Computational modeling and simulation (CM&S) has the potential to revolutionize medical devices by accelerating innovation and providing comprehensive evidence of long-term safety. For example, CM&S can provide performance benchmarks, assess design parameter interdependencies, evaluate a variety of use conditions, provide visualization of complex processes and become a core element of device submissions and approvals. This presentation will begin with an overview of the use of CM&S throughout the orthopaedic implant lifecycle, followed by a review of the current regulatory direction regarding the use of CM&S in device submissions. Next, a series of case studies based on a variety of orthopaedic implants will demonstrate the application of CM&S at various phases of the product lifecycle in more detail. The examples will also highlight the effects of modeling assumptions on model credibility and some verification and validation best practices.
This presentation will position CM&S as a credible and common means for device companies and FDA to demonstrate the safety of medical devices, and thereby ensure safety, reduce cost and accelerate the pathway toward “first in the world” access to products in the U.S.
Medical Device Development - Concept to Commercialization | Jahnavi Lokre | L...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
CAE is the use of computer software to simulate performance in order to improve product designs or assist in the resolution of engineering problems for a wide of industries this includes simulation validation and optimization of products processes and manufacturing tools
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
Medical Device Development - Concept to Commercialization | Jahnavi Lokre | L...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
CAE is the use of computer software to simulate performance in order to improve product designs or assist in the resolution of engineering problems for a wide of industries this includes simulation validation and optimization of products processes and manufacturing tools
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
Design controls are not an easy subject to address during and after the design of medical devices and manufacturing processes. Design controls should drive the device design process, not be an afterthought. This session focuses on treating design as a separate entity within the quality management system, user needs vs. design inputs, continuation of design controls after the transfer process, design review and more.
THIS PPT CONTAINS WHAT IS MEANT BY THE VIRTUAL MANUFACTURING AND APPLICATION AND DRAWBACKS ,
AND IT CONTAINS ABOUT HOW IT IS REALISED USED IN PRESENTSCENARIO.
Numerical Solution for the Design of a Ducted Axisymmetric Nozzle using Metho...IJRES Journal
Supersonic nozzles find application in the field of Rocket Propulsion. A method for the design of a ducted axisymmetric nozzle for high speed, low density flows is described and this work was carried out in the rules of Aerodynamics with the aim of projecting a computational method for the calculation of a Ducted Axisymmetric nozzle of minimum length, using the method of characteristics, by expanding a flow of air until to the required Mach Number. A thorough understanding of the method of characteristics and its application to the design of a Ducted Axisymmetric nozzle is required. We make use of the compatibility equations involved in the axisymmetric method of characteristics, Prandtl-Meyer function and develop a MATLAB program with the help of which the contour of the ducted axisymmetric nozzle has been developed for an exit Mach number 2.5, with an output of 4 expansions. A similar code was also developed, but for the two-dimensional case for 30 expansions as it more was simpler. Finally, the desired exit Mach number has been achieved giving a minimum length of the nozzle with a shock free and isentropic flow. We will be dealing with the various aspects of the draft code and its implementation, as well as the results obtained.
As part of device description, required by 21 CFR 807.92(a)(4), medical device manufacturers will have to present how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, materials used, physical, chemical and biological properties.
Labeling/Advertising and Promotion, Import/Export, and Enforcement ActionsMichael Swit
Presentation to the Regulatory Affairs Certification (RAC) Review Course, sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group, on August 2, 2014, in Irvine, CA. See slides 4-58 for Labeling/Advertising Discussion; slide 59 to 72 for Imports/Exports, and 73 to end for Enforcement Actions
FDA Regulations and Medical Device Pathways to Market | Kevin Daly | Lunch & ...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
This presentation consist of what ISO 14971 is and why is it important to consider this standard while designing a medical device or any device for that matter. It will help u understand what Risk actual is and importance of risk management in medical device industry. It gives you insight about Risk management technique. You will Understand FMEA and how to use it.
January 29, 2014 Presentation to Compliance2Go webinar, focusing on:
• Legal Framework for 510(k)’s
• Strategy Considerations – Claims & Functions
• Device Modifications
• Regulatory Mechanisms to Implement Changes
• The Review
• What To Do if FDA Says You’re NSE
• Key Lessons Learned
• Reform and Other Recent Trends at FDA
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Pallavi Christeen
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims. Additional benefits may include your product being made safer for end-users. The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the member’s states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.
Key Words: European Union, CE marking, New Approach Directives, EEA, Regulatory requirements.
Metrology & The Consequences of Bad Measurement DecisionsRick Hogan
Learn the risks of making decisions based on bad measurement data, including case studies like the torque wrench that cost NASA nearly 2 billion dollars.
Computational Modeling & Simulation in Orthopedics: Tools to Comply in an Ev...April Bright
Computational Modeling & Simulation has the ability to revolutionize the orthopedic device industry by reducing and in some instances eliminating the need for benchtop testing and clinical trials. Dr. Afshari shared his experience in establishing the credibility of computational models for product design and development purposes, and highlighted was that modeling fits with the regulatory and standards framework.
Design controls are not an easy subject to address during and after the design of medical devices and manufacturing processes. Design controls should drive the device design process, not be an afterthought. This session focuses on treating design as a separate entity within the quality management system, user needs vs. design inputs, continuation of design controls after the transfer process, design review and more.
THIS PPT CONTAINS WHAT IS MEANT BY THE VIRTUAL MANUFACTURING AND APPLICATION AND DRAWBACKS ,
AND IT CONTAINS ABOUT HOW IT IS REALISED USED IN PRESENTSCENARIO.
