Finland and Norway Biotech: Polaris the merger product of Targovax and Oncos Therapeutics
Reporter: Aviva Lev-Ari, PhD, RN
SOURCE
http://labiotech.eu/polaris-a-new-nordic-leader-in-immuno-oncology/
Archive for the ‘Medical Devices R&D Investment’ Category
Finland and Norway Biotech: Polaris the merger product of Targovax and Oncos Therapeutics
Posted in CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, Pharmaceutical Drug Discovery, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment on January 11, 2016| Leave a Comment »
Focused Ultrasounds and Their Applications in Medicine
Posted in Medical Devices R&D Investment, Medical Imaging Technology, Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound on December 19, 2015| Leave a Comment »
Focused Ultrasounds and Their Applications in Medicine
Reporter: Danut Dragoi, PhD
Any waves focused in a point of material that support their propagation produce heating effects that are useful in medical applications.
Doctors in Los Angeles applied this heating principle for acoustic waves. They use high intensity focused ultrasounds to kill certain cancer tumors that allows the patient to go home on the same day. Surgeons at the Keck Medical Center of the University of Southern California became the first doctors to use this procedure on a patient with the help of high intensity focused ultrasound, or HIFU, and new robotic technology.
The principle of focused wave is not new, but the technology to apply it is. In many places of the world the research on ultrasound applications is producing important results. Doctors from Europe imported equipment to apply this technique. An excellent review and description of how HIFU technique is working given here .
We need to highlight that the temperature increases exponentially with the distance close to the focus point inside the human body where instantaneous protein destruction occurs. As remarked in the review paper mentioned in the previous link the various methods of focusing ultra sound (US) waves have been another important issue.
The simplest and cheapest (often most accurate) method may be a self-focusing, for instance, a spherically curved US source (transducer). An US transducer constructed according to this method, has a beam focus fixed at the position determined from the geometrical specifications of the transducer. To compensate for its lack of versatility, a flat US transducer with an interchangeable acoustic lens system was devised. The acoustic lens enables variation of focusing properties such as focal length and focal geometry. However, a drawback of the lens system is that US waves undergo sonic attenuation and the sonic signal has to be guided due to absorption by the lens.
Recently, a phased array US transducer technique was adopted for HIFU therapy. By sending temporally different sets of electronic signals to each specific transducer component, this technique enables beam steering and focusing, which can move a focal spot in virtually any direction within physically allowed ranges.
HIFU clinical applications are listed here. Among important clinical applications, there are listed:
- prostate tumors: with several devices under ultrasonic guidance and commercially available as (Ablatherm®, Sonablate ®), Fibroids with MRgHIFU procedures and available as Exablate ® (Insightec + GE)-
- FDA 2004 and Philips CE approved Dec 2009, breast cancer on clinical research, bone tumors on clinical research, brain on small clinical studies with limitation: skull (bone) acoustic interface and no motion,
- liver using Haifu® under ultrasonic guidance MRgHIFU procedures: small clinical studies with limitation on aeric and bone interfaces and motions.
From technological point of view, the most important element of a HIFU is the piezoelectric transducer that takes an alternative voltage of high frequency and convert the electrical energy into acoustic energy.
The physics of generation of ultrasounds is shown in the link here. The electronic circuits behind the HIFU devices is refined over a period of about two decades reaching today with commercial devices available not only for research but also for private clinics around the world.
The precision of focusing the acoustic power into a small region of the human soft tissue depends on the working distance of the HFU device as well as high accuracy of controlling the image of the targeted area. Successes of this technology is reported in here.
SOURCE
Implantable Artificial Kidney
Posted in Clinical & Translational, Curation, K, Medical Devices R&D Investment, Nephrology, tagged artificial kideney on November 7, 2015| Leave a Comment »
Implantable Artificial Kidney
Larry H. Bernstein, MD, FCAP, Curator
LPBI
Artificial kidney research gets a boost
“We aim to conduct clinical trials on an implantable, engineered organ in this decade, and we are coordinating our efforts with both the NIH and the U.S. Food and Drug Administration,” Roy said.
