Infosys Medical Devices and Engineering Services x Kaleidoscope Innovation
The Healthcare and Medical devices industry is undergoing a revolutionary transformation in the way solutions and devices are being formulated and developed. Medical devices are becoming more connected than ever and remote patient monitoring with data analytics is becoming a norm.
It is imperative for the medical device companies to adopt a strategic approach to stay ahead of the innovation curve by leveraging technology advancements in multiple areas such as mobility, wireless, cloud, and analytics to drive innovation that addresses market needs and challenges of longer device development cycles, optimization of development processes, and high production costs.
At Infosys, we help our clients in designing customized devices, end-to-end product development, maintenance, manufacturing support, regulatory documentation, and product compliance and certifications. We also help optimize R&D cost and improve supply chain efficiencies by leveraging new technologies and partner ecosystems. This is to bring innovative medical devices and Software as a Medical Device applications into the market with the objective of improving patient care while reducing the cost of care.
Our ISO 13485 certified processes and Quality Management System ensures high-quality product development which enables our client to meet their regulatory needs and objectives. With our recent acquisition of product design and development firm, Kaleidoscope Innovation, we plan to redefine patient treatment and consumer health across the globe.
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
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.
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.
Breaking the Mold: Alternative Materials for Sustainable Product Development
Over the past year, Kaleidoscope has begun to identify areas of opportunity for sustainability improvements within our culture and the products we design. One area we have been exploring is the potential of alternative materials within our product development process. Through a vendor partnership with 3D Color and RyPax, the team has been able to perform a preliminary evaluation of a molded fiber tray through small batch prototyping.
What is Molded Fiber?
Molded fiber or molded pulp is a material used for making molded forms from a variety of natural fibrous materials and/or recycled paper pulp. It is commonly used for a variety of packaging applications, from clamshell containers to consumer electronics packaging. The Kaleidoscope team was eager to evaluate potential packaging and product designs utilizing this technology. To do so, we teamed up with 3D Color to produce a small batch of 100 trays, which were originally designed for thermoformed plastic sheet.
Process and Environmental Impact Considerations
The mixed material used to make these trays contained bamboo fibers and bagasse, a by-product of sugarcane processing. There are a variety of other types of natural materials that can make up the base mixture, resulting in different physical properties.
The team also learned that there are two different methods that can be used in the molding process: dry press and wet press. The trays that were evaluated were generated via the dry-press method, where the material is formed in a tool, dried, and cured. These trays have a 1.2mm wall thickness and ~5° draft angle. The maximum wall thickness that can be achieved with this method is ~2.0mm. The minimum draft angle that can be achieved is ~5°.
The wet-press, or “heated-press” method, differs in that the mold is formed using a heated tool. With this method, the maximum wall thickness is ~1.2mm and minimum draft angle of 1° draft can be achieved. Wet press can produce a higher fidelity finish, though the heated tool requires more energy than the dry press method.
Preliminary Performance Evaluation
Upon receiving the batch of dry-press trays, some qualitative observations were able to be made:
Features and edges were surprisingly sharp and visually on par with what’s expected from plastic thermoforming.
Structural strength was similar to an egg carton, even with a significantly thinner wall thickness.
A uniform off-white color was achieved. Fibers that make up the tray were visible upon close inspection.
The material released particulate when stressed, with the particulate being very small pieces of the fiber.
The underside of the trays had a slightly rougher surface due to the screen used in the molding process for moisture evacuation.
To understand the trays’ performance over time, we also performed simulated accelerated aging. We stored the trays at 60degC for 30 days, which is approximately equal to one year of aging, per the Arrhenius equation. The team noted several observations after removing the trays from the aging chamber:
Slight warping was present in some samples.
Accompanying creases seemed to occur in areas that were not stiffened by curved/bent geometry.
This exercise just scratched the surface of testing needed to ensure a product made using this technology meets its requirements. However, it allowed for several basic discoveries that will inform how we might use this manufacturing process in the future. Moving forward the team has determined that the following should be considered, depending on the application and the requirements:
What different natural fiber material sources yield significantly different properties? (e.g., Do corn husks have the same properties as bagasse?)