Numerical Solution for the Design of a Ducted Axisymmetric Nozzle using Metho...IJRES Journal
Supersonic nozzles find application in the field of Rocket Propulsion. A method for the design of a ducted axisymmetric nozzle for high speed, low density flows is described and this work was carried out in the rules of Aerodynamics with the aim of projecting a computational method for the calculation of a Ducted Axisymmetric nozzle of minimum length, using the method of characteristics, by expanding a flow of air until to the required Mach Number. A thorough understanding of the method of characteristics and its application to the design of a Ducted Axisymmetric nozzle is required. We make use of the compatibility equations involved in the axisymmetric method of characteristics, Prandtl-Meyer function and develop a MATLAB program with the help of which the contour of the ducted axisymmetric nozzle has been developed for an exit Mach number 2.5, with an output of 4 expansions. A similar code was also developed, but for the two-dimensional case for 30 expansions as it more was simpler. Finally, the desired exit Mach number has been achieved giving a minimum length of the nozzle with a shock free and isentropic flow. We will be dealing with the various aspects of the draft code and its implementation, as well as the results obtained.
As part of device description, required by 21 CFR 807.92(a)(4), medical device manufacturers will have to present how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, materials used, physical, chemical and biological properties.
Labeling/Advertising and Promotion, Import/Export, and Enforcement ActionsMichael Swit
Presentation to the Regulatory Affairs Certification (RAC) Review Course, sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group, on August 2, 2014, in Irvine, CA. See slides 4-58 for Labeling/Advertising Discussion; slide 59 to 72 for Imports/Exports, and 73 to end for Enforcement Actions
FDA Regulations and Medical Device Pathways to Market | Kevin Daly | Lunch & ...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
This presentation consist of what ISO 14971 is and why is it important to consider this standard while designing a medical device or any device for that matter. It will help u understand what Risk actual is and importance of risk management in medical device industry. It gives you insight about Risk management technique. You will Understand FMEA and how to use it.
January 29, 2014 Presentation to Compliance2Go webinar, focusing on:
• Legal Framework for 510(k)’s
• Strategy Considerations – Claims & Functions
• Device Modifications
• Regulatory Mechanisms to Implement Changes
• The Review
• What To Do if FDA Says You’re NSE
• Key Lessons Learned
• Reform and Other Recent Trends at FDA
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Pallavi Christeen
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims. Additional benefits may include your product being made safer for end-users. The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the member’s states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.
Key Words: European Union, CE marking, New Approach Directives, EEA, Regulatory requirements.
Metrology & The Consequences of Bad Measurement DecisionsRick Hogan
Learn the risks of making decisions based on bad measurement data, including case studies like the torque wrench that cost NASA nearly 2 billion dollars.
Computational Modeling & Simulation in Orthopedics: Tools to Comply in an Ev...April Bright
Computational Modeling & Simulation has the ability to revolutionize the orthopedic device industry by reducing and in some instances eliminating the need for benchtop testing and clinical trials. Dr. Afshari shared his experience in establishing the credibility of computational models for product design and development purposes, and highlighted was that modeling fits with the regulatory and standards framework.
Verifications and Validations in Finite Element Analysis (FEA)Kartik Srinivas
Verifications and Validations in Finite Element Analysis (FEA) using Advanced Scientific and Engineering Services AdvanSES Material characterization Fatigue Testing Strain Gauging Engineering Services Ansys Abaqus LS-Dyna MSC-Marc
Calibration and Validation of Micro-Simulation ModelsWSP
Calibration and Validation of Micro-Simulation Models is a presentation delivered by François Bélisle, Eng., B.Sc., M.Sc., WSP | Parsons Brinckerhoff, Laurent Gauthier, Polytechnique Montréal and Nicolas Saunier, Polytechnique Montréal at the 2015 Transportation Association of Canada (TAC) Conference & Exhibition, from September 27 to 30.
After studying this chapter, the reader will be able to
• understand the importance of metrology
• appreciate the significance of inspection
• appreciate the concepts of accuracy and precision
• explain the objectives of metrology and measurements
• understand the general measurement concepts
• elucidate the different sources and types of errors
• compare the different types of measurements
Instruments for linear and angular measurements
2014 PV Reliability, Operations & Maintenance Workshop: A PV Cosmology Perspective for Ushering In: The Next Era in PV: Collaborative O&M Standards Development,
High Performance PV, John Balfour
The Future of Digital Health and Wearables in OrthopedicsrablesApril Bright
Orthopedic device companies have responded to payors’ adoption of bundled payments and FDA’s promotion of digital health tools by commercializing products that track patients beyond the O.R. Digital health tools, including wearables, provide device companies with revenue streams that respond to hospitals’ episode of care requirements and patients’ personalized medicine needs, while simultaneously creating a feedback loop for product ideas. Christopher E. Pelt, M.D., a surgeon enrolled in Zimmer Biomet’s mymobility clinical study with the Apple Watch app, offered perspective on the benefits of wearables and shares ways that the technology will impact patients, surgeons and device companies in the future.
The Future of Personalized Implants in Joint Replacement: Additive, Robotics,...April Bright
Orthopedics is primed for mass customization of implants thanks to advancements in additive, AI and robotics. Fully leveraged, the technologies can produce patient-specific implants that achieve clinical benefit, decrease cost and maintain O.R. workflow. Founder and Chief Medical Officer of Monogram Orthopaedics, Douglas Unis, M.D., shares his reimagined vision of personalized joint replacement implants and just-in-time inventory solutions.