Roy is a professor in the Department of Bioengineering and Therapeutic Sciences in the Schools of Pharmacy and Medicine, and technical director of The Kidney Project at UCSF, a multi-institutional collaboration. The Kidney Project team has prototyped and begun testing key components of the coffee-cup-sized device, which mimics functions of the human kidney.
Roy and Fissell will present updates on development of the device Nov. 3-8 at Kidney Week 2015 in San Diego, part of a major meeting of the American Society of Nephrology.
NIBIB is overseeing and funding the continuation of their work for four years under a cooperative agreement through its Quantum Program, created to support the development of “biomedical technologies that will result in a profound paradigm shift in prevention, detection, diagnosis, and/or treatment of a major disease or national public health problem.” This is the second major grant the researchers have received through the program.
Alternative to dialysis
In part because the U.S. population has grown older and heavier and is more likely to develop high blood pressure and diabetes, conditions often associated with kidney failure, the number of individuals diagnosed with kidney failure is growing year-over-year and has risen 57 percent since 2000, according to the National Kidney Foundation. More than 615,000 people now are being treated for kidney failure. U.S. government statistics indicate that kidney failure costs the U.S. health care system $40 billion annually and accounts for more than 6 percent of Medicare spending.
The waiting list for kidney transplants in the United States has grown to more than 100,000 people. The number of available kidneys has remained stagnant for the past decade, and only about one in five now on the list is expected to receive a transplant.
More than 430,000 of those with kidney failure now undergo dialysis, which is more costly and less effective than transplantation and typically requires hours-long stays at a clinic, three times weekly. Only about one in three patients who begins dialysis survives longer than five years, in comparison to more than four in five transplant recipients.
Fissell, associate professor in the Department of Medicine at Vanderbilt and medical director for The Kidney Project, said, “This project is about creating a permanent solution to the scarcity problem in organ transplantation. We are increasing the options for people with chronic kidney disease who would otherwise be forced onto dialysis.”
Along with Roy at UCSF and Fissell at Vanderbilt, a national team of scientists and engineers at universities and small businesses are working toward making the implantable artificial kidney available to patients.
According to B. Joseph Guglielmo, PharmD, dean of the UCSF School of Pharmacy, “The grant from NIBIB is a striking affirmation of the promise associated with this device, as well as NIH confidence in the ultimate success of The Kidney Project. Patients with chronic kidney failure are in real need of alternatives to transplant and dialysis; this School of Pharmacy and campus priority clearly demonstrates the research rewards of working collaboratively.”
In September the project was designated for inclusion in the FDA’s new Expedited Access Pathway program to speed development, evaluation, and review of medical devices that meet major unmet needs in fighting life-threatening or irreversibly debilitating diseases. The program evolved from an earlier FDA program called Innovation Pathway 2.0, in which The Kidney Project team was one of three device-development groups selected for a pilot initiative focused on kidney failure. Members of the FDA regulatory staff have continually been in communication with Roy and other project leaders to help guide device testing and criteria for data collection.
The aim of the new program is to speed the FDA’s premarket approval (PMA) process for scientific and regulatory review of safety and effectiveness of Class III medical devices — those with the potential to provide major benefits, but that also might potentially pose major risks.
“The new program brings FDA reviewers, scientists, and leadership together with our team to define a roadmap to regulatory approval and product launch,” Roy said.
Early studies of prototype are encouraging
One component of the new artificial kidney is a silicon nanofilter to remove toxins, salts, some small molecules, and water from the blood. Roy’s research team designed it based on manufacturing methods used in the production of semiconductor electronics and microelectromechanical systems (MEMS). The new silicon nanofilters offer several advantages — including more uniform pore size — over filters now used in dialysis machines, according to Roy. The silicon nanofilter is designed to function on blood pressure alone and without a pump or electrical power.
