Avoid Post-M&A Supply Chain Surprises - OMTEC 2017
•
1 like•2,054 views
The primary responsibility of the post-close supply chain transition team is to achieve and maintain uninterrupted upstream supply and an excellent downstream customer experience while delivering the projected savings from the combined company. This presentation provides guidance on ways to identify, assess and avoid or minimize opportunities for supply chain disruption immediately after closing, as well as best practices for successful supply chain consolidation and integration.
Report
Share
Report
Share
Download to read offline
Recommended
Operations: Top Reasons for Long Lead Times and What to Do About Them
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.
Plan for Success Strategies to Align Reimbursement and Commercialization - OM...
Product launch is not the time to start securing reimbursement for your device. Reimbursement remains a complex process for orthopaedic companies that could be lessened if properly aligned throughout commercialization. Mr. Hunter shares the who, what and when of reimbursement to ensure that you’ve received proper coverage prior to launch.
Leverage Computational Modeling and Simulation for Device Design - OMTEC 2017
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.
Regulatory and Quality Affairs: Answers to FDA and ISO Gray Areas
The document discusses regulatory gray areas and provides examples of how experts navigate ambiguous requirements. It addresses topics like complaints, clinical evaluation reports, unique device identification, and validation sample sizes. For complaints, it provides case examples and discusses when to investigate and report. For clinical evaluation reports, it discusses author credentials and responding when not all indications have data. For unique device identification, it discusses applicability based on size. For validation, it discusses sample size requirements and working with suppliers. Finally, it discusses supplier relationships and appropriate handling of defects. The key takeaway is that communication, documentation, and asking for help can aid in navigating regulatory uncertainties.
How to Assess New Technology - OMTEC 2017
Creating robust product pipelines is a top priority for most global orthopaedic device companies, yet our industry’s commercial success rate for new product launches remains less than 20%. Traditionally one of the largest contributors to the less-than-stellar success rate is failure in the very first steps of the development process: a new technology assessment. We will examine the ways that companies address challenges associated with new technology assessments, and some of the key lessons learned.
Analyze and Optimize Your Supply Chain Operations for Higher Performance - OM...
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.
Computational Modeling & Simulation in Orthopedics: Tools to Comply in an Ev...
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.
QMS Effectiveness: Tracking and Trending Quality Data - OMTEC 2017
What measurements are useful, and which metrics’ baseline makes sense to show the effectiveness of your quality management system? This presentation takes an ISO 13485 and 21 CFR, Part 820 approach to deciding what measurements are important, how trending makes an impact on risk-based decision-making, and why management review is just one of the ways to discuss and document your Quality Data activities.
Recommended
Operations: Top Reasons for Long Lead Times and What to Do About Them
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.
Plan for Success Strategies to Align Reimbursement and Commercialization - OM...
Product launch is not the time to start securing reimbursement for your device. Reimbursement remains a complex process for orthopaedic companies that could be lessened if properly aligned throughout commercialization. Mr. Hunter shares the who, what and when of reimbursement to ensure that you’ve received proper coverage prior to launch.
Leverage Computational Modeling and Simulation for Device Design - OMTEC 2017
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.
Regulatory and Quality Affairs: Answers to FDA and ISO Gray Areas
The document discusses regulatory gray areas and provides examples of how experts navigate ambiguous requirements. It addresses topics like complaints, clinical evaluation reports, unique device identification, and validation sample sizes. For complaints, it provides case examples and discusses when to investigate and report. For clinical evaluation reports, it discusses author credentials and responding when not all indications have data. For unique device identification, it discusses applicability based on size. For validation, it discusses sample size requirements and working with suppliers. Finally, it discusses supplier relationships and appropriate handling of defects. The key takeaway is that communication, documentation, and asking for help can aid in navigating regulatory uncertainties.
How to Assess New Technology - OMTEC 2017
Creating robust product pipelines is a top priority for most global orthopaedic device companies, yet our industry’s commercial success rate for new product launches remains less than 20%. Traditionally one of the largest contributors to the less-than-stellar success rate is failure in the very first steps of the development process: a new technology assessment. We will examine the ways that companies address challenges associated with new technology assessments, and some of the key lessons learned.
Analyze and Optimize Your Supply Chain Operations for Higher Performance - OM...
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.
Computational Modeling & Simulation in Orthopedics: Tools to Comply in an Ev...
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.
QMS Effectiveness: Tracking and Trending Quality Data - OMTEC 2017
What measurements are useful, and which metrics’ baseline makes sense to show the effectiveness of your quality management system? This presentation takes an ISO 13485 and 21 CFR, Part 820 approach to deciding what measurements are important, how trending makes an impact on risk-based decision-making, and why management review is just one of the ways to discuss and document your Quality Data activities.
FDA Inspections are Different from ISO Audits, So Don't Treat Them the Same -...
ISO audits and FDA inspections differ logistically, and should be approached in different manners. This presentation will explain the real-time differences between the two and, most importantly, give you strategies for preparation, behavioral tips for success during and after the assessments and recommendations for responding to the Registrar or FDA if deficiencies were discovered.
Integrating Mobile Health into Product Development - OMTEC 2017
This presentation focuses on consumer trends and engagement along with ideas for integrating mobile health into product development and sales and marketing.
Design Controls: Building Objective Evidence and Process Architecture to Mee...
This session provides detailed examples to demonstrate what objective evidence is important to generate and use during design control compliance but, more importantly, to develop and issue a beneficial design history file meeting the requirements in 21 CFR, Part 820.30 and ISO 13485:2016. Aside from the importance of design controls for compliance, Mr. Gagliardi demonstrates how this section of the QS regulation and the ISO standard can be facilitated as a leading edge business tool.
Additive Manufacturing - Design Considerations Rapid Fire - OMTEC 2018
Easing the Secondary Production Process During Design: The design stage is where the smart decisions are made in additive manufacturing — not only on ways to increase clinical outcomes and additive processes, but also to ease post-processing. In these areas, the process can be made efficient and cost-effective. Receive tips and tricks on orientation, supports, stock material and design features.
Enhancing Design through Engineering and Manufacturing Collaboration: Unlike conventional methods, additive manufacturing requires design and manufacturing teams to work closely together very early in the design phase. In a world where the pace of innovation is nearly vertical, it’s imperative to understand this concept early to make additive manufacturing work for you. This discussion lends a high-level overview of best practices when working with internal or external suppliers, and shows examples of the use of additive manufacturing to create innovative medical device designs.
Vital QMS Process Validation Statistics - OMTEC 2018
According to 21 CFR, Part 820, medical device manufacturers are required to validate as well as monitor and control parameters for their processes. The guideline on Quality Management Systems does not specify how this is accomplished; only that “a process is established that can consistently conform to requirements” and “studies are conducted demonstrating” this. Thorough process development, optimization and control using appropriate statistical methods and tools is recommended for demonstrating that your process is both stable and capable. This session will demonstrate ways to efficiently and effectively apply recommended statistical methods and tools to process validation—with no statistical expertise needed. Using realistic process data, participants will learn how to apply tools, interpret results and draw meaningful conclusions throughout Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
Packaging Solutions that Improve Time to Market
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.