What is the right thickness for the application?
Simulated Environmental/Distribution Testing
Whether the recycled paper pulp and/or natural fiber-based material is the product or the packaging, does it survive expected conditions? Shipping, temperature and humidity fluctuations, and shelf life are all variables that need to be considered.
For sealed packaging, how well does the material keep water out? How well does it “breathe”?
Coatings, including thin sheet PLA.
How well does coating remain applied to tray?
What properties does the coating give to the tray? Water resistance, decreased particulate shedding?
Can the material receive printing/stamping?
Can dyes be added to the material?
Do stickers or adhesive remain adhered?
What is the order quantity and required fidelity?
In general, it was learned from the experience of our partners that the cost of molded fiber parts is approximately 2-3 times that of a plastic vacuum formed part in a production run. What does this mean for trays that are more complex?
Are the perceived benefits of using the molded fiber material overcome by the accumulation of energy, coatings, markings, etc. that may be used in making this product?
These tray prototypes were high fidelity and can prevent the need for expensive and time-consuming production-quality tooling early in the development process. Fibrous particulate is present on and in this material. If your product is sensitive to foreign material, a coated molded fiber tray is likely a better choice than an uncoated tray. Heat/aging seems to influence the integrity of the part, though this is only a preliminary finding. Due to relatively low structural strength compared to plastic, we recommend designing for strength, and reducing stress concentrations where possible. We are still evaluating this technology, and fortunately, partners like 3D Color make the iterative design and test cycle faster and less costly.
Leveraging diverse design and manufacturing experience, evaluating new technologies and materials, and cultivating strong vendor relationships is nothing new for Kaleidoscope. Though these are among our strongest skillsets, we recognize that there is significant potential to better drive sustainability within the products we design and provide meaningful material and technology alternatives for the clients we serve.
About the Authors/Companies:
Headquartered in Cincinnati, Ohio, Kaleidoscope Innovationprovides medical, consumer, and industrial clients with full-service insights, design, human factors, and product development. For more than 30 years we have been helping our clients grow their capabilities, gain usable knowledge, and get worthwhile results. As a full-spectrum product design and development firm, we are an expert extension of your product vision. Our teams collaborate across disciplines, providing specialized input to produce the ideal intersection between function and form. To ensure the soundness of our work, Kaleidoscope houses a full range of test labs, and we employ an award-winning team that embraces every challenge, applying their experience, ingenuity, and passion.
We help our clients shape first impressions into lasting ones. At 3D Color, we help the world’s best designers, marketers, brand builders and researchers bring their ideas to life. With industry-leading capabilities in advanced prototyping, exceptional comp production, custom color development, efficient sales sample programs and an innovation incubator, we’re a full-service strategic partner to the visionaries who are shaping the future of packaged goods.
Sr Design Engineer
Grant 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 instrumentation. 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)!
As a part of the Kaleidoscope team, Sophie has had the opportunity to collaborate with diverse and talented individuals to understand complex problems and provide meaningful human-centered solutions. Sophie is driven by the chance to create a positive emotional connection with users through the experiences she crafts. Prior to joining Kaleidoscope, she has worked for companies like Depuy Synthes of Johnson and Johnson, The Clorox Company, and a physical therapy startup, BAND Connect. When she is not captivated by a design problem, Sophie enjoys getting her creative energy out through activities like pottery and cooking.
Director of Model Services
Mike leads the model shop team at 3D Color and utilizes a wide range of techniques to meet clients’ challenges. With 28 years of experience and a passion for model making, Mike leads by example and teaches his craft to his team and to the company’s clients. Mike enjoys the “hands-on” nature of our work and the problem-solving thinking needed to complete projects. In his free time, Mike enjoys his family, travel, and the wicked game of golf.