The second major component is a “bioreactor” that contains human kidney tubule cells embedded within microscopic scaffolding. These cells perform metabolic functions and reabsorb water from the filtrate to control blood volume. A project collaborator, H. David Humes, MD, professor in the Department of Internal Medicine at the University of Michigan, earlier showed that such a bioreactor, used in combination with ultrafiltration in an external device, greatly increased survival in comparison to dialysis alone in the treatment of patients with acute kidney failure in a hospital intensive care unit.
The artificial kidney being developed by Roy and Fissell is designed to be connected internally to the patient’s blood supply and bladder and implanted near the patient’s own kidneys, which are not removed.
Unlike human kidney transplant recipients, patients with the implantable artificial kidney will not require immunosuppressive therapy, according to Roy. Preliminary preclinical studies indicate that the non-reactive coatings developed for device components are unlikely to lead to filter clogging or immune reactions, he said, and that bioreactor cells can survive for at least 60 days under simulated physiological conditions.
About one-half of the new funding from NIBIB will support lab studies on methods for optimizing performance of the bioreactor’s kidney cells. The remainder will enable refinements for the mechanical design of the nanofilter unit and biocompatibility of the artificial kidney. The filter will be evaluated in preclinical studies aimed at achieving clot-free operation and stable filtration for 30 days.
Private philanthropy and UCSF support already have been vital in sustaining The Kidney Project, and even with the FDA’s new and more flexible pathway, additional funding will be required to meet project timelines, Roy said.
Disclosure: Roy and Fissell have ownership in Silicon Kidney, a start-up company that will advance the commercialization of silicon membrane technology.
New Medical Devices and Human Factors Implications
Posted in Medical Devices R&D Investment on November 3, 2015| Leave a Comment »
New Medical Devices and Human Factors Implications
Curator: Danut Dragoi, PhD
Today medical devices become more and more sophisticated due to advancement in medicine as well as electronic technology and materials. New products that penetrates new markets have a human factor which is the acceptance of the product, that is determinant on shaping a growing market. Marketing people were working with the public, ultimately the buyer, through different channels, like industry presentations, advertisement, promotional free devices and samples, international conferences etc. On the other hand, the buyer is supposed to have some knowledge on the news on medical breakthroughs as well as understanding their benefits for human health. The human factor discussed here talks about the costs, investments, official requirements and materials information in medical device design. It is critical for the manufacturers of medical devices to align their production to FDA requirements before they become a factor on the pricing of the new product. The FDA 510(k) Human Factors Guidance is a key consideration for all companies in the medical device sector. The relationship between design control activities and human factors is shown in the table here. The risk analysis factor is mentioned three times in the table. It means that from concept to final product, the designer of the product has to accommodate tight requirements of not only high qualities but also right functionality that work properly and are thoroughly verified. In the reference here is discussed the improving medical implant performance through retrieval information from the users, designers, engineers, scientists, and experts. At the request of the National Institutes of Health’s Office of Medical Applications of Research, RAND company provided technical and historical background for the NIH Technology Assessment Conference on Improving Medical Implant Performance Through Retrieval Information: Challenges and Opportunities. RAND Issue Papers explore topics of interest to the policy-making community. In the report of RAND company it is mentioned that bio-materials provide components for many life-saving and life-enhancing medical devices, including implantable items such as heart valves, orthopedic prostheses, and intraocular lenses. U.S. firms produce more of such devices and hold more patents on them than firms from any other nation. However, manufacturers of these devices face a potential shortage of the bio-materials necessary to make them. Producers of bio-materials have in recent years cut off or restricted the supply of their products to the makers of implantable medical devices. The resulting uncertainty over the availability of commercial bio-materials, including “off-the-shelf” materials that are still used in other industrial applications, is likely to have a number of repercussions. In concluding remarks of RAND report it is mentioned that balancing the interests of the various parties in the bio-materials debate—injured patients, benefited patients, manufacturers, and researchers—and considering potential benefits and risks to future patients that may come from research (or the lack thereof) is complex. If the policy approach we use in striking this balance does not appropriately regard the interests of all parties, including current and future patients who could benefit from implantable devices, the overall benefit to the public could be lessened.
