1) due to its lack of stickiness, which raised concerns about its ability to remain adhered to the skin.
Application refers to the process of placing a bandage onto the skin—in our case, along the forearm. Niceful and Welly received the highest scores (4) for smooth application and visible adherence to both hairy and non-hairy skin. Nexcare received the lowest score (1) because proper application required careful attention to the performance of the application steps, particularly involving peeling individual border pieces from the bandage. The Nexcare bandage also requires more pressure to seal properly and showed poor adhesion on hairy skin.
Figure 4 +5. All bandages immediately following application
Leave-On Test refers to a trial involving two researchers wearing each of the four bandages continuously on their forearms for 72 hours. During this period, both researchers took three showers, completed two workouts, and were exposed to average outdoor temperatures of 85°F. Nexcare and Welly received the highest score (4) for maintaining strong adhesion throughout the full 72 hours. Niceful received the lowest score (1) as it detached after just 6 hours for one researcher and 19 hours for the other—both shortly after their first shower. For one of the researchers, Band-Aid detached after their second shower, approximately 30 hours after application.
Figure 6. Niceful bandage (right), 19 hours after application and moments before it detached
Removal (post leave-on test) refers to the process of taking off the bandage after the 72-hour wear period described above. Notably, no bandage received a perfect score of 4 in this category. Welly received the highest score (3) for this removal, as it caused only minimal discomfort. Band-Aid received the lowest score (0) because one researcher experienced the bandage detaching after just 30 hours so it could not be fairly compared to the other bandages that adhered for the full 72-hours. Niceful also received the lowest score (0), as both researchers reported the bandage falling off prematurely—after 6 and 19 hours, respectively.
Final Thoughts
This evaluation has made clear that even though these bandages initially seem very similar, they each have specific strengths and weaknesses. The Band-Aid bandage wrapper has easily identifiable instructions for opening, and the bandage material feels comfortable and smooth on the skin. The Nexcare bandage packaging has the most user-friendly labeling and maintained a strong adherence to the skin for the entire 72-hour leave-on test. The Niceful bandage package was easy to open and unwrap, felt stickiest during the adhesive touch test, could be applied with minimal difficulty, and did not hurt during immediate removal. The Welly bandage was easy to unwrap, could be applied with minimal difficulty, and maintained a strong adherence to the skin for the entire 72-hour leave-on test.
With these considerations in mind, here are our final bandage recommendations:
Best for kids: Welly
Pain free removal: Niceful
Best longevity: Nexcare or Welly
Best comfort: Band-Aid or Welly
Most waterproof: Nexcare
Overall favorite: Welly! The endearing designs, comfort, and longevity of wear made the Welly bandage our overall favorite.
Next time you’re at the store picking out adhesive bandages, remember these considerations to help you choose the best one for your needs.
Rebecca Chompff is a Senior Human Factors Engineer at Kaleidoscope Innovation. With a background in Psychology and Human Factors Engineering, she is dedicated to translating real-world user insights into actionable design improvements that enhance both usability and user satisfaction. Driven by empathy and evidence, Rebecca ensures every design decision reflects the needs and experiences of the people who actually use it.
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.
PFAS in MedTech: From Risk to Readiness
A global reckoning with "forever chemicals" is underway and the medical device industry sits at the center of the storm. With new mandates from the EPA, REACH, and MDR accelerating, OEMs face a growing dilemma: how to maintain product performance while eliminating PFAS compounds once considered essential. For companies still focused on short-term compliance, the real risk may not be regulation, it's stagnation.
The PFAS Reckoning Has Arrived
Polyfluoroalkyl Substances (PFAS) are a class of over 12,000 synthetic chemicals known for their durability, hydrophobicity, and resistance to heat, oil, and chemicals. In MedTech, these properties make PFAS indispensable across tubing, coatings, gaskets, and packaging; products where performance and patient safety are non-negotiable.
However, the same traits that make PFAS effective also make them nearly indestructible in the environment. Studies show minimal release during device use, but manufacturing and disposal are significant sources of environmental contamination. The result: mounting global regulation, growing public concern, and industry-wide pressure to evolve.
The global PFAS testing market is expected to grow from approximately USD540 million in 2024 to USD1.45 billion by 2033, at a CAGR of 11.5% (Straits Research). For OEMs, this isn't just about staying compliant, it's about staying competitive.
What the Industry Isn’t Saying
Despite rising urgency, many MedTech companies are still reacting, not preparing. Their strategies are fragmented: stopgap testing, rushed reformulations, and isolated supplier assessments. These efforts may satisfy short-term audits but don’t solve the long-term problem.
