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• Biocompatibility & Testing
  

  Lessons from the Lab: Testing Orthopedic Devices

  Changes in testing protocols and revised regulatory demands make testing experts even more valuable than they’ve ever been.

  Sean Fenske, Editor-in-Chief 09.15.20
  

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• Biocompatibility & Testing
  

  Nelipak Facility Earns ISO/IEC 17025 Accreditation

  Provides a comprehensive range of testing services to support package testing requirements.

  Nelipak 09.10.20
  

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• Biocompatibility & Testing
  

  Avoiding Contradictions: Testing Advice for Manufacturers

  Manufacturers need to evaluate their approach to preclinical testing. Avoiding contradictory study design is the most effective path forward for study sponsors.

  Mark R. Cunningham, Ph.D., Senior Director of Science and Technology, Technical Services, WuXi AppTec 08.11.20
  

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• Biocompatibility & Testing
  

  Conducting Chemical Characterization/Risk Assessment for FDA Submissions

  Chemical characterization/risk assessment is a powerful methodology for addressing select biocompatibility endpoints.

  Robert A. Allen, Ph.D., Senior Associate, Regulatory Affairs, MCRA LLC 05.20.20
  

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  Trump Signs Bill Replenishing Coronavirus Relief Funding

  Legislation provides $484 billion for company payrolls, hospitals, small business loans, and a national testing system.

  Staff and Wire reports 04.24.20
  

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• Imaging | Large Joint
  

  RSIP Vision Launches AI for 3D Knee Image Reconstruction

  Creates rich 3D modeling of each knee bone based solely on widely available X-ray images.

  PR Newswire 03.18.20
  

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• MIS/Robotics
  

  Rise of the Robots: A Robotic-Assisted Surgery Synopsis

  Pre-planning and surgical precision are driving physician acceptance and market adoption of robotic-assisted technology in orthopedics.

  Michael Barbella, Managing Editor 03.13.20
  

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• Biologics
  

  Made-to-Order Muscles Could Be Served in a Hospital Near You

  Dr. Ali Tamayol recently developed a handheld bioprinter pen that could significantly change the way musculoskeletal procedures are performed.

  Sam Brusco, Associate Editor 03.13.20
  

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• Design
  

  The Importance of Usability/Human Factors Testing

  When is the work of human factors over, and how does your team know they are prepared for summative testing?

  Maria Shepherd, President and Founder, Medi-Vantage 03.13.20
  

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• Large Joint
  

  Particle Particulars: Why this Analysis Is Foundational for Successful Devices

  In the mid-2000s, medical device experts were hopeful they’d found one solution to longer-lasting implants.

  Dawn A. Lissy, President & Founder, Empirical 03.13.20
  

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• Design | Instruments
  

  A Case Study of Design Controls and Orthopedic Instruments

  Most orthopedic instruments are Class I so manufacturers aren’t required to apply formal design controls, but recently, attitudes are changing.

  Victoria Trafka, President & Principal Engineer, Engineering & Quality Solutions Inc. 03.13.20
  

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• 

  Senators Introduce Bill to Address Medical Supply Vulnerabilities

  Bill would study and develop action plan to address U.S. dependence on foreign-made medical equipment and boost domestic production and supply.

  Lamar Alexander (R-TN) and Dick Durbin (D-IL) 03.12.20
  

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• Supply Chain
  

  Senators Introduce Bill to Address Medical Supply Vulnerabilities

  Bill would study and develop action plan to address U.S. dependence on foreign-made medical equipment and boost domestic production and supply.

  Lamar Alexander (R-TN) and Dick Durbin (D-IL) 03.12.20
  

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  FDA Suspends Foreign Inspections

  The agency has postponed most foreign inspections through April, effective immediately.

  Food and Drug Administration 03.10.20
  

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  FDA Suspends Foreign Inspections

  The agency has postponed most foreign inspections through April, effective immediately.

  Food and Drug Administration 03.10.20
  

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• Spine/Neurology
  

  DiscGenics Completes Enrollment in U.S. Trial for DDD Cell Therapy

  Study will evaluate the efficacy of injectable Discogenic Cell therapy in patients with symptomatic, single-level, mild to moderate lumbar DDD.

