3D Designing and Printing Implants on Demand - OMTEC 2017

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• Future of 3D printing in the hospital/surgeon office setting • Technology enhancements needed to meet surgeon requests

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3D Designing and Printing Implants on Demand - OMTEC 2017

More from April 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.

Engineers: Practical Application of Project Management Principles

April 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.

Regulatory and Quality Affairs: Answers to FDA and ISO Gray Areas

April 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.

The Future of Orthobiologics in Trauma Procedures

April 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.

Spine Implants: Porous Coatings vs. Porous Materials vs. Additive Manufacturing

April Bright

How to Influence People: The Value of Employee Engagement

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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).

Real-World Evidence: The Future of Data Generation and Usage

April Bright

Orthopedic Coatings: Predictions for 2025

April 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.

Engineers: Apply Automation to Increase Quality, Speed to Market

April 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.

OSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities

April 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.

Unique Device Identification: Manufacturer, Hospital and Global Implications

April 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.

Additive Manufacturing - Mechanical Test Methods - OMTEC 2018

April Bright

Analyze and Optimize Your Supply Chain Operations for Higher Performance - OM...

April Bright

The new EU Medical Device Regulation (MDR) is the single largest change to medical device regulations in Europe since the 1993 introduction of CE Marking. As grandfathering of existing products is not permitted, the new regulations affect all medical devices sold throughout Europe. There is a temptation for medical device companies to think that the transition arrangements through 1Q20 under MDR leave a considerable amount of time to ensure compliance. Research predicts that companies that do not address MDR early will suffer from potential bottlenecks among Notified Bodies for certification completion and capacity shortages by compliance professionals in the preparatory process. If you have not started to plan for the transition, now is the time to act. This presentation will take you through the main regulation changes and outline key requirements affecting manufacturers moving forward.

EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck

April Bright

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.

Maximizing Use of Your Supplier Scorecard - OMTEC 2018

April Bright

Considerations for Your Minimally Invasive Device - OMTEC 2018

April Bright

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).

Vital QMS Process Validation Statistics - OMTEC 2018

April Bright

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.

Additive Manufacturing - Powder Considerations Rapid Fire - OMTEC 2018

April Bright

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.

Additive Manufacturing - Design Considerations Rapid Fire - OMTEC 2018

April Bright

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.

Leveraging Data to Develop, Execute and Exceed the Expectations of Your Regu...

April Bright

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.

Additive Manufacturing Discussion Panel – Developing a Roadmap for Regulatory...

April Bright

More from April Bright (20)

Engineers: Practical Application of Project Management Principles

Regulatory and Quality Affairs: Answers to FDA and ISO Gray Areas

The Future of Orthobiologics in Trauma Procedures

Spine Implants: Porous Coatings vs. Porous Materials vs. Additive Manufacturing

How to Influence People: The Value of Employee Engagement

Real-World Evidence: The Future of Data Generation and Usage

Orthopedic Coatings: Predictions for 2025

Engineers: Apply Automation to Increase Quality, Speed to Market

OSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities

Unique Device Identification: Manufacturer, Hospital and Global Implications

Additive Manufacturing - Mechanical Test Methods - OMTEC 2018

Analyze and Optimize Your Supply Chain Operations for Higher Performance - OM...

EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck

Maximizing Use of Your Supplier Scorecard - OMTEC 2018

Considerations for Your Minimally Invasive Device - OMTEC 2018

Vital QMS Process Validation Statistics - OMTEC 2018

Additive Manufacturing - Powder Considerations Rapid Fire - OMTEC 2018

Additive Manufacturing - Design Considerations Rapid Fire - OMTEC 2018

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Additive Manufacturing Discussion Panel – Developing a Roadmap for Regulatory...

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