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LPBI’s Plan to LAUNCH a US based ’S’ Corporation – A Global Distributorship of 3D Printing and related BioMedical Technologies, DBA, LM-3DP-GD

Curator: Aviva Lev-Ari, PhD, RN

I.   Gerard Loiseau and Danut Dragoi — ARE JOINING LPBI Team in the Deals, Funding and Partnership Practice

II.   FOCUS for US based ’S’ Corporation – A Global Distributorship of 3D Printing and related BioMedical Technologies, include:

  1. 3D Printing for Tissue Engineering — Irina, Yoel, Danut
  2. 3D Printing for Biomedical Applications — Adam, Aviva, Yossi
  3. 3D Printing for On Demand Drug Dosing and Drug Printing – Dr. Stephen J Williams, Dr. Peter NelBoeck
  4. 3D Printing for BioBanking = Dr. Stephen J Williams

On BioBanking:

http://pharmaceuticalintelligence.com/2013/01/13/personalized-medicine-an-institute-profile-coriell-institute-for-medical-research-part-3/

  • Whole-Genome Sequencing Data will be Stored in Coriell’s Spin off For-Profit Entity

http://pharmaceuticalintelligence.com/2013/01/30/whole-genome-sequencing-data-will-be-stored-in-coriells-spin-off-for-profit-entity/

  • Nation’s Biobanks: Academic institutions, Research institutes and Hospitals – vary by Collections Size, Types of Specimens and Applications: Regulations are Needed

http://pharmaceuticalintelligence.com/2013/01/26/nations-biobanks-academic-institutions-research-institutes-and-hospitals-vary-by-collections-size-types-of-specimens-and-applications-regulations-are-needed/

III.   We are seeking an Incoming CEO of Leaders in Medical 3D Printing Global Distribution (LM-3DP-GD)

IV.   Gerard Loiseau and Aviva will approach Private Equity Investors for Capital to launch the US based ’S’ Corporation positioned for Global Operations

V.   Intellectual Property of LM-3DP-GD include:

  1. A Team of Technical Experts with advanced degrees in Material Science, BioEngineering and Pharmacology
  2. Market Intelligence White Paper on 3D Printing Market for Tissue Engineering in US Mid Atlantic by Dr. Stephen J Williams
  3. Market Intelligence White Paper on 3D Printing Market for Tissue Engineering in US Mid West by Dr. Irina Robu
  4. Market Intelligence White Paper on 3D Printing Market for Tissue Engineering in Canada by Dr. Irina Robu
  5. Market Intelligence White Paper on 3D Printing Market for Tissue Engineering in California by Dr. Danut Dragoi (Work-in-Progress)
  6. Market Intelligence White Paper on 3D Printing Market for Tissue Engineering in Israel by Yoel Ezra, MSc
  7. Market Intelligence White Paper on 3D Printing Market for Tissue Engineering in Scandinavia by Dr. Yossi Ezer
  8. Market Intelligence White Paper on 3D Printing Market for Tissue Engineering @P&G by Adam Sonnenberg, Bsc
  9. Market Intelligence White Paper on 3D Printing Market for Tissue Engineering @GE Life Sciences, @J&J, @MIT – BioMaterials Lab
  10. Japan’s Ceramics and Glass Industrieshttp://pharmaceuticalintelligence.com/2015/07/29/japans-ceramics-and-glass-industries/

VI.   Market Segments

http://pharmaceuticalintelligence.com/2015/07/27/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/

  1. Translation centers like CIMIT
  2. Biodesign,
  3. Bioenterprise,
  4. 3D Printing start-ups
  5. Pediatric Cardiac Surgeons – TE Cardiac Devices for Pediatrics (Orphan Devices)
  6. Big Pharma
  7. Corporate R&D Departments at Lead Medical Devices Companies:

7A.   Top Ten Cardiovascular Medical Devices Industry Leaders

Medtronic

Abbott Labs 

Baxter

Johnson&Johnson 

Engologix 

Boston Scientific 

St Jude Medical 

Becton Dickson 

EdwardsLS 

Bard (C.R.) 

