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Search Keyword: UDI

ConnectSx Launches UDidentify Mobile App

by BONEZONE | Jan 2018 (Supplier News Items) The free app scans and validates HIBCC and GS1 barcodes used for compliance with FDA unique device identification (UDI) ConnectSx, a Mokena, Illinois-based startup providing SaaS solutions that support ... Read more »

The Brazilian Market: A Regulatory Overview for Orthopaedic Products

by Juliana Ramos Gouveia | Jan 2018 (Legal, Clinical & Regulatory) ... (ANVISA) had a long waiting line to schedule GMP audits, delaying the ability of many companies to start their business in Brazil. However, in October 2017, regulation RDC 183/17 was published to change ... Read more »

Startup Aims to Monitor Joint Loosening and Infection with Implantable Sensors

by Carolyn LaWell | Jan 2018 (Research & Development) ... that up is really substantial. All the lab studies—x-rays, bone scans, MRIs—don’t give you the answer; they approximate a diagnosis. The real diagnosis is a clinical judgment. But if you can solidify parameters—for ... Read more »

Augmedics Bringing X-Ray Vision to Surgery with X-VISION Visualization System

by Rob Meyer | Jan 2018 (Research & Development) ... or and Augmedics CEO and Co-Founder Nissan Elimelech, who has ten years of experience in various medical device markets, including spine (Medtronic). Below we share his words, vision and future plans. W ... Read more »

Consensus Orthopedics’ TracPatch Targets Efficiency in Post-Op Care

by Carolyn LaWell | Jan 2018 (Research & Development) ... 2017, and will launch TracPatch ACL and a demo of TracPatch Hip at the 2018 AAOS meeting. The company’s pipeline includes applications in multiple orthopaedic specialties, including shoulder and elbow. ... Read more »

Be Prepared When Suppliers are Acquired

by David Finch | Jan 2018 (Supply Chain Management) ... components, instruments and implants, including process and inspection technique. Required approval or minimal notification for all process and country of origin changes with minimum time requirement ... Read more »

Arcam EBM Expanding Into New Facility

by BONEZONE | Jan 2018 (Supplier News Items) ... M component. In 2016, Arcam was part of GE Additive’s U.S. $1.4BB investment in additive technology, materials and services worldwide. Arcam then took numerous strategic steps to expand in 2017, including:  ... Read more »

Study: Rotation Medical Bioinductive Implant Promotes Consistent Rotator Cuff Healing, Mitigates Tear Progression

by BONEZONE | Dec 2017 (Research & Development) ...  12-month results including:  Significant improvement in clinical scores, with mean tendon thickness increased by 2mm, and new tissue indistinguishable from underlying tendon 94% of patients showin ... Read more »

MedTech Momentum Launches Video Production Studio

by BONEZONE | Dec 2017 (Supplier News Items) The venture covers a wide range of video formats for medical companies to choose from. MedTech Momentum's new video production studio is dedicated to serving medical companies around the globe. Th ... Read more »

J-Pac Medical Receives ISO:13485:2016 Registration Ahead of Schedule

by BONEZONE | Dec 2017 (Supplier News Items) ... for organizations in the supply chain. It is a major update from the 2003 standard and is designed to respond to latest quality management system practices, including changes in technology and regulatory ... Read more »

Computational Modeling and Simulation Expanding in Orthopaedic Device Life Cycles

by Marc Horner, Ph.D. & Mehul Dharia | Dec 2017 (Research & Development) ... for Computational Modeling As shown in the previous section, CM&S studies are an integral part of the total product life cycle of orthopaedic implants that can provide significant benefits to the device ... Read more »

Examining Methods to Determine Sample Sizes

by Deborah Munro | Dec 2017 (Legal, Clinical & Regulatory) ... an intervention is deemed necessary (probability) PL—lower threshold beyond which an intervention is deemed unnecessary (probability) α—Type I error of concluding lot is acceptable when it is not, ... Read more »

