Is AI Ready for the Operating Room?

Like Coleridge’s Ancient Mariner, today’s surgeon often feels adrift on a sea of data — data everywhere, but not a byte to decide.

Large language models have proven valuable for novices: medical students, trainees, and clinicians looking to rapidly synthesize current guidelines. But for experienced surgeons making complex intraoperative decisions, these tools often fall short. They lack the nuance of years of clinical judgment and can occasionally miss the mark entirely.

So the question becomes: how do we turn the ocean of clinical data surrounding modern healthcare into something surgeons can actually use to improve outcomes?

Consider spine surgery. Today, many surgical decisions—instrumentation choices, level selection, alignment strategy—still rely primarily on the surgeon’s personal experience, supplemented by literature and peer discussion. That individual “database” is powerful but limited.

The cost of those limitations is real. In the U.S. alone, failed spine surgery accounts for roughly $5B in annual healthcare spend and according to one report, as much as $20B, often driven by incomplete or poorly synthesized information at the time of decision-making.

Innovations are emerging. Systems like advanced surgical navigation provide imaging-enhanced “eyes” to guide hardware placement, while new platforms are beginning to leverage aggregated datasets to support planning. These are important steps forward.

But most current systems share a constraint: their intelligence is limited by the datasets they were trained on. Further, the inherent segmentation of knowledge in for example imaging data, may not provide the whole picture.

Now imagine a different model.

What if the “training dataset” wasn’t a purchased proprietary database—but the entire clinical data ecosystem of a health system itself?

Within most hospital systems already exists a decade or more of rich clinical information:

  • patient demographics
  • imaging and operative data
  • treatment decisions across hundreds of physicians
  • long-term outcomes
  • and often cost and resource utilization

In addition, by enabling multi-variable consideration within a single model, we would be able to provide the best possible care, more closely tailored to an individual patient’s needs.

In that environment, surgical planning tools no longer rely solely on static historical training sets and subsets of clinical variables. Instead, they draw from living clinical intelligence, helping surgeons make decisions informed by the most current and locally relevant data available.

This is where design, engineering, and clinical insight must converge.

At Kaleidoscope Innovation, together with our parent company Infosys, we work at the intersection of the physical and digital healthcare ecosystem—helping medtech organizations bring these next-generation capabilities, many of them AI-revolutionized, to life.

In addition to design, workflow and human factors insight; advanced engineering and digital system architecture, and regulatory and medical affairs expertise, Kaleidoscope’s AI-related work centers around:

  • Dataset evaluation
  • Model training & validation
  • Usability (UX) & integration within the surgical system

While Infosys focuses on:

  • Ethical AI model creation
  • Cyber Security considerations

The highest order of value we offer clients is an end-to-end development capability that transforms complex data ecosystems into clinically meaningful, regulatory-ready solutions.

The future of surgical planning will not come from AI alone. It will come from thoughtfully designed systems that turn real-world clinical data into real-time clinical wisdom.

If you're exploring how AI-enabled platforms, smart devices, or connected surgical ecosystems might fit into your roadmap, I'd welcome the conversation.

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Author

  • Dr. Elliott Fegelman

    Chief Medical Officer | [email protected]

    Experienced general surgeon with 40+ years in medicine and 25 in the operating room – now applying clinical rigor and commercial instinct to product design strategy, med tech innovation and making digital at the bedside meaningful.

Navigating the Regulatory Pathway for Smarter, Safer, More Efficient and Effective Medical Device Submissions

When it comes to medical device development, innovation gets all the excitement and attention, but the less glamorous regulatory process is a non-negotiable hurdle that can delay even the most advanced technology from reaching the market. That’s why it’s essential to establish a solid regulatory strategy that anticipates and mitigates risks, accelerates approvals, and ultimately aligns with your business goals, right from the start.

Kaleidoscope Innovation’s team of seasoned regulatory experts have developed an end-to-end regulatory assessment designed to map out the path to clearance or approval with efficiency and precision. Here’s an overview of our approach.