FDA Update: Inspections, Observations and Metrics - OMTEC 2017
This FDA-focused presentation offers a glimpse into trends behind three initiatives that orthopaedic device professionals need to fully understand: inspections, Case for Quality and 483 Observations. First, a high-level view of FDA inspections will discuss methodology and implementation. Second, FDA’s observations of non-compliance will be discussed, pointing out important historical trends. Finally, as the industry matures, professionals should expect changes to the breadth and depth of FDA’s focus. This is where Case for Quality and the Medical Device Metrics Initiative will be covered. FDA has placed an increased emphasis on data and metrics. Gain insight into ways to leverage data to improve, monitor and control processes that drive quality improvement.
Additive Manufacturing: Considerations for Powder Metals - OMTEC 2017
As metal powder additive manufacturing advances from rapid prototyping to mass production, the importance of powder characteristics and composition has become widely recognized. In this presentation, various techniques for powder production will be explored, with the emphasis on variants in atomization technology. Conventional and emerging techniques for measuring powder characteristics will be discussed. Analysis of finished components that meet or exceed expected properties, while at the same time taking advantage of revolutionary part design, will be addressed. It is the intent to assist component designers and manufacturing engineers in both alloy selection and specification determination for optimum property results.
Together for sustainability -
Intertek provides strategic support across the entire supply chain through testing, inspection, auditing, and certification services. They have a global network with over 35,000 employees in more than 100 countries. Their services help clients innovate while complying with regulations, focus on core business by mitigating risks, and make decisions based on data. Case studies show how they have helped clients with regulatory compliance, material selection, sustainability assessments, and developing partnerships with suppliers.
Additive Manufacturing: Industry Addresses Standards, Quality, Evidence Build...
The SME Medical Additive Manufacturing/3D Printing Workgroup collaborates to identify challenges, develop resources and facilitate changes to support anyone using the technologies for medical/biomedical applications. Ms. McDaniel shares the group's progress and the headwinds that remain with non-technology barriers to adoption.
Leveraging Data to Develop, Execute and Exceed the Expectations of Your Regu...
Scientific data, homegrown or from published literature, is essential to your regulatory strategy…be it establishing substantial equivalence in FDA 510(k) applications, qualifying a device as a legitimate predecessor in the context of a Technical File for CE Mark, predicting the performance of a device in development, judging a new device in verification and validation testing and, with proper planning, expanding indications for use and identifying new marketable claims of performance (or mitigation of risk and liability). In this session, participants will be exposed to various vital data sources and obtain practical examples for putting them to meaningful use.
How to Make Postmarket Surveillance More Cost Effective
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.
Modernize the Orthopaedic Supply Chain: A Surgeon’s View
This document discusses modernizing the orthopedic supply chain from a surgeon's perspective. It describes current issues with the supply chain that can lead to medical errors and waste, including complex compatibility rules between implant systems, small labels, and time pressure in the operating room. The author outlines a new system called OrthoSecure that uses barcodes and electronic displays to efficiently check implant compatibility and prevent errors. A study found this system prevented all errors in over 4,600 joint replacements and reduced wasted implants. The document advocates expanding this approach and using supply chain data to further increase efficiency and cost savings.
Global Regulatory Outlook: 2017 and Beyond - OMTEC 2017
This document provides an overview of global regulatory trends in 2017 and beyond for medical devices. Key points include increased emphasis on clinical data and post-market surveillance across regions. The EU is transitioning to the new Medical Device Regulation which increases requirements for technical documentation and quality management systems. Notified Bodies face challenges meeting demand under new rules. The US 21st Century Cures Act aims to streamline approval of certain lower-risk devices and accessories. Single audits through the Medical Device Single Audit Program may replace some regulatory inspections globally.
CAPA: Using Risk-Based Decision-Making Toward Closure
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.
Additive Manufacturing Discussion Panel – Developing a Roadmap for Regulatory...
FDA published guidance on additive manufacturing technical considerations in late 2017, outlining the Agency’s long-awaited position on use of the technology for medical devices. At the time, FDA said that the 31-page document was considered “leapfrog” guidance, a term reserved for the Agency’s anticipation that its initial thoughts on an emerging technology will change over time. In short, more questions and answers have arisen — and will continue to do so as the technology is adopted. This FDA guidance is critical to the additive manufacturing narrative. However, standards and best practices surrounding the technology are being discussed globally on a daily basis. This discussion puts representatives from ASTM, FDA, SME and DePuy Synthes in one room, for one conversation, that will provide attendees with practical, actual guidance not only for current times, but also for what is on the horizon.
How Design Controls & Risk Management Best Practices Reduce Customer Complain...
We all know how much emphasis FDA inspectors and ISO auditors place on your customer complaint and CAPA processes. And rightfully so.
But what if there were things you could do to minimize the struggles and challenges associated with customer complaint and CAPA management?
Good news. You can decrease the number of customer complaints and reduce the volume of issued CAPAs through good product development Design Controls and Risk Management practices.
Specifically this presentation will cover:
-Influence Design Controls has on Customer Complaints
-How Customer Complaints impact your CAPA system
-Best practices for Design Controls
-Best practices for Risk Management
-Risk-based approaches to Customer Complaint and CAPA management
FDA Design Controls: What Medical Device Makers Need to Know
The document provides an overview of a presentation on FDA Design Controls. It introduces the two presenters, David Amor and Jon Speer, who are experts in medical device quality systems and design controls. The presentation will cover topics related to design controls regulations, including intended use, user needs, design inputs, design reviews, risk management, design outputs, design verification and validation, and regulatory submissions. It is meant to help medical device companies understand and comply with FDA design control requirements.
5 Predictions for the Medical Device Industry in 2018 (and how you can prepare)
What should the medical device industry expect in 2018?
Great question.
From ISO 13485 being revised in 2016, the EU MDR / IVDR being revised in 2017, and the MDSAP program going live in 2017, regulatory changes have been rampant and significant for medical device professionals.
This presentation covers:
- Why you should expect it to be harder for devices to get to market and stay there in the EU
- How to avoid the mad dash to update ISO 13485 certification before the deadline
- Where the latest revision of ISO 14971 is and when to expect the next update
- About Health Canada and their MDSAP deadline
- Why companies are shifting from being compliance-focused to quality-focused
Watch the presentation, commentated by Greenlight Guru's founder Jon Speer, here: https://www.greenlight.guru/webinar/2018-medical-device-industry-predictions
The Medical Device Milestone Map
Medtech start-ups from inception to exit: what are the key milestones and what are the ACTUAL timelines and costs?
A data-driven approach to figuring out the new reality of medical device venture capital investing.
