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Articles in category: Business Critical

Orthopaedic Pediatric Market Attracts New Products and Players

by BONEZONE | Sep 2017

The pediatric segment of the orthopaedic market is growing rapidly. Consider some of these happenings since 4Q16 as you plan future product development....

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 »

EIT Acquires 3D-Printed Spine Patents

by BONEZONE | Aug 2017

Emerging Implant Technologies acquired a portfolio of 3-D printed expandable spinal fusion cages for vertical and lateral expansion. The first products based on these patents will launch in 2018.... Read more »

Alphatec Spine Set for Rebuilding

by BONEZONE | Aug 2017

Alphatec Spine posted 2Q17 revenue of $24.4MM, -24.4% vs. 2Q16, and 1H17 revenue of $52.4MM, -21.2% vs. 1H16. Though revenues continue to underperform vs. the prior year, leadership sees substantial opportunities for turnaround.... Read more »

Improve Your Performance With These Tips

by Carolyn LaWell | 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 »

Nail Your Next Interview

by Carolyn LaWell | Aug 2017

Applicants have the upper hand in today’s job market due to the large number of open positions and state of industry growth. But you'll still have to work hard at landing your next job.   ... Read more »

Orthopaedics' Talent Gap: Working to Fill the Manufacturing Void

by Carolyn LaWell | Aug 2017

The collective brain power and skill set of the individuals within a company make that business successful. The orthopaedic industry faces hiring obstacles that hinder company and, ultimately, industry growth.... Read more »

ConMed Acquires MedShape’s ACL System to Boost Arthroscopy Portfolio

by BONEZONE | Jul 2017

Revamped marketing and R&D priorities, product launches, recent licensing agreements and now, an acquisition and portfolio expansion with the ExoShape system—all play a part in the company's multi-pronged turnaround initiative. The all-PEEK fasteners fill a gap in the company's offerings.... Read more »

Zimmer Biomet CEO Resigns

by Julie Vetalice | Jul 2017

Zimmer Biomet announced preliminary 2Q17 overall results alongside news of the departure of David Dvorak, its CEO of ten years. Dan Florin, Senior Vice President and CFO, will serve as interim CEO.... Read more »

Arthroscopy/Soft Tissue Technologies to Watch: 1H17 Funding Recap

by Julie Vetalice | Jul 2017

Funding announcements that we tracked from orthopaedic companies in 1H17 included eight arthroscopy/soft tissue-related technologies we’d like to highlight because of their novelty and early-stage backing.... Read more »

Want to Talk About Your Invention? Follow These Five Rules

by John W. Boger, Esq. | Jul 2017

Before you show your invention or share your idea, get familiar with these five rules to protect yourself and your creation.... 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 »

Upgrade Your Orthopaedic Toolbox to Achieve Your 2017 Priorities

by Carolyn LaWell | May 2017

Companies are exploring myriad approaches to diversification, from launching new brands to entering new markets to engaging in acquisitions. These paths are often directed by company size and focus.... Read more »

Orthopaedic Industry Revenue Reaches $48.1 Billion

by Carolyn LaWell | May 2017

Orthopaedic industry revenue reached $48.1 billion worldwide in 2016 and grew at 3.2%, ~$1.5 billion over 2015, according to our estimates published in the ORTHOPAEDIC INDUSTRY ANNUAL REPORT®. ... 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 »

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 »

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 »

The Forgotten Phase of M&A: Post-Close Supply Chain Integration

by David Finch | Feb 2017

Proper implementation post-close will allow your supply chain to deliver immediate and long-term value and avoid integration delays and disruptions.... Read more »

What Great Product Managers Can Teach Us About Our Work

by Carolyn LaWell | Jan 2017

What is your individual product? What do you create, day in and day out, for your colleagues and your customers? Applying lessons in communication, decision making and strategy from great product managers may spur new ideas for ways to think in an even bigger picture.... Read more »

The Forgotten Phase of M&A: Mitigating Supply Chain Risks

by David Finch | Nov 2016

The primary responsibility of the supply chain team post-M&A is the assurance of uninterrupted upstream and downstream product supply. These essential steps will assist you in identifying supply chain risk and developing a plan to minimize that risk.... 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 »

