Paradigm shifts and concerns in supply chain, warranties, liability and IP - Ernst-Jan Louwers - Louwers IP|Technology Advocaten - www.louwersadvocaten.nl
Reprinting the law - legal aspects of 3D bioprinting - Ernst-Jan LouwersErnst-Jan Louwers
Presentation on bioprinting, protheses and personalized medicine at 3D Bioprinting Conference held at Maastricht on 19th June 2014. Legal aspects of 3D printing / additive manufacturing: also legally disruptive tech! Don't underestimate or miss disruptive developments like this! Be prepared and share best practices in everyone's best interest.
This document discusses 3D printing and its applications in medical libraries and healthcare. It begins with an overview of 3D printing technologies and materials. Examples are then provided of medical uses like presurgical modeling, implants, prosthetics and tissues. The document also explores emerging areas such as bioprinting and 4D printing. Potential roles for medical libraries are proposed, such as housing 3D printers and providing related instructional resources. Risks involving 3D printed objects like guns are addressed. The document concludes by emphasizing the opportunities yet challenges of this developing technology.
3D bioprinting has potential to revolutionize medicine by enabling the creation of organs and tissues for transplantation. It allows for customized prosthetics and could decrease costs and wait times for organ transplants. Further development of the technology may one day enable the printing of more complex organs like kidneys and livers directly in patients. However, challenges remain such as ensuring quality control of bioprinted organs and regulating the industry.
Bioprinting and 3D printing for educational centresjosbaema
Do you know the benefits for educational centers and universities of integrating 3D printing and bioprinting technologies in their activity? contact us: info@regemat3D.com
This document provides an overview of 3D bioprinting technologies and their applications in medicine. It discusses how researchers have used 3D printing to create structures like a bionic ear with integrated electronics and a vascular system within a printed heart. The document also describes ongoing work to develop a 3D printer for human embryonic stem cells to produce tissues for drug testing and organ transplantation. Finally, it discusses concepts for using bioprinting to rapidly heal wounds and burns through cell spraying.
3D bioprinting uses 3D printing technology to print biological materials and tissues. It has potential applications in medicine such as printing organs, blood vessels and prosthetics. Proponents argue it could help address shortages of donated organs and tissues. However, critics note challenges remain such as high costs, lack of regulation and ensuring quality control. If these challenges can be overcome, 3D bioprinting may transform medicine by enabling customized prosthetics and tissues and reducing wait times for organ transplants.
3D Bio-Printing; Becoming Economically FeasibleJeffrey Funk
These slides use concepts from my (Jeff Funk) course entitled analyzing hi-tech opportunities to analyze the increasing economic feasibility of bio-printing. Due to a lack of available kidney and other organ donors for organ transplants, 3D printing has emerged as an important alternative for many people. Bioprinting is done by using a computer model of an individual’s body to generate a data set for an organ that can be printed with a 3D printer and grown in a bio-reactor. The falling cost of materials and 3D printers is improving their economic feasibility.
Future of 3D Printing in Pharmaceutical & Healthcare SectorPrashant Pandey
The document discusses the future of 3D printing in pharmaceuticals and healthcare. It begins with a brief history of 3D printing, including its invention in 1984 and early applications in healthcare around 2000. It then provides details on the 3D printing process and some of the most common 3D printing technologies used in medical applications. The document outlines innovations like ZipDose, a 3D printed pill, and trends toward bioprinting of living tissues and organs. It forecasts growth in the 3D printing market, especially for medical uses. Challenges to adoption in India are noted as well as the transformative potential of 3D printing for medicine.
Reprinting the law - legal aspects of 3D bioprinting - Ernst-Jan LouwersErnst-Jan Louwers
Presentation on bioprinting, protheses and personalized medicine at 3D Bioprinting Conference held at Maastricht on 19th June 2014. Legal aspects of 3D printing / additive manufacturing: also legally disruptive tech! Don't underestimate or miss disruptive developments like this! Be prepared and share best practices in everyone's best interest.
This document discusses 3D printing and its applications in medical libraries and healthcare. It begins with an overview of 3D printing technologies and materials. Examples are then provided of medical uses like presurgical modeling, implants, prosthetics and tissues. The document also explores emerging areas such as bioprinting and 4D printing. Potential roles for medical libraries are proposed, such as housing 3D printers and providing related instructional resources. Risks involving 3D printed objects like guns are addressed. The document concludes by emphasizing the opportunities yet challenges of this developing technology.
