This document discusses smart and innovative machining processes. It begins by describing various machining operations like turning, milling, grinding, and wire EDM. It then shows how collaboration between designers, buyers, and manufacturers can lead to design for manufacturing practices that streamline processes. For example, modifying a part design reduced the cost per part from $178 to $37.40 for a lot size of 1,000 parts. The document also covers metal injection molding, noting its suitability for complex small parts in high volumes, and outlines design considerations and capabilities for the process.
Sanford Process Corporation Company Introduction and Recent Anodizing Develop...Sanford Process Co.
Sanford Process is at the forefront of patented innovation in anodizing aluminum; with the first low voltage hard aluminum anodizing system and more recently with micro-crystalline anodizing, MICRALOX. Sanford Process licenses developed technologies and provides contract development work on an exclusive or non-exclusive basis. We deliver validated process and product design solutions with detailed instructions, and can also arrange complete part processing through our sister company, DCHN LLC.
Sanford Process Corporation Company Introduction and Recent Anodizing Develop...Sanford Process Co.
Sanford Process is at the forefront of patented innovation in anodizing aluminum; with the first low voltage hard aluminum anodizing system and more recently with micro-crystalline anodizing, MICRALOX. Sanford Process licenses developed technologies and provides contract development work on an exclusive or non-exclusive basis. We deliver validated process and product design solutions with detailed instructions, and can also arrange complete part processing through our sister company, DCHN LLC.
An internship conducted at Concept Industries, where I researched techniques such as Blade Sputtering and others to make production as efficient as possible, by reducing costs and maximizing revenue
A spherical aluminum oxide abrasive is the best choice for polishing resins like polycarbonate and acrylic. Here's why. Learn more: http://nanophase.com/markets/optical-surface-polishing/
"Nano Alumina Slurries for Improved Polishing on Thermoset and Thermoplastic Resins" was presented by Abigail Hooper at Optifab 2015 in Rochester, NY.
Reducing the Cost Base through Metallurgical Examination of Grinding Balls.Johann Petrick
Grinding balls form the major portion of the consumable cost of mineral processing plants and has been estimated in some instances to be as high as 40–45% of the total cost of comminution. Therefore it is essential that operators understand the Metallurgical properties influencing performance and develop and maintain a robust Quality Control (QC) Program to ensure constant supply of good quality grinding balls.
Conformal Coating Noxious Gas Corrosion Comparison TestMomentive
Silicone conformal coatings' corrosion resistance performance has been tested in comparison to competitive materials such as silicone resin, polyolefin, polyurethane and acrylic. See the results.
Conformal Coating Salt Spray Comparison Test Momentive
Silicone conformal coatings' and other competitive materials such as silicone resin, polyolefin, polyurethane and acrylic underwent salt spray testing to understand their ability to withstand critical elements. See the results.
Controlled experiments and trials have led to improved throughput and cost reduction in filter glass polishing. This presentation explores how to achieve a deterministic process to reduce variability in optical polishing. Learn more: http://nanophase.com/markets/optical-surface-polishing/
"Deterministic Polishing from Theory to Practice" was presented by Abigail Hooper at Optifab 2015 in Rochester, NY.
Company profile SAV Chemicals pvt. ltd.Maxpromotion
We are Joint venture with Taiwan based Cartell Chemicals. With technology support from Taiwan, SAV Chemical aims to provide a total Instant Adhesive Solution to Indian market for both consumer and Industrial segments. To supply the increasing demand of instant adhesives in India, SAV Chemicals offers a range of different grades and packaging. It is a solution for a product range from low viscosity to high viscosity for applications like rubber, metal, acrylic, wood, flex and so on. With the international quality and packing standards, SAV Chemicals MXBON branded products have the USPS' of Reusable, Quick and Strong Bonding, Higher Shelf Life and Competitive Prices. We are increasing our footprints to pan India and currently started work in major cities in India.