Ia perspective-on-supply-chain-risk
The document discusses the growing challenges that companies face from supply chain risk and how internal audit functions can help address these challenges. It notes that supply chain disruptions can significantly hurt profitability, shareholder value, and reputation. It recommends that companies take a holistic approach to identifying critical suppliers and assessing their financial health and stability to develop leading risk indicators. It also suggests that internal audit can help by reviewing supply chains to identify vulnerabilities, developing monitoring processes, and assessing risk controls. The overall message is that internal audit can play a key role in helping companies strengthen their supply chain risk management.
Supply Chain optimization & risks factors
This white paper discuss on building a supply chain beyond risks factors surrounding organization operations. Companies today work on several supply chain strategies to improve their supply chain.
Risk factors in as-is process and how to eliminate those risks.
More Related Content
What's hot
FDA Inspections are Different from ISO Audits, So Don't Treat Them the Same -...
ISO audits and FDA inspections differ logistically, and should be approached in different manners. This presentation will explain the real-time differences between the two and, most importantly, give you strategies for preparation, behavioral tips for success during and after the assessments and recommendations for responding to the Registrar or FDA if deficiencies were discovered.
Integrating Mobile Health into Product Development - OMTEC 2017
This presentation focuses on consumer trends and engagement along with ideas for integrating mobile health into product development and sales and marketing.
Design Controls: Building Objective Evidence and Process Architecture to Mee...
This session provides detailed examples to demonstrate what objective evidence is important to generate and use during design control compliance but, more importantly, to develop and issue a beneficial design history file meeting the requirements in 21 CFR, Part 820.30 and ISO 13485:2016. Aside from the importance of design controls for compliance, Mr. Gagliardi demonstrates how this section of the QS regulation and the ISO standard can be facilitated as a leading edge business tool.
Additive Manufacturing - Design Considerations Rapid Fire - OMTEC 2018
Easing the Secondary Production Process During Design: The design stage is where the smart decisions are made in additive manufacturing — not only on ways to increase clinical outcomes and additive processes, but also to ease post-processing. In these areas, the process can be made efficient and cost-effective. Receive tips and tricks on orientation, supports, stock material and design features.
Enhancing Design through Engineering and Manufacturing Collaboration: Unlike conventional methods, additive manufacturing requires design and manufacturing teams to work closely together very early in the design phase. In a world where the pace of innovation is nearly vertical, it’s imperative to understand this concept early to make additive manufacturing work for you. This discussion lends a high-level overview of best practices when working with internal or external suppliers, and shows examples of the use of additive manufacturing to create innovative medical device designs.
Vital QMS Process Validation Statistics - OMTEC 2018
According to 21 CFR, Part 820, medical device manufacturers are required to validate as well as monitor and control parameters for their processes. The guideline on Quality Management Systems does not specify how this is accomplished; only that “a process is established that can consistently conform to requirements” and “studies are conducted demonstrating” this. Thorough process development, optimization and control using appropriate statistical methods and tools is recommended for demonstrating that your process is both stable and capable. This session will demonstrate ways to efficiently and effectively apply recommended statistical methods and tools to process validation—with no statistical expertise needed. Using realistic process data, participants will learn how to apply tools, interpret results and draw meaningful conclusions throughout Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
Packaging Solutions that Improve Time to Market
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.
FDA Update: Inspections, Observations and Metrics - OMTEC 2017
This FDA-focused presentation offers a glimpse into trends behind three initiatives that orthopaedic device professionals need to fully understand: inspections, Case for Quality and 483 Observations. First, a high-level view of FDA inspections will discuss methodology and implementation. Second, FDA’s observations of non-compliance will be discussed, pointing out important historical trends. Finally, as the industry matures, professionals should expect changes to the breadth and depth of FDA’s focus. This is where Case for Quality and the Medical Device Metrics Initiative will be covered. FDA has placed an increased emphasis on data and metrics. Gain insight into ways to leverage data to improve, monitor and control processes that drive quality improvement.
Additive Manufacturing: Considerations for Powder Metals - OMTEC 2017
As metal powder additive manufacturing advances from rapid prototyping to mass production, the importance of powder characteristics and composition has become widely recognized. In this presentation, various techniques for powder production will be explored, with the emphasis on variants in atomization technology. Conventional and emerging techniques for measuring powder characteristics will be discussed. Analysis of finished components that meet or exceed expected properties, while at the same time taking advantage of revolutionary part design, will be addressed. It is the intent to assist component designers and manufacturing engineers in both alloy selection and specification determination for optimum property results.
Together for sustainability -
Intertek provides strategic support across the entire supply chain through testing, inspection, auditing, and certification services. They have a global network with over 35,000 employees in more than 100 countries. Their services help clients innovate while complying with regulations, focus on core business by mitigating risks, and make decisions based on data. Case studies show how they have helped clients with regulatory compliance, material selection, sustainability assessments, and developing partnerships with suppliers.
Additive Manufacturing: Industry Addresses Standards, Quality, Evidence Build...
The SME Medical Additive Manufacturing/3D Printing Workgroup collaborates to identify challenges, develop resources and facilitate changes to support anyone using the technologies for medical/biomedical applications. Ms. McDaniel shares the group's progress and the headwinds that remain with non-technology barriers to adoption.
Leveraging Data to Develop, Execute and Exceed the Expectations of Your Regu...
Scientific data, homegrown or from published literature, is essential to your regulatory strategy…be it establishing substantial equivalence in FDA 510(k) applications, qualifying a device as a legitimate predecessor in the context of a Technical File for CE Mark, predicting the performance of a device in development, judging a new device in verification and validation testing and, with proper planning, expanding indications for use and identifying new marketable claims of performance (or mitigation of risk and liability). In this session, participants will be exposed to various vital data sources and obtain practical examples for putting them to meaningful use.
How to Make Postmarket Surveillance More Cost Effective
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.
Modernize the Orthopaedic Supply Chain: A Surgeon’s View
This document discusses modernizing the orthopedic supply chain from a surgeon's perspective. It describes current issues with the supply chain that can lead to medical errors and waste, including complex compatibility rules between implant systems, small labels, and time pressure in the operating room. The author outlines a new system called OrthoSecure that uses barcodes and electronic displays to efficiently check implant compatibility and prevent errors. A study found this system prevented all errors in over 4,600 joint replacements and reduced wasted implants. The document advocates expanding this approach and using supply chain data to further increase efficiency and cost savings.
Global Regulatory Outlook: 2017 and Beyond - OMTEC 2017
This document provides an overview of global regulatory trends in 2017 and beyond for medical devices. Key points include increased emphasis on clinical data and post-market surveillance across regions. The EU is transitioning to the new Medical Device Regulation which increases requirements for technical documentation and quality management systems. Notified Bodies face challenges meeting demand under new rules. The US 21st Century Cures Act aims to streamline approval of certain lower-risk devices and accessories. Single audits through the Medical Device Single Audit Program may replace some regulatory inspections globally.
