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Search Keyword: UDI

12 Growing Orthopaedic Companies Expand Their Patent Portfolios

by BONEZONE | Jul 2018 (Legal, Clinical & Regulatory) ...  a collagen scaffold, can be applied in multiple indications including repair of bone, tendons, peripheral nerves, etc. In May, Orthocell announced that it was granted an EU patent, “Method for Producin ... Read more »

Surgeons Seek Innovation in Instruments, Delivery of Care

by Carolyn LaWell | Jul 2018 (Voice of Industry) ... on actual problems, an audience member asked how surgical techniques will change over the next five to 10 years, and what might that mean for new products? Dr. Sweeney: The most difficult challenge that ... Read more »

Finding Your Way in a Post-Lean/Six-Sigma World Using Operations Science

by Edward S. Pound | Jul 2018 (Business Critical) ... software the client will buy, with industry analysts writing sponsored “studies” to generate revenue. The final word on success or failure usually rests with a company’s finance and accounting executives ... Read more »

Supply Chain Quality Panel, Part II: OEM and Supplier Perspectives

by Rob Meyer | Jul 2018 (Supply Chain Management) In this installment, supply chain experts from Autocam Medical, MicroPort Orthopedics, Orchid Orthopedic Solutions and Zimmer Biomet discuss challenges associated with EU MDR, third-party audits and the ... Read more »

Carpenter Technology Announces Plans for Emerging Technology Center

by BONEZONE | Jul 2018 (Supplier News Items) ... future solutions for our customers ranging from new alloys to revolutionary 3D-printed parts,” said CEO Tony R. Thene. Carpenter has made several strategic investments in the last 16 months, including ... Read more »

Supply Chain Quality Panel, Part I: OEM and Supplier Perspectives

by Rob Meyer | Jun 2018 (Supply Chain Management) ... improvement efforts. In Part II, we present the panelists’ comments on European Union Medical Device Regulation, third-party audits and the need for more consistency in validations across industry.    ... Read more »

Making a Device Design Change? Document These Critical Steps

by EduQuest Staff | Jun 2018 (Legal, Clinical & Regulatory) ...  and cannot be completed via an engineering change process, then you should follow your corporate process and its required level of documentation, including creation of a new or revised design plan fo ... Read more »

Zimmer Biomet Responds to FDA Form 483

by Julie Vetalice | Jun 2018 (Legal, Clinical & Regulatory) ... studies performed “in lieu of” revalidation are not sufficient to ensure the sterility of previously distributed product. Zimmer Biomet response excerpt: As reported in response to Observation 1(B) from ... Read more »

MedTorque, MPS Precimed Announce Distribution Agreement for European Market

by BONEZONE | Jun 2018 (Supplier News Items) ... with MPS Precimed, a global provider of trauma products. The agreement gives Switzerland-based MPS Precimed access to MedTorque’s product portfolio for distribution in the European market, including ... Read more »

Hospital, Surgeons Provide Insight Into Purchasing Priorities

by Rob Meyer | Jun 2018 (Voice of Industry) The OMTEC® 2018 opening Keynote Panel offered perspective on hospital actions and priorities while addressing critical industry topics including pressure from public and private payors, bundled payments, ... Read more »

FDA 510(k) Highlights: Five Companies Gain First Orthopaedic Clearances

by Julie Vetalice | Jun 2018 (Legal, Clinical & Regulatory) ... across a range of specialties, including orthopaedics Finally, in arthroscopy/soft tissue repair, here’s a startup that may make an interesting acquisition target. Aevumed | PHANTOM Suture Anchor ... Read more »

Metal Craft and Riverside Machine & Engineering Hires New Business Development Manager

by BONEZONE | Jun 2018 (Supplier News Items) ... & Engineering manufactures precision products for several industries, including orthopaedic, aerospace, military/defense, etc. Its capabilities include: Prototyping Wire EDM Welding Laser etching ... Read more »

Generic Device OEM Defines Value in Orthopaedic Care

by Steve Lichtenthal | Jun 2018 (Business Critical) ...  However, it is undeniable that saving on the cost of implants, whether in out- or in-patient settings, could have incredible impact for the value of our healthcare dollars. Independent studies have prove ... Read more »

Röchling Acquires Precision Medical Products

by BONEZONE | Jun 2018 (Supplier News Items) ... cluding syringes for bone cement. This acquisition better positions Röchling to implement its “growth strategy in the U.S.,” according to comments from company leadership. Röchling Advent Tool & M ... Read more »

