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Articles written by BONEZONE

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 »

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

by BONEZONE | Jun 2017

Of 56 products gaining clearance under FDA's Orthopedic Panel in May, we highlight the following four: a locking plate, next-gen meniscus repair implant, SI joint fusion device and new total hip. ... Read more »

UNM Pursuing 3D Printing of Tissue for Extremity Reconstruction

by BONEZONE | Jun 2017

With the support of a $20,000 grant from The American Foundation for Surgery of the Hand, a research team at UNM seeks to make 3Dprinted bone/ligament hybrid tissue for use in hand and wrist procedures. ... Read more »

R&D Recap: Leading Orthopaedic Device Company Product Initiatives

by BONEZONE | Jun 2017

Acquisitions, divestitures, market entries and exits have contributed to the shaping of product portfolios of the orthopaedic industry’s larger players, in recent years. We review their product development initiatives over the last 18 months to offer a good look at your competitors’ strateg ... Read more »

3D Scan of Bones Shows Joint Evolution

by BONEZONE | May 2017

Patient after patient presenting with similar musculoskeletal disorders—shoulder impingement, hip arthritis, knee dislocation—led orthopaedic surgeon Paul Monk, M.D., to ask himself a series of questions: Why are these happening? Are these conditions getting worse? Are our bodies fit for their p ... 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 »

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 »

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 »

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 »

Value Analysis Committees, EU’s MDR Highlighted in OMTEC Surgeon Keynote

by BONEZONE | Apr 2017

Increased regulatory scrutiny and payor power continue to affect healthcare globally, leading companies to create cross-department teams and seek collaboration amongst customers within the supply chain in order to remain innovative and competitive. ... Read more »

Exit Interview: Longtime Orchid CEO Mike Miller Retires

by BONEZONE | Mar 2017

In fewer than 18 years, Mike Miller founded and led Stealth Technologies from a five-man operation supplying high-performance auto parts to its existence today as Orchid Orthopedic Solutions, one of the larger contract manufacturers in orthopaedics. ... Read more »

Silver Ions Found Effective in Fighting Infections while Forming Bone

by BONEZONE | Mar 2017

An international team of researchers developed a scaffold that could prevent or kill MRSA and support bone tissue formation. ... Read more »

Once an Easy Path, Europe’s Regulatory Approval Toughens

by BONEZONE | Mar 2017

Enactment of the EU's Medical Device Regulations is expected to increase challenges for orthopaedic companies seeking CE Mark Approval. ... Read more »

NuVasive Ahead on In-House Manufacturing Hires

by BONEZONE | Mar 2017

The company machined 40,000 pieces in its Ohio manufacturing facility in 2016. ... Read more »

Exactech Divests Spine Assets

by BONEZONE | Mar 2017

ChoiceSpine expands breadth of product and global distribution with acquisition. ... Read more »

Suppliers Prioritize Additive Manufacturing Initiatives to Start 2017

by BONEZONE | Mar 2017

Carpenter, GE, Materialise and Siemens announce collaborations, acquisitions to address additive technology. ... Read more »

AAOS Preview: 34 Companies to Meet

by BONEZONE | Feb 2017

As you consider your priorities for the AAOS Annual Meeting, keep in mind that the conference continues to attract exhibiting supplier and service providers. This list allows you to identify companies by their main capability. ... Read more »

AAOS President Offers 5-Year Outlook on Device Advancements

by BONEZONE | Feb 2017

As industry and surgeons prepare to descend on San Diego for the American Academy of Orthopaedic Surgeons’ Annual Meeting, we asked AAOS President Gerald R. Williams Jr., M.D., to offer perspective on the prominent areas for technology advancements in the coming years. ... Read more »

China’s Medtech Policy Sets Path for Orthopaedic Manufacturers

by BONEZONE | Feb 2017

The Chinese government has prioritized medical device development, as well as local and international investments by domestic device companies. These initiatives, along with shifts in OEM to hospital distribution channels and newly-structured tiered healthcare, are expected to affect and shape the o ... Read more »

FDA Update: Final Guidance on Medical Device Reporting

by BONEZONE | Jan 2017

FDA has issued final guidance on Medical Device Reporting (MDR) for Manufacturers. The goal of the guidance, says FDA, is to detect and correct device problems in a timely manner. ... Read more »

Additive Manufacturing Experts Talk Quality

by BONEZONE | Dec 2016

Talk of the promise of additive manufacturing and 3D printing often centers on aspects of cost, speed, advanced designs, clinical outcomes. With any technology used in our highly-regulated, patient-facing industry, quality—of the process, of the machine, of the finished product, of the knowledge o ... Read more »

Revisiting Predictions: Orthobiologics, Payors and ASCs

by BONEZONE | Dec 2016

Robert S. Bray, Jr., M.D., revisits predictions from his OMTEC 2014 keynote—talking sustainable medicine, orthobiologics, care delivery and what can be gained from a relationship between OEMs and insurers. ... Read more »

2016: The Year in Products and Services

by BONEZONE | Dec 2016

What are you working on for 2017? How do your daily tasks align with overall growth objectives? We look forward to sharing your successes in these pages next year. Until then, let’s reflect on what fueled momentum this year. ... Read more »

What Should Your Supply Chain Look Like in Five Years?

by BONEZONE | Nov 2016

The supply chain has undergone greater scrutiny as stakeholders question how to find efficiency in process and spend. What changes will this spur to ensure success today—and five years from now? Supply chain experts weighed in at OMTEC 2016. ... Read more »

Clinical Data: A Snapshot of Recent Announcements

by BONEZONE | Nov 2016

Your surgeon and hospital customers will continue to demand clinical and economic data, no matter the type of implant or the size of your company. Wherever your responsibilities lie within your company, it’s important to consider how your work contributes to better patient outcomes, and know ... Read more »

Additive Manufacturing: A Snapshot of Recent Actions

by BONEZONE | Oct 2016

The unknowns of additive manufacturing have held up some companies from fully committing to its adoption. But, this hasn’t stopped them from progressing and making significant investments. Here's some action from the last few months. ... Read more »

Positioned for Growth: Exactech, Others Move Surgical Assistance Forward

by BONEZONE | Oct 2016

First total shoulder procedures and the first U.S. knee revision procedure have now been performed using ExactechGPS, a Guided Personalized Surgery system combining pre-op planning with intra-op real-time computer assistance. ... Read more »

Five Questions with Dr. Christopher Bono, NASS President

by BONEZONE | Oct 2016

In preparation for NASS, we spoke with Executive Director and CEO Eric Muehlbauer and Christopher M. Bono, M.D., President of NASS. Both discussed reimbursement matters—a concern for surgeons and device manufacturers alike. What else was on the President’s mind? ... Read more »

Stryker to Acquire Instratek

by BONEZONE | Sep 2016

Instratek markets staple and hammertoe implants and instrumentation for foot, ankle and upper extremity procedures. The transaction is expected to close in 4Q16. ... Read more »

NASS Preview: Growing Spine - International Markets, MIS and Product Portfolios

by BONEZONE | Sep 2016

In speaking with Eric Muehlbauer, Executive Director and CEO of NASS about the Society's priorities, as well as where the greatest opportunities lie for surgeons and device companies, three topics arose. ... Read more »

NASS Preview: Suppliers to Build your Orthopaedic Products

by BONEZONE | Aug 2016

NASS 2016 welcomes more than 70 suppliers to its exhibit floor. Use this list to identify your next new partner. ... Read more »

5 Questions on the Adoption of Additive Manufacturing

by BONEZONE | Aug 2016

The orthopaedic industry has become more invested in additive manufacturing, as demonstrated by product launches, partnerships and FDA’s recent guidance document on the technology. But, what do surgeons think about it? ... Read more »