CAPA: Using Risk-Based Decision-Making Toward Closure
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.
Additive Manufacturing Discussion Panel – Developing a Roadmap for Regulatory...
FDA published guidance on additive manufacturing technical considerations in late 2017, outlining the Agency’s long-awaited position on use of the technology for medical devices. At the time, FDA said that the 31-page document was considered “leapfrog” guidance, a term reserved for the Agency’s anticipation that its initial thoughts on an emerging technology will change over time. In short, more questions and answers have arisen — and will continue to do so as the technology is adopted. This FDA guidance is critical to the additive manufacturing narrative. However, standards and best practices surrounding the technology are being discussed globally on a daily basis. This discussion puts representatives from ASTM, FDA, SME and DePuy Synthes in one room, for one conversation, that will provide attendees with practical, actual guidance not only for current times, but also for what is on the horizon.
How Design Controls & Risk Management Best Practices Reduce Customer Complain...
We all know how much emphasis FDA inspectors and ISO auditors place on your customer complaint and CAPA processes. And rightfully so.
But what if there were things you could do to minimize the struggles and challenges associated with customer complaint and CAPA management?
Good news. You can decrease the number of customer complaints and reduce the volume of issued CAPAs through good product development Design Controls and Risk Management practices.
Specifically this presentation will cover:
-Influence Design Controls has on Customer Complaints
-How Customer Complaints impact your CAPA system
-Best practices for Design Controls
-Best practices for Risk Management
-Risk-based approaches to Customer Complaint and CAPA management
FDA Design Controls: What Medical Device Makers Need to Know
The document provides an overview of a presentation on FDA Design Controls. It introduces the two presenters, David Amor and Jon Speer, who are experts in medical device quality systems and design controls. The presentation will cover topics related to design controls regulations, including intended use, user needs, design inputs, design reviews, risk management, design outputs, design verification and validation, and regulatory submissions. It is meant to help medical device companies understand and comply with FDA design control requirements.
5 Predictions for the Medical Device Industry in 2018 (and how you can prepare)
What should the medical device industry expect in 2018?
Great question.
From ISO 13485 being revised in 2016, the EU MDR / IVDR being revised in 2017, and the MDSAP program going live in 2017, regulatory changes have been rampant and significant for medical device professionals.
This presentation covers:
- Why you should expect it to be harder for devices to get to market and stay there in the EU
- How to avoid the mad dash to update ISO 13485 certification before the deadline
- Where the latest revision of ISO 14971 is and when to expect the next update
- About Health Canada and their MDSAP deadline
- Why companies are shifting from being compliance-focused to quality-focused
Watch the presentation, commentated by Greenlight Guru's founder Jon Speer, here: https://www.greenlight.guru/webinar/2018-medical-device-industry-predictions
The Medical Device Milestone Map
Medtech start-ups from inception to exit: what are the key milestones and what are the ACTUAL timelines and costs?
A data-driven approach to figuring out the new reality of medical device venture capital investing.
What's hot (20)
FDA Inspections are Different from ISO Audits, So Don't Treat Them the Same -...
FDA Inspections are Different from ISO Audits, So Don't Treat Them the Same -...
Integrating Mobile Health into Product Development - OMTEC 2017
Integrating Mobile Health into Product Development - OMTEC 2017
Design Controls: Building Objective Evidence and Process Architecture to Mee...
Design Controls: Building Objective Evidence and Process Architecture to Mee...
Additive Manufacturing - Design Considerations Rapid Fire - OMTEC 2018
Additive Manufacturing - Design Considerations Rapid Fire - OMTEC 2018
Vital QMS Process Validation Statistics - OMTEC 2018
Vital QMS Process Validation Statistics - OMTEC 2018
FDA Update: Inspections, Observations and Metrics - OMTEC 2017
FDA Update: Inspections, Observations and Metrics - OMTEC 2017
Additive Manufacturing: Considerations for Powder Metals - OMTEC 2017
Additive Manufacturing: Considerations for Powder Metals - OMTEC 2017
Additive Manufacturing: Industry Addresses Standards, Quality, Evidence Build...
Additive Manufacturing: Industry Addresses Standards, Quality, Evidence Build...
Leveraging Data to Develop, Execute and Exceed the Expectations of Your Regu...
Leveraging Data to Develop, Execute and Exceed the Expectations of Your Regu...
How to Make Postmarket Surveillance More Cost Effective
How to Make Postmarket Surveillance More Cost Effective
Modernize the Orthopaedic Supply Chain: A Surgeon’s View
Modernize the Orthopaedic Supply Chain: A Surgeon’s View
Global Regulatory Outlook: 2017 and Beyond - OMTEC 2017
Global Regulatory Outlook: 2017 and Beyond - OMTEC 2017
CAPA: Using Risk-Based Decision-Making Toward Closure
CAPA: Using Risk-Based Decision-Making Toward Closure
Additive Manufacturing Discussion Panel – Developing a Roadmap for Regulatory...
Additive Manufacturing Discussion Panel – Developing a Roadmap for Regulatory...
How Design Controls & Risk Management Best Practices Reduce Customer Complain...
How Design Controls & Risk Management Best Practices Reduce Customer Complain...
FDA Design Controls: What Medical Device Makers Need to Know
FDA Design Controls: What Medical Device Makers Need to Know
5 Predictions for the Medical Device Industry in 2018 (and how you can prepare)
5 Predictions for the Medical Device Industry in 2018 (and how you can prepare)
Similar to Avoid Post-M&A Supply Chain Surprises - OMTEC 2017
Ia perspective-on-supply-chain-risk
The document discusses the growing challenges that companies face from supply chain risk and how internal audit functions can help address these challenges. It notes that supply chain disruptions can significantly hurt profitability, shareholder value, and reputation. It recommends that companies take a holistic approach to identifying critical suppliers and assessing their financial health and stability to develop leading risk indicators. It also suggests that internal audit can help by reviewing supply chains to identify vulnerabilities, developing monitoring processes, and assessing risk controls. The overall message is that internal audit can play a key role in helping companies strengthen their supply chain risk management.
Supply Chain optimization & risks factors
This white paper discuss on building a supply chain beyond risks factors surrounding organization operations. Companies today work on several supply chain strategies to improve their supply chain.
Risk factors in as-is process and how to eliminate those risks.
gscm-25-challenges-in-global-manufacturing-pptx.pptx
The document discusses strategies used by "Complexity Masters" - companies that have successfully managed increasing supply chain complexity. It identifies forces like cost pressures that drive complexity. It also analyzes paradoxes where company priorities don't align with actions. Complexity Masters resolve these through strategies like collaborating with customers, managing products, and advanced technology. They have mastered processes within their organization and across partners.
Creating a secure supply chain
This document discusses the importance of supply chain security and the risks faced by companies' supply chains. It summarizes a study that found that while most companies believe their supply chains are well-protected, 1 in 3 reported a breach that resulted in added costs, delays, and lost business. Common supply chain risks included issues with suppliers, logistics disruptions, production problems, and natural disasters. The document advocates for risk management strategies to assess vulnerabilities and protect intellectual property and business continuity.