Innovation in Orthopedics: Surgeon PerspectivesApril Bright
How can orthopedic manufacturers capitalize on the next wave of innovation? Which advancements will experience the greatest adoption in orthopedics, and why? The future of orthopedics is happening now. Progress is being made on materials that increase implant longevity, designs that improve patient outcomes and speed recovery, robotic and computer-assisted technologies that enhance accuracy, reliability and speed. This panel boasts future-minded surgeon entrepreneurs and researchers who have varied practical experience from the leading edge of tomorrow’s solutions. They shared perspective on what’s working in orthopedics, what gaps remain and how orthopedic manufacturers can develop new, relevant products that solve problems and alleviate pressures for surgeons and hospitals.
Antimicrobial Coatings: The Research and Regulatory PerspectiveApril Bright
Coatings have long been considered an avenue for infection prevention in orthopedic procedures. These coatings, some of which utilize silver, have largely not been commercialized because regulators seek greater evidence of their safety, creating a long, expensive road for device companies. Announcements in the last half of 2018 and early 2019 indicate that companies continue to push to get them on the market and that productive conversations are taking place with regulators. This session began with a history of antimicrobial coatings followed by a look at recent research and technology.
Leverage These Effective Communication Skills to Get Your Message AcrossApril Bright
Your success is highly dependent upon how well you communicate with your colleagues, your customers and your providers. Effective communication helps you reduce conflict and confusion while increasing motivation and productivity. No matter your age or title, communication is a timeless skill to practice and hone. Leveraging decades of training and managerial experience within device companies and his role as a professor, G. Bryan Cornwall provided the practical steps that you must take to become an excellent communicator.
Operations: Top Reasons for Long Lead Times and What to Do About ThemApril Bright
Long lead times remain one of the most vocalized challenges that orthopedic manufacturers face today. Customers, profits, plans and personnel are all negatively impacted by them. James Kwan has worked on the OEM and the supplier sides of orthopedics, and shared his ideas and successful experiences to help you optimally respond to lead times, reduce them and ultimately create and sustain an agile supply chain.
Joint Replacement: The Current and Future Impact of CoatingsApril Bright
The control of surface properties to reduce wear and corrosion and improve biocompatibility is of particular interest today as device companies—and surgeons, payors and patients—seek to extend the life of knee and hip implants. In this session, device companies shared research on their joint replacement coatings and materials, covering pros, cons and the future of their technology.
Engineers: Practical Application of Project Management PrinciplesApril Bright
Predictability throughout the commercialization chain is critical to allow manufacturers to speed products to market and gain share within the growing orthopedic industry. As an engineer, your technical and regulatory expertise will be overshadowed if you cannot properly plan and execute a project. One skill every engineer must learn and hone is project management. Start with the steps shared in this session.
Regulatory and Quality Affairs: Answers to FDA and ISO Gray AreasApril Bright
Every day, people like you in companies everywhere are sidetracked from more pressing priorities by questions and scenarios that aren’t clearly explained in a regulation or standard (a.k.a. "gray areas"). This panel of regulatory and quality experts were charged with mitigating your roadblocks and getting you on your way. Our panel shared their perspective on the pressing questions received from a pre-conference attendee questionnaire, including UDI and supplier relationships.
The Future of Orthobiologics in Trauma ProceduresApril Bright
Based on his clinical research interests in utilization of Alpha-BSM bone graft substitute and OP-1 recombinant BMP in the repair of fractures, Daniel N. Segina, M.D., outlined opportunities and challenges for surgeons and device companies in biologic development. To make his case, Dr. Segina reviewed the spectrum of orthobiologics used in trauma cases today, shared perspective on what is and isn’t working and forecasted the future of regenerative medicine.
Spine Implants: Porous Coatings vs. Porous Materials vs. Additive ManufacturingApril Bright
Spine implant materials and surface characteristics are popular topics among engineers and surgeons. How do surface technologies relate to spine implants and bone integration and fusion? What are the pros and cons of various materials and surfaces? In this interactive session, members of industry and academia reviewed and presented research related to use of
• porous plasma spray coating,
• porous PEEK, and
• additive manufactured titanium in spinal devices.
How to Influence People: The Value of Employee EngagementApril Bright
Engagement is a powerful tool to drive accomplishment of individual and company objectives. Success requires a genuine interest in achieving the goals of the company as well as making connections between those goals and the personal motivations of your team. Employee engagement is lauded by many as the single most fulfilling aspect of their jobs.
Real-World Evidence: The Future of Data Generation and UsageApril Bright
As data is captured through electronic health records, registries and unique device identifiers, the generation of evidence based on this data is expected to play a crucial role in informing orthopedic manufacturers’ decisions before and after regulatory approval. While regulators, payors, hospitals and manufacturers support this shift, they acknowledge that gaps remain in its optimal execution. Priority considerations include how to generate evidence to expedite regulatory market decisions, device indication expansion, postmarket studies, postmarket surveillance and reimbursement decisions. The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is leading the conversation with various stakeholders, including FDA and orthopedic device companies to support the sustainable generation of Real-World Evidence (RWE) using Real-World Data (RWD).
Orthopedic Coatings: Predictions for 2025April Bright
What are the next innovations in orthopedic coatings? What orthopedic market stands to benefit the most from coatings? What’s stalling coating innovation? This session brought together the device company and coating manufacturer perspective to discuss which coatings will be used in orthopedics in the next decade.
Engineers: Apply Automation to Increase Quality, Speed to MarketApril Bright
We live in the age of machine learning, artificial intelligence and other automated systems. Why, then, are we performing tedious tasks that we can streamline during the product development phase? First, there is Design Verification testing. Second, there is Design Validation testing. Some of these tests use simple pass/fail attribute data, while others use continuous data. We will focus on ways to automate the analysis of that continuous data, which can ensure more accurate and timely results.
