Orthopaedic Care Shifts to Outpatient and Urgent Care ClinicsApril Bright
The Shift in Care Delivery - As the healthcare delivery system evolves, hospitals may no longer be the first stop for patients seeking orthopaedic care. This is evidenced by the growing trend of surgeons moving to the outpatient setting, as patients seek less invasive procedures. Orthopaedic urgent care centers have also emerged as a viable alternative, due to their ability to address price concerns in the industry by reducing time and overhead costs for both providers and patients.
Attendees gain more insight into this shift, and learn how it will affect demands on manufacturers from a product design and delivery standpoint.
The Future of Digital Health and Wearables in OrthopedicsrablesApril Bright
Orthopedic device companies have responded to payors’ adoption of bundled payments and FDA’s promotion of digital health tools by commercializing products that track patients beyond the O.R. Digital health tools, including wearables, provide device companies with revenue streams that respond to hospitals’ episode of care requirements and patients’ personalized medicine needs, while simultaneously creating a feedback loop for product ideas. Christopher E. Pelt, M.D., a surgeon enrolled in Zimmer Biomet’s mymobility clinical study with the Apple Watch app, offered perspective on the benefits of wearables and shares ways that the technology will impact patients, surgeons and device companies in the future.
The Future of Personalized Implants in Joint Replacement: Additive, Robotics,...April Bright
Orthopedics is primed for mass customization of implants thanks to advancements in additive, AI and robotics. Fully leveraged, the technologies can produce patient-specific implants that achieve clinical benefit, decrease cost and maintain O.R. workflow. Founder and Chief Medical Officer of Monogram Orthopaedics, Douglas Unis, M.D., shares his reimagined vision of personalized joint replacement implants and just-in-time inventory solutions.
Modernize the Orthopaedic Supply Chain: A Surgeon’s ViewApril Bright
Orthopaedic device manufacturers face increased pressure to assist their hospital customers with the shift to value and accompanying quality and cost mandates. Hospitals have responded to these pressures by supporting more surgeries with reduced hospital and vendor staff, making the implant management process ripe for errors.
As the Hospital for Special Surgery's Chief of Knee Services since 2006 and Co-Chairman of the Quality Coordinating Committee since 2008, Steven Haas, M.D., has experienced firsthand the way that tremendous inefficiencies in the implant delivery system impact surgical outcomes and lead to greater costs for the hospital and manufacturer. For orthopaedic device company attendees, Haas will offer recommendations to assist hospital partners in meeting quality and cost demands.
During his Keynote Address, Haas will explain how technology can modernize the orthopaedic supply chain, including inventory management and the device labeling process, and eliminate "never events."
We’re at a point in healthcare where every dollar is watched, and a more efficient supply chain could be used to offset the cost of newer or improved implants.
Computational Modeling & Simulation in Orthopedics: Tools to Comply in an Ev...April Bright
Computational Modeling & Simulation has the ability to revolutionize the orthopedic device industry by reducing and in some instances eliminating the need for benchtop testing and clinical trials. Dr. Afshari shared his experience in establishing the credibility of computational models for product design and development purposes, and highlighted was that modeling fits with the regulatory and standards framework.
Innovation in Orthopedics: Surgeon PerspectivesApril Bright
How can orthopedic manufacturers capitalize on the next wave of innovation? Which advancements will experience the greatest adoption in orthopedics, and why? The future of orthopedics is happening now. Progress is being made on materials that increase implant longevity, designs that improve patient outcomes and speed recovery, robotic and computer-assisted technologies that enhance accuracy, reliability and speed. This panel boasts future-minded surgeon entrepreneurs and researchers who have varied practical experience from the leading edge of tomorrow’s solutions. They shared perspective on what’s working in orthopedics, what gaps remain and how orthopedic manufacturers can develop new, relevant products that solve problems and alleviate pressures for surgeons and hospitals.
Real-World Evidence: The Future of Data Generation and UsageApril Bright
As data is captured through electronic health records, registries and unique device identifiers, the generation of evidence based on this data is expected to play a crucial role in informing orthopedic manufacturers’ decisions before and after regulatory approval. While regulators, payors, hospitals and manufacturers support this shift, they acknowledge that gaps remain in its optimal execution. Priority considerations include how to generate evidence to expedite regulatory market decisions, device indication expansion, postmarket studies, postmarket surveillance and reimbursement decisions. The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is leading the conversation with various stakeholders, including FDA and orthopedic device companies to support the sustainable generation of Real-World Evidence (RWE) using Real-World Data (RWD).
