OEMs and suppliers see promise in the ability of manufacturing and software to expand the use of custom implants in orthopaedics. Multiple companies are focused on the custom market. This session provides the surgeon perspective on these devices. What are the benefits? When should and shouldn't they be used? Will the market take off?
Implant related complications and failureJignesh Patel
This document discusses complications related to dental implants. It begins by discussing surgical complications such as hemorrhage, hematoma, neurosensory disturbances, and implant malposition. It then discusses biological complications affecting the peri-implant soft tissues, such as inflammation, recession, and progressive bone loss which can lead to peri-implantitis. Mechanical complications are also summarized, including screw loosening/fracture and implant fracture.
This document discusses single tooth dental implants. It provides information on:
- The goals of single tooth implants which is to mimic the function and esthetics of natural teeth.
- Key factors for achieving a sound esthetic result including bone and gingival contours, implant positioning, and ceramist skills.
- Diagnosing implant cases by assessing hard and soft tissues and treatment planning the surgical and restorative aspects.
- Guidelines for restoration design, implant placement, and occlusion to ensure biomechanical success and esthetics.
This document discusses the theoretical background and techniques of the Hobo full mouth rehabilitation approach. It defines key terms like condylar guidance, incisal guidance, and disocclusion. It explains that the goal of reorganizing occlusion is to address issues like trauma, poor function, or lack of space. The optimal occlusion balances factors like condylar path, incisal guidance, and cuspal angles. The articulator aims to replicate these concepts to guide reconstruction of the full mouth.
Treatment planning of dental implants /orthodontic courses by Indian dental...Indian dental academy
Indian Dental Academy: will be one of the most relevant and exciting training center with best faculty and flexible training programs for dental professionals who wish to advance in their dental practice,Offers certified courses in Dental implants,Orthodontics,Endodontics,Cosmetic Dentistry, Prosthetic Dentistry, Periodontics and General Dentistry.
Splints are removable dental appliances that are used to treat temporomandibular disorders by establishing neuromuscular harmony in the jaw. There are two main types of splints - permissive splints, which allow the jaw to move freely, and nonpermissive splints, which restrict jaw movement. Splints are fabricated based on a thorough examination of the patient's jaw function and musculature to determine the appropriate treatment. They are adjusted over time and used in conjunction with other therapies to relax muscles, seat the jawbone condyles correctly, and reduce jaw pain and dysfunction.
implant placement protocol where and when marwan mohamed
The document discusses various factors related to dental implants including bone density, implant placement protocols, loading protocols, and implant success factors. Bone density directly impacts implant success, and there are four types of bone. Implant placement can be immediate, early, or delayed and loading can be immediate, early, or delayed depending on factors like primary stability, soft tissue healing, and bone quality. Key considerations for placement and loading protocols include esthetics, function, surrounding soft tissues and bone structure, and primary versus secondary stability.
A wide range of disorders affect TMJ than can be managed conservatively initially by consuming soft and liquid diet, getting
heat therapy or physiotherapy done etc.
In advanced stages it needs treatment with splints, botox or more definitively surgical management.
For more information, you can book an appointment at
Dr Sachdeva's Dental Aesthetic And Implant Institute,
I 101, Ashok Vihar Phase 1, Delhi- 110052
Contact us at
• Phone : +919818894041,01142464041
• Our Websites:
• www.sachdevadentalcare.com
• www.dentalclinicindelhi.com
• www.dentalimplantindia.co.in
• www.dentalcoursesdelhi.com
• www.facialaestheticsdelhi.com
• Google+ link: https://goo.gl/vqAmvr
• Facebook link: https://goo.gl/tui98A
• Youtube link: https://goo.gl/mk7jfm
• Linkedin link: https://goo.gl/PrPgpB
• Slideshare link : http://goo.gl/0HY6ep
• Twitter Page : https://goo.gl/tohkcI
• Instagram page : https://goo.gl/OOGVig
Implant related complications and failureJignesh Patel
This document discusses complications related to dental implants. It begins by discussing surgical complications such as hemorrhage, hematoma, neurosensory disturbances, and implant malposition. It then discusses biological complications affecting the peri-implant soft tissues, such as inflammation, recession, and progressive bone loss which can lead to peri-implantitis. Mechanical complications are also summarized, including screw loosening/fracture and implant fracture.
This document discusses single tooth dental implants. It provides information on:
- The goals of single tooth implants which is to mimic the function and esthetics of natural teeth.
- Key factors for achieving a sound esthetic result including bone and gingival contours, implant positioning, and ceramist skills.
- Diagnosing implant cases by assessing hard and soft tissues and treatment planning the surgical and restorative aspects.
- Guidelines for restoration design, implant placement, and occlusion to ensure biomechanical success and esthetics.
This document discusses the theoretical background and techniques of the Hobo full mouth rehabilitation approach. It defines key terms like condylar guidance, incisal guidance, and disocclusion. It explains that the goal of reorganizing occlusion is to address issues like trauma, poor function, or lack of space. The optimal occlusion balances factors like condylar path, incisal guidance, and cuspal angles. The articulator aims to replicate these concepts to guide reconstruction of the full mouth.
Treatment planning of dental implants /orthodontic courses by Indian dental...Indian dental academy
Indian Dental Academy: will be one of the most relevant and exciting training center with best faculty and flexible training programs for dental professionals who wish to advance in their dental practice,Offers certified courses in Dental implants,Orthodontics,Endodontics,Cosmetic Dentistry, Prosthetic Dentistry, Periodontics and General Dentistry.
Splints are removable dental appliances that are used to treat temporomandibular disorders by establishing neuromuscular harmony in the jaw. There are two main types of splints - permissive splints, which allow the jaw to move freely, and nonpermissive splints, which restrict jaw movement. Splints are fabricated based on a thorough examination of the patient's jaw function and musculature to determine the appropriate treatment. They are adjusted over time and used in conjunction with other therapies to relax muscles, seat the jawbone condyles correctly, and reduce jaw pain and dysfunction.
implant placement protocol where and when marwan mohamed
The document discusses various factors related to dental implants including bone density, implant placement protocols, loading protocols, and implant success factors. Bone density directly impacts implant success, and there are four types of bone. Implant placement can be immediate, early, or delayed and loading can be immediate, early, or delayed depending on factors like primary stability, soft tissue healing, and bone quality. Key considerations for placement and loading protocols include esthetics, function, surrounding soft tissues and bone structure, and primary versus secondary stability.
A wide range of disorders affect TMJ than can be managed conservatively initially by consuming soft and liquid diet, getting
heat therapy or physiotherapy done etc.
In advanced stages it needs treatment with splints, botox or more definitively surgical management.