OSMA: Orthopedic Industry's Top Regulatory Challenges and OpportunitiesApril Bright
The Orthopaedic Surgical Manufacturers Association, a collective voice of orthopedic device companies that influences the decision of worldwide regulatory agencies and standards bodies, will highlight the main regulatory changes impacting the industry. This session is for any orthopedic professional who wants a forecast of regulatory pressures and seeks direction on how to shape change. Attendees will learn how FDA, European agencies and IMDRF are approaching harmonization and alignment of standards, regulations and guidance. OSMA Members will provide future trends and opportunities afforded via FDA’s National Evaluation System for Health Technology (NEST), facilitation of innovation through partnerships and global harmonization of regulatory submissions and facility assessments.
Unique Device Identification: Manufacturer, Hospital and Global ImplicationsApril Bright
Unique device identification (UDI) is gaining global adoption. Now is the time for companies to take a step back and ask: Is my UDI framework scaleable? UDI experts answered questions on the U.S. regulation and provided perspective on ways that device manufacturers can implement a working system—including data management—that can scale with product development and UDI compliance needs. Attendees gained an understanding of new global regulations and practical, implementable advice for compliance.
Additive Manufacturing - Mechanical Test Methods - OMTEC 2018April Bright
Medical devices fabricated from additively-manufactured materials must undergo a variety of mechanical tests before receiving regulatory approval. Due to the complexity of manufacturing processes and the limited clinical knowledge of AM devices, they are subject to additional scrutiny by manufacturers and Notified Bodies. Several test methods for characterizing these devices are presented in this session, as well as the differences between testing additively-manufactured devices and those fabricated with traditional machining methods.
Analyze and Optimize Your Supply Chain Operations for Higher Performance - OM...April Bright
The operations science pioneered through Factory Physics provides practical concepts to analyze and optimize supply chain operations. This presentation covers basic approaches for operations science to enhance your world, with all its variability in product mix, demand, people and processes. You will get applications of the science to apply immediately.
EU MDR Preparation: Seize the Market Opportunity and Avoid the BottleneckApril Bright
The new EU Medical Device Regulation (MDR) is the single largest change to medical device regulations in Europe since the 1993 introduction of CE Marking. As grandfathering of existing products is not permitted, the new regulations affect all medical devices sold throughout Europe. There is a temptation for medical device companies to think that the transition arrangements through 1Q20 under MDR leave a considerable amount of time to ensure compliance. Research predicts that companies that do not address MDR early will suffer from potential bottlenecks among Notified Bodies for certification completion and capacity shortages by compliance professionals in the preparatory process. If you have not started to plan for the transition, now is the time to act. This presentation will take you through the main regulation changes and outline key requirements affecting manufacturers moving forward.
0x01 - Newton's Third Law: Static vs. Dynamic AbusersOWASP Beja
f you offer a service on the web, odds are that someone will abuse it. Be it an API, a SaaS, a PaaS, or even a static website, someone somewhere will try to figure out a way to use it to their own needs. In this talk we'll compare measures that are effective against static attackers and how to battle a dynamic attacker who adapts to your counter-measures.
About the Speaker
===============
Diogo Sousa, Engineering Manager @ Canonical
An opinionated individual with an interest in cryptography and its intersection with secure software development.
Sharpen existing tools or get a new toolbox? Contemporary cluster initiatives...Orkestra
UIIN Conference, Madrid, 27-29 May 2024
James Wilson, Orkestra and Deusto Business School
Emily Wise, Lund University
Madeline Smith, The Glasgow School of Art
Have you ever wondered how search works while visiting an e-commerce site, internal website, or searching through other types of online resources? Look no further than this informative session on the ways that taxonomies help end-users navigate the internet! Hear from taxonomists and other information professionals who have first-hand experience creating and working with taxonomies that aid in navigation, search, and discovery across a range of disciplines.
This presentation by Morris Kleiner (University of Minnesota), was made during the discussion “Competition and Regulation in Professions and Occupations” held at the Working Party No. 2 on Competition and Regulation on 10 June 2024. More papers and presentations on the topic can be found out at oe.cd/crps.
This presentation was uploaded with the author’s consent.
Acorn Recovery: Restore IT infra within minutesIP ServerOne
Introducing Acorn Recovery as a Service, a simple, fast, and secure managed disaster recovery (DRaaS) by IP ServerOne. A DR solution that helps restore your IT infra within minutes.
Obesity causes and management and associated medical conditions
Leverage Computational Modeling and Simulation for Device Design - OMTEC 2017
1.
2. 14 June, 2017
Leveraging Computational
Modeling and Simulation for
Device Design
Marc Horner, Ph.D.
Technical Lead, Healthcare
ANSYS, Inc.
Mehul Dharia
Principal Research Engineer
Zimmer Biomet
3. •This session will review the following aspects of computational
modeling and simulation (CM&S) as it relates to the total
product lifecycle of orthopaedic products:
–Review CM&S throughout the orthopaedic implant lifecycle
–Overview of the regulatory direction regarding CM&S for
device submissions
–Examples of ways in which computer modeling transforms
product development, including examples that demonstrate
the contemporary regulatory framework
–Opportunities and challenges in the use of computer models
Takeaways
4. 4
Phases in the Design Cycle
• Conceptualization
• Concept Development
• Verification & Validation
• Marketing Claims
• Post-Market Evaluation
5. 5
Simulation in the Design Cycle
• Conceptualization
– Anatomical fit
• Verification & Validation
– Strength (Performance)
– Contact Mechanics (Wear)
– Disassociation (Constraints, Locking mechanisms)
– Stability (Fixation)
– MRI, Packaging, etc.