Cartiva Receives FDA PMA for Synthetic Cartilage Implant

by BONEZONE | Jul 2016

Cartiva received FDA Premarket Approval for the Synthetic Cartilage Implant to treat arthritis of the great toe. This is reported to be the first synthetic cartilage device and the first product in the forefoot to gain FDA approval. ... Read more »

OMTEC 2016: Download Presentations Critical to Your Success

by BONEZONE | Jun 2016

OMTEC 2016, with its critical education sessions and bustling exhibit floor, whirred by in a flash. If you weren't able to attend the event, missed a session you wanted to attend, or just needed to see your favorite speaker's presentation one more time, you're in luck. Download slideshow presentatio ... 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 »

AcceLinx Launched to Fuel Warsaw Entrepreneurship

by BONEZONE | May 2016

AcceLinx was developed with the understanding that innovation in orthopaedics has become more complex, and the timeline from concept to market has extended to six or more years due to regulatory and reimbursement scrutiny. Selected entrepreneurs will have access to strategic resources, guidance and ... 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 »

Trauma Surgeon Develops Fixation Platform, Looks to Future Innovations

by BONEZONE | May 2016

Thomas “Toney” Russell, M.D., an orthopaedic trauma surgeon and President and CEO of Innovision, developed the N-force fixation platform to meet his own clinical needs in optimal fixation of fractures in the extremities and pelvis. The N-force system was a massive regulatory endeavor for a surge ... Read more »

March’s Most Read Articles

by BONEZONE | Apr 2016

What were the most read articles for the month? Read on to catch up on the product launches and clearances at AAOS 2016, get the lowdown on prototyping demands and learn more about the Promimic/Danco Anodizing strategic partnership. Then read on with recommended reading. ... 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 »

Proving Medical Necessity: the Need for Evidence in Reimbursement

by BONEZONE | Mar 2016

Providers, OEMs and suppliers all say that they’ve been impacted by complexities in the reimbursement system. For example, bundled payments and an increased burden of evidence have changed the way that products are developed and launched. One theme has arisen from the many conversations—not a ne ... Read more »

Supply, Cost and Quality Lead Concerns among Raw Materials Providers

by BONEZONE | Mar 2016

Supply and demand factors, price pressures and enhanced regulatory scrutiny are expected to influence the raw materials portion of the orthopaedic supply chain in 2016. Eight of the 27 raw material suppliers exhibiting at OMTEC weighed in on these themes. ... Read more »

Companies Expected to Invest Device Tax Benefit in R&D

by BONEZONE | Mar 2016

Even if it’s small, research and development budgets are expected to get a boost in 2016 and 2017 as companies plan to invest in innovation with the earnings pocketed from the suspension of the medical device tax. ... Read more »

New Guidance for UHMWPE Submissions

by BONEZONE | Feb 2016

FDA recently released draft guidance outlining new information companies must include when submitting devices with Ultra High Molecular Weight Polyethylene (UHMWPE) for approval.  ... Read more »

Handling Disruption: The Need for Proprietary Business Models

by BONEZONE | Feb 2016

The economic and regulatory environment for medical devices is changing. OMTEC Keynote Speaker Bill Tribe, Partner at consulting firm AT Kearney, discusses ways to protect and grow your business. ... Read more »

Laser Processing: A Guide to OMTEC 2016 Exhibitors

by BONEZONE | Feb 2016

As we approach OMTEC 2016, BONEZONE is taking a closer look at the exhibitors you’ll meet at the event. In this round: Laser Processing. ... Read more »

The Top Industry News from 2015

by BONEZONE | Jan 2016

Need a refresher on compliance initiatives and industry-shaping events? We’ve recapped the six most-read articles of 2015. ... Read more »

A Look at FDA’s 2016 Priorities, Status of 2015 Priorities

by BONEZONE | Jan 2016

FDA released its annual priority list for the new year, as well as previously-issued final guidance documents, on which CDRH is accepting feedback as part of its retrospective review. ... Read more »

UDI Update: Trays and Kits

by BONEZONE | Jan 2016

FDA released draft guidance for its Convenience Kit exemption, offering orthopaedic device manufacturers more direction on labeling device trays and kits with unique identifiers (UDIs). The proposed change would clarify the definition of convenience kit, reducing the number of accepted exemptions an ... Read more »

AAOS 2016: What to Expect, Suppliers to Meet

by BONEZONE | Jan 2016

Of the ~700 companies set to exhibit at this year’s AAOS Annual Meeting, here’s a look at select suppliers who will be on site ready to serve you. ... Read more »

Congress Suspends Medical Device Tax

by BONEZONE | Jan 2016

The medical device tax, fought by industry since its inception, was suspended as part of the $1.8 trillion spending and tax bill passed by Congress and signed by President Obama in the waning days of 2015. The 2.3 percent tax on medical device sales received a suspension for 2016 and 2017. ... Read more »

UDI Ruled a Requirement for EHRs

by BONEZONE | Dec 2015

A final rule issued by the Office of the National Coordinator for Health IT of the U.S. Department of Health and Human Services will require providers to incorporate UDIs into electronic health records, allowing providers to track devices used by their patients at any point of care. ... Read more »

Zoning In with Orthopaedic Surgeon Entrepreneurs

by BONEZONE | Dec 2015

BONEZONE looked back on some of the orthopaedic surgeon interviews conducted throughout the year to see what they had to say about the direction of the industry. Here, we recap four of those insights. ... Read more »

FDA Outlines Critical Quality Measures

by BONEZONE | Sep 2015

FDA’s Director of the Division of Manufacturing and Quality discussed recent Agency initiatives that emphasize quality over compliance. ... Read more »

Wright Medical’s AUGMENT Bone Graft Approved by FDA

by BONEZONE | Sep 2015

Wright Medical's AUGMENT receives long-awaited FDA approval for ankle/hindfoot indication. ... Read more »

Zoning In With LDR’s Christophe Lavigne

by BONEZONE | Sep 2015

Christophe Lavigne, CEO and President of LDR, spoke to BONEZONE on the direction of his company, highlighting strategies for growth. ... Read more »

NASS Preparation: Suppliers to Meet on the Exhibit Floor

by BONEZONE | Sep 2015

Of the 321 exhibitors at this year’s NASS Annual Meeting, 21 are suppliers and service providers listed in the ORTHOWORLD/BONEZONE Supplier Directory. Learn who they are and what they offer. ... Read more »

OEMs Weigh in on Managing Supplier Quality

by BONEZONE | Aug 2015

OEMs tackled the topic of supplier quality during a panel discussion at OMTEC 2015. Here are a few highlights from the conversation on supplier approval, development and priorities. ... Read more »

CMS Targets Hip and Knee Reimbursement

by BONEZONE | Aug 2015

The U.S. Centers for Medicare & Medicaid Services (CMS) proposed a bundled payments program to accelerate value-based care that, once passed, could impact hip and knee implant pricing. ... Read more »

Master Your Sterilization Process

by BONEZONE | Aug 2015

At OMTEC® 2015, Jozef Mastej, Vice President of Operations, Gibraltar Laboratories, Inc. outlined the cleaning and sterilization validation process for reprocessing reusable devices. ... Read more »

Smith & Nephew’s Syncera Focuses on Organization of OR Instruments

by BONEZONE | Aug 2015

Smith & Nephew’s Syncera business unit acquired two assets from S2 Interactive, a surgical software development company, to offer customers the ability to access and manage data from the instruments used during a procedure. ... Read more »

Zoning In with Doug Kohrs

by BONEZONE | Jul 2015

Doug Kohrs wants to be a catalyst for change in the orthopaedic industry as Managing Director of Responsive Orthopedics, a new company that recently received its first 510(k) for a total knee system and is focused on value-based healthcare solutions. ... Read more »

