Decentralized Clinical Trials (DCTs) have created a whole new chapter for clinical research trials. Rather than requiring in-person visits to specific doctor offices or research locations, DCTs take a digital approach to collecting clinical data. This transforms the way research data is collected, stored, and analyzed and allows more access for participants. By including the use of new tools, from wearable devices to virtual visits and online apps, DCTs will help make clinical research more patient-centric. These changes should also have a positive impact on the overall cost of studies. Considering these upcoming options for how research can be conducted, understanding decentralized trials is imperative for the medical community and anyone impacted by research.
Our dedicated Clinical Science and Regulatory teams at Kaleidoscope are poised to support Decentralized Clinical Trials. From offering regulatory guidance and implementing robust quality management systems to overseeing data monitoring and reporting, we are equipped to address various aspects of your DCTs. Our skilled Clinical Science team specializes in device management and excels in providing remote data services from any location. Entrust us with your DCT needs, and let our teams deliver the highest quality service tailored to your requirements.
Precision in Practice: Navigating Usability Studies
Conducting a successful usability study, particularly for summative validation of medical products, can require a great deal of preparation and coordination of many moving parts. Whether it’s successfully simulating your target use environment or nailing down the exact scenarios and tasks to be presented, everything must come together. After all, nobody wants to waste the time and money it requires to complete a study if the result doesn’t align with what was intended.
One of the best ways to ensure success is to perform a pilot study with your protocol before starting the actual study. A pilot study is like a miniature version of the actual study conducted with far fewer participants. This approach helps confirm the study design will work as expected, the desired data can be obtained, the participants understand the task prompts, and more. For best results, the pilot study participants should be as close to actual participants as feasible; the same applies to the use environment. You’ll also want to conduct the pilot study early enough before the actual study to ensure there is sufficient time to update the protocol according to the findings.
Many people use the terms “dry run” and “pilot study” interchangeably, but there is technically a difference. A dry run is done to practice the protocol both before the pilot study and after the finalization of the protocol, ensuring the moderator and notetaker/analyst are comfortable with the product and script. This activity can be done with proxy participants or with no participants at all. What’s notable about a dry run is that it can be done in place of a pilot study if the participant population is expensive or difficult to recruit, if the protocol is very simple or essentially a repeat of a previous study, or if the timing does not permit a full pilot study.
While there can never be guarantees, these are proven ways to exponentially increase the odds of a study’s success. Taking the time upfront will ultimately save time and effort when it’s time to conduct the actual study. At Kaleidoscope, we've conducted hundreds of studies, so our process is as rigorous and dialed in as possible. If you're looking for a rock-solid research partner, we're ready to roll up our sleeves.
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.
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.
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.
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.
Orthopedics Unleashed: The AI-Implant Revolution
The orthopedic segment is currently undergoing a remarkable transformation that is fueled by the convergence of smart implants and artificial intelligence (AI), ushering in a new era of innovation. This powerful combination is revolutionizing the field, enhancing diagnosis, improving surgical precision, optimizing post-operative care, and delivering better outcomes for patients. In this article, we delve into the top 10 ways in which smart implants and AI are driving this transformation, paving the way for a new standard of personalized and data-driven patient care.
REAL-TIME MONITORING AND FEEDBACK: Smart implants embedded with sensors and wireless connectivity enable real-time monitoring of vital parameters such as joint movement, implant performance, and tissue response. This data provides valuable insights to healthcare professionals, facilitating early detection of complications and enabling timely interventions.
PREDICTIVE ANALYTICS FOR PROACTIVE INTERVENTION: By harnessing the power of AI and machine learning algorithms, smart implants can analyze large volumes of patient data to predict and prevent adverse events. These predictive models help identify patients at high risk of implant failure or post-operative complications, allowing for proactive interventions and personalized care plans.
PRECISION SURGERY AND NAVIGATION: AI-powered surgical planning and navigation systems provide surgeons with detailed anatomical information, assisting in precise implant placement and alignment. This technology improves surgical outcomes, reduces complications, and enhances patient satisfaction.