Experimental Study on Surface Roughness by Using Abrasive ParticlesIJERA Editor
New advancement of technology and never satisfying demands of the civilization are putting huge pressure on the natural fuel resources and these resources are at a constant threat to its sustainability. Surface finish has a vital influence on functional properties such as wear resistance and power loss due to friction on most of the engineering components. Voltage, mesh number, revolutions per minute (rpm) of electromagnet, and percentage weight of abrasives has been identified as important process parameters affecting surface roughness. The experiments were planned using response surface methodology and percentage change in surface roughness (ΔRa) was considered as response. Analysis of experimental data showed that percentage change in surface roughness (ΔRa) was highly influenced by mesh number followed by percentage weight of abrasives, rpm of electromagnet, and voltage. The process has been investigated extensively in the finishing of cylindrical surfaces. The surface finish was found to improve significantly with an increase in the grain size, relative size of abrasive particles vis-à-vis the iron particles, feed rate and current. Super finishing is a micro-finishing process that produces a controlled and smooth surface condition on work pieces. It is not primarily a sizing operation, its major purpose is to produce a surface on a work piece capable of sustaining uneven distribution of a load by improving the geometrical accuracy. The wear life of the parts micro finished to maximum smoothness is extended considerably. According to the design of experimentation, mathematical model for Lapping operation on advance ceramic material is proposed. In order to get minimum values of the surface roughness, optimization of the mathematical model is done and optimal operation of the examined factors is going to be determined. The obtained res
For more than 75 years we've fostered an unexpected, innovative way of looking at and solving challenges. From the soles of the boots that first walked on the moon to tires that more tightly hug the roads here on earth, we invent solutions that work- solutions that deliver real results.
The Indian Dental Academy is the Leader in continuing dental education , training dentists in all aspects of dentistry and
offering a wide range of dental certified courses in different formats.for more details please visit
www.indiandentalacademy.com
Experimental Investigations on Tribiological Properties of 6061-T6 Al Alloy b...IJAEMSJORNAL
Microstructure and tribological properties of Al-TiB2 nano surface composite fabricated by Friction Stir Processing (FSP) were evaluated. To vary the percentage of TiB2 three different slot thickness viz. 1mm, 1.5 mm and 2mm were considered. Microstructural evaluations showed a nearly uniform distribution of TiB2 in the aluminium matrix after FSP with the addition of composite powder. Microhardness test results shoes FSW of Al6061-T6 alloy with 2mm groove width has more hardness. tribological properties were evaluated at two different sliding velocities 0.314m/s and 0.48m/s and results shows that at lower loads there is no much difference in wear rate of surface composite made with different slot sizes but with increase in load and sliding velocity wear rate was increased , however, larger slot Al6061-TiB2 Surface composites show better wear resistance.
FDA and other governing bodies controlling the standards of medical devices are reaching deeper into the supply chains that support OEMs. As a result, OEMs are now re-evaluating their supplier quality strategies to ensure that every machined component and piece of raw material entering their production floor is 100 percent validated – making quality management a more complex undertaking. Evaluating material suppliers from a risk mitigation standpoint has become a challenging, and somewhat elusive, undertaking for manufacturers of medical devices. The session will answer the questions: What is risk mitigation as it applies to raw material suppliers in the medical device industry? How can orthopaedic device companies combat it?
OEMs and suppliers see promise in the ability of manufacturing and software to expand the use of custom implants in orthopaedics. Multiple companies are focused on the custom market. This session provides the surgeon perspective on these devices. What are the benefits? When should and shouldn't they be used? Will the market take off?
An internship conducted at Concept Industries, where I researched techniques such as Blade Sputtering and others to make production as efficient as possible, by reducing costs and maximizing revenue
A spherical aluminum oxide abrasive is the best choice for polishing resins like polycarbonate and acrylic. Here's why. Learn more: http://nanophase.com/markets/optical-surface-polishing/
"Nano Alumina Slurries for Improved Polishing on Thermoset and Thermoplastic Resins" was presented by Abigail Hooper at Optifab 2015 in Rochester, NY.
Reducing the Cost Base through Metallurgical Examination of Grinding Balls.Johann Petrick
Grinding balls form the major portion of the consumable cost of mineral processing plants and has been estimated in some instances to be as high as 40–45% of the total cost of comminution. Therefore it is essential that operators understand the Metallurgical properties influencing performance and develop and maintain a robust Quality Control (QC) Program to ensure constant supply of good quality grinding balls.
Conformal Coating Noxious Gas Corrosion Comparison TestMomentive
Silicone conformal coatings' corrosion resistance performance has been tested in comparison to competitive materials such as silicone resin, polyolefin, polyurethane and acrylic. See the results.
