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Materialise Launches Additive Simulation Software

by BONEZONE | Oct 2018 (Supplier News Items) ... a wider audience. Users can apply simulation results directly to the support generation and orientation tools in their Materialise Magics environment. The simulation software supports fast reruns on a ... Read more »

Flex-Cell Precision Gains ISO 13485:2016/9001:2015 Certifications

by BONEZONE | Oct 2018 (Supplier News Items) ... and is designed to respond to latest quality management system practices, including changes in technology and regulatory requirements and expectations.  ISO 9001:2015 specifies requirements for a quality ... Read more »

Corin Increases Footprint with Acquisition of Global Orthopaedic Technology

by Julie Vetalice | Oct 2018 (Business Critical) ... has grown through alliances that combine its hip and knee implants with computer-assisted-surgery systems, including: A 2015 collaboration with Materialise to use its 3D surgical planning software ... Read more »

Crucial Validation Considerations for Instrument Cases and Trays

by Rob Meyer | Oct 2018 (Legal, Clinical & Regulatory) ...  studies done at the higher end of these parameters (high temperature, pressure, most harsh detergents, and functional cycles applied) and this replicates possible excursions found throughout all Steril ... Read more »

NASS Conversations Reaffirm Focus on Additive, Computer-Assisted Surgery, Materials

by Carolyn LaWell | Oct 2018 (Business Critical) ...  NuVasive demonstrated its Pulse platform which incorporates multiple technologies, including the company’s neuromonitoring system, along with surgical planning, rod bending, imaging, navigation and ... Read more »

Orthobiologics for Fracture Repair, Knee Cartilage Defects: 3Q18 Study Highlights

by Julie A. Vetalice & Rob Meyer | Oct 2018 (Business Critical) Bone Therapeutics (ALLOB® allogeneic bone cell therapy) and Histogenics (NeoCart® tissue-engineered knee implant) are two of the five companies we tracked that announced completed studies in the last three ... Read more »

11 Arthroscopy/Soft Tissue Repair Companies Worth Watching

by Julie Vetalice | Oct 2018 (Research & Development) ... 2018, the company closed a $1.5MM funding and affirmed plans for 2019 launch of human clinical studies. CartiHeal | Kfar Saba, Israel | Founded 2009 Agili-C Unicondylar Implant: A cell-free, off-the-shelf ... Read more »

Surgeon Entrepreneurs Focus on Infection Prevention, Virtual Reality Training

by Carolyn LaWell | Oct 2018 (Voice of Industry) ...  insert themselves into a virtual O.R. with all they need to perform a procedure. The remote technology allows for "post-op" performance assessment, including time/motion and instrument handling. “O ... Read more »

How to Respond to FDA Inspection Observations, Even Those You Dispute

by Martin Browning | Oct 2018 (Legal, Clinical & Regulatory) ...  written response immediately. This assures that your response is seen by all interested parties, including the investigators’ supervisor (who is usually a district compliance officer) and to other higher-up ... Read more »

In’Tech Medical Commences Full Launch of Wayvio

by BONEZONE | Sep 2018 (Supplier News Items) ... inventory management tool allows device companies to locate instruments throughout the supply chain, from warehouse to O.R. Its mobile app features device identity tracking (a UDI requirement) and eases ... Read more »

Large Spine Players Focus Acquisitions on Robotics, Navigation, Additive

by BONEZONE | Sep 2018 (Business Critical) ... complements Globus’ 2Q18 purchase of KB Medical, developer of the AQrate Robotic Assistance system. Surgimap is widely used by Globus’ competitors, including DePuy Synthes, K2M, Medtronic, NuVasive, Orthofix, ... Read more »

25 Considerations for Companies Seeking Clarity in Design Controls

by John Gagliardi | Sep 2018 (Legal, Clinical & Regulatory) ... and assessment of these requirements.  Since early 1984, FDA has identified lack of design controls as one of the major causes of device recalls. The intrinsic quality of devices, including their safety ... Read more »