• Surgical Guidance
– Optimal use of product
• Marketing Claims
– Comparison of designs (“selling” the Science)
• Post-Market Evaluation
– Evaluate unforeseen situations
Implant heating during MRI
Relationship
between implant
position and µ-
motion
Verma et al.
Pre-ORS (2014)
8. • Leverage “Big Data” for regulatory decision-making
• Modernize biocompatibility and biological risk evaluation of device materials
• Leverage real-world evidence and employ evidence synthesis across multiple
domains in regulatory decision-making3
• Advance tests and methods for predicting and monitoring medical device
clinical performance
• Develop methods and tools to improve and streamline clinical trial design
• Develop computational modeling technologies to support regulatory
decision-making
• Enhance the performance of Digital Health and medical device cybersecurity
• Reduce healthcare associated infections by better understanding the
effectiveness of antimicrobials, sterilization and reprocessing of medical
devices
• Collect and use patient input in regulatory decision-making
• Leverage precision medicine and biomarkers for predicting medical device
performance, disease diagnosis and progression
2017 Regulatory Science Priorities
“Design for Clean”
MDDTs
9. 9
Model Reporting
* issued September 20, 2016
Summarizes information to be included in a CM&S Report
Scope:
•Fluid Mechanics and Mass Transport
•Solid Mechanics
•Electromagnetics and Optics
•Ultrasound
•Heat Transfer
Report Sections:
•Governing Equations • System Properties
•System Conditions • System Discretization
•Numerical Implementation • Validation
10.
11. 11
Standards Committee
– Provide procedures for assessing and
quantifying the accuracy and credibility of
computational models and simulations.
ASME V&V Standards Committee
V&V in Computational
Modeling and Simulation
V&V 10 - Verification and
Validation in Computational
Solid Mechanics
V&V 20 - Verification and
Validation in Computational
Fluid Dynamics and Heat
Transfer
V&V 30 - Verification and
Validation in Computational
Simulation of Nuclear System
Thermal Fluids Behavior
V&V 40 - Verification and
Validation in Computational
Modeling of Medical Devices
V&V 50 - Verification and
Validation of Computational
Modeling for Advanced
Manufacturing
12. 12
V&V 40 Charter
– Provide procedures to standardize
verification and validation for
computational modeling of medical
devices
– Charter approved in January 2011
Motivating Factors
– Regulated industry with limited ability to
validate clinically
– Increased emphasis on modeling to
support device safety and/or efficacy
– Use of modeling hindered by lack of V&V
guidance and expectations within medical
device community
ASME V&V 40 Overview
V&V in Computational
Modeling and Simulation
V&V 10 - Verification and
Validation in Computational
Solid Mechanics
V&V 20 - Verification and
Validation in Computational
Fluid Dynamics and Heat
Transfer
V&V 30 - Verification and
Validation in Computational
Simulation of Nuclear System
Thermal Fluids Behavior
V&V 40 - Verification and
Validation in Computational
Modeling of Medical Devices
V&V 50 - Verification and
Validation of Computational
Modeling for Advanced
Manufacturing
13. The V&V40 guide outlines a process for making risk-informed
determinations as to whether a computational model is
credible for decision-making for a specified context of use.
Risk-Informed Credibility Assessment
Framework
14. The question of interest describes the specific question, decision or
concern that is being addressed.
Context of use defines the specific role and scope of the computational
model used to inform that decision.
Question of Interest
and Context of Use
15. Model risk is the possibility that the model
may lead to a false/incorrect conclusion about
device performance, resulting in adverse
outcomes.
- Model influence is the contribution of the
computational model to the decision relative
to other available evidence.
- Decision consequence is the significance
of an adverse outcome resulting from an
incorrect decision.
* Blood pump image courtesy Mark Goodin, SimuTech Group
Risk Assessment
16. Model credibility refers to the
trust in the predictive
capability of the computational
model for the COU.
Trust can be established
through the collection of V&V
evidence and by
demonstrating the applicability
of the V&V activities to
support the use of the CM for
the COU.
Credibility Factors
Verification Validation
Applicability
Code Solution Model Comparator
Output
Assessment
SoftwareQuality
Assurance
NumericalAlgorithm
Verification
DiscretizationError
UseError
NumericalSolverError
SystemConfiguration
SystemProperties
BoundaryConditions
GoverningEquations
SampleCharacterization
ControlOverTestConditions
MeasurementUncertainty
Equivalencyofinputand
outputtypes
Rigorof
OutputComparison
Relevanceofthe
QuantitiesofInterest
Applicabilityto
theContextofUse
Credibility Assessment
18. The Path Forward
Assessing
Computational Model
Credibility through
Verification and
Validation:
Application to
Medical Devices
currently in DRAFT form
“Develop computational modeling technologies
to support regulatory decision-making”
Hierarchical
ValidationofCM&S
20. 20
Conceptualization
Anatomical Fit
• “Better conform to anatomy” → “Better clinical outcomes”
• ZiBRA*:
– Morphological Analysis
– Statistical Shape Analyses
– Automated Landmark Detection & Virtual Surgery
– Component Placement Optimization
– Implant Fit Assessment
• Extensive digital anatomic library
– Captures ethnic and gender variation across the global population
– Caucasian / African American / European / Indian / Chinese / Japanese / Korean
Zimmer Biomet Internal Software
21. 21
Anatomical Fit
Tibial Baseplate
• Compromise Between
– Proper Rotation (kinematics)
– Minimum Overhang (impingement)
– Optimal Coverage (stability)
• Subtle shape differences between ethnicities and genders
Dai et al, J Ortho Res 31; 2013
22. 22
Anatomical Fit
Tibial Baseplate
optimizes the “compromise” between kinematics,
impingement and fixation aspects
Zimmer Biomet Persona
Tibial Baseplate
• One design for the global population
24. 24
Strength Testing
Based on Standard
TKA Tibial Baseplate THA Stem
• What if a Standard is not specific enough?
