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Articles written by Rob Meyer

Streamlined Inspections Imperative to Success of Micro-Machining Complex Components

by Rob Meyer | Dec 2018

Maintaining the quality and repeatability that device companies require involves consistent, reliable and verifiable measurement and inspection of these small and complex parts, which in some cases is needed down to the micro and sub-micron levels. ... Read more »

Companies Look to Materials to Provide Innovation, Respond to Trends

by Rob Meyer | Nov 2018

Device companies seek to distinguish themselves from competitors by utilizing technologies and selecting materials that are not only cost-efficient, but provide the properties required for high-performance orthopaedic devices. ... Read more »

GEO CART Designed to Address Operating Room, Supply Chain Efficiency

by Rob Meyer | Nov 2018

Gramercy Extremity Orthopedics’ GEO CART® is a mobile storage and point-of-sale system that houses 2,000+ sterile-packed instruments and implants that are tracked and managed with RFID technology. It aims to address issues such as O.R. product availability, sterile processing risks and device bil ... Read more »

WishBone Medical’s Purchase of Red Star: Rare OEM Acquisition of Supplier

by Rob Meyer | Nov 2018

In line with the small number of OEM/supplier M&A transactions that have occurred in orthopaedics during the last five years, the deal came about because of a familiarity between the two companies in combination with various market forces. ... Read more »

Professional, Personal Success Linked to Knowing Yourself and Achieving Your Goals

by Rob Meyer | Nov 2018

Leveraging decades of training, managerial and life experience, orthopaedic industry veteran G. Bryan Cornwall, Ph.D., PEng, shares the insights that helped him hone his own professional and personal development skills. ... Read more »

DJO’s OaraScore Tool May Help Determine Total Knee Outpatient Risk

by Rob Meyer | Nov 2018

OaraScore software assesses length of stay, tracks readmission rates and compares encrypted data to all other physicians utilizing the tool, which evaluates nine critical co-morbidity factors and overall medical conditions in its calculation. It is a component of DJO’s MotionMD® web-based Sa ... Read more »

Zimmer Biomet Completes First Procedures Using ROSA Knee Robot

by Rob Meyer | Nov 2018

These first five cases were all performed in a single surgery day by one surgeon—this perhaps hints at the company’s positioning of ROSA as efficient and minimally disruptive to procedure flow. ROSA is expected to receive FDA 510(k) approval in 1H19. ... Read more »

OEMs Continue Focus on Reducing Instruments in Operating Rooms

by Rob Meyer | Oct 2018

Several device companies within the last two years have capitalized on the shift toward simpler surgeries with fewer instruments in the forms of recent product launches or revisions, process initiatives and 510(k) clearances. ... Read more »

Crucial Validation Considerations for Instrument Cases and Trays

by Rob Meyer | Oct 2018

Common challenges device company engineers face during validation of delivery systems include case/tray longevity, robustness of design, maintaining integrity of ID markings and establishment of worst-case testing parameters.  ... Read more »

Sterilization Expert Stresses Importance of Biocompatibility, Endotoxins, Planning

by Rob Meyer | Oct 2018

Recent updates to standards and regulatory guidance have made these processes more complex: “When you look at [sterilization] as a process, rather than a step, you’re much more capable of avoiding problems rather than reacting to them when they happen." ... Read more »

ACL Reconstruction Startup Secures Funding to Support IDE Clinical Trial

by Rob Meyer | Sep 2018

Company founder Martha Murray, M.D., pioneered Bridge-Enhanced® ACL Repair (BEAR) technology, a proprietary bio-engineered sponge used as a bridging scaffold to stimulate healing of a torn ACL. MIACH Orthopaedics has initiated an IDE to support future FDA Premarket Approval. ... Read more »

Spinal Cages Continue Trend Toward Metals, Expandable Designs

by Rob Meyer | Aug 2018

"Cage design has been a game changer in spine surgery." Three veteran spine surgeons provide insight into the shift to titanium, a forecast for the next five years in cage technology and thoughts on device companies' priorities. ... Read more »

Surgeons Establish Society to Advance Complex Additive Applications

by Rob Meyer | Aug 2018

The American Orthopaedic Society of 3D Printing was formed to allow for orthopaedic surgeons to collaborate on the use of complex and customized clinical applications of additive manufacturing in revisions, limb salvage, and reconstructive surgeries. ... Read more »

206 Ortho Secures Patent for Technology That Incorporates Biodegradable Material

by Rob Meyer | Jul 2018

The company has developed a bio-inspired non-metallic composite and implants made with a high-strength, biodegradable material intended to repair load-bearing bone and resorb completely. 206 Ortho is pursuing additional funding and potential commercialization partners. ... Read more »

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

by Rob Meyer | Jul 2018

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 need for more consistency across industry. ... Read more »

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

by Rob Meyer | Jun 2018

In this installment, supply chain experts from Autocam Medical, MicroPort Orthopedics, Orchid Orthopedic Solutions and Zimmer Biomet discuss customer differentiation, building partnerships, regulatory challenges and continuous improvement efforts.  ... Read more »

Hospital, Surgeons Provide Insight Into Purchasing Priorities

by Rob Meyer | Jun 2018

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, value analysis committees and outpatient surgeries.  ... Read more »

FDA Clears Artificial Intelligence Software for Wrist Fractures

by Rob Meyer | Jun 2018

Medical imaging diagnostic group Imagen Technologies created OsteoDetect software, which identifies fractures in x-rays using an AI algorithm to analyze images. ... Read more »

Robotics in Orthopaedic Surgery: Answers to Three Questions

by Rob Meyer | May 2018

We examine the players and products, address data and adoption, and look at who is driving the push toward the technology. ... Read more »