For more information, you can book an appointment at
Dr Sachdeva's Dental Aesthetic And Implant Institute,
I 101, Ashok Vihar Phase 1, Delhi- 110052
Contact us at
• Phone : +919818894041,01142464041
• Our Websites:
• www.sachdevadentalcare.com
• www.dentalclinicindelhi.com
• www.dentalimplantindia.co.in
• www.dentalcoursesdelhi.com
• www.facialaestheticsdelhi.com
• Google+ link: https://goo.gl/vqAmvr
• Facebook link: https://goo.gl/tui98A
• Youtube link: https://goo.gl/mk7jfm
• Linkedin link: https://goo.gl/PrPgpB
• Slideshare link : http://goo.gl/0HY6ep
• Twitter Page : https://goo.gl/tohkcI
• Instagram page : https://goo.gl/OOGVig
use of waxes in dentistry/cosmetic dentistry course by Indian dental academyIndian dental academy
Indian Dental Academy: will be one of the most relevant and exciting training center with best faculty and flexible training programs for dental professionals who wish to advance in their dental practice,Offers certified courses in Dental implants,Orthodontics,Endodontics,Cosmetic Dentistry, Prosthetic Dentistry, Periodontics and General Dentistry.
Lateral pedicle graft is a surgical technique used to increase attached gingiva around teeth affected by recession. It involves raising a partial-thickness flap of tissue from an adjacent donor site and rotating it to cover the exposed root surface. The pedicle flap provides good vascularization and ability to cover denuded roots. However, it is limited to one or two teeth and carries risks of recession at the donor site. Key steps include preparing the recipient and donor sites, outlining incisions, raising and positioning the pedicle flap, and suturing to cover the exposed root.
Basic Surgical Techniques for Endosseous Implant Placement discusses the history and process of dental implants. It describes how Branemark discovered that titanium bonds directly to living bone, called osseointegration. The document outlines the 4 steps of a typical surgical procedure: 1) initial surgery, 2) osseointegration period, 3) abutment connection, and 4) final prosthetic restoration. It also discusses factors that influence osseointegration like biocompatible materials and atraumatic surgery.
Ridge preparation for implant placement - part 1Hesham El-Hawary
- criteria of ideal ridge
- implants timing protocol
- implants planning and case selection
- clinical types of bone
- preventive methods to preserve the alveolar ridge
Indian Dental Academy: will be one of the most relevant and exciting training
center with best faculty and flexible training programs for dental
professionals who wish to advance in their dental practice,Offers certified
courses in Dental implants,Orthodontics,Endodontics,Cosmetic Dentistry,
Prosthetic Dentistry, Periodontics and General Dentistry.
This document defines and discusses overdentures, which are removable partial or complete dentures that rest on remaining natural teeth or dental implants. Overdentures help preserve remaining bone by preventing accelerated bone resorption. They also improve manipulative skills by maintaining proprioception. Appropriate candidates include those with periodontal disease, few remaining teeth, insufficient tooth structure, loss of vertical dimension, or congenital/acquired defects. Key factors in selecting abutment teeth include their periodontal status, location, and endodontic/prosthetic condition. Treatment may involve an immediate denture, extracting hopeless teeth, and subsequent periodontal/endodontic work. Tooth preparations reduce crown length and taper occlusogingiv
Stress & force factors in implants /certified fixed orthodontic courses by I...Indian dental academy
The Indian Dental Academy is the Leader in continuing dental education , training dentists in all aspects of dentistry and offering a wide range of dental certified courses in different formats.
Indian dental academy provides dental crown & Bridge,rotary endodontics,fixed orthodontics,
Dental implants courses.for details pls visit www.indiandentalacademy.com ,or call
0091-9248678078
The main concept of osseodensification technique is that the drill designing creates an environment which enhances the initial primary stability through densification of the osteotomy site walls by means of autografting of bone.
This document discusses the prosthodontic rehabilitation of patients who have undergone mandibulectomy. It describes different classifications of mandibular defects and the goals of mandibular reconstruction. Key diagnostic considerations for prosthodontic treatment are discussed such as the location and extent of the defect, remaining teeth, jaw rotation, and mouth opening. Surgical reconstruction techniques and approaches to rehabilitation for partially or fully edentulous patients are presented, including the use of implants, guidance prostheses, and overlay dentures. Close follow-up is important when rehabilitating mandibulectomy patients prosthodontically.
Occlusal Considerations For Implant Supported Prostheses Implant Protectes O...Mohammed Alshehri
Trauma from occlusion refers to pathological changes in the periodontium caused by excessive force from chewing muscles. While excessive force alone does not cause tissue breakdown, it may act as a co-factor in plaque-induced periodontal disease by enhancing the rate of progression. Proper treatment of plaque is important to arrest tissue destruction, even if occlusal trauma persists. Treating occlusal trauma alone through adjustment or splinting may reduce mobility but not stop further breakdown from untreated plaque.
The primary success metric of dental implants is achieving osseointegration, which is influenced by many factors including implant design, surface treatments, as well as treatment method. Implant drilling is also a major influential factor.
Hallux varus is a deformity of the great toe characterized by three key radiographic findings: a negative hallux abductus angle, negative IM 1-2 angle, and tibial sesamoid peaking. Patients typically present with pain, difficulty with shoes, and decreased push off ability. Treatment begins with orthotics and splinting but often requires surgery involving medial soft tissue release and lateral tightening, with tendon transfers used to correct deformity and maintain correction. Classification systems aim to guide surgical decision making by considering joint flexibility and deforming forces at work.
This document discusses treatment options for missing maxillary central incisors. It describes various causes for missing central incisors including trauma, decay, fractures, and extractions. The main treatment options discussed are removable partial dentures and fixed partial dentures. Removable partial dentures are less invasive but can cause damage to tissues over time and require good oral hygiene. Fixed partial dentures like conventional bridges or resin-bonded bridges offer a more permanent solution but require more tooth preparation. Implant-supported bridges are also mentioned as a treatment option.
This document discusses osseointegration, which refers to the direct structural and functional connection between bone and the surface of a load-bearing dental implant without intervening soft tissue. It traces the history and development of osseointegration from early experiments in the 1950s to its current understanding. The key aspects covered include definitions of osseointegration, the biological process of bone formation around implants over time, factors that influence osseointegration success, and future directions for improving integration.
The document discusses activator therapy, a type of functional appliance used to correct Class II malocclusions. It begins with the history and development of functional appliances and the activator specifically. The activator was developed by Viggo Andresen in the 1950s as a removable appliance to alter mandibular position and muscle function. The document describes the construction of the activator, including taking a construction bite to reposition the mandible forward. It discusses various theories on how the activator works, primarily through muscle stimulation or tissue elasticity. The effects are both orthodontic and orthopedic through guiding tooth movement and altering jaw growth. Proper diagnosis and model analysis is important before fabricating the activator.
This document discusses single tooth defects in the posterior quadrants and their restoration. It compares fixed dental prostheses to implants, noting that implants are generally preferred when adjacent teeth are healthy or nearly so. For endodontically treated teeth, a fixed restoration is preferred if sufficient tooth structure remains and occlusion and parafunction are minimal. Considerations for implant placement include anatomic factors, timing of placement, and prosthodontic issues like abutment selection and cement versus screw retention. The goal is to restore function while avoiding complications like fracture, overload, and peri-implantitis.
This document discusses bone grafting and grafting techniques. It defines what a graft is, describes different types of bone grafts including autografts, allografts, and bone graft substitutes. It covers the biological process of bone graft incorporation and lists various techniques for harvesting and placing bone grafts, such as onlay grafts, dual onlay grafts, and fibula grafts. Risks, advantages, and disadvantages of different graft options are also summarized.