SUPPLY CHAIN MANAGEMENT A BETTER UNDERSTANDING
The document discusses supply chain management. It defines supply chain as a series of companies working together to create and distribute a product, from suppliers to production companies to customers. While supply chains have long existed, companies traditionally focused only on their direct activities. This led to disconnects in the chain. The document outlines the basic flow of products from suppliers to customers through multiple companies and processes. It also discusses trends in supply chain management in India, including high inventory levels, transportation costs, and a need for more integration between organizations across the supply chain.
PPT SCM Functions
This document discusses supply chain management. It defines supply chain management as the system involved in transforming raw materials into final products and distributing those products to customers. It also discusses key aspects of supply chain management including procurement, purchasing specifications, supplier selection factors, outsourcing, integration strategies, and relationship types. Total quality management and its principles are also summarized as they relate to supply chain management.
Top Five Retail Supply Chain Issues
Retailers today are faced with unprecedented challenges ranging from shifting retail formats, overabundance of consumer choice, fast-changing technology, greater focus on quality and price to a tough economic climate. The result is that those who are not constantly innovating run the risk of falling behind. This white paper looks at the top five supply chain challenges that retailers face today and maps out a series of strategies to address these challenges based on research and direct experience in supporting retailers to maintain a competitive advantage in a highly competitive market.
PEX 2015 PA Consulting playing cards
Peter Sirman from PA Consulting chaired the 2015 PEX conference. Here are four burning questions we hear from our clients and our point of view on how to fix them.
Supplier financial stability and risk differentiation in turbulent times -sup...
There is a Darwinian effect occurring in the supply chain as Fortune 1000 companies cut weaker suppliers. The simple fact is that in today’s longer global supply chains, product
moves over greater distances and across more multinational borders than in the more localized supply chains of the past. In an era of wildly fluctuating commodity prices and security regulations, the coordination and execution required for international shipments has become
more of a challenge than in the past.
Managing Today’s Supply Chain
The document discusses key topics related to managing supply chains, including definitions, trends, best practices, and risks. It provides definitions of supply chain management and logistics management. It outlines trends changing supply chains such as globalization, technology advances, and sustainability issues. Leading practices discussed include focusing on cash flow, visibility, and strategic supplier/customer relationships. Risks covered involve disruptions, regulatory changes, and factors within and outside a company's control.
ERA Apathy Report-April-2013
This document summarizes the findings of a report on business spending habits in Britain. The key findings are:
- There is a culture of apathy towards strategic purchasing and supply chain management. Purchasing decisions are often reactive and lack strategic oversight.
- Many businesses lack purchasing controls and processes, leaving purchasing decisions to inexperienced junior staff without proper guidance or approval.
- Most businesses do not regularly review suppliers or have strategic relationships with them, instead viewing them as adversaries focused solely on price.
- Purchasing is seen as a low priority and is not valued as a strategic function. Staff receive little training and there are few incentives for securing good deals.
- Overall, the short-
Scoring High on the Supply Chain Maturity Model
This is my presentation from CSCMP Europe 2007 conference. Discover how leading practices are being used to transform supply chain performance by attending this session on the Global Value Chain Study. This study, undertaken by IBM Global Business Services in conjunction with APQC, identifies current practices, captures significant trends and establishes operational performance benchmarks in several key areas of Supply Chain Management: New Product Development, Planning, Procurement, and Logistics. By analyzing responses from
companies across a range of industries, in multiple geographies worldwide, it provides unique insight into challenges and demonstrates how supply chain management is changing from a static and cost-centric function to an evolving, integrated business model.
Supply Chain Management in the E-Business Era
This document reports on a research study into supply chain strategies in the e-business era. It finds that effective supply chain management is critical for successful e-business implementation. While integration with suppliers and customers is a primary objective, the focus is on cost reduction rather than customer service. E-business strategies are not fully supporting improved customer service. Barriers to greater integration include system integration challenges and supplier capabilities, especially among small and medium enterprises.
SCM
The document outlines several challenges that companies face in managing their global supply chains. Key challenges include selecting strategic global suppliers, reducing supply chain costs while meeting customer demands, ensuring high product quality and safety, implementing lean initiatives, consolidating suppliers, accessing new technologies, reducing operating costs, managing omni-channel selling, responding to changing customer preferences, expanding into new markets, balancing trade-offs, dealing with increasing complexity, and fully understanding supplier capabilities. Taking proactive steps to address these challenges will help companies better serve customers, operate efficiently, and grow profitably.
160513 Study Sourcing in risk and compliance functions
This document summarizes insights from a benchmark study on sourcing risk and compliance functions in international financial institutions. Key findings include:
1) Sourcing risk and compliance functions can improve effectiveness and efficiency while reducing costs by up to 30%. It allows banks to focus on differentiators and quickly adapt to regulatory changes.
2) Most banks implement a nearshoring model, with hubs in locations like India and Eastern Europe. Examples of successfully sourced functions include risk modeling and standardized transaction decisions.
3) Success requires a strong business case, transparency on current functions, and ensuring additional risks are managed within risk appetite. Detailed planning is also important to realize benefits while mitigating execution risks.
Supply Chain Risk Strategies for Emerging Markets by Brittain Ladd
This document discusses supply chain risk strategies for companies operating in emerging markets. It notes that while emerging markets offer growth opportunities, they also present significant risks that companies need to manage. The document outlines various types of supply chain risks, such as macroeconomic risks, risks from partners and internal operations. It emphasizes that companies should take a holistic approach to assessing risks across their entire supply chains and implement resilience strategies to mitigate vulnerabilities. Managing supply chain risk is particularly important in emerging markets due to factors like unclear regulations and infrastructure challenges.
Mergers and Acquisitions: Preparing for Change
The document discusses avoiding mistakes during transactions by providing lessons learned from experience. It summarizes an event presented by Bryan Livingston and Paul Puri of M&A International, the world's leading mid-cap investment banking organization. The document provides information on transaction planning, potential buyer motivations, types of transactions, and examples of enhancing transaction prices.
Supply Chain - How Vulnerable
Organizations are increasingly reliant on extended global supply chains, making them more vulnerable to disruptions. Supply chains are complex with many interconnections between suppliers and customers. This complexity has created challenges for businesses as more global supply chains are also more vulnerable. A study by the Business Continuity Institute found that most organizations do not have full visibility of their supply chains and over half of disruptions originate from lower tier suppliers. The complexity and lack of visibility in supply chain networks demonstrates why ensuring supply chain resilience is essential for businesses.
Supply Chain Blind Spots That You Might Be Missing.pptx
Every supply chain participant is experiencing unprecedented degrees of connection. Brands are more global and influential than ever before. More suppliers are being linked to more downstream partners in ways that we could not have predicted even a decade ago.