New UDI Draft Guidance Addresses Direct Marking of Reprocessed Devices

by BONEZONE | Jul 2015

FDA’s most recent UDI draft guidance, Unique Device Identification: Direct Marking of Devices, addresses common questions posed by labelers preparing for the September 24, 2015 compliance deadline. ... Read more »

Getting Lean: Strive for Built-in-Quality

by BONEZONE | Jul 2015

During his OMTEC presentation, Joe Mazzeo pinpointed the principles necessary to build a culture of inherent quality, stressing strong leadership and cultural tenets to drive lean manufacturing and create value. ... Read more »

FDA Launches Searchable UDI Database

by BONEZONE | Jun 2015

FDA recently announced the launch of AccessGUDID, a website that allows users to search and download information on devices that require identification. ... Read more »

Zoning In With Richard Randall

by BONEZONE | May 2015

Richard Randall, recently appointed CEO of OMNI, plans to drive growth by expanding the company’s robotics portfolio and targeting new partners to implement robotic devices for joint surgeries. ... Read more »

U.S. Registry Offers New TJR Data

by BONEZONE | May 2015

Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement or FORCE-TJR, is a four-year, $12 million project funded by the Agency for Healthcare Research and Quality that establishes a comprehensive database on total hip and knee replacement patients and outcomes. ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | May 2015

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. An asterisk denotes those receiving their first clearance for an orthopaedic product. ... Read more »

CDRH Proposes Nationwide Postmarket Surveillance System

by BONEZONE | Apr 2015

The Center for Devices and Radiological Health has proposed a National Medical Device Postmarket Surveillance System expected to serve the needs of patients, clinicians, payors and manufacturers. ... Read more »

Amedica’s Clinical Results Show Silicon Nitride Achieves Same Fusion Rate as PEEK

by BONEZONE | Apr 2015

Interim results from the CASCADE clinical trial indicate that silicon nitride composite interbody spinal devices alone, without bone graft or synthetic bone void filler, achieved similar fusion rates and clinical scores as patients implanted with traditional spacers using autograft. ... Read more »

OMTEC 2015 Preview: Meet 25 Longtime Exhibitors

by BONEZONE | Apr 2015

Of 2015 OMTEC exhibitors, nearly 20 percent have presented their solutions at the conference since its early days. Discover who these companies are and what they bring to OMTEC year after year. ... Read more »

OMTEC 2015 Preview: Meet First-time Exhibitors

by BONEZONE | Mar 2015

Of ~130 unique companies set to exhibit at OMTEC 2015, 28 are first-timers. We’ve profiled these companies to let you know who they are and what they do. ... Read more »

New Technology Doubles Tissue Life

by BONEZONE | Mar 2015

Researchers at the University of Missouri School of Medicine have developed a new technology that reportedly more than doubles the storage life of bone and cartilage grafts from organ donors. ... Read more »

Zoning In with Rod Mayer

by BONEZONE | Mar 2015

How can small companies thrive in the orthopaedic industry? Rod Mayer, President of Nextremity Solutions, shares solutions for success. ... Read more »

Actions Underway in a Push to Repeal the Medical Device Tax

by BONEZONE | Jan 2015

With support from both major parties, U.S. legislators have introduced bills in renewed attempts to repeal the medical device tax. ... Read more »

Researchers Study Nanostructures to Allow Biocompatibility Between Metal and Human Bone Tissues

by BONEZONE | Jan 2015

Scholars at The Research Center for Advanced Materials are studying the use of nanostructures to manufacture implants needed in Mexico. ... Read more »

FDA Publishes Priorities for 2015

by BONEZONE | Jan 2015

FDA’s Center for Device and Radiological Health issued its list of priorities for 2015, including guidance documents it intends to publish and other initiatives. ... Read more »

Zoning In with Mark Augusti

by BONEZONE | Dec 2014

Mark Augusti of Integra LifeSciences discusses the company’s recent developments, including the creation of an independent spine company, SeaSpine. ... Read more »

21 Notable Products from 2014

by BONEZONE | Dec 2014

What new products made your list of most innovative in 2014? Here is a list of some of the more innovative technologies released within their market segment. ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Dec 2014

Discover which orthopaedic companies recently received strategic FDA 510(k) clearances to market their products. ... Read more »

FDA Extends UDI Compliance Date for Certain Orthopaedic Implants

by BONEZONE | Dec 2014

A variety of fixation screws, plates and spinal devices will not need to meet UDI labeling requirements until 2016. ... Read more »

AJRR Releases Annual Report on Hip and Knee Arthroplasty

by BONEZONE | Dec 2014

Report data covers 43,823 primary revision procedures, reflecting 4.5 percent of joint replacements conducted every year in the U.S. ... Read more »

Surgeons and CEOs to Deliver Industry Forecasts at ORTHOWORLD Symposium

by BONEZONE | Dec 2014

What does the future hold for the orthopaedic industry? The State and Future of the Orthopaedic Industry™ Symposium, held January 20 in Nashville, will provide perspective on critical dynamics shaping the industry. ... Read more »

Spine Product Launches in 2014

by BONEZONE | Oct 2014

Spine companies launched more than three dozen products between January and August of this year. To better understand market trends and what you can expect to be featured at NASS, a partial list of products, their indications and geographic availability follows. ... Read more »

Zoning In with Dr. Vijay Goel

by BONEZONE | Oct 2014

Dr. Vijay Goel, Co-Director of the Center for Disruptive Musculoskeletal Innovation (CDMI) shares the Center’s mission and initiatives to strengthen patient outcomes through academic resources supporting research. ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Oct 2014

See which orthopaedic companies recently received 510(k) clearances to market their products. ... Read more »

FDA Publishes Q&A on UDIs

by BONEZONE | Sep 2014

The deadline for Unique Device Identifier (UDI) implementation for medical devices is September 24, 2014. FDA has issued a 14-page Q&A document to help manufacturers prepare. ... Read more »

CMS Proposes Changes to Open Payments

by BONEZONE | Aug 2014

CMS has proposed changes to Open Payments’ regulations, including requiring reporting the name of the device related to the payment. ... Read more »

Choosing Materials in a Shifting Global Regulatory Environment

by BONEZONE | Aug 2014

Orthopaedic device manufacturers face increasing pressures related to the safety of raw materials used in implants and instruments. Consider these factors when determining material utilization for a new product. ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Aug 2014

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. An asterisk denotes those companies receiving first clearance for an orthopaedic product.  ... Read more »

Zoning In with Trent Northcutt

by BONEZONE | Aug 2014

Since its founding in February 2012, Aurora Spine has launched more than a dozen products and became a public company traded on the Toronto Stock Exchange. CEO Trent Northcutt discusses the keys to growth management. ... Read more »

Center for Disruptive Musculoskeletal Innovation Launched by Industry and Academia

by BONEZONE | Jul 2014

The Center for Disruptive Musculoskeletal Innovations (CDMI) seeks to jointly define issues that hinder innovation and ideal patient outcomes, then use university resources to identify potential solutions. These solutions will be pursued with a common funding pool that supports graduate student rese ... Read more »

Greater Memphis Medical Device Council Forms to Support Industry Health

by BONEZONE | Jul 2014

Seventeen medical device manufacturers have formed the GMMDC to address issues critical to the local medical device industry. GMMDC will seek to assist in matters of workforce training and education on available career paths to ensure a robust pool of talent for local manufacturers. ... Read more »

Suppliers Speak to Economic and Regulatory Challenges in Global Expansion

by BONEZONE | Jul 2014

New market entry presents logistical hurdles for every company. Suppliers provide insight based on their own experience of opening overseas operations. ... Read more »