Fluid control and soft tissue management / cosmetic dentistry trainingIndian dental academy
Indian Dental Academy: will be one of the most relevant and exciting
training center with best faculty and flexible training programs
for dental professionals who wish to advance in their dental
practice,Offers certified courses in Dental
implants,Orthodontics,Endodontics,Cosmetic Dentistry, Prosthetic
Dentistry, Periodontics and General Dentistry.
Treatment planning for dental implants/fixed orthodontics coursesIndian dental academy
Indian Dental Academy: will be one of the most relevant and exciting training center with best faculty and flexible training programs for dental professionals who wish to advance in their dental practice,Offers certified courses in Dental implants,Orthodontics,Endodontics,Cosmetic Dentistry, Prosthetic Dentistry, Periodontics and General Dentistry.
Standard surgical procedure for implant placement Diana Abo el Ola
The lecture gives in details step by step how to replace an implant in the osteotomy site. Also, mention the preoperative and postoperative procedures.
Surgeon Perspective on Additive Manufacturing April Bright
As additive manufacturing gains popularity as a production process, it’s important to understand the perspective of surgeons engaged with the technology. Nirav Shah, M.D., has consulted with device companies on additively-manufactured implants and is involved in the research of 3D-printed tissue. He will share his perspective and research on the current state of additive manufacturing in orthopaedics, and provide ideas on how the technology could be used in the future.
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.
use of waxes in dentistry/cosmetic dentistry course by Indian dental academyIndian dental academy
Indian Dental Academy: will be one of the most relevant and exciting training center with best faculty and flexible training programs for dental professionals who wish to advance in their dental practice,Offers certified courses in Dental implants,Orthodontics,Endodontics,Cosmetic Dentistry, Prosthetic Dentistry, Periodontics and General Dentistry.
Lateral pedicle graft is a surgical technique used to increase attached gingiva around teeth affected by recession. It involves raising a partial-thickness flap of tissue from an adjacent donor site and rotating it to cover the exposed root surface. The pedicle flap provides good vascularization and ability to cover denuded roots. However, it is limited to one or two teeth and carries risks of recession at the donor site. Key steps include preparing the recipient and donor sites, outlining incisions, raising and positioning the pedicle flap, and suturing to cover the exposed root.
Basic Surgical Techniques for Endosseous Implant Placement discusses the history and process of dental implants. It describes how Branemark discovered that titanium bonds directly to living bone, called osseointegration. The document outlines the 4 steps of a typical surgical procedure: 1) initial surgery, 2) osseointegration period, 3) abutment connection, and 4) final prosthetic restoration. It also discusses factors that influence osseointegration like biocompatible materials and atraumatic surgery.
Ridge preparation for implant placement - part 1Hesham El-Hawary
- criteria of ideal ridge
- implants timing protocol
- implants planning and case selection
- clinical types of bone
- preventive methods to preserve the alveolar ridge
Indian Dental Academy: will be one of the most relevant and exciting training
center with best faculty and flexible training programs for dental
professionals who wish to advance in their dental practice,Offers certified
courses in Dental implants,Orthodontics,Endodontics,Cosmetic Dentistry,
Prosthetic Dentistry, Periodontics and General Dentistry.
This document defines and discusses overdentures, which are removable partial or complete dentures that rest on remaining natural teeth or dental implants. Overdentures help preserve remaining bone by preventing accelerated bone resorption. They also improve manipulative skills by maintaining proprioception. Appropriate candidates include those with periodontal disease, few remaining teeth, insufficient tooth structure, loss of vertical dimension, or congenital/acquired defects. Key factors in selecting abutment teeth include their periodontal status, location, and endodontic/prosthetic condition. Treatment may involve an immediate denture, extracting hopeless teeth, and subsequent periodontal/endodontic work. Tooth preparations reduce crown length and taper occlusogingiv
Stress & force factors in implants /certified fixed orthodontic courses by I...Indian dental academy
The Indian Dental Academy is the Leader in continuing dental education , training dentists in all aspects of dentistry and offering a wide range of dental certified courses in different formats.
Indian dental academy provides dental crown & Bridge,rotary endodontics,fixed orthodontics,
Dental implants courses.for details pls visit www.indiandentalacademy.com ,or call
0091-9248678078
The main concept of osseodensification technique is that the drill designing creates an environment which enhances the initial primary stability through densification of the osteotomy site walls by means of autografting of bone.
This document discusses the prosthodontic rehabilitation of patients who have undergone mandibulectomy. It describes different classifications of mandibular defects and the goals of mandibular reconstruction. Key diagnostic considerations for prosthodontic treatment are discussed such as the location and extent of the defect, remaining teeth, jaw rotation, and mouth opening. Surgical reconstruction techniques and approaches to rehabilitation for partially or fully edentulous patients are presented, including the use of implants, guidance prostheses, and overlay dentures. Close follow-up is important when rehabilitating mandibulectomy patients prosthodontically.
Occlusal Considerations For Implant Supported Prostheses Implant Protectes O...Mohammed Alshehri
Trauma from occlusion refers to pathological changes in the periodontium caused by excessive force from chewing muscles. While excessive force alone does not cause tissue breakdown, it may act as a co-factor in plaque-induced periodontal disease by enhancing the rate of progression. Proper treatment of plaque is important to arrest tissue destruction, even if occlusal trauma persists. Treating occlusal trauma alone through adjustment or splinting may reduce mobility but not stop further breakdown from untreated plaque.
The primary success metric of dental implants is achieving osseointegration, which is influenced by many factors including implant design, surface treatments, as well as treatment method. Implant drilling is also a major influential factor.
Hallux varus is a deformity of the great toe characterized by three key radiographic findings: a negative hallux abductus angle, negative IM 1-2 angle, and tibial sesamoid peaking. Patients typically present with pain, difficulty with shoes, and decreased push off ability. Treatment begins with orthotics and splinting but often requires surgery involving medial soft tissue release and lateral tightening, with tendon transfers used to correct deformity and maintain correction. Classification systems aim to guide surgical decision making by considering joint flexibility and deforming forces at work.
This document discusses treatment options for missing maxillary central incisors. It describes various causes for missing central incisors including trauma, decay, fractures, and extractions. The main treatment options discussed are removable partial dentures and fixed partial dentures. Removable partial dentures are less invasive but can cause damage to tissues over time and require good oral hygiene. Fixed partial dentures like conventional bridges or resin-bonded bridges offer a more permanent solution but require more tooth preparation. Implant-supported bridges are also mentioned as a treatment option.
This document discusses osseointegration, which refers to the direct structural and functional connection between bone and the surface of a load-bearing dental implant without intervening soft tissue. It traces the history and development of osseointegration from early experiments in the 1950s to its current understanding. The key aspects covered include definitions of osseointegration, the biological process of bone formation around implants over time, factors that influence osseointegration success, and future directions for improving integration.
The document discusses activator therapy, a type of functional appliance used to correct Class II malocclusions. It begins with the history and development of functional appliances and the activator specifically. The activator was developed by Viggo Andresen in the 1950s as a removable appliance to alter mandibular position and muscle function. The document describes the construction of the activator, including taking a construction bite to reposition the mandible forward. It discusses various theories on how the activator works, primarily through muscle stimulation or tissue elasticity. The effects are both orthodontic and orthopedic through guiding tooth movement and altering jaw growth. Proper diagnosis and model analysis is important before fabricating the activator.