ASTM F1800-12 ISO 7206-4
25. 25
Total Ankle Replacement
Strength Testing
•Standard provides guidance
– Does not provide specifics for strength testing
•Method
– Develop biomechanical loading rationale
– Input to Simulation
– Determine worst case condition from simulation
– Develop test
Trabecular Metal
(TM)
Trabecular Metal
(TM)
Talar
Component
Tibial Tray
HXPE
Zimmer Biomet
Trabecular Metal Total Ankle
Dharia et al, World Congress of Biomechanics, 2014
Talus
Tibia
26. 26
Biomechanical Input
Forces & Kinematics
• Joint Forces Axial Compressive Load
•Flexion/Extension Internal/External Rotation
•Anterior/Posterior Translation
– obtained from Bell et al., 1997
Seireg & Arvikar, J Biomech, 1975
Procter, J Biomech, 1982
Anderson et al, J Biomech, 2001
Stauffer et al, Clin Orthop Rel Res, 1977
Lamoreux , Bull Prosthet Res, 1971
Bahr et al, Knee Surg, 1998
Singer et al, JBJS, 2013
Stauffer et al, Clin Orthop Rel Res, 1977
30. 30
Fatigue Test
Physiologically Motivated Inputs
• Test Orientations
– 41% & 45% Gait Positions for Tibia & Talus assemblies
– Apply axial load
– 10 Mc test
Dharia et al, World Congress of Biomechanics, 2014
Tibia Talus
31. 31
Foot
Physiologically Motivated Inputs ??
• Hallux Valgus
– Open Wedge Osteotomies
• Osteotomy Cut, Open Wedge
• Place Spacer/Implant(s)
• Loading??
www.arthrex.com
Defect Correction
32. 32
Musculoskeletal Model
Loading through 1st Metatarsal
• Kinematic Foot Model
– 26 segments (bones)
– Contains bones, muscles, ligaments, joints
– 75 Forces through 1st Metatarsal
Al-Munnajed et al, J Biomech Eng., March 2016, Vol. 138
Y
Z
X
Ligaments Muscles
Dharia et al, BMES/FDA Frontiers in Medical Device, 2016
33. 33
Patient & Surgical Variability
Surgical Guidance
• 5 Osteotomy Planes
– Defined using the ZiBRATM Anatomical Modeling System*
•Neutral (N): perpendicular to long axis
•5° in abduction (AB)
•5° in adduction (AD)
•5° in dorsiflexion (DF)
•5° in plantar-flexion (PF)
Dharia et al, BMES/FDA Frontiers in Medical Device, 2016
*Bischoff et al., ASME/FDA Frontiers in Medical Devices, 2013
Compressive
Force
Flexion/Extension
Moment
34. 34
Proximal Tibial Locking Plate
Optimal Screw Configurations
• Potential Screw Configurations
– Models A & D has hole 6 unsecured
Dharia et al., Orthopaedic Research Society, 2006
35. 35
Optimal Screw Configurations
Surgical Guidance
• Maximum Principal Stress
– Peak stress at unsecured hole 6 in Models A & D.
Dharia et al., Orthopaedic Research Society, 2006
37. 37
Contact Mechanics
Contact Area & Pressure (CAREA/CPRESS)
• Edge Loading
– Cause
•Deformity, V/V Malalignment, Congruency
– Effect
– Point or edge loading on polyethylene
– Increased wear
– Catastrophic failure
Easley, JBJS Am 2011;93:1455-1468
Espinosa, JBJS Am 2010 Laflamme, AOFAS 2012Assal, F&A Intl 2003
38. 38
Test Setup
ASTM F 2665-09
– Contact Area and Contact Pressure should be
determined at various flexion angles
• 0°, ±10°, ±15° tibiotalar flexion angles
•800 N load
AP View ML View
Dharia et al, World Congress of Biomechanics, 2014
39. 39
Results
CAREA/CPRESS
• Mean Contact Area
• Contact Pressure - Comparison to Predicate
Contact
Area
Contact
Pressure
New Design
Predicate Design
Dharia et al, World Congress of Biomechanics, 2014
40. 40
How are these Results Relevant?
CAREA/CPRESS
– Does not represent physiological condition - tested at constant 800N load.
– All the load and motion profiles (IE, AP, Axial loads etc.) are not captured at
the tested flexion angles.
– The known worst case gait position (41%) is not tested.
– Simulation can provide better insights.
Contact Area Contact Pressure
Dharia et al, World Congress of Biomechanics, 2014
41. 41
CAREA/CPRESS Comparison
Neutral Implantation
• Comparison to Predicates
– Fixed Bearing and Mobile Bearing
Fixed Bearing
Predicate
Mobile Bearing
Predicate
Dharia et al, American Orthopaedic Foot & Ankle Soc., 2011 Dharia et al, American Orthopaedic Foot & Ankle Soc., 2013
43. 43
Micromotion
Reverse Shoulder Arthroplasty
• Stability predictions in RSA
Zimmer Biomet Comprehensive Reverse Shoulder System
Subsidence
Lift-off
Normalized
Micromotion
Dharia et al, Intl Society of Technology & Arthroplasty, 2016
44. 44
Total Ankle Replacement
Clinical Outcomes
• Low Survivability
– 78% to 95% @ 5 years
– Revision rate >double of THA, TKA
•High Revision Rates (loosening)
– 26% (Australian Registry, 2013)
– 48% (New Zealand Registry, 2013)
– 50% (Swedish Registry, 2013)
– 68% (Daniels et al., 2014)
• Design Features Affecting Loosening
– Fixation features (Keel etc.)