Top Ten Cardiovascular Medical Devices Companies – the Share of Top Institutional Investors

http://pharmaceuticalintelligence.com/options/healthcare-institutional-investors/top-ten-cardiovascular-medical-devices-companies-the-share-of-top-institutional-investors/

7B.   Top Ten Orthopedic Medical Devices Industry Leaders and HealthCare Equipment

Zimmer 

Stryker

Cooper

Wright Medical

ResMed Inc 

Steris Corp

Sirona Dental Systems

Varian Medical Systems

CareFusion

Natus Medical

Smith & Nephew

Top Ten Orthopedic Medical Devices – Top Ten Institutional Investors

http://pharmaceuticalintelligence.com/options/healthcare-institutional-investors/top-ten-orthopedic-medical-devices-top-ten-institutional-investors/

SOURCES on 3D Printing for Medical Applications

http://pharmaceuticalintelligence.com/2015/07/25/sources-on-3d-printing-for-medical-applications/

Re-Creation of the Big Pharma Model via Transformational Deals for Accelerating Innovations: Licensing vs In-house inventions

Reporter: Aviva Lev-Ari, PhD, RN

SOURCE

Teva-Allergan Buy Likely Heralds More Big Deals Teva’s acquisition of Allergan’s generic-drugs unit for $40.5 billion is likely to trigger more deal-making in the already-frenzied health-care sector. Bernstein analyst Ronny Gal said investors had highlighted

  • AbbVie,
  • Amgen,
  • Pfizer and
  • Biogen as potential transaction partners.

“Allergan clearly spells interest in using this case for acquisitions,” he said. (denise.roland@wsj.com; @deniseroland)

SOURCE

Market Talk is a stream of real-time news and market analysis that is available on Dow Jones Newswires.

Allegan

“We will have the potential to add scale in existing therapeutic areas, expand into new therapeutic areas and geographies and evaluate strategic transformational deals as we continue to build on our position as the most dynamic branded growth pharma company,” Allergan CEO Brent Saunders said.

In a sign of its continuing ambition, Allergan announced a deal on Sunday, saying it will pay $560 million upfront for Naurex Inc. and its antidepressant-drug candidate.

SOURCE

http://www.wsj.com/articles/teva-to-buy-allergan-generics-for-40-5-billion-1437988044

Allergan: Pharma’s Biggest Dealmaker Is On The Hunt Again

by Matthew Herper Forbes Staff – My favorite Write @Forbes on Pharma and HealthCare

For investors in the generic business, this may be a bit of a warning that stock prices are getting too heady. Saunders (I spoke to him between meetings this morning, as he went on just an hour of sleep) says he expects Teva stock to rise over the long-term, and thinks that the deal for Allergan will improve as that happens. But he also agrees that he’s getting an amazing multiple, and says that two factors led him to the “bittersweet” decision to sell: the great price, and the fact that consolidation among drug purchasers (CVS, Walgreens) and insurers (Aetna buying Humana, Anthem buying Cigna) led Saunders and Bisarro to realize that they had to either bulk up or get out. And they didn’t want to bulk up. Investors in Mylan Pharmaceuticals, which spurned Teva’s advances: Beware.

Saunders is obviously game. One thing that distinguishes him from Valeant billionaire Michael Pearson, the drug industry’s other great consolidator, is that Saunders comes to this from a different place. A decade ago, it looked like he was being groomed by Hassan to potentially take over Schering-Plough before that company ran into problems and got bought by Merck. Unlike Pearson, he’s not looking so much to dismantle the big pharma model as to re-create it.