This document discusses single tooth defects in the posterior quadrants and their restoration. It compares fixed dental prostheses to implants, noting that implants are generally preferred when adjacent teeth are healthy or nearly so. For endodontically treated teeth, a fixed restoration is preferred if sufficient tooth structure remains and occlusion and parafunction are minimal. Considerations for implant placement include anatomic factors, timing of placement, and prosthodontic issues like abutment selection and cement versus screw retention. The goal is to restore function while avoiding complications like fracture, overload, and peri-implantitis.
This document discusses bone grafting and grafting techniques. It defines what a graft is, describes different types of bone grafts including autografts, allografts, and bone graft substitutes. It covers the biological process of bone graft incorporation and lists various techniques for harvesting and placing bone grafts, such as onlay grafts, dual onlay grafts, and fibula grafts. Risks, advantages, and disadvantages of different graft options are also summarized.
Fluid control and soft tissue management / cosmetic dentistry trainingIndian dental academy
Indian Dental Academy: will be one of the most relevant and exciting
training center with best faculty and flexible training programs
for dental professionals who wish to advance in their dental
practice,Offers certified courses in Dental
implants,Orthodontics,Endodontics,Cosmetic Dentistry, Prosthetic
Dentistry, Periodontics and General Dentistry.
Treatment planning for dental implants/fixed orthodontics coursesIndian dental academy
Indian Dental Academy: will be one of the most relevant and exciting training center with best faculty and flexible training programs for dental professionals who wish to advance in their dental practice,Offers certified courses in Dental implants,Orthodontics,Endodontics,Cosmetic Dentistry, Prosthetic Dentistry, Periodontics and General Dentistry.
Standard surgical procedure for implant placement Diana Abo el Ola
The lecture gives in details step by step how to replace an implant in the osteotomy site. Also, mention the preoperative and postoperative procedures.
Surgeon Perspective on Additive Manufacturing April Bright
As additive manufacturing gains popularity as a production process, it’s important to understand the perspective of surgeons engaged with the technology. Nirav Shah, M.D., has consulted with device companies on additively-manufactured implants and is involved in the research of 3D-printed tissue. He will share his perspective and research on the current state of additive manufacturing in orthopaedics, and provide ideas on how the technology could be used in the future.
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.
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.
This document discusses smart and innovative machining processes. It begins by describing various machining operations like turning, milling, grinding, and wire EDM. It then shows how collaboration between designers, buyers, and manufacturers can lead to design for manufacturing practices that streamline processes. For example, modifying a part design reduced the cost per part from $178 to $37.40 for a lot size of 1,000 parts. The document also covers metal injection molding, noting its suitability for complex small parts in high volumes, and outlines design considerations and capabilities for the process.
Modernize the Orthopaedic Supply Chain: A Surgeon’s ViewApril Bright
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.
FDA and other governing bodies controlling the standards of medical devices are reaching deeper into the supply chains that support OEMs. As a result, OEMs are now re-evaluating their supplier quality strategies to ensure that every machined component and piece of raw material entering their production floor is 100 percent validated – making quality management a more complex undertaking. Evaluating material suppliers from a risk mitigation standpoint has become a challenging, and somewhat elusive, undertaking for manufacturers of medical devices. The session will answer the questions: What is risk mitigation as it applies to raw material suppliers in the medical device industry? How can orthopaedic device companies combat it?
What Is It? Product Development vs. Product Management April Bright
This session will focus on the respective roles and responsibilities of the Product Manager vs. the Development Engineer from a product’s inception through its lifecycle maintenance. Attendees will learn how to leverage the cross-functional product team to deliver results, business vs. technical aspects of product development, putting the customer first and navigating the organization in order to get things done.
Steps to Compliance with the European Medical Device RegulationsApril Bright
The document summarizes proposed changes to the European Medical Device Regulations (MDR). It discusses expanding the regulations to cover clinical investigations in Europe and adverse incident reporting. It outlines the classification system for medical devices and conformity assessment procedures. Key aspects include new definitions, unique device identification requirements, essential safety and performance standards, and requirements for economic operators, notified bodies, and identification/traceability of devices. The European database EUDAMED is also mentioned.
Unique Device Identification or UDI is a forever project. What's the best way for orthopaedic device companies to receive return on their investment? What best practices can be learned for a continually-smooth process? How can the data be leveraged to enhance your company’s value proposition? The true value of UDI is not in the identification number, but in the data that can be generated as a result of UDI. This session will provide attendees with an outline of the opportunities that manufacturers can leverage beyond implementation.
Achieving Built-in-Quality: Actions and ImplementationApril Bright
Built-In-Quality is achieved through the use and implementation of lean manufacturing principles. Dr. Joseph M. Juran, a pioneer in modern quality management principles, created the Juran Trilogy. The Juran Trilogy focuses on long-term quality improvement through quality planning, quality control and continuous improvement. This presentation will focus on how effectively applying the Juran Trilogy can help an organization achieve the objective of Built-In-Quality.
Disposable instruments and procedural kits undergo comprehensive product development and testing to meet quality and regulatory requirements. Extensive validation and verification testing is performed on packaging, sterilization methods, aging, and the instruments themselves to ensure clinical robustness. This includes testing instruments through simulated clinical reprocessing cycles to validate they can withstand repeated cleaning, sterilization, and use over their intended lifetimes. Understanding how instruments will perform after many reprocessing cycles is important for material selection, design, and establishing appropriate cleaning and sterilization instructions.
Packaging Solutions that Improve Time to MarketApril Bright
This session will discuss packaging solutions designed to improve time to market and lower costs for OEMs. Kelly Lucenti will discuss challenges imposed from the research and development phase to production, as well as trending issues with packaging design and validations. The presentation will highlight the importance of OEMs engaging their packaging groups early in the design phase, and ways that leveraging existing validations can speed time to market and cut major costs.
Design for Manufacturability Rapid Fire April Bright
Design for manufacturability (DFM) is a broadly-implemented step in today’s development process to ensure that a designed product can actually be manufactured. While the concept sounds simple, there are nuances to every supplier relationship and every new process.
Three suppliers—a contract manufacturer, additive manufacturer and plastics company—will each spend 15 minutes answering the following question: With orthopaedic customers, our greatest DFM pain point is ___ and the best strategy to change that is ___.
OEMs will learn best practices and ways to approach DFM with their supplier partners.
How to Make Postmarket Surveillance More Cost EffectiveApril Bright
When it comes to postmarket surveillance (PMS), it’s common for the costs to outweigh the value. But, by working with the right team, you’ll be able to execute a study that maximizes return on investment and minimizes the financial impact of conducting further observational research. Postmarket study challenges that must be addressed include enrollment delays, patient attrition, long-term follow-up, resourcing demands and global payor requirements. This session will provide a case study of one orthopaedic company’s seamless transition between postmarket approval and post-approval studies.