The Forgotten Phase of M&A: Supply Chain Infrastructure

by David Finch | Sep 2016

Avoid disruptions in customer service and financial performance by reviewing the people, processes and supporting systems of upstream and downstream supply chains.... 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: 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 »

Medtronic, Zimmer Biomet Enter 2-level Cervical Disc and Robotic Markets

by Carolyn LaWell | Aug 2016

In efforts to invigorate revenue growth, Medtronic and Zimmer Biomet have focused on niche technologies that expand their portfolios—but have yet to prove wide scale adoption.... Read more »

What the Future of Orthopaedics Means for You

by Carolyn LaWell | Jun 2016

To thrive in the healthcare environment of tomorrow, device companies will need to operate within a greater portion of the supply chain, assisting upstream and downstream customers in finding operational value. This will require OEMs to forge stronger relationships, focus on internal efficiencies an... 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 »

Proper Equipment Utilization Reduces Costs and Improves Margins

by David Finch | Jun 2016

When it comes to reducing cost or improving margins, the first place many companies go is their suppliers. Although there may be opportunity there, often the most cost-saving and margin-improving benefits can be found on their own factory floor. A good tool to measure this is to calculate your Overa... Read more »

9 Naïve Notions About S&OP

by Tom Wallace | Jun 2016

In advance of OMTEC 2016, BONEZONE is looking back at some timeless articles and presentations from previous conferences that energized audiences and equipped attendees with actionable solutions. In this article, Tom Wallace pulls back the curtain on 9 Sales & Operation Planning (S&OP) Myths... Read more »

Evaluating Opportunities in a Dynamic Market

by Mark Siders, Ph.D. | Jun 2016

In advance of OMTEC 2016, BONEZONE is looking back at some timeless articles and past presentations that energized audiences and equipped attendees with actionable solutions. Mark Siders' framework for evaluating opportunities provided insight into some of the primary motivations that would lea... 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 »

AAOS Conversations Center on CJR and Future of Bundled Payments

by Carolyn LaWell | Mar 2016

The upcoming launch of the Comprehensive Care for Joint Replacement program fueled Annual Meeting conversations regarding the best response by device companies to bundled payment reimbursement models, including those that extend beyond joint reconstruction. Regulatory, R&D and supply chain folks... Read more »

AAOS 2016 Recap: Product Launches and Clearances

by Hannah Corcoran | Mar 2016

Industry trends such as bundled payments, additive manufacturing and robotics were hot topics at this year’s AAOS Annual Meeting.... 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 »

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 »

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 »

Supplier Consolidation Continues with Greatbatch’s Acquisition of Lake Region

by Carolyn LaWell | Oct 2015

Greatbatch purchased Lake Region for ~$1.73 billion, allowing the company to scale parallel to its main customers—Johnson & Johnson, Medtronic and St. Jude Medical. ... Read more »

Manufacturing or Selling Medical Devices in Mexico: A Regulatory Conundrum

by John Gagliardi | Oct 2015

Mexico is making significant steps on in-roads into the medical device industry and is ready for success. Industry analysts predict that the fabrication and selling of medical devices and related technologies will increase 75 percent over the next decade.... Read more »

Brazil Remains Among Top Ten Markets, Despite Economic Downturn

by Hannah Corcoran | Oct 2015

Claiming the 7th largest economy in the world and the largest in South America, Brazil is a force in the global medical device market.... 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 »

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 »

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 »

Executives Warn of Paradigm Shift in R&D Spend

by Carolyn LaWell | Aug 2015

The keynote addresses at OMTEC 2015 highlighted the bottleneck between product development and product adoption.... Read more »

Zimmer Closes Biomet Acquisition

by Carolyn LaWell | Jun 2015

Zimmer has completed its acquisition of Biomet to form the world's second-largest orthopaedic device company, with estimated market share of 17 percent.... Read more »

Globus Medical Completes Acquisition of Supplier Branch Medical

by Carolyn LaWell | Jun 2015

The spine company, which currently uses Branch to manufacture about a quarter of its products, plans to boost that number to 50 percent or more in coming years.... 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 »

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 »

