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Articles in category: Business Critical

Infographic: Orthopedics' Largest Companies

by BONEZONE | Apr 2021

Seven companies hold 64% of the orthopedic industry's market share. Each of these companies post annual revenue over $1 billion....

Read more »

A Coating Primer: Technologies for Orthopedic Implants

by Parimal Bapat | Apr 2021

Coatings play a pivotal role in the success of an orthopedic implant. Manufacturers should understand the differences among the numerous types of coatings, including titanium plasma spray, non-spherical and spherical bead coatings and hydroxyapatite.   ... Read more »

4 Spine Acquisitions from 1Q21

by BONEZONE | Apr 2021

NuVasive, SeaSpine, Implanet and Neo Medical announced purchases to expand their spine portfolios.   ... Read more »

Infographic: 15 Orthopedic Robots

by BONEZONE | Mar 2021

The number of orthopedic robots has expanded to 15 systems from 12 companies. While today's robots are primarily used to perform more predictable procedures through real-time feedback and implant placement accuracy, future generations are expected to incorporate AI, AR and greater surgical... Read more »

From Powder to Package: Identifying the Right AM Suppliers

by 3D Systems | Mar 2021

Top supplier to orthopedic device manufacturers partners with additive manufacturing experts to deliver scaled manufacturing of advanced devices ready for the surgical suite.... Read more »

Breakthrough Technology: A Look at Orthopedic Companies with FDA Device Designation

by Kathie Taylor | Mar 2021

To keep a finger on the pulse of innovative orthopedic technologies close to entering or on the market, and to understand the hurdles they’ve cleared thus far, we highlight a dozen+ companies that have participated in FDA's Breakthrough Devices Program.... Read more »

In the Zone: An Ode to Problem Solving

by Carolyn LaWell | Mar 2021

To be a prolific problem-solver, you need to ensure that you are asking the right questions. The March issue of BONEZONE highlights actions and advice from some of the industry's great problem solvers. ... Read more »

Infographic: Orthopedic Industry Revenue 2020 vs. 2019

by BONEZONE | Feb 2021

Orthopedic industry revenue declined more than 10% in 2020 vs. 2019, according to ORTHOWORLD®'s early estimates.The nature of orthopedic conditions meant that not all markets experienced the same decreases in revenue. ... Read more »


From One Leader to Another: Bridge Your Teams’ Communication Divides

by Patrick McGuire | Feb 2021

Companies that have exceled at the transition of teams working from home are those that have incorporated and embody, as part of their own internal team culture, the positive benefits of diversity in age, personalities, work preferences and more.   ... Read more »

Sometimes ‘No’ is the Best Answer

by Carolyn LaWell | Feb 2021

With so many internal and external forces vying for your time and energy, it’s essential to be deliberate in what you say yes to.   ... Read more »

5 Considerations for Design for Manufacturing

by Kathie Taylor | Feb 2021

A well-planned DFM process can ensure function, reliability and quality so that orthopedic device companies meet their product goals.   ... Read more »

Combined Technologies Offer Stringent Finishing Results for Trauma Implants

by Rosler | Feb 2021

From intramedullary devices like nails and rods to cranial plates, there are numerous uses for trauma implants, each with its own unique surface finishing needs and requirements.... Read more »

8 Tips for Startups on Successful Execution

by Kathie Taylor | Jan 2021

Orthopedic startups should follow these eight tips for successful business execution.   ... Read more »

Infographic: 3 Top Orthopedic Trends for 2021

by BONEZONE | Jan 2021

As we consider 2021 trends, an increase in enabling technology adoption, procedure shifts to ASCs and M&A activity top the list. ... Read more »

Sensors Gain Spotlight in 3 Recent Orthopedic Announcements

by BONEZONE Staff | Jan 2021

Stryker and Exactech acquired new technology, while Canary Medical received new funding. The three companies will utilize tools in joint replacement, including intraoperative feedback, implanted sensors and wearables.   ... Read more »