01

Background & Purpose: Laying the Foundation

The first step is to develop a comprehensive understanding of your product’s intended use, target markets, and previous regulatory history. It’s also essential to align your goals with regional requirements—whether for the U.S. (FDA), EU (MDR), or other global territories—ensuring that every decision is guided by both compliance and market strategy. Here are some guidelines we use:

  • Define the Intended Use/Indications for Use
  • Identify key territories for regulatory clearance
  • Summarize any prior submissions, rejections, or correspondence to avoid duplication and leverage existing work

02

Product Description: Translating Innovation into Regulatory Language

Next, we break down your device’s design and functionality into a format that regulators understand, capturing the critical elements—from technical schematics to visual documentation—that describe the full scope of your product. This is an area in which Kaleidoscope excels. Our product assessments include:

  • Detailed device description and illustrations
  • Identification of any planned iterations that could impact classification or approval timelines

03

Medical Device Definition: Clarifying Classification Early

Accurate classification is critical, identifying whether your product meets the FDA’s definition of a medical device or qualifies under non-device pathways. These include:

  • General Wellness classifications
  • Non-device Clinical Decision Support (CDS) tools

By making this determination early, we help uncover faster or lower-risk pathways and avoid unnecessary regulatory burden.

04

Product Regulation: Finding the Right Regulatory Fit

Using FDA databases and internal expertise allows us to determine the appropriate regulatory classification and product codes based on the intended use and technology profile. Kaleidoscope’s regulatory specialists:

  • Cross-reference public databases to identify potential regulations
  • Select the most appropriate product codes and submission routes, whether a 510(k), De Novo, or PMA

05

Identifying Predicate & Reference Devices: Building a Case for Equivalence

If pursuing a 510(k), our team will research potential predicate devices to demonstrate substantial equivalence and streamline your path to market.

We also explore:

  • Reference devices that can support safety and performance claims
  • Strategies for leveraging this data to shorten timelines and reduce required testing

06

Regulatory Recommendations: Strategic Pathways to Market

This is not an area you can check boxes, and having an experienced team lead the effort eases the burden and stress for our clients. We craft a regulatory roadmap that aligns with your product and your business. Our process addresses:

  • Early FDA engagement (Q-Sub, Pre-Sub, or Pre-IDE meetings), including communications and strategic negotiations that facilitate the best outcomes
  • Opportunities to apply for Breakthrough Device Designation or Safer Technologies Program (STeP)
  • The most efficient marketing pathway, such as a Special 510(k) or De Novo, based on cost, timing, and risk

07

Testing Requirements: Designing for Approval

Aligning our experience with your product needs, we develop a targeted testing strategy using:

  • Relevant regulatory guidance documents
  • Precedent data from similar cleared devices
  • Listings on ClinicalTrials.gov
  • Industry standards and FDA expectations

Our recommendations consider everything from biocompatibility and electrical safety to usability testing and human factors engineering (HFE). Our team can also go beyond testing to implementation, tapping Kaleidoscope’s in-house Human Factors team and/or wet lab, conducting clinical trials, and more.

08

Marketing Submission Content: Getting Everything in Order

We ensure you're fully prepared for submission with a checklist that covers every requirement. Our regulatory team compiles, reviews, and often authors the following, delivering final approved versions for company submission:

  • All necessary 510(k), De Novo, or PMA documentation
  • Establishment registration and device listing
  • Small business qualification options, when applicable
  • Quality System Regulation (QSR) readiness; we can also build your QMS from scratch in paper or digital format
  • References to the most current FDA guidance documents and ISO standards

With decades of experience working with industry leaders like Baxter and a range of small start-up businesses, Kaleidoscope Innovation has earned a reputation for combining deep regulatory knowledge with world-class product development. Our approach helps new projects get started from the ground up and provides clearance for those that are further along. In all cases, we target long-term success, risk mitigation, and accelerated timelines.

 

Let’s map your regulatory path with confidence. > Let's start something.

 

Download this Regulatory Strategy At-a-Glance Guide to see how we simplify FDA submissions and accelerate approvals.

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Author

  • Colleen Murphy

    Director of Regulatory Affairs | [email protected]

    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.

The Future Is Beautiful: 5 Beauty Packaging Trends Defining 2026

Beauty is no longer just skin deep. Neither is beauty packaging design. As wellness, neuroscience, luxury, and AI reshape consumer expectations, brands must rethink how cosmetic packaging communicates value, efficacy, and emotion.

At Kaleidoscope Innovation, we’ve identified five beauty packaging trends defining 2026. Trends that are transforming how products look, feel, and perform on shelf and online.

 

The New Language of Luxury

Luxury is being redefined and it’s moving beyond fashion. Once-dominant labels like Celine and Prada are now channeling their influence into beauty. Wellness is the new status symbol, and self-care rituals have replaced designer handbags as markers of personal value.