Heroes in Basic Medical Research – Leroy Hood
Posted in Cell Biology, Signaling & Cell Circuits, Chemical Biology and its relations to Metabolic Disease, Chemical Genetics, Clinical & Translational, Clinical Diagnostics, Clinical Genomics, Diagnostics and Lab Tests, Disease Biology, Genome Biology, Genomic Expression, Genomic Testing: Methodology for Diagnosis, Health Economics and Outcomes Research, Innovations, Intellectual Property, Innovations, Commercialization, Investment in technological breakthrough, Mass automation of plasma proteins, Medical Devices R&D Investment, Metabolism, Metabolomics, Molecular Genetics & Pharmaceutical, Patents, Pharmaceutical Discovery, Population Health Management, Genetics & Pharmaceutical, Rapid automation of plasma protein pools, tagged Bioanalytical Chemistry, genomics, large scale automation, Proteomics on September 6, 2015| Leave a Comment »
Heroes in Basic Medical Research – Leroy Hood
Larry H Bernstein, MD, FCAP, Curator
Leaders in Pharmaceutical Intelligence
Series E. 2; 4.5
Leroy Hood, MD, PhD
Dr. Hood created the technological foundation for the sciences of genomics (study of genes) and proteomics (study of proteins) through the invention of five groundbreaking instruments and by explicating the potentialities of genome and proteome research into the future through his pioneering of the fields of systems biology and systems medicine. Hood’s instruments not only pioneered the deciphering of biological information, but also introduced the concept of high throughput data accumulation through automation and parallelization of the protein and DNA chemistries.
The first four instruments were commercialized by Applied Biosystems, Inc., a company founded by Dr. Hood in 1981, and the ink-jet technology was commercialized by Agilent Technologies, thus making these instruments immediately available to the world-community of scientists.
The first two instruments transformed the field of proteomics. The protein sequencer allowed scientists to read and analyze proteins that had not previously been accessible, resulting in the characterization of a series of new proteins whose genes could then be cloned and analyzed. These discoveries led to significant ramifications for biology, medicine, and pharmacology. The second instrument, the protein synthesizer, synthesized proteins and peptides in sufficient quantities to begin characterizing their functions. The DNA synthesizer, the first of three instruments for genomic analyses, was used to synthesize DNA fragments for DNA mapping and gene cloning. The most notable of Hood’s inventions, the automated DNA sequencer developed in 1986, made possible high-speed sequencing of human genomes and was the key technology enabling the Human Genome Project.
In the early 1990s Hood and his colleagues developed the ink-jet DNA synthesis technology for creating DNA arrays with tens of thousands of gene fragments, one of the first of the so-called DNA chips, which enabled measuring the levels of 10,000s of expressed genes. This instrument has also transformed genomics, biology, and medicine.
In 1992, Hood created the first cross-disciplinary biology department, Molecular Biotechnology, at the University of Washington. In 2000, he left the UW to co-found Institute for Systems Biology, the first of its kind. He has pioneered systems medicine the years since ISB’s founding.
In 2000, Hood and two colleagues founded the Institute for Systems Biology (ISB), a nonprofit research institute integrating biology, technology, computation and medicine to take a systems (holistic) approach to studying the complexity of biology and medicine by analyzing all elements in a biological system rather than studying them one gene or protein at a time (an atomistic approach).
Hood has made many seminal discoveries in the fields of immunology, neurobiology and biotechnology and, most recently, has been a leader in the development of systems biology, its applications to cancer, neurodegenerative disease, and the linkage of systems biology to personalized medicine.
Hood’s efforts in a systems approach to disease have led him to pioneer a new approach to medicine that he coined P4 Medicine in 2003. His view is that P4 medicine will transform the practice of medicine over the next decade, moving it from a largely reactive discipline to a proactive one.
Dr. Hood’s outstanding contributions have had a resounding effect on the advancement of science since the 1960s. Throughout his career, he has adhered to the advice of his mentor, Dr. William J. Dreyer: “If you want to practice biology, do it on the leading edge, and if you want to be on the leading edge, invent new tools for deciphering biological information.”
