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Articles Tagged "Editor's Choice"

Integra LifeSciences Announces First Procedures with XT Revision Total Ankle

by BONEZONE | Dec 2018

Integra XT represents one of the first FDA-cleared devices indicated specifically for revision arthroplasty. The system features include an augmented posterior sloped talus to address subsidence by rebuilding posterior talar height and a design that mimics natural ankle kinematics.... Read more »

In2Bones: 4Q18 Product Launches Focus on Fracture Repair, Foot Deformities

by BONEZONE | Dec 2018

These three products include a transparent PEEK implant for pediatric and adult flat foot deformity; titanium-alloy bone plates, also featuring a transparent PEEK hub and a plating system for ankle fracture repair/ osteotomies.... Read more »

DePuy Synthes: A Look at PUREVUE and 2018 Product Launches

by BONEZONE | Dec 2018

The PUREVUE™ Visualization imaging platform, now available globally, has application in minimally invasive endoscopic surgery. We also recap the company’s product launches in arthroscopy/soft tissue, joint replacement, spine and trauma.... Read more »

Cobalt Chrome Additive Total Knee Successfully Tested by Italian Startup

by BONEZONE | Dec 2018

Rejoint's EBM additively-manufactured cobalt chrome YourKnee™ —which utilizes pre- and intra-op computer assisted technology, wearables, artificial intelligence and surgical simulation— achieved a first complete mechanical test. First surgery is slated for 1Q19 in Italy. Limited launch is... Read more »

FDA Priorities: People, Simplicity and a Risk-Based Approach to Speed Time to Market

by BONEZONE | Dec 2018

By utilizing a more straightforward methodology, FDA can free up and better use resources to focus on high-risk areas that have the biggest impact. "Simplicity requires that FDA remain limber," writes John Gagliardi. "For industry to be innovative, the federal government must be innovative as well."... Read more »

Foot and Ankle Implant Opportunities Lie in Design, Technique Improvements

by BONEZONE | Dec 2018

David Kay, M.D., a foot/ankle surgeon, shares what he see in his crystal ball regarding plates, biologics and total ankle replacement: "We have a lot of unfinished work. Observe and listen to surgeons, sterile processing, material handlers and supervisors. Suspend your view of the world to see the p... Read more »

Contract Manufacturers Responding to Market Forces are Primed for Growth

by BONEZONE | Dec 2018

We estimate that revenue for the orthopaedic contract manufacturing market reached $5 billion in 2017, +7.6% from 2016. We examine the sector’s market forces, capability trends, main players and future growth drivers to inform you how your supplier partners are transforming their businesses.... Read more »

Can You Trust E-Signatures From Your Software Package Vendor?

by BONEZONE | Dec 2018

Martin Browning from EduQuest provides insight into the validity of e-signatures from vendors: "Validation must include documentation, or it is not validation. At a minimum, you must establish (note the regulatory meaning of that word) the validity of the e-signatures you want to accept based on you... Read more »

FDA Takes Several Steps to Strengthen Medical Device Cybersecurity Program

by BONEZONE | Dec 2018

In order to stay current with the evolving technological landscape and increased insight into cyber threats, FDA recently addressed cybersecurity, including updating previous guidance, a new cybersecurity playbook and a program with the Department of Homeland Security.... Read more »

Companies Look to Materials to Provide Innovation, Respond to Trends

by BONEZONE | 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 »

FDA 510(k) Highlights from 2018: Shoulder and Ankle Joint Replacement Products on Tap

by BONEZONE | Nov 2018

Several of these clearances reflect additions of stemless/short stem, glenoid components and reverse applications, as well as additively-manufactured and porous/porous-coated designs, allowing companies to offer a wider array of products. ... Read more »

GEO CART Designed to Address Operating Room, Supply Chain Efficiency

by BONEZONE | 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 »

Medacta Invests in Personalized Medicine with Acquisition of Swiss Technology Company

by BONEZONE | Nov 2018

Medacta gains access to Balgrist CARD’s MyOsteotomy, a tool for planning/executing complex osteotomy with a patient-specific approach. MyOsteotomy combines 3D pre-op planning and custom drilling, cutting and reduction guides to produce an “exact preoperative assessment and an accurate, controlle... Read more »