Kaleidoscope Innovation Integrates Regulatory Mark to Offer Global Regulatory Service
CINCINNATI, Aug. 17, 2022 /PRNewswire/ -- Kaleidoscope Innovation announced today that the regulatory, quality and clinical affairs consulting group, Regulatory Mark, is now part of the team at Kaleidoscope Innovation, an Infosys company specializing in the full spectrum of product design and development.
Led by regulatory industry veterans Alison Sathe and Colleen Murphy, the Regulatory Mark team will work closely with Elliott Fegelman, MD, Kaleidoscope's Chief Medical Officer and VP of Medical Affairs, to expand and streamline the design consultancy's regulatory strategy, licensing and support services. This includes leading FDA and EU MDR regulatory submissions for global regulatory licensing and ongoing compliance.
According to Fegelman, this formal partnership was a natural progression in an already strong working relationship between Kaleidoscope and Regulatory Mark. Since 2016, Kaleidoscope Innovation and Regulatory Mark have completed approximately 40 joint regulatory submission projects for medical device clients—all of which received regulatory clearance.
As the regulatory affairs market grows exponentially, Kaleidoscope projects they will triple the volume of packages they will submit for US and global EU clearance during the next two years.
"This merger allows us to offer a true total product lifecycle (TPLC) approach and integrate seamlessly with Kaleidoscope's existing best-in-class processes," Sathe and Murphy explained. "From regulatory strategy and planning at the concept stage through design and development and into post-market we can share insights to ensure efficient regulatory submissions and ongoing compliance."
"The joining of these leadership teams and capabilities will allow us to offer our medical device clients—and ultimately the patients they serve—even more comprehensive and efficient services," Fegelman explained. "We're augmenting what's already there—now with in-house, end-to-end capabilities."
Kaleidoscope Innovation, an Infosys company, is a full-service product development firm innovating across medical, consumer and industrial markets. For over 30 years clients have partnered with Kaleidoscope to improve the human experience. Offering both consultancy-style and onsite services, they provide a full breadth of disciplines to meet their partners where needed, including: Insights & Human Factors, Medical Affairs, Industrial Design & User Experience, Engineering, Visualization and Software Development.
Design influences a product’s lifecycle performance and cost, starting from its development. Product development costs rise significantly if a defect is identified at a later stage. Using virtual tools for new product introduction simulates possible scenarios upfront for comprehensive testing. It gets products to the market quickly and saves money for a successful launch.
Design influences a product’s lifecycle performance and cost, starting from its development.
Conceptualization and design stages determine more than 70% of a product’s lifecycle decisions
Virtual tools are an effective way to design new products that serve specific customer needs.
Virtual models of new products accelerate their evaluations to shrink the development cycle time.
Organizations should create virtual replicas of workplaces for human-machine interactions studies from multiple perspectives.
Lifecycle cost is the total cost (direct and indirect) a product incurs in its life span. Conceptualization and design stages determine more than 70% of a product’s lifecycle decisions and cost.1 The earlier an issue is identified, specifically in the design stage, the easier it is to fix and avoid costly rework. Virtual replicas (or digital twins) of products, processes, and environments streamline design and new product development to reduce costs and time to market.
A common assertion is between 80% and 90% of new products fail. However, realistic failure rates vary by industry, from 36% in healthcare to 45% in consumer goods.2 Professor Clayton Christensen, best known for his theory of disruptive innovation, believes the success mantra is to design products that serve its intended customers. Manufacturers should focus on the function that a customer who buys a product would want it to do.3
To enable that, virtual representations of the product under development, in orchestration with humans and other entities in the ecosystem, is an effective approach. The approach encourages innovation. Designers visualize the product’s operating condition, create digital prototypes for trial runs, and carry out tests on a global scale. Virtual tools like 3D computer models and digital twins support informed decisions in early product design stages. This mitigates the risk of a wrong product release or a poor customer experience.
Virtual products are an effective way to design new products that serve specific customer needs.