FDA Clears Artificial Intelligence Software for Wrist Fractures

by Rob Meyer | Jun 2018 (Research & Development) ... the review of posterior-anterior and medial-lateral x-ray images of adult wrists. OsteoDetect can be used in various settings, including primary care, ER, urgent care and specialty care. It can also ... Read more »

Eurocoating SpA to Acquire Italian Manufacturing Division of CoorsTek Medical

by BONEZONE | Jun 2018 (Supplier News Items) ...  design and manufacturing services including machining, finishing, coating and sterile packaging services, providing solutions for both implants and instruments. CoorsTek Medical is a U.S. manufacture ... Read more »

NN Life Sciences to Exhibit at OMTEC® 2018

by BONEZONE | Jun 2018 (Supplier News Items) ... industries including orthopaedics, has announced that its Life Sciences division will exhibit at OMTEC® 2018, the world’s only conference exclusively serving the orthopaedic industry, which takes place ... Read more »

HP, Siemens Expand Additive Manufacturing Strategic Partnership

by BONEZONE | Jun 2018 (Supplier News Items) ... formats including 3MF, enabling designers to produce desired color parts with a reliable workflow, according to the companies. Users of NX and Solid Edge for HP’s Multi Jet Fusion technology will have ... Read more »

GF Machining Solutions Names New Distributor in Ohio and Kentucky

by BONEZONE | Jun 2018 (Supplier News Items) ... variety of industries including orthopaedics, named Ellison Technologies as its official distributor in Kentucky and southern Ohio, including Columbus and Dayton. Ellison also supports GF Machining Solutions ... Read more »

Coatings Developer, Manufacturer Sono-Tek Exhibits Growth Trends

by BONEZONE | May 2018 (Supplier News Items) ... coating systems for markets including orthopaedics, recently reported significant revenue growth and an increase in gross margin. “We had excellent growth trends through the year. Strong market conditions ... Read more »

Laser Marking: Suppliers, OEMs Both Reaping Benefits of Versatile Technology

by BONEZONE | May 2018 (Research & Development) ... t measures by having permanent markings on products." The implementation of unique device identification (UDI) requires orthopaedic device companies to identify methods to comply with the permanent marki ... Read more »

North Grove Enterprises Launches New Website

by BONEZONE | May 2018 (Supplier News Items) ... handles Ratchet screwdrivers Curettes Contract manufacturing Single-use products, including flexible light tubes Bone mixing and delivery devices Implant and related instrument design services ... Read more »

Mid-Journey on the Road to the Forgotten Knee

by Robert Poggie | May 2018 (Voice of Industry) ... stands today, primary TKR reliably results in a durable joint with low potential for revision, but most patients sense the artificial knee and some studies estimate that about 20% are dissatisfied with ... Read more »

In’Tech Medical to Acquire Bradshaw Medical

by Rob Meyer | May 2018 (Supplier News Items) ...  implants and instruments—has entered into an agreement to acquire Bradshaw Medical. Financial terms were not disclosed. Bradshaw is a contract manufacturer of instruments, including ratchet and torqu ... Read more »

Robotics in Orthopaedic Surgery: Answers to Three Questions

by Rob Meyer | May 2018 (Research & Development) ...  (three primary knee systems, including the new Journey II XR bi-cruciate knee system) and costs roughly 50% less than Mako, according to a Canaccord Genuity research report published in April. Given thes ... Read more »

Study: Indentations on Artificial Femoral Heads Could Improve Implant Longevity

by Rob Meyer | May 2018 (Research & Development) ... of Arkansas (including Min Zou, Ph.D, professor of mechanical engineering and Dipankar Choudhury, post-doctoral fellow in the Center for Advanced Surface Engineering), in collaboration with a research ... Read more »

Increase Your Knowledge With Advice on Technology, Cost Pressures, Patient Outcomes

by Rob Meyer | May 2018 (Business Critical) ... often confusing topic. Is Your System Ready for Scale? UDI: Manufacturer, Hospital and Global Implications We are constantly reminded how important it is touch base with industry on a regular ... Read more »

Optimizing Your Supply Chain with Science, Data and People

by Rob Meyer | May 2018 (Supply Chain Management) ... same time, productive and effective person-to-person relationships are crucial to any successful operation, including supply chains. “When optimizing a supply chain, companies need to successfully combine ... Read more »

Meddux Development Names New Partners

by BONEZONE | May 2018 (Supplier News Items) Chad Herremans and Nathan White join the company in VP roles. Meddux Development, an engineering design and development firm that specializes in a variety of products, including minimally invasive ... Read more »