– Fixation Approach (cemented, cementless)
– Bony Support
Bonnin et al., 2004; Henricson et al, 2007; Hosman et al., 2007
Labek et al., 2011
Bischoff et al., Orthopaedic Research Society, 2016
45. 45
Bony Support
Flat vs Anatomical Cut
• Assumption: ↑Bony Support, ↑Stability, ↑Load Transfer
• Hypothesis: Anatomical Cut → ↑Bony Support
– ↑Bony Density (HU); ↑Surface Area (SA)
•CT Data: ~0.5mm slice thickness
Brigido and DiDomenica, 2016
Source Ethnicity Talus count Tibia count Matched pairs
Total cohort Caucasian, Korean,
Japanese, Indian
N=52
34M / 18F
N=81
56M / 25F
N=30
23M / 7F
Bischoff et al., Orthopaedic Research Society, 2016
46. 46
Bony Support
Method
• Tibia
• Talus
•Output
– Normalized HU (Density)
– Normalized SA (surface area)
– Normalized Bony Support (HU*SA)
Articulation
axis
2mm depth
4mm depth
6mm depth
Resection depth
defined based on high
point of talar dome
Resection depth defined
based on distal
center of tibia
6mm depth
4mm depth
2mm depth
Anatomic
HU↑
HU ↓FlatFlat
Bischoff et al., Orthopaedic Research Society, 2016
47. 47
Bony Support
Results
Observations:
1.Boney support is statistically significantly increased for anatomic cuts relative to
flat cuts at all cut depths, for tibia and talus
2.Depth of cut most significantly influences boney support for flat cuts of talus
(~90% increase from 2-6mm), attributed to increased SA with depth
Tibia Talus
Bischoff et al., Orthopaedic Research Society, 2016
51. 51
Tibial Tray Anterior Liftoff
Model & Experiment
• Model Experiment
Load on anterior
tibial spine
Dharia et al, ASME Verification & Validation Symposium, 2014
52. 52
Tibial Tray Anterior Liftoff
Results
• The ratio (Medium/small) of predicted
versus measured load compared within
2.2%.
– Model is validated for Rank Ordering sizes
• Model vs Exp Absolute Values
– 1.5% for medium
– 3.5% for small
– Model is validated to use in lieu of testing
• Submit 510(k) of new (similar) design
– Outcome?
Size Measured Force (N) Predicted Force (N) % difference
Medium Average 744.1 733 1.5%
Small Average 426.6 412 3.5%
Ratio, medium/small 1.74 1.78 2.2%
Dharia et al, ASME Verification & Validation Symposium, 2014
ModelExperiment
53. 53
Tibial Tray Anterior Liftoff
V&V 40 Approach
• How Good is Good Enough?
– Depends on COU
– Risk informed credibility requirement
• What is the Decision Consequence?
• What is the Model Influence?
– What additional information is available?
• Predicate device
• Testing on predicate device and/or new device
– Plan V&V activities accordingly
• Computer Model & Comparator (e.g. Experiment)
54. 54
Context Of Use (COU)
Tibial Tray Anterior Liftoff
•Differentiation
– Based on additional information available (outside of model)
•Predicate device, Benchtop Testing
• COU1, Performance evaluation without testing: The tibial component anterior
liftoff is evaluated exclusively using the computational model.
• COU2, Performance evaluation with testing: The model is used to predict the
worst-case size across the proposed product portfolio in terms of tibial component
anterior liftoff, and this worst case is then physically tested.
• COU3, Superiority evaluation without testing: The model is used to predict the
tibial component anterior liftoff across all sizes in the proposed product portfolio,
with no associated benchtop testing. Results are benchmarked against similar
modeling results from a successful predicate device.
No Predicate Device Predicate Device
None COU1 COU3
Worst Case COU2 COU4 (a,b)
Matrix of Proposed COUs
Existence of Predicate Device
Benchtop Testing
55. 55
Context Of Use (COU)
Tibial Tray Anterior Liftoff
• COU4, Superiority evaluation with testing: Model predictions of tibial
component anterior liftoff are supported by benchtop testing, and evaluation of the
proposed product portfolio is benchmarked against that of a predicate device.
– This may occur in multiple ways.
No Predicate Device Predicate Device
None COU1 COU3
Worst Case COU2 COU4 (a,b)
Matrix of Proposed COUs
Existence of Predicate Device
Benchtop Testing
56. 56
Context Of Use (COU)
Examples
• COU1: Tibial component liftoff is evaluated exclusively using the computational
model. No predicate device exists to compare with the computed results. No
bench testing will be performed for this device.
• COU2: A worst case size of a new design family will be determined for tibial
component liftoff using computational model, which will then be tested in
laboratory to ensure that it meets functional requirements. No predicate device
exists.
• COU3: Tibial component liftoff of new device and a predicate device is evaluated
using the computational model. No bench testing will be performed.
• COU4a: A worst case size of a new design family will be determined for tibial
component liftoff using computational model, which will then be tested in
laboratory to compare with test results of a predicate device.
• COU4b: A worst case size for a new and a predicate design will be determined for
tibial component liftoff using computational model. The worst design will then be
tested in laboratory to ensure that it meets functional requirements.