Survey Finds Most Med Device Companies Have Positive Outlook for 2015; Same Challenges Remain

by Hannah Corcoran | Feb 2015

A recent survey published by Emergo Group suggests that medical device professionals feel confident about the industry’s climate in 2015, despite continual challenges in the areas of pricing and regulations.... Read more »

ISO 55000 Released to Assist Operations Leaders with Financial Management

by Randy W. Rapin | Jan 2015

As the orthopaedic industry adapts to the rapidly changing worldwide healthcare market, it can learn from the failures of other large, global industries that lacked a unified plan for daily financial success. ISO 55000, released in 2014, allows leaders to keep a check on the pulse of their company's... Read more »

The Seven Phases of M&A

by Don Urbanowicz | Oct 2014

Given healthy balance sheets and cheap debt, large and mid-sized buyers are well positioned to pursue acquisition opportunities in 2015 and beyond. CEOs seeking to buy or sell should consider these best practices and expert tips.... 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 »

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 »

Sunshine Act and Beyond: Improving Compliance

by Vahan Minassian | May 2014

A crucial component of the new regulatory environment is adherence to the Physician Payment Sunshine Act, requiring manufacturers to report payments or transfers of value made to HCPs and teaching hospitals.This article provides an overview of current challenges and key strategies for enhancing comp... Read more »

The Fallacy of Profit as a Percentage of Sales: Part II

by Doug Hicks | May 2014

I previously explained why profit as a percentage of sales is a flawed performance measurement for a manufacturing organization and suggested alternative measurements. These alternatives are, however, only surrogates for this somewhat more complex methodology.... 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 »

What’s Ahead for Healthcare?

by Ted Kucklick | Mar 2014

What’s ahead for healthcare in the era of digital health, fundraising, crowdfunding and Obamacare? The Consumer Electronics Show and OneMedForum shed some light for the medical device industry.... Read more »

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Mar 2014

Here we present 2013 vs. 2012 revenue for a range of orthopaedic and spine companies. Company specific performance highlights follow. ... Read more »

The Fallacy of Profit as a Percentage of Sales: Part I

by Doug Hicks | Mar 2014

Profit as a percentage of sales is about as good a tool for measuring the value of a product or customer to an organization as a thermometer is for determining a wind-chill index. Consider this approach for true measurement.... 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 »

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Dec 2013

Here we present 3Q13 revenue for a range of orthopaedic and spine companies. Company specific performance highlights follow. ... 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 »

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 »

How to Find Savings in the Excise Tax Era

There is much more to the medical device excise tax than reporting and remitting. Some manufacturers might benefit from re-evaluating their obligations to reduce their liability.... Read more »

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Oct 2013

Here we present final 2Q13 revenue for orthopaedic and spine companies. Company specific performance highlights follow.... 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 »

Mindfulness Training Adopted to Reduce Errors

by Max Sherman | Sep 2013

An increased number of warning letters and recalls due to human error have the FDA focused more on quality assurance than solely regulatory compliance. Specific training can improve memory capacity and task focus.... Read more »

Energize Your Team to Increase Productivity and Competitive Advantage

by Susan Germaine | Aug 2013

If you want a team that will outperform and overcome obstacles, develop these characteristics of an anabolic leader.... Read more »

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Aug 2013

Revenue for companies that have reported 2Q to date is presented below. Company specific performance highlights follow.... Read more »

India Considering New Device Regulations

by John Gagliardi | Aug 2013

With an evolving regulatory situation, medical device companies must stay up-to-date in order to achieve success in India. Orthopaedic OEMs should take the following steps to gain share in what will soon be the most populated country in the world.... 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 »

China Becomes Vastly Improved Player

by John Gagliardi | Jul 2013

China’s medical device market is growing fast and the competition is fierce. Companies looking to enter the market or expand their business need to understand the changing industry.... 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 »

Conquering the German Market in Six Months

by Stefan Pickartz | May 2013

The German healthcare and medical device industries are the largest in Europe. To be a successful player in the market, manufacturers need to understand industry structure and trends.... Read more »