Conformal Coating Salt Spray Comparison Test Momentive
Silicone conformal coatings' and other competitive materials such as silicone resin, polyolefin, polyurethane and acrylic underwent salt spray testing to understand their ability to withstand critical elements. See the results.
Controlled experiments and trials have led to improved throughput and cost reduction in filter glass polishing. This presentation explores how to achieve a deterministic process to reduce variability in optical polishing. Learn more: http://nanophase.com/markets/optical-surface-polishing/
"Deterministic Polishing from Theory to Practice" was presented by Abigail Hooper at Optifab 2015 in Rochester, NY.
Company profile SAV Chemicals pvt. ltd.Maxpromotion
We are Joint venture with Taiwan based Cartell Chemicals. With technology support from Taiwan, SAV Chemical aims to provide a total Instant Adhesive Solution to Indian market for both consumer and Industrial segments. To supply the increasing demand of instant adhesives in India, SAV Chemicals offers a range of different grades and packaging. It is a solution for a product range from low viscosity to high viscosity for applications like rubber, metal, acrylic, wood, flex and so on. With the international quality and packing standards, SAV Chemicals MXBON branded products have the USPS' of Reusable, Quick and Strong Bonding, Higher Shelf Life and Competitive Prices. We are increasing our footprints to pan India and currently started work in major cities in India.
Experimental Study on Surface Roughness by Using Abrasive ParticlesIJERA Editor
New advancement of technology and never satisfying demands of the civilization are putting huge pressure on the natural fuel resources and these resources are at a constant threat to its sustainability. Surface finish has a vital influence on functional properties such as wear resistance and power loss due to friction on most of the engineering components. Voltage, mesh number, revolutions per minute (rpm) of electromagnet, and percentage weight of abrasives has been identified as important process parameters affecting surface roughness. The experiments were planned using response surface methodology and percentage change in surface roughness (ΔRa) was considered as response. Analysis of experimental data showed that percentage change in surface roughness (ΔRa) was highly influenced by mesh number followed by percentage weight of abrasives, rpm of electromagnet, and voltage. The process has been investigated extensively in the finishing of cylindrical surfaces. The surface finish was found to improve significantly with an increase in the grain size, relative size of abrasive particles vis-à-vis the iron particles, feed rate and current. Super finishing is a micro-finishing process that produces a controlled and smooth surface condition on work pieces. It is not primarily a sizing operation, its major purpose is to produce a surface on a work piece capable of sustaining uneven distribution of a load by improving the geometrical accuracy. The wear life of the parts micro finished to maximum smoothness is extended considerably. According to the design of experimentation, mathematical model for Lapping operation on advance ceramic material is proposed. In order to get minimum values of the surface roughness, optimization of the mathematical model is done and optimal operation of the examined factors is going to be determined. The obtained res
For more than 75 years we've fostered an unexpected, innovative way of looking at and solving challenges. From the soles of the boots that first walked on the moon to tires that more tightly hug the roads here on earth, we invent solutions that work- solutions that deliver real results.
The Indian Dental Academy is the Leader in continuing dental education , training dentists in all aspects of dentistry and
offering a wide range of dental certified courses in different formats.for more details please visit
www.indiandentalacademy.com
Experimental Investigations on Tribiological Properties of 6061-T6 Al Alloy b...IJAEMSJORNAL
Microstructure and tribological properties of Al-TiB2 nano surface composite fabricated by Friction Stir Processing (FSP) were evaluated. To vary the percentage of TiB2 three different slot thickness viz. 1mm, 1.5 mm and 2mm were considered. Microstructural evaluations showed a nearly uniform distribution of TiB2 in the aluminium matrix after FSP with the addition of composite powder. Microhardness test results shoes FSW of Al6061-T6 alloy with 2mm groove width has more hardness. tribological properties were evaluated at two different sliding velocities 0.314m/s and 0.48m/s and results shows that at lower loads there is no much difference in wear rate of surface composite made with different slot sizes but with increase in load and sliding velocity wear rate was increased , however, larger slot Al6061-TiB2 Surface composites show better wear resistance.
FDA and other governing bodies controlling the standards of medical devices are reaching deeper into the supply chains that support OEMs. As a result, OEMs are now re-evaluating their supplier quality strategies to ensure that every machined component and piece of raw material entering their production floor is 100 percent validated – making quality management a more complex undertaking. Evaluating material suppliers from a risk mitigation standpoint has become a challenging, and somewhat elusive, undertaking for manufacturers of medical devices. The session will answer the questions: What is risk mitigation as it applies to raw material suppliers in the medical device industry? How can orthopaedic device companies combat it?