Why a Well-Conceived Test Plan is Crucial to Efficient Product Development

by Robert Poggie | Dec 2017 (Legal, Clinical & Regulatory) ... FDA guidance documents (including those associated with safety such as validation-test requirements for cleaning of reusable instruments), sterilization of products, shipping and handling and shelf life. ... Read more »

Magnus René and Johan Brandt (CEO and CFO) Announce Plans to Leave Arcam

by BONEZONE | Dec 2017 (Supplier News Items) ... was relocated to the U.S. Subsequently, Brandt was appointed Executive Vice President and CFO of Arcam. In the past year alone, Arcam has taken numerous strategic steps to expand, including: Spin-out ... Read more »

Learn to Incorporate Sensors Into Your Next Design Idea

by Deborah Munro | Dec 2017 (Research & Development) ... it’s exposed. The shape and depth of the etch depend on several factors, including obvious ones like time and the chemical used, and not-so-obvious ones like the crystal orientation in your chosen wafer. ... Read more »

Sanford Health Stem Cell Therapy Trial First in U.S. for Shoulder Injuries

by Rob Meyer | Dec 2017 (Research & Development) ...  If so, enrollment in that trial will begin in 2018. Dr. Pearce said Sanford Health considered other types of orthopaedic injuries for its proposal, including osteoarthritis and knee, hip, wrist and bac ... Read more »

Medical Device Single Audit Program Attracts Growing Interest from U.S. Companies

by John Gagliardi | Dec 2017 (Legal, Clinical & Regulatory) ... were slow to adopt the Medical Device Single Audit Program (MDSAP) in its pilot days, the initiative has gained traction since FDA’s Center for Devices and Radiological Health (CDRH) named it an official ... Read more »

Understanding the Critical Differences Between Supplier Audit and Evaluations

by Martin Browning | Dec 2017 (Supply Chain Management) Martin Browning from EduQuest provides insight on evaluations and audits: "All of us who conduct audits recognize that most of them are nothing more than snapshots in time. In contrast, an evaluation gather ... Read more »

Concept Laser, GE Break Ground on 3D Printing Campus

by BONEZONE | Dec 2017 (Supplier News Items) ... dental customers. The company is headquartered in Lichtenfels, with >200 employees throughout operations including Texas and China and a global network of >35 distributors and agents. GE has invested ... Read more »

UDI Direct Marking Guidance Finalized by FDA

by Rob Meyer | Nov 2017 (Legal, Clinical & Regulatory) ... recently finalized guidance on direct marking a medical device with unique device identification (UDI), providing orthopaedic manufacturers with an unsurprising position on marking methods and identical ... Read more »

Invibio Makes Series of Investments to Drive Clinical Outcome Improvement

by BONEZONE | Nov 2017 (Supplier News Items) The investments include faster time-to-market for devices through streamlined device-development strategies that consider the total costs of care. Invibio, global provider of PEEK-OPTIMA polymers to ... Read more »

Smith & Nephew's NAVIO Used in Bi-Cruciate Retaining Total Knee Replacement

by BONEZONE | Nov 2017 (Research & Development) ... and ligament balance and offers robotics-assisted bone preparation, removing bone identified by the surgeon's patient-specific plan. NAVIO is now available in partial and total knee options, includin ... Read more »

Teleflex Medical OEM Announces New Suture Technology

by BONEZONE | Nov 2017 (Supplier News Items) ... including the use of allograft tissue for orthopaedic procedures. It’s offered in USP suture sizes 1 to 5 and available in several color and pattern options. Source: Teleflex Medical    ... Read more »

5 Steps to a Collaborative Supplier Agreement

by Kate Vitasek | Nov 2017 (Supply Chain Management) ... contract is signed. Simply put, this means defining the governance mechanisms that parties will use to help them “Live as We.”    Including governance in a formal contract is essential, because relationships ... Read more »

