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 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.
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?
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.
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.
Mastering Combination Product Development: From Immersion to Validation
THE IMMERSIVE BEGINNING
Our journey kicks off with immersion, a creative problem-solving phase. Here, we ensure that solutions are at the ready for any potential roadblocks. We dive into the waters to test the concept's feasibility and identify potential challenges. We also map out short and long-term objectives, charting the course for product development.
MASTERING THE ART OF DESIGN
With a clear vision in mind, we start breathing life into it through meticulous planning and execution. Crafting a combination product resembles assembling an intrurate puzzle, where every detail carries significance. This stage revolves around rigorous testing and evaluation to pinpoint the best and most efficient design solutions.
CONSTRUCTING THE FUTURE
This phase is undeniably exhilarating. Building the product is where the concept takes tangible form. Transitioning from design to reality, prototyping takes center stage. It grants us the opportunity to scrutinize every element, ensuring the product's integrity and functionality.
THE PINNACLE TEST
Validation stands out as perhaps the most pivotal step in the entire process. During this phase, the product undergoes comprehensive reviews and testing to unveil any last-minute imperfections or errors. This thorough examination ensures the product is primed for its grand debut in the market. Validation acts as the ultimate litmus test, determining the readiness of the combination product for integration into various healthcare services.
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 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.
Unleashing the Power of a One-Stop Shop Product Development Partner
In the competitive business world today, time and dedicated company resources are more important than ever before. Companies face several challenges bringing innovative products to the market efficiently. Developing a new product requires expertise in various disciplines, from design and engineering to manufacturing and regulatory compliance. Managing your time and amplifying your limited resources will allow you to navigate these complexities successfully.
Developing a business relationship with a one-stop shop to amplify your time and resources can be a game changer to the success of your projects. Ultimately impacting and improving the lives of the user. Let us take a closer look at the value of partnering with a one-stop shop like Kaleidoscope.
1. CONVENIENCE AND STREAMLINED COMMUNICATION
One benefit of a one-stop shop is convenience. Customers can find everything they need in a single location, saving them time, effort, and potential stress. This eliminates the need to juggle multiple vendors and stakeholders, so they can have access to various products, services, or information in a quick and efficient manner. By having all the necessary expertise and resources under one roof, businesses can enjoy streamlined communication and collaboration. Which will increase your customers' satisfaction and trust, drawing in new customers at the same time.
2. TIME AND EFFICIENCY AND EXPERIENCE
Working aside a turnkey product development partner can optimize time efficiency and experience. It eliminates potential bottlenecks, handover delays, and coordination challenges that can occur when working with multiple vendors. Additionally, the partner's expertise and experience allow for efficient project management, ensuring timelines are met, and deadlines are achieved. By accelerating the product development timeline, businesses can gain a competitive edge, capture market opportunities, and generate revenue. By offering a wide range of services, a one-stop shop saves customers valuable time that they can allocate to other activities or responsibilities.
3. RESOURCE AND COST OPTIMIZATION
Collaborating with a one-stop shop product development partner offers reduced costs and resource optimization benefits. You can now work at full efficiency, maximizing processes, leveraging time-saving strategies, and achieving more goals for your business. Instead of managing multiple contracts, vendors, and overhead costs, businesses can leverage the partner's comprehensive services and infrastructure. This consolidation results in cost savings, as businesses eliminate redundant expenses and optimize resource allocation. Additionally, the partner's economies of scale, supplier relationships, and manufacturing capabilities can drive further cost efficiencies throughout the product development journey.
4. COMPETITIVE EDGE
Partnering with a reputable one-stop shop automatically can provide a significant advantage. It enables individuals or businesses to improve decision making. With a more precise and thorough approach in the choices you make, you will have more time for thorough testing and validation, reducing the likelihood of costly errors or product recalls. By ensuring the best of product quality and compliance, customers can build trust with businesses, leading to better brand reputation. Being able to respond quickly to market changes, customer demands, or emerging opportunities, creates an efficient environment where you can deliver products or services faster than competitors, giving you a competitive edge in the market.
5. END-TO-END EXPERTISE AND EXPERIENCE
A one-stop shop product development partner brings together a diverse team of experts with extensive experience across all stages of the product development lifecycle. From initial concept design and prototyping to engineering, manufacturing, and regulatory compliance, the partner possesses the necessary expertise to guide businesses through each phase. This comprehensive knowledge base ensures that no aspect of the product development process is overlooked, resulting in a robust and successful end-to-end product.
A one-stop shop product development partner offers substantial value to businesses embarking on the journey of bringing innovative products to market. Here at Kaleidoscope, we have the benefit of engaging with our business partners at our multi-disciplined campus. Our electronics fabrication and advanced prototyping part of our campus is where products come to life. We can perform rapid prototyping and the integration of new equipment to see product development success. We work closely with our customers from ideation to creating end-to-end solutions. We strongly believe in working to your fullest potential and allotting the required time and resources to get things done right the first time.
From streamlining communication and collaboration to providing end-to-end expertise. We accelerate time to market, optimize costs, reduce risks, and enhance product quality. The benefits are far-reaching, leading businesses to navigate the complexities of product development more efficiently and effectively, driving success and achieving their growth objectives. So, the next time your project requirements, resources or timeline have you feeling stressed or overwhelmed connect with Kaleidoscope Innovation.
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
“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.
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