OEMs and suppliers see promise in the ability of manufacturing and software to expand the use of custom implants in orthopaedics. Multiple companies are focused on the custom market. This session provides the surgeon perspective on these devices. What are the benefits? When should and shouldn't they be used? Will the market take off?
Orthopaedic Care Shifts to Outpatient and Urgent Care ClinicsApril Bright
The Shift in Care Delivery - As the healthcare delivery system evolves, hospitals may no longer be the first stop for patients seeking orthopaedic care. This is evidenced by the growing trend of surgeons moving to the outpatient setting, as patients seek less invasive procedures. Orthopaedic urgent care centers have also emerged as a viable alternative, due to their ability to address price concerns in the industry by reducing time and overhead costs for both providers and patients.
Attendees gain more insight into this shift, and learn how it will affect demands on manufacturers from a product design and delivery standpoint.
Surgeon Perspective on Additive Manufacturing April Bright
As additive manufacturing gains popularity as a production process, it’s important to understand the perspective of surgeons engaged with the technology. Nirav Shah, M.D., has consulted with device companies on additively-manufactured implants and is involved in the research of 3D-printed tissue. He will share his perspective and research on the current state of additive manufacturing in orthopaedics, and provide ideas on how the technology could be used in the future.
Modernize the Orthopaedic Supply Chain: A Surgeon’s ViewApril Bright
Orthopaedic device manufacturers face increased pressure to assist their hospital customers with the shift to value and accompanying quality and cost mandates. Hospitals have responded to these pressures by supporting more surgeries with reduced hospital and vendor staff, making the implant management process ripe for errors.
As the Hospital for Special Surgery's Chief of Knee Services since 2006 and Co-Chairman of the Quality Coordinating Committee since 2008, Steven Haas, M.D., has experienced firsthand the way that tremendous inefficiencies in the implant delivery system impact surgical outcomes and lead to greater costs for the hospital and manufacturer. For orthopaedic device company attendees, Haas will offer recommendations to assist hospital partners in meeting quality and cost demands.
During his Keynote Address, Haas will explain how technology can modernize the orthopaedic supply chain, including inventory management and the device labeling process, and eliminate "never events."
We’re at a point in healthcare where every dollar is watched, and a more efficient supply chain could be used to offset the cost of newer or improved implants.
Orthopaedic Device Industry Business Models: 2020 and BeyondApril Bright
During last year’s closing keynote, Dr. Wael Barsoum underscored the importance of producing transformational, innovative products to stay competitive and maintain a strong company and a healthy supply chain. This year, Dr. Bill Tribe will shine the “innovation lens” on the value of transforming your business.
Dr. Tribe co-authored the often-cited “Medical Devices: Equipped for the Future?” study in which the orthopaedics sector is called out specifically as facing an extreme combination of forces — none of which come as a surprise or are new, but when viewed holistically (as in the image below), paint a rather obvious picture of the need for companies to respond. As you can see, orthopaedics is the only sector with 4 of 5 “hot” areas…and in this case, the odd one out (regulatory scrutiny) is still marked “critical.”
From a top-down view, the five “disruptors” listed above are acute (power shift to payors, regulatory scrutiny, unclear sources of innovation, new healthcare delivery models, need to serve lower socio-economic classes). They impact the overall orthopaedic industry intensely – but how are they impacting you? Dr. Tribe’s Keynote Address will take into account the uniqueness of the OMTEC audience: large and small OEMs, Suppliers and Service Providers.
As stated in the A.T. Kearney study, “Each company faces a different set of headwinds…while the macro-factors held true, individual experiences and prioritization depended on factors such as market geography, product life cycles and go-to-market strategies. The most effective strategies are therefore likely to be company specific.”
What will be your business model in 2020? 2025?
Will you be considering cost-structure, deployment of inventory, commercial logistics, quality and regulatory frameworks, R&D, innovation and data collection?
Dr. Tribe will break down the issues and share potential approaches to help you navigate toward a more relevant and lucrative business model – regardless of where you are in the process.
Predicting an instrument's performance over time is essential to the design phase. This session will cover reliability testing and performance deterioration, including recommendations for tests that should be performed to ensure that an instrument will function through a lifetime of use, and ways to collect measurable outputs of the instrument from initial use to the end of its lifecycle.
