Innovation Archives | Kaleidoscope

Qualitative Research: AI’s Role in Analysis Advancement

BACKGROUND

Qualitative research plays a pivotal role in enriching our comprehension of individual narratives and experiences. It is a cornerstone methodology for design researchers seeking to forge a deep connection with user perspectives, particularly during the initial phases of the design process. This approach is instrumental in guiding iterative design developments, ensuring that end-user needs are comprehensively addressed. Qualitative data encompasses a diverse array of formats, including textual content, photographs, and videos. Typically, these studies involve a more focused sample size, often with 10 or fewer participants, to facilitate an intensive, detail-oriented analysis that quantitative methods may not capture.

Although qualitative research is the methodology of choice for design researchers, the approach requires a considerable time commitment. Qualitative data is known for being unwieldy at times, and words and images require more hours of analysis than numeric data. Often, our clients are eager to obtain research findings as quickly as possible to move a product or system into production. Therefore, large scale qualitative studies are not feasible for most design research projects. With the recent surge in the availability of AI language model tools, we speculated that ChatGPT could be used to analyze extremely large sets of qualitative data more efficiently. To that end, we conducted a 6-month project testing ChatGPT as a potential tool for qualitative data analysis.

THE CURRENT PROJECT

Our aim in conducting this project was to determine if AI could produce insights from a large dataset that would otherwise be unmanageable and time prohibitive for a human researcher. We used data from 25,000 open response questions to explore the capacity and capability of ChatGPT as computer-assisted qualitative data analysis software (CAQDAS). The dataset we used was provided by the VIA Institute on Character, a local non-profit organization with which we are affiliated. We decided to experiment with ChatGPT to determine if it could reliably and accurately analyze text data. Our expectation was that if ChatGPT could analyze qualitative datasets with tens or hundredsof thousands of respondents, new pathways for qualitative researchers may develop.Using AI for data analysis could change the trajectory of a research design and lead to large scale qualitative studies that were not possible before now.

PROCEDURE

To test the limits of ChatGPT 4.0 (the only version with the means to upload files), we tried two different approaches to determine the capability of the tool.

METHOD 1: QUICK AND EASY

We started with a vague set of user queries to place the data preparation load on the CAQDAS and to determine if it would complete the same tasks a human researcher would.

User Query: Analyze the data in column AQ, identify themes, and provide 3-5 insights based on participant responses.

Result: Not useful.

ChatGPT did not automatically clean the data without instruction which caused an error. The output from ChatGPT indicated the data file was either too long or too complex and it was unable to proceed with analysis. The raw data included responses such as “N/A” or random strings of letters, which a researcher would have deleted or ignored before analysis.
Lacking more specific instruction, ChatGPT defaulted to a quantitative approach to data analysis, even though the data were text responses. One of the first outputs ChatGPT produced was a count of the most common phrases in the dataset.

We concluded that this approach to creating user queries was not useful. ChatGPT attempted to analyze the data but quickly became overwhelmed and either produced an error message or continued to attempt analysis, getting caught in the AI version of theMac’s “spinning wheel of death.”

METHOD 2: THE GUIDED ANALYST

We then provided ChatGPT with more specific instructions. We instructed it toclean, review and code the data, then create insights using a theoretical framework as a guide for analysis.

User Query: I'd like to analyze some text data using Peace Psychology and Positive Psychology as theoretical frameworks. Include content from the VIA Institute on Character as an additional framework. Focus on data in the 'Open Responses_Political Differences' column.

First, ignore text that indicates a respondent did not want to answer such as 'N/A' or random strings of letters. Leave those cells blank. Next, use descriptive codessuch as a phrase that describes the content of the targeted data.

Create a new document and filter the data from columnAD. Group the data according to the codes created in columnAD and list each data point that corresponds to the code.

Create 3-5 insights using the coded data in ColumnAD using positive psychology and peace psychology as theoretical frameworks.

Create a Word document and place the insights you created in it. Make the file available for download.

Result: Success

ChatGPT produced a list of five insights using the VIA classification of character strengths as a framework, supported by references to positive psychology and peace psychology.

Our last step was to think about how to test the accuracy and reliability of the findings. Rachael has a strong background in qualitative methodology, so she extracted a sample of 20 data points and used a traditional qualitative approach to code the data. We also queried ChatGPT using the same data set with similar user queries to determine the degree of similarity between both sets of outputs.

Accuracy

Within the first 20 rows of participant responses, we identified at least three codes related to the five insights ChatGPT produced. We were pleased with the accuracy of the codes as they related to the insights from our sample data.

Reliability

Both researchers requested insight generation from ChatGPT using similar but not identical queries. Chat GPT’s output for both sets of queries was closely aligned. Three of the five generated insights were nearly identical between the two researchers and two were unique per researcher. It is important to note that even within research teams, differences arise between researchers’ interpretation of qualitative data. Disagreements are resolved through discussion and are typical of a qualitative research project.

Finally, we tested some of the limits of ChatGPT with several ad hoc user queries. Ourqueries produced a great deal of information in a very short period.