When end users receive virtual training of a complicated product’s operation (like an aircraft engine), memory retention happens in the background. Any number of such instances can be created at a negligible marginal cost for repetitive usage. A central digital setup saves the cost of setting up multiple physical arrangements at different locations.
Parameters of Successful New Products
Product failures are more from a commercial perspective than technical. More than 25% of revenue and profits across industries come from new products, according to a study by McKinsey. Successful products relate to a set of core capabilities, with the top-most as follows:4
Collaboration to execute tasks as a team.
Investment to mine market insights and their inclusion in the product.
Plans for new product launches, comprising target customer segments, key messages to communicate, and objectives to achieve.
Talent development for new product launches with defined career paths and incentives.
At the same time, the primary reasons for product failures and mitigants are the following:5
Gap in meeting product expectations; delay launch until product completion.
Inability to support rapid growth if a product is successful; set ramp-up plans to avoid this.
Low demand for a new product; perform due diligence for customer requirement before planning a product. Launch products in suitable markets.
Difficulty in new product usage; provide proper customer orientation and training.
Virtual tools for product design address the above reasons for failure and increase the chances of successful product launches.
Design Thinking with Virtual Tools
Design thinking is a popular, technology-agnostic approach for new systems design and problem solving. It balances the technical feasibility of products, financial viability, and desirability from a customer’s perspective (see Figure 1). It is even more impactful when implemented along with virtual product design tools.
Figure 1. Design thinking at the sweet spot of desirability, viability, and feasibility
The design thinking cycle starts from empathy to understand a customer’s needs from their perspective, followed by defining, ideating, prototyping, and validating, in iterative loops. New product development and customer participation encourage collaboration in a virtual environment to practice design thinking. Immersive environments using mixed reality (combinations of augmented reality or AR and virtual reality or VR) create a working environment close to the real world, to identify and correct issues much ahead (see Figure 2).
Figure 2. Virtual tools used across design thinking stages
Virtual models of new products accelerate their evaluations to shrink the development cycle time.
Design firm IDEO, for example, wanted to perform ethnographic research to capture customer requirements for new products. However, it was difficult to identify key observations from many data points and recreate them later, even with expensive videos or photos. It addressed the challenge through a VR camera.6
Kaleidoscope Innovation, a design and development unit within Infosys, designed a large freezer project using virtual tools. Such projects usually undergo several time-consuming team reviews. The team created a 3D model in a VR environment that helped designers walk around the product early in the design phase, evaluate its usability from multiple perspectives, and tackle proposed changes to design.
This virtual model did not change the overall project plan, but accelerated evaluation and decisions around it, shrinking the product development cycle time. The team selected the best design without spending time and money on physical prototypes.
Automation in WareHouses
Humans work with machines in warehouses. Material handlers carry out order fulfillment along with pick-and-place robots. Workers’ safety in all situations is important.
A leading e-commerce player wanted to validate design decisions for robots working in its order fulfillment warehouses to gain insights into their safe working alongside humans. Kaleidoscope Innovation created a virtual environment where employees interacted with robots in different situations. The team created a digital twin to simulate several configurations of robots and their working environment. The company recorded the results and interviewed employees about pros and cons of each situation.
The VR-based solution provided a cost-effective and safe way for the e-commerce firm to test new concepts in human-robot interaction and capture data and feedback before implementation. It helped the managers zoom out and look at the big picture, in contrast to one robot or equipment at a time.
Training for Product Usage
Operators need training to work on machines with complex functionality and procedures, to stay safe and productive. VR-based training prepares humans before hands-on operation on a machine. For instance, Rolls-Royce has rolled out a VR-based training kit for its airline customers to manage aircraft engine maintenance and repair.
Infosys’s VR-based program provides step-by-step instructions to train employees in a hospital environment. The program uses physical gestures to simulate actual tasks involved in a job. Gamification with scores and points keeps employees engaged and motivated. Scores reflect an individual’s strengths and weaknesses. Training data is integrated with the central learning management system for records.