SOURCE

http://www.forbes.com/sites/matthewherper/2015/07/27/allergan-pharmas-biggest-dealmaker-is-on-the-hunt-again/?utm_medium=email&utm_campaign=Daily%20Digest%20Send%20Control%202015-07-27&utm_source=Sailthru&utm_term=Daily%20Digest%20Horizon%20Control

Praluent – FDA approved as Cholesterol-lowering Medicine for Patient non responsive to Statin due to Genetic origin of Hypercholesterolemia

Reporter: Aviva Lev-Ari, PhD, RN

Regeneron hasn’t announced its price for Praluent, but CEO Leonard Schleifer, above, said “we’ve come up with a price that provides value to the health-care system.” PHOTO: ASSOCIATED PRESS

The first of a powerful new class of cholesterol-lowering medicines won approval from U.S. regulators Friday—a highly anticipated medical advance that nevertheless promises to escalate the growing clamor over drug costs.

The drug, called Praluent and developed by Regeneron Pharmaceuticals Inc. and SanofiSA, provides a new and in some cases desperately needed option for several million high-risk heart patients who can’t get their cholesterol to desirable levels with the blockbuster group of medicines known as statins.

  • Praluent works by blocking a protein called PCSK9, which interferes with the body’s ability to clear artery-damaging cholesterol from the blood.
  • A series of genetic discoveries a decade ago laid the foundation for Praluent and its rivals. After French researchers linked mutations in the PCSK9 gene to high LDL levels and early heart disease in French families, researchers Helen Hobbs and Jonathan Cohen at University of Texas Southwestern Medical Center, Dallas, wondered if other mutations might have the opposite effect.

But the companies are pricing the drug at $14,600 a year, an especially high amount for a medicine aimed at a common condition like heart disease. By contrast, statins, which are available in generic versions and remain the mainstay drug option for cholesterol reduction, can be purchased for just a few dollars a month.

Regeneron and Sanofi defended Praluent’s price. An antibody that patients inject themselves, it will cost substantially less than similarly administered drugs such as Humira and Enbrel for rheumatoid arthritis and other autoimmune diseases, which are prescribed for thousands of patients and which they said list for more than $38,000 a year.

The toll in the U.S. for cardiovascular disease amounts to more than $300 billion a year, according to estimates, while treating an individual heart attack can range from $60,000 to $120,000, said Leonard Schleifer, Regeneron’s chief executive officer. Expectations—not yet proven—are that the marked cholesterol reductions seen with Praluent will translate into fewer deaths and costly events.

The company believes “we’ve come up with a price that provides value to the health-care system,” Dr. Schleifer said.

  • Regeneron says it believes between 8 million and 10 million patients in the U.S. meet those criteria.
  • Statins are taken by some 40 million Americans, and in addition to a healthy diet and exercise, remain the mainstay strategy to lower LDL cholesterol, the chief culprit in the accumulation of deposits in the coronary arteries that lead to heart attacks.

SOURCE

http://www.wsj.com/articles/fda-approves-cholesterol-drug-from-regeneron-sanofi-1437762374

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.

http://pharmaceuticalintelligence.com/2016/04/05/update-on-fda-policy-regarding-3d-bioprinted-material/

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

Logo of pharmthera

P&T Community Current issue Registration Submit an Article
P T. 2014 Oct; 39(10): 704–711.
PMCID: PMC4189697

Medical Applications for 3D Printing: Current and Projected Uses

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.1,36

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.35,7

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.

NEWS from Leaders in Pharmaceutical Business Intelligence – NEW Volumes in the BioMed e-Series on Amazon and 694,298 Journal views of 3,085 Scientific Articles

Editor-in-Chief: Aviva Lev-Ari, PhD, RN

 

 

BioMedical e-Books e-Series: Cardiovascular, Genomics, Cancer, BioMed, Patient Centered Medicine

http://pharmaceuticalintelligence.com/biomed-e-books/

Series A: e-Books on Cardiovascular Diseases

Content Consultant: Justin D Pearlman, MD, PhD, FACC

Volume One: Perspectives on Nitric Oxide in Disease Mechanisms (2013)