Ten Common Procurement Challenges and How to Solve Them.pptx
Ten Common Procurement Challenges and How to Solve Them.pptxTYASuite Software Solutions Private limited
The document discusses 10 common procurement challenges that businesses face and solutions to address them. The challenges include reducing quality to cut costs, lack of clear supplier specifications and requirements, insufficient supplier evaluation, lack of knowledge about supplier capabilities, absence of key performance indicators, lack of trust in suppliers, lack of transparency, not having formal contracts, supplier inflexibility, and relying on inaccurate data. The solutions proposed are establishing sustainable practices, using procurement software, ongoing supplier monitoring and reviews, transparency on both sides, and ensuring legally binding contracts. The conclusion recommends a cloud-based procurement software to help organizations overcome these challenges.Similar to Avoid Post-M&A Supply Chain Surprises - OMTEC 2017 (20)
gscm-25-challenges-in-global-manufacturing-pptx.pptx
gscm-25-challenges-in-global-manufacturing-pptx.pptx
Supplier financial stability and risk differentiation in turbulent times -sup...
Supplier financial stability and risk differentiation in turbulent times -sup...
160513 Study Sourcing in risk and compliance functions
160513 Study Sourcing in risk and compliance functions
Supply Chain Risk Strategies for Emerging Markets by Brittain Ladd
Supply Chain Risk Strategies for Emerging Markets by Brittain Ladd
Supply Chain Blind Spots That You Might Be Missing.pptx
Supply Chain Blind Spots That You Might Be Missing.pptx
Ten Common Procurement Challenges and How to Solve Them.pptx
Ten Common Procurement Challenges and How to Solve Them.pptx
More from April Bright
The Future of Digital Health and Wearables in Orthopedicsrables
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,...
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 Perspectives
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 Perspective
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 Across
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.
Joint Replacement: The Current and Future Impact of Coatings
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 Principles
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.
The Future of Orthobiologics in Trauma Procedures
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 Manufacturing
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 Engagement
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 Usage
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 2025
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 Market
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 Opportunities
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 Implications
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 2018
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.
EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
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.
Maximizing Use of Your Supplier Scorecard - OMTEC 2018
Supplier scorecards provide a comparative look at suppliers and a heightened understanding of internal challenges within your organizations. Orthopaedic device companies rely on scorecards to monitor the performance of suppliers that are an extension of their own operations. The right elements in the scorecard (e.g. weighted factors of quality, delivery, cost, responsiveness, SCAR, CAPA, etc.) will strengthen your confidence, control and relationship with your suppliers while simultaneously providing essential indicators to drive positive change.
Considerations for Your Minimally Invasive Device - OMTEC 2018
What does minimally invasive surgery mean to you? What do you consider when designing an MIS device? Who are you designing the devices for? Patrick Sweeney, M.D., surgeon entrepreneur, imparts his take on product needs for MIS, and the future of MIS in orthopaedics.
Additive Manufacturing - Powder Considerations Rapid Fire - OMTEC 2018
Understanding the Cost Drivers of Metal Powders: The true costs associated with additive manufacturing processes are often not well understood. To fully grasp the actual manufacturing costs, and therefore the economic viability of AM, each aspect of the entire chain needs to be well understood and controlled. This presentation uncovers the costs and main cost controls surrounding the metal powders used in AM.
Practical Implementation of PEKK Additively Manufactured Orthopaedic Devices: learn how much of the discussion surrounding implementation of additive manufacturing has been focused more on the machine and less on the material and process system, resulting in new structures that then needed to be considered for applications and validated for incorporation into new products.
More from April Bright (20)
The Future of Digital Health and Wearables in Orthopedicsrables
The Future of Digital Health and Wearables in Orthopedicsrables
The Future of Personalized Implants in Joint Replacement: Additive, Robotics,...
The Future of Personalized Implants in Joint Replacement: Additive, Robotics,...
Antimicrobial Coatings: The Research and Regulatory Perspective
Antimicrobial Coatings: The Research and Regulatory Perspective
Leverage These Effective Communication Skills to Get Your Message Across
Leverage These Effective Communication Skills to Get Your Message Across
Joint Replacement: The Current and Future Impact of Coatings
Joint Replacement: The Current and Future Impact of Coatings
Engineers: Practical Application of Project Management Principles
Engineers: Practical Application of Project Management Principles
Spine Implants: Porous Coatings vs. Porous Materials vs. Additive Manufacturing
Spine Implants: Porous Coatings vs. Porous Materials vs. Additive Manufacturing
How to Influence People: The Value of Employee Engagement
How to Influence People: The Value of Employee Engagement
Real-World Evidence: The Future of Data Generation and Usage
Real-World Evidence: The Future of Data Generation and Usage
Engineers: Apply Automation to Increase Quality, Speed to Market
Engineers: Apply Automation to Increase Quality, Speed to Market
OSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities
OSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities
Unique Device Identification: Manufacturer, Hospital and Global Implications
Unique Device Identification: Manufacturer, Hospital and Global Implications
Additive Manufacturing - Mechanical Test Methods - OMTEC 2018
Additive Manufacturing - Mechanical Test Methods - OMTEC 2018
EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
Maximizing Use of Your Supplier Scorecard - OMTEC 2018
Maximizing Use of Your Supplier Scorecard - OMTEC 2018
Considerations for Your Minimally Invasive Device - OMTEC 2018
Considerations for Your Minimally Invasive Device - OMTEC 2018
Additive Manufacturing - Powder Considerations Rapid Fire - OMTEC 2018
Additive Manufacturing - Powder Considerations Rapid Fire - OMTEC 2018
Recently uploaded
The Intersection between Competition and Data Privacy – CAPEL – June 2024 OEC...
The Intersection between Competition and Data Privacy – CAPEL – June 2024 OEC...OECD Directorate for Financial and Enterprise Affairs
This presentation by Tim Capel, Director of the UK Information Commissioner’s Office Legal Service, was made during the discussion “The Intersection between Competition and Data Privacy” held at the 143rd meeting of the OECD Competition Committee on 13 June 2024. More papers and presentations on the topic can be found at oe.cd/ibcdp.
This presentation was uploaded with the author’s consent.
The Intersection between Competition and Data Privacy – KEMP – June 2024 OECD...
The Intersection between Competition and Data Privacy – KEMP – June 2024 OECD...OECD Directorate for Financial and Enterprise Affairs
This presentation by Katharine Kemp, Associate Professor at the Faculty of Law & Justice at UNSW Sydney, was made during the discussion “The Intersection between Competition and Data Privacy” held at the 143rd meeting of the OECD Competition Committee on 13 June 2024. More papers and presentations on the topic can be found at oe.cd/ibcdp.
This presentation was uploaded with the author’s consent.
ServiceNow CIS-ITSM Exam Dumps & Questions [2024]
• For a full set of 530+ questions. Go to
https://skillcertpro.com/product/servicenow-cis-itsm-exam-questions/
• SkillCertPro offers detailed explanations to each question which helps to understand the concepts better.