3D bioprinting has potential to revolutionize medicine by enabling the creation of organs and tissues for transplantation. It allows for customized prosthetics and could decrease costs and wait times for organ transplants. Further development of the technology may one day enable the printing of more complex organs like kidneys and livers directly in patients. However, challenges remain such as ensuring quality control of bioprinted organs and regulating the industry.
Bioprinting and 3D printing for educational centresjosbaema
Do you know the benefits for educational centers and universities of integrating 3D printing and bioprinting technologies in their activity? contact us: info@regemat3D.com
This document provides an overview of 3D bioprinting technologies and their applications in medicine. It discusses how researchers have used 3D printing to create structures like a bionic ear with integrated electronics and a vascular system within a printed heart. The document also describes ongoing work to develop a 3D printer for human embryonic stem cells to produce tissues for drug testing and organ transplantation. Finally, it discusses concepts for using bioprinting to rapidly heal wounds and burns through cell spraying.
3D bioprinting uses 3D printing technology to print biological materials and tissues. It has potential applications in medicine such as printing organs, blood vessels and prosthetics. Proponents argue it could help address shortages of donated organs and tissues. However, critics note challenges remain such as high costs, lack of regulation and ensuring quality control. If these challenges can be overcome, 3D bioprinting may transform medicine by enabling customized prosthetics and tissues and reducing wait times for organ transplants.
3D Bio-Printing; Becoming Economically FeasibleJeffrey Funk
These slides use concepts from my (Jeff Funk) course entitled analyzing hi-tech opportunities to analyze the increasing economic feasibility of bio-printing. Due to a lack of available kidney and other organ donors for organ transplants, 3D printing has emerged as an important alternative for many people. Bioprinting is done by using a computer model of an individual’s body to generate a data set for an organ that can be printed with a 3D printer and grown in a bio-reactor. The falling cost of materials and 3D printers is improving their economic feasibility.
Future of 3D Printing in Pharmaceutical & Healthcare SectorPrashant Pandey
The document discusses the future of 3D printing in pharmaceuticals and healthcare. It begins with a brief history of 3D printing, including its invention in 1984 and early applications in healthcare around 2000. It then provides details on the 3D printing process and some of the most common 3D printing technologies used in medical applications. The document outlines innovations like ZipDose, a 3D printed pill, and trends toward bioprinting of living tissues and organs. It forecasts growth in the 3D printing market, especially for medical uses. Challenges to adoption in India are noted as well as the transformative potential of 3D printing for medicine.
3D bioprinting uses a layer-by-layer printing process to construct living human tissues and organs by depositing hydrogels, collagen, and cells according to a digital model. It has the potential to help reduce transplant waiting lists by printing organs like livers, kidneys, and hearts. While the technology offers advantages like precision and reduced timelines, challenges remain around organ rejection, high costs, and ethical issues.
Patricia Bacus Bioprinting organs one step at a timeKim Solez ,
The document discusses the progress and current capabilities of 3D bioprinting organs. It outlines how bioprinting has advanced from early inventions in the 1980s to present-day abilities to print tissue and implant basic structures. While bioprinting has made strides in printing simple tissues and structures, key challenges remain in developing techniques for vascularization, replicating organ complexity and function, achieving sufficient size, and addressing issues of cost. The future of bioprinting is positioned to realize more complex organ printing and potential in situ surgical applications.
Chris Leigh-Lancaster_Inside 3D Printing MelbourneMediabistro
The document describes Invetech's NovoGen MMX Bioprinter, which is the world's first commercial 3D bioprinter. It can print layers of cell aggregates and biogel to construct tissues and blood vessels. The bioprinter has high precision motion axes and dual print heads to print both biogel and cells. It also has thermal control of the biogel and automated cartridge loading. The bioprinter reduces the time needed for blood vessel printing from over 8 hours previously to less than an hour. It provides precise printing down to 20 microns and uses laser calibration and closed-loop motor control. Examples are given of tissues and applications printed so far, ranging from liver tissue to cartilage
This document discusses how 3D printing is reshaping healthcare and manufacturing. It is enabling mass customization in areas like hearing aids and dental aligners. In the operating room, 3D printing allows for customized surgical guides, implants, and models for pre-operative planning and education. It is also used to create customized prosthetics and bracing. The document envisions future applications of 3D printing like tissue engineering and organ printing.