Company Financials: Orthopaedics and Spine

by Julie Vetalice | May 2013

Here we present final 4Q12 and 2012 revenue for remaining companies, as well as Biomet’s latest fiscal quarter. Company specific performance highlights follow.... 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 »

Three Reasons Ireland’s Orthopaedic Sector Attracts Foreign Investments

by Brian Thornes, M.D. | Apr 2013

People, taxes and innovation are Ireland’s competitive advantage that attracts investment from overseas orthopaedic companies.... Read more »

Strategic Company Financials: Orthopaedics and Spine

by Julie Vetalice | Apr 2013

Here we present final 4Q12 and 2012 revenue for remaining companies, as well as Biomet’s latest fiscal quarter. Exhibit 1 displays orthopaedic sales increases by product segment for 2012 vs. 2011 unless otherwise noted. Performance highlights that follow pertain to a blend of 4Q12 and 2012.... 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 »

Six Steps to Successfully Executing a Strategic Plan

by Don Urbanowicz | Mar 2013

A strategic plan maps the key decisions an organization must follow in order to survive and thrive. These strategy and implementation steps act as a guide to ensure success.... Read more »

Entering the Market in Argentina

by Pablo Carbonell | Feb 2013

Argentina’s medical device industry has strengthened along with the country’s economy over the last decade, making it an attractive emerging market to do business. OEMs must first take these regulatory steps to manufacture or import products in this South American country. ... Read more »

Passing Brazil’s Inspections to Take Product to Market

by John Gagliardi | Jan 2013

Over the past few years, I have had the opportunity to help orthopaedic medical device companies prepare for and logistically manage inspections conducted by ANVISA. This article explains the Agencia Nacional de Vigilancia Sanitaria foundation upon which the regulatory framework is established, and ... 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 »

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 »

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Dec 2012

ORTHOWORLD’s estimates place 3Q12 market growth at 3% over 3Q11, as shown in Exhibit 1 on the following page. Performance highlights follow and pertain to 3Q unless otherwise noted.... Read more »

The Global Orthopaedic Supplier Market

by Julie Vetalice | Dec 2012

In 2011, ORTHOWORLD estimated 2009 annual global orthopaedic supplier market sales to be ~$2 billion. At that time, slowing growth from the 2008 orthopaedic original equipment manufacturer sector was reflected in supplier side revenue. In 2010 and 2011, the supplier market commenced signs of a gentl... 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 »

Untangling: Why Behavior Change is So Darn Hard

by Susan Germaine | Dec 2012

Most of us believe that we are fairly conscious about the decisions and choices we make, when in reality, our life experiences have programmed our brains to think, anticipate and respond in ways—both positive and negative—that are consistent with our pasts. Our brains have the amazing capacity t... 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 »

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 »

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Oct 2012

ORTHOWORLD’s estimates place overall 2Q12 market growth at 5% over 2Q11, as shown in Exhibit 1. Performance highlights follow and pertain to 2Q12, unless noted otherwise.Exhibit 1: Increases by Product Segment: 2Q12 vs. 2Q11    NOTES TO EXHIBIT 11 Orthopaedic products; constant cu... Read more »

Medical Device Excise Tax: Achieving Compliance with Confidence

Complying with indirect taxes is a legal mandate that is not core to a business, yet the operational outlay is great. On January 1, 2013, indirect tax compliance for medical device manufactures will get even more complicated, burdensome and expensive. Passed as part of the Affordable Care Act (ACA)... 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 »

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 »

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Aug 2012

ORTHOWORLD’s estimates place overall 1Q12 market growth at 4% over 1Q11, as shown in Exhibit 1. Performance highlights follow and pertain to 1Q12, unless noted otherwise. Exhibit 1: Orthopaedic Sales Increases1 by Product Segment: 1Q12 vs. 1Q11 NOTES TO EXHIBIT 1 Orthopaedic products; ... Read more »

WHO AM I? Who would I like to be? Engaged? Effective? Inspirational?

by Brian Moore | Jun 2012

The most important job we all face is to manage ourselves. The better job we do of it, the more effective and valuable we are. I am sure that most of you have heard the expression, “The only constant is change.” Issues of job security, constant regulation pressure, more expected for less, time p... 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 »