Sr. Editor: Larry Bernstein, MD, FCAP, Editor: Aviral Vatsa, PhD and Content Consultant: Stephen J Williams, PhD

http://www.amazon.com/dp/B00DINFFYC

 

Series D: e-Books on BioMedicine

Content Consultant: Larry H Bernstein, MD, FCAP

Volume One: Metabolic Genomics & Pharmaceutics (2015)

Author, Curator and Editor: Larry H Bernstein, MD, FCAP

http://www.amazon.com/dp/B012BB0ZF0

Our Open Access Online Scientific Journal

http://www.pharmaceuticalIntelligence.com

is a scientific, medical and business, multi-expert authoring environment for information syndication in several domains of Life Sciences, Medicine, Pharmaceutical and Healthcare Industries, BioMedicine, Medical Technologies & Devices. Scientific critical interpretations and original articles are written by PhDs, MDs, MD/PhDs, PharmDs, Technical MBAs as Experts, Authors, Writers (EAWs) on an Equity Sharing basis.

Journal Content Descriptors on 7/27/2015

694,298 views

3,085 Scientific Articles

352 Categories of Research

6,951 Tags

Followers (includes Publicize)

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535 Facebook

NIH Clicks 2,583

Nature Clicks 1,572

As everyday objects get connected, brace yourself for network effects, says one economist.

Sourced through Scoop.it from: www.technologyreview.com

See on Scoop.itCardiovascular Disease: PHARMACO-THERAPY

Luciano Floridi issued a challenge to…

Sourced through Scoop.it from: www.businessinsider.com.au

See on Scoop.itCardiovascular Disease: PHARMACO-THERAPY

2015 Synergy: A Multidisciplinary Approach to Interventional Oncology, November 3-8, 2015, Eden Roc Hotel, Miami Beach, FL

Reporter: Aviva Lev-Ari, PhD, RN

Agenda

http://synergymiami.org/

http://synergymiami.org/media/FINAL-Synergy-Brochure-2015-7.21.15.pdf

SOURCE

From: “Interventional Oncology 360” <newsletters@InterventionalOncology360.com>

Date: July 23, 2015 at 9:51:19 AM EDT

To: avivalev-ari@alum.berkeley.edu

Subject: Meet Your Faculty – Synergy 2015

Reply-To: newsletters@InterventionalOncology360.com

SOURCES on 3D Printing for Medical Applications

Curator: Aviva Lev-Ari, PhD, RN

http://www.3dprinterstocks.com/a-list-of-3d-printing-companies/

http://bioprintingworld.com/

http://3dpireports.com/3d-printing-medical-healthcare-report/

http://mdmeast.mddionline.com/track/medical

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4189697/

http://www.cit.com/middle-market/common-interests/3d-printing-healthcare/index.htm?cmp=PaidSearch&gclid=CjwKEAjwxMetBRDJx6Sz2p7DsQ0SJADJHAqNX6iO93Wdbr8THP0VtBb0cTlJ7ZoYbSv0Q-749-P9DRoCQYnw_wcB&jcpid=8a8ae4cd4baa8b72014bc034820c3bb7&jsf=7ef20487-5c3f-403d-84e7-3ed6a0983caf:35584

http://3dprintingindustry.com/medical/

http://www.tcs.com/SiteCollectionDocuments/White%20Papers/3D-Printing-New-Opportunities-for-Medical-Device-Industry_0315-1.pdf

http://www.meddeviceonline.com/doc/3d-printing-in-medicine-questions-that-need-to-be-answered-0001

http://3dprint.com/55890/buy-3d-printer-cheap/

http://3dprintboard.com/

http://3dprint.com/76087/ripple-maker-3d-print-coffee/

MEDICAL DEVICE INDUSTRY TRENDS 2015: 3D PRINTING TECHNOLOGIES

3d printer3D printing is a disruptive technology in the medical device industry. There are a variety of 3D printing methods to create metal and plastic parts for medical devices and clinical use. Each method involves fabricating a part one layer at a time by applying layers of liquid material onto various substrates.