Orthopaedic Device Industry Business Models: 2020 and BeyondApril Bright
During last year’s closing keynote, Dr. Wael Barsoum underscored the importance of producing transformational, innovative products to stay competitive and maintain a strong company and a healthy supply chain. This year, Dr. Bill Tribe will shine the “innovation lens” on the value of transforming your business.
Dr. Tribe co-authored the often-cited “Medical Devices: Equipped for the Future?” study in which the orthopaedics sector is called out specifically as facing an extreme combination of forces — none of which come as a surprise or are new, but when viewed holistically (as in the image below), paint a rather obvious picture of the need for companies to respond. As you can see, orthopaedics is the only sector with 4 of 5 “hot” areas…and in this case, the odd one out (regulatory scrutiny) is still marked “critical.”
From a top-down view, the five “disruptors” listed above are acute (power shift to payors, regulatory scrutiny, unclear sources of innovation, new healthcare delivery models, need to serve lower socio-economic classes). They impact the overall orthopaedic industry intensely – but how are they impacting you? Dr. Tribe’s Keynote Address will take into account the uniqueness of the OMTEC audience: large and small OEMs, Suppliers and Service Providers.
As stated in the A.T. Kearney study, “Each company faces a different set of headwinds…while the macro-factors held true, individual experiences and prioritization depended on factors such as market geography, product life cycles and go-to-market strategies. The most effective strategies are therefore likely to be company specific.”
What will be your business model in 2020? 2025?
Will you be considering cost-structure, deployment of inventory, commercial logistics, quality and regulatory frameworks, R&D, innovation and data collection?
Dr. Tribe will break down the issues and share potential approaches to help you navigate toward a more relevant and lucrative business model – regardless of where you are in the process.
Orthopaedic Care Shifts to Outpatient and Urgent Care ClinicsApril Bright
The Shift in Care Delivery - As the healthcare delivery system evolves, hospitals may no longer be the first stop for patients seeking orthopaedic care. This is evidenced by the growing trend of surgeons moving to the outpatient setting, as patients seek less invasive procedures. Orthopaedic urgent care centers have also emerged as a viable alternative, due to their ability to address price concerns in the industry by reducing time and overhead costs for both providers and patients.
Attendees gain more insight into this shift, and learn how it will affect demands on manufacturers from a product design and delivery standpoint.
The Future of Digital Health and Wearables in OrthopedicsrablesApril Bright
Orthopedic device companies have responded to payors’ adoption of bundled payments and FDA’s promotion of digital health tools by commercializing products that track patients beyond the O.R. Digital health tools, including wearables, provide device companies with revenue streams that respond to hospitals’ episode of care requirements and patients’ personalized medicine needs, while simultaneously creating a feedback loop for product ideas. Christopher E. Pelt, M.D., a surgeon enrolled in Zimmer Biomet’s mymobility clinical study with the Apple Watch app, offered perspective on the benefits of wearables and shares ways that the technology will impact patients, surgeons and device companies in the future.
The Future of Personalized Implants in Joint Replacement: Additive, Robotics,...April Bright
Orthopedics is primed for mass customization of implants thanks to advancements in additive, AI and robotics. Fully leveraged, the technologies can produce patient-specific implants that achieve clinical benefit, decrease cost and maintain O.R. workflow. Founder and Chief Medical Officer of Monogram Orthopaedics, Douglas Unis, M.D., shares his reimagined vision of personalized joint replacement implants and just-in-time inventory solutions.
Modernize the Orthopaedic Supply Chain: A Surgeon’s ViewApril Bright
Orthopaedic device manufacturers face increased pressure to assist their hospital customers with the shift to value and accompanying quality and cost mandates. Hospitals have responded to these pressures by supporting more surgeries with reduced hospital and vendor staff, making the implant management process ripe for errors.
As the Hospital for Special Surgery's Chief of Knee Services since 2006 and Co-Chairman of the Quality Coordinating Committee since 2008, Steven Haas, M.D., has experienced firsthand the way that tremendous inefficiencies in the implant delivery system impact surgical outcomes and lead to greater costs for the hospital and manufacturer. For orthopaedic device company attendees, Haas will offer recommendations to assist hospital partners in meeting quality and cost demands.
During his Keynote Address, Haas will explain how technology can modernize the orthopaedic supply chain, including inventory management and the device labeling process, and eliminate "never events."
We’re at a point in healthcare where every dollar is watched, and a more efficient supply chain could be used to offset the cost of newer or improved implants.