Coatings for implants and instruments continue to evolve as manufacturers seek the best surface for their devices. Attendees will leave this session with knowledge of new coating research and manufacturing techniques. Three suppliers will speak on the benefits, applications and manufacturing processes of three different coatings. A Q&A with all three presenters will follow.
Strategies for Device Approval in China, India, South Korea and AustraliaApril Bright
This session will describe the orthopaedic device regulatory and registration requirements in Asia Pacific markets. Regulatory steps and strategies will be presented for each of these countries. The discussion will also cover ways to gain regulatory information about competitors already selling in these markets. Attendees will leave the session with an understanding of timelines, costs and complexity for approval.
Defining Your Leadership Style in a Performance-Based OrganizationApril Bright
To be an effective leader, you must learn to recognize that in different organizational situations, the style of leadership may need to change to be successful. This presentation discusses what defines a performance-based organization and how to improve accountability and responsibility. Attendees receive guidance on how to set expectations, how to achieve continued efficiency from a highly-focused group, how to push an underperforming group to productivity and how to be an effective leader to tenured vs. millennial employees.
As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including:
How does FDA recommend we direct mark screws and small implants?
How should we proceed as we await the guidance on the Convenience Kit exemption?
What are best practices for entering submissions to GUDID?
How is FDA enforcing UDI?
FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.
CAPA: Using Risk-Based Decision-Making Toward ClosureApril Bright
Implementing a risk‐based CAPA process within a QMS is a necessity in the improvement of controls aligned with product and process non-conformances, adverse events, audit findings, complaints, etc. Making decisions concerning scope and extent about these “defectives” is a modern and cost-saving approach to improvement and compliance. Every non-conformity does not force you to open a corrective action. While almost every problematic issue needs at least a correction, the biggest payback is to use corrective actions on systemically-driven problems that are repetitive and recurring.
Applying the methods of determining risk to the device’s complete life cycle will give your company a complete look at all of the device’s risks—including those relative to processes. Manufacturers should be able to justify that they have reduced the risks as far as possible as part of their risk management plan and ongoing corrective and preventive actions.
Significant changes are underway that impact the quality and regulatory systems of medical device companies and their suppliers. ISO 13485:2016 adds new requirements to address risk management and to better align the standard with global regulatory requirements (FDA, MDD, JPAL, etc.). With the release of ISO 9001:2015, the ISO 9001 and ISO 13485 standards are no longer integrated. A new single audit MDSAP program will be in effect beginning 2017 that incorporates applicable FDA, Canadian, Brazilian, Australian and Japanese quality system requirements into the annual ISO 13485 audit cycle. The presentation will provide an overview of these changes and the steps required to incorporate these changes into existing quality management systems.
The document provides an overview of recent advances in various types of joint arthroplasty procedures, including the hip, knee, shoulder, and elbow. It discusses new implant designs, materials, surgical techniques such as minimally invasive procedures, computer navigation, and in some cases robotics. The goal of many new procedures and devices is to better restore normal joint biomechanics, reduce invasiveness and recovery times, and increase implant longevity and patient function.
Hip implants are used to replace damaged or diseased hip joints. The document discusses the history and development of hip implants from the 1950s onwards. It describes the key figures like Sir John Charnley who pioneered total hip arthroplasty. The anatomy of the hip joint and biomechanics considerations for implant design are outlined. Different types of femoral and acetabular components including cemented, cementless, and alternative bearing surfaces are explained. Indications, contraindications and risks of hip replacement surgery are also summarized.
This document describes a novel surgical technique for primary ACL reconstruction using both autograft and a biomimetic graft. The technique involves a four-stranded anatomical single-bundle reconstruction that places the femoral tunnel low to overlap both the AM and PL bundles. Preliminary results on 18 elite football players showed improved IKDC scores, reduced pivot shift, and allowed return to full athletic performance by 3.5 months. However, long-term follow up is still needed to evaluate the outcomes of this new single-bundle technique.
Total hip replacement (THR) and total knee replacement (TKR) are common surgical procedures used to treat severe arthritis of the hip and knee joints. THR involves replacing damaged hip bone and cartilage with prosthetic components, while TKR replaces knee joint surfaces. Nursing care focuses on managing pain, ensuring proper positioning and exercise to aid mobility, and monitoring for complications like infection, bleeding, or prosthesis displacement. Education on activity restrictions and long-term self-care is also important for recovery.
The Ceramax Ceramic Total Hip Replacement is designed to replace damaged hip joints due to conditions like osteoarthritis. It uses a ceramic material called BIOLOX delta that is stronger and tougher than other ceramics. The cementless implant has a porous coating and hydroxyapatite layer to help the bone grow into the implant and stabilize it. The device is intended to last 15 years or more to rehabilitate hips and improve mobility.
Aseptic loosening is the most common cause of total knee arthroplasty failure. It occurs without infection and is associated with osteolysis and inflammation. Wear particles from the prosthetic components are phagocytosed by macrophages, triggering a biological response that leads to bone resorption around the implant. This causes loosening. Diagnosis involves imaging to detect osteolysis and loosening. Treatment is revision surgery, with goals of restoring joint alignment and stability. Prevention relies on surgical technique to minimize wear particle production and ensure adequate cement penetration for fixation.
This document discusses total elbow arthroplasty. It provides an overview of the different types of elbow implants, including fully constrained, semi-constrained, and unconstrained designs. Semi-constrained implants are most commonly used. Patient selection criteria and contraindications are outlined. Post-operative care involves restricting motion and weight-bearing initially. Common complications include instability, polyethylene wear, osteolysis, loosening, and infection. Revision surgery may be needed in cases of painful or failed elbow replacements.
Design of durable total hip replacement athroplasty implantAkeem Azeez
The document outlines the design of a durable implant for total hip arthroplasty. It begins with an introduction to total hip replacement and the anatomy of the hip joint. It then discusses the indications for total hip replacement and compares the wear rates of different implant combinations such as metal-on-polyethylene, ceramic-on-polyethylene, metal-on-metal, and ceramic-on-ceramic. The proposed solution is to use an alumina matrix composite for the femoral head to address its brittle nature and increase fracture toughness. This would potentially reduce revision rates and costs compared to current implant designs.
Bobic Vladimir - OATS - ICRS Gothenburg 290617Vladimir Bobic
This document discusses the historical perspective and development of autologous osteochondral grafting (OATS). It provides context on the inventor's contributions to cartilage imaging, repair, rehabilitation, and the International Cartilage Repair Society (ICRS). The document then summarizes the indications, contraindications, complications, and long-term outcomes of OATS based on the inventor's experience and findings from the literature. Key challenges discussed include graft integration, donor site morbidity, and addressing larger cartilage defects.
This document provides an overview of total hip replacement (THR) including its history, hip anatomy and biomechanics, component designs and selection, surgical procedure, and potential complications. Some key points include: Sir John Charnley introduced the modern concept of THR in the 1960s using a metal femoral stem, polyethylene acetabular component, and bone cement. Component design goals include restoring normal hip biomechanics and providing initial stability for bone ingrowth. Femoral components can be cemented or cementless, and acetabular components can be cemented, cementless, or constrained. Specialized components are used for reconstruction or minimally invasive approaches.