Biocompatible and drug-contact materials help 3D printing technologies produce customized medical devices. 3D printing also makes simultaneous production of multiple individualized items possible. This improves manufacturing efficiency while conserving time and energy.

New 3D technologies combined with ever-expanding choices in printing materials and applications are creating trends in the medical device industry and even in clinical research.

3D Printing Trends in Medical Devices
Dental laboratories and hearing aid manufacturers already use 3D printing technology to mass-produce customized medical devices. 3D printing also enables the development of groundbreaking concepts and procedures in preclinical studies of material science, toxicology, neuroimaging and other disciplines. Other trends for 3D printing in medical devices include external wearable devices, clinical study devices and specialty implants.

External Wearable Devices
Because of its ability to produce customized devices that are both lightweight and strong, 3D printing will revolutionize wearable mechanical braces. Made for external use, these devices can be much larger or thicker than surgically implanted devices, overcoming any mechanical strength issues presented by three-dimensional printing.

3D Systems unveiled its 3D printed Bespoke Braces™ for young people with idiopathic scoliosis in June 2014. It uses selective laser sintering technology to create comfortable, flexible, durable braces.

Clinical Study Devices
Clinical researchers will increasingly turn to 3D printing in feasibility and first-in-human studies where low build quantities and postevaluation design changes are likely. Reducing both costs and development time, 3D printing is fast replacing injection molds for manufacturing devices with multiple plastic components. 3D printing also helps scientists conduct validation and pivotal studies with large patient study sizes earlier by making large numbers of pieces available quickly, ideally while other components of the study are still under development.

NovaScan utilized 3D printing to develop a disposable patient-contacting tip and reusable hand piece used during breast cancer detection.

Implants
3D printing will continue pushing orthopedic and dental device manufacturing forward. There are a number of companies using 3D printing technology to create implants with intricate surface textures or requiring complex geometry. The U.S. Food and Drug Administration continues to approve these devices for implant. For example, the FDA gave 510(k) clearance to the German company joimax for 3D printed spine implants.

Other companies are following suit. Researchers in China introduced the first 3D printed sternum in July 2015. Knee replacement specialists ConforMIS recently introduced their own 3D printed custom joint implants.

Using direct metal printing technology, 3D Systems created a titanium alloy acetabular cup with a porous surface. Additive manufacturing with 3D printing allows manufacturers to control effective porosity and thickness of materials to improve fixation of orthopedic implants in the bone.

The use of 3D printing will continue to grow in the medical device industry. Metal additive manufacturing will adopt three-dimensional printing for the commercial production of orthopedic implants. These printed medical devices will also propel the development of customizable external device components with low load-bearing components. 3D printing will also be essential in clinical study applications to reduce cost and shorten research time.

3D printing will use an ever-growing number of materials to make medical devices; therefore, the development of new printable materials will shape trends in the evolution of 3D printing for medical devices and research.

Clinical researchers and those in the medical device industry are embracing 3D printing for a number of applications ranging from true medical devices to clinical use. 3D printing continues to give researchers and those in the medical device industry new ways to think about creating groundbreaking and disruptive medical technologies.

Source

http://www.3dsystems.com/sites/www.3dsystems.com/files/06_09_2014_3d_systems_introduces_3d_printed_bespoke_braces_for_chronic_condition_scoliosis_final.pdf

http://www.novascanllc.com/

http://www.beckersspine.com/orthopedic-a-spine-device-a-implant-news/item/26251-fda-clears-joimax-endoscopic-lumbar-interbody-fusion-system-6-things-to-know.html

http://3dprintingindustry.com/2015/07/10/the-first-3d-printed-sternum-implant-deemed-a-success/

http://3dprint.com/78272/conformis-3d-printed-knee/

http://www.3dsystems.com/sites/www.3dsystems.com/files/06_09_2014_3d_systems_introduces_3d_printed_bespoke_braces_for_chronic_condition_scoliosis_final.pdf

SOURCE