AD HOC REQUESTS:

Code Participant Country of Origin: We queried the data set to determine if each participants’ country of origin represented an individualistic or collectivist nation(coded as “country designation”). We asked ChatGPT to code each participant’s country of origin using this designation. The codes were placed in a new column created by ChatGPT.
Group Data and Analyze Frequency: We asked ChatGPT to examine the most common keywords and themes by country of origin. It provided a summary for all countries represented in this data set with the most frequently used codes according to participant’s country of origin.
Character Strength Frequency by Country Designation: We prompted ChatGPT to organize the data according to country designation and create a bar chart to illustrate the frequency of character strengths chosen as most beneficial by participants.

All the ad hoc requests were completed successfully. ChatGPT confirmed its approach with users before completing each step. For example, after requesting the data be coded according to country designation, ChatGPT responded:

Sure! In order to label countries as "collectivist" or "individualist," I would need a reference or criteria to determine which category each country falls into. There are various sources and studies that have categorized countries based on their cultural dimensions, including the work by Geert Hofstede.

Do you have a specific reference or criteria in mind that you'd like me to use? Alternatively, I can use Hofstede's cultural dimensions as a general guideline.

ChatGPT also encouraged us to use caution when interpreting the findings from the between-country analysis, because significantly more participants were from individualistic nations.

LESSONS LEARNED

We learned through this project that ChatGPT exhibits several esoteric preferences for working with Excel files. We only used Excel to upload data sets, so our suggestions are restricted to this software.

1. ChatGPT cannot analyze data if it has been tagged with a data type. The output will state that it completed the user query, but new files will not show any changes.

SOLUTION: Remove any Data Types tags before uploading Excel files toChatGPT.

2. ChatGPT prefers references to column names instead of the letters Excel uses to identify columns.

SOLUTION: If a user query contains a letter identifier instead of a column name, remove the space between the word “Column” and the letter.

CORRECT: “Provide a mean for the data in columnAI.”

INCORRECT: “Provide a mean for the data in Column AI.”

3. Unless instructed, ChatGPT will not automatically clean uploaded data. If a user attempts to request analysis before cleaning, it will respond with an error message.

SOLUTION: Provide explicit instructions for data cleaning before analysis.

HUMAN RESEARCHER VALUE

We shared just a fraction of the user queries we submitted over a 6-month period to test ChatGPT as a qualitative analysis tool. We presented the successes and failuresas linear, concise processes for readability. However, early in the project, ChatGPT was often overwhelmed with requests and our queries resulted in error messages. Queries usually required several back-and-forth inputs between researchers and the AI to clarify instructions. With little or no guidance, ChatGPT was unable to produce results. We found that the AI required specific instructions to function as computer-assisted qualitative data analysis software. Our bottom-line recommendation is that well trained researchers test the tool using a data set for which they already possess human produced findings. Compare those findings with ChatGPT's output and evaluate its reliability and accuracy.

Based on our brief examination of ChatGPT’s capability, we advise only well-trained researchers with extensive qualitative research experience to use AI as a computer-assisted data analysis tool. As in any other profession, expertise and training are the best predictors of quality work. As the saying goes, garbage in garbage out.Users with no idea how to design a rigorous research study will not provide the needed input for AI to perform adequately.

Our early work indicates the potential for AI to assist in qualitative data analysis. Like other CAQDAS products such as MAXQDA and NVivo, the software serves as a management and organizational tool. We envision ChatGPT as a marginally higher-leveltool with the capacity for categorizing and summarizing qualitative data, with the proper guidance and instruction.

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Authors

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.
Grant Cothrel

Senior Design Engineer | [email protected]
Grant is a Senior Design Engineer who enjoys being faced with new challenges, and recognizes that well-designed products lead to better experiences and outcomes for users. He loves the design process, and has operated primarily in medical device and industrial applications. His passion to understand, innovate, and simplify has been supported and strengthened by the Kaleidoscope team and their talented partners. At home, he always has a fun project in the works (think: wooden bicycle, handheld Theremin, one-string electric guitar)!

Designing for the Unknown

ENCOUNTERING DATA GAPS

For a product to be successful, it’s critical for designers to understand the environment in which the product will be used. For a medical device, this environment is often inside the human body. While some anthropometric data such as height, weight, and arm reach, are well documented, there are many critical anatomical measures that remain unknown, particularly in the realm of women’s health.

While collaborating with a medical partner to address postpartum hemorrhage (PPH,) the leading cause of maternal death worldwide, Kaleidoscope encountered this common product design challenge. During preliminary research, the team found that there was little to no readily available data on vaginal dimensions immediately following childbirth. The scarcity of this particular data is not surprising, as the anatomy changes rapidly postpartum. Understandably, collecting this data isn’t a priority for mothers or caregivers, who are focused on the wellbeing of the newborn. Nevertheless, this lack of data created a significant challenge for the Kaleidoscope PPH design team.

TOOLS FOR BRIDGING THE GAP

Whether we are creating a medical device, a smart pet collar, or an industrial freezer, the team at Kaleidoscope utilizes a number of different methods when designing for the unknown. One way we obtain the data we need is simply to collect it ourselves! Armed with calipers and tape measures, we might venture into the field or bring samples into our studio to take direct measurements. Direct observation, whether in person or through videos and photos, is another way we round out our understanding of a unique user experience.