Hemiarthroplasty involves replacing the femoral head while retaining the natural acetabulum. It is commonly used to treat fractures of the femoral neck in elderly patients. There are two main types - unipolar, which replaces just the head, and bipolar, which adds an inner bearing. Selection depends on factors like bone quality and joint stability. Cemented stems are generally preferred in patients with poor bone stock, while uncemented can be used if bone is adequate. Positioning and fixation are important to optimize function and stability.
Dental CT imaging is a technique developed in 1987 to image the complex jaw bone structures. It involves acquiring high resolution axial CT scans of the jaw and using reconstruction software to generate panoramic and cross-sectional views for examination of jaw anatomy and implant planning. Dental CT provides detailed images of teeth, bone quality, anatomy, and any pathologies present to aid in dental procedures and implant placement. Reformatted views allow evaluation of bone cortices and precise measurements for implant planning and simulation.
This document discusses arthroscopic rotator cuff repair. It begins with the anatomy of the rotator cuff and classifications of tears. It then discusses techniques for arthroscopic repair including single versus double row repairs and different types of sutures and anchors. It summarizes studies comparing biomechanical properties and retear rates of different repair methods. The document concludes with long term follow up of repairs showing rerupture rates increase with larger tear size and age.
CONMED's New Orthopedic Products & In-Booth Presentation ScheduleCONMED Corporation
The document introduces several new medical devices from CONMED, including cordless powered surgical tools, soft tissue fasteners, surgical video equipment, blades, sutures, and anchors. It provides information on the innovative designs of these products and how they are intended to improve surgical outcomes. Product details and specifications are given for each item. The document also lists in-booth presentation times and topics at a medical conference to promote CONMED's new technologies.
This document provides an overview of total elbow arthroplasty. It discusses the history and evolution of elbow prostheses. Modern total elbow arthroplasty involves replacing the distal humerus and proximal ulna with prosthetic components. Indications include rheumatoid arthritis, osteoarthritis, fractures, and previous failed elbow procedures. Implant designs can be fully constrained, semi-constrained, or unconstrained depending on bone and soft tissue integrity. Complications include loosening, infection, instability, and nerve issues. The goal of total elbow arthroplasty is to relieve pain and restore elbow function and range of motion.
Pelvic osteotomies can be broadly classified as redirectional, acetabuloplasties, and salvage osteotomies. Redirectional osteotomies like Salter's and Sutherland's are used for pediatric patients with congruent hips to improve acetabular coverage. Acetabuloplasties including Pemberton and Dega are for congruent hips where the acetabulum is large relative to the femoral head. Salvage osteotomies such as Chiari are indicated for incongruent hips when other procedures are not possible. The goal of all these osteotomies is to improve hip biomechanics, reduce pain, and prevent or treat osteoarthritis.
This design project aimed to create a low-cost spinal orthosis for scoliosis treatment in low-resource settings. The design uses an adjustable two-part plastic shell fastened with screws and a simple hook-and-loop strap mechanism. Validation tests assessed effectiveness, safety, affordability and other requirements. Force and deformation tests on prototypes showed promise while highlighting areas for future work like improved ventilation and fitting adjustability.
The Future of Digital Health and Wearables in OrthopedicsrablesApril Bright
Orthopedic device companies have responded to payors’ adoption of bundled payments and FDA’s promotion of digital health tools by commercializing products that track patients beyond the O.R. Digital health tools, including wearables, provide device companies with revenue streams that respond to hospitals’ episode of care requirements and patients’ personalized medicine needs, while simultaneously creating a feedback loop for product ideas. Christopher E. Pelt, M.D., a surgeon enrolled in Zimmer Biomet’s mymobility clinical study with the Apple Watch app, offered perspective on the benefits of wearables and shares ways that the technology will impact patients, surgeons and device companies in the future.
The Future of Personalized Implants in Joint Replacement: Additive, Robotics,...April Bright
Orthopedics is primed for mass customization of implants thanks to advancements in additive, AI and robotics. Fully leveraged, the technologies can produce patient-specific implants that achieve clinical benefit, decrease cost and maintain O.R. workflow. Founder and Chief Medical Officer of Monogram Orthopaedics, Douglas Unis, M.D., shares his reimagined vision of personalized joint replacement implants and just-in-time inventory solutions.
Innovation in Orthopedics: Surgeon PerspectivesApril Bright
How can orthopedic manufacturers capitalize on the next wave of innovation? Which advancements will experience the greatest adoption in orthopedics, and why? The future of orthopedics is happening now. Progress is being made on materials that increase implant longevity, designs that improve patient outcomes and speed recovery, robotic and computer-assisted technologies that enhance accuracy, reliability and speed. This panel boasts future-minded surgeon entrepreneurs and researchers who have varied practical experience from the leading edge of tomorrow’s solutions. They shared perspective on what’s working in orthopedics, what gaps remain and how orthopedic manufacturers can develop new, relevant products that solve problems and alleviate pressures for surgeons and hospitals.
Antimicrobial Coatings: The Research and Regulatory PerspectiveApril Bright
Coatings have long been considered an avenue for infection prevention in orthopedic procedures. These coatings, some of which utilize silver, have largely not been commercialized because regulators seek greater evidence of their safety, creating a long, expensive road for device companies. Announcements in the last half of 2018 and early 2019 indicate that companies continue to push to get them on the market and that productive conversations are taking place with regulators. This session began with a history of antimicrobial coatings followed by a look at recent research and technology.
Leverage These Effective Communication Skills to Get Your Message AcrossApril Bright
Your success is highly dependent upon how well you communicate with your colleagues, your customers and your providers. Effective communication helps you reduce conflict and confusion while increasing motivation and productivity. No matter your age or title, communication is a timeless skill to practice and hone. Leveraging decades of training and managerial experience within device companies and his role as a professor, G. Bryan Cornwall provided the practical steps that you must take to become an excellent communicator.
Operations: Top Reasons for Long Lead Times and What to Do About ThemApril Bright
Long lead times remain one of the most vocalized challenges that orthopedic manufacturers face today. Customers, profits, plans and personnel are all negatively impacted by them. James Kwan has worked on the OEM and the supplier sides of orthopedics, and shared his ideas and successful experiences to help you optimally respond to lead times, reduce them and ultimately create and sustain an agile supply chain.
Computational Modeling & Simulation in Orthopedics: Tools to Comply in an Ev...April Bright
Computational Modeling & Simulation has the ability to revolutionize the orthopedic device industry by reducing and in some instances eliminating the need for benchtop testing and clinical trials. Dr. Afshari shared his experience in establishing the credibility of computational models for product design and development purposes, and highlighted was that modeling fits with the regulatory and standards framework.
Joint Replacement: The Current and Future Impact of CoatingsApril Bright
The control of surface properties to reduce wear and corrosion and improve biocompatibility is of particular interest today as device companies—and surgeons, payors and patients—seek to extend the life of knee and hip implants. In this session, device companies shared research on their joint replacement coatings and materials, covering pros, cons and the future of their technology.
Engineers: Practical Application of Project Management PrinciplesApril Bright
Predictability throughout the commercialization chain is critical to allow manufacturers to speed products to market and gain share within the growing orthopedic industry. As an engineer, your technical and regulatory expertise will be overshadowed if you cannot properly plan and execute a project. One skill every engineer must learn and hone is project management. Start with the steps shared in this session.