Effective Supplier Scorecards Rely on Identifying Key Metrics, Data, Inputs

by Julie Vetalice | Sep 2018 (Supply Chain Management) ... there programs or software that do a better job? Would these get looked at in an audit? Excel is an excellent tool that accommodates this activity for several reasons: it’s relatively easy to create, ... Read more »

AIRO Focuses on Robotic, Artificial Intelligence Application for Joint Reconstruction

by BONEZONE | Sep 2018 (Research & Development) ... require, including chondral regenerative procedures, partial resurfacing, total joint replacement and revision.  With whom does AIRO partner and collaborate? Robertson: At the core of our research ... Read more »

ACL Reconstruction Startup Secures Funding to Support IDE Clinical Trial

by Rob Meyer | Sep 2018 (Research & Development) ...  to MIACH, preclinical studies suggest that knees treated with BEAR have a significantly lower rate of arthritis than those treated with traditional ACL reconstruction. The company has initiated an ID ... Read more »

Danco Anodizing Expands Spinal Rod Capability

by BONEZONE | Sep 2018 (Supplier News Items) Danco is now able to provide a longitudinal line on both straight and curved rods.                              Danco Anodizing has announced capability ... Read more »

Wright Medical’s Acquisition of Cartiva Offers Boost for Lower Extremity Business

by Julie A. Vetalice & Rob Meyer | Sep 2018 (Business Critical) ...  to what Wright leadership described as a ~$420MM addressable market in the U.S. SCI is also entered in clinical studies for the treatment of first carpometacarpal joint osteoarthritis at the base of th ... Read more »

Stryker Moves to Strengthen Spine Business with $1.4 Billion Purchase of K2M

by Julie A. Vetalice & Rob Meyer | Sep 2018 (Business Critical) ... among the top three players in spine (excluding orthobiologics), stepping over NuVasive—thus, changing the lineup to #1) Medtronic, #2 DePuy Synthes, #3) Stryker, according to our estimates. (See Exhibit ... Read more »

LaVezzi Precision Receives ISO 13485:2016 Certification

by BONEZONE | Sep 2018 (Supplier News Items) ... is designed to respond to latest quality management system practices, including changes in technology and regulatory requirements and expectations.  Companies have until March 1, 2019 to update their ... Read more »

Renishaw, Ibex Engineering Open Additive Manufacturing Demo Center

by BONEZONE | Aug 2018 (Supplier News Items) ...  which allows visitors to work through the development of an AM machine build file including material parameter development. Renishaw is a precision engineering and manufacturing technologies compan ... Read more »

Lucideon Appoints Commercial Engineer for Healthcare

by BONEZONE | Aug 2018 (Supplier News Items) ... retrieval studies during her career, combining failure analysis techniques with clinical data in order to assess the performance and survivorship of joint replacement systems. Lucideon performs full ... Read more »

Senvol Awarded Grant by NIST for Additive Data

by BONEZONE | Aug 2018 (Supplier News Items) ... come from NIST’s various round-robin test studies, as well as from its AM Benchmark Test Series. The project will culminate with an integration between Senvol ML and NIST’s AM Material Database (AMMD) ... Read more »

510(k) Recap: New Products from Companies You Know

by Julie Vetalice | Aug 2018 (Legal, Clinical & Regulatory) We provide a recap of how companies including Additive Orthopedics, Arthrex, Corin, DJO, Exactech, Orthofix, Wright Medical, Zimmer Biomet and more are supporting new product launches and maintaining their ... Read more »

First Two United States Patients Receive CartiHeal’s Agili-C Implants

by Julie A. Vetalice & Rob Meyer | Aug 2018 (Research & Development) ... published in ORTHOKNOW®. “There are a number of technologies out there in clinical studies. …We put money into [CartiHeal] because we think [Agili-C] is good enough that we want to be part of it, but not ... Read more »

