Product Development Archives

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.

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.

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.

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:

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.

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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.

Designed to Change the World: How Kaleidoscope Innovation and Infosys Are Building the Future Together

In this episode of InfyPod, host Mia Haler sits down with Ben Ko, CEO of Kaleidoscope Innovation, to explore how the company is shaping the future of product development as Infosys' Product Innovation Center of Excellence. From groundbreaking medical devices and industrial robotics to premium consumer experiences, Ben shares how Kaleidoscope blends engineering, design, and human empathy to deliver innovation that matters. He also reflects on the cultural alignment between Infosys and Kaleidoscope, the power of cross-disciplinary collaboration, and the immense growth unlocked through their integration.

“Every business needs product innovation to survive. Kaleidoscope helps you build trust—and open doors—to the R&D budgets that fuel your client’s future.” – Ben Ko, CEO of Kaleidoscope Innovation

Insights:

Design + Engineering + Empathy = Innovation That Matters
Kaleidoscope works at the intersection of science and art to deliver real-world impact, from life-saving medical devices to intuitive consumer experiences.
400% Growth Since Acquisition
Kaleidoscope’s partnership with Infosys has unlocked new industries and exponential scale, fueled by global access and trust from enterprise leaders.
Human-Centered Design at the Core
Whether it’s surgical robotics or premium consumer goods, Kaleidoscope’s cross-disciplinary teams prioritize users—not just specs.
Culture as a Catalyst
Shared values like humility, collaboration, and excellence have driven seamless integration with Infosys and elevated innovation across both companies.
From Video Game Controllers to the Electrical Grid
Kaleidoscope applies the same rigor to everything, from gaming hardware to infrastructure modernization, proving their process is industry-agnostic and impact-driven.
What’s Next: The Return to Consumer Roots
With expertise in robotics, computer vision, and automation, Kaleidoscope is reinventing products for iconic food, beverage, and consumer brands.
A Strategic Entry Point into R&D
Infosys clients spend far more on R&D than IT. Kaleidoscope is the bridge that lets Infosys partners unlock that deeper, stickier, and more innovative relationship.

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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.

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Author

Madison Bates

Human Factors Engineer | [email protected]

Eradicating Eye Disease

PulseSight (Formally Eyevensys) approached Kaleidoscope’s ID team with the following need:

“Help us develop and train ophthalmologists on how to perform our innovative electrotransfection gene therapy procedure.”

Unlike most pharmaceuticals that treat conditions of the eye, PulseSight’s non-viral gene therapy teaches the eye to heal itself. Very cool stuff!

So, Kaleidoscope’s designers got to work, collaborating with surgeons, practicing the procedure in situ, not only illustrating but also developing techniques for the procedure itself. The final procedure guide and accompanying trainer helped ensure PulseSight’s clinical trial progressed even more smoothly.

“Sunny” is the nickname for the anatomical model Kaleidoscope’s design and engineering team developed to train retinal surgeons on the innovative new Electrotransfection Gene Therapy pioneered by PulseSight.

To properly prepare surgeons for the novel obstacles experienced in the procedure, Kaleidoscope’s team of designers created this model to accurately simulate limited orbital access and the rotational effects of the rectus muscles of the human eye.

While Sunny doesn’t talk much, he definitely has seen a lot!

As experts in the field of Ophthalmic drug delivery devices, Kaleidoscope's team helped redesign the product from the ground up, improving the overall usability of the device and the efficacy and accuracy of the drug delivery.

Surface Studio On Table Mockup by Anthony Boyd Graphics

Learn more here: https://kascope.com/case-study/pulsesight-therapeutics/

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Author

Jake Schubert

Senior Lead Industrial Designer | [email protected]
Jake Schubert is a Senior Lead Industrial Designer at Kaleidoscope Innovation. His technical expertise and collaboration with our engineering team are instrumental in ensuring that user needs, design, and engineering intent converge seamlessly in our market-ready products.

The Future of Industrial Design

It’s time to evolve the way we train young industrial designers.

I’ve often heard designers express frustration about the decline in the quality of education for industrial designers and the curriculum’s failure to teach the foundational skills needed to enter the profession.

Having managed Kaleidoscope’s industrial design co-op program for five years and mentored co-ops throughout my career, I can’t say I disagree. Though young designers still have so much passion for their craft, their portfolios often reveal that the required skills are lacking.

What’s changed over the last decade? Our world.

Born after the dawn of the internet, today’s young designers have grown up surrounded by technology and unlimited access to information. While their innate curiosity has not changed, the way they learn and the tools they use certainly have.

For me, growing up pre-internet came with advantages and disadvantages. Much of my understanding of the world and the products around me came from my curiosity about and interaction with tangible objects. Whether it was building things with my father in the garage or taking objects apart and putting them together to see how they worked, my learning came from the physical world around me.