3D bioprinting uses inkjet-based or laser-based systems to deposit "bioink" droplets containing living cells or biomaterials layer by layer according to digital designs. This allows for the reproduction of human tissues and organs. Multiple printheads can deposit different cell types. A company called CELL-INK has developed a universal bioink for printing 3D tissue models. While a kidney transplant costs $80,000, bioprinting a kidney would cost $280,000 but take around 10 hours. Bioprinting offers customization and personalization but faces challenges regarding organ quality and costs, though it provides opportunities in new software, materials and customized designs.
3D bioprinting uses a layer-by-layer printing process to construct living human tissues and organs by depositing hydrogels, collagen, and cells. Over 6,000 people in the UK are waiting for organ transplants. The technology has the potential to print organs like livers, kidneys, and even hearts to help address the shortage of donor organs. However, 3D bioprinting also raises ethical issues and implanted organs may face rejection by the human body.
Tips for better 3D printing for medical applicationsDesign World
One of the hottest applications for 3D printing / Additive Manufacturing is medical. Dental appliances, surgical models, prosthetic prototypes and some end use versions, skeletal support, and other applications are possible because of the unique capabilities of 3D printers. In this webinar we will hear from three vendors with applications in this field; their challenges, their successes, and what they’ve learned about working with 3D printers in this industry.
In this webinar you will learn:
The best medical applications for 3D printing today
Material considerations, including mechanical and thermal properties and biocompatibility.
Design tips
View the recording: http://www.designworldonline.com/upcoming-live-webinar-tips-for-better-3d-printing-for-medical-applications/
PriMA is developing a lower-cost prosthetic arm using 3D printing and sensory feedback. The project is being conducted by interdisciplinary students at Florida Institute of Technology as part of their capstone design project. The goal is to create an affordable prosthetic arm option with high functionality. The team aims to eventually start a 3D printing technology company and bring innovation to the prosthetics industry.
3D Medical Printing for Natural Disaster and Military ApplicationsRising Media, Inc.
Osiris Biomed 3D is developing a process called Instant Implants to 3D print and implant customized medical devices during a single surgery. This would allow patients to be scanned, have a custom implant printed and sterilized, and implanted all in one operation instead of multiple surgeries over several weeks. The company aims to deploy this technology in mobile surgical units to provide on-site treatment for wounded soldiers or disaster victims. Osiris estimates its process could save thousands per implant and significantly reduce recovery times compared to current methods.
The document discusses the digital era in the design and manufacturing of orthodontic appliances. It outlines how technological advances have led to computational tools for designing fixed orthodontic appliances digitally. The authors aim to illustrate appliances they have digitally designed and manufactured, such as a Hyrax appliance, palatal expanders with mini screws, and Nance space maintainers. The benefits of digital design and manufacturing include producing customized appliances with perfect fit and adjustment, decreasing time for both patients and clinicians, and limiting incidents like breakages.
Computational Disease Management with Wearable DevicesPetteriTeikariPhD
Machine Learning modelling of disease trajectory with deep
learning and/or Gaussian Processes.
Alternative download link:
https://www.dropbox.com/s/jg73ymvkenx8rv4/computational_disease_management.pdf?dl=0
it is a seminar slide that i prepared on the topic 3d bioprinting. it may be a help to whom taking seminar on that topic. It is not covered its full area only the basics of bio printing ..
Three Dimensional Printing Scheme PresentationRita Barakat
3D bioprinting aims to simulate physiological environments to promote cell and tissue growth. Scaffolds allow cell attachment, migration, and diffusion of nutrients, and emulate the extracellular matrix. Common scaffold materials include hydrogels like agarose, gelatin, and collagen. 3D printing techniques like inkjet printing and extrusion methods are used to build scaffolds in a layer-by-layer process and incorporate cells and hydrogels. The goal is to develop techniques to print more complex, multicellular tissues and provide nutrients to maintain cell viability.
University of Michigan live-saving tracheal splints using the EOS FORMIGA P 100Machine Tool Systems Inc.
Please find attached a case study about the manufacturing of live-saving tracheal splints using the FORMIGA P 100. During a research collaboration between the University of Michigan and EOS we made the resorbable material polycaprolactone (PCL) processable. I want to highlight the statement of Dr. Hollister because he emphasizes the openness of the EOS systems:
“I chose EOS because we were looking for a system that was flexible and allowed us to change parameter settings like laser power, speed, powder-bed temperature, and so on, which we needed to do to customize our builds.”
As always the case study can be found on our website.
3D printing has the potential to significantly disrupt intellectual property. As 3D printing becomes more accessible to the average consumer through lower-cost printers and the ability to print complex objects at home, it will become harder to control intellectual property. The document discusses how 3D printing may lead to the democratization of design and manufacturing, lowering barriers to entry and allowing for designs to be printed away from traditional controls. While some industries like aerospace and healthcare still have protection due to technical limitations today, the growing capabilities of 3D printing materials and machines increases the risks to the intellectual property system over time if democratization accelerates.