Computational Modeling & Simulation in Orthopedics: Tools to Comply in an Ev...April Bright
Computational Modeling & Simulation has the ability to revolutionize the orthopedic device industry by reducing and in some instances eliminating the need for benchtop testing and clinical trials. Dr. Afshari shared his experience in establishing the credibility of computational models for product design and development purposes, and highlighted was that modeling fits with the regulatory and standards framework.
Innovation in Orthopedics: Surgeon PerspectivesApril Bright
How can orthopedic manufacturers capitalize on the next wave of innovation? Which advancements will experience the greatest adoption in orthopedics, and why? The future of orthopedics is happening now. Progress is being made on materials that increase implant longevity, designs that improve patient outcomes and speed recovery, robotic and computer-assisted technologies that enhance accuracy, reliability and speed. This panel boasts future-minded surgeon entrepreneurs and researchers who have varied practical experience from the leading edge of tomorrow’s solutions. They shared perspective on what’s working in orthopedics, what gaps remain and how orthopedic manufacturers can develop new, relevant products that solve problems and alleviate pressures for surgeons and hospitals.
Real-World Evidence: The Future of Data Generation and UsageApril Bright
As data is captured through electronic health records, registries and unique device identifiers, the generation of evidence based on this data is expected to play a crucial role in informing orthopedic manufacturers’ decisions before and after regulatory approval. While regulators, payors, hospitals and manufacturers support this shift, they acknowledge that gaps remain in its optimal execution. Priority considerations include how to generate evidence to expedite regulatory market decisions, device indication expansion, postmarket studies, postmarket surveillance and reimbursement decisions. The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is leading the conversation with various stakeholders, including FDA and orthopedic device companies to support the sustainable generation of Real-World Evidence (RWE) using Real-World Data (RWD).
Orthopaedic Device Industry Business Models: 2020 and BeyondApril Bright
During last year’s closing keynote, Dr. Wael Barsoum underscored the importance of producing transformational, innovative products to stay competitive and maintain a strong company and a healthy supply chain. This year, Dr. Bill Tribe will shine the “innovation lens” on the value of transforming your business.
Dr. Tribe co-authored the often-cited “Medical Devices: Equipped for the Future?” study in which the orthopaedics sector is called out specifically as facing an extreme combination of forces — none of which come as a surprise or are new, but when viewed holistically (as in the image below), paint a rather obvious picture of the need for companies to respond. As you can see, orthopaedics is the only sector with 4 of 5 “hot” areas…and in this case, the odd one out (regulatory scrutiny) is still marked “critical.”
From a top-down view, the five “disruptors” listed above are acute (power shift to payors, regulatory scrutiny, unclear sources of innovation, new healthcare delivery models, need to serve lower socio-economic classes). They impact the overall orthopaedic industry intensely – but how are they impacting you? Dr. Tribe’s Keynote Address will take into account the uniqueness of the OMTEC audience: large and small OEMs, Suppliers and Service Providers.
As stated in the A.T. Kearney study, “Each company faces a different set of headwinds…while the macro-factors held true, individual experiences and prioritization depended on factors such as market geography, product life cycles and go-to-market strategies. The most effective strategies are therefore likely to be company specific.”
What will be your business model in 2020? 2025?
Will you be considering cost-structure, deployment of inventory, commercial logistics, quality and regulatory frameworks, R&D, innovation and data collection?
Dr. Tribe will break down the issues and share potential approaches to help you navigate toward a more relevant and lucrative business model – regardless of where you are in the process.
OSMA: Orthopedic Industry's Top Regulatory Challenges and OpportunitiesApril Bright
The Orthopaedic Surgical Manufacturers Association, a collective voice of orthopedic device companies that influences the decision of worldwide regulatory agencies and standards bodies, will highlight the main regulatory changes impacting the industry. This session is for any orthopedic professional who wants a forecast of regulatory pressures and seeks direction on how to shape change. Attendees will learn how FDA, European agencies and IMDRF are approaching harmonization and alignment of standards, regulations and guidance. OSMA Members will provide future trends and opportunities afforded via FDA’s National Evaluation System for Health Technology (NEST), facilitation of innovation through partnerships and global harmonization of regulatory submissions and facility assessments.
How to Make Postmarket Surveillance More Cost EffectiveApril Bright
When it comes to postmarket surveillance (PMS), it’s common for the costs to outweigh the value. But, by working with the right team, you’ll be able to execute a study that maximizes return on investment and minimizes the financial impact of conducting further observational research. Postmarket study challenges that must be addressed include enrollment delays, patient attrition, long-term follow-up, resourcing demands and global payor requirements. This session will provide a case study of one orthopaedic company’s seamless transition between postmarket approval and post-approval studies.
