Category: Article

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.

Back to Insights + News

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.

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. 

  1. 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.
  2. 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. 
  3. 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. 
  4. 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. 
  5. 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. 
  6. 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. 
  7. 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. 
  8. 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. 
  9. 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. 
  10. 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. 

Back to Insights + News

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.

Unlock Hidden Productivity: A Research Guide for Industrial Designers

In today's fast-paced and competitive world, industrial designers face the exciting challenge of creating innovative and user-centric products that capture the market's attention. While their expertise lies in design aesthetics and functionality, the role of research in the design process cannot be underestimated. Research is the key that unlocks valuable insights, fuels inspiration, and ensures that designs are grounded in real-world needs and preferences. However, for industrial designers and other professionals who are not trained in research methods, navigating the realm of research can feel daunting. In this article, we will define research methodology and provide suggestions for selecting the right one for your project. 

RESEARCH METHODOLOGY 

Once a client settles on a research question, it is up to the design researcher to select the methodology that facilitates a rigorous approach. Think of methodology as a framework for conducting a research study. The chosen methodology will guide a researcher in methods and procedures that ensure the results or findings are valid and reliable. 

QUANTITATIVE: Quantitative methodology is used to determine if relationships between variables exist, to test a hypothesis, or to measure a phenomenon. Quantitative data is used to make group comparisons or identify patterns. Data are numbers and reported in a standard reporting structure. Descriptive and inferential statistics require quantitative data. The output of quantitative analysis is referred to as results. 

QUALITATIVE: Qualitative methodologies are used to understand a phenomenon more deeply, to obtain a detailed description of an experience, or to understand how or why an event occurs. Qualitative data may be text or images and uses a flexible reporting structure. Interview transcripts and video recordings represent qualitative data types. The output of qualitative analyses is called findings. 

MIXED METHODS: Mixed methods research includes aspects of quantitative and qualitative methodologies in the same study or series of studies. Mixed methods approaches can be used sequentially or concurrently. Often, results or findings from one phase will be used to design a subsequent phase of a project. A Time & Motion Study consisting of quantitative measurement of a motion in a workflow followed by a one-on-one interview is an example of a mixed methods study. The qualitative findings could be used to understand the results of the quantitative phase more deeply, to provide context for interpreting the results, or to triangulate the results and findings. 

WHICH ONE SHOULD I USE?  

Choice of research methodology should be determined using several factors: 

  1. Research Purpose: If the purpose is to understand or explore, a qualitative methodology is likely the best approach. If a client wants to know how much or to determine if a new workflow is more productive than the old one, a quantitative approach will likely be appropriate. If a client wants both, a mixed methods approach will be best. 
  2. Budget: Generally, qualitative studies are more time-intensive than quantitative studies. If a client’s budget is limited, a quantitative approach may be best. 
  3. Decisions: If a client wants to use the findings of a study to generate ideas or inform iterative design requirements, a qualitative approach may be best. If a client wants to evaluate changes to a process or product, a quantitative approach is required. 

The next step in planning a research study is to decide what methods will be used to collect data. Methods specific to each methodology exist but are beyond the scope of this article. If you are interested in learning more, check out some of the popular methods from a reliable source: narrative inquiry, survey, and ethnography are a few examples of methods you may encounter in the field. By embracing research methodology as an integral part of the design process, industrial designers can confidently embark on their creative journey, armed with insights that empower them to craft extraordinary products that not only meet user needs but also set new standards of innovation in their industry. 

Back to Insights + News

Author

  • 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.

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.

Back to Insights + News

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.

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.  

Back to Insights + News

Author

  • 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

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.

Image 1
Image 2

 

"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.

Back to Insights + News

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.

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. 

Back to Insights + News

Authors

  • Eric Kennedy

    Principal Engineer | [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.

  • 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.

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. 

Back to Insights + News

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. 

Back to Insights + News

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.

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 “A System 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

Automation Enabled Improvements:

  • Improved surgical planning / operation
  • AI-assisted surgical robotics
  • Supply chain automation
  • Reduced non-conformances, out-of-commission instrument sets
  • Reduced waste, reprocessing costs
  • Smart intra-op assistant / training

Recommendations Engine:

  • 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]

Back to Insights + News

Authors

  • Eric Kennedy

    Principal Engineer | [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