Infographic: Top Orthopedic Companies' M&A History

by BONEZONE | Nov 2020

DePuy Synthes, Stryker, Zimmer Biomet and Smith+Nephew made 40 orthopedic company or technology purchases since 2016. We detail the who, what and when.... Read more »

Medtronic Launches Proprietary Surface Technology on AM Devices

by 3D Systems | Nov 2020

To unlock the advantages of additive manufacturing, Medtronic sought a partner that could assist with the regulatory path, offer integrated manufacturing and software solutions and expert help.... Read more »

Infographic: Top 10 Spine Companies with Subsegment

by BONEZONE | Oct 2020

Ten spine companies produced global sales of $100 million in 2019, serving a diverse set of needs across the market from deformity to trauma to artificial disc replacement to vertebroplasty.... Read more »

5 Tips Startups Need to Know for Success

by Kathie Taylor | Sep 2020

Nimble startups remain critical to driving market innovation in orthopedics. To experience success, companies need to time the market, focus heavily on product development and develop a strong pipeline. ... Read more »

Think Deep: Tools to be Less Distracted in Your Work

by Carolyn LaWell | Sep 2020

Ridding yourself of distraction to meaningfully focus on your work takes discipline and time. The result, though, enables more profound, more holistic quality of thought and less time investment overall.... Read more »

New Alloy Emerges in Response to Patient Sensitivities and Regulatory Changes

by Gaurav Lalwani, Ph.D. | Sep 2020

BioDur®, an essentially nickel- and cobalt-free stainless-steel alloy, has been identified for use in implantable medical devices and surgical instruments. Additionally, the material can be additively manufactured.   ... Read more »

Acquisition Combines NN, Inc. and MW Industries' Orthopedic Portfolios

by Carolyn LaWell | Aug 2020

MW Industries' parent company is acquiring NN Life Sciences for $825 million, and is combining the two entities into MW Industries Life Sciences.... Read more »

How to Accelerate Orthopedic Innovation with Additive Manufacturing

by Gautam Gupta, Ph.D. | Aug 2020

Industry leaders that adopt additive manufacturing are delivering highly effective products at a reduced overall cost and helping improve the standard of care.... Read more »

Additive Manufacturing Advancements to Boost Use in Orthopedics

by Kathie Taylor | Aug 2020

The additive manufacturing market is expected at a CAGR of +20% by 2024. The medical device industry, and orthopedics specifically, are expected to experience strong growth due to advancements in additive manufacturing technology and processes. ... Read more »

SI Joint Fusion Market Has Rapid Growth Potential

by Mike Evers | Aug 2020

Minimally invasive SI joint fusion is an increasingly common treatment for patients with low back pain and represents a high-growth niche within the spine market. ... Read more »

Zimmer Biomet’s mymobility Shows Data’s Promise in Orthopedics

by Carolyn LaWell | Jul 2020

Zimmer Biomet is making enhancements to its mymobility app while simultaneously advancing its OrthoIntel platform, which gathers data throughout a patient's care cycle. ... Read more »

Understand the Best Process for Your Surface Finishing

by Bernhard Kerschbaum | Jul 2020

Orthopedic component surfaces must be ground, smoothed and polished without changing their required shape and functionality to promote hygiene, sterilization and strength. Therefore, it is essential to understand the differences among finishing processes and technologies and the best application of ... Read more »

4 Orthopedic Companies to Watch from MedTech Innovator’s Cohort

by Patrick McGuire | Jul 2020

Orthopedic startups focused on enabling technology and new materials made MedTech Innovator's 2020 Cohort. The companies were chosen from over 1,000 applicants. ... Read more »

Video: How to Respond to Digital Health Disruption

by Carolyn LaWell | Jun 2020

How will COVID-19 spur the digital disruption in orthopedics? How should industry react? Our video interview with digital health expert Dr. Stefano Bini provides answers. ... Read more »