Ceramics Expo 2018: Three Takeaways for Orthopaedic Engineers

by Rob Meyer | May 2018 (Research & Development) ... of calcium phosphate ceramic scaffolds for use as bone graft substitutes in spine applications, including the past three years with the biologics team at Medtronic. “We all want a consistent final product ... Read more »

Protecting Your Design with Patents

by Andrew Rapacke | May 2018 (Legal, Clinical & Regulatory) ... Mr. Rapacke has worked with orthopaedic doctors and medical device companies to obtain IP protections on valuable business assets. Mr. Rapacke has experience working in a number of industries, including ... Read more »

MCRA Presents on Medical Device Regulation to Chinese FDA

by BONEZONE | May 2018 (Supplier News Items) ... overview of the regulatory processes for introducing medical device technologies to the U.S. market, insights on key regulatory topics and case studies within the neuro-musculoskeletal industry. “This ... Read more »

NN Life Sciences Facility Receives MDSAP Certification

by BONEZONE | Apr 2018 (Supplier News Items) ... received the Medical Devices Single Audit Program (MDSAP) certification. The facility is part of NN's Life Sciences division. This certification allows NN Life Sciences to meet the regulatory needs o ... Read more »

Medbio Receives ISO 13485:2016 Certification

by BONEZONE | Apr 2018 (Supplier News Items) ... 2003 standard and is designed to respond to latest quality management system practices, including changes in technology and regulatory requirements and expectations.  This certification is the culmination ... Read more »

ConnectSx Launches Free Inventory App for Sales Reps

by BONEZONE | Apr 2018 (Supplier News Items) The iOS-native mobile app brings transparency to the surgical supply chain by helping users schedule cases, manage inventory, track UDI data and generate billing documents. ConnectSx, a Mokena, Illinois-based ... Read more »

Successful Medical Device Design Transfers Hinge on Advance Planning

by David Finch | Apr 2018 (Research & Development) ... processes and assembly instructions been documented and validated? Are all drawings and specifications complete for product, component and raw materials? Is the bill of material complete, including ... Read more »

Start Simple: Advice to Effectively Use Statistical Methods in Process Validation

by Rob Meyer | Apr 2018 (Research & Development) ... that “a process is established that can consistently conform to requirements” and “studies are conducted demonstrating” this.  How can you make the best decision? Thorough process development, optimization ... Read more »

3Diligent Expands Digital Manufacturing Services

by BONEZONE | Apr 2018 (Supplier News Items) ... and online portal beyond the scope of its 3D printing offering. 3Diligent now offers a range of services including milling, turning, electro discharge machining, water jetting and laser cutting. Casting ... Read more »

Why One Surgeon Entrepreneur is Focused on MIS, Orthobiologics and UDI

by Julie Vetalice | Apr 2018 (Voice of Industry) ... ConnectSx, an eHealth company that addresses inventory management, UDI compliance, just-in-time training/knowledge delivery, and electronic transaction capabilities delivering new efficiency and discipline ... Read more »

Evonik Launches New Composites, Intensifies Research on Regenerative Medicine

by BONEZONE | Apr 2018 (Supplier News Items) ... for medical devices including bioresorbable RESOMER® and high-performance PEEK VESTAKEEP®, announced strategic initiatives including a new line of composites and an increased focus on regenerative medicine. ... Read more »

Nelipak to Offer Freestanding Rotary Medical Tray and Blister Heat Sealers

by BONEZONE | Apr 2018 (Supplier News Items) ... suitable for Class-7 cleanroom operations. Nelipak’s machines seal a variety of coated lid materials including Tyvek®, paper, film or foil and ensure validated seals when used in conjunction with the company’s ... Read more »

Acquisitions Position NN, Inc. as Major Orthopaedic Supplier

by Rob Meyer | Apr 2018 (Business Critical) ... n metal and plastic components, instruments and assemblies for a variety of markets, including orthopaedics, on a global basis. The company is relocating its Johnson City, Tennessee HQ to Charlotte, Nor ... Read more »

Medical Component Specialists Introduces Mandrel Quick Ship Program

by BONEZONE | Apr 2018 (Supplier News Items) ...  MCS—an OMTEC® 2018 exhibitor—designs and manufactures medical components including mandrels, pins, medical drills and staples for orthopedic and interventional applications. MCS also possesses laser ... Read more »