New European Medical Device Regulations: Keeping Your Orthopaedic and Spine ...April Bright
For years, notified bodies and industry experts have warned orthopaedic device companies to prepare for the forthcoming EU Medical Device Regulation (MDR). Though the regulation is expected to be officially published in the first half of 2017, a recent study shows that not only are companies not prepared, but regulatory and quality affairs professionals say that they have not studied the regulation closely.
The regulation includes new requirements for orthopaedic (and especially spine) companies that must be met in a timely manner to keep products on the market. Among the MDR changes are more stringent clinical evidence, identification of a “qualified person,” implementation of UDI and rigorous postmarket oversight.
Dr. Li covers highlights of the regulation and the provided transition period toward fulfillment of the new expectations. He explains the impact of device up-classification and the need for additional clinical data toward passing this new regulation successfully and toward fulfilling the postmarket reporting requirements accordingly.
In this report, ISR leverages the insights and real-world experiences investigative sites have with electronic medical records (EMRs) and clinical trials. The report examines how sites currently use EMRs for various clinical trial activities and provides recommendations to improve trial efficiency.
Point of Care - EOS Additive Manufacturing with Selective Laser Sintering - ...Machine Tool Systems Inc.
Technology Keeps Patient First.
Healthcare providers operate in an evolving
environment influenced by policy, regulations,
and changing technology. Yet, the number one
priority remains patient care.
In a recent survey1, nearly half (49%) of healthcare
provider executives said revamping the patient
experience is one of their organization’s top three
priorities over the next five years.
This focus is helping fuel the rise of point-ofcare
(POC) manufacturing enabled by additive
manufacturing (AM), commonly known as
3D printing.
Presentation from OIS@ASCRS 2016
Mark Packer, MD, Chief Medical Officer
Video Presentation:
https://www.youtube.com/watch?v=CWwqmEDJOhM&index=20&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw
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.
High Performance IOL Power Calculation…. at the push of a buttonMichael Mrochen
earSight Innovations is developing new technologies that allow accurate measurement of the eye with the ability to move cataract surgery outcomes to a new level. Cataract surgery is the most commonly performed surgery in the world with over 20 million surgeries conducted annually.
Leverage Computational Modeling and Simulation for Device Design - OMTEC 2017April Bright
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.
Dr. Kelvin Chan gave a short explanation on what real-world evidence (RWE) is, how they can be used in cancer care and what benefits patients can get from the real-world evidence. He will also introduce the Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration, which is a pan-Canadian collaboration working on developing a framework to generate and use real-world evidence to inform cancer drug funding decisions.
The webinar was followed by an interactive question & answer session.
OSMA: Orthopedic Industry's Top Regulatory Challenges and OpportunitiesApril Bright
The Orthopaedic Surgical Manufacturers Association, a collective voice of orthopedic device companies that influences the decision of worldwide regulatory agencies and standards bodies, will highlight the main regulatory changes impacting the industry. This session is for any orthopedic professional who wants a forecast of regulatory pressures and seeks direction on how to shape change. Attendees will learn how FDA, European agencies and IMDRF are approaching harmonization and alignment of standards, regulations and guidance. OSMA Members will provide future trends and opportunities afforded via FDA’s National Evaluation System for Health Technology (NEST), facilitation of innovation through partnerships and global harmonization of regulatory submissions and facility assessments.
How to Make Postmarket Surveillance More Cost EffectiveApril Bright
When it comes to postmarket surveillance (PMS), it’s common for the costs to outweigh the value. But, by working with the right team, you’ll be able to execute a study that maximizes return on investment and minimizes the financial impact of conducting further observational research. Postmarket study challenges that must be addressed include enrollment delays, patient attrition, long-term follow-up, resourcing demands and global payor requirements. This session will provide a case study of one orthopaedic company’s seamless transition between postmarket approval and post-approval studies.
New European Medical Device Regulations: Keeping Your Orthopaedic and Spine ...April Bright
For years, notified bodies and industry experts have warned orthopaedic device companies to prepare for the forthcoming EU Medical Device Regulation (MDR). Though the regulation is expected to be officially published in the first half of 2017, a recent study shows that not only are companies not prepared, but regulatory and quality affairs professionals say that they have not studied the regulation closely.
The regulation includes new requirements for orthopaedic (and especially spine) companies that must be met in a timely manner to keep products on the market. Among the MDR changes are more stringent clinical evidence, identification of a “qualified person,” implementation of UDI and rigorous postmarket oversight.