Study: Indentations on Artificial Femoral Heads Could Improve Implant Longevity

by Rob Meyer | May 2018

By simulating the textured surface of cartilage, researchers from the University of Arkansas and the Czech Republic have found that using prostheses with square micro-dimples could extend the life of hip implants. ... Read more »

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

by Rob Meyer | May 2018

We asked you to share one piece of advice for 2018 and beyond—we highlight several of your responses and offer some guidance of our own. ... Read more »

Optimizing Your Supply Chain with Science, Data and People

by Rob Meyer | May 2018

It is recommended to implement your optimal management of inventory, capacity and response time buffers to get the best possible solution for your unique challenges. ... Read more »

Ceramics Expo 2018: Three Takeaways for Orthopaedic Engineers

by Rob Meyer | May 2018

Topics of interest included a deep dive into the role of advanced data analytics in manufacturing and the future of ceramics in the spine space. ... Read more »

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

by Rob Meyer | Apr 2018

Thorough process development, optimization and control using appropriate statistical methods and tools is recommended to show that processes are stable and capable. ... Read more »

Acquisitions Position NN, Inc. as Major Orthopaedic Supplier

by Rob Meyer | Apr 2018

The recent acquisition of Paragon Medical, coupled with purchases of several other household names during the past three years, means that NN has positioned itself as a top-five contract manufacturing player.  ... Read more »

Extremities Players Seek to Bolster Shoulder Revenue with Stemless Implants

by Rob Meyer | Apr 2018

Exactech’s FDA-cleared Equinoxe is competition for Wright Medical and Zimmer Biomet’s offerings. The three are the only FDA-cleared stemless shoulders in the U.S. ... Read more »

Scientists Successfully Test New Titanium Plate for Bone Tissue Repair

by Rob Meyer | Apr 2018

In animal testing, the patented titanium fiber plates did not demonstrate bone embrittlement after close contact for prolonged periods. ... Read more »

Rapid + TCT Additive Conference Ramps up Medical Presence with MMI Series

by Rob Meyer | Mar 2018

This year’s event, April 23-26 in Fort Worth, Texas, features several educational sessions and topics of interest for orthopaedic medical device professionals. ... Read more »

Globus Medical Making Sizable Push Into Trauma Market

by Rob Meyer | Mar 2018

The company debuted its suite of FDA-510(k)-cleared trauma products in four families at the 2018 American Academy of Orthopaedic Surgeons annual meeting. ... Read more »

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

by Rob Meyer | Mar 2018

In addition, companies including Stryker, Smith & Nephew and DePuy Synthes have launched some of their latest technologies in hip, biologics, spine and more. ... Read more »

Vital Validation Considerations for Your Company's Next Packaging Project

by Rob Meyer | Feb 2018

Common problems that OEMs face during packaging validation include determining what validations are actually necessary, understanding all timelines and costs associated with each validation type and re-executing if validation fails.  ... Read more »

Medical Device Packaging is Shaped by Increased Regulations

by Rob Meyer | Feb 2018

Global unique device identification (UDI) and ISO updates are among the regulations and standards that companies must monitor in the coming years. ... Read more »

Precision, Accuracy Among Swiss Machining Benefits

by Rob Meyer | Feb 2018

"Because of the technology," one supplier says, "you’re able to drop off parts to the customer complete and don’t have to go to secondary operations, which costs money and time. Swiss-type screw machines are so complete, in terms of capabilities." ... Read more »

Smith & Nephew’s eCAP Shows 97% Decrease in Readmission Rates

by Rob Meyer | Feb 2018

The initiative is designed to mitigate risk associated with readmissions in value-based healthcare reimbursement models. ... Read more »

FDA Issues Direct Final Rule to Alter Outdated Requirements on Biologics Inspections

by Rob Meyer | Feb 2018

The rule amends that inspections will be risk-based, not biennial. ... Read more »

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

by Rob Meyer | Jan 2018

With its first application in minimally invasive spine procedures, X-VISION technology is designed to save time during surgery, reduce radiation exposure and reduce the number of repeat operations and hospitalizations. ... Read more »

FDA Releases Priorities for 2018

by Rob Meyer | Jan 2018

Among the Agency’s 2018 priorities is an alternative, fast-track 510(k) pathway for certain devices. ... Read more »

CMS Finalizes Joint Bundled Payment, Outpatient Payment Changes

by Rob Meyer | Dec 2017

The Centers for Medicare & Medicaid Services (CMS) made changes to the bundled payment model for Comprehensive Care for Joint Replacement, and finalized cancellation of the mandatory hip fracture and cardiac bundled payment models. ... Read more »

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

by Rob Meyer | Dec 2017

The hospital system is attempting fat-based stem cell treatments on orthopaedic patients, using the cells to heal small/partial thickness rotator cuff tears. It's the first trial in the U.S. to gain FDA approval for the use of adipose stems cells to treat the injury. ... Read more »

UDI Direct Marking Guidance Finalized by FDA

by Rob Meyer | Nov 2017

FDA did not offer device companies new direction on methods to direct mark, as it would be difficult to account for the wide variety of existing devices, use conditions and reprocessing methods. ... Read more »

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

by Rob Meyer | Nov 2017

Rotation Medical’s collagen-based bioinductive implant for rotator cuff repair boosts Smith & Nephew’s arthroscopy/soft tissue portfolio and focus on regenerative medicine. ... Read more »

AAOS to Launch Orthopaedic Registries, Integrate With AJRR

by Rob Meyer | Nov 2017

As data plays an increasingly important role in orthopaedics, the American Academy of Orthopaedic Surgeons announced plans to create registries for a broad range of conditions and procedures. ... Read more »