INTELLIGENT REHABILITATION AND PHYSICAL THERAPY: Smart implants, in conjunction with AI-driven rehabilitation programs, enable personalized and adaptive physical therapy. By monitoring patient progress and adjusting therapy regimens in real-time, these systems optimize recovery and rehabilitation, leading to faster and more successful outcomes.
ENHANCED PATIENT ENGAGEMENT AND EDUCATION: Smart implants equipped with patient-centric interfaces and mobile applications empower patients to actively participate in their own care. These technologies provide educational resources, track progress, offer reminders, and enable direct communication with healthcare providers, fostering a collaborative and engaged patient experience.
REMOTE MONITORING AND TELEHEALTH: AI-powered remote monitoring solutions enable healthcare providers to remotely assess patient progress, detect potential complications, and provide virtual consultations. This approach improves access to care, reduces healthcare costs, and enhances patient convenience, particularly for those in remote or underserved areas.
DATA-DRIVEN TREATMENT DECISION MAKING: AI algorithms can analyze vast amounts of patient data, clinical trials, and research studies to provide evidence-based treatment recommendations. This data-driven approach enhances treatment decision-making, optimizing outcomes and reducing variability in care.
PERSONALIZED IMPLANT DESIGN AND MANUFACTURING: AI algorithms can analyze patient-specific data, such as anatomical scans and biomechanical parameters, to design and manufacture personalized orthopedic implants. This customization improves implant fit, functionality, and patient satisfaction.
PREDICTIVE MAINTENANCE AND LONGEVITY ASSESSMENT: Smart implants equipped with AI algorithms can continuously monitor implant performance and assess the risk of wear, fatigue, or failure. This predictive maintenance approach allows for proactive interventions, reducing the likelihood of unplanned revisions and improving implant longevity.
BIG DATA ANALYTICS FOR RESEARCH AND INNOVATION: The integration of smart implants and AI generates vast amounts of patient data, contributing to large-scale data repositories for research and innovation. AI algorithms can analyze this data to identify trends, patterns, and insights, leading to breakthroughs in orthopedic treatments, implant designs, and surgical techniques.
The integration of smart implants and AI is reshaping the orthopedic segment, unlocking new possibilities for personalized, data-driven, and patient-centric care. From real-time monitoring to precision surgery, predictive analytics to remote monitoring, these innovations are transforming the way orthopedic conditions are diagnosed, treated, and managed. As we continue to explore the potential of smart implants and AI in orthopedics, it is evident that this convergence will play a pivotal role in improving patient outcomes, reducing healthcare costs, and advancing the field of orthopedic medicine into a new era of innovation and excellence.
Moreover, the article also acknowledges the importance of orthopedic product development, design, and consulting in driving these advancements. Medical device engineering consultants are key players in translating concepts to commercialization, ensuring the successful development of products such as Total Hip Arthroplasty Systems, Total Knee Arthroplasty Systems, Trauma Plates and Screw Systems, Surgical Navigation Systems, Cervical Plates and Screws, Facet Screw Systems, and Interbody Fusion Devices. This collaborative effort between orthopedic design experts and engineering consultants contributes to the overall quality improvement projects within the orthopedic field. Additionally, the incorporation of concepts like augmented reality, fixation, and retractor systems further underscores the comprehensive scope of innovation within orthopedics.
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.
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.
The Trio Shaping the Future of Orthopedic Product Development
In the orthopedic industry, ensuring patient safety, minimizing infection risks, and optimizing cost-effectiveness are paramount considerations. To achieve these goals, three key elements play a crucial role: sterilization, reusable instrumentation, and packaging. In this article, we explore the best practices of this triad from an expert's perspective, emphasizing the impact on patient outcomes, operational efficiency, and environmental sustainability within orthopedic product development.
Sterilization: A Critical Imperative in Orthopedic Product Development
Sterilization is a fundamental aspect of medical device product development, manufacturing, and usage. By eliminating microorganisms and reducing the risk of surgical site infections (SSIs), proper design and sterilization protocols safeguard patient safety. The chosen sterilization method, such as steam, ethylene oxide, or gamma irradiation, will impact both material choice and part geometry.