Beauty packaging must reflect this new lexicon of luxury. It should feel wellness-forward, minimalist, and elevated enough to belong on a vanity or a curated wellness space. Think materials that feel medical-grade yet indulgent. Design systems that cue clinical efficacy with aesthetic restraint. In this era, health is wealth, and packaging is proof.

Beauty packaging design trends

Sleep is the New Serum

Sleep-maxxing is the latest self-optimization frontier. Consumers are stacking products and routines to enhance overnight recovery. The uglier you go to bed, the more radiant you wake up.

Brands like Estée Lauder and Oskia are doubling down on circadian science, and even Goop is getting in on the act with sleep-training video content.

The category is evolving from passive rest to active restoration and packaging must follow suit. It should communicate performance as much as calm. Plush textures, midnight tones, and thoughtful ergonomics can reinforce the idea of high-function luxury designed for night rituals.

 

Designing for Her, Finally

For too long, women’s wellness was overlooked. Despite women making up over half the U.S. population, only 4% of clinical trials from 2007–2020 focused on gynecological health. The gap is now impossible to ignore.

Searches for terms like “PCOS” and “vaginal microbiome” are skyrocketing, and brands like Seed, Olly, and Perelel are responding with smart, empowering products.

For designers, this means building trust through packaging: calm, confident, and intuitive, not clinical or condescending. It’s time to move past pink and passive and into packaging that reflects real needs, real science, and real women.

Beauty packaging design trends

Beauty and the Brain

The next frontier in beauty is emotional and neurological. Consumers increasingly understand the connection between how they look and how they feel.

Mood-boosting skincare is emerging as a key category, with brands like Neurae and CapBeauty pioneering neurocosmetics that interact with serotonin and dopamine pathways. Emotional wellbeing is becoming part of the beauty promise.

For packaging, this opens the door to sensory design: joyful color, satisfying shapes, unexpected interactions. Gen Z isn’t just asking, “How does this make me look?” They’re asking, “How does this make me feel?”

 

Smart Packaging for Smart Shoppers

With Gen Z consulting AI for everything from skincare routines to ingredient breakdowns, beauty consumers are more informed than ever.

Forward-looking packaging must do more than look good; it must act smart. Take Dove’s temperature-sensitive bottle label or the rise of scannable codes offering real-time advice. Science-backed design and intelligent labeling are no longer extras, they’re expectations. The next generation of beauty packaging will need to be a trusted advisor, not just a pretty face.

 

Final Take: Designing What’s Next

These beauty packaging trends for 2026 demonstrate that packaging is becoming more than a container, it’s a strategic brand touchpoint for experience, emotion, and intelligence. At Kaleidoscope Innovation, we don't just observe these shifts. We’re designing into them.

If your brand is ready to connect with consumers through bold visual storytelling, strategic design systems, and packaging that delivers both form and function, our graphic design teams are here to help. From concept to commercialization, we bring insight, strategy, and creativity that move brands forward.

Let’s design what’s next, beautifully, together.

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Author

Why Participant Representativeness Matters in Human Factors Validation Studies

FDA guidance and international standards for human factors emphasize the importance of conducting a robust validation, or summative, study before a device goes to market. The guidance and standards clearly state that a validation study must evaluate whether the device can be used safely and effectively by intended users, in intended use environments, and for intended uses.

One of the most crucial elements in any usability study is participant recruitment. Ensuring you have the right participants who accurately represent your target user population is essential for generating meaningful and regulatory-ready data. However, recruiting representative participants can be a complex and nuanced process, often involving logistical hurdles, strict inclusion criteria, and potential access limitations.

That’s where Kaleidoscope Innovation comes in. Our team can help you navigate the challenges of participant recruitment, offering expert support and strategic guidance to ensure your study includes the right users and meets regulatory expectations. 

"The most important consideration for test participants in human factors validation testing is that they represent the population of intended users."FDA, 2016 (Ref. 1)

“A usability test calls for a sample of representative users to interact with a given medical device.” IEC 62366-1:2015 (Ref. 2) 

What is Representativeness?

Representativeness can be defined as, “serving as a typical or characteristic example of a particular group of people or of a particular thing.” In a validation study, representative means the participants should reflect the range of end users who will operate the device in the real world. This includes not just their professional roles, such as nurses or physicians, but also relevant characteristics such as age, physical or cognitive abilities, and levels of experience or training.