Smith & Nephew Adds to Sports Medicine Portfolio with Rotation Medical Acquisition

by Rob Meyer | Nov 2017 (Business Critical) ... in the arthroscopy/soft tissue space, including ArthroCare in 2014 and BST-CarGel’s cartilage repair product in 2016. The Rotation Medical acquisition follows the announcement that SNN CEO Olivier Bohuon ... Read more »

Examining Critical Trends in Trauma Surgery

by Carolyn LaWell | Nov 2017 (Voice of Industry) ... weight-bearing after [surgery]. Infection Prevention Dr. McKee: Infection is becoming an extremely significant concern in multiple areas of orthopaedic trauma, including occurrence of acute infections ... Read more »

AAOS to Launch Orthopaedic Registries, Integrate With AJRR

by Rob Meyer | Nov 2017 (Business Critical) ... organizations have developed registries, including the North American Spine Society, Orthopaedic Trauma Association and AdvaMed. As AAOS makes further announcements, it will be interesting to watch whether ... Read more »

CoorsTek Medical Announces First Human Implantation of New Sacroiliac Fusion System

by BONEZONE | Oct 2017 (Supplier News Items) ...  The Integrity-SI Fusion system embraces the principles of arthrodesis, including thorough joint preparation, compression and stability via the proprietary instrumentation. It also utilizes proprietary ... Read more »

3D Printing, Expandable Cages Popular Among Pre-NASS Product Launches

by BONEZONE | Oct 2017 (Business Critical) ... ® growing rods with the RELINE® Small Stature pediatric deformity fixation system. The company also received expanded FDA 510(k) clearance of the TLX™ interbody fusion system, including an expandable 2 ... Read more »

Smith & Nephew CEO Announces 2018 Retirement; Acquisition Buzz Returns

by BONEZONE | Oct 2017 (Business Critical) ... ious distributors in geographic regions like Brazil, Columbia, Russia, Turkey, etc. SNN was also itself the subject of multiple acquisition rumors from 2011 to the present, including reported over ... Read more »

Minnesota Rubber and Plastics Doubles Clean Room Manufacturing Capacity

by BONEZONE | Oct 2017 (Supplier News Items) ... operations, including the addition of new cleaning and packaging equipment. Minnesota Rubber and Plastics provides high performance elastomers and thermoplastics to the medical device industry. Source: ... Read more »

Grace College and OrthoWorx Update Orthopaedic Graduate Studies Program

by BONEZONE | Oct 2017 (Supplier News Items) After six years of successful operation and more than 100 graduates of ORCA, it was time to revise the program. Grace College and OrthoWorx have launched an updated curriculum for their collaborative ... Read more »

Coatings Support Early Integration, Infection Prevention

by Carolyn LaWell | Oct 2017 (Voice of Industry) ... me been able to generate coatings that are osteoconductive and have osteostimulatory characteristics. Our more recent work shows that coatings can also have other very attractive attributes, including  ... Read more »

Your EU Medical Device Regulation Guide

by Deborah Munro | Oct 2017 (Legal, Clinical & Regulatory) ... Medical Devices Background The European Single Market has 28 Member States of the European Union (including the U.K.), the European Economic Area (Liechtenstein, Norway and Iceland) and Switzerland (through ... Read more »

Quebec: Orthopaedic Innovation Hub

by Robert Poggie | Oct 2017 (Voice of Industry) ... at École de technologie supérieure (ETS, engineering school, University of Quebec), Montreal is home to more than a handful of research labs, including the National Research Council of Canada, whose past ... Read more »

NuVasive Founder Talks Minimally Invasive Surgery

by Carolyn LaWell | Oct 2017 (Voice of Industry) ... disc thermal modulation, or “cooked discs”?). In my opinion, the theory and science was lacking or incomplete at best, and the advocates as well as the audience were insufficiently objective and lacked ... Read more »

CAPA Notes from an FDA Inspection

by John Gagliardi | Oct 2017 (Legal, Clinical & Regulatory) ... just a “participant” in the general scheme of compliance architecture. Some examples include: CAPA gets top management’s attention at Management Review. Quality audits and corrective actions taken are ... Read more »