  DiscGenics Inc. 03.05.20
  

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  FDA Offers Coronavirus Update Regarding Product Safety

  The agency outlines the steps it will take to ensure the quality of foreign products.

  U.S. Food and Drug Administration 02.25.20
  

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  FDA Offers Coronavirus Update Regarding Product Safety

  The agency outlines the steps it will take to ensure the quality of foreign products.

  U.S. Food and Drug Administration 02.25.20
  

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• Spine/Neurology
  

  Magnet-Controlled Bioelectronic Implant Could Relieve Pain

  MagNI can be wirelessly charged and programmed with magnetic fields.

  Rice University 02.20.20
  

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• 

  3D Printed Devices in Orthopedic Implants Comprise Nearly Half of Total Sales

  Market expected to grow 16 percent annually through 2029.

  Future Market Insights 02.19.20
  

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• Packaging & Sterilization
  

  Proceed with Caution: Medtech Seeks Safe Packaging and Sterilization Solutions

  Concerns surrounding ethylene oxide have brought the packaging and sterilization segments to the forefront for medical device manufacturers.

  Mark Crawford, Contributing Writer 02.18.20
  

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• 

  Recalibrating for 2020: Tips for a Better New Year

  In 2019, I had to take a long, hard look at both my businesses and my industry to find balance and a way forward through the ripple effects of big changes.

  Dawn A. Lissy, President & Founder, Empirical 02.18.20
  

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  Arch Acquires MMi Sonora

  Bolsters Arch’s position as a supplier to the medical market.

  Arch Global Precision 02.18.20
  

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• Extremities | Spine/Neurology
  

  4WEB Medical Achieves Record Revenue in 2019

  Investments in product development and clinical research drive growth.

  PR Newswire 02.13.20
  

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• Biologics
  

  Global Bone Graft and Substitutes Market to Reach $4.67B by 2027

  Adoption of inorganic growth strategies, increase in road accidents and injuries is expected to boost growth.

  Business Wire 02.07.20
  

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• Spine/Neurology
  

  Soin Neuroscience Develops New Spinal Cord Stimulator

  Starts early stage human proof of concept studies.

  PRNewswire 01.22.20
  

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• 3-D Printing/Additive Mfg. | Biocompatibility & Testing
  

  LimaCorporate Opens 3D Printing Center & Advanced Laboratory for Testing and Analysis

  Both will strengthen the collaboration between all departments and surgeons.

  PR Newswire 01.17.20
  

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• Machining & Tooling
  

  Solar Atmospheres, Western PA Adds Machining Capacity

  To support rapid growth within their mechanical testing department.

  Solar Atmospheres 12.17.19
  

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• 

  FDA OKs First Test to Help Screen for Newborn Duchenne Muscular Dystrophy

  PerkinElmer's test measures dried blood samples collected from the prick of a newborn’s heel 24 to 48 hours after birth.

  U.S. Food and Drug Administration 12.13.19
  

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• 3-D Printing/Additive Mfg. | Biocompatibility & Testing | Biologics | Instruments | Materials | MIS/Robotics | Spine/Neurology
  

  Sounding Board: Looking Back at 2019 and Gazing at 2020

  ODT editorial advisory board members share their thoughts on the most significant events of 2019 and what they expect to watch in 2020.

  Online Exclusives Sean Fenske, Editor-in-Chief 12.10.19
  

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• Packaging & Sterilization
  

  Viant to Halt EtO Sterilization at Michigan Plant by End of Year

  EGLE had been investigating over the past year and issued Viant several violations for inadequate capture and control of ethylene oxide emissions.

  Michigan Department of Environment, Great Lakes, and Energy (EGLE) 12.04.19
  

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• Spine/Neurology
  

  Micro Spine Implant Could Restore Standing and Walking

  Hair-like electrical wires send electrical signals to trigger networks that already know how to do the hard work.

  University of Alberta Faculty of Medicine & Dentistry 12.03.19
  

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• 3-D Printing/Additive Mfg. | Machining & Tooling | Materials | Molding
  

  From Nitinol to Nanotubes: A Materials Science Roundtable

  While new materials are being made available, orthopedic device makers still lean on the well-established options for most new development.