Dr. Li covers highlights of the regulation and the provided transition period toward fulfillment of the new expectations. He explains the impact of device up-classification and the need for additional clinical data toward passing this new regulation successfully and toward fulfilling the postmarket reporting requirements accordingly.
In this report, ISR leverages the insights and real-world experiences investigative sites have with electronic medical records (EMRs) and clinical trials. The report examines how sites currently use EMRs for various clinical trial activities and provides recommendations to improve trial efficiency.
Point of Care - EOS Additive Manufacturing with Selective Laser Sintering - ...Machine Tool Systems Inc.
Technology Keeps Patient First.
Healthcare providers operate in an evolving
environment influenced by policy, regulations,
and changing technology. Yet, the number one
priority remains patient care.
In a recent survey1, nearly half (49%) of healthcare
provider executives said revamping the patient
experience is one of their organization’s top three
priorities over the next five years.
This focus is helping fuel the rise of point-ofcare
(POC) manufacturing enabled by additive
manufacturing (AM), commonly known as
3D printing.
Presentation from OIS@ASCRS 2016
Mark Packer, MD, Chief Medical Officer
Video Presentation:
https://www.youtube.com/watch?v=CWwqmEDJOhM&index=20&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw
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.
High Performance IOL Power Calculation…. at the push of a buttonMichael Mrochen
earSight Innovations is developing new technologies that allow accurate measurement of the eye with the ability to move cataract surgery outcomes to a new level. Cataract surgery is the most commonly performed surgery in the world with over 20 million surgeries conducted annually.
Leverage Computational Modeling and Simulation for Device Design - OMTEC 2017April Bright
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.
Dr. Kelvin Chan gave a short explanation on what real-world evidence (RWE) is, how they can be used in cancer care and what benefits patients can get from the real-world evidence. He will also introduce the Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration, which is a pan-Canadian collaboration working on developing a framework to generate and use real-world evidence to inform cancer drug funding decisions.
The webinar was followed by an interactive question & answer session.
Percutaneous image-guided cryoablation of spinal metastases: A systematic reviewAhmad Ozair
Percutaneous cryoablation (PCA) is a minimally invasive technique that has been recently used to treat spinal metastases with a paucity of data currently available in the literature. A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Prospective or retrospective studies concerning metastatic spinal neoplasms treated with current generation PCA systems and with available data on safety and clinical outcomes were included. In the 8 included studies (7 retrospective, 1 prospective), a total of 148 patients (females = 63%) underwent spinal PCA. Tumors were located in the cervical (3/109 [2.8%], thoracic (74/109 [68.8%], lumbar (37/109 [33.9%], and sacrococcygeal (17/109 [15.6%] regions. Overall, 187 metastatic spinal lesions were treated. Thermo-protective measures (e.g., carbo-/hydro-dissection, thermocouples) were used in 115/187 [61.5%] procedures. For metastatic spinal tumors, the pooled mean difference (MD) in pain scores from baseline on the 0–10 numeric rating scale was 5.03 (95% confidence interval [CI]: 4.24 to 5.82) at a 1-month follow-up and 4.61 (95% CI: 3.27 to 5.95) at the last reported follow-up (range 24–40 weeks in 3/4 studies). Local tumor control rates ranged widely from 60% to 100% at varying follow-ups. Grade I-II complications were reported in 9/148 [6.1%] patients and grade III-V complications were reported in 3/148 [2.0%]) patients. PCA, as a stand-alone or adjunct modality, may be a viable therapy in appropriately selected patients with painful spinal metastases who were traditionally managed with open surgery and/or radiation therapy.
Agence spatiale canadienne : Innovations technologiques pour le soutien médic...TechnoMontréal
Dr Raffi Kuyumjian - Médecin de vol, Agence spatiale canadienne - présentation 10 octobre dans le cadre de la grande conférence métropoline le FUTUR DE LA SANTÉ : innovez pour une population connectée.
Keynote address by Brent James at the 2013 Saskatchewan Health Care Quality Summit. For more information about the summit, visit www.qualitysummit.ca. Follow @QualitySummit on Twitter.
Dr. Brent James describes how Intermountain Healthcare is systematically, and successfully, bringing together clinicians, patients and leaders to: establish best practices; drive out waste in their system; and ultimately deliver better, safer care. Dr. James will share insights about the structures, strategies and relationships that have been pivotal in transforming their health system.
Presentation given in March 2014 as an invited speaker at the PIMA Medical Society (http://www.pimamedicalsociety.org/schedule/). These society presentations are widely attended by physicians in the Tucson area. The topic was innovation in CT surgery at UA.