Defining Your Leadership Style in a Performance-Based OrganizationApril Bright
To be an effective leader, you must learn to recognize that in different organizational situations, the style of leadership may need to change to be successful. This presentation discusses what defines a performance-based organization and how to improve accountability and responsibility. Attendees receive guidance on how to set expectations, how to achieve continued efficiency from a highly-focused group, how to push an underperforming group to productivity and how to be an effective leader to tenured vs. millennial employees.
As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including:
How does FDA recommend we direct mark screws and small implants?
How should we proceed as we await the guidance on the Convenience Kit exemption?
What are best practices for entering submissions to GUDID?
How is FDA enforcing UDI?
FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.
CAPA: Using Risk-Based Decision-Making Toward ClosureApril Bright
Implementing a risk‐based CAPA process within a QMS is a necessity in the improvement of controls aligned with product and process non-conformances, adverse events, audit findings, complaints, etc. Making decisions concerning scope and extent about these “defectives” is a modern and cost-saving approach to improvement and compliance. Every non-conformity does not force you to open a corrective action. While almost every problematic issue needs at least a correction, the biggest payback is to use corrective actions on systemically-driven problems that are repetitive and recurring.
Applying the methods of determining risk to the device’s complete life cycle will give your company a complete look at all of the device’s risks—including those relative to processes. Manufacturers should be able to justify that they have reduced the risks as far as possible as part of their risk management plan and ongoing corrective and preventive actions.
Unique Device Identification or UDI is a forever project. What's the best way for orthopaedic device companies to receive return on their investment? What best practices can be learned for a continually-smooth process? How can the data be leveraged to enhance your company’s value proposition? The true value of UDI is not in the identification number, but in the data that can be generated as a result of UDI. This session will provide attendees with an outline of the opportunities that manufacturers can leverage beyond implementation.
Packaging Solutions that Improve Time to MarketApril Bright
This session will discuss packaging solutions designed to improve time to market and lower costs for OEMs. Kelly Lucenti will discuss challenges imposed from the research and development phase to production, as well as trending issues with packaging design and validations. The presentation will highlight the importance of OEMs engaging their packaging groups early in the design phase, and ways that leveraging existing validations can speed time to market and cut major costs.
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.
Design for Manufacturability Rapid Fire April Bright
Design for manufacturability (DFM) is a broadly-implemented step in today’s development process to ensure that a designed product can actually be manufactured. While the concept sounds simple, there are nuances to every supplier relationship and every new process.
Three suppliers—a contract manufacturer, additive manufacturer and plastics company—will each spend 15 minutes answering the following question: With orthopaedic customers, our greatest DFM pain point is ___ and the best strategy to change that is ___.
OEMs will learn best practices and ways to approach DFM with their supplier partners.
How to Make Postmarket Surveillance More Cost EffectiveApril Bright
When it comes to postmarket surveillance (PMS), it’s common for the costs to outweigh the value. But, by working with the right team, you’ll be able to execute a study that maximizes return on investment and minimizes the financial impact of conducting further observational research. Postmarket study challenges that must be addressed include enrollment delays, patient attrition, long-term follow-up, resourcing demands and global payor requirements. This session will provide a case study of one orthopaedic company’s seamless transition between postmarket approval and post-approval studies.
Coatings for implants and instruments continue to evolve as manufacturers seek the best surface for their devices. Attendees will leave this session with knowledge of new coating research and manufacturing techniques. Three suppliers will speak on the benefits, applications and manufacturing processes of three different coatings. A Q&A with all three presenters will follow.
What Is It? Product Development vs. Product Management April Bright
This session will focus on the respective roles and responsibilities of the Product Manager vs. the Development Engineer from a product’s inception through its lifecycle maintenance. Attendees will learn how to leverage the cross-functional product team to deliver results, business vs. technical aspects of product development, putting the customer first and navigating the organization in order to get things done.
Strategies for Device Approval in China, India, South Korea and AustraliaApril Bright
This session will describe the orthopaedic device regulatory and registration requirements in Asia Pacific markets. Regulatory steps and strategies will be presented for each of these countries. The discussion will also cover ways to gain regulatory information about competitors already selling in these markets. Attendees will leave the session with an understanding of timelines, costs and complexity for approval.