  Mark Crawford, Contributing Writer 12.02.19
  

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• MIS/Robotics | Packaging & Sterilization
  

  Anxious Undertones: A Review of 2019

  Despite a healthy U.S. economy and solid corporate growth, the medtech industry was wracked with worries in 2019.

  Michael Barbella, Managing Editor 12.02.19
  

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• 

  ‘If You’re Reading This, You Need to Be at This Meeting’

  The AAOS/FDA/Industry Townhall is taking place March 24, 2020, at the AAOS annual meeting in Orlando.

  Dawn A. Lissy, President & Founder, Empirical 12.02.19
  

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• Design | Large Joint | Spine/Neurology
  

  Five Reasons for the Small World of Orthopedic Product Development

  Why do product development people tend to stay within the orthopedic and spine industry and not cross over into other medtech sectors?

  Victoria Trafka, BSME, MSME, President and Lead Engineer, Engineering & Quality Solutions Inc. 12.02.19
  

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• Spine/Neurology
  

  Intralink-Spine Achieves ISO 13485 Certification

  Company has also completed ISO 10993 biocompatibility testing.

  Business Wire 11.20.19
  

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  First Patient Treated With CurvaFix Rodscrew

  The curved device is designed to aid pelvic trauma surgery.

  Globe Newswire 11.11.19
  

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  4WEB Medical Completes Cell Differentiation and Gene Expression Study

  In-vitro study establishes platform for advancing implant technology through mechanobiology.

  PR Newswire 11.08.19
  

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• Bracing/Prosthetics
  

  Computerized Bionic Leg Helps Amputees Walk

  University of Utah's self-powered prosthetic limb has a computer processor and motorized joints in the ankle and knee.

  University of Utah 10.30.19
  

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• 

  Rheumatoid Arthritis Diagnosis Test Market Expected to Grow 4 Percent By End of 2020

  Autoimmune diseases, prescription of off-label nonsteroidal anti-inflammatory drugs, and other pain management drugs will fuel demand, report shows.

  Persistence Market Research 10.21.19
  

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• Spine/Neurology
  

  FDA Grants 510(k) Clearance to 4WEB Medical's Cervical Stand-Alone Interbody Fusion Device

  Company expands implant portfolio with the addition of the Cervical Spine Truss System - Stand-Alone.

  PR Newswire 10.15.19
  

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  WishBone Medical Adds Resorbable Implants to its Product Lineup

  Company gains distribution rights to OsteoCrete.

  Globe Newswire 10.07.19
  

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• Bracing/Prosthetics
  

  AI Improves Control of Prosthetic Hands

  Researchers show success towards goal of EMG-controlled prosthetics using deep learning.

  PRNewswire 10.02.19
  

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  TÜV Rheinland Becomes a Notified Body for the New Medical Device Regulation

  New regulation came into effect May 2017.

  TÜV Rheinland 10.01.19
  

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• 3-D Printing/Additive Mfg. | Spine/Neurology
  

  Kanfit3D Enters Joint Research Venture with Brescia University

  Project to develop special surface parameters for Ti64 implants.

  Kanfit3D 09.25.19
  

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• Biologics
  

  NASS News: DiscGenics Announces Publication of Preclinical Data for Disc Degeneration Treatment

  Data demonstrate that intradiscal injection of Discogenic Cells may be a viable treatment for human degenerative disc disease.

  PR Newswire 09.24.19
  

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• Biocompatibility & Testing
  

  Automated Analysis Advantages for Part Validation

  Accomplishing part fabrication validation can be better facilitated through the incorporation of automated protocols.

  Edward Jaeck, Vice President of Strategic Growth and Business Development, Lowell Inc. 09.17.19
  

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• Machining & Tooling
  

  Tried and True Metalworking

  While device manufacturers are curious about newer parts fabrication technologies, they still rely heavily on traditional machining providers.

  Mark Crawford, Contributing Writer 09.17.19
  

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• Biocompatibility & Testing
  

  Making the Grade: A Testing and Analysis Roundtable

  This roundtable discussion examines the technological and regulatory factors affecting the third-party testing and analysis services industry.

  Sam Brusco, Associate Editor 09.17.19
  

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