Sometimes—like trying to determine dimensions of internal anatomy—this just isn’t feasible. In those cases, we turn to subject matter experts. Surgeons, with their deep experiential knowledge of anatomy, are able to describe what they have encountered in situ, providing additional insights into the nuanced aspects of human anatomy, such as texture, firmness and what it feels like to manipulate different anatomical structures. These insights proved to be a vital element in overcoming the data gaps encountered by the PPH design team.

OUT-OF-THE-BOX INSPIRATION

When the Kaleidoscope team explores new product categories, we find that drawing inspiration from successful analogous products is another valuable strategy. If we’re creating a handheld device, referencing power tools, hair dryers, or hot glue guns as adjacent products can help guide the design in the correct direction. The key here is relevance—referencing products familiar to end-users ensures that the design resonates with their expectations. If we are developing a surgical device for ophthalmologists, (who are used to small, delicate instruments that they control with their fingertips,) it would be more appropriate to reference delicate tools such as those used by sculptors than it would be to reference tools used by auto mechanics.

While designing for a post-partum hemorrhage solution, analogous products included menstrual cups and discs, which share similar placement within the vaginal canal. These adjacent products provided the Kaleidoscope team with a good starting point for shape and dimensions of the device, as well as inspiration for materials and durometers to explore. These analogous references were part of the constellation of information used by the PPH team while exploring potential solutions to our data gap.

EMBRACING FLEXIBLE SOLUTIONS

At the end of the day, secondary research can only get us so far. In the absence of precise anatomical dimensions, adaptability can be a powerful tool in the designer’s toolbox. Whether the solution is fully adjustable (like an office chair) or offers different size options (like audio earbuds with multiple size tips,) a thoughtfully designed adjustable or flexible product ensures that one size does NOT need to fit all—rather, we can design a solution that easily adapts to meet the needs of all users.

Being on the cutting edge of new product development often means navigating uncharted territory. At Kaleidoscope, we've mastered the art of designing for the unknown with a combination of creative data collection, analogous product inspiration, and thoughtful adaptability. By transforming uncertainty into opportunity for our partners, we create products and experiences that improve outcomes for everyone.

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Author

Tom Gernetzke

Senior Industrial Designer | [email protected]
Tom Gernetzke is a senior lead industrial designer at Kaleidoscope Innovation and has spent the last 12 years creatively bringing new product ideas to life.

CES Optimist or Cynic?

Connectivity of people and devices is a significant macro trend across various products and technologies. Throughout history, most tech innovations have stemmed from the essential need for human interconnectivity including language, printing, roads, telecommunication, and the internet.

Optimistically, products like Withings' new "BeamO" represent a noteworthy evolution—a handheld device sensing temperature, heart rate, ECG, O2 levels, and features a stethoscope. This advancement enables a mobility-limited population to interact more effectively with healthcare providers, providing higher fidelity and real-time patient information. These products accumulate valuable data points over time, facilitating meaningful trend analysis.

However, my inner cynic sees that these types of products are usually marketed toward able-bodied and mobile people. Products like this can be used as excuses to avoid human-to-human interaction… or be reasons to replace human interaction. (You may have seen the AI powered robotic barista!) Every day, we see the impact of people losing the skills of basic public human interaction and common courtesy.

Overall, my optimistic perspective embraces the potential these new technologies bring to the human experience. While acknowledging potential pitfalls, I advocate for a larger role of Design within companies exploring these technologies. Engaging in discourse is crucial to finding a balance that enhances rather than degrades our collective experiences.

Now, are you more of an optimist or a cynic?

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Author

Karl Vanderbeek

VP of Design & Human Factors
Karl is passionate about creating worthwhile and valuable product design with an amazing team, focused on building beautiful and intuitive experiences prioritizing the user’s needs and expectations. His team brings these visions to reality by collaborating closely with Kaleidoscope’s Insights, Human Factors and Engineering teams. Karl’s Industrial Design background includes working with brands across a wide variety of industries, ranging from healthcare and medical, to consumer and housewares, to industrial products and toys. He has earned more than 40 design and utility patents over the past 20+ years.

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.

The Power of Creativity, Innovation and Community

The 2023 International Design Conference hosted by the Industrial Designers Society of America and held in the bustling city of New York was a true testament to the power of creativity, innovation and community. Co-created with the NYC design community and powered by NYC Chapter Chair Vincent Lin, this event served as a melting pot of the brightest minds in design, converging to discuss the future of design and its potential to address global challenges. It was as much a vibrant celebration of innovation and camaraderie as it was a stage for essential conversations about design's pivotal role in sculpting a resilient and sustainable future.

FINDING YOUR FLOW, TRUSTING YOUR INTUITION

The conference itself got off to an invigorating start with an insightful talk by Cormac Ó Conaire from PA Consulting. He explored the concept of staying in the 'flow', underscoring its potential to boost creative prowess. Cormac argued the value of pushing oneself to face challenges, which he outlined as key components in achieving a flow state. While he acknowledged that tools aren't indispensable to achieving flow, he suggested that they could enhance and sustain it. "Team flow is a unique state of mind," he noted - and the shared experience of the IDC, much like team flow, created a unique state of mind, fostering a heightened sense of engagement, collaboration, and innovation.