NN, Inc. To Relocate Global Headquarters

by BONEZONE | Sep 2017 (Supplier News Items) ... for a variety of markets, including orthopaedics, on a global basis. Its 33 manufacturing plants are located throughout North America, Western Europe, Eastern Europe, South America and China, with specific ... Read more »

Collagen Solutions Announces Completion of Assessments in ChondroMimetic Study

by BONEZONE | Sep 2017 (Supplier News Items) ... in the knee. With the last patient enrolled, data is being compiled and audited for submission as part of a package for regulatory approval and re-establishment of the CE mark, with ex-U.S. commercialization ... Read more »

Spine Companies $100MM to $2BB: Strategic Activity Update

by Julie Vetalice | Sep 2017 (Business Critical) ... ’s vertebral augmentation business, including all AVAmax, AVAflex, AVAtex and AVAprep branded products. Stryker’s Mako robotics technology hasn’t broken out of joint recon yet, though it’s certainly reasona ... Read more »

Centinel Spine to Acquire DePuy Synthes prodisc Assets

by Carolyn LaWell | Sep 2017 (Research & Development) ... U.S. clinical studies to secure approval for other products in the portfolio. The Viscogliosi Bros. have a history with the technology, having purchased prodisc-L from Aesculap in 1999 which was then ... Read more »

Zimmer Biomet Launches Persona Partial Knee

by BONEZONE | Sep 2017 (Research & Development) ...  for use with partial knees. In mid-2Q, ZBH entered into a license agreement for use of patent families supporting technology created by Dr. Peter Bonutti, including patents that address robotic unicompartmental ... Read more »

Additive Manufacturing Evidence: Industry Advances the Dialogue

by Carolyn LaWell | Sep 2017 (Voice of Industry) A new white paper produced by the Society of Manufacturing Engineers’ (SME) Medical Additive Manufacturing/3D Printing Workgroup offers an evidence-building framework that may be used to conduct studies ... Read more »

Orthopaedic Pediatric Market Attracts New Products and Players

by BONEZONE | Sep 2017 (Business Critical) ... a new brand to house its collection of products and services (apps, games, education tools) that treat pediatric orthopaedic and congenital deformities, including the TL HEX TrueLok Hexapod system and ... Read more »

CMS Proposes Total Joint Bundled Payment, Outpatient Payment Changes

by BONEZONE | Aug 2017 (Business Critical) ... for Comprehensive Care for Joint Replacement and including ambulatory surgical centers for knee replacement. The Centers for Medicare & Medicaid Services (CMS) recently released two proposals related ... Read more »

MTD is an Inc. 5000 Fastest-Growing Company

by BONEZONE | Aug 2017 (Supplier News Items) ... factors contributed to MTD's growth, including payoff from long-term projects that moved from pipeline to production and the achievement of ISO 13485 Certification in 2016. MTD Micro Molding provide ... Read more »

Globus Medical Receives Clearance for Excelsius GPS

by BONEZONE | Aug 2017 (Research & Development) Globus Medical received FDA 510(k) clearance to market their robotic guidance and navigation system, supporting minimally invasive or open orthopaedic procedures including screw placement in spine and ... Read more »

EIT Acquires 3D-Printed Spine Patents

by BONEZONE | Aug 2017 (Business Critical) ... based on these patents will launch in 2018. The patents address multiple geographies, including the U.S. and Europe, and are based on "living hinge" designs by Morgan P. Lorio, M.D. EIT's additively-manufactur ... Read more »

Alphatec Spine Set for Rebuilding

by BONEZONE | Aug 2017 (Business Critical) Alphatec Spine posted 2Q17 revenue of $24.4MM, -24.4% vs. 2Q16, and 1H17 revenue of $52.4MM, -21.2% vs. 1H16. Though revenues continue to underperform vs. the prior year, leadership sees substantial opportunities ... Read more »