Hood is now pioneering new approaches to P4 medicine
Co-founder and Chairman P4 Medicine institute
—predictive, preventive, personalized and participatory, and most recently, has embarked on creating a P4 pilot project on 100,000 well individuals, that is transforming healthcare.
In addition to his ground-breaking research, Hood has published 750 papers, received 36 patents, 17 honorary degrees and more than 100 awards and honors. He is one of only 15 individuals elected to all three National Academies—the National Academy of Science, the National Academy of Engineering, and the Institute of Medicine. Hood has founded or co-founded 15 different biotechnology companies.
http://www.youtube.com/watch%3Fv%3D5aE8tgbsl9U Feb 18, 2015 … Dr. Leroy Hood, President and Co-founder, Institute for Systems Biology, gives a talk entitled “Systems Medicine and a Longitudinal, …
http://www.youtube.com/watch%3Fv%3DaYGTLj02sx0 Nov 19, 2014 … … of Healthcare? A Personal View of Biological Complexity, Paradigm Changes, Systems Biology and Systems Medicine .Speaker: Leroy Hood.
http://www.youtube.com/watch%3Fv%3DnT1MvnH6j8Q Sep 26, 2014 … Dr. Leroy Hood discusses how P4 (Predictive, Preventive, … EMBC 2014 Theme Keynote Lecture with Dr. Emery Brown – Duration: 58:49. by …
Protected: INVENTION: 3D Reparative Transforming BioStent – Concept Description
Posted in 3D Printing for Medical Application, Cardiac and Cardiovascular Surgical Procedures, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, Frontiers in Cardiology and Cardiovascular Disorders, PCI, Stents & Tools on September 3, 2015|
Protected: INVENTION: 3D Reparative Transforming BioStent – Concept Description
Posted in 3D Printing for Medical Application, Cardiac and Cardiovascular Surgical Procedures, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, Frontiers in Cardiology and Cardiovascular Disorders, PCI, Stents & Tools on August 27, 2015|
Transformation of Health Care Technologies by IBM, Apple, Johnson & Johnson and Medtronic
Posted in Digital HealthCare – biotech & internet joint ventures, Drug Delivery Platform Technology, Medical Devices R&D Investment on August 10, 2015| Leave a Comment »
IBM Announces Deals With Apple, Johnson & Johnson, and Medtronic In Bid To Transform Health Care by Matthew Herper, Forbes Staff
Reporter: Aviva Lev-Ari, PhD, RN
Big Blue is certainly putting some muscle into medicine. Some 2,000 employees will be involved in a new Watson-in-medicine business unit. The Armonk, N.Y.-based computing giant is making two acquisitions, too, buying Cleveland’s Explorys, an analytics company that has access to 50 million medical records from U.S. patients, and Dallas’ Phytel, a healthcare services head of IBM’s Life Science company that provides feedback to doctors and patients for follow-up care. Deal prices were not disclosed.
It is also announcing some big partnerships:
• Apple AAPL +3.6% will work to integrate Watson-based apps into its HealthKit and ResearchKit tool systems for developers, which allow the collection of personal health data and the use of such data in clinical trials.
• Johnson & Johnson JNJ +0.95%, which is one of the largest makers of knee and hip implants, will use Watson to create a personal concierge service to prepare patients for knee surgery and to help them deal with its after effects.
• Medtronic MDT +0.18%, the maker of implantable heart devices and diabetes products, will use Watson to create an “internet of things” around its medical gadgets, collecting data both for patients’ personal use and, once it’s anonymized, for understanding how well the devices are working. Initially, the focus is on diabetes.
SOURCE
NIH and FDA on 3D Printing in Medical Applications: Views for On-demand Drug Printing, in-Situ direct Tissue Repair and Printed Organs for Live Implants
Posted in 3D Printing for Medical Application, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, Drug Delivery Platform Technology, FDA, FDA Regulatory Affairs on July 27, 2015| Leave a Comment »
NIH and FDA on 3D Printing in Medical Applications: Views for On-demand Drug Printing, in-Situ direct Tissue Repair and Printed Organs for Live Implants
UPDATED on 4/5/2016
Update on FDA Policy Regarding 3D Bioprinted Material
Curator: Stephen J. Williams, Ph.D.