• It is recommended to score above 85% in SkillCertPro exams before attempting a real exam.
• SkillCertPro updates exam questions every 2 weeks.
• You will get life time access and life time free updates
• SkillCertPro assures 100% pass guarantee in first attempt.
ACTIVE IMPLANTABLE MEDICAL DEVICE IN EUROPE
This presentation will help you to know about the classification ,approval process and article related to active implantable medical device
Using-Presentation-Software-to-the-Fullf.pptx
Slides on 7 Commonly Used Presentation Softwares; thier usage and features.
Artificial Intelligence, Data and Competition – SCHREPEL – June 2024 OECD dis...
Artificial Intelligence, Data and Competition – SCHREPEL – June 2024 OECD dis...OECD Directorate for Financial and Enterprise Affairs
This presentation by Thibault Schrepel, Associate Professor of Law at Vrije Universiteit Amsterdam University, was made during the discussion “Artificial Intelligence, Data and Competition” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/aicomp.
This presentation was uploaded with the author’s consent.
2 December UAE National Day - United Arab Emirates
UAE National Day, celebrated on December 2nd, commemorates the unification of the seven emirates and reflects national pride and unity.
Pro-competitive Industrial Policy – LANE – June 2024 OECD discussion
Pro-competitive Industrial Policy – LANE – June 2024 OECD discussionOECD Directorate for Financial and Enterprise Affairs
This presentation by Nathaniel Lane, Associate Professor in Economics at Oxford University, was made during the discussion “Pro-competitive Industrial Policy” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/pcip.
This presentation was uploaded with the author’s consent.
Artificial Intelligence, Data and Competition – ČORBA – June 2024 OECD discus...
Artificial Intelligence, Data and Competition – ČORBA – June 2024 OECD discus...OECD Directorate for Financial and Enterprise Affairs
This presentation by Juraj Čorba, Chair of OECD Working Party on Artificial Intelligence Governance (AIGO), was made during the discussion “Artificial Intelligence, Data and Competition” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/aicomp.
This presentation was uploaded with the author’s consent.
Artificial Intelligence, Data and Competition – OECD – June 2024 OECD discussion
Artificial Intelligence, Data and Competition – OECD – June 2024 OECD discussionOECD Directorate for Financial and Enterprise Affairs
This presentation by OECD, OECD Secretariat, was made during the discussion “Artificial Intelligence, Data and Competition” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/aicomp.
This presentation was uploaded with the author’s consent.
Pro-competitive Industrial Policy – OECD – June 2024 OECD discussion
Pro-competitive Industrial Policy – OECD – June 2024 OECD discussionOECD Directorate for Financial and Enterprise Affairs
This presentation by OECD, OECD Secretariat, was made during the discussion “Pro-competitive Industrial Policy” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/pcip.
This presentation was uploaded with the author’s consent.
Proposal: The Ark Project and The BEEP Inc
1.) Introduction
Our Movement is not new; it is the same as it was for Freedom, Justice, and Equality since we were labeled as slaves. However, this movement at its core must entail economics.
2.) Historical Context
This is the same movement because none of the previous movements, such as boycotts, were ever completed. For some, maybe, but for the most part, it’s just a place to keep your stable until you’re ready to assimilate them into your system. The rest of the crabs are left in the world’s worst parts, begging for scraps.
3.) Economic Empowerment
Our Movement aims to show that it is indeed possible for the less fortunate to establish their economic system. Everyone else – Caucasian, Asian, Mexican, Israeli, Jews, etc. – has their systems, and they all set up and usurp money from the less fortunate. So, the less fortunate buy from every one of them, yet none of them buy from the less fortunate. Moreover, the less fortunate really don’t have anything to sell.
4.) Collaboration with Organizations
Our Movement will demonstrate how organizations such as the National Association for the Advancement of Colored People, National Urban League, Black Lives Matter, and others can assist in creating a much more indestructible Black Wall Street.
5.) Vision for the Future
Our Movement will not settle for less than those who came before us and stopped before the rights were equal. The economy, jobs, healthcare, education, housing, incarceration – everything is unfair, and what isn’t is rigged for the less fortunate to fail, as evidenced in society.
6.) Call to Action
Our movement has started and implemented everything needed for the advancement of the economic system. There are positions for only those who understand the importance of this movement, as failure to address it will continue the degradation of the people deemed less fortunate.
No, this isn’t Noah’s Ark, nor am I a Prophet. I’m just a man who wrote a couple of books, created a magnificent website: http://www.thearkproject.llc, and who truly hopes to try and initiate a truly sustainable economic system for deprived people. We may not all have the same beliefs, but if our methods are tried, tested, and proven, we can come together and help others. My website: http://www.thearkproject.llc is very informative and considerably controversial. Please check it out, and if you are afraid, leave immediately; it’s no place for cowards. The last Prophet said: “Whoever among you sees an evil action, then let him change it with his hand [by taking action]; if he cannot, then with his tongue [by speaking out]; and if he cannot, then, with his heart – and that is the weakest of faith.” [Sahih Muslim] If we all, or even some of us, did this, there would be significant change. We are able to witness it on small and grand scales, for example, from climate control to business partnerships. I encourage, invite, and challenge you all to support me by visiting my website.
Disaster Management project for holidays homework and other uses
It talks about disaster management in a helful way.
Why Psychological Safety Matters for Software Teams - ACE 2024 - Ben Linders.pdf
Psychological safety in teams is important; team members must feel safe and able to communicate and collaborate effectively to deliver value. It’s also necessary to build long-lasting teams since things will happen and relationships will be strained.
But, how safe is a team? How can we determine if there are any factors that make the team unsafe or have an impact on the team’s culture?
In this mini-workshop, we’ll play games for psychological safety and team culture utilizing a deck of coaching cards, The Psychological Safety Cards. We will learn how to use gamification to gain a better understanding of what’s going on in teams. Individuals share what they have learned from working in teams, what has impacted the team’s safety and culture, and what has led to positive change.
Different game formats will be played in groups in parallel. Examples are an ice-breaker to get people talking about psychological safety, a constellation where people take positions about aspects of psychological safety in their team or organization, and collaborative card games where people work together to create an environment that fosters psychological safety.
The Intersection between Competition and Data Privacy – OECD – June 2024 OECD...
The Intersection between Competition and Data Privacy – OECD – June 2024 OECD...OECD Directorate for Financial and Enterprise Affairs
This presentation by OECD, OECD Secretariat, was made during the discussion “The Intersection between Competition and Data Privacy” held at the 143rd meeting of the OECD Competition Committee on 13 June 2024. More papers and presentations on the topic can be found at oe.cd/ibcdp.
This presentation was uploaded with the author’s consent.