Norman Noble Adds Additive Manufacturing Capabilities

by BONEZONE | Apr 2018 (Supplier News Items) ... customer needs, including shape-setting fixtures for nitinol-based rapid prototypes, prototype-to-production manufacturing for next-gen medical implant designs and the manufacture of aerospace and commercial ... Read more »

Baum Precision Machining Adds 5-Axis Machine

by BONEZONE | Apr 2018 (Supplier News Items) The company specializes in CNC milling and serves several industries, including medical. Baum Precision Machining has added a 5-Axis Machining Center, the Yasda PX30i, to its Pipersville, Pennsylvania ... Read more »

FDA and Customs Monitoring of International Purchasing: What You Need to Know

by John Gagliardi | Apr 2018 (Legal, Clinical & Regulatory) ... offices in 2008, posting staff in strategic locations around the world, including China, Europe, India and Latin America. FDA overseas offices work closely with their respective foreign governments, industries ... Read more »

Extremities Players Seek to Bolster Shoulder Revenue with Stemless Implants

by Rob Meyer | Apr 2018 (Research & Development) ... market. Though stemless shoulders are relatively new, several analysts, including Larry Biegelsen of Wells Fargo Securities, noted that the FDA clearance of the Equinoxe “will continue to grow the category.” ... Read more »

NN, Inc. Announces Definitive Agreement To Acquire Paragon Medical

by BONEZONE | Apr 2018 (Supplier News Items) ...  complex medical components, implants, instruments and devices for the global market, including orthopaedics. Headquartered in Johnson City, Tennessee, NN has 44 facilities in North America, Western Europe, Easter ... Read more »

Evonik to Transform Project House into Collaborative R&D Center

by BONEZONE | Mar 2018 (Supplier News Items) The company will add to its additive manufacturing capability with this strategic investment. Evonik, a supplier of polymers (including bioresorbable RESOMER® and high-performance PEEK VESTAKEEP®) ... Read more »

Micro Machine Names Jeffrey G. Roberts President & CEO

by BONEZONE | Mar 2018 (Supplier News Items) ... surgical technology. His industry experience includes executive leadership positions in a variety of market segments, including arthroscopy/soft tissue, large and small joint replacement and trauma. Micro ... Read more »

Knee and Hip Manufacturers Focus on Additive, Materials, Robotics

by Carolyn LaWell | Mar 2018 (Voice of Industry) ... portable and cost effective, including procedure-time-neutral and reduction of instruments. “To be successful in the robotics category, we believe there are certain fundamentals that need to exist ... Read more »

Globus Medical Making Sizable Push Into Trauma Market

by Rob Meyer | Mar 2018 (Research & Development) ... where GMED displayed its growing portfolio of FDA 510(k)-cleared trauma products in four families, including fracture plates, compression screws, cannulated screws, intramedullary nails and external fixation. ... Read more »

nanoMAG Receives ISO 13485:2016 Certification

by BONEZONE | Mar 2018 (Supplier News Items) ... to the increased regulatory requirements 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 ... Read more »

Innovnano and Portuguese University Partner on 3D Implant Project

by BONEZONE | Mar 2018 (Supplier News Items) ...  Researchers will work to optimize the particle shape of the zirconia-based composite materials to produce the best compromise between porosity and mechanical resistance, and also on in vitro and in vivo studies ... Read more »

NN, Inc. Acquires Bridgemedica

by BONEZONE | Mar 2018 (Supplier News Items) ... segment and expands the company’s new product design engineering and development capabilities. NN designs and manufactures high-precision components and assemblies for a variety of markets, including ... Read more »

TKRs, Associated Products Among Strategic Announcements, Launches at AAOS 2018

by Rob Meyer | Mar 2018 (Business Critical) In addition, companies including Stryker, Smith & Nephew and DePuy Synthes have launched some of their latest technologies in hip, biologics, spine and more. The American Academy of Orthopedic Surgeons’ ... Read more »

AcceLINX Adding Three Experts to Consultant Roster, Collaborating With AMB Surgical

by BONEZONE | Mar 2018 (Supplier News Items) ... of Senior Director of Manufacturing/Site Leader. He has also held many positions in product development, including that of Director of Global Development -Extremities at Zimmer. Mr. Domyhan has more ... Read more »

Vital Validation Considerations for Your Company's Next Packaging Project

by Rob Meyer | Feb 2018 (Supply Chain Management) ... larger vs. smaller companies. Not long ago, large companies were doing feasibility studies very informally with little to no documentation. Some now require full traceability, a pre-approved feasibility ... Read more »