The Fused and the Fractured: New Entrants to U.S. Spine and Trauma

by Julie Vetalice | Aug 2017 (Legal, Clinical & Regulatory) ...  Used in >10,000 cases in >15 countries, including Australia, France, Germany, Korea and the Netherlands Developing 3D-printed patient specific implants to treat complex spinal disorders; first procedur ... Read more »

DePuy Synthes Launches Distal Radius Sterile Kit

by BONEZONE | Aug 2017 (Research & Development) ... s occur each year in the U.S., spanning both sexes and all ages, and that wrist fracture is one of the most common fractures presenting in the ER in patients under 65. Studies have indicated that surgic ... Read more »

Robotics, 3D Printing Gain Larger Adoption with Globus Medical, K2M Acquisitions

by Julie Vetalice | Aug 2017 (Research & Development) ... technology and corporate structure as well as oversee global commercial activity and ops (including IT and RA/QA responsibilities—they’re firming up their foundations).    Mazor’s unifying R&D and ... Read more »

3D-Printed Model Reduces Surgery Time, Cost

by BONEZONE | Aug 2017 (Research & Development) ... the Journal of Children’s Orthopaedics, including ten patients undergoing treatment for slipped capital femoral epiphysis in the study. In five of the procedures, 3D-printed models were used to prepare, ... Read more »

The Joint Surgeon's Wish List

by Julie Vetalice | Aug 2017 (Voice of Industry) ... practice he performs primary hip and knee arthroplasties, including complex revisions—fueling his research focus on biophysical disruption of biofilms in total joint arthroplasty and the care of patients ... Read more »

Design Validation: More than Just User Testing

by BONEZONE | Aug 2017 (Research & Development) ...    “While testing is always a part of validation, additional validation methods are often used in conjunction with testing, including analysis and inspection methods, compilation of relevant scientific ... Read more »

Trauma and Spine Gain New Players with First 510(k)s in 1H17

by BONEZONE | Aug 2017 (Legal, Clinical & Regulatory) ... including degenerative disc disease, spondylolisthesis, trauma and spinal stenosis Radicle Orthopaedics | New York, New York, USA | Founded 2012 Segment: Trauma K161334, RASL Repair ... Read more »

Improve Your Performance With These Tips

by Carolyn LaWell | Aug 2017 (Business Critical) ... y real constant in your life is you. Moore outlined critical aspects for us as individuals to improve our performance, including how to remain engaged in our work, how to react to other’s behavior a ... Read more »

Spine Fusion Stimulated by Sugar-Coated Nanomaterial

by BONEZONE | Jul 2017 (Research & Development) ... animal model, researchers studied the effect of sugar-coated nanomaterial on the activity of bone morphogenetic protein 2 (BMP-2). By incorporating the nanomaterial, which was delivered on a collagen sponge, ... Read more »

Tegra Medical Names New General Manager

by BONEZONE | Jul 2017 (Supplier News Items) ... in Franklin, Massachusetts. Mr. Rieth is a Six Sigma Black Belt with more than 25 years of management experience in several industries across several functions, including engineering, manufacturing, ... Read more »

Cadence Rhode Island Facility Earns Worksite Health Award

by BONEZONE | Jul 2017 (Supplier News Items) ...  Cadence has four U.S. facilities with nearly 500 employees. The company presently seeks to fill numerous positions, including CNC Techs, Machine Operators, Tool & Die Maker, Tooling Engineer, etc. Visi ... Read more »

DEKRA Expands Lab for Material Testing and Damage Analysis

by BONEZONE | Jul 2017 (Supplier News Items) ... ith a new field emissions scanning electron microscope (SEM). The SEM offers in-depth insights with applications including fractured surface investigations, surface characterization and residue identification.  ... Read more »

Renishaw Contributes Additive Manufacturing Technology to Canadian Medical Design Center

by BONEZONE | Jul 2017 (Supplier News Items) ... and surgical instruments, including joint replacement devices, cutting jigs and surgical guides. ADEISS is pursuing ISO 13485 accreditation in the U.S., Canada and Europe. Source: Renishaw  ... Read more »