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Jun 2012

ORTHOWORLD’s estimates place overall 2011 market growth at 4% over 2010, as displayed in Exhibit 1. Performance highlights follow and pertain to both 4Q11 and 2011, as indicated.  Exhibit 1: Orthopaedic Sales Increases1 by Product Segment: 2011 vs. 2010 Notes to Exhibit 1 Orthopaedic p... 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 »

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 »

Do You Know Your Customer’s Boss?

by Malcolm Vivian | Mar 2012

Device companies, including those in orthopaedics, have traditionally recognized that their primary customer has been the physician. With the recent trend of hospitals acquiring physician practices and physicians seeking employment at hospitals, most device companies would admit they really don't kn... Read more »

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Mar 2012

ORTHOWORLD's preliminary estimates place overall 2011 market growth at 5% over 2010, as displayed in Exhibit 1. Performance highlights follow, and address both 4Q11 and 2011, as indicated. Exhibit 1Orthopaedic Sales1 Increases by Product Segment: 2011 vs. 2010 Notes to Exhibit 1:1. Orthopaedic p... 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 »

Raising Money for Your Medical Device Startup

by Ted Kucklick | Dec 2011

So, you have a great idea. Now what? Ideas by themselves are worthless. Executing on ideas takes capital. How do you go about getting this? Bootstrapping and Resourcefulness Tina Seelig, Professor of Entrepreneurship at Stanford, wrote a book, What I Wish I Knew When I Was 20. In it, she describes... 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 »

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 »

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 »

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Dec 2011

ORTHOWORLD estimates place overall market growth at 5% over 3Q10, as shown in Exhibit 1, which displays orthopaedic sales growth by product segment. Performance highlights follow, and relate to 3Q unless otherwise noted. Exhibit 1: Orthopaedic Sales Increases1 by Product Segment: 3Q11 vs. 3Q10 ... Read more »

Company Financials: Orthopaedic and Spine

by Julie Vetalice | Oct 2011

ORTHOWORLD estimates place 2Q11 market growth at 5% over 2Q10 as shown in Exhibit 1, which displays 2Q orthopaedic sales growth by product segment for select companies. Performance highlights follow.   Exhibit 1: Orthopaedic Sales1 Increases by Product Segment: 2Q11 vs. 2Q10  Notes to... Read more »

Blogs and Apps That Bring Solutions

by Julie Vetalice | Oct 2011

The Vested Outsourcing blog serves several purposes, including education, comment and, of course, fun. The blog comprises four dropdown pages that include summaries of the 10 Ailments that can disrupt or derail outsourcing deals, explanations of the Five Rules or principles that guide practitioners ... Read more »

Blogs and Apps that Bring Solutions

by Julie Vetalice | Aug 2011

Real-time Technology Solution Manages Orthopaedic Surgery Schedules, Inventory Tracking and Implant Traceability... Read more »

1Q11 Company Financials: Orthopaedic and Spine

by Julie Vetalice | Aug 2011

Here we present available company earnings for 1Q11. Our estimates place overall market growth at 4% over 1Q10, as seen in Exhibit 1, which displays 1Q orthopaedic sales growth by product segment for select companies. Performance highlights follow. Highlights pertain to 1Q11 unless otherwise noted. ... Read more »

How (Not) to Fail as an Entrepreneur (or R&D Engineer, Buyer, Product Manager...)

by Ted Kucklick | Aug 2011

Dear Reader: While this article focuses upon avoiding the common pitfalls of the start-up entrepreneurial company, there are lessons here that anyone working in any company can benefit from, since at the end of the day we are really all entrepreneurs, and work in an increasingly competitive world. W... Read more »

2010 Company Financials: Orthopaedic and Spine

by Julie Vetalice | Jun 2011

Here are the remaining full-year performance highlights for select orthopaedic companies. We include 4Q10 revenue breakdowns where available, as well. Detail relates to full year, unless otherwise noted. Exhibit 1 displays growth by product segment. Exhibit 1: Orthopaedic Sales1 Increases by Produc... Read more »

Blogs and Apps That Bring Solutions

by Julie Vetalice | Jun 2011

  InVivoLink Introduces OrthoPod, a Tablet-based Implant Registry Application;  Emergo Group Medical Device Blog for QA/RA Professionals;  IMARC Research Blog... Read more »