Steps to Compliance with the European Medical Device RegulationsApril Bright
The trilogue negotiations for the European Medical Device Regulations are expected to conclude by June. Whether or not the long-awaited regulations receive another postponement, orthopaedic manufacturers cannot put off preparation or they risk their ability to sell products in Europe. Dr. Tariah will walk attendees through the greatest pain points for orthopaedic manufacturers when complying with the new regulations.
Significant changes are underway that impact the quality and regulatory systems of medical device companies and their suppliers. ISO 13485:2016 adds new requirements to address risk management and to better align the standard with global regulatory requirements (FDA, MDD, JPAL, etc.). With the release of ISO 9001:2015, the ISO 9001 and ISO 13485 standards are no longer integrated. A new single audit MDSAP program will be in effect beginning 2017 that incorporates applicable FDA, Canadian, Brazilian, Australian and Japanese quality system requirements into the annual ISO 13485 audit cycle. The presentation will provide an overview of these changes and the steps required to incorporate these changes into existing quality management systems.
It's a presentation prepared by me on Chemical milling a type of non traditional machining process to help the students to know the key concept about it.
I am John Nash . Currently associated with matlabassignmentexperts.com as a Matlab Homework Help Expert. After completing my Master's in Mechanical Engineering, University of Sydney, I was in search of an opportunity that would expand my area of knowledge hence I decided to help students with their homework. I have written several Design and Manufacturing Assignments to help students overcome numerous difficulties.
Embedded capacitors can be placed inside of magnetics, power converter silicon, or even the PCB. Based on our AO-CAP's aluminum polymer technology, our KAP is an embedded capacitor.
This presentation shows a preview of the technology. Use the contact form below if you'd like to discuss for your application.
Presented at APEC 2017 in Tampa, Flordia.
Assembly of the components (Crank shaft, Connecting rod, Gudgeon pin and Piston) by
using different manufacturing processes from the material generated as a scrap during
manufacturing of different products through various processes.
Surface hybrid nanocomposites via friction stir processingmohammed noor
Friction stir Processing (FSP) is a new innovative technology developed based on the principle of Friction Stir Welding (FSW) technique.
In FSP, the ceramic particulates are reinforced into the base metal by adding it into the groove and Friction Stir Processing (FSP) is performed.
In this study, the aluminum alloy 6061 is chosen as the base metal, alumina and graphite Nano powder as reinforcement.
The process parameters such traverse speed of 64 mm/min and the tool rotational speed of 1060 rpm and tilt angle of 2deg were selected, The Friction Powder Processing was carried out on vertical milling machine.
New parameters such as powder type and number of passes were involved and we also study the effect of heat treatment.
The influence of FSP was checked using some tests such as the microstructure analysis that was carried out using optical microscope (OM) and the mechanical characteristics were analyzed using tensile test and hardness test.
The micrograph results revealed that powder particulates were evenly distributed in the stir zone and reduction in grain size also observed; the reason for the grain size reduction was stirring action of the FPP tool’s pin.
The tensile strength results showed a significant improvement in strength by a percent of
50% compared to base metal but when T6 heat treatment is applied, the tensile strength decreased.
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.
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.
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.
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.
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.
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
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.
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.
3. EDMTurning
When Do I Choose Machining?
Tight Tolerance • Complex Geometry • Repeatable Process • Surface Finishes
Metal Sintering Injection Molding
GrindingEDMMilling Turning
The Challenging Way
Machining
15. Lot Size 50
Part Price: $178.00
Total: $8,900.00
Lot Size 1,000
Part Price: $60.00
Total: $60,000.00
Lot Size 1,000
Part Price: $37.40
Total: $37,400.00
Cost of Original Design
“DFM”
Cost of New Design
Lot Size 50
Part Price: $116.00
Total: $5,800.00
Savings
Lot Size 50
Total Savings: $3,100.00
Lot Size 1,000
Total Savings: $22,600.00
16. Smart and Innovative Machining
Designer:
Reduced
Lead Time
Buyer:
Reduced
Cost
Machining for:
• Complex Geometry
• Tight Tolerance
• Surface Finish
• Repeatable
Manufacturer:
Streamlined
Process
18. Praxis Overview
Contract manufacturer of titanium components
Medical Device Manufacturing since 2008
Solely focus on titanium PM
ISO 13485 Certified | Production and Design
19. Overview
Titanium Metal Injection Molding
Technology overview
Value proposition
Cost comparison to machining
Considerations for molding
Limitations of molding
Secondary operations for MIM
20. MIM – Metal Molding Technology
Metal Injection Molding
MIM is a forming process using powdered metal, high
pressure and thermal energy to efficiently make small,
complex parts.