Renishaw Supports Engineers of the Future

by BONEZONE | Jul 2017 (Supplier News Items) Renishaw offers an extensive education outreach program including 139 STEM ambassadors who support a variety of STEM activities with local schools.    In support of education that will impact the engineering ... Read more »

Zimmer Biomet CEO Resigns

by Julie Vetalice | Jul 2017 (Business Critical) ... the board seeks to fill the vacancy. While overall preliminary 2Q17 ZBH revenue of ~$1.95BB (including non-ortho) is an increase of +1.1% vs. 2Q16, the company’s organic growth is expected to post a ... Read more »

Reimbursement Tips: Four Things Payors Want

by Julie Vetalice | Jul 2017 (Legal, Clinical & Regulatory) ... mindful of—what’s important to them. Familiarize yourself with these, and you’re ahead of the game. Increasing Clinical Data Requirements You’re not just doing a study. It’s studies. Payors seek multiple ... Read more »

Arthroscopy/Soft Tissue Technologies to Watch: 1H17 Funding Recap

by Julie Vetalice | Jul 2017 (Business Critical) ... Series C financing led by several investors, including Smith & Nephew, which took a minority stake in the business. Funds will support U.S. marketing and ex-U.S. regulatory approvals for the mi-eye2 system, ... Read more »

Rosler Launches New Machine for Total Joint Finishing

by BONEZONE | Jun 2017 (Supplier News Items) ... DL-2 can be used to process total joints, including hip femoral heads, acetabular cups, knee joints (femur and tibia), shoulders and ankles. Source: Rosler Image courtesy of Rosler.  ... Read more »

Yes, Your Work Influences Implant Purchasing

by Carolyn LaWell | Jun 2017 (Voice of Industry) ... manufacturers may offer global packages across various platforms, including cardiovascular, general surgery, orthopaedics, neurosurgery, pain management and even hospital equipment, such as hospital beds ... Read more »

Infection Prevention Spurs New R&D Ideas

by BONEZONE | Jun 2017 (Research & Development) ... n and fracture repair. Webster has studied the use of ceramic nanomaterials to control surface energy to decrease infection, promote bone growth and inhibit inflammation. “Nanotechnology allows you  ... Read more »

May 510(k) Review: New Players in SI Joint Fusion, Hip Recon

by BONEZONE | Jun 2017 (Legal, Clinical & Regulatory) ... , with secondaries including Stryker’s Exeter, Accolade, Trident and DePuy’s Pinnacle device with GVF liner   Sources: FDA 510(k) Releasable Database, company websites, information in the public doma ... Read more »

Carpenter Aligns with Samuel, Son & Co for Additive Manufacturing Supply Chain Solutions

by BONEZONE | Jun 2017 (Supplier News Items) ... including medical. Source: Carpenter Technology Corporation  ... Read more »

R&D Recap: Leading Orthopaedic Device Company Product Initiatives

by BONEZONE | Jun 2017 (Business Critical) ... launch of the TSpace XP interbody system, which is treated with Plasmapore XP.  Aesculap also presented long-term data from study of its activ-L artificial lumbar disc. Studies indicate that, at five ... Read more »

Device Recalls: Prepare for the Unexpected to Minimize Operational and Fiscal Damage

by John Gagliardi | Jun 2017 (Legal, Clinical & Regulatory) ... consignee. Putting the distributors on your approved supplier list by conducting an audit of their ability to recall (reconciliation and accountability) is a must these days. What if you have records to ... Read more »

Proving Your New Design is Production Equivalent

by Denise Dion | Jun 2017 (Research & Development) ... to my specified design outputs—including my specified method of manufacture?  When you change the method of manufacturing, you also need to assess the ability of that method to produce a device that ... Read more »