How Additive Manufacturing is Changing Orthopedic Device Development

by Jeph Ruppert | Jun 2020

Companies need to answer a series of questions before adopting additive manufacturing. While a valuable tool for orthopedic device design innovation, you first need to ensure that additive manufacturing is the appropriate solution for your desired outcome.... Read more »

Infographic: Top 5 Companies by Orthopedic Segment

by BONEZONE | Jun 2020

A look at the five largest orthopedic companies in each product segment shows 14 companies claim a spot in the ranking. ... Read more »

How to Prepare for Your Next Meeting

by Patrick McGuire | Jun 2020

People are shockingly bad at running meetings. These practices will allow you to prepare for and execute a meeting that embraces different opinions and feedback. ... Read more »

Orthopedic Outlook: COVID-19’s Impact on Industry Growth and Trends

by BONEZONE | Jun 2020

Global orthopedic sales increased by +3.8% to $53 billion in 2019. COVID-19 has created much uncertainty for the industry's forecast. We’re planning for a disruption to orthopedic procedure volumes and day-to-day business to last through 2020 and into 2021. ... Read more »

How to Transform Your Culture to Build Effective Teams

by Patrick McGuire | Jun 2020

Altering team culture can be a long journey, but organizations that are successful in this approach benefit from harmonious and productive environments.... Read more »

Additive Manufacturing Success Relies on Titanium Powder Quality

by Gaurav Lalwani, Ph.D. | Jun 2020

Titanium equivalency study white paper and degradation study webinar detail the properties of Ti64 ELI powder produced by the EIGA and PA processes.... Read more »

Traditional Metals Meet Mainstream Adoption in Orthopedics

by Kathie Taylor | May 2020

Here’s a look at some of the leading metals in the orthopedic market and what’s pushing the development of new materials and manufacturing processes.... Read more »

What Should an Industry 4.0 Workforce Look Like in Orthopedics?

by Heather Tunstall | May 2020

The advancement of automation on the manufacturing floor requires orthopedic companies to face a shift in talent acquisition and expectations, including a higher level of technical acumen needed to compete successfully in this space.... Read more »

M&A Update: Stryker and Wright Medical, RTI Surgical, ATEC

by Mike Evers | May 2020

Orthopedic M&A activity is challenged by the COVID-19 environment. We review earlier announced acquisitions and provide thoughts on future activity.   ... Read more »

COVID-19 Heightens Focus on the Cost of Orthopedic Care

by Carolyn LaWell | Apr 2020

In this video interview with Peter Althausen, M.D., we discuss how COVID-19 will change care delivery, including shifting procedures to outpatient settings and placing scrutiny on implant utilization.... Read more »

Infographic: Mid-Tier Orthopedic Device Companies

by BONEZONE | Apr 2020

The mid-tier orthopedic device companies generate revenue between $200 million and $500 million. In 2019, they combined to grow 5.8% year over year.... Read more »

6 Best Practices for Successful Product Commercialization

by Heather Tunstall | Apr 2020

You've settled on a concept for your next orthopedic device. Great! These critical steps will assist you through your feasibility, development and commercialization actions. ... Read more »

Orthopedic Companies Provide Help in Challenging Times

by Julie A. Vetalice | Mar 2020

COVID-19 has created unprecedented challenges for our healthcare system. A growing number of device manufacturers and suppliers have employed their manufacturing, technology and regulatory expertise to help hospitals and, ultimately, patients. ... Read more »

COVID-19: Orthopedic Procedure Deferrals Will Lead to Revenue Declines

by Mike Evers | Mar 2020

Orthopedic surgeries are being delayed for an unknown amount of time due to the fluid COVID-19 pandemic. Our guidance recommends that all companies in all market segments expect and plan for revenue decreases in 2020 and potentially beyond. ... Read more »