The design versatility of plastic injection molding with
the performance of metal
21. General MIM Process
Step 1: Feedstock Formation
• Mixture of powdered metal with binder
Step 2: Injection Molding
• Binder melts and flows into the mold carrying
metal powder which forms a green part
Step 3: De-binding
• Removal of the binder via thermal or chemical
methods
Step 4: Sintering
• A thermal process at ~70-90% of a materials
melt temperature, the component undergoes
significant shrinkage (~12-20% linear) resulting
in a density of >98%
Additional Secondary Processing: HIP, heat treating,
machining, surface finish, cleaning, passivation, laser
marking
22. Value of titanium MIM
MIM provides cost savings through better material utilization
Reduction in part weight through design
Reduction in raw material usage
Typically COGS reduction of 25% minimum to initiate MIM project
Increased profitability through reduced COGS
Enhanced design flexibility
Well suited for parts <50 g
Combination of components
Adding complexity may not add cost
Maintain bar stock material performance (Ti-6Al-4V)
24. Manufacturing method considerations
Machining Factor Molding
Simpler 3D geometry
>25% effective density
Geometry Complex 3D geometry
<25% effective density
N/A Size
<150 g (0.3 lbs)
<6” OAL
>0.02” wall thickness
< +/-0.001” Tolerances > +/-0.001” to +/-0.003”
<10k Annual Volume >10k
Note: general considerations
25. Effective density
Bar stock versus powder - Ti-6Al-4V
Powder cost is ~3x of bar stock
Powder material costs are equal to bar
stock after 73% of bar stock has been
machined away
MIM candidates have low effective
densities
Typically ~25% of the material density
Effective Density = part mass / initial volume
26. MIM Considerations
Annual volumes
Design Freeze
Upfront costs and lead times
Mold cost & lead time
Product development cost & lead time
Secondary operations
Existing product: convert from machined to MIM
New product: design for MIM
27. Mold: Timelines and Approximate Costs
Description Lead time / costs
Prototype Mold
1-6 weeks
$5k - $20k
Production Mold
6-12 weeks
$15k - $100k
Mold life: typically 100k cycles without maintenance
28. Design Guidelines
Desirable
• Aspect ratios of 5:1 or less preferred
• Uniform wall thickness is desired, with max variation around 5X
• Wall thickness larger than 0.020 in and smaller than 0.5 in
• Minimum draft 0.5°
• Cored out features to reduce part weight
• Flat surfaces
Allowable
• Asymmetry
• Ribs and bosses
• Grooves and threads
• Decorative features (i.e. texture, logo, lettering)
Avoid
• Undercuts, no drafts
• Small diameter holes <0.050”
• Sharp corners or points
• Wall thickness <0.020”
• Large parts, parts with high aspect ratio
29. MIM Design Considerations
Gating
Location, removal, vestige
Parting line
Mismatch and flash allowances
Ejector mark
Protrusions and depression allowances
Injection molded specific issues
Mating components
Critical surfaces
Functional / cosmetic
allowances
30. Dimensional Capabilities
• Dimensional precision of +/- 0.1% to +/- 0.5%
• Influenced by feature type and geometry
• Typical mass: 0.01g to 150g
• Wall thickness: from 0.5 mm (0.020 in) to 12 mm (0.5 in)
• Size range is heavily geometry dependent
• Surface finish
• Bead blast finish of ~32 µ in. Ra
• Polished finish of <10 µ in. Ra
• Minimum radius 0.07 mm (0.003 in)
31. Secondary Operations for MIM
• Potential secondary operations of MIM components:
• Machining
• Tolerances exceeding +/-0.1% will require secondary machining
• Drilling & tapping
• Polishing & grinding
• Passivation & anodizing
• Laser welding
MIM product and mold cost can be optimized based on mold
complexity, secondary operations and annual volume.
32. Value proposition
• Enhanced profitability over conventional alternatives
• Complex, small to medium sized parts
• Enhanced design flexibility
• Comparable material performance
• High volume manufacturing capability