Biomaterials Derived from Beer-brewing Waste May Have Use in Bone Regeneration

by BONEZONE | Jul 2014

Using wastes generated by the brewing of beer, researchers have developed biocompatible materials that may be used to create scaffolds upon which bone may regenerate. ... Read more »

Effective Tools for Patent Searches

by BONEZONE | Jul 2014

Management has given the go-ahead to design a new device. As an engineer, you’ll now conduct a patent search to ensure that your technology won’t infringe upon other patents. What tools—free or otherwise—should you use to ensure that your search is comprehensive? ... Read more »

Survey Finds Half of Surgeons Worldwide Unwilling to Use Generics

by BONEZONE | Jun 2014

A recent survey found 52 percent of orthopaedic surgeons worldwide would not be willing to use generic implants. A greater number of U.S. surgeons said they were willing to use low-cost implants compared to surgeons in other regions. ... Read more »

FDA to Host Public Workshop on Additive Manufacturing

by BONEZONE | Jun 2014

FDA will host a forum to address scientific and technical challenges posed by the additive manufacturing process used in medical devices. ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | May 2014

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Arthrosurface, Ellipse Technologies, Extremity Medical, Flower Orthopedics, MTP Solutions, Nexus Spine, Prosidyan and Tyber Medical.  ... Read more »

Study: U.S. Demand for Total Joint Replacement Remains Steady

by BONEZONE | May 2014

A new study showed that the economic downturns in the 2000s did not substantially influence the national growth trends for hip and knee arthroplasty in the U.S. The study, which appeared in The Journal of Bone and Joint Surgery, also predicts that the demand for total joint replacement will surge th ... Read more »

Zoning In with Robert Weigle

by BONEZONE | May 2014

Robert Weigle, CEO of Benvenue Medical, discusses the importance of embracing clinical data in bringing the Kiva Vertebral Compression Fracture Treatment System to market. ... Read more »

Consolidation Continues as Zimmer Intends to Acquire Biomet

by BONEZONE | May 2014

Zimmer announced its intention to acquire Biomet for $13.35 billion. With combined revenue of $7.8 billion for the calendar year 2013, the finalized deal would allow the merged company to become the second largest orthopaedic manufacturer with an estimated market share of about 17 percent. ... Read more »

IlluminOss Presents Novel Approach to Fracture Fixation

by BONEZONE | Apr 2014

Implanted in about 400 patients to date, IlluminOss Medical's PBSS is a deviation from traditional hardware used in fracture fixation technologies. BONEZONE spoke with the company's CEO about the technology and plans to gain market share. ... Read more »

Coatings: Trends and Technologies in the Orthopaedic Industry

by BONEZONE | Apr 2014

As the orthopaedic industry has evolved, so too have coatings for implants and instruments. BONEZONE queried five companies to better understand trends in coatings. ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Mar 2014

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Benvenue Medical, Edge Orthopaedics, Integrity Spine, Lanterna Medical Technologies, Mikron Makina, MTP Solutions, Toby Orthopedics, Virak Orthopedic Research.  ... Read more »

Metal Craft Enters New Growth Phase

by BONEZONE | Mar 2014

With the second generation of leadership at the helm, Metal Craft is striving to maintain the family business values it was founded upon while growing to the next level of service that its customers demand. ... Read more »

Zoning In with Robert Johnson

by BONEZONE | Mar 2014

Acumed appointed Robert Johnson as president in 2013. Here, he shares how he drives continual improvement. ... Read more »

Researchers Develop Surface Treatment to Reduce Infection

by BONEZONE | Mar 2014

Researchers at Aalto University are developing a method of analyzing surface treatment processes to reduce the risk of infection. ... Read more »

Webinar: Making Your Management Review Meetings More Effective

by BONEZONE | Mar 2014

The FDA issued more than 200 findings against management responsibility and the management review process in 2012. This webinar outlines one method that makes the management review process simple, efficient and foolproof. ... Read more »

High-Demand Education Featured at OMTEC 2014

by BONEZONE | Feb 2014

A number of the most-read BONEZONE articles from 2013 will be covered in greater depth as educational sessions at OMTEC 2014. Continue reading to learn how to enhance your expertise now and in June. ... Read more »

CDRH 2014-2015 Priorities Focus on Clinical Trials and PMAs

by BONEZONE | Feb 2014

CDRH's 2014-2015 Strategic Priorities address the difficulty that manufacturers face in seeking and obtaining regulatory approvals. ... Read more »

FDA Publishes List of Priorities for 2014

by BONEZONE | Jan 2014

FDA’s Center for Device and Radiological Health issued a list of guidance documents that it intends to publish in FY2014. The topics that might be of interest to orthopaedic device companies include the following. ... Read more »

FDA Posts 510(k) Communication Timeline

by BONEZONE | Jan 2014

FDA has developed a timeline that provides 510(k) applicants with an understanding of communication during the review process. ... Read more »

FDA Promotes Voluntarily Correcting Violations with New Program

by BONEZONE | Jan 2014

FDA recently announced details of a new pilot program that will allow medical device companies to voluntarily identify and correct regulatory violations rather than undergo FDA inspection. ... Read more »

Defining Innovation

by BONEZONE | Dec 2013

What is innovation? It’s not just one thing. Read what orthopaedic professionals had to say on its definition and development. ... Read more »

U.S. OIG Issues POD Report; Reliance Medical Files a Suit

by BONEZONE | Dec 2013

The U.S. Office of Inspector General of the Dept. of Health and Human Services' overview of prevalence and use of physician owned distributors (PODs) of spinal devices does not make specific recommendations for action, but notes that in FY11, PODs supplied devices used in ~1 in 5 spinal fusions bill ... Read more »

Rising Obesity Rates Driving Surge in U.S. TKR

by BONEZONE | Dec 2013

The rise in obesity rates in people under age 65 appears to be having a dramatic influence on the number of total joint replacement surgeries in the U.S., contrary to the belief that Baby Boomers and weekend warriors are spurring the rise in the procedures. ... Read more »

National Joint Registry for England, Wales and Northern Ireland: Findings from 10th Annual Report

by BONEZONE | Dec 2013

The NJR Steering Committee launched its tenth report in late September. Data from more than 1.4 million procedures are now registered with considerable growth expected now that elbow and shoulder replacement data collection is underwayand Northern Ireland has joined the NJR . The report also contain ... Read more »

CMS Issues Proposed Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis

by BONEZONE | Dec 2013

The U.S. Centers for Medicare & Medicaid Services proposes that Percutaneous Image-guided Lumbar Decompression for lumbar spinal stenosis is not reasonable and necessary. Therefore, CMS proposes that PILD for LSS is non-covered by Medicare. ... Read more »

Surgeons Describe Anterolateral Ligament in the Human Knee

by BONEZONE | Dec 2013

Knee surgeons in Belgium have provided the first full anatomical description of a human knee ligament that may play a role in anterior cruciate ligament tears. Research indicates that the anterolateral ligament is present in 97% of all human knees, and that pivot shift is caused by an injury in that ... Read more »

ACL Injuries Six Times More Likely after Reconstruction

by BONEZONE | Dec 2013

Studies suggest that athletes who have undergone anterior cruciate ligament (ACL) reconstruction are six times as likely to require another ACL surgery within 24 months as someone who has never experienced an ACL tear. ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Dec 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Altus Spine, Anchor Innovation, Beijing Libeier Bio-Engineering Institute, Binder Biomedical, Corentec, Elite Surgical, Innovative Surgical Designs, Intelligent Implant, Jeil Medical, NovoSource, Tybe ... Read more »