Carpenter Technology Names New VP, CFO

by BONEZONE | Aug 2018 (Supplier News Items) Timothy Lane has over 20 years of financial experience, including 11 years with Carpenter. Carpenter Technology, a global producer of alloy-based materials, powder metals and specialty wire for additive ... Read more »

Nelson Laboratories Purchases Gibraltar Laboratories

by BONEZONE | Aug 2018 (Supplier News Items) ... “The Gibraltar team is known for these values and also has an excellent reputation for designing specialized studies that help manufacturers prove the safety, efficacy and regulatory compliance of their ... Read more »

3D Systems Enters into Partnership with GF Machining Solutions

by BONEZONE | Aug 2018 (Supplier News Items) ...  3D Systems offers digital design and manufacturing solutions, including metal 3D printers used to create patient-specific implants for spinal and other applications. GF Machining Solutions is a provider ... Read more »

Medbio Acquired by Private Equity Firm

by BONEZONE | Aug 2018 (Supplier News Items) ... certified ISO Class 8 clean room for molding, along with several certified ISO Class 7 clean rooms for assembly and packaging. Medbio molds most medical grade thermoplastics, including implant-grade PEEK. ... Read more »

HAPPE Spine Latest Company to Manufacture PEEK Devices in Novel Ways

by Julie A. Vetalice & Rob Meyer | Aug 2018 (Business Critical) ...  Along with HAPPE, Genesis Innovation Group’s portfolio includes a number of orthopaedic companies including Shoulder Innovations, Magnesium Development, iMagen Orthopedics and Imascap. PEEK vs. titanium ... Read more »

Spinal Cages Continue Trend Toward Metals, Expandable Designs

by Rob Meyer | Aug 2018 (Voice of Industry) ...  spine cage technology to three veteran spine surgeons. While all three confirmed the shift to incorporate titanium, they also provided insight which we thought you would find interesting—including  ... Read more »

How the European Union's MDR Will Impact Your Company's Supply Chain

by Carolyn LaWell | Aug 2018 (Legal, Clinical & Regulatory) ... considerations for audits.                                            Mike Wolf Clinical data requirements tend to dominate conversations about the ... Read more »

FDA Responds to Additive Questions on 510(k) Submissions, Reusing Powder, Testing

by Carolyn LaWell | Aug 2018 (Legal, Clinical & Regulatory) ...  of re-uses). Cleanliness of Medical Parts, including removing power residue, has no standardized protocol or acceptance criteria. The recommendation is to develop standard test methods, metrics and acceptanc ... Read more »

Year-to-Date Funding Recap: Robotics, Imaging, ACL Implant, Cervical Disc and More

by BONEZONE | Jul 2018 (Business Critical) ... support commercialization of Nitinol-based cage technology, used to treat periarticular fractures in the proximal humerus. Medartis raised gross proceeds of CHF 123.9MM and CHF 142.6MM, including an ... Read more »

Empirical Celebrates 20th Anniversary

by BONEZONE | Jul 2018 (Supplier News Items) ...  Capabilities have broadened from testing to include regulatory expertise, consulting and a wide array of manufacturing processes, including prototyping, Swiss machining, multi-axis milling, grinding, ... Read more »

12 Growing Orthopaedic Companies Expand Their Patent Portfolios

by BONEZONE | Jul 2018 (Legal, Clinical & Regulatory) ...  property protection. CelGro, 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 a ... Read more »

Surgeons Seek Innovation in Instruments, Delivery of Care

by Carolyn LaWell | Jul 2018 (Voice of Industry) ... Change? In response to the surgeon panel’s directive to focus innovation on actual problems, an audience member asked how surgical techniques will change over the next five to 10 years, and what might ... 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 (Supply Chain Management) ... 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) ... etc. before releasing these products for use in the U.S. FDA established foreign offices in 2008, posting staff in strategic locations around the world, including China, Europe, India and Latin America. ... 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) ... footprint; 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 ... 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 »