3D Systems to Add Intelligent Monitoring, Remote Service to 3D Printers

by BONEZONE | Jun 2017 (Supplier News Items) ...  and manufacturing solutions, including metal 3D printers used to create patient-specific implants such as spinal implants. The ThingWorx Platform and remote services are intended to maximize printer availabilit ... Read more »

Foster Launches Antimicrobial Combat Additives in Master Batches

by BONEZONE | Jun 2017 (Supplier News Items) ... master batches for blending with medical device polymers. Components made with these antimicrobial polymer blends may be able to kill harmful bacteria that leads to infections, including MRSA and CRE. ... Read more »

CRO Boston Biomedical Opens Office in Israel

by BONEZONE | May 2017 (Supplier News Items) ... opened an affiliate office in Tel Aviv, Israel. This branch is helmed by co-Chief Executive Officers Ms. Tami Abudi, also serving as Director of Clinical Development, and Ms. Adi Richter, Director of Legal ... Read more »

GHX Gains New Majority Owner

by BONEZONE | May 2017 (Supplier News Items) ... focus for GHX in the past several years has been the implementation of Unique Device Identification or UDI on orthopaedic and other medical devices, as FDA has released guidelines and enacted its enforcement. UDI ... Read more »

Don't Treat Your FDA Inspection Like an ISO Audit

by John Gagliardi | May 2017 (Legal, Clinical & Regulatory) ... and the approach of the investigator or the auditor that makes the experience very different.  In the books, the current Good Manufacturing Practices/QS Regulation and ISO 13485:2016 resemble each ... Read more »

3D Scan of Bones Shows Joint Evolution

by BONEZONE | May 2017 (Voice of Industry) ... joints, including the knee.” “We hope findings such as these will help inform the next generation of orthopaedic interventions,” Monk says. “This research highlights the musculoskeletal factors that ... Read more »

Pareto Analysis: Tools for New Product Testing

by John McCloy | May 2017 (Research & Development) ... Materials (ASTM), the American Society of Metals (ASM) and the American Welding Society (AWS). Additionally, Mr. McCloy maintains numerous industry and scholastic licenses and certifications including ... Read more »

Orthopaedic Industry Revenue Reaches $48.1 Billion

by Carolyn LaWell | May 2017 (Business Critical) ... from a plethora of opportunities waiting to be embraced, including in the trauma, arthroscopy/soft tissue and orthobiologics markets. We fully expect new technologies and new business models to continue ... Read more »

When Do I See a CAPA Specialist?

by Denise Dion | May 2017 (Legal, Clinical & Regulatory) ... not conforming, do an initial investigation the same as you would for a complaint. If there is a need for further investigation, you open a CAPA. If you have internal audit findings that indicate—say, ... Read more »

First Graduate Completes Tegra Medical's Toolmaker Apprentice Program

by BONEZONE | May 2017 (Supplier News Items) ...  learn all aspects of machining including how to plan a machining job, how to program the machines and how to perform CAD drawing and solid modeling. At least 95% of the apprentices’ time at Tegra Medica ... Read more »

Cadence Launches Redesigned Website

by BONEZONE | Apr 2017 (Supplier News Items) ...  capabilities, including videos, news and events. The responsive design is easily viewed from a computer, tablet or mobile device.  At the end of 2016, the company launched the mobile-friendl ... Read more »

Proxy Biomedical Rebrands as Aran Biomedical

by BONEZONE | Apr 2017 (Supplier News Items) ... Biomedical, as part of an overall restructuring strategy that reflects a broader range of capabilities servicing key growth markets, including Orthopaedics. Headquartered in Galway, Ireland, the company ... Read more »

Wytech Acquired Micro-Tube Fabricators

by BONEZONE | Apr 2017 (Supplier News Items) The combined entities including recently acquired Morton Bowen, Colorado, will provide a broad spectrum of engineering, manufacturing, assembly, and value-added services to medical device OEMs. Wytech ... Read more »