UPDATED on 11/12/2015
NIH Considers Guidelines for CAR-T therapy: Report from Recombinant DNA Advisory Committee
FDA Guidance on Use of Xenotransplanted Products in Human: Implications in 3D Printing
FDA Guidance Documents Update Nov. 2015 on Devices, Animal Studies, Gene Therapy, Liposomes
FDA Cellular & Gene Therapy Guidances: Implications for CRSPR/Cas9 Trials
New FDA Draft Guidance On Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products – Implications for 3D BioPrinting of Regenerative Tissue
FDA Guidance on Use of Xenotransplanted Products in Human: Implications in 3D Printing
FDA Guidance Documents Update Nov. 2015 on Devices, Animal Studies, Gene Therapy, Liposomes
FDA Cellular & Gene Therapy Guidances: Implications for CRSPR/Cas9 Trials
New FDA Draft Guidance On Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products – Implications for 3D BioPrinting of Regenerative Tissue
SOURCE
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4189697/
FUTURE TRENDS
3D printing is expected to play an important role in the trend toward personalized medicine, through its use in customizing nutritional products, organs, and drugs.3,9 3D printing is expected to be especially common in pharmacy settings.5 The manufacturing and distribution of drugs by pharmaceutical companies could conceivably be replaced by emailing databases of medication formulations to pharmacies for on-demand drug printing.1 This would cause existing drug manufacturing and distribution methods to change drastically and become more cost-effective.1 If most common medications become available in this way, patients might be able to reduce their medication burden to one polypill per day, which would promote patient adherence.5
The most advanced 3D printing application that is anticipated is the bioprinting of complex organs.3,11 It has been estimated that we are less than 20 years from a fully functioning printable heart.8 Although, due to challenges in printing vascular networks, the reality of printed organs is still some way off, the progress that has been made is promising.3,7 As the technology advances, it is expected that complex heterogeneous tissues, such as liver and kidney tissues, will be fabricated successfully.9 This will open the door to making viable live implants, as well as printed tissue and organ models for use in drug discovery.9 It may also be possible to print out a patient’s tissue as a strip that can be used in tests to determine what medication will be most effective.1 In the future, it could even be possible to take stem cells from a child’s baby teeth for lifelong use as a tool kit for growing and developing replacement tissues and organs.3
In situ printing, in which implants or living organs are printed in the human body during operations, is another anticipated future trend.13 Through use of 3D bioprinting, cells, growth factors, and biomaterial scaffolding can be deposited to repair lesions of various types and thicknesses with precise digital control.10 In situ bioprinting for repairing external organs, such as skin, has already taken place.13 In one case, a 3D printer was used to fill a skin lesion with keratinocytes and fibroblasts, in stratified zones throughout the wound bed.13 This approach could possibly advance to use for in situ repair of partially damaged, diseased, or malfunctioning internal organs.13 A handheld 3D printer for use in situ for direct tissue repair is an anticipated innovation in this area.10 Advancements in robotic bioprinters and robot-assisted surgery may also be integral to the evolution of this technology.13
Medical applications for 3D printing are expanding rapidly and are expected to revolutionize health care.1Medical uses for 3D printing, both actual and potential, can be organized into several broad categories, including:
- tissue and organ fabrication;
- creation of customized prosthetics, implants, and anatomical models; and
- pharmaceutical research regarding drug dosage forms, delivery, and discovery.2
The application of 3D printing in medicine can provide many benefits, including:
the customization and personalization of medical products, drugs, and equipment;
- cost-effectiveness;
- increased productivity;
- the democratization of design and manufacturing; and
- enhanced collaboration.1,3–6
However, it should be cautioned that despite recent significant and exciting medical advances involving 3D printing, notable scientific and regulatory challenges remain and the most transformative applications for this technology will need time to evolve.3–5,7
A number of fairly simple 3D-printed medical devices have received the FDA’s 510(k) approval.17
COMMON TYPES OF 3D PRINTERS
All 3D printing processes offer advantages and disadvantages.3 The type of 3D printer chosen for an application often depends on the materials to be used and how the layers in the finished product are bonded.11 The three most commonly used 3D printer technologies in medical applications are: selective laser sintering (SLS), thermal inkjet (TIJ) printing, and fused deposition modeling (FDM).10,11 A brief discussion of each of these technologies follows.