Data-driven models for efficient diagnosis and disease management. From Academia to Startups.
Talk given at Crabb Lab Meeting, City University, London UK – Wed 23 August 2017
The document discusses how 3D printing may disrupt intellectual property. It notes that 3D printing could democratize manufacturing by allowing anyone to make anything at home. This may undermine the traditional IP system by making it hard to control designs and easy for people to print patented objects without permission. The document also examines how different industries like aerospace, healthcare, automotive and fashion may be impacted. It considers issues like how protectable designs are with 3D printing and the potential risks to the IP system if democratization of manufacturing increases.
Limitations & future of 3 d printing in orthopedicsVaibhav Bagaria
3D printing or Rapid prototyping is impacting Orthopaedics and Joint replacement in a significant manner. Patient Specific instruments and Implants are increasingly being issued apart from 3D printed Biomodels. The final frontier of tissue printing however remains a significant challenge.
3D bioprinting uses a layer-by-layer printing process to construct living human tissues and organs by depositing hydrogels, collagen, and cells. Over 6,000 people in the UK are waiting for organ transplants. The technology has the potential to print organs like livers, kidneys, and even hearts to help address the shortage of donor organs. However, 3D bioprinting also raises ethical issues and implanted organs may face rejection by the human body.
This document discusses bioprinting vessel-like constructs using hyaluronan hydrogels crosslinked with tetrahedral polyethylene glycol tetracrylates. Rheology testing found the crosslinked hydrogels were stiffer than PEGDA crosslinked hydrogels. Cell viability studies showed increased proliferation over 7 days for cells encapsulated in the hydrogels. The bioprinted constructs maintained cell viability for up to 4 weeks in culture. This technique provides an alternative for engineering vascularized tissue constructs.
3D bioprinting uses a layer-by-layer printing process to construct living human tissues and organs by depositing hydrogels, collagen, and cells according to a digital model. It has the potential to help reduce transplant waiting lists by printing organs like livers, kidneys, and hearts. While the technology offers advantages like precision and reduced timelines, challenges remain around organ rejection, high costs, and ethical issues.
Patricia Bacus Bioprinting organs one step at a timeKim Solez ,
The document discusses the progress and current capabilities of 3D bioprinting organs. It outlines how bioprinting has advanced from early inventions in the 1980s to present-day abilities to print tissue and implant basic structures. While bioprinting has made strides in printing simple tissues and structures, key challenges remain in developing techniques for vascularization, replicating organ complexity and function, achieving sufficient size, and addressing issues of cost. The future of bioprinting is positioned to realize more complex organ printing and potential in situ surgical applications.
Chris Leigh-Lancaster_Inside 3D Printing MelbourneMediabistro
The document describes Invetech's NovoGen MMX Bioprinter, which is the world's first commercial 3D bioprinter. It can print layers of cell aggregates and biogel to construct tissues and blood vessels. The bioprinter has high precision motion axes and dual print heads to print both biogel and cells. It also has thermal control of the biogel and automated cartridge loading. The bioprinter reduces the time needed for blood vessel printing from over 8 hours previously to less than an hour. It provides precise printing down to 20 microns and uses laser calibration and closed-loop motor control. Examples are given of tissues and applications printed so far, ranging from liver tissue to cartilage
This document discusses how 3D printing is reshaping healthcare and manufacturing. It is enabling mass customization in areas like hearing aids and dental aligners. In the operating room, 3D printing allows for customized surgical guides, implants, and models for pre-operative planning and education. It is also used to create customized prosthetics and bracing. The document envisions future applications of 3D printing like tissue engineering and organ printing.
3D bioprinting uses inkjet-based or laser-based systems to deposit "bioink" droplets containing living cells or biomaterials layer by layer according to digital designs. This allows for the reproduction of human tissues and organs. Multiple printheads can deposit different cell types. A company called CELL-INK has developed a universal bioink for printing 3D tissue models. While a kidney transplant costs $80,000, bioprinting a kidney would cost $280,000 but take around 10 hours. Bioprinting offers customization and personalization but faces challenges regarding organ quality and costs, though it provides opportunities in new software, materials and customized designs.