The conversation segued into a fascinating discussion led by Juliette Laroche and Ziyuan Zhu from IDEO about the potential of generative AI in product design. They envisioned a future where AI is applied to everyday objects, imbuing them with personality and interactivity. They explored how AI could be harnessed for material exploration, promising unexpected but beneficial outcomes. Afsin Mehnin from Card79 built on the intangible power of designers to harness these new tools, discussing the role of intuition in industrial design. He spoke about how intuition could be honed through experience and pattern recognition, and how physical creation was a unique form of learning and intuition.

SUSTAINABILITY AND REJUVENATION

The theme of sustainability was powerfully reinforced by Jarred Evans from PDR Consulting. Tackling the formidable challenge of achieving net zero in product design, he emphasized the crucial significance of material selection, lifecycle consideration, and financial sustainability. A case study on stroller design offered a practical example of how sustainability goals could be met through mindful design and material choices. "Product design has changed, and not everyone is ready. It's about picking the best worst solution. Better now is an improvement on perfect never," he advised the audience of designers and industry leaders from across the country and the globe.

Ranee Lee from OCAD University continued the narrative on sustainability and rejuvenation. She detailed the inspiring journey of DESIGNwith, a community-based creative collective from Toronto. The social and environmental lab collaborated with middle-aged women from economically disadvantaged urban areas to rejuvenate their communities through design. This successful co-design project demonstrated the enormous potential of design as a tool for socio-economic upliftment and the passion for a more caring world is evident in the work created by the team at DESIGNwith.

"We are seeking a caring design practice in a post-pandemic world."

Ranee Lee from OCAD University

CELEBRATING THE INTERSECTIONS OF IDENTITY & DESIGN

One of the most emotionally resonant talks was presented by Joey Zeledon, who shared their journey as a trans nonbinary person in the design industry, highlighting the importance of authenticity and self-acceptance. They spoke about the intersection of cultural and personal narratives, suggesting that designers often wear a 'costume' that represents their professional identity. Zeledon emphasized the importance of challenging traditional design norms and questioned whether designers consider their own identities in the same way we consider product transformations. They proposed viewing product design as a means of helping products find their identities, thus creating new narratives around identity and design.

Shawn Williams expanded upon the role of one's personal journey and lived experience in design, focusing on the impact of mentorship and community in shaping your career and impact in the industry. He credited his mentors, particularly Ms. Johnson who bought him his first notebook, for fostering his talent. Williams emphasized that possessing a tool as simple as a #2 pencil can grow to symbolize power in design. As the youngest member of Diversify by Design (DxD), he shared how senior designers within the organization embraced and nurtured the next generation, fostering a sense of community. We too have the opportunity to support the next generation of designers, creating an industry that is more welcoming to all.

SEE YOU NEXT YEAR!

In conclusion, the 2023 International Design Conference was a vibrant celebration of design thinking, innovation, and community, showcasing the transformative potency of design in sculpting a resilient and sustainable future. The event was not merely a discourse on the future of design but also an inspiring testament to the power of community and mentorship in the industry. It left attendees inspired, enlightened, and looking forward to what design's future holds. We are thrilled to announce that the flame of creativity will continue to burn bright in Austin, Texas, the chosen location for the next year's International Design Conference in 2024. The design community worldwide eagerly anticipates the innovation, collaboration, and inspiration that the vibrant city of Austin promises to offer.

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Author

Caterina Rizzoni

Lead Industrial Designer | [email protected]
Caterina Rizzoni is a lead industrial designer at Kaleidoscope Innovation and is the Director-at-Large of Conferences for IDSA.

Rapid Prototyping Revolutionizing Orthopedic Device Development

Rapid prototyping has emerged as a transformative force within the field of orthopedic device development, reshaping the way medical devices are conceptualized, tested, and brought to market. In this article, we delve into the substantial influence that rapid prototyping is exerting on the orthopedic industry, exploring its advantages, applications, and prospective implications.

Accelerating Innovation and Iteration through Orthopedic Product Development

The dynamic realm of orthopedic product development has found a robust ally in rapid prototyping. This innovation leverages advanced 3D printing and additive manufacturing technologies to swiftly transform digital models into tangible prototypes. In a mere matter of hours or days, engineers and designers working on orthopedic research can iterate and refine designs, hastening the innovation cycle. This acceleration paves the way for speedier iterations, efficient incorporation of feedback, and optimal design enhancements. The outcome? Augmented device performance, elevated functionality, and an expedited journey from concept to commercialization.

Customization and Personalization in Orthopedic Device Design

Orthopedic devices necessitate tailored solutions to harmonize with the distinctive anatomical requisites of individual patients. The prowess of rapid prototyping empowers product development teams to craft patient-specific orthopedic implants and instruments. This is achieved through the fusion of advanced imaging techniques, computer-aided design, and orthopedic design consulting. By capitalizing on these rapid prototyping technologies, orthopedic professionals can engineer bespoke solutions that not only offer impeccable fit, but also precise alignment and superior functionality. The upshot? Optimized patient outcomes, heightened satisfaction, and an orthopedic product development landscape poised for transformation.