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

by BONEZONE | 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 »

DePuy Synthes to Co-Promote Ortho Development’s KASM Knee Spacer

by BONEZONE | Oct 2018

The post-replacement device to treat infection complements DePuy Synthes’ rollout of its recently launched ATTUNE Revision knee. This strategic agreement is exclusive to the U.S. and will begin in the latter part of 2018.... Read more »

NuVasive Announces Christopher Barry to Succeed Gregory Lucier as CEO

by BONEZONE | Oct 2018

Christopher Barry joins NuVasive from Medtronic, where he has served as Senior Vice President and President, Surgical Innovations, since January 2015. Gregory Lucier will remain Chairman of the Board.... Read more »

Corin Increases Footprint with Acquisition of Global Orthopaedic Technology

by BONEZONE | Oct 2018

Global Orthopaedic Technology (GOT), which bills itself as the largest Australian-owned orthopaedic implant designer and manufacturer, was established in 1999 and serves Australia and the U.S.—two markets in which Corin has an established presence.... Read more »

OEMs Continue Focus on Reducing Instruments in Operating Rooms

by BONEZONE | 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 BONEZONE | 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 »

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

by BONEZONE | Oct 2018

The spine industry is fixated on two concepts: procedure enhancement via surgical assistance technologies and device design via coatings, materials and manufacturing.... Read more »

Big Data, Biologics and Failure Rates Among Significant Interests for Surgeon

by BONEZONE | Oct 2018

"There has never been a greater need for the lowest rates of failure possible," says Dr. Adolph J. Yates. "Proven devices with low revision rates might be ... the safest bet compared to new designs that have yet to be vetted in an after-market environment."... Read more »

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

by BONEZONE | Oct 2018

Martin Browning from EduQuest provides insight on responding to Form 483 observations: "It’s critical to show FDA that you are in control of the situation and are attempting to comply voluntarily by doing everything possible and reasonable to ensure that your products meet Agency specifications."... Read more »

b-ONE Ortho Gains FDA 510(k) Clearance for Total Hip

by BONEZONE | Sep 2018

The b-ONE™ cementless total hip system is the company’s first product following a US $20.0MM round of Series A financing.... Read more »

Large Spine Players Focus Acquisitions on Robotics, Navigation, Additive

by BONEZONE | Sep 2018

Medtronic, DePuy Synthes, Stryker and Globus Medical—four of the five largest spine companies ranked by revenue—announced acquisitions in the last month. We recap the additions to their product portfolios.... Read more »

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

by BONEZONE | Sep 2018

The correct metrics for your scorecard can include elements of quality, on time delivery, cost vs. value, and can yield actionable information. It’s not enough to collect data and see what the numbers are, though—you have to do something with it.... Read more »

Musculoskeletal New Ventures Conference Offers Insights on Funding, Startups

by BONEZONE | Sep 2018

Orthopaedic professionals can expect to hear about technologies being commercialized by 22 companies along with insight from long-term investors during the conference, held October 23-24 in Memphis, Tennessee.... Read more »

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

by BONEZONE | Aug 2018

The Israeli startup develops implants to treat cartilage and osteochondral defects in traumatic and osteoarthritic joints; to date, 80 patients in Europe and Israel have been treated in the pivotal Agili-C IDE study.... Read more »

HAPPE Spine Latest Company to Manufacture PEEK Devices in Novel Ways

by BONEZONE | Aug 2018

The company was formed by Genesis Innovation Group with investments from cultivate(MD) Capital Funds I and II, and is based on the work of Ryan K. Roeder, Ph.D., and researchers from the University of Notre Dame that began over 10 years ago.... Read more »

Cerapedics Enrolls Patients in P-15L Peptide-Enhanced Bone Graft IDE Trial

by BONEZONE | Aug 2018

P-15L graft, a substitute for autologous bone, is based on synthetic small peptide technology and was developed to spur bone growth via cell attraction, attachment and activation. Cerapedics has enrolled the first of 364 patients in this IDE clinical trial.... Read more »

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

by BONEZONE | Aug 2018

OEMs must engage partners in conversations about the information needed from each party for Medical Device Regulation in order to meet regulatory requirements, timelines for CE Mark approval and make critical considerations for audits.... Read more »