3D bioprinting uses a layer-by-layer printing process to construct living human tissues and organs by depositing hydrogels, collagen, and cells. Over 6,000 people in the UK are waiting for organ transplants. The technology has the potential to print organs like livers, kidneys, and even hearts to help address the shortage of donor organs. However, 3D bioprinting also raises ethical issues and implanted organs may face rejection by the human body.
Tips for better 3D printing for medical applicationsDesign World
One of the hottest applications for 3D printing / Additive Manufacturing is medical. Dental appliances, surgical models, prosthetic prototypes and some end use versions, skeletal support, and other applications are possible because of the unique capabilities of 3D printers. In this webinar we will hear from three vendors with applications in this field; their challenges, their successes, and what they’ve learned about working with 3D printers in this industry.
In this webinar you will learn:
The best medical applications for 3D printing today
Material considerations, including mechanical and thermal properties and biocompatibility.
Design tips
View the recording: http://www.designworldonline.com/upcoming-live-webinar-tips-for-better-3d-printing-for-medical-applications/
PriMA is developing a lower-cost prosthetic arm using 3D printing and sensory feedback. The project is being conducted by interdisciplinary students at Florida Institute of Technology as part of their capstone design project. The goal is to create an affordable prosthetic arm option with high functionality. The team aims to eventually start a 3D printing technology company and bring innovation to the prosthetics industry.
3D Medical Printing for Natural Disaster and Military ApplicationsRising Media, Inc.
Osiris Biomed 3D is developing a process called Instant Implants to 3D print and implant customized medical devices during a single surgery. This would allow patients to be scanned, have a custom implant printed and sterilized, and implanted all in one operation instead of multiple surgeries over several weeks. The company aims to deploy this technology in mobile surgical units to provide on-site treatment for wounded soldiers or disaster victims. Osiris estimates its process could save thousands per implant and significantly reduce recovery times compared to current methods.
The document discusses the digital era in the design and manufacturing of orthodontic appliances. It outlines how technological advances have led to computational tools for designing fixed orthodontic appliances digitally. The authors aim to illustrate appliances they have digitally designed and manufactured, such as a Hyrax appliance, palatal expanders with mini screws, and Nance space maintainers. The benefits of digital design and manufacturing include producing customized appliances with perfect fit and adjustment, decreasing time for both patients and clinicians, and limiting incidents like breakages.
Computational Disease Management with Wearable DevicesPetteriTeikariPhD
Machine Learning modelling of disease trajectory with deep
learning and/or Gaussian Processes.
Alternative download link:
https://www.dropbox.com/s/jg73ymvkenx8rv4/computational_disease_management.pdf?dl=0
it is a seminar slide that i prepared on the topic 3d bioprinting. it may be a help to whom taking seminar on that topic. It is not covered its full area only the basics of bio printing ..
Three Dimensional Printing Scheme PresentationRita Barakat
3D bioprinting aims to simulate physiological environments to promote cell and tissue growth. Scaffolds allow cell attachment, migration, and diffusion of nutrients, and emulate the extracellular matrix. Common scaffold materials include hydrogels like agarose, gelatin, and collagen. 3D printing techniques like inkjet printing and extrusion methods are used to build scaffolds in a layer-by-layer process and incorporate cells and hydrogels. The goal is to develop techniques to print more complex, multicellular tissues and provide nutrients to maintain cell viability.
University of Michigan live-saving tracheal splints using the EOS FORMIGA P 100Machine Tool Systems Inc.
Please find attached a case study about the manufacturing of live-saving tracheal splints using the FORMIGA P 100. During a research collaboration between the University of Michigan and EOS we made the resorbable material polycaprolactone (PCL) processable. I want to highlight the statement of Dr. Hollister because he emphasizes the openness of the EOS systems:
“I chose EOS because we were looking for a system that was flexible and allowed us to change parameter settings like laser power, speed, powder-bed temperature, and so on, which we needed to do to customize our builds.”
As always the case study can be found on our website.
3D printing has the potential to significantly disrupt intellectual property. As 3D printing becomes more accessible to the average consumer through lower-cost printers and the ability to print complex objects at home, it will become harder to control intellectual property. The document discusses how 3D printing may lead to the democratization of design and manufacturing, lowering barriers to entry and allowing for designs to be printed away from traditional controls. While some industries like aerospace and healthcare still have protection due to technical limitations today, the growing capabilities of 3D printing materials and machines increases the risks to the intellectual property system over time if democratization accelerates.
Data-driven models for efficient diagnosis and disease management. From Academia to Startups.