Efficient Testing and Validation of Orthopedic Devices

Prototypes conjured through rapid prototyping techniques transcend the realm of theory. They are subjected to rigorous testing and validation processes that mirror real-world circumstances. For orthopedic product design teams, this means a proactive identification of potential design glitches, a comprehensive evaluation of performance parameters, and steadfast regulatory compliance. By fostering an environment of early feedback and iterative testing, manufacturers can effectively curtail errors, slash costs, and expedite the time to market for orthopedic devices. The outcome? Enhanced efficiency, reduced risk, and orthopedic product development that adheres to the highest standards.

Collaboration and Stakeholder Engagement in Orthopedic Design Consulting

The power of rapid prototyping extends beyond the realm of design teams to foster productive collaboration among diverse stakeholders in orthopedic device development. By providing tangible prototypes for visualization and interaction, rapid prototyping emboldens surgeons, engineers, and stakeholders to contribute valuable insights. This collaborative approach facilitates informed decisions regarding design adaptations, usability enhancements, and functional requisites. The ultimate goal? Orthopedic instrumentation that seamlessly align with the desires and needs of end-users, culminating in heightened adoption and acceptance within the healthcare community.

Cost-Effectiveness, Risk Mitigation, and Orthopedic Engineering

The conventional pathways of orthopedic product development are often fraught with steep upfront costs, protracted timelines, and inherent risks. Rapid prototyping emerges as a potent antidote to these challenges, seamlessly curtailing development costs and compressing timeframes. Moreover, it serves as a vanguard against design pitfalls, identifying and resolving issues in their embryonic stages. By harnessing the potential of rapid prototyping, orthopedic product development teams adeptly allocate resources, attenuate financial risk, and usher innovative products to market with unprecedented efficacy.

Future Implications of Orthopedic Device Engineering

The impact of rapid prototyping in orthopedic device development is poised to burgeon exponentially in the forthcoming years. As materials, 3D printing technologies, and artificial intelligence continue to evolve, innovation will flourish, enabling the genesis of intricate and sophisticated orthopedic devices. Rapid prototyping shall remain at the heart of translating these breakthroughs into tangible solutions, relentlessly pushing the boundaries of orthopedic care.

In conclusion, the landscape of orthopedic device development stands forever transformed by the advent of rapid prototyping. Through its application, orthopedic professionals have been empowered to create patient-specific solutions, improve device performance, and enhance patient outcomes. With the orthopedic industry embracing rapid prototyping technologies, we can expect an accelerated pace of innovation, a more personalized approach to care, and the development of advanced orthopedic devices that will shape the future of musculoskeletal medicine.

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Author

Matt Suits

Head of Sales | [email protected]
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.

Technology’s New Helping Hand

In today's fast-paced world, it's become almost second nature for us to order products online and have them delivered right to our doorstep. From the newest gadgets to the clothes on your back, the efficiency of the process is truly remarkable. But have you ever stopped to wonder what goes on behind the scenes during this intricate process? How do companies plan, implement, and control where your goods and services are shipped to with such precision and speed? Let’s delve into the fascinating world of supply chain management and discover the secrets behind its efficiency.

At the heart of this remarkable process lies a well-orchestrated network of manufacturers, distributors, logistics providers, and retailers. A talented group of people uniquely specialized in their field to get these finished goods to your doorstep. Together they ensure that your products meet customer needs in a timely, cost-effective manner by optimizing their operations and working with meticulous planning and coordination.

The journey begins here at Kaleidoscope, we embark on the process of product development, collaborating closely with companies like P&G. Take Tide Pods, for example. We design, engineer, and test the product to meet consumer demands. From ideation to final production, extensive research and development are essential to creating innovative and high-quality products. This journey requires a strong partnership and collaborative effort to bring these ideas to life.

Once the products are ready to go, they are transported to distribution centers or warehouses strategically located to facilitate efficient distribution. These distribution centers act as hubs where products are received, sorted, and prepared for further transportation. Advanced technologies, such as automation and robotics, are employed to ensure that each delivery is assigned the most appropriate route, minimizing travel time and maximizing efficiency.

  Once an order is placed, logistics comes into play. Sophisticated systems manage inventory, track shipments, and optimize routes to ensure timely delivery. The products are carefully packaged and labeled, ready to embark on their journey to the customer's doorstep. This process can be transported to you in various modes, including trucks, trains, ships, airplanes, and depending on the urgency of the delivery even drones.

One of the key drivers of efficiency in this process is advanced technology. Logistics is a rapidly growing industry full of artificial intelligence, machine learning, and big data analytics. This technology is constantly analyzing vast amounts of data, so that companies can gain valuable insights into consumer behavior, and demand patterns. Furthermore, with the ability to track our packages in real-time we can track shipments, demand forecasting, route optimization, and manage inventory. This abundance of technology helps improve overall supply chain performance.

Another crucial aspect of efficient product delivery is what’s called “last-mile logistics”. This final step of the journey from the distribution center to the customer's doorstep can often be the most challenging. To overcome this, companies are using innovative strategies to enhance efficiency and customer satisfaction. Delivery through drones, autonomous vehicles, and even crowdsourced delivery services are being tested and implemented to reduce delivery times and overcome the challenges of urban congestion. 