So how can we adapt the way we train young designers? I don’t have an encompassing solution to this question. But I do believe the first step is to recognize the impact of these generational and cultural changes so we can tweak the curriculum by incorporating literal hands-on experiences into students’ education. Let’s bring back model-making and shop courses, all the while emphasizing why these efforts are essential to one’s foundation and growth as a designer.

I’m sure all of you new and veteran designers have your own perspectives on the subject. What do you think of the state of today’s educational design programs? How can we ensure the next generation of designers are as prepared and skilled as possible?

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Author

Jake Schubert

Senior Lead Industrial Designer | [email protected]
Jake Schubert is a Senior Lead Industrial Designer at Kaleidoscope Innovation. His technical expertise and collaboration with our engineering team are instrumental in ensuring that user needs, design, and engineering intent converge seamlessly in our market-ready products.

Orthopedic Best Practices You May Have Overlooked

Device development and commercialization requires a comprehensive approach that encompasses scientific rigor, innovation, regulatory compliance, and market readiness. With the increasing demand for advanced orthopedic solutions, it is crucial for organizations to adopt best practices to ensure successful device development from concept to commercialization. In this article, we explore the practices used in product development that can drive excellence in orthopedic development by accelerating time to market and delivering optimal patient outcomes.

1. MULTIDISCIPLINARY COLLABORATION:

By fostering a multidisciplinary approach, organizations can leverage diverse expertise, perspectives, and insights throughout the development process. Often, the best solution is provided by a new perspective. Successful orthopedic product development teams should include the following stakeholders: orthopedic surgeons (outside the ‘friends and family’ network), engineers, material scientists, industrial designers, regulatory experts, and market strategists. This collaboration enables the integration of clinical insights, engineering advancements, and market trends to create user-friendly devices that meet the needs of both patients and healthcare professionals.

2. HUMAN FACTORS ENGINEERING:

Integrating human factors engineering (HFE) into orthopedic device development is critical for ensuring usability, safety, and patient satisfaction. HFE focuses on optimizing the interaction between users and devices, considering factors such as ergonomics, user interfaces, and intuitive design. By conducting thorough user research, usability testing, and risk assessments, organizations can identify and address potential usability issues early in the development process, resulting in orthopedic instrumentation and implants that are intuitive, effective, and aligned with user needs.

3. REGULATORY COMPLIANCE:

Orthopedic products are subject to stringent regulatory requirements to ensure patient safety and device effectiveness. Adhering to regulatory standards and engaging with regulatory authorities early in the development process is essential. By establishing a robust regulatory strategy, organizations can navigate the complex regulatory landscape, streamline the approval process, and accelerate time to market. Companies need to explore all regulatory avenues and not limit themselves to the 510(K) and take advantage of other regulations such as the FDA’s new De Novo process for unique claims and gain a competitive advantage. Compliance with regulations is crucial for successful commercialization and market access.

4. DESIGN FOR MANUFACTURING AND ASSEMBLY (DFMA):

Designing orthopedic devices with manufacturability and assembly in mind is a best practice that can enhance efficiency, reduce costs, and improve scalability. DFMA principles involve optimizing device design to minimize complexity, facilitate efficient manufacturing processes, and ensure consistency in quality. By collaborating closely with manufacturing partners early in the development process and incorporating DFMA considerations in prototypes, organizations can streamline production, minimize design iterations, and accelerate time to market.

5. POST-MARKET SURVEILANCE AND FEEDBACK:

Monitoring the performance and safety of orthopedic devices in real-world settings is crucial for continuous improvement and regulatory compliance. Establishing post-market surveillance programs to actively collect feedback from healthcare professionals and patients can provide valuable insights into device performance. Potential issues can be identified, and iterative enhancements will drive long term product life. This ongoing feedback loop helps organizations address any concerns, optimize device performance, and maintain regulatory compliance throughout the device lifecycle.

By embracing these best practices, organizations can enhance the development and commercialization of orthopedic devices, delivering solutions that improve patient outcomes and meet market demands. Multidisciplinary collaboration, human factors engineering, regulatory compliance, design for manufacturing and assembly, and post-market surveillance form a comprehensive framework for success in this evolving field. As the demand for innovative orthopedic solutions continues to grow, adopting these best practices is essential for organizations aiming to make a significant impact in the orthopedic device market and contribute to the advancement of patient care.

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Author

Nick Bailey

Staff Design Engineer | [email protected]
Nick Bailey, PE, is a mechanical engineer at Kaleidoscope Innovation based in Cincinnati, Ohio, and has over 9 years of experience designing and developing products from concept to market. Nick has spent the majority of his time bringing medical devices through the FDA from R&D and has designed over 100 patient matched implants and custom instruments.