Talk given at Crabb Lab Meeting, City University, London UK – Wed 23 August 2017
The document discusses how 3D printing may disrupt intellectual property. It notes that 3D printing could democratize manufacturing by allowing anyone to make anything at home. This may undermine the traditional IP system by making it hard to control designs and easy for people to print patented objects without permission. The document also examines how different industries like aerospace, healthcare, automotive and fashion may be impacted. It considers issues like how protectable designs are with 3D printing and the potential risks to the IP system if democratization of manufacturing increases.
Limitations & future of 3 d printing in orthopedicsVaibhav Bagaria
3D printing or Rapid prototyping is impacting Orthopaedics and Joint replacement in a significant manner. Patient Specific instruments and Implants are increasingly being issued apart from 3D printed Biomodels. The final frontier of tissue printing however remains a significant challenge.
3D bioprinting uses a layer-by-layer printing process to construct living human tissues and organs by depositing hydrogels, collagen, and cells. Over 6,000 people in the UK are waiting for organ transplants. The technology has the potential to print organs like livers, kidneys, and even hearts to help address the shortage of donor organs. However, 3D bioprinting also raises ethical issues and implanted organs may face rejection by the human body.
This document discusses bioprinting vessel-like constructs using hyaluronan hydrogels crosslinked with tetrahedral polyethylene glycol tetracrylates. Rheology testing found the crosslinked hydrogels were stiffer than PEGDA crosslinked hydrogels. Cell viability studies showed increased proliferation over 7 days for cells encapsulated in the hydrogels. The bioprinted constructs maintained cell viability for up to 4 weeks in culture. This technique provides an alternative for engineering vascularized tissue constructs.
This document summarizes research on skin bioprinting. It discusses the current state of the field, challenges, and potential applications. Some key points made include:
- Skin cells have been successfully bioprinted and cultured, but bioprinted skin constructs currently lack functionality to be used as skin implants due to the absence of features like skin pigmentation and vascularization.
- The field of skin bioprinting is still in its infancy, with more work needed on materials, printing processes, and maturation processes.
- Bioprinting shows potential as an enabling technology for developing skin models and personalized skin matching techniques using 3D imaging.
- Functional organs are more complex than
Kidneys, hearts, livers, and lungs are the most coveted organs for transplant, but 117,521 people in the US still need organs due to shortages. 3D bioprinting uses cells as "ink" to build tissues and organs layer-by-layer using bio-printers like the NovoGen MMX. This mimics the natural biological process of embryonic development. Current progress includes bioprinting human ears and building kidney and skin grafts. In the future, bioprinting may help double the number of organs available by reducing transplant wait times. However, challenges remain in vascularizing large organs and achieving full integration and function.
3D bioprinting is a technique that uses 3D printing and viable living cells to print tissue for medical use, such as reconstructive surgery. It works by collecting cells and turning them into "bioink" which is then printed, layer by layer, with hydrogel, to build tissue. Advantages include replacing human tissue without transplants and higher survival rates of printed cells. Disadvantages include ensuring the printed cells properly fit in the body and the complexity of printing complicated tissues. Applications include creating living organs for transplants, testing new drugs on printed cells rather than animals, and direct printing of cells onto the human body.
Applications of 3 d printing in biomedical engineeringDebanjan Parbat
Medical applications of 3D printing are expanding rapidly and may revolutionize healthcare. Current uses include creating customized prosthetics and implants, anatomical models for surgery planning, and complex drug dosage forms through various printing techniques like selective laser sintering and inkjet printing. Researchers are working to develop organ printing through layer-by-layer deposition of living cells and biomaterials. While significant advances have been made, the most transformative applications like full organ printing will require more time and addressing remaining scientific and regulatory challenges.
Bioprinting was defined as the use of material transfer processes for patterning and assembling biologically relevant materials- molecules, cells, tissues, and biodegradable biomaterials with a prescribed organization to accomplish one or more biological function. This is a developmental biology- inspired approach to tissue engineering and is based on the assumption that tissues and organs are self- organizing systems, and that cells and especially micro tissues can undergo biological self- assembly and self- organization without any external influence in the form of instructive, supporting and directing rigid templates or solid scaffolds.
Bioprinting or the biomedical application of rapid prototyping, also defined as layer- by- layer additive biomanufacturing, is an emerging transforming biomimetic technology that has potential for surpassing traditional solid scaffold- based tissue engineering. It is a rapid prototyping technology based on three dimensional, automated, computer-aided deposition of ‘‘bioink particles’’ (multicellular spheroids) into a ‘‘biopaper’’ (biocompatible gel; e.g. collagen) by a bioprinter
This document discusses 3D bioprinting and its potential applications. It begins with definitions of bioprinting and discusses its goals in tissue engineering. Current achievements are summarized, including the first 3D printed bladder in 2006 and liver in 2009. Requirements for organ bioprinting are outlined, including cell sources, scaffold materials, and bioprinting technologies. The document concludes that bioprinting has potential to help address the shortage of organs for transplantation.