No Predicate Device Predicate Device
None COU1 COU3
Worst Case COU2 COU4 (a,b)
Matrix of Proposed COUs
Existence of Predicate Device
Benchtop Testing
57. 57
Model Risk
•Decision Consequence
– Revision Surgery
• Independent of model
•Model Influence
– LOW: Results from the model are a negligible factor in the decision associated
with the question being answered. (COU4)
– HIGH: Results from the model are the primary factor in the decision associated
with the question being answered (COU1)
Lower
Higher
COU1
COU1
COU1-4
COU4
COU4
58. 58
V&V Activities
Credibility Factors
•Two modeling assumptions
– Polyethylene Material
– Component Size & Locking Region
Geometry
Credibility Factors
Software Quality Assurance
Numerical Code Verification
Discretization Error*
Numerical Solver Error
Use Error
Model Form
Model Input
Test Samples
Test Conditions
Equivalency of Input
Parameters
Output Comparison*
Relevance of the Quantities of
Interest *
Relevance of the Validation
Activities to the COU*
Applicability
Activities
Verification
Code
Calculation
Validation
Computational
Model
Comparator
Assessment
59. 59
V&V Activities
Model Validation – Model Form
•Constitutive polyethylene material
model
– Several material models available in literature
– How does selected material model impacts
model predictions
• May not justify further quantification
• May have to try one or more material models
to:
– Quantify impact on predictions
– Increase confidence that decision related to COU
is not impacted by material model selection
Lower
Risk
Higher
Risk
Credibility Factors
Software Quality Assurance
Numerical Code Verification
Discretization Error
Numerical Solver Error
Use Error
Model Form
Model Input
Test Samples
Test Conditions
Equivalency of Input
Parameters
Output Comparison
Relevance of the Quantities of
Interest
Relevance of the Validation
Activities to the COU
Applicability
Activities
Verification
Code
Calculation
Validation
Computational
Model
Comparator
Assessment
60. 60
V&V Activities
Model Validation – Model Input
System Configuration
•Component Size
•Variation in Locking Region Geometry
– Sensitivity Analyses on Tolerance in
individual component size
• Nominal dimensions
• LMC, MMC
• LMC, MMC
– Both Tibial Component and Tbial Tray
– All component sizes
Lower
Risk
Higher
Risk
Credibility Factors
Software Quality Assurance
Numerical Code Verification
Discretization Error
Numerical Solver Error
Use Error
Model Form
Model Input
Test Samples
Test Conditions
Equivalency of Input
Parameters
Output Comparison
Relevance of the Quantities of
Interest
Relevance of the Validation
Activities to the COU
Applicability
Activities
Verification
Code
Calculation
Validation
Computational
Model
Comparator
Assessment
61. 61
V&V Activities
Model Validation – Model Input
System Conditions
•Insertion of Poly Tibial into Metal Tray
• No Interference Fit
• Interference Fit to capture residual stress
• May have to model the insertion process
Quantify the sensitivity of the modeling assumptions
on modeling predictions
Lower
Risk
Higher
Risk
Credibility Factors
Software Quality Assurance
Numerical Code Verification
Discretization Error
Numerical Solver Error
Use Error
Model Form
Model Input
Test Samples
Test Conditions
Equivalency of Input
Parameters
Output Comparison
Relevance of the Quantities of
Interest
Relevance of the Validation
Activities to the COU
Applicability
Activities
Verification
Code
Calculation
Validation
Computational
Model
Comparator
Assessment
62. 62
V&V Activities
Comparator Validation – Test Samples
•Quantification of locking region
geometry
• Use production parts
• Inspect key parameters
– Understand which tolerance band is tested
• Specifically produce parts
– At targeted dimension within tolerance
band
Lower
Risk
Higher
Risk
Credibility Factors
Software Quality Assurance
Numerical Code Verification
Discretization Error
Numerical Solver Error
Use Error
Model Form
Model Input
Test Samples
Test Conditions
Equivalency of Input
Parameters
Output Comparison
Relevance of the Quantities of
Interest
Relevance of the Validation
Activities to the COU
Applicability
Activities
Verification
Code
Calculation
Validation
Computational
Model
Comparator
Assessment
63. 63
V&V Activities
Validation Assessment – Equivalency of Input Parameters
•Tibiofemoral Contact
•Tibial Tray – Poly Contact
• Apply load through contact patch
– Use Constraints to mimic Tray
• Model Femoral & Tibial Tray as a rigid body
• Model the femoral and Tibial Tray component
Lower
Risk
Higher
Risk
Credibility Factors
Software Quality Assurance
Numerical Code Verification
Discretization Error
Numerical Solver Error
Use Error
Model Form
Model Input
Test Samples
Test Conditions
Equivalency of Input
Parameters
Output Comparison
Relevance of the Quantities of
Interest
Relevance of the Validation
Activities to the COU
Applicability
Activities
Verification
Code
Calculation
Validation
Computational
Model
Comparator
Assessment
64. • Computational modeling is extensively used throughout the total product life cycle.
– Not just to simulate testing, but also to “drive” test methods
• With advancement in computational technologies (both h/w and s/w), CM&S is expanding
to several “non-traditional” disciplines (MRI labeling, drop-testing, morphological analysis,
patient-specific modeling, etc.)
• Researchers are already working on developing tools for using modeling as a surrogate for
clinical studies (in silico patients) and innovative manufacturing processes, such as additive
manufacturing
• FDA guidance is already available for reporting computational modeling studies in the
regulatory submissions.
• After 6+ years of efforts involving multiple members from academia, FDA, and industry, a
V&V standard for using computer models in medical devices is expected to release in the
latter half of 2017.
– A similar guidance from FDA is in works as well
• Efforts are ongoing to expand these V&V efforts by involving regulatory bodies outside of
US (important because devices are made for global population)
Conclusions