2010 Company Financials: Orthopaedic and Spine

by Julie Vetalice | Mar 2011

The following summarizes publicly available year over year earnings results to date. Our estimates place year over year market growth at 5% thus far, as indicated in Exhibit 1, which displays growth by product segment. Performance highlights relate to 2010, unless otherwise noted. Exhibit 1: Orthop... Read more »

Blogs and Apps That Bring Solutions

by Julie Vetalice | Mar 2011

Bradshaw Medical offers its free Bradshaw Medical iPhone App;  ODIN Technologies’ “Insider's BLOG from the RFID Experts”;   Mobile Workforce workSmart!: Cloud-based Solution for End-to-End Control of Supply Chain;      Precision Machined Products Association Blog... Read more »

Comparative Effectiveness: From Theory to Practice

by Isabella Sledge, M.D. | Dec 2010

How is comparative effectiveness research being used for decision-making in orthopaedics, and what does the future hold? Comparative effectiveness research (CER) refers to assessing the body of evidence that compares the benefits and harms of different treatment methods. What differentiates CER fro... Read more »

3Q10 Company Financials: Orthopaedic and Spine

by Julie Vetalice | Dec 2010

Following is a first look at select company financials for 3Q10. Our estimates place year over year market growth at 4%, as indicated in Exhibit 1, which displays growth by product segment. Performance highlights relate to 3Q10, unless otherwise noted. Exhibit 1: Orthopaedic Sales1 Increases by Pro... Read more »

The Benefits of Capturing Product Data Are High - The Costs of Doing So Don’t Have to Be

by Geoffrey T. Mather | Dec 2010

Co-authored by Keith Kennedy Perhaps more than at any other time in recent years, we are witnessing rapid changes in the way products and procedures are developed and measured in orthopaedics. In addition to innovative product advancements, there is a groundswell of interest in tracking product and... Read more »

Selective Retention: The Key to Keeping the People You Want

by Drue De Angelis | Dec 2010

Finding good people is a challenge many have voiced in 2010. In the last issue of BONEZONE, Ben Craigs disposed on those aspects unique to hiring “Generation Me.” (See “Generation [Hire] Me,” BONEZONE Fall 2010.) In this article, we focus upon keeping the quality people you already have as e... Read more »

2010 Orthopaedic Year in Review, Positive Signs for 2011

by Stephen Blumenreich | Dec 2010

Co-authored by Christoper Dorn It would be easy to look at 2010 and focus on the negative. Difficult economic times, including higher levels of unemployment, have put downward pressure on procedure volumes. The financing environment has been challenging overall, but especially so for earlier-stage ... Read more »

Generation (Hire) ME

by Ben Craigs | Sep 2010

You are extremely lucky that this publication found out I was available for a writing project and that I am taking my valuable time to write this insightful article. Without my expertise, it is likely you would not be fully educated on this topic and this publication would lose credibility having no... Read more »

Industry’s New Customer: Hospital + Surgeon

by Marshall Steele, M.D. | Sep 2010

This article appeared in ORTHOKNOW® July 2010. Your peers found it to be extremely valuable and educational; hence we are republishing it here in its entirety. --Editor I started practicing orthopaedics in 1975, when joint replacement was in its infancy. There is no doubt that, along with arthro... 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 »

The Coming Tide of Comparative Effectiveness: Tsunami or Wave of Opportunity?

by Isabella Sledge, M.D. | Jun 2010

Comparative effectiveness: “…comparing two (or more) treatments to determine which is most effective.” Turkelson CM. “Comparative effectiveness: What’s it all about?” AAOS Now, September 2009. “…the generation and synthesis of evidence that compares the benefits and harms of alter... Read more »

Enter 2010 and Leave Fear Behind

by Shirley A. Engelhardt | Mar 2010

I cannot recall a more unsettling year in the more than 20 years that I’ve been involved in orthopaedics. Last year, 2009, began with a global economic meltdown and ended with many folks still scared into non-action. Fear and uncertainty reverberated down the halls of many a hospital and in the co... Read more »