This document discusses several legal issues related to 3D printing including intellectual property, product liability, supply chains, and regulations. It notes that 3D printing is causing paradigm shifts that require redesigning businesses and relationships. Key topics covered include intellectual property of materials, methods, tools, and 3D printed output; potential product liability for service providers and consumers; and how supply chains may be impacted as consumers become manufacturers. The document advises working with a lawyer to navigate these issues, understand choices around open vs closed systems, and develop a roadmap to bring 3D printed products to market while managing risks.
This document discusses the emerging technology of 3D printing and whether regulation is coming. It notes that 3D printing offers opportunities in areas like manufacturing and healthcare but also challenges regarding intellectual property, safety standards, and controlling access to dangerous items like guns. While some regulators have concerns, the technology also has supporters in the European Commission and among innovators. The document concludes that regulation is coming within the next 1-2 years, but the specifics will depend on how the technology develops and which concerns gain prominence.
Breathe - Empowering parents of children with asthmaDayOne
Presentation by Moritz Dietsche (Haako) at the DayOne Expert Event Legal challenges and opportunities for digital health innovation.
it is essential to address the legal aspects early on and make them part of the solution. This was shown by this start-up showcase:
Innovation in Healthcare: HSG Meets ETH Alumni EventPeter Vogel
The document discusses innovations in medical technology (MedTech). It notes that MedTech enables healthy lives, increases healthcare efficiency, contributes to economic growth, and had global sales of over $350 billion in 2014. Emerging trends in MedTech that may reach the market by 2018 include electronic technologies, synthetic organs/tissue, detection/diagnostics/monitoring, decentralized care technologies, and invasiveness-reducing technologies. The document focuses on 3D printing and its applications in medicine like creating prosthetics and anatomical models.
The presentation illustrates a novel model for collaborative crowdsourcing and other collaborative environments where IPR tracking and protection constitutes a key issue. After a comparison between different approaches for innovation and R&D, the new architecture is introduced, with a focus on problem solving activities. Particular attention is given to the relationships (scientific, social, economical, legal) between firms and participants to the sessions and among participants themselves. The study also investigates the complex IPR framework necessary to involve firms and to promote users’ participation exploiting simultaneously collaboration and meritocracy. The paper also presents an original software application tool for tracing and tracking the IPR generated in collaborative and Open Innovation environments. The software’s use and results are demonstrated through a case study.
This document discusses the use of both human-led and technology-led techniques in research. It notes that while technology is widespread, human interactions are still critical to understanding consumer needs and experiences. Both qualitative and quantitative approaches have strengths and weaknesses, so a combination of methods is needed. The document provides examples of specific human-led techniques like ethnography and in-home visits, as well as technology-led methods like online communities and data analytics. It emphasizes that the right mix of approaches depends on the specific research question being investigated.
IDTechEx Research: Problems That Printed Electronics is SolvingIDTechEx
This document provides an overview of printed electronics and how it is addressing problems in various industries. It summarizes challenges in industries like retail, healthcare, wearables, vehicles, and consumer electronics related to costs, customization, form factors, and more. It then provides brief examples of how printed electronics is enabling thinner, flexible, and stretchable devices to help solve these issues through applications like sensors, displays, and energy storage. The document is an introduction to opportunities for printed electronics from IDTechEx, an emerging technology research firm.
dtg is a design and technology group led by Eli Ganon that provides services related to technology strategy, transformation, analytics, market research, product development, and regulatory compliance across multiple sectors including healthcare, life sciences, manufacturing and medical devices. dtg works with clients to develop innovative solutions through Eli's expertise in areas such as informatics, analytics, medical imaging, electronic health records and medical devices.
This document discusses how technology can help put patients first by improving healthcare delivery through electronic medical records, telemedicine, mobile health apps, and other digital innovations. However, it notes that meaningful change requires addressing challenges such as interoperability issues, usability problems, engaging patients, changing behaviors, and demonstrating clear returns on investment. Overall, technology must be developed and implemented carefully in partnership with doctors to truly benefit patients.
1. The document discusses the challenges of implementing augmented intelligence in the life sciences industry. It notes that achieving the right human-AI partnership requires having the right intelligence, mindset, data, and expertise.