Milling: Suppliers on Cost Reduction, Lead Time, Accuracy, Capital Investment

by BONEZONE | Aug 2018

Experts from Jarvis Surgical, MedTorque, Phillips Precision Medicraft and TOMZ explain the factors that play into economical and productive milling operations. They also provide a forecast of how milling technology may evolve in the next five to 10 years and share what they hear most from their OEM ... Read more »

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

by BONEZONE | Aug 2018

An agency representative, and experts from ASTM, DePuy Synthes, and SME, talked additive regulatory issues at OMTEC 2018. Among the insight provided: "Have a good process flow map of all of the steps involved. People tend to focus on the printing portion, but there are a number of steps upstream and... Read more »

OEMs Share Perspectives on Additive Manufacturing Challenges

by BONEZONE | Aug 2018

While many opportunities arise for companies that implement additive manufacturing, headwinds are also faced. Experts from K2M, 4WEB Medical, LimaCorporate and Ampower provide insight into design, quality, lead time and other critical AM issues. ... Read more »

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

by BONEZONE | Jul 2018

This alternative approach to Lean and Six Sigma allows executives to build business success by making decisions guided by practical, scientific principles.... Read more »

Making a Device Design Change? Document These Critical Steps

by BONEZONE | Jun 2018

No matter where you are in the design process and no matter your internal procedures, control and documentation of design change is critical for safe and effective products.... Read more »

Hospital, Surgeons Provide Insight Into Purchasing Priorities

by BONEZONE | 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 510(k) Highlights: Five Companies Gain First Orthopaedic Clearances

by Julie Vetalice | Jun 2018

To provide insight on new competitors entering the U.S. orthopaedic market, we offer details on five companies and their first orthopaedic FDA 510(k) clearances.... Read more »

Generic Device OEM Defines Value in Orthopaedic Care

by BONEZONE | Jun 2018

We are witnessing the transformation of healthcare - the push to capture cost and outcomes data to support moving from fee-for-service to pay-for-performance medicine. ... Read more »

FDA Clears Artificial Intelligence Software for Wrist Fractures

by BONEZONE | 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 »

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

by BONEZONE | May 2018

"The laser is one of the most versatile tools an engineer has," one supplier says. "Lasers can not only be used for traceability and company identification (logos, names, etc.), but also incorporate anti-counterfeit measures by having permanent markings on products."... Read more »

Executive Interview: Elos Medtech Commits New Investments to Orthopaedic Market

by BONEZONE | May 2018

Jodie Gilmore, Managing Director of Elos Medtech Onyx, explains how the company is developing cross-site relationships and building out capabilities and capacity.... Read more »

Mid-Journey on the Road to the Forgotten Knee

by BONEZONE | May 2018

Much was achieved in total knee replacement during the last 45 years in materials, design and computer technology. Robert A. Poggie, Ph.D., President of BioVera, takes a look back at the history and also looks forward to predict advancements.... Read more »

In’Tech Medical to Acquire Bradshaw Medical

by BONEZONE | May 2018

The transaction, of which financial terms were not disclosed, directly aligns with In'Tech’s recent strategic focus on global expansion. ... Read more »

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

by BONEZONE | 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 »

Integer to Divest Advanced Surgical and Orthopedics to MedPlast

by BONEZONE | May 2018

The sale, which closes in 3Q18 and is for $600MM in cash, adds a range of metals manufacturing capabilities (e.g. machining, stamping, coating and metal forming) for MedPlast, as well as design, development and prototyping services. ... Read more »

coflex Gains Disposable Instrument PMA, NASS Coverage Policy Recommendation

by BONEZONE | May 2018

These two developments could assist Paradigm Spine in adoption of its novel product that has faced reimbursement hurdles.... Read more »

Ceramics Expo 2018: Three Takeaways for Orthopaedic Engineers

by BONEZONE | 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 »

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

by BONEZONE | Apr 2018

The ultimate goal is to ensure that all medical device products manufactured or distributed in the U.S. are both safe and effective for human use. ... Read more »

Extremities Players Seek to Bolster Shoulder Revenue with Stemless Implants

by BONEZONE | 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 »

