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.

Back to Insights + News

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.

Back to Insights + News

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.

Back to Insights + News

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.
Back to Insights + News

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.