By utilizing evidence based practice enhanced recovery after
surgery (ERAS) protocols implement several steps along the care pathway to help minimise the surgical stress response caused from surgical insult. Radical Cystectomy is associated with the highest morbidity of all urological procedures [1]; with extended length of hospital stay and high complication rates reported post operatively [1-
2]. In 2013, following a literature review the ERAS society published guidelines detailing 22 ERAS items for patients undergoing radical cystectomy.
Antimicrobial Coatings: The Research and Regulatory PerspectiveApril Bright
Coatings have long been considered an avenue for infection prevention in orthopedic procedures. These coatings, some of which utilize silver, have largely not been commercialized because regulators seek greater evidence of their safety, creating a long, expensive road for device companies. Announcements in the last half of 2018 and early 2019 indicate that companies continue to push to get them on the market and that productive conversations are taking place with regulators. This session began with a history of antimicrobial coatings followed by a look at recent research and technology.
Leverage These Effective Communication Skills to Get Your Message AcrossApril Bright
Your success is highly dependent upon how well you communicate with your colleagues, your customers and your providers. Effective communication helps you reduce conflict and confusion while increasing motivation and productivity. No matter your age or title, communication is a timeless skill to practice and hone. Leveraging decades of training and managerial experience within device companies and his role as a professor, G. Bryan Cornwall provided the practical steps that you must take to become an excellent communicator.
Operations: Top Reasons for Long Lead Times and What to Do About ThemApril Bright
Long lead times remain one of the most vocalized challenges that orthopedic manufacturers face today. Customers, profits, plans and personnel are all negatively impacted by them. James Kwan has worked on the OEM and the supplier sides of orthopedics, and shared his ideas and successful experiences to help you optimally respond to lead times, reduce them and ultimately create and sustain an agile supply chain.
Joint Replacement: The Current and Future Impact of CoatingsApril Bright
The control of surface properties to reduce wear and corrosion and improve biocompatibility is of particular interest today as device companies—and surgeons, payors and patients—seek to extend the life of knee and hip implants. In this session, device companies shared research on their joint replacement coatings and materials, covering pros, cons and the future of their technology.
Engineers: Practical Application of Project Management PrinciplesApril Bright
Predictability throughout the commercialization chain is critical to allow manufacturers to speed products to market and gain share within the growing orthopedic industry. As an engineer, your technical and regulatory expertise will be overshadowed if you cannot properly plan and execute a project. One skill every engineer must learn and hone is project management. Start with the steps shared in this session.
Regulatory and Quality Affairs: Answers to FDA and ISO Gray AreasApril Bright
Every day, people like you in companies everywhere are sidetracked from more pressing priorities by questions and scenarios that aren’t clearly explained in a regulation or standard (a.k.a. "gray areas"). This panel of regulatory and quality experts were charged with mitigating your roadblocks and getting you on your way. Our panel shared their perspective on the pressing questions received from a pre-conference attendee questionnaire, including UDI and supplier relationships.
The Future of Orthobiologics in Trauma ProceduresApril Bright
Based on his clinical research interests in utilization of Alpha-BSM bone graft substitute and OP-1 recombinant BMP in the repair of fractures, Daniel N. Segina, M.D., outlined opportunities and challenges for surgeons and device companies in biologic development. To make his case, Dr. Segina reviewed the spectrum of orthobiologics used in trauma cases today, shared perspective on what is and isn’t working and forecasted the future of regenerative medicine.
Spine Implants: Porous Coatings vs. Porous Materials vs. Additive ManufacturingApril Bright
Spine implant materials and surface characteristics are popular topics among engineers and surgeons. How do surface technologies relate to spine implants and bone integration and fusion? What are the pros and cons of various materials and surfaces? In this interactive session, members of industry and academia reviewed and presented research related to use of
• porous plasma spray coating,
• porous PEEK, and
• additive manufactured titanium in spinal devices.
How to Influence People: The Value of Employee EngagementApril Bright
Engagement is a powerful tool to drive accomplishment of individual and company objectives. Success requires a genuine interest in achieving the goals of the company as well as making connections between those goals and the personal motivations of your team. Employee engagement is lauded by many as the single most fulfilling aspect of their jobs.
Orthopedic Coatings: Predictions for 2025April Bright
What are the next innovations in orthopedic coatings? What orthopedic market stands to benefit the most from coatings? What’s stalling coating innovation? This session brought together the device company and coating manufacturer perspective to discuss which coatings will be used in orthopedics in the next decade.