Artificial Intelligence, Data and Competition – LIM – June 2024 OECD discussion
Artificial Intelligence, Data and Competition – LIM – June 2024 OECD discussionOECD Directorate for Financial and Enterprise Affairs
This presentation by Yong Lim, Professor of Economic Law at Seoul National University School of Law, was made during the discussion “Artificial Intelligence, Data and Competition” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/aicomp.
This presentation was uploaded with the author’s consent.
怎么办理(lincoln学位证书)英国林肯大学毕业证文凭学位证书原版一模一样
原版定制【微信:bwp0011】《(lincoln学位证书)英国林肯大学毕业证文凭学位证书》【微信:bwp0011】成绩单 、雅思、外壳、留信学历认证永久存档查询，采用学校原版纸张、特殊工艺完全按照原版一比一制作（包括：隐形水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠，文字图案浮雕，激光镭射，紫外荧光，温感，复印防伪）行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备，十五年致力于帮助留学生解决难题，业务范围有加拿大、英国、澳洲、韩国、美国、新加坡，新西兰等学历材料，包您满意。
【业务选择办理准则】
一、工作未确定，回国需先给父母、亲戚朋友看下文凭的情况，办理一份就读学校的毕业证【微信bwp0011】文凭即可
二、回国进私企、外企、自己做生意的情况，这些单位是不查询毕业证真伪的，而且国内没有渠道去查询国外文凭的真假，也不需要提供真实教育部认证。鉴于此，办理一份毕业证【微信bwp0011】即可
三、进国企，银行，事业单位，考公务员等等，这些单位是必需要提供真实教育部认证的，办理教育部认证所需资料众多且烦琐，所有材料您都必须提供原件，我们凭借丰富的经验，快捷的绿色通道帮您快速整合材料，让您少走弯路。
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
【关于价格问题（保证一手价格）】
我们所定的价格是非常合理的，而且我们现在做得单子大多数都是代理和回头客户介绍的所以一般现在有新的单子 我给客户的都是第一手的代理价格，因为我想坦诚对待大家 不想跟大家在价格方面浪费时间
对于老客户或者被老客户介绍过来的朋友，我们都会适当给一些优惠。
Recently uploaded (20)
The Intersection between Competition and Data Privacy – CAPEL – June 2024 OEC...
The Intersection between Competition and Data Privacy – CAPEL – June 2024 OEC...
The Intersection between Competition and Data Privacy – KEMP – June 2024 OECD...
The Intersection between Competition and Data Privacy – KEMP – June 2024 OECD...
Legislation And Regulations For Import, Manufacture,.pptx
Legislation And Regulations For Import, Manufacture,.pptx
Artificial Intelligence, Data and Competition – SCHREPEL – June 2024 OECD dis...
Artificial Intelligence, Data and Competition – SCHREPEL – June 2024 OECD dis...
Prsentation for VIVA Welike project 1semester.pptx
Prsentation for VIVA Welike project 1semester.pptx
2 December UAE National Day - United Arab Emirates
2 December UAE National Day - United Arab Emirates
Pro-competitive Industrial Policy – LANE – June 2024 OECD discussion
Pro-competitive Industrial Policy – LANE – June 2024 OECD discussion
Artificial Intelligence, Data and Competition – ČORBA – June 2024 OECD discus...
Artificial Intelligence, Data and Competition – ČORBA – June 2024 OECD discus...
Artificial Intelligence, Data and Competition – OECD – June 2024 OECD discussion
Artificial Intelligence, Data and Competition – OECD – June 2024 OECD discussion
Pro-competitive Industrial Policy – OECD – June 2024 OECD discussion
Pro-competitive Industrial Policy – OECD – June 2024 OECD discussion
Disaster Management project for holidays homework and other uses
Disaster Management project for holidays homework and other uses
Why Psychological Safety Matters for Software Teams - ACE 2024 - Ben Linders.pdf
Why Psychological Safety Matters for Software Teams - ACE 2024 - Ben Linders.pdf
The Intersection between Competition and Data Privacy – OECD – June 2024 OECD...
The Intersection between Competition and Data Privacy – OECD – June 2024 OECD...
Artificial Intelligence, Data and Competition – LIM – June 2024 OECD discussion
Artificial Intelligence, Data and Competition – LIM – June 2024 OECD discussion
Avoid Post-M&A Supply Chain Surprises - OMTEC 2017
- 2. Avoiding Post-M&A Supply Chain Surprises OMTEC 2017 David Finch Insight Collaboration Partners
- 3. Discussion Points Why are we here today Supply chain in M&A due diligence The post-close 100-day plan Integration and maximizing post-close supply chain value creation and savings Questions
- 4. Why is Supply Chain Focus Critical to M&A Success?
- 5. From Accenture Many supply chain managers get into the merger process very late. In fact, more than half of those we contacted did not get into the process until the merger was basically closed. They, therefore, are playing catch up and have to do many things quickly. More than 30% observed problems in inventories, including out-of-stock items and inventory buildups Inadequate planning was identified as having the greatest negative impact in merger transactions Such failures resulted in a general increase in supply chain operating costs and efficiencies; an inventory buildup that increased the cost of goods sold; less than optimal effects upon customers who could not get products; a drop in product quality and a significant increase in out-of-stock products. * A survey of supply chain executives
- 6. From The Boston Consulting Group A high proportion of deals fail to deliver value. Companies focus on capturing short-term financial synergies rather than taking a holistic view and fail to create high performing supply chains with significant long-term upside that provide sustained value for customers and stakeholders. During M&A due diligence, companies overlook the overall business and operational compatibility. Companies drastically underestimate the complexity, resources, communication and management focus needed to execute a successful integration.
- 7. From Deloitte The supply chain touches every aspect of the company’s performance: revenue, cost, balance sheet, customer service, risk management and compliance. Yet mergers often fail to account for the significant enterprise-wide impact of supply chains.
- 8. From The Wall Street Journal The best planned corporate mergers and acquisitions often go to waste when supply chains are treated like any other back-office function. The integration of supply chains is a critical, highly complicated and exceedingly high risk undertaking with rewards that can be difficult to measure.
- 9. How to Minimize and Avoid Post-M&A Supply Chain Surprises
- 10. The Due Diligence Phase Limitations due to Confidentiality Concerns Focus on High risk areas for supply chain disruption Inventory viability Regulatory – product registration Exclusive supply agreement and design ownership Supply chain support systems and integration with ERP/financial system Voice of the customer Identify key administrators – the “go-to” people
- 11. Post Close – Clearly Identify Current State Rule number one trumps consolidation Go slow to go fast People – Capture knowledge and Retention of the “doers” Deep inventory analysis Upstream Supply Downstream customer experience Identify Future State
- 12. Integration – Delivery Future State Make people decisions based on critical functions and activities Assess Compatibility of planning systems and data integrity before initiating software integration Supplier Consolidation Inventory and distribution consolidation Eliminate true redundancy
- 13. Questions
- 14. “Change upsets the delicate balance between departments and throughout the organization in so many ways that may not be immediately visible but can show their effects over time.”