Why You Should Care

Medical errors can happen when devices are not intuitive or forgiving of user mistakes, especially under stress. A validation study aims to uncover these risks by testing the device in simulated, but realistic, conditions. If the participants do not adequately reflect the intended user population, the study can miss critical usability issues. For example, a device that is easy for a tech-savvy nurse to use may confuse an elderly caregiver at home. If a representative of that caregiver isn’t included in the validation study, designers might not discover the problem until after the device is already in the users’ hands. And finally, failing to include representative users can delay regulatory acceptance or approval, and potentially lead to the need for additional studies.

Getting it Right in Your Study

Recruiting a representative sample often takes more effort and planning than it might initially seem. It requires thinking beyond who is most accessible and making sure to include people who may be harder to recruit but are essential to evaluating real-world use.

Engaging users early, such as through formative research or with assistance from a design research team, the exact user characteristics necessary for device use can be successfully identified. These characteristics might include users with vision or dexterity limitations, individuals with limited technological experience, or those with lower health literacy. By emphasizing a proactive approach for ensuring participant representativeness, the likelihood of costly design changes later in development is reduced, safety risks are minimized, and there will be an increased likelihood that the final product will be intuitive, efficient, and safe to use. likelihood that the final product will be intuitive, efficient, and safe to use.

Human factors validation studies are about identifying and mitigating risk, not just ticking a regulatory box. Ensuring the participants recruited are truly representative of your device’s user population is a cornerstone of a successful study. Skipping this step risks both regulatory rejection and patient safety.

References

  1. S. Food and Drug Administration. (2016, February 3). Applying human factors and usability engineering to medical devices: Guidance for industry and Food and Drug Administration staff.
  2. International Electrotechnical Commission. (2015). IEC 62366-1:2015 Medical devices – Part 1: Application of usability engineering to medical devices.
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Author

  • Rebecca Chompff

    Senior Human Factors Engineer | [email protected]

    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.

Engineering the Future Grid

The power grid isn’t struggling just because demand is rising.
It’s struggling because it was never designed to adapt.

EV charging infrastructure, AI-driven data centers, electrified manufacturing, renewable energy, and climate-related events are changing how electricity is generated and used. Instead of predictable, centralized demand, organizations are dealing with localized spikes, distributed energy sources, and operating conditions that shift faster than infrastructure and product development cycles can keep up.

The International Energy Agency has already flagged electricity grids as a potential bottleneck in the clean energy transition. In the U.S. alone, demand is projected to grow roughly 26% by 2035. But one of the biggest challenges isn’t software or analytics. It’s turning scientific insight into deployable, field-ready equipment fast enough.

That’s where many grid modernization efforts slow down. Control strategies exist, sensing technologies show promise, and automation concepts often look strong on paper. But manufacturability, integration, reliability, and maintenance aren’t always considered early enough. The result is prototypes that work in controlled environments but struggle in the field, deployment timelines that stretch longer than planned, and solutions that become harder to scale cost-effectively.

From our perspective at Kaleidoscope, the opportunity is connecting the full journey, from research and engineering through product design and manufacturability to full systems integration across disciplines such as robotics, automation, and equipment design. After all, grid innovation only matters when equipment is installed, operational, and scalable.

Whether you’re advancing new sensing technologies, automation solutions, or renewable energy systems, we are your product development partner. 

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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.

process mapping in product development

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.

Let's map out your next project, together.

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Author

  • Charlotte Lux

    Design Research Manager | [email protected]

    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.

  1. Band-Aid - Flexible Fabric Knuckle & Fingertip Bandages, H-shape
  2. Niceful - Silicone Foam Dressing Gentle Border, square shape
  3. Nexcare - Waterproof Clear Bandages, hexagon shape
  4. Welly - Adhesive Flexible Fabric Bravery Badges, oval shape

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.

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Authors

  • Rebecca Chompff

    Senior Human Factors Engineer | [email protected]

    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 Morgan

    Human Factors Engineer | [email protected]

    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
  • Potential regulatory submissions, re-certifications, and/or additional reporting requirements

“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.”

Cally Edgren, Director of Sustainability, Assent

 

A Smarter Path Forward

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.

Let’s start something, together.

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Authors

  • Colleen Murphy

    Director of Regulatory Affairs | [email protected]

    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 Sathyanarayana

    Infosys Engineering Sales | [email protected]

    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. Empathy Builds 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 concepts like 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.

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Author

  • Rachael Clark

    Senior Design Researcher | [email protected]

    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:

  1. 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.
  2. 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.
  3. 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.

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Authors

  • Matt Suits

    VP, Head of Sales

    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 Sathyanarayana

    Infosys Engineering Sales | [email protected]

    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.