Regulatory and Quality Affairs: Answers to FDA and ISO Gray AreasApril Bright
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.
The Future of Orthobiologics in Trauma ProceduresApril Bright
Based on his clinical research interests in utilization of Alpha-BSM bone graft substitute and OP-1 recombinant BMP in the repair of fractures, Daniel N. Segina, M.D., outlined opportunities and challenges for surgeons and device companies in biologic development. To make his case, Dr. Segina reviewed the spectrum of orthobiologics used in trauma cases today, shared perspective on what is and isn’t working and forecasted the future of regenerative medicine.
Spine Implants: Porous Coatings vs. Porous Materials vs. Additive ManufacturingApril Bright
Spine implant materials and surface characteristics are popular topics among engineers and surgeons. How do surface technologies relate to spine implants and bone integration and fusion? What are the pros and cons of various materials and surfaces? In this interactive session, members of industry and academia reviewed and presented research related to use of
• porous plasma spray coating,
• porous PEEK, and
• additive manufactured titanium in spinal devices.
How to Influence People: The Value of Employee EngagementApril Bright
Engagement is a powerful tool to drive accomplishment of individual and company objectives. Success requires a genuine interest in achieving the goals of the company as well as making connections between those goals and the personal motivations of your team. Employee engagement is lauded by many as the single most fulfilling aspect of their jobs.
Real-World Evidence: The Future of Data Generation and UsageApril Bright
As data is captured through electronic health records, registries and unique device identifiers, the generation of evidence based on this data is expected to play a crucial role in informing orthopedic manufacturers’ decisions before and after regulatory approval. While regulators, payors, hospitals and manufacturers support this shift, they acknowledge that gaps remain in its optimal execution. Priority considerations include how to generate evidence to expedite regulatory market decisions, device indication expansion, postmarket studies, postmarket surveillance and reimbursement decisions. The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is leading the conversation with various stakeholders, including FDA and orthopedic device companies to support the sustainable generation of Real-World Evidence (RWE) using Real-World Data (RWD).
Orthopedic Coatings: Predictions for 2025April Bright
What are the next innovations in orthopedic coatings? What orthopedic market stands to benefit the most from coatings? What’s stalling coating innovation? This session brought together the device company and coating manufacturer perspective to discuss which coatings will be used in orthopedics in the next decade.
Engineers: Apply Automation to Increase Quality, Speed to MarketApril Bright
We live in the age of machine learning, artificial intelligence and other automated systems. Why, then, are we performing tedious tasks that we can streamline during the product development phase? First, there is Design Verification testing. Second, there is Design Validation testing. Some of these tests use simple pass/fail attribute data, while others use continuous data. We will focus on ways to automate the analysis of that continuous data, which can ensure more accurate and timely results.
OSMA: Orthopedic Industry's Top Regulatory Challenges and OpportunitiesApril Bright
The Orthopaedic Surgical Manufacturers Association, a collective voice of orthopedic device companies that influences the decision of worldwide regulatory agencies and standards bodies, will highlight the main regulatory changes impacting the industry. This session is for any orthopedic professional who wants a forecast of regulatory pressures and seeks direction on how to shape change. Attendees will learn how FDA, European agencies and IMDRF are approaching harmonization and alignment of standards, regulations and guidance. OSMA Members will provide future trends and opportunities afforded via FDA’s National Evaluation System for Health Technology (NEST), facilitation of innovation through partnerships and global harmonization of regulatory submissions and facility assessments.
Unique Device Identification: Manufacturer, Hospital and Global ImplicationsApril Bright
Unique device identification (UDI) is gaining global adoption. Now is the time for companies to take a step back and ask: Is my UDI framework scaleable? UDI experts answered questions on the U.S. regulation and provided perspective on ways that device manufacturers can implement a working system—including data management—that can scale with product development and UDI compliance needs. Attendees gained an understanding of new global regulations and practical, implementable advice for compliance.
Additive Manufacturing - Mechanical Test Methods - OMTEC 2018April Bright
Medical devices fabricated from additively-manufactured materials must undergo a variety of mechanical tests before receiving regulatory approval. Due to the complexity of manufacturing processes and the limited clinical knowledge of AM devices, they are subject to additional scrutiny by manufacturers and Notified Bodies. Several test methods for characterizing these devices are presented in this session, as well as the differences between testing additively-manufactured devices and those fabricated with traditional machining methods.
Analyze and Optimize Your Supply Chain Operations for Higher Performance - OM...April Bright
The operations science pioneered through Factory Physics provides practical concepts to analyze and optimize supply chain operations. This presentation covers basic approaches for operations science to enhance your world, with all its variability in product mix, demand, people and processes. You will get applications of the science to apply immediately.
Beyond the Veil: Unraveling the Secrets of Your Dreamsamerhanoor20
Unravel the enigmatic threads of your subconscious mind...
In this captivating presentation, we'll venture into the mystical realm of dreams, where secrets lie hidden and mysteries await unraveling. Join us on a journey to:
1:Decipher the cryptic language of your dreams
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4:Discover the secrets that lie beyond the veil of reality
Prepare to be mesmerized by the mysteries of your own mind...
The musiconn services for musicologists and music librariansJürgen Diet
These slides have been presented in a presentation by Jürgen Diet at the IAML-congress 2024 in Stellenbosch ("International Association of Music Libraries, Archives and Documentation Centers"). Jürgen Diet is the deputy head of the music department in the Bavarian State Library.
Client Management Skills.pptx for corporate worldartemacademy2
Effective client management skills are crucial for fostering strong, long-lasting business relationships. These skills involve active listening, clear communication, and a deep understanding of client needs. By actively listening, professionals can gather valuable insights, allowing them to tailor their services to meet specific client requirements. Clear communication ensures that expectations are set correctly and any potential issues are addressed promptly. Building rapport and trust through consistent and honest interactions is essential for maintaining client satisfaction and loyalty. #ClientManagement #ActiveListening 🎧🤝
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11June 2024. An online pre-engagement session was organized on Tuesday June 11 to introduce the Science Policy Lab approach and the main components of the conceptual framework.
About 40 experts from around the globe gathered online for a pre-engagement session, paving the way for the first SASi-SPi Science Policy Lab event scheduled for June 18-19, 2024 in Malmö. The session presented the objectives for the upcoming Science Policy Lab (S-PoL), which featured a role-playing game designed to simulate stakeholder interactions and policy interventions for food systems transitions. Participants called for the sharing of meeting materials and continued collaboration, reflecting a strong commitment to advancing towards sustainable agrifood systems.
2. CURRENT AND FUTURE USE OF CUSTOM
IMPLANTS IN ORTHOPAEDIC SURGERY
OMTEC 2016 CHICAGO
P James Burn FRACS
Consultant Orthopaedic Surgeon
Canterbury District Health Board
Christchurch
New Zealand
pjamesburn@xtra.co.nz
3. DISCLOSURES:
• Founding shareholder of Ossis Ltd (NZ)
• Founding shareholder of Enztec Ltd (NZ)
• Receive royalties from the Enztec Stardrill
4. PERSONAL PRACTICE PROFILE
( NZ POPULATION 4 MILLION)
PrimaryTHR 2,000+
Last 1,000 cases 0% dislocation for PrimaryTHR post. approach
Revision rate 0.04 per 100 component years, with LIMA PF cup
(lowest on the NZJR)
RevisionTHR 300
PrimaryTKR 950 +
Primary UKR 400 +
RevisionTKR 97+
Custom hemi-pelvic replacements 3 + 1rev
+spine, foot and ankle and general orthopaedics.