Many plastics are not temperature stable with steam and may degrade with gamma irradiation. Tight interfaces and blind holes challenge EO gas / steam penetration to all host sites. And depending on how packaging is configured on a sterilization pallet, large devices may shield others from receiving a full dose of gamma ray. The rigorous validation of both cleaning and sterilization processes adhering to regulatory standards are essential to maintain the orthopedic instrumentation and implants.
Packaging: Safeguarding Integrity and Sustainability
Whether it’s a single use peel pouch or reusable surgical case, orthopedic devices require specialized packaging to ensure product integrity, sterility maintenance, and efficient handling.
Peel Pouch/Tray: Engineering seal width both for sterile integrity and ease of use. Heavier devices are more likely to put stress on sterile seal unless properly constrained. Right-size pouches within cartons to minimize creases, opt for a gentle roll instead. Execute verification tests after accelerated, real-time aging, and ASTM D4169 transit simulation. Testing doesn’t end at submission, incorporate in-process testing per ASTM F88 for ongoing vigilance.
Reusable Surgical Case: Layout instrumentation/implants as it makes sense for the procedure work-flow with spacing that allows steam ingress. Orientation angle should facilitate shedding of moisture, avoid any upward facing cavities as to prevent condensation pooling. A large amount plastic instruments in the tray puts you at risk of failing dry time testing. Keep total tray weight within bounds of regional requirements.
In addition, incorporating usability testing on packaging designs will help facilitate proper aseptic presentation and a smooth transition from sterile to non-sterile environments are essential for healthcare professionals. Optimal packaging design also considers sustainability aspects, such as the use of eco-friendly materials and minimizing excess packaging waste.
Regulatory Compliance, Quality Assurance, and Continuous Improvement
Sterilization, reusable instrumentation, and packaging are tightly regulated areas within the orthopedic industry. Regulatory bodies, such as the FDA and international standards organizations, provide guidelines and requirements to ensure the safety and efficacy of devices. Compliance with these regulations is essential to gain market approval and maintain patient trust. Manufacturers must establish robust quality management systems, conduct thorough validation studies, and implement effective quality control measures such as inspection and quarterly audits to ensure the reliability and consistency of sterilization, reusable instrumentation, and packaging processes. See ISO 11737, 11137, and AMI ST79.
Thanks to orthopedic research, device designs are continually advancing highlighting new materials and features. This progress extends to quality improvement projects, sterilization methods, and packaging innovations. Collaboration between industry expert consultants and regulatory authorities is vital for driving innovation and ensuring that decision making considers whether changes can be adopted into previous studies or if new testing is required.
Sterilization, reusable instrumentation, and packaging form a critical triad in the medical device industry, encompassing patient safety, operational efficiency, and environmental sustainability. Through meticulous sterilization protocols, the use of reusable instruments, and the development of optimized packaging solutions, orthopedic professionals can enhance patient outcomes, reduce costs, and minimize their ecological footprint. By prioritizing regulatory compliance, fostering continuous improvement, and embracing innovative technologies, the orthopedic community can maintain the highest standards of quality and safety. It is only through a comprehensive understanding and integration of sterilization, reusable instrumentation, and packaging practices that orthopedic product development teams can continue to evolve and flourish while delivering exceptional care to patients.
Eric Kennedy is an engineer at Kaleidoscope Innovation based in Cincinnati, Ohio, and has over 15 years of global medical device experience leading large- and medium-scale concept-to-launch orthopedic, micro-surgical, cardiovascular and ophthalmic devices.
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.
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.
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.
The Future of AI-powered Healthcare
What is artificial intelligence (AI)? Is it the evoking computer from sci-fi aware of its own existence and determined to destroy humanity? Is it a robot that does our job for us while we kick our feet up? Right now, maybe it is neither, it can be defined as “ASystem that mimics human intelligence to perform complex tasks using advanced learning algorithms that capture underlying patterns and relationships from the data they collect.” The tasks and benefits from such a system can be many but generally serve as three main use categories: accuracy improvement, automation of tasks, or a recommendations engine.