Looking Ahead to 2014

by BONEZONE | Dec 2013

What should orthopaedic device manufacturers consider when doing business in 2014? BONEZONE asked regional experts to provide advice specific to multiple geographies. ... Read more »

Zoning In with Todd Andres

by BONEZONE | Dec 2013

Todd Andres combined his background in materials and medical devices to co-found Spinal Elements in 2003. Since then, he has led the California-based company as its CEO. Here, he shares how to find opportunities and the challenges of building a company. ... Read more »

Lessons in M&A

by BONEZONE | Nov 2013

Mergers and acquisitions require great human and capital resources. Two OEMs share how they completed transactions this year. ... Read more »

Japan: Entering an Established Market

by BONEZONE | Nov 2013

While much emphasis has been placed on the double-digit growth in emerging markets, there are advantages to expanding business in established markets. This month, BONEZONE speaks to NuVasive about the orthopaedic industry in Japan. ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Nov 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Binder Biomedical, Corentec, Jeil Medical, NovoSource, ORTHOSoft, Renovis Surgical, Tyber Medical, Vertebral Technologies. ... Read more »

Ace Your Next Test

by BONEZONE | Oct 2013

Changes to regulations and standards as well as innovation in materials and design make it a challenge to keep up to speed with testing requirements. Testing laboratories describe the latest challenges and trends to help OEMs uncover opportunities and capitalize on efficiencies, safety and speed to ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Oct 2013

The following companies recently received strategic FDA 510(k) clearances: Advanced Interventional Technology, CoreNexus, Crosstrees Medical, Emerge Medical, Ingen Orthopedics, JG Spine, Next Orthosurgical, Osseus Fusion Systems, Shanghai Sanyou Medical and Vivorte. ... Read more »

Zoning In with Howard Levy

by BONEZONE | Oct 2013

Howard Levy joined Biomet and the orthopaedic device industry in 2007, after serving in global strategic sourcing leadership positions that spanned diverse industries. Here he shares supply chain trends and the best professional advice he’s received. ... Read more »

Consumers Union Seeks Warranties to Support Hip, Knee Implants

by BONEZONE | Oct 2013

The Consumers Union is asking U.S. manufacturers to back products with a 20-year warranty. Other suggested requirements include the following. ... Read more »

FDA Finalizes UDI Requirements

by BONEZONE | Sep 2013

Final rule does not mandate direct part marking for implantable devices, provides manufacturers of Class III implants one year to comply. ... Read more »

How to Choose a Notified Body

by BONEZONE | Sep 2013

The right Notified Body will support device manufacturers in accomplishing current and long-term goals. Here are questions to ask and trends to consider when searching for the right partner. ... Read more »

A Supplier’s View on the Indian Market

by BONEZONE | Sep 2013

One supplier discusses the opportunities and challenges it has experienced working in India’s growing orthopaedic device market. ... Read more »

Featured Video Block (2)

by BONEZONE | Aug 2013

Phillips Precision Medicraft Principles by: Phillips Precision Medicraft    Phillips Precision Medicraft, a manufacturer of advanced orthopedic implants, instrumentation, sterilization delivery systems, cases and trays, meets the complex demands of its customers by investing in people, ... Read more »

Zoning In with Tom Till

by BONEZONE | Aug 2013

After 25 years with DePuy Synthes, Tom Till left the device manufacturing world to educate the next generation of engineers, machinists and technicians. He shared lessons learned throughout his career. ... Read more »

ACL Injuries More Common after Reconstruction

by BONEZONE | Aug 2013

Studies suggest that athletes who have undergone ACL reconstruction are 6x as likely to require another ACL surgery within 24 months as someone who has never experienced an ACL tear. ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Aug 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Pantheon Spinal, Pinnacle Spine, Spine Wave, Synergy Biomedical, X-Spine Systems.  ... Read more »

Spotlight on Asia

by BONEZONE | Aug 2013

The Asian population is quickly aging and accumulating wealth, ripening conditions for the orthopaedic industry to grow 15 to 18 percent each year for the next decade. BONEZONE breaks down the markets in China and India. ... Read more »

Looking Back at INFUSE: 2002 to Today

by BONEZONE | Aug 2013

In mid-June, two independent research groups released a long-awaited review of trial data regarding the use of Medtronic’s INFUSE. The following timeline summarizes events that brought us here from the product’s initial clearance. ... Read more »

Need for Data in Unproven Implants

by BONEZONE | Aug 2013

A review of data found registry reports are accurate in providing information about hip and knee arthroplasty devices, though researchers expressed concern about the use of devices still “unproven,” without long-term survivorship data. ... Read more »

Voices from OMTEC 2013

by BONEZONE | Aug 2013

Orthopaedic device manufacturers, suppliers and industry experts met at OMTEC to discuss how to mitigate regulatory, manufacturing and supply chain challenges. Here are a few of the important conversations you may have missed. ... Read more »

Unique Challenges in Instrument Manufacturing

by BONEZONE | Jul 2013

What challenges are unique to the manufacture of orthopaedic instruments? We ask a supplier for perspective. ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Jun 2013

The following companies recently received strategic FDA 510(k) clearances: Apogee OrthoSolutions, Biomedical Enterprises, Cleveland Clinic/Custom Orthopaedic Solutions, Institute of Musculoskeletal Science & Education, Metasurg, NovoSource, NUTEK Orthopaedics, Pantheon Spinal, Providence Medical ... Read more »

Bone Substitutes: Swapping Autograft for Bioactive Glass

by BONEZONE | Jun 2013

Studies show bioactive glass is a viable treatment for complete bone repair. BONEZONE spoke with BonAlive about the science behind the technology. ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | May 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Alphatec Spine, Biomecanica Industria e Comerico, Dallen Medical, Facet-Link, Flower Orthopedics, Global Manufacturing Technology, Kalitec Direct, Maxim Surgical, Myelotec, Orthopaedic Implant Company ... Read more »

Accutek Weighs In on the State of Testing

by BONEZONE | May 2013

John McCloy built a nimble testing laboratory in order to handle economic and regulatory changes. BONEZONE spoke to McCloy about the current orthopaedic device market, testing and future regulations. ... Read more »

Spotlight on Europe

by BONEZONE | May 2013

Companies seeking to expand within the European Union need to consider more than just regulatory factors. This month’s Global Spotlight focuses upon the two largest medical device markets in Europe, Germany and France, as well as Ireland, which has seen greater foreign investment. ... Read more »

The Basics: A Look at the French Medical Device Market

by BONEZONE | May 2013

France’s medical device industry faces a high level of competition. Biomatlante shares its experience operating in its home country. ... Read more »

BONEZONE Authors Present Solutions at OMTEC 2013

by BONEZONE | Apr 2013

Want to get more in depth on the topics you read in BONEZONE®? Many of the familiar authors you read here will present at OMTEC 2013, providing a live and interactive approach to your relevant issues, while equipping you with tools to enhance your performance. ... Read more »

FDA Recognizes Computer Simulated Performance Data in Device Evaluation

by BONEZONE | Apr 2013

FDA seeks to draft verification and validation guidelines in response to more medical device manufacturers using computer modeling and simulation. ... Read more »

Industry Outlook Remains Positive Despite Excise Tax

by BONEZONE | Apr 2013

Survey finds medical device professionals are more positive about the business environment, excise tax, regulatory environment and emerging markets major focuses in 2013. ... Read more »

Strategic Orthopaedic 510(k) Update

by BONEZONE | Apr 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Alphatec Spine, Biomecanica Industria e Comerico, Dallen Medical, Flower Orthopedics, Global Manufacturing Technology, Kalitec Direct, Maxim Surgical, Myelotec, Orthopaedic Implant Company, Orthopro, ... Read more »