NN, Inc. Announces Definitive Agreement To Acquire Paragon Medical

by BONEZONE | Apr 2018

The acquisition, at a price of $375MM in cash, will close during 2Q18 and positions NN as one of the 10 largest contract manufacturers in orthopaedics.... Read more »

Knee and Hip Manufacturers Focus on Additive, Materials, Robotics

by BONEZONE | Mar 2018

Among our takeaways from the American Academy of Orthopaedic Surgeons Annual Meeting include the trend that products must correlate to better patient outcomes and more efficient (quicker, less expensive) procedures.... Read more »

Globus Medical Making Sizable Push Into Trauma Market

by BONEZONE | 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 »

Medical Device Packaging is Shaped by Increased Regulations

by BONEZONE | Mar 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 »

Episurf Medical to Launch Custom Ankle Implants Using Episealer® Technology

by BONEZONE | Feb 2018

The Stockholm, Sweden-based company is preparing a 2Q18 launch of patient-specific Episealer® implants to treat osteochondral lesions of the talus in the ankle. ... Read more »

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

by BONEZONE | Feb 2018

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

Articulus Bio Gains Funding, Focusing on Total Ankle Replacement

by BONEZONE | Jan 2018

The company is addressing the issue of wear debris and seeks capital to collect data on sub-assembly components of its Tendonoid™ Web Joint technology.... Read more »

FDA Issues First De Novo Clearance Under Orthopaedic Panel

by BONEZONE | Jan 2018

IlluminOss Medical recently received FDA de novo clearance for the IlluminOss Bone Stabilization System to treat pathological fractures.... Read more »

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

by BONEZONE | 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 »

Consensus Orthopedics’ TracPatch Targets Efficiency in Post-Op Care

by BONEZONE | Jan 2018

TracPatch data provides the healthcare provider with anytime, anywhere insight into a patient’s recovery, allowing for immediate care adjustments.... Read more »

Be Prepared When Suppliers are Acquired

by BONEZONE | Jan 2018

With the recent M&A activity in the supplier space, all OEMs should be prepared in the event an important supplier is acquired or merged with.... Read more »

FDA Releases Priorities for 2018

by BONEZONE | Jan 2018

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

Forward Momentum Continues in Artificial Discs

by BONEZONE | Dec 2017

We highlight recent clinical trial results, a procedural milestone and a device launch.... Read more »

FDA Finalizes Additive Manufacturing Guidance

by BONEZONE | Dec 2017

FDA published its guidance on additive manufacturing technical considerations, outlining the Agency’s long-awaited position on use of the technology for medical devices.... Read more »

CMS Finalizes Joint Bundled Payment, Outpatient Payment Changes

by BONEZONE | 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 »

Computational Modeling and Simulation Expanding in Orthopaedic Device Life Cycles

Computational modeling and simulation (CM&S) can revolutionize medical devices by accelerating innovation and providing evidence of long-term safety.... Read more »

Examining Methods to Determine Sample Sizes

by BONEZONE | Dec 2017

Consider use of the acceptance sampling approach or the six sigma acceptable error approach to determine a sample size using statistics.  ... Read more »

Learn to Incorporate Sensors Into Your Next Design Idea

by BONEZONE | Dec 2017

Microelectromechanical Systems, referred to as MEMS devices or sensors, are being used for tasks that were previously only conceived of in science fiction.... Read more »

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

by BONEZONE | Dec 2017

While device manufacturers were slow to adopt the program in its pilot days, the initiative has gained traction since FDA named it an official program earlier in 2017.   ... Read more »

DT MedTech Receives 510(k) Clearance for Hintermann Total Ankle

by BONEZONE | Nov 2017

The Hintermann Series H2 is a semi-constrained cemented prosthesis for primary or revision surgery, also indicated to treat failed total ankle replacement or non-union/mal-union of the ankle arthrodesis.... Read more »

New Grant to Support Device Coating Research

by BONEZONE | Nov 2017

Numerate, a drug design company applying AI to transform small molecule drug discovery, was awarded a grant by the National Institute of Arthritis and Musculoskeletal and Skin Diseases to improve outcomes for orthopaedic implant recipients.... Read more »

Examining Critical Trends in Trauma Surgery

by BONEZONE | Nov 2017

Complex fractures and complications from fractures are challenging trauma surgeons’ views on periprosthetic fractures, infection prevention, weight-bearing recommendations and percutaneous pelvic fractures.... Read more »

China: Do You Need to Revamp Your Customer Channel?