MTD Micro Molding Celebrates 45 Years of Micro Manufacturing

by BONEZONE | Apr 2017 (Supplier News Items) ... By 2001, MTD began producing highly-complex micro injection molded medical device components, including bioabsorbable molded parts. Since then, Mr. Tully's son Dennis assumed ownership of the company ... Read more »

Design Intent: Do I Need to Perform Verification and Validation?

by Denise Dion | Apr 2017 (Research & Development) ... with the device. If you have documented your characterization studies and your impact analysis, you have performed design verification. Furthermore, based on that data, it appears that you believe that ... Read more »

Nelipak Acquires Computer Designs, a Medical Thermoformer

by BONEZONE | Apr 2017 (Supplier News Items) ... k acquired Tegrant Alloyd Brands, another manufacturer of thermoformed rigid packaging serving medical markets, including orthopaedics. Source: Nelipak  ... Read more »

Clinical Data and CE Mark: What are We Doing Wrong?

by Carolyn LaWell | Mar 2017 (Legal, Clinical & Regulatory) A reader informed us that companies are failing the clinical evaluation portion of the initial CE Mark or audit process, and asked what insights we might offer now and at OMTEC. Here's our response. Th ... Read more »

Ideagen Acquired IPI Solutions

by BONEZONE | Mar 2017 (Supplier News Items) ... end of 2016 for £5.5MM (~US $6.8MM). IPI and Ideagen both serve multiple industries, including medical devices. IPI is the developer of the Visual FAIR software application for quality and compliance ... Read more »

Reducing the 1% Failure Rate through Testing & Analysis

by John McCloy | Mar 2017 (Research & Development) ... error, including technique, judgment and infection Hypersensitivity, including rejection of foreign body, pain, sinus reactions Product, including design, manufacturing, materials, metallurgy and chemistry  ... Read more »

Silver Ions Found Effective in Fighting Infections while Forming Bone

by BONEZONE | Mar 2017 (Research & Development) ... create patient-specific bone and surgically implant those cells and tissues while diminishing, or potentially eliminating, the risk of MRSA infection.” Additional studies are underway and, if successful, ... Read more »

Once an Easy Path, Europe’s Regulatory Approval Toughens

by BONEZONE | Mar 2017 (Legal, Clinical & Regulatory) ...  stressed by Emergo and other regulatory agencies. At OMTEC 2017, Emergo’s Vice President of Global Regulatory Affairs, Evangeline Loh, Ph.D., will provide a global regulatory outlook, including a revie ... Read more »

Exactech Divests Spine Assets

by BONEZONE | Mar 2017 (Business Critical) ... charges related to ex-U.S. operations. Terms were not disclosed. The transaction allows Exactech to focus on joint reconstruction in hip, knee and extremities, including shoulder and ankle. The transaction ... Read more »

China’s Medtech Policy Sets Path for Orthopaedic Manufacturers

by BONEZONE | Feb 2017 (Business Critical) ... for Innovative Medical Device was released by the CFDA in May 2014, 91 medical devices have been approved for expedited review, including eight imported multinational products. There were five orthopaedic ... Read more »

The Forgotten Phase of M&A: Post-Close Supply Chain Integration

by David Finch | Feb 2017 (Business Critical) ... process, including quality, engineering, sales and marketing, in addition to supply chain and procurement. Make sure that drawings, specifications and functional acceptance criteria of both companies ... Read more »

Interbody Fusion Outcomes May Be Improved by Use of PEEK-OPTIMA HA Enhanced Polymer

by BONEZONE | Jan 2017 (Supplier News Items) Studies suggest potential patient benefits and specific improvements in overall pain and neurological function. Early clinical results demonstrated high fusion rates at 6 months and beneficial clinical ... Read more »

U.S. Court Rules in Favor of CoorsTek Medical in Ceramic Hip Suit

by BONEZONE | Jan 2017 (Supplier News Items) ... p was cleared by FDA for use in hip implants determined by FDA to be substantially equivalent to predicate systems incorporating the latest generation of advanced ceramic material, including Ceramtec’s Biol ... Read more »