The Future of Additive Manufacturing in Orthopaedic Implants

by BONEZONE | Mar 2013

Additive manufacturing is expected to be a $3.5 billion industry by 2017. Orthopaedic device manufacturing has the ability to grow with the application. ... Read more »

FDA Releases New Requirements for Combination Products

by BONEZONE | Mar 2013

FDA's final rule on cGMP for combination products provides a definition of these products and the new requirements. ... Read more »

ASTM Names New Standard for Raw Materials

by BONEZONE | Mar 2013

ASTM added a PEKK raw material standard for medical device implants that if met, will reduce the testing needed to obtain regulatory approval. ... Read more »

Spotlight on Argentina

by BONEZONE | Feb 2013

Argentina’s orthopaedic device market faces the same challenges as those experienced around the world: pricing pressure and increasing productivity while reducing costs. However, it’s a young market ripe for growth. ... Read more »

Breakthrough in NiTiNOL Use in Implants

by BONEZONE | Feb 2013

The use of nickel titanium or NiTiNOL in large orthopaedic devices has been limited in basic materials and devices. MedShape overcame these technological challenges to produce its new ankle arthrodesis nail. ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Feb 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Camber Spine, Eleven Blade Solutions, K7, LSK BioPartners, Metric Medical Devices, Stanmore Implants ... Read more »

Spotlight on Brazil

by BONEZONE | Jan 2013

The World Bank ranks Brazil as the sixth largest country in the world in terms of gross domestic product at $2.47 trillion in 2011 GDP, and expects the country to continue to climb the list. Brazil’s increasing growth suggests that it is an attractive gateway to doing business in South America. ... Read more »

OEM/Supplier Issues Roundtable, Part II: Orthopaedic Industry Leaders Weigh in on Commercialization Challenges

by BONEZONE | Jan 2013

As the New Year begins, it’s important that OEM and supplier relationships start off on the right footing. Price increases and heightened regulatory scrutiny mean that clear communication will be needed on both ends for successful commercialization. We asked OEMs to respond to one question regardi ... Read more »

Supplier Roundtable, Part II: Materials Suppliers Prepare for 2013

by BONEZONE | Jan 2013

More responses from suppliers! Pressures from material costs and Federal regulations are expected to increase in 2013. To ensure commercialized product quality, safety and performance, suppliers and OEMs will need to maintain vigilant communication and share industry awareness. Read on for material ... Read more »

Johns Hopkins Research Team Reports Knee Cartilage Repair Success with Biomaterial + Microfracture

by BONEZONE | Jan 2013

Results from a 15-patient pilot study suggest that a new hydrogel and adhesive implant + microfracture procedure performed as well in humans as it did in the lab. At 6 months, MRI showed that patients receiving the implant had new cartilage filling an average 86% of defects in the knee, while those ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Jan 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: B2B Spine, Brainlab, Christopher D. Endara, Emerge Medical, Everest Spine, Fairway Medical, Foundry (Newco XI), Frontier Medical, InSurgical, NCS Lab, Ouroboros Medical, Stabiliz Orthopaedics, Z-Medic ... Read more »

Silicon Nitride Material in Orthopaedic Implants: Features and Benefits

by BONEZONE | Dec 2012

As an implant material, what does Silicon Nitride offer vs. titanium or PEEK? A team from Amedica explores the material's potential benefits supporting new bone growth, enhanced imaging, antimicrobial features and more. ... Read more »

Blogs and Apps that Bring Solutions

by BONEZONE | Dec 2012

UPDATE: Mr. Packard's blog has moved to Medical Device Academy. Also, find his BONEZONE articles  by clicking on the author tab on the homepage. Quality Control can be stale. Reading about it can be even duller. Rob Packard wants to change that by bringing the topic to life with his blog, QC i ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Dec 2012

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Alliance Spine, Aston Medical, Iconacy Orthopedic, Implanet, Intelligent Implant Systems, Osseon Therapeutics, Providence Medical, Safe Orthopaedics, Shanghai Kinetic, Shoulder Options, Weigao Orthopa ... Read more »

OEM/Supplier Issues Roundtable: Orthopaedic Industry Leaders Weigh in on Commercialization Challenges

by BONEZONE | Dec 2012

Solid communication between OEMs and suppliers keeps both sides proactively engaged in product commercialization and smooths the working relationship. As industry looks ahead to the coming year, we sought the OEM response to a single question: As you consider the year ahead, what action(s) can ... Read more »

Staffing Solutions: CNC Machinists in Training

by BONEZONE | Dec 2012

BONEZONE presents a short list of schools and programs in the U.S. that provide CNC operator education, in response to readers’ challenges in finding qualified machinists. Locations in California, Illinois, Indiana, Michigan and more. ... Read more »

Supplier Roundtable: Materials Suppliers Prepare for 2013

by BONEZONE | Nov 2012

Pressures from material costs and Federal regulations are expected to increase in 2013. To ensure commercialized product quality, safety and performance, suppliers and OEMs will need to maintain vigilant communication and share industry awareness. Read on for material suppliers'  guidance for O ... Read more »

Suppliers and Service Providers Offer Innovative Solutions

by BONEZONE | Nov 2012

Innovative products and services are produced every day. Finding them is the hard part. We invited suppliers and service providers to share their solutions that serve your specific challenges. Read on to see the innovations that can serve your needs.   ... Read more »

Purac Acquires Fiberlive Technology from Vivoxid

by BONEZONE | Oct 2012

Purac Biomaterials acquired FiberLive™, Vivoxid’s composite technology comprising resorbable glass fibers and polymers. FiberLive boasts strength reportedly up to 6 times higher than cortical bone, and comparable to metal. FiberLive technology has potential clinical application in the manufactu ... Read more »

FDA Draft Guidance: Refuse to Accept 510(k) Policy

by BONEZONE | Oct 2012

On August 13, 2012, FDA issued a draft guidance, “Refuse to Accept Policy for 510(k)s.” This guidance explains procedures and criteria FDA intends to use in assessing whether a 510(k) submission is administratively complete and should be accepted for substantive review. It’s primarily designed ... Read more »

Call for Abstracts: The 7th International Conference on Ethical Issues in Biomedical Engineering

by BONEZONE | Oct 2012

Deadline for abstract submission is November 5, 2012. Notification of abstract acceptance is December 15, 2012. Accepted abstracts will be published in the International Journal of Medical Implants and Devices, to be distributed at the meeting, and select papers will publish in Ethics in Biology, En ... Read more »

The Ohio State University, Cleveland Clinic Form Alliance To Focus On Accelerated Commercialization

by BONEZONE | Oct 2012

Cleveland Clinic Innovations and The Ohio State University's Technology Commercialization and Knowledge Transfer Office entered into an alliance to accelerate and commercialize medical innovations. The collaboration is focused on improving and extending the lives of patients, and will have a positiv ... Read more »

Supply Chain Development in Orthopaedics

by BONEZONE | Oct 2012

The following is a transcript from the OMTEC 2012 Opening Panel Discussion, Supply Chain Development in Orthopaedics. Video available online.  Moderator, David Floyd: Challenges for OEMs mean challenges for the suppliers. The tightening of regulatory scrutiny, more overseas manufacturing ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Oct 2012

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk. Accel SpineMatisse Anterior Cervical Interbody Fusion Cage, K121569*• ... Read more »

Polymer Composite May Eliminate Bone Formation in Soft Tissue

by BONEZONE | Oct 2012

With support from a 3-year, $2.9 million grant from the U.S. Department of Defense, researchers at Carnegie Mellon University, the U.S. Military Academy and the Naval Medical Center are developing nanostructural polymer-based treatments that may eliminate the pathological formation of bone in soft t ... Read more »