An effective and efficient pathway to customers is important everywhere in orthopaedics, but perhaps nowhere is it more critical and complex than in China. ... Read more »

Coatings Support Early Integration, Infection Prevention

by BONEZONE | Oct 2017

After reviewing company product launches, research and discussions, it's clear that implant coatings are of great interest to orthopaedic professionals.... Read more »

Musculoskeletal Transplant Foundation Rebrands as MTF Biologics

by BONEZONE | Oct 2017

Today, the surgeon-founded entity offers R&D in pursuit of new biologics to support tissue regeneration. ... Read more »

CAPA Notes from an FDA Inspection

by BONEZONE | Oct 2017

Corrective and Preventive Actions or CAPA touches nearly every process in the Quality Management System (QMS). Read insight gained by John Gagliardi while participating in the interactions between the inspector and the medical device manufacturer.... Read more »

DePuy Synthes Adds Hip Replacement Navigation through JointPoint Co-market Agreement

by BONEZONE | Sep 2017

DePuy Synthes entered into an exclusive U.S. agreement with JointPoint to co-market a surgical navigation platform for total hip replacement, beginning in 2H17.... Read more »

CMS Proposes Total Joint Bundled Payment, Outpatient Payment Changes

by BONEZONE | Aug 2017

The Centers for Medicare & Medicaid Services (CMS) released two proposals related to total joint reconstruction that could impact procedure payments. CMS is proposing changes to the bundled payment model for Comprehensive Care for Joint Replacement and including ambulatory surgical centers for k... Read more »

Improve Your Performance With These Tips

by BONEZONE | Aug 2017

What's your single most significant professional challenge, right now? We posed that question in an OMTEC attendee survey, and just over 25% of respondents answered with people- or skills-related hurdles. How can we improve performance?  ... Read more »

Infection Prevention Spurs New R&D Ideas

by BONEZONE | Jun 2017

Post-surgical infection control remains a topic of importance in orthopaedic product development, as surgeons, researchers and device companies continually seek to reduce complications, readmissions, revisions and cost. The sense of priority was validated at OMTEC® 2017, when these groups met to ad... Read more »

Elos Medtech’s Advantage Lies in Nimble Approach to Serve Orthopaedic Customers

by BONEZONE | May 2017

As part of its strategy to become a global solutions provider to the medical device industry, Elos Medtech acquired U.S. based Onyx Medical in 2015, effectively establishing a presence in the largest orthopaedic market.... Read more »

Leading Supply Chains Adopt These Principles

by BONEZONE | May 2017

As a purchasing or sourcing professional, you face pressures to understand and work with every facet of your own business while simultaneously working with supplier customers who face their own set of demands. At the end of the day, work needs to get done. These principles provide a reminder of rela... Read more »

Material Scientist Predicts Hip and Knee Advancements

by BONEZONE | May 2017

Surgical assistance technologies and services to track episodes of care have dominated joint reconstruction product development conversations in recent years, as players seek to innovate in a space that already claims highly successful procedures and implants.... Read more »

FDA 510(k) Insights: March Clearance Highlights

by BONEZONE | Apr 2017

Strategic FDA 510(k)s released in March 2017 include a cannula from AJU Pharm, Bodycad's uni knee, a new company from Surgical Frontiers' portfolio and a revision system from MicroPort Orthopedics.... Read more »

Class II Design Problem Solved with Simulation

by Eric Lintula | Oct 2016

Many articles generalize design controls, but few provide direct application. This article offers a broad overview for engineers and their managers to highlight the milestones of a design process from design request to purchase order, using Finite Element Analysis.... Read more »

Making the Most of UDI

by Chris Mosby | Aug 2016

UDI regulations have altered your business. Gaining solid ROI from your compliance efforts comes down to internal efficiency, capturing your own master data and learning how to use that data for product development, marketing and logistics.... Read more »