A multinational industrial and consumer goods manufacturer wanted to create an e-training platform for its new operators. It had a few integrated assembly lines for its finished items. The Kaleidoscope Innovation team created a virtual training module along the assembly line, one workstation at a time. The team used front-end user interface elements to guide users for equipment operations. It tracked performance metrics in the backend to provide feedback for correction. Best practices of creating a virtual replica of one workstation are used at later stations.
While collaborative, remote and hybrid working has surged since the pandemic, the future is in three-dimensional virtual and mixed reality workspaces. Organizations benefit from a virtual 3D replica of its workspaces, equipment, products, avatars, or personas. Employee collaborations lead to faster new product development with effective interactions. Teams share ideas, explore, and invent new concepts. Early collaboration of team members in multiple locations enables them to make more informed decisions in the product development process.
Organizations should create virtual replicas of workplaces for human-machine interactions studies from multiple perspectives.
The future of work in healthcare, retail, engineering, and manufacturing is where humans and human-like machines work together. Organizations should proactively create such workspaces virtually and study human-machine interaction from safety, productivity, and employee morale perspectives before any physical implementation.
A Case for Onsite Services: The Flexibility and Affordability of Direct Product Development
Kaleidoscope Innovation realized early in its business journey that the individuals, organizations and companies they worked with could benefit from insights, design and development services through one of two different channels: consultancy and onsite services. This case study examines the onsite services side of the business and the benefits it brings to the firm’s partners.
Though Kaleidoscope Innovation started as a product development consultancy, it became evident that the company could complement their robust consultancy-style offerings with assistance for business partners seeking onsite services. When talking with business partners, Kaleidoscope discovered a common thread: many wanted or needed additional personnel to work in teams on projects but were constrained by headcount limitations or budget. These partners needed a flexible solution that would allow them to expand or augment the size and specialized skills of their teams when needed. To fill this need, Kaleidoscope expanded its product development business to offer onsite services.
Similar to the consultancy side of the business, Kaleidoscope’s onsite placement division provides companies with services across the product development spectrum. The onsite services placement team connects companies with the expertise they need—skilled designers, engineers, digital modelers, animators, project managers, technical writers, design researchers and more. Because the consultancy side of the business also comprises professionals working in these specialized fields, Kaleidoscope Innovation knows what to look for when connecting business partners with talent for their teams.
How It Works
As an example, a leading medical manufacturer identifies what resources they are seeking, such as an industrial designer for their projects. The business partner needs this industrial designer to work onsite as part of its team, but the company is not in a position to create a full-time, long-term position. This could be for any number of reasons, from headcount constraints, to budget, to a desire for low-risk entry. Given any one of these issues, Kaleidoscope Innovation can offer a creative, low-risk, high-return solution. Kaleidoscope’s onsite placement services team handles the process of finding and acquiring an experienced industrial designer. Kaleidoscope Innovation hires that person as a Kaleidoscope employee who works onsite at the partner’s business for the desired length of time. The partner can keep the employee onsite or cease using the person’s services as needed. Kaleidoscope takes responsibility for the HR implications. The business partner simply pays a monthly fee to Kaleidoscope for the industrial designer’s services. “When it comes to building relationships, we care about our employees and our partners,” says Joe Campbell, Recruiting Account Manager. “This is more than a placement opportunity. This is one person’s career and another person’s project.” When an onsite project is completed, the employee may be assigned to another onsite project or work at the consultancy. Dave Banks, who leads Kaleidoscope’s marketing team, is one example of a Kaleidoscope employee who started work in the onsite placement division and transitioned back into the consultancy. “Kaleidoscope is always looking for top talent,” says Banks. “We hire high-caliber, quality people whether it’s onsite or in-house, and this allows an easy transition for someone to move between the two. Often, our business partners become so happy with the people that Kaleidoscope places, they hire them full-time.”
Value For Businesses
Committed to improving the human experience through meaningful innovation, Onsite Services from Kaleidoscope Innovation flex to solve problems, filling the gaps with qualified people.