Spotlight on Titanium: An Interview with C. Jeffrey Wise

by BONEZONE | Oct 2012

We posed two questions to C. Jeffrey Wise of Titanium Industries to gain knowledge on titanium from a supplier’s perspective. His responses follow. BONEZONE: Specifically, what causes the price fluctuations and availability of titanium? C. Jeffrey Wise: Price fluctuations for titanium are both c ... Read more »

The State of American Medicine - Orthopaedics and the Vampire Economy

by BONEZONE | Aug 2012

Individuals and private corporations, not the government, make the world better. Dr. Lee Hieb has studied economics and history, and has thoughts to share on how an ever-growing bureaucracy may affect orthopaedics. ... Read more »

Market Growth Rates in Orthopaedics - OMTEC 2012 Opening Panel Discussion

by BONEZONE | Aug 2012

Where do you see the orthopaedic market going from here? Is orthopaedics still a growth story? Is the early intervention space an expanding market? ... Read more »

Medicare: Trends in Beneficiaries Served and Hospital Resources Used in Implantable Medical Device Procedures

by BONEZONE | Aug 2012

Results from a U.S. government agency report summarize data on average length of stay, patient characteristics, discharges, etc. Highlights include: In the U.S. in 2009, knee, hip and shoulder replacement and lumbar fusion procedures accounted for 98% of Medicare's orthopaedic implantable device ... Read more »

Blue Cross Blue Shield of Michigan and Local Hospitals Seek to Improve Quality of Hip and Knee Replacement

by BONEZONE | Aug 2012

The newly-formed Michigan Arthroplasty Registry Collaborative Quality Initiative will work with Blue Cross Blue Shield and local hospitals to develop best practices for hip and knee replacement procedures. The initiative builds upon collaboration between the Blues and hospitals that has improved qua ... Read more »

FDA to Guide Device Makers on Marketing Application

by BONEZONE | Aug 2012

FDA plans to provide medical device makers feedback before they apply for marketing approval to help companies identify regulatory requirements early in the device development process. The new program, called Pre-Sub, was introduced one day after the Congress passed the FDA User Fee Reauthorization ... Read more »

Young Injured Athletes May Fare Better when Treated with Autograft ACL

by BONEZONE | Aug 2012

Studies suggest that young athletes who underwent anterior cruciate ligament (ACL) reconstruction with allograft were ~7 times more likely to require revision surgery vs. those who received autograft. Further, ACL allograft reconstructions were found to fail much earlier, on average, than autograft. ... Read more »

Gluing Bones with Polyurethane Hierarchical Nanocomposites

by BONEZONE | Aug 2012

Most bone adhesives are not able to withstand stresses that materials would find in vivo. Synthetic adhesives often pose biocompatibility problems, leading to necroses or higher infection rates. Researchers at the University of Illinois Urbana-Champaign are investigating improvements to the mechani ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Aug 2012

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk. CitieffeExternal Fixator, K113384 For knee or elbow applications Fo ... Read more »

Big Government's Argument for Government-run Medicine - Orthopaedics and the Vampire Economy

by BONEZONE | Jul 2012

Big government seeks to increase access to healthcare, increase quality and decrease costs. How does the government do the opposite of this in every sense?  ... Read more »

An Environment of Oppresive Taxation and Overregulation - Orthopaedics and the Vampire Economy

by BONEZONE | Jul 2012

Taxation and overregulation are sucking the blood out of the American economy - and out of us.  ... Read more »

What are the Symptoms of America's Disease of Decline? - Orthopaedics and the Vampire Economy

by BONEZONE | Jul 2012

General symptoms include under- and unemployment, escalating prices, diminishing middle class. ... Read more »

What are the Economic Signs of America's Disease of Decline? - Orthopaedics and the Vampire Economy

by BONEZONE | Jul 2012

Economic signs: Criminalization of violators; spending and borrowing; syndicalism; autarky... ... Read more »

What is the Diagnosis? How do we Survive? - Orthopaedics and the Vampire Economy

by BONEZONE | Jul 2012

Filtering these signs and symptoms through experts, F.A. Hayek, William Welk and Thomas DiLorenzo, Ph.D.  ... Read more »

What is the Outcome? - Orthopaedics and the Vampire Economy

by BONEZONE | Jul 2012

What was the outcome of these economic realities? ... Read more »

Conclusions: The Tipping Point - Orthopaedics and the Vampire Economy

by BONEZONE | Jul 2012

Stay lean, mean and be able to turn on a dime. Consider the solution of the 3 Cs: Cash, catastrophic insurance and local charity  ... Read more »

Medical Device Excise Tax - OMTEC 2012 Opening Panel Discussion

by BONEZONE | Jul 2012

Why is the Medical Device Excise Tax bad for the orthopaedic industry? Are the orthopaedic device companies overreacting to the Excise Tax? How will the Medical Device Excise Tax affect smaller companies? ... Read more »

Trends in Innovation and R&D Investment - OMTEC 2012 Opening Panel Discussion

by BONEZONE | Jul 2012

What are the trends in R&D investment with orthopaedic companies? Are today's hip and knee replacements good enough? ... Read more »

Supply Chain Development in Orthopaedics - OMTEC 2012 Opening Panel Discussion

by BONEZONE | Jul 2012

What are the key overall trends for orthopaedic suppliers? Does the volume of inventory that OEMs keep onhand have a direct impact on the supply base? Do offshore manufacturing facilities affect OEM make vs. buy decisions? Does the investment community pay attention to the supply segm ... Read more »

FDA - The Fly in the Ointment - OMTEC 2012 Opening Panel Discussion

by BONEZONE | Jul 2012

Is the FDA in the "denial" business? Is the FDA just in an "anti-industry" phase, or will this trend become the new status quo? What is the impact of regulatory compliance policy on the supply chain? ... Read more »

The Orthopaedic Industry in Five Years - OMTEC 2012 Opening Panel Discussion

by BONEZONE | Jul 2012

Imagine we are attending OMTEC 2017 - what one thing in the orthopaedic industry will be most fundamentally changed?  ... Read more »

Natural Killer Cells Found to Play Important Role in Chondrocyte Rejection

by BONEZONE | Jun 2012

Studies indicate that human Natural Killer (NK) cells, part of the innate immune system, play a key role in rejection following xenotransplantation of porcine chondrocytes. A research team from the Bellvitge Biomedical Research Institute is investigating porcine chondrocyte transplantation to human ... Read more »

Gel Could Repair Cartilage Following Debilitating Sports Injuries

by BONEZONE | Jun 2012

Researchers at the University of Sydney are developing an injectable hybrid hydrogel that mimics the behavior of chondrocytes, and could have application in the repair of damaged cartilage, particularly in the knee. Chief investigator on the project, Associate Professor Fariba Dehghani, has stated ... Read more »

Metal-on-Metal Hips in the News

by BONEZONE | Jun 2012

Metal-on-Metal Hips in the News FDA to discuss risks and benefits of metal-on-metal hip replacements: Expert, patient recommendations being sought. FDA's Orthopaedic Device Advisory Panel will meet in June 27-28, 2012 to seek expert scientific and clinical advice on the risks and benefits of metal ... Read more »

The Orthopaedic Regulatory and Clinical Affairs Program at Grace College: A Joint Partnership

by BONEZONE | Jun 2012

Grace College shares an address with a $38 billion global industry in Warsaw, Indiana, the orthopaedic capital of the world. Today, device innovators like Biomet, DePuy and Zimmer are also getting into the business of education—out of necessity. The Lilly Endowment, an Indiana-based foundation th ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Jun 2012

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk. Ascendx Spine Acu-Cut Vertebral Augmentation System, K113452 For use ... Read more »

Spaghetti Highways: Tools of Regenerative Medicine?