Instrument Testing: How to Capture the Best Data

by BONEZONE | Jul 2016

Vagueness in standard methods and regulatory guidance surrounding instrument testing and validation has left OEMs questioning what best practices to apply to their devices.... Read more »

New Trauma Technologies Emerge to Treat Infections

by BONEZONE | Jul 2016

Infection control has been on the radar of various orthopaedic device companies, from start-up to top five. In the trauma market, technologies intended to minimize post-surgical infections are emerging as a potential solution to curb rising healthcare costs.... Read more »

How to Register Your Device in Australia

by Chris Mosby | Jul 2016

This article provides a high-level view of how a company can enter the Australian market and leverage their CE Marking in the process.... Read more »

Invibio Settles FTC Antitrust Allegations Concerning PEEK Market

by BONEZONE | May 2016

Invibio, the first company to sell implant-grade polyetheretherketone or PEEK, agreed to settle Federal Trade Commission (FTC) charges that it violated antitrust law by using long-term, exclusive contracts to maintain a market monopoly.... Read more »

Midwest Orthopaedics at Rush Offers Flat Fee Payment Option, Shares Price Structure

by BONEZONE | May 2016

Midwest Orthopaedics at Rush (MOR), in Chicago, Illinois, is now offering patients package pricing—a flat fee payment option—for treating some of the most common orthopaedic conditions. MOR has listed the price structure on their website. At present, there are five surgical procedures that ... Read more »

DFM: Partnerships, Considerations and Whom to Involve

by BONEZONE | May 2016

Design for manufacturability (DFM) is an essential element to the success of new devices from a standpoint of time and cost. Designs must be created with manufacturing in mind, before the design is locked down, to mitigate areas in production that would drive up costs and delay product launch. Howev... Read more »

OEMs Achieve Sustainable Manufacturing Costs Through Supplier Relationships

by BONEZONE | Apr 2016

For cost reductions and supplier relationships to be sustainable, you must address more than just the quoted price. You must attack real supply chain improvement and cost drivers at both the supplier and the OEM with the intent to reduce cost while maintaining or improving margins. This article... Read more »

FDA Releases UDI Education as Deadline Approaches

by BONEZONE | Apr 2016

FDA released a series of resources to help companies understand GUDID submission, UDI labelling regulations and compliance schedules. The resources include slideshow presentations and video interviews with FDA.... Read more »

FDA Releases Final Guidance on Human Factors and Usability Engineering

by BONEZONE | Apr 2016

The Agency released the final guidance on considerations for human factors data in premarket submissions, as well as two draft guidances on the topic.... Read more »

NASS Recap: Surface-treated, 3D-printed Cages among New Launches in Interbody Space

by Carolyn LaWell | Nov 2015

Spine companies continue to focus on surface treatments and new manufacturing processes to support more solid fusions.... Read more »

International and Domestic Manufacturers Compete to Serve Growing Asian Population

by Ames Gross | Oct 2015

Orthopaedics remains an attractive and growing market, especially in Asia. Multiple factors contribute to the growth of the orthopaedic market in this region.... Read more »

Collaboration and Resources Needed to Close Skills Gap in the Orthopaedic Industry

by Hannah Corcoran | Mar 2015

It is often difficult for orthopaedic device manufacturers to fill certain positions, due to the technical requirements and high-level skills needed for the job. Collaboration among stakeholders is necessary to secure qualified workers.... Read more »

Five Steps to Regulatory Strategy Development

by Mark D. Kramer, RAC | Mar 2014

Regulatory requirements continue to evolve and become increasingly complex. A solid strategy and execution can maximize opportunity to achieve regulatory goals and provide competitive advantage.... Read more »

Labor Hours or Machine Hours: Which is Preferable?

by Douglas T. Hicks, CPA | Dec 2013

A manufacturer that fails to segregate indirect and support costs driven by the operation of equipment from those driven by the work of individuals will seldom arrive at product or process costs that reflect economic reality.... Read more »

Mitigate Patent Infringement Risk with an FTO

by John W. Boger, Esq. | Oct 2013

Performing an FTO search is a critical tool when developing or getting ready to launch a new product. Here's how to execute the three-stage process.... Read more »