PFAS regulation is converging globally, and the timelines are tightening:
EPA: Mandatory reporting under TSCA, hazardous substance classification under CERCLA
EU MDR: Mandatory endocrine-disruptor assessments under Annex I Section 10.4
REACH: PFAS classified as SVHCs, broad material restrictions in play
What most OEMs aren’t planning for:
Design impact of alternative materials (lubricity, sterilization, durability, heat stability, chemical resistance, non-reactive properties)
Disruption to validated supply chains
Reputational damage for delayed response or environmental exposure
Re-testing for biocompatibility due to limited data on potential toxicants, extractables, and leachables
“Medical devices and medicinal products generate some of the highest emissions of PFAS… The MedTech industry has grown too comfortable with ‘essential use’ exemptions and is ignoring the growing liability, supply chain and regulatory risk of PFAS use.”
Kaleidoscope and Infosys have developed a strategic, AI-powered PFAS compliance framework to support MedTech OEMs across every stage of the product lifecycle. More than just risk detection, it helps organizations adapt, act, and lead with confidence.
The Infosys framework, supported by Kaleidoscope’s design-led approach, empowers OEMs to proactively manage compliance through six integrated phases:
Discover: Map inventory and perform AI/ML-powered risk assessments
Validate: Confirm PFAS presence with targeted testing and supplier reconciliation
Engage: Align your supply base with proactive communication and remediation planning
Comply: Track global regulatory obligations, maintain clean documentation, and prepare for audits
Innovate: Rethink materials with R&D, align with ESG goals, and embed Design for Compliance (DfC)
Sustain: Establish dashboards, training programs, and continuous improvement loops to stay ahead
This lifecycle approach transforms PFAS risk into a driver for smarter design, stronger supply chains, and long-term product resilience.
The Business Case for Action
PFAS compliance isn't just about avoiding penalties, it’s about positioning your organization for sustained success. The framework delivers measurable value across the enterprise:
Risk Reduction: Avoid costly penalties and product recalls
Market Access: Ensure compliance with EU MDR, REACH, and EPA rules
Brand Reputation: Demonstrate proactive chemical safety stewardship
Operational Efficiency: Streamline workflows across global teams
ESG Alignment: Support sustainability goals and investor expectations
Done right, PFAS compliance becomes a business advantage.
Design-Led Compliance
PFAS strategy is as much about design as it is about regulation. Material substitution can affect usability, sterilization, manufacturability, and long-term product performance. That’s why Kaleidoscope applies a multi-disciplinary approach to compliance, bridging design, engineering, human factors, and regulatory expertise.
We ask the critical questions early:
Will this alternative maintain lubricity and durability over time?
Does the new material withstand our sterilization method?
Can the design still pass usability validation?
Will the alternative material trigger additional biocompatibility testing?
A PFAS-free solution must still perform, protect, and pass regulatory scrutiny to succeed.
What’s Next
The shift away from PFAS is forcing the industry to accelerate innovation. First movers won’t just be compliant—they’ll own the next generation of IP in high-performance coatings, fluoropolymer alternatives, and sustainable design.
As regulatory scrutiny intensifies, so does opportunity. The MedTech leaders of tomorrow will be those who treat compliance as a catalyst, not a constraint.
Kaleidoscope and Infosys are here to help you rethink materials, future-proof your products, and lead you into a cleaner, smarter era.
With over 25 years of experience in Regulatory Affairs, Colleen brings deep expertise in global medical device compliance, clinical trial strategy, and FDA, Health Canada, and ICH regulations—guiding products from protocol development through submissions, audits, and post-market support.
Ajay leads Sales for Engineering Services in Life Sciences at Infosys, enabling MedTech and pharmaceutical firms to accelerate innovation through advanced product engineering and digital platforms. With deep expertise in R&D, regulatory compliance, and connected technologies, he helps organizations navigate complex challenges and deliver sustainable, patient-centric solutions.
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.
Ajay leads Sales for Engineering Services in Life Sciences at Infosys, enabling MedTech and pharmaceutical firms to accelerate innovation through advanced product engineering and digital platforms. With deep expertise in R&D, regulatory compliance, and connected technologies, he helps organizations navigate complex challenges and deliver sustainable, patient-centric solutions.
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.
BENEFITS OF MAPPING
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Figure 1. Bandage Packages – Left to right: Band-Aid, Nexcare, Niceful, Welly
Figure 2. Wrapped Bandages – Left to right: Band-Aid, Nexcare, Niceful, Welly
Figure 3. Unwrapped Bandages – Left to right: Band-Aid, Nexcare, Niceful, Welly
Figure 4 +5. All bandages immediately following application
Figure 6. Niceful bandage (right), 19 hours after application and moments before it detached
Design and Prototyping
Formative Usability Testing and Evaluation