by BONEZONE | Jun 2012

Researchers are investigating synthetic nanofilament gels resembling spaghetti that may serve as smart scaffolds for a variety of applications, including the regeneration of cartilage and bone. So-called “noodle gels” may align stem cells for proper repair of damaged tissue, and gels containing ... Read more »

“Bone-like” Nanofibrous Scaffold May Spur Osseointegration in Orthopaedic Applications

by BONEZONE | Jun 2012

Researchers are investigating the performance of electrospun polyvinyl alcohol, nano-hydroxyapatite and collagen nanofibers as biomimetic materials for modifying implant surfaces to encourage osseointegration for orthopaedic applications. Electrospinning is a technique that may enable fabrication o ... Read more »

FDA and industry reach agreement in principle on medical device user fees

by BONEZONE | Mar 2012

FDA and representatives from the medical device industry reached an agreement in principle on proposed recommendations for the 3rd reauthorization of a Medical Device User Fee program. Recommendations would authorize FDA to collect $595 million in user fees over 5 years, plus adjustments for inflati ... Read more »

Sharp Rise in Use of Bone Growth Factor for Spinal Fusion Surgery

by BONEZONE | Mar 2012

Studies suggest that the use of bone morphogenetic protein (BMP) for spinal fusion has risen sharply over the past decade, increasing costs substantially with no evidence of improved outcomes. Analysis of ~17,000 spinal fusion procedures to treat lumbar spinal stenosis revealed an increase of use f ... Read more »

Study suggests that nanodiamond coatings are safe for implants

by BONEZONE | Mar 2012

Researchers are investigating the ability of nanodiamond coatings to reduce wear in joints made of metal alloys. Debris from metal surfaces is absorbed by macrophages, which secrete chemicals that cause swelling and pain. Studies have suggested that diamond coating may shed less debris and in small ... Read more »

New Technology to Track Movement and Durability of Implants in Hip and Knee Replacement Patients

by BONEZONE | Mar 2012

A new tracking system developed by Halifax Biomedical is being used by Midwest Orthopaedics at Rush physicians to allow patients with hip and knee replacements to know over time how their implants are interacting with their bodies. This marks the first time in the U.S. that surgeons are implanting ... Read more »

SIRAKOSS develops new synthetic bone graft substitute, MaxSi

by BONEZONE | Mar 2012

SIRAKOSS has developed MaxSi™, a synthetic bone graft substitute, and is in pursuit of funding to support regulatory clearance and clinical trials for the product, to support global market introduction. The company will initially focus upon applications in the spinal market, to be followed by tra ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Mar 2012

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk. Arrowhead Medical Device TechnologiesArrow-Lok Digital Fusion System, K ... Read more »

Blogs and Apps that Bring Solutions

by BONEZONE | Mar 2012

  Business Intelligence Solutions: Automating the Business of Regulatory Compliance;  GHX: The Healthcare Hub blog ... Read more »

Imaging Analytics: Optimizing Time Efficiencies

by BONEZONE | Dec 2011

ORTHOWORLD is pleased to announce the inclusion of ImageIQ in the educational session lineup for OMTEC 2012. Prior to its formation as a stand-alone company, ImageIQ operated for over a decade as a core service within the Cleveland Clinic. Today, ImageIQ offers a unique solution for biotechnology a ... Read more »

Sector Snapshot: The Orthopaedic OEM and Supplier Markets

by BONEZONE | Dec 2011

In 2009, ORTHOWORLD estimated annual global orthopaedic supplier market sales to be approximately $2 billion. At that time, slowing growth in the orthopaedic original equipment manufacturer (OEM) sector was reflected in the supplier side, though competition remained high and consolidation/collaborat ... Read more »

Blogs and Apps That Bring Solutions

by BONEZONE | Dec 2011

  Improve Sales Productivity and Decrease Training Costs with RepAssist;  Download New EduQuest Advisories on Your Kindle ... Read more »

Leading Strategic Initiatives Blog: Tools and Insights for Turning Vision into Results

by BONEZONE | Dec 2011

Greg Githens has substantial direct experience in designing, developing, leading and coaching the direction of strategic initiative programs. BONEZONE readers first met Mr. Githens in 2008 at his OMTEC workshop, “Practices and Skills for Innovation and High-Speed New Product Development.” Since ... Read more »

A Surgeon's Thoughts on Moving Forward

by BONEZONE | Dec 2011

We recently queried our Orthopaedic Surgeon Editorial Board to learn their personal views on industry challenges. The first response came from Charles R. Gordon, M.D.   Charles Gordon, M.D. is a clinician, scientist and entrepreneur. His experiences as a neurosurgeon and in the care of patien ... Read more »

Funding Activity in Orthopaedics and Spine

by BONEZONE | Dec 2011

Transactions are presented alphabetically by name of company, and represent funding secured or planned-for. Amendia raised $0.45MM of planned $5MM roundProducts include Savannah MIS polyaxial pedicle screw, Phenix PEEK-OPTIMA cervical interbody device, Diamond anterior cervical plate Ascendx Spi ... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Dec 2011

The following companies recently received strategic FDA 510(k) clearances for devices in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk. Algea TherapiesAffirm Vertebral Compression Fracture System ... Read more »

Merger and Acquisition Activity in Orthopaedics and Spine

by BONEZONE | Dec 2011

Transactions are presented by quarter of closure, then alphabetically by name of acquired company. 1Q11 Applied Spine Technologies (AST) acquired by Rachiotek Will continue U.S. clinical trials for Stabilimax spine stabilization system (>100 patients enrolled) Beijing Wei Rui Li Medical ... Read more »

Challenges in the Supply Chain

by BONEZONE | Dec 2011

As stated by the Supply Chain Council, current economic pressures have had at least one positive effect: companies have taken an intense look at their supply chains, questioning all assumptions and endeavoring to root out inefficiencies. Roundtable discussions allow OEMs and suppliers to learn from ... Read more »

BONEZONE Videos Main Page

by BONEZONE | Oct 2011

Welcome to BONEZONE's Video Page.  Over the coming months, we will bring you instructional and informative presentations from individuals and organizations committed to helping you solve commercialization challenges, identify opportunities and improve your performance.  Would you like to s ... Read more »

Thoughts on Low-Cost Orthopaedic Device Companies

by BONEZONE | Oct 2011

In July, The Wall Street Journal published an article titled “Low-Cost Orthopedic Device Firms Aim To Shake-Up Market.” The following thread arises from an ORTHOWORLD Linkedin group discussion in which the question was posed, What are the group's thoughts/opinions on small firms offering discou ... Read more »

BSI Enhances its Medical Device Training Curriculum with RABQSA

by BONEZONE | Oct 2011

RABQSA International (RABQSA) and BSI Group America have co-developed an innovative Medical Devices training curriculum, created for individuals wishing either to become trained to audit to the Medical Devices Standard (ISO 13485) or simply to understand the requirements of a medical devices quality ... Read more »

Summary of the Patient Protection and Affordable Care Act

by BONEZONE | Jun 2010

Dear Reader, I attempted to read all 234,812 words of the Patient Protection and Affordable Care Act. (By comparison, Harry Potter and the Order of the Phoenix clocks in at 257,000 words.) Even with a strict Catholic primary education and two college degrees, I found it nearly completely incomprehe ... Read more »

Forrest R. Whittaker, Chief Executive Officer, Avalign Technologies, Inc.

by BONEZONE | Jun 2010

Mr. Whittaker was named Chief Executive Officer of Avalign Technologies, Inc., in January 2007. His company-wide responsibility covers the four operating divisions of Avalign: Advantis Medical, Instrumed International, Nemcomed and NGInstruments. Mr. Whittaker has over 30 years of experience in the ... Read more »