Medical Device Packaging is Shaped by Increased Regulations

by Rob Meyer | Feb 2018 (Supply Chain Management) Global unique device identification (UDI) and ISO updates are among the regulations and standards that companies must monitor in the coming years. Increased regulatory oversight is shaping medical ... Read more »

Spine, Trauma Companies Continue a Focus on Sterile Packaging

by BONEZONE | Feb 2018 (Supply Chain Management) ...  of goods low and quality standards high, says Chief Commercial Officer Ryan D. Schlotterback. Sterile packaging has offered numerous opportunities, including differentiation in the marketplace and efficienc ... Read more »

Precision, Accuracy Among Swiss Machining Benefits

by Rob Meyer | Feb 2018 (Research & Development) ... , including orthopaedic-specific bone screws (cannulated, self-drilling, polyaxial and pedicle). Norman Noble operates over 55 Swiss-style turning machines, which are located in an independent producti ... Read more »

The Contribution of Biomaterials to the Dawning of the Age of the Forgotten Hip

by Robert Poggie | Feb 2018 (Voice of Industry) ... bearing, after learning that PTFE (Teflon) was not the solution. The success of THA depends upon many factors including design, surgical technique, post-operative care and materials, with the latter arguably ... Read more »

The Medical Device Labelling Process Needs to Start Early in Design Controls

by John Gagliardi | Feb 2018 (Legal, Clinical & Regulatory) ... decision, “Most, if not all advertising, is labeling. The term ‘labeling’ is defined in the FD&C Act as including all printed matter accompanying any article. Congress did not, and we cannot, exclude from ... Read more »

Renishaw’s SFP2 Improves Surface Measurement Ability of REVO System

by BONEZONE | Feb 2018 (Supplier News Items) ... specializes in precision measurement and additive manufacturing systems for a variety of industries, including healthcare. Source: Renishaw        ... Read more »

Surgeon Touts Benefits of Molybdenum-Rhenium in Spinal Applications

by Carolyn LaWell | Feb 2018 (Research & Development) ...  bone growth. MoRe is about 60%more wettable than titanium. We’ve done studies in which we’ve put small pieces of MoRe on rods in a rabbit femur and made it flush with the surface of the cortex. The ca ... Read more »

Are You Capturing the Right Inspection Information?

by Janis Olson | Feb 2018 (Supply Chain Management) ... the Auditing Resource Center and co-wrote the PDA technical report on computer system supplier auditing.  EduQuest can be reached by email.  EduQuest  ... Read more »

United Performance Metals Achieves ISO 9001:2015 Certification

by BONEZONE | Feb 2018 (Supplier News Items) ... a wide inventory of products, including stainless steel, duplex stainless steel, Prodec®, nickel alloys, cobalt alloys, cobalt chrome moly, titanium, aluminum and alloy steel in coil, sheet, strip, plate, ... Read more »

Total Plastics International, Restoration Medical Polymers Enter Into Distribution Agreement

by BONEZONE | Feb 2018 (Supplier News Items) ... TPI will work directly with customers on all product requirements including Type I and II, cross-linked, vitamin E and any specialty requirements of UHMWPE, as well as stocking material and vendor managed ... Read more »

UDI: Is Your System Ready for Scale?

by Carolyn LaWell | Jan 2018 (Legal, Clinical & Regulatory) UDI requirements have led to layers of regulatory decoding, data collection and dissemination, additional costs and moments of confusion, annoyance and disapproval. Call it a forever project, program, ... Read more »

Medilogic Gains ISO 13485/9001 Certifications

by BONEZONE | Jan 2018 (Supplier News Items) ... system practices, including changes in technology and regulatory requirements and expectations.  ISO 9001:2015 specifies requirements for a quality management system when an organization: a) needs to ... Read more »

GE Additive Opens Munich Customer Experience Center

by BONEZONE | Jan 2018 (Supplier News Items) ...  The Customer Experience Center in Munich, launched with an investment of $15 million, will employ up to 50 GE Additive employees, including technicians and engineers specializing in additive design and ... Read more »

RTI Surgical Expanding Spine Fusion Portfolio, Acquires Zyga Technology

by BONEZONE | Jan 2018 (Business Critical) ...  $100MM market in the U.S., slated to exceed $200MM by 2024, with SI joint fusion procedures growing 20%.  In September 2017, Highmark expanded positive coverage for minimally invasive sacroiliac joint fusion, includin ... Read more »

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 »