In developing a SAMD (Software As a Medical Device) product consider both the regulatory guidelines and best practices. The FDA is partnering with industry to develop regulations in this emerging field, they recently released a guidance on Clinical Decision Support Software describing the criterion in which software is considered a medical device by the agency. And, during software life-cycle development, ISO 62304 outlines the processes of risk management, maintenance, configuration management, and problem resolution.
Developers should build in systems on the front end for data mining whether in the form of document capturing tools, video data collection, speech recognition, or otherwise. And, comprehensive cybersecurity around these data sources in addition to the access, analysis, and output systems.
Lastly, algorithms should take bias into account. This is already present in the diagnosis making process today, clinicians can jump to conclusions based on early information and stick to their guns even as new information becomes available (premature closure / anchoring). The algorithms themselves can have bias, in how data is fitted when machine learning is automated.
Automation Bias: Tendency of people to show deference to automated output, maybe due to person’s lack of confidence/experience, or assumption that the automation designed to make the correct determination.
Fitting Bias: Over Fitting- Automation has been overly relying on the trained data and does not provide correct responses when given new information. Under Fitting - Machine is under trained and doesn’t correctly identify relationships between the variables.
Widespread AI use is in its infancy, its currently being leveraged across several surgical products currently on the market including surgery planners, guidance systems, AR, blood loss monitoring, and predictive analytics. The future holds many opportunities for AI to burn down existing healthcare challenges.
Accuracy Improvement:
Comprehensive Patient Medical Information
Summarization and Highlighting of Patient Case History
Accurate Encoding of procedures and diagnosis for insurance
Accurate diagnosis from medical images
Risk-aware decision making –using predictive analysis of surgical outcome, implant choice, length of hospital stay, risk of re-hospitalization
Post op x-ray, feedback loop, feedback to surgeon on trending accuracy stats, predictive risks
Physician burnout - make less errors during diagnosis
Physician shortage – making fewer surgeons more efficient
Patient/procedure/surgeon customized device on demand
Fair surgeon success ratings based on predictive risk/outcomes
Informing consumers on surgeon/facility for their condition to maximize outcomes
It probably won’t be too far into the future before some of these AI-enabled improvements become mainstream practice in the healthcare domain. The recent advances in ChatGPT have shown how complex knowledge intensive tasks such as text summarization, essay generation, intelligent Q&A (Question and Answer), etc. can be accomplished by current language models. Convolutional Neural Networks (CNN)-based deep learning models are showing promise for automatic detection and classification of tumors in medical imaging. Advanced Machine Learning (ML), Rule-based modeling, and Embedded-AI can help with addressing other opportunities such as risk prediction, improved surgical planning, AI-assisted robotic devices, supply chain automation, and customized recommendations
AI will help in bringing consistency in the process, improve overall efficiency, reduce cost of operations while adhering and improving the regulatory compliance.
Interested in implementing AI/ML technology into your business?
Kaleidoscope uses advanced learning algorithms to capture patterns and relationships within your data to help you better understand the data collected and provide both exploratory and predictive analytics based on findings. Contact Matt Suits: [email protected]
Eric Kennedy is an engineer at Kaleidoscope Innovation based in Cincinnati, Ohio, and has over 15 years of global medical device experience leading large- and medium-scale concept-to-launch orthopedic, micro-surgical, cardiovascular and ophthalmic devices.
Dr. Ravi Nandigam
Principal Consultant
Dr. Ravi Nandigam is a Principal Consultant in the Advanced Engineering Group at Infosys. He has 15 years of experience applying Artificial Intelligence, Machine Learning, and Software-based solutions in diverse Engineering domains. Dr.Nandigam is an inventor of a patent and author of many technical articles in peer-reviewed international journals on topics of AI/ML-based applications in Engineering.
Dr. Ravi Kumar G. V. V.
Vice President and Head Advanced Engineering Group (AEG)
Dr. Ravi Kumar is Vice President and Head Advanced Engineering Group (AEG) of Engineering Services, Infosys. He led numerous innovations and applied research projects for more than 26 years. His areas of expertise include mechanical structures and