2. Three key challenges are highlighted - ensuring relevant data, developing deep subject matter expertise, and cultivating a growth mindset. Overcoming these challenges requires aligning human-centered solutions using the appropriate intelligence supported by data and relying on expert knowledge.
3. The hardest part of augmented intelligence in life sciences is implementing it in a way that improves clinical outcomes for healthcare providers and patients through better decision making and performance. This requires getting the right balance of intelligence, data, expertise, and mindset.
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Re-/bioprinting the law - 28 January 2015 - Ernst-Jan Louwers
1. Re-/bioprinting the law
Paradigm shifts and concerns in supply
chain, warranties, liabilities and IP
Ernst-Jan Louwers
3D Bioprinting Conference
MECC Maastricht, 28 January 2015
2. Eindhoven The Hague
Who are we?
• Lean and mean niche firm
• Specialised and no nonsense
• Focus on intersection of law and
technology
3. What do we do?
Protect and attack
Enable and empower
5. “By 2016, 3D printing of tissues
and organs (bioprinting) will
cause a global debate about
regulating the technology or
banning it for both human and
nonhuman use.”
Gartner 2013
6. Shift happens…
What about you?
Are you aware of your legal position and
risks in R&D or commercialisation?
Where is your role in the value chain of
the future?
7. Agenda
• Topics to consider
• Intellectual property
• (Product)liability
• Roadmap to market
• Joint R&D and (open) innovation
8. It’s not easy…
Many topics to consider
Ownership
Body parts or
cells
Implants
Data
Intellectual
property and
secrecy
Compliance
Existing
regulations*
Ethics and
codes of
conduct
Fundamental
rights
Privacy
R&D
Collaboration
Background
IP and
knowhow
Foreground IP
and
knowhow
Valorisation
and
exploitation
Supply chain
Changing
rolls
Relationships
Risk
Liability
* Among others EU Directives and US FDA regulations on
admission and classification of medical devices.
9. Why?
Awareness, assessment and precaution!
Intellectual
Property
Material
Method
Output
Liability
Risk
Who?
When?
Supply
chain
R&D
Factory
Reseller
17. Starting material patentable?
• Products of nature: in principle not
patentable
• Isolated human genes?
o US: NO, but…
o AMP/Myriad case
o Europe: until now YES
o Comparable to plant breeding
o Public opinion…
• Nonhuman (synthetic): YES
18. Methods patentable?
• Technology of bioprinting: YES
• Products directly resulting from method?
o in principle YES (‘product by process’)
21. Tissue and parts: IP protected?
Can you patent an ear?
Printed using human cells from Lieuwe van
Gogh, great-grandson of Vincent van
Gogh (sharing 1/16th of the same genes)
22. Output: IP protected?
Can you patent an ear?
• Printed human tissue/organs patentable?
o function and structure significantly different from
human cells
o not simply ‘products of nature’
• Inventive step?
• Novelty?
o right ear is same as left ear - no novelty?
• Output of method: ‘product by process’
24. • 3D printed jaw patentable?
• 3D printed joints patentable?
• Shape and function?
• Or only the material?
BUT again:
• Method and output as ‘product by process’
• Mixtures and intermediate result may be
patentable
Protheses and dental & IP
28. Changing the game…
• Hospitals to become factories
• Doctors becoming engineers
• Engineers becoming doctors
• Dentists printing implants
• Industry becoming suppliers of human
tissue and spares
33. Spare parts and implants
• Print it yourself protheses…?
• Limited warranty?
• Product liability?
• Remove?
• Recall?
• Existing regulations and classifications?
34.
35. Not only business plan
Roadmap to market
But also legal plan
Material Method Hardware
Software
and data
Output
36. Let’s roll the dice:
whatever your game is…
Protect Contract Manage
RepositionReconsider Reorganize
37. Share (and save)
• Sharing
o best practices
o legal insights
o policies
• Agreements
o consortium agreements
o licenses
o R&D
38. Joint R&D – Open innovation
Agreements…
• Input
o Efforts
o Background knowhow and IP
• Output
o Foreground knowhow and IP
o Exploitation
• Governance (steering committee)
• Secrecy and patents
• Liability
• (De)escalation
39. Rolling the dice
What about you?
Where do you stand in the value chain
of the future?
Reconsider your (legal) position and
relationships!
40. • IP strategy: offensive - defensive
• Assessment and compliance
• Formalisation of your role
• Joint R&D - consortium agreements
• Valorisation, licensing and
commercialisation
Legal roadmap