So, the next time you receive a package at your doorstep, take a moment to appreciate the incredible logistics infrastructure and the efforts that go into making it happen. Acknowledging that behind these technological advancements, there is a dedicated workforce of logistics professionals who work tirelessly to ensure the smooth flow of goods. The evolving world of logistics continues to push boundaries and find innovative solutions to meet the increasing demands of e-commerce and consumer expectations. It's an exciting time to witness the transformation of how products reach us with such efficiency and convenience.

What do you think the future of logistics will look like as technology advances? Do you have any experiences or insights to share about the logistics behind product deliveries? We'd love to hear your thoughts in the comments below.

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Authors

Taylor Schmitt

Marketing Co-op | [email protected]
Taylor Schmitt is currently a student at The Ohio State University, where she studies marketing. She loves exploring new opportunities and facing new challenges. While working at Kaleidoscope she has been able to work closely with the sales team to support business growth and brand visibility
Matt Suits

Head of Sales | [email protected]
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.

Improving Vision and Quality of Life with Samsara’s Implantable Miniature Telescope

Tom Ruggia, Samsara’s CEO, talks about the innovative technology that improves the vision of people with untreatable retinal disorders. The discussion also covers the importance of partnerships, tele-medicine, and the human-centric approach.

Hosted by Jeff Kavanaugh, Chief Learner and Sharer of the Infosys Knowledge Institute.

“I like innovators, of course, but I like people who really get into the task at hand and the objective. I love to see masters at their craft. So I was intrigued and got to know Kaleidoscope well… we were working in a laboratory, working on a design of a drug-delivery technology that was making its way to market… What they did with that, it wasn't just, "Let's create a catheter that gets there." It was, "Let's create a catheter that gets there. Let's make sure the surgeon experience is perfect.”

“The telescope will focus on tissue just around the section which has lost vision. So we go around the lesion with the light that we magnify, and then the brain can take that image and use it as a central image thanks to the magnified light.”

“The doctors are very aware that wet AMD can be treated, and that's thanks to the treatment innovations. What doctors are not as aware is the other treatments for late-stage disease.”

“There are currently 4 million patients that are appropriate for our technology who have not had a previous cataract surgery and have concomitant late-stage AMD. So for those 4 million patients, we want to get this SING IMT out there, and we feel we can get it to the masses and train the surgeons appropriately.”

- Tom Ruggia

INSIGHTS

11% of elderly patients will have age-related macular degeneration. So many of them making it to the latter stages of the disease around the world. We see this disease in various populations. Macular degeneration affects the tissue in the center of the back of the eye.
Patients lose central vision that begins, let's say, somewhere in your 50s and can progress through your life to where you're almost centrally blind, can't see faces, can't read, can't drive, which happens rather quickly.
And there are treatments for some parts of the disease. So inside the back of the eye you may create new blood vessels, and neovascularization as common in this disease state. So when the eye creates new blood vessels in that very tight tissue plain, it's a recipe for disaster, so to speak. Generally, those patients lose vision very fast and that's referred to commonly as wet AMD or neovascular AMD, and there's treatments for wet AMD, but you're not treating the underlying condition; you're treating the neovascularization.
So there's injections like Lucentis or Eylea, which are very common today. They can rescue that fast onset of vision loss in wet-AMD patients. The patients still progress along the disease cascade. Some patients that don't experience neovascularization can be referred to as dry-AMD patients. Those patients will progress and then eventually lose that central vision, and the wet-AMD patients over time will also lose their central vision thanks to the underlying disease state. It's a very sad condition. It leads to debilitation and reliant on caregivers.
What doctors are not as aware is the other treatments for late-stage disease, and today, really those treatments are limited to external devices that can be used to magnify light and change the central focus of the light. The retina specialists are not aware of the technology. Some are not favorable to the technology, and the patients get a bit of fatigue, because so many of them that have dry AMD are told that there's no pharmaceutical intervention, there's no surgical interventions that can help them, and they go into a reluctance to come back and see the doctor.
If you lose the ability to drive at 20:80 and lose most of your central vision, 20:160's far worse than that. Most of our patients come in, maybe they can only see the big E on the very top of the chart.
We're approved in Europe, we've been commercializing this device in Europe now for a year, and we're seeing an average of three to four lines improvement. What that means is the patient starts with the ability to just see the big E on the top of the chart, but then can see four lines deeper. So getting very close to that 20:80 or possibly even better than 20:80 after surgery.
So we re-engineered the technology with human factors in mind. Surgeon factors, of course; the delivery now can be done in 28 minutes on average where it was 70 minutes prior; but also with patient-centric design in mind. Now the six-and-a-half millimeter incision in the eye is about half the size of the previous incision, leading to faster recovery and less chance for issues with the cornea.

LISTEN ON

ABOUT TOM RUGGIA

President and CEO – Samsara Vision

Thomas Ruggia joined Samsara Vision as the Chief Executive Officer in July 2020. With nearly 20 years of ophthalmology business experience, he has a comprehensive and nuanced understanding of the healthcare environment in the United States and abroad, as well as significant experience in the development and commercialization of vision products with differing regulatory and pricing structures.