Engineers: Apply Automation to Increase Quality, Speed to MarketApril Bright
We live in the age of machine learning, artificial intelligence and other automated systems. Why, then, are we performing tedious tasks that we can streamline during the product development phase? First, there is Design Verification testing. Second, there is Design Validation testing. Some of these tests use simple pass/fail attribute data, while others use continuous data. We will focus on ways to automate the analysis of that continuous data, which can ensure more accurate and timely results.
Unique Device Identification: Manufacturer, Hospital and Global ImplicationsApril Bright
Unique device identification (UDI) is gaining global adoption. Now is the time for companies to take a step back and ask: Is my UDI framework scaleable? UDI experts answered questions on the U.S. regulation and provided perspective on ways that device manufacturers can implement a working system—including data management—that can scale with product development and UDI compliance needs. Attendees gained an understanding of new global regulations and practical, implementable advice for compliance.
Additive Manufacturing - Mechanical Test Methods - OMTEC 2018April Bright
Medical devices fabricated from additively-manufactured materials must undergo a variety of mechanical tests before receiving regulatory approval. Due to the complexity of manufacturing processes and the limited clinical knowledge of AM devices, they are subject to additional scrutiny by manufacturers and Notified Bodies. Several test methods for characterizing these devices are presented in this session, as well as the differences between testing additively-manufactured devices and those fabricated with traditional machining methods.
Analyze and Optimize Your Supply Chain Operations for Higher Performance - OM...April Bright
The operations science pioneered through Factory Physics provides practical concepts to analyze and optimize supply chain operations. This presentation covers basic approaches for operations science to enhance your world, with all its variability in product mix, demand, people and processes. You will get applications of the science to apply immediately.
EU MDR Preparation: Seize the Market Opportunity and Avoid the BottleneckApril Bright
The new EU Medical Device Regulation (MDR) is the single largest change to medical device regulations in Europe since the 1993 introduction of CE Marking. As grandfathering of existing products is not permitted, the new regulations affect all medical devices sold throughout Europe. There is a temptation for medical device companies to think that the transition arrangements through 1Q20 under MDR leave a considerable amount of time to ensure compliance. Research predicts that companies that do not address MDR early will suffer from potential bottlenecks among Notified Bodies for certification completion and capacity shortages by compliance professionals in the preparatory process. If you have not started to plan for the transition, now is the time to act. This presentation will take you through the main regulation changes and outline key requirements affecting manufacturers moving forward.
Maximizing Use of Your Supplier Scorecard - OMTEC 2018April 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.
Considerations for Your Minimally Invasive Device - OMTEC 2018April Bright
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.
Vital QMS Process Validation Statistics - OMTEC 2018April 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).
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.
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.
Sharpen existing tools or get a new toolbox? Contemporary cluster initiatives...Orkestra
UIIN Conference, Madrid, 27-29 May 2024
James Wilson, Orkestra and Deusto Business School
Emily Wise, Lund University
Madeline Smith, The Glasgow School of Art
This presentation by Morris Kleiner (University of Minnesota), was made during the discussion “Competition and Regulation in Professions and Occupations” held at the Working Party No. 2 on Competition and Regulation on 10 June 2024. More papers and presentations on the topic can be found out at oe.cd/crps.
This presentation was uploaded with the author’s consent.
0x01 - Newton's Third Law: Static vs. Dynamic AbusersOWASP Beja
f you offer a service on the web, odds are that someone will abuse it. Be it an API, a SaaS, a PaaS, or even a static website, someone somewhere will try to figure out a way to use it to their own needs. In this talk we'll compare measures that are effective against static attackers and how to battle a dynamic attacker who adapts to your counter-measures.
About the Speaker
===============
Diogo Sousa, Engineering Manager @ Canonical
An opinionated individual with an interest in cryptography and its intersection with secure software development.
This presentation, created by Syed Faiz ul Hassan, explores the profound influence of media on public perception and behavior. It delves into the evolution of media from oral traditions to modern digital and social media platforms. Key topics include the role of media in information propagation, socialization, crisis awareness, globalization, and education. The presentation also examines media influence through agenda setting, propaganda, and manipulative techniques used by advertisers and marketers. Furthermore, it highlights the impact of surveillance enabled by media technologies on personal behavior and preferences. Through this comprehensive overview, the presentation aims to shed light on how media shapes collective consciousness and public opinion.
Have you ever wondered how search works while visiting an e-commerce site, internal website, or searching through other types of online resources? Look no further than this informative session on the ways that taxonomies help end-users navigate the internet! Hear from taxonomists and other information professionals who have first-hand experience creating and working with taxonomies that aid in navigation, search, and discovery across a range of disciplines.