CUSTOM ACETABULAR CASES 30
6. “ADDITIVE MANUFACTURE 1998” BEFORE
ACCESSIBLE SOFTWARE AND PRINTING
MY 3RD ITERATION TITANIUM HEMI-PELVIC
IMPLANTS WERE FABRICATED IN TITANIUM ALLOY
9. THE BIO-MODEL OF THE PELVIC DISSOCIATION AND IIIB
OUTLINE OF THE PROPOSED IMPLANT
Fracture line
through
posterior column
= 2 parts
THE NEED FOR CUSTOM IMPLANTS (HIP)
10. MRS MP 70YRS
SURGEONS: PCA / JB
TOTAL SURGICAL TIME REVISION ALL COMPONENTS: 2.3 HRS
DISCHARGED DAY 5 FULL WEIGHT BEARING
1ST GENERATION E-BEAM CUSTOM IMPLANT
dealing with bone loss and the dissociation: 2008
14. TOTAL NUMBER OF CASES USING EBM
ACETABULAR IMPLANTS = 102
Ossis Ltd, NZ and Med. Modelling / 3D Systems USA
NZ AND AUSTRALIAN MARKETS OF 24 MILLION
15. WHAT WOULDYOU PREFER TO USE
AS AN ORTHOPAEDIC SURGEON?
• Larger spherical cup
• Oblong cup
• Bone graft
• Autograft (not in revision cases)
• Allograft (banked femoral head)
• Allograft (Acetabular replacement)
• Synthetic Bone substitutes,TCP, DBM
• “Metal graft” substitution
• Cages/Rings
• Triflanged implants
INVENTORY COST!
16. OR A ONE-PIECE SOLUTIONTHAT IS
PATIENT PERFECT SPECIFIC!
17. A REAL PROBLEM AFTER 4 REVISION SURGERIES:
WHATTO DOWITHTHIS CASE?
22. MED MODELLING / OSSIS MESH
SEM PICTURE
THE MOST IMPORTANT “BIOLOGICAL” FEATURE
23. STRESS SHIELDING AND FATIGUE FAILURE
Too
stiff...stress
shielding
Too thin... broken
stem but the bone
stock was saved!!
82 yr female
with worn PE
liner
82 yr male with
thigh pain
BIOLOGY NOT RESPECTED
24. CAUSES OF FAILURE OF IMPLANTS
PROBLEM
1. MODULUS MIS-MATCH
2. MAL-POSITION
3. FRICTION
4. WEAR PARTICLES
5. INFECTION
SOLUTIONS
1. MATERIALS AND STRUCTURE
2. EDUCATION and
INSTRUMENTATION
3. BETTERTRIBOLOGY
4. MATERIALS AND SURFACES
5. SURGICAL TECHNIQUE,
SURFACE COATINGS
25. RESPECT BIOLOGY AND ITS SOLUTIONS
DESIGNTHE IMPLANT TO “BLEND IN”
WITH MODULUS MATCHING
RESPECTTHE PRIMARY AND SECONDARY TRABECULAE
UNDERSTANDTHE SUBCHONDRAL BONE PLATE
UNDERSTANDTHE GROWTH PATTERN OF A LONG BONE
26. 3D PRINTING OF MATERIALS
THIS IS A TOOLTHAT CAN ADDRESSTHE
ANISOTROPIC REQUIREMENTS OF THE
IMPLANT TO MATCH BONE
THE METALLURGY OF PRINTED METALS MAY
NEED FURTHER IMPROVEMENT i.e. HIP
TREATMENT
27. WHY USE CUSTOM IMPLANTS:
ARE THEY FISCALLY VIABLE?
They reduce the inventory in revision and
complex primary: TRUE?
The dead stock sitting in hospitals is avoided
$$$$ : TRUE
The surgery is rehearsed during design:
Unexpected findings minimized: TRUE
Make primary implants more useable
in revision surgery: TRUE
29. WHO PAYS CURRENTLY IN N.Z.
PUBLIC HOSPITALS WITH PRIOR APPROVAL OF
SERVICE MANAGERS
PRIVATE INSURANCE COMPANIES,AGAIN PRIOR
APPROVAL AND EXPLANATION
30. DO THE OUTCOMES OF CUSTOMISED
IMPLANTS EXTRAPOLATE TO
STANDARD PROVEN IMPLANTS?
The “IdentiFit Hip” experience (milled stem)
?20% per annum failure, Dr J Hart,Australia
OPEN QUESTION
31. WHY CUSTOM IMPLANTS? A SMALL STEP
AFTER REQUIRED IMAGING ANYWAY!
The complexity is simplified:TRUE
(surgeon’s pulse < patient’s!)
32. PRE-OP PLANNING AND CT SCANNING
• Tray size would be known
• Augment thickness planned and
manufactured
• Bearing thickness still not predictable
• Saving on inventory required
33. Inventory required 3 thicknesses of hemi-
augments X 6 trays = 18 , or full size augments =
18: Grand total could be 36 parts
REVISION: 9/6/2016, CURRENT OFF THE SHELF
LCS AND AUGMENT OF IMPLANT, NOT BONE STOCK
37. CUSTOMISED PRIMARY IMPLANTS RATHER
THAN CUSTOM AUGMENTS
InTHR: easily “do-able” due to spherical bearings
(adjustable neck lengths etc.)
InTKR: Surface geometry critical for outcomes to be
predictable (PE does not adapt as menisci!)
In knees the soft tissue elasticity and balance is
variable, needing a range of sizes
InTrauma: specialised fixation plates
38. AM SPINAL IMPLANTS 2011
But still a range of heights per level needed
Indications: very small female.
40. INSERTION OPTIONS FOR
CUSTOM IMPLANTS
1. Standard instruments to give
standard “internal” cuts
2. Customised cutting blocks but accuracy can be
problematical (Oxford Knee 2/22 accurate in NZ
trial, Mr R Maxwell)
3. Robotic bone shaping using data files from the
implant: MAKO etc.
42. THE FUTURE
New biocompatible materials (polyimide
etc.)
“Plastic” knees
Custom implants incorporating
active surfaces
(antimicrobial and osteo-inductive)
Composite structures ( AM parts
and standard parts)
43. DESIGNS ARE INFINITE BUT A
CAUTIONARY NOTE…
RULES OF BIOLOGY CANNOT BE BROKEN…
Particulates, surface finishes, corrosion
THE REACTION OF LIVINGTISSUES
NEEDSTO CONSIDERED…
Osteolysis, ALVAL, toxicity of ion release,
impurities in and on implants
THE MATERIAL’S SPECIFIC ENGINEERING
PARAMETERS HAVETO BE ALLOWED FOR...
Fatigue resistance, loadings,
corrosion and valency, scratches
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