Selective Laser Sintering
An SLS printer uses powdered material as the substrate for printing new objects.11 A laser draws the shape of the object in the powder, fusing it together.11 Then a new layer of powder is laid down and the process repeats, building each layer, one by one, to form the object.11 Laser sintering can be used to create metal, plastic, and ceramic objects.11 The degree of detail is limited only by the precision of the laser and the fineness of the powder, so it is possible to create especially detailed and delicate structures with this type of printer.11
Thermal Inkjet Printing
Inkjet printing is a “noncontact” technique that uses thermal, electromagnetic, or piezoelectric technology to deposit tiny droplets of “ink” (actual ink or other materials) onto a substrate according to digital instructions.10 In inkjet printing, droplet deposition is usually done by using heat or mechanical compression to eject the ink drops.10 In TIJ printers, heating the printhead creates small air bubbles that collapse, creating pressure pulses that eject ink drops from nozzles in volumes as small as 10 to 150 picoliters.10 Droplet size can be varied by adjusting the applied temperature gradient, pulse frequency, and ink viscosity.10
TIJ printers are particularly promising for use in tissue engineering and regenerative medicine.10,13Because of their digital precision, control, versatility, and benign effect on mammalian cells, this technology is already being applied to print simple 2D and 3D tissues and organs (also known as bioprinting).10 TIJ printers may also prove ideal for other sophisticated uses, such as drug delivery and gene transfection during tissue construction.10
Fused Deposition Modeling
FDM printers are much more common and inexpensive than the SLS type.11 An FDM printer uses a printhead similar to an inkjet printer.11 However, instead of ink, beads of heated plastic are released from the printhead as it moves, building the object in thin layers.4,11 This process is repeated over and over, allowing precise control of the amount and location of each deposit to shape each layer.4 Since the material is heated as it is extruded, it fuses or bonds to the layers below.4 As each layer of plastic cools, it hardens, gradually creating the solid object as the layers build.11 Depending on the complexity and cost of an FDM printer, it may have enhanced features such as multiple printheads.11 FDM printers can use a variety of plastics.11 In fact, 3D FDM printed parts are often made from the same thermoplastics that are used in traditional injection molding or machining, so they have similar stability, durability, and mechanical properties.4
REFERENCES
1. Schubert C, van Langeveld MC, Donoso LA. Innovations in 3D printing: a 3D overview from optics to organs. Br J Ophthalmol. 2014;98(2):159–161. [PubMed]
2. Klein GT, Lu Y, Wang MY. 3D printing and neurosurgery—ready for prime time? World Neurosurg.2013;80(3–4):233–235. [PubMed]
3. Banks J. Adding value in additive manufacturing: Researchers in the United Kingdom and Europe look to 3D printing for customization. IEEE Pulse. 2013;4(6):22–26. [PubMed]
4. Mertz L. Dream it, design it, print it in 3-D: What can 3-D printing do for you? IEEE Pulse.2013;4(6):15–21. [PubMed]
5. Ursan I, Chiu L, Pierce A. Three-dimensional drug printing: a structured review. J Am Pharm Assoc.2013;53(2):136–144. [PubMed]
6. Gross BC, Erkal JL, Lockwood SY, et al. Evaluation of 3D printing and its potential impact on biotechnology and the chemical sciences. Anal Chem. 2014;86(7):3240–3253. [PubMed]
7. Bartlett S. Printing organs on demand. Lancet Respir Med. 2013;1(9):684. [PubMed]
8. Science and society: Experts warn against bans on 3D printing. Science. 2013;342(6157):439. [PubMed]
9. Lipson H. New world of 3-D printing offers “completely new ways of thinking:” Q & A with author, engineer, and 3-D printing expert Hod Lipson. IEEE Pulse. 2013;4(6):12–14. [PubMed]
10. Cui X, Boland T, D’Lima DD, Lotz MK. Thermal inkjet printing in tissue engineering and regenerative medicine. Recent Pat Drug Deliv Formul. 2012;6(2):149–155. [PMC free article] [PubMed]
11. Hoy MB. 3D printing: making things at the library. Med Ref Serv Q. 2013;32(1):94–99. [PubMed]
12. 3D Print Exchange. National Institutes of Health; Available at: http://3dprint.nih.gov. Accessed July 9, 2014.