Before joining Samsara Vision, Mr. Ruggia spent five years at Johnson & Johnson, working at Johnson & Johnson Vision and The Janssen Pharma Co, respectively. Most recently at Johnson & Johnson Vision, he was the Vice President WW Customer Experience and Ocular Surface Disease, responsible for two global commercial teams working in customer strategy, customer service, and field technical service. At Janssen, he was the commercial strategy leader in ophthalmology assigned to an asset in development for AMD. Previously, Mr. Ruggia spent fourteen years at Alcon, a division of Novartis, working in a variety of ophthalmology sales and marketing roles with escalating responsibility. He graduated with a Bachelor of Science from The College of New Jersey in 1998.

Connect with Tom Ruggia on LinkedIn

Mentioned in the podcast

About the Infosys Knowledge Institute

Samsara Vision, Implantable Telescope Technology

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Innovation Leadership & How to Build the Ideal Innovation Team

In this article about innovation leadership and the ideal innovation team, Kaleidoscope VP of R&D, Medical, Michael Clem DVM, MS examines the functional and cross-functional expertise needed to drive the best innovation resources to turn creative ideas into quality products that benefit consumers.

People often think of Thomas Edison when they think of innovation. This focus on the single inventor can sometimes give the wrong impression of how successful innovations take place. In reality, Edison surrounded himself with teams of creative individuals. It has been said that innovation is a team sport, requiring teamwork.

But how do you approach staffing your ideal team to drive innovation in your company?

Perhaps the most important aspect of innovation leadership and building the ideal innovation team is to foster cross-functionality. Really focus on getting people who serve specific functions in the team, but who also have a shared vision and shared incentives. This ideal innovation team is not just assigned to a common project, not just sitting together. The ideal innovation team is really working together and pushing boundaries to take on additional roles outside of their areas of specialization.

From a functional expertise perspective, here are the essential functions or team members:

Engineering

Engineers bring technical expertise in product design and development to the team. Over time, I came to broadly characterize two types of engineers as critical to successful development. Both types have their own inherent strengths and are equally valuable.

"Idea" Engineers
These are the creative “inventive engineers” who are always coming up with new ideas. These individuals are extremely important to have on the team, but often hard to keep focused. They like to move on to the next challenge or exciting problem to solve. These out-of-the-box thinkers come up with new solutions to break new ground.

"Closer" Engineers
These are the heavy lifters who are needed to follow through to make the big, creative ideas become a reality. They work out the problems, build the prototypes and run the tests. They are essential to getting to final designs that can be manufactured. This is certainly not to say that these individuals are not creative or that they do not also come up with great ideas. They just tend to excel in dotting the “i’s” and crossing the “t’s” required to advance a radical idea.

These team members capture opportunities as defined by Thomas Edison when he said, “Opportunity is missed by most people, because it shows up dressed in overalls and looks like work.”

Occasionally, someone will find an individual engineer who embodies both characteristics, but in my experience, most people excel in one direction or the other.

CAD Design

Fifteen years ago, it was not the norm for engineers to do their own CAD. However, the digital design world has evolved and this is no longer the case. With that said, having a dedicated CAD designer on the team can free engineers to concentrate on other tasks. Otherwise, engineers would be devoting “screen time” to refining concept design for rapid prototyping. In many instances, a seasoned CAD designer can fulfill the role of the “closer” or heavy-lifting engineer. They will build models, test and refine designs for manufacturing.

Industrial Design

Industrial Design is an extremely valuable skill to have at all stages of concept development. Industrial designers bring the Design Thinking process to life. Beginning with understanding customer needs, translating insights into concept design, and integrating human factors into usability, their work is essential. Good industrial design work isn’t possible when the designers are brought in at the end to “make it look good.” It must be incorporated from the beginning of the process.

Marketing/Business

Early in the process, the team needs to be thinking about the market and whether their ideas would fit in the current market environment. Marketers and business people know what sells and how to make the case for the product. In many companies, they often drive a project and should always be included in discussions and planning from the outset.

“Hard work is still wasted on features that don’t make the marketing headlines,” says GV Design Partner Jake Knapp in an article on product design and marketing. “Instead of the icing on the cake, I like to think of marketing as the sugar in the batter. You’ve got to get it in before the cake gets baked.”

Clinical

In medical device design and development, the team should include an expert with in-depth clinical understanding. This is often the end-user physician. In addition to physicians though, it is crucial that the team also consider inputs from the entire healthcare ecosystem. This includes personnel who may be involved in the purchase, such as the value-analysis committee. (Learn more about the essential role of a value analysis committee.) Also the project needs to consider those involved in the preparation or use of the final product, such as technicians and nursing staff. This clinical knowledge may come from an individual clinician or a physician advisory panel, augmented by formal usability and concept research with users.

Support Functions

In an innovation setting, there will need to be additional support functions. Some of these important roles might be contracted from the outside, depending on the size of the organization. These roles include legal advisors, HR professionals, finance professionals, IT professionals, regulatory affairs, quality and operations management professionals.

Leadership

Ideally, the team leader should come from one of the functional roles on the team, engineering, marketing or design. The team leader serves as the main point of contact with management and other entities that need to be engaged to keep the project moving forward, and they must be able to recruit.

With the team leader also playing a functional role on the team. They are more like a “Player Coach,” providing direction while making meaningful contributions to the advancement of the project. At the same time, every member of a high performance innovation team needs to be a leader in his or her own right.