Acorn Recovery: Restore IT infra within minutesIP ServerOne
Introducing Acorn Recovery as a Service, a simple, fast, and secure managed disaster recovery (DRaaS) by IP ServerOne. A DR solution that helps restore your IT infra within minutes.
4. ENVIRONMENT
• Stakeholders
– Doctors (Medical/Procedural), Industry
(Pharma/Device), Insurers (CMS/TPP/Wcomp),
Hospitals
– Employers, Politicians
• Goals
– Vary based on stakeholder and circumstances
5. ENVIRONMENT
CHALLENGES
• Increasing expenses/cost
• Limited data on efficacy
• Coverage and pre-
authorization
(BIOLOGICS/FUSION)
• Declining rates of
reimbursement
• Regulations
(Ins/Procedure/Implants)
– Fed/State/Hospital
OPPORUNITIES
• ASC
• POH
• PODs
• Monitoring/DME/Imaging
• Gain-sharing/
Collaboration/
Directorships
6. CPT/RUC PROCESS
CPT (AMA) = DESCRIPTION
• Meets 3x/yr, Open meeting,
Define physician service
• Code submission – anyone can
submit
• PMA representation (NASS,
AAOS, ISAS, AANS, CNS,
AAPMR, AAPM, ASA, etc.)
• Panel – specialists and
insurers, CMS
• Accept, reject, table, work
group
• AMA owns and decides
RUC (CMS) = VALUATION
• Meets 3x/yr, Closed meeting,
determine work of service
• Survey
• Compares
• Recommendations
• CMS final rule
• RVUs
• Intraop is only part of work
value
• One Pie
7. CODES
• Most insurers follow
CMS policies
• Category 1
– Insurers must have
coverage/payment
• Category 3
– Tracking
– NOT EXPERIMENTAL
• Unlisted
• Inpatient/Outpatient
• Surgery
– Faster, easier, shorter
LOS = less pay
– Intensity weight in
formula
16. Interbody Device - 22851
• 22851 – 1 code into 3
• 1995 last valued, 2005 45k @ 640k, 2015 125k
for 50mill, 6.7 work RVU
• 22853 – disc defect for fusion
• 22854 – vertebral defect for fusion
• 22859 – disc or vertebral defect (non-fusion)
17. 22853
• Insertion of biomechanical interbody device(s)
(e.g., synthetic cage, mesh) with integral
anterior instrumentation for device anchoring
(e.g., screws, flanges), when performed, to
intervertebral disc space in conjunction with
interbody arthrodesis, each interspace
• 7.64 RVU (4.88 work RUC rec, 4.25 work CMS)
19. 22854/22859
• Insertion of biomechanical
interbody device(s) (e.g.,
synthetic cage, mesh) with
integral anterior
instrumentation for device
anchoring (e.g., screws,
flanges), when performed, to
vertebral corpectomy(ies)
(vertebral body resection,
partial or complete) defect, in
conjunction with interbody
arthrodesis, each contiguous
defect
• 9.89 RVU (5.5 work RUC/CMS)
• Insertion of biomechanical
interbody device(s) (e.g.,
synthetic cage, mesh,
methylmethacrylate) to
intervertebral disc space or
vertebral body defect without
interbody arthrodesis, each
contiguous defect
• 9.89 RVU (6 work RUC, 5.5
work CMS)
23. Interspinous Devices
• History of devices (X-STOP then coflex)
• 22867 with decompression
• 22868
• 22869 without decompression
• 22870
24. 22867/22868
• Insertion of interlaminar/interspinous process
stabilization/distraction device, without
fusion, including image guidance when
performed, with open decompression,
lumbar: single level
• Second level (list separately in addition to
code for primary procedure)
25.
26. 22869/22870
• Insertion of interlaminar/interspinous process
stabilization/distraction device, without open
decompression or fusion, including image
guidance when performed, lumbar; single
level
• Second level (list separately in addition to
code for primary procedure)
27.
28. FORWARD
• Understand the system
• Innovation
– Improvement or benefit (for
whom?), Validation?
Comparative effectiveness?
– Faster with shorter LOS = less
reimbursement
– volume increase, (can = less
reimbursement)
– Site of service change (ASC,
office) can = less
reimbursement
– ?long-term sequelae? Who
pays?
• Collaborate – with whom
depends on goal
• PMA involvement
• Consider unintended
consequences
• Data to support efficacy and
cost
• Marketing vs. coding
• Bundle vs. Split, New vs.
Different version
• Amazon/Uber