13. Ozbolat IT, Yu Y. Bioprinting toward organ fabrication: challenges and future trends. IEEE Trans Biomed Eng. 2013;60(3):691–699. [PubMed]
14. Bertassoni L, Cecconi M, Manoharan V, et al. Hydrogel bioprinted microchannel networks for vascularization of tissue engineering constructs. Lab on a Chip. 2014;14(13):2202. [PMC free article][PubMed]
15. Centers for Disease Control and Prevention Colorectal cancer statistics. Sep 2, 2014. Available at:http://www.cdc.gov/cancer/colorectal/statistics. Accessed September 17, 2014.
16. Khaled SA, Burley JC, Alexander MR, Roberts CJ. Desktop 3D printing of controlled release pharmaceutical bilayer tablets. Int J Pharm. 2014;461(1–2):105–111. [PubMed]
17. Plastics Today. FDA tackles opportunities, challenges, of 3D printed medical devices. Jun 2, 2014. Available at: http://www.plasticstoday.com/articles/FDA-tackles-opportunities-challenges-3D-printed-medical-devices-140602. Accessed July 9, 2014.
18. Food and Drug Administration Public workshop—additive manufacturing of medical devices: an interactive discussion on the technical considerations of 3D printing. Sep 3, 2014. Available at:http://www.fda.gov/medicaldevices/newsevents/workshopsconferences/ucm397324.htm. Accessed September 17, 2014.
20th Software Design for Medical Devices Summit this October 26 – 28 in Boston
Posted in Medical Devices R&D Investment, Medical Imaging Technology, Scientific & Biotech Conferences: Press Coverage on July 22, 2015| Leave a Comment »
20th Software Design for Medical Devices Summit this October 26 – 28 in BostonReporter: Aviva Lev-Ari, PhD, RN
Unlock IQPC’s knowledge toolbox and learn more from our recent interview with Brian Nantz, Senior Software Engineer at GE Healthcare one of our speakers at the 20th Software Design for Medical Devices Summit this October 26 – 28 in Boston.
www.SDMDConference.comEvent Brochurehttp://www.sdmdconference.com/media/1001866/1001866_Brochure.pdf>> Exclusive Interview
To hear more from Brian, attend his session on ‘Medical Devices in a Big Data World‘ at 4:00pm on Main Conference Day 1 (Wednesday, October 28, 2015). Download the agenda for more information on this session and the other sessions from GE Healthcare, Maquet USA, Medtronic, Greatbatch, Systelabs, Baxter International Inc., and many more. save up to $400! Register Online | Via Email | Call 1-800-882-8684
I look forward to seeing you in Boston this fall! Warm Regards, Dionne Vaz Senior Marketing Manager |
http://www.sdmdconference.com/media/1001866/48286.pdf
SOURCE
From: Dionne Vaz <enquiryIQPC@iqpc.com> on behalf of Dionne Vaz <enquiryIQPC@iqpc.com>
Reply-To: Dionne Vaz <enquiryIQPC@iqpc.com>
Date: Wednesday, July 22, 2015 at 1:16 PM
To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>
Subject: Exclusive Interview with GE Healthcare on Medical Devices
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