Transitional Innovation Leadership
In this model, leadership may be transitional. Marketing and Industrial Design may lead the early stages of the project. For example, in the phases of understanding the customer needs, conducting market research and developing insights that shape the work. Later, leadership may transition to Engineering and Design leading during the ideation and concept development phases. At that time, Marketing then focuses on developing the business case for moving forward. With concepts in hand, leadership may transition back to Marketing for final validation research, pricing and launch planning.

Regardless of which function is taking the lead for a project phase, the best innovation comes when other functions are included throughout. This helps everyone to better understand what needs to be done from a big picture perspective. This also helps teams feel more invested in the outcome as well. Cross functional teams mean getting rid of information silos and opening communication.

Hot Teams

These ideal innovation teams can also be thought of as “hot teams.” These embody the idea of a cohesive group, working well together. Here the whole is greater than the sum of the parts.

The ideal innovation team does not need people who can only work in their specific areas of expertise, but who exhibit cross-functionality. People who don’t fear trying new roles. These individuals possess certain characteristics, such as their abilities to work together as a team. They also use their leadership skills to advance the work before them, take directives from management and embrace a fluctuating team structure.

They should also possess the tact and ability to navigate corporate processes to accomplish their team’s goals. But, be highly focused on reaching these relevant milestones in line with the end objective(s).

All things considered, ideal innovation teams need to have the right combination of skill sets, and must be willing to work collaboratively.

For those interested in learning more about how to form the ideal innovation team, I have written an e-book with input from my innovation-minded colleagues at Kaleidoscope that is free and available for download here. In the Ships and Castles Model I describe details on how to navigate front-end innovation efforts while fortifying an existing product line.

Ideal Innovation Team Sources

“Rapid Team Learning: Lessons from Team New Zealand America’s Cup Campaign,”
by Kambiz Maani + Campbell Benton
Ships and Castles Model: 7 Steps for Fortifying Your Base While Navigating Front-End Navigation
GV: How to build an opinionated product: design the marketing first

Clinical, Technical, Commercial and Organizational Considerations

Over the course of my 25 years working on and leading teams engaged in medical device development, I have experienced a variety of approaches to staffing the ideal innovation team.

In Part 1 of this series, I described a “functional approach” based on key technical skills team members should possess. Alternatively, in this section I describe a leaner approach based on critical categories of thinking required for medical device development.

In a lean startup environment, you can’t always access or afford all of the specific skills you might desire. At the same time, you do need to ensure your team is prepared to address the clinical, technical and commercial considerations inherent in developing medical product innovations. Depending on your organization’s size, the team may also need to be prepared to address organizational variables.

Building a team to address the clinical, technical, commercial and organizational considerations of product development requires a different way of looking at the individuals you choose. Rather than focusing on a person’s primary technical skill (i.e. engineering, design, marketing), identify team members who have the breadth of experiences necessary to successfully navigate the requirements in each category of thinking. From my experience, these individuals can come from various technical backgrounds.

Let’s look at the role each category plays in medical product innovation.

Clinical Considerations

In medical device development, a deep understanding of the users and clinical problem is critical to developing successful solutions. For instance, the concept development team must understand the problem, anatomy, physiology, pathology, users, use environment and so on.

Someone on the team needs to develop this multilayered understanding. This allows the team to represent patients, physicians, other healthcare professionals and key stakeholders who will benefit from the solution.

Depending on their training and backgrounds, this in-depth clinical knowledge might be a stretch for some. But with diligent observational research, relationships with consulting subject matter experts and secondary research, this knowledge can (and must) be integrated into the team. A good scientific or clinical advisory group, composed of relevant subject matter experts, can be invaluable.

Although this clinical understanding speaks specifically to medical device development, it has an equally critical corollary in any field of innovative product development. Simply foster a deep understanding of the end users and the job(s) they are trying to accomplish.

Some methods and tools that can help develop this knowledge include:

Ethnography and customer observation
Regulatory assessments
Procedure maps
Clinical stakeholder assessment

Commercial Considerations

Much like fostering an understanding of clinical considerations in your team members, integrating commercial considerations is highly important. Even if your innovation team is staffed exclusively with engineers or individuals with technical backgrounds, someone on the team needs to be ready and able to put on a business thinking hat. Ideally, this individual would come from a business or marketing background or have additional experience in these fields.

Examples of commercial considerations the team should address include:

Customer value proposition
Claims exploration
Competitive assessment
Business plan development

Innovation teams that fail to incorporate these commercial considerations in developing their solutions run the risk of creating wonderful technical solutions that the market will not embrace for any number of reasons.

Tools to help make sure the innovation team addresses these considerations include:
Concept selection criteria
Concept exploratory research
Customer segmentation and persona development
Financial modeling

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Author

Dr. Mike Clem, DVM, MS

Vice President of R&D
Vice President of Research and Development, Medical, Mike Clem, DVM, MS, thrives at the juncture of medical technology and clinical understanding. From his training as a veterinary surgeon through more than 20 years with Johnson & Johnson, Ethicon Endo-Surgery, Ethicon and Cordis, he has developed innovative solutions to complex customer problems. He covers medical device design for Kaleidoscope.