What You Need to Know About Surgeons and Hospitals Increasing Alignment

by Patrick Vega | Mar 2020

The hospital and physician relationship, historically fraught with mistrust and skepticism, is being supplanted by greater transparency and true collaboration. Device companies can leverage this trend as an opportunity.... Read more »

AAOS Cancels Annual Meeting. Now What?

by Carolyn LaWell | Mar 2020

The 2020 Annual Meeting was canceled out of concern of the spread of COVID-19. We anticipate more updates from the society, as well as planned announcements from device companies. ... Read more »

The Quality of Your Thought Matters

by Carolyn LaWell | Mar 2020

The quality of your thinking is demonstrated numerous times throughout your day, whether it be the questions you ask and the responses you give to colleagues’ questions or how you tackle execution of deep work. Your ability to think critically in small and big moments is directly linked to your pr... Read more »

7 Steps You Need to Follow to Develop a Quality Culture

by Jon Speer | Mar 2020

There’s a difference between meeting quality regulatory standards and fostering a quality culture in your device company. This guide walks you through the development, implementation and maintenance of a quality culture.... Read more »

Infographic: Top 10 Orthopedic Device Companies

by BONEZONE | Feb 2020

Billions of dollars separate the top 3 orthopedic device companies from the rest of the pack. Our infographic details the 10 largest players and highlights which company will enter the ranking if Stryker's pending acquisition of Wright Medical is complete.... Read more »

The Sterilization Saga: EtO and the Push for New Technology

by Heather Tunstall | Feb 2020

While the debate about EtO's environmental impact continues, industry and regulators are looking to standardize and increase capacity for lesser-used sterilization technologies. ... Read more »

What is the Future of Orthopedic Innovation? Insight from HSS.

by Carolyn LaWell | Feb 2020

Doug Leach, industry veteran turned HSS commercialization leader, talks digital tools, additive manufacturing and provider partnerships ahead of his OMTEC Keynote.... Read more »

Can Technology Boost DePuy Synthes' Knee Franchise?

by Mike Evers | Feb 2020

DePuy Synthes’ competitors have dominated both industry news cycles and the market itself. Rajit Kamal, Vice President and Global Knee Franchise Leader, aims to change that through a combination of hardware and technology.... Read more »

This is What it Takes to be Competitive in Today's Medical Device Market

by Heather Tunstall | Feb 2020

Findings from a new survey of 524 medical device professionals can help you benchmark yourself against best-in-class companies in the areas of product and quality management.... Read more »

SeaSpine, 7D Surgical Enter Co-marketing Agreement

by Julie A. Vetalice | Feb 2020

The relationship brings surgical guidance that is complementary to SeaSpine's current and future spinal systems.   ... Read more »

RSIP Vision: Company to Watch in Surgical Planning

by Julie A. Vetalice | Feb 2020

RSIP Vision has taken additional steps to apply its technologies to the planning of hip and shoulder replacement.   ... Read more »

Jabil Launches Healthcare Group, Cites J&J as a Factor

by BONEZONE | Feb 2020

Jabil combines Nypro with its orthopedic, spine, trauma and associated instruments businesses to deliver a breadth of advanced manufacturing solutions and technical capabilities.   ... Read more »

Year in Review: Orthopedic Companies with First U.S. Products

by Julie A. Vetalice | Jan 2020

One of our favorite lists that we compile every year is newer companies that hit our radar. This review pinpoints 17 companies that received their first FDA 510(k) clearances last year, so you’ll mostly find new names in the segments of Joint Replacement, Spine, Trauma Sports Medicine.... Read more »

RTI Surgical to Become Pure-Play Spine Company with Sale of OEM Business

by Julie A. Vetalice | Jan 2020

Subsequent to closing of the $490 million transaction, the company will be a global spine company targeting double-digit growth.   ... Read more »

Exactech Names New CEO, Darin Johnson

by Julie A. Vetalice | Jan 2020

New President and CEO Darin Johnson will build on Exactech’s foundation in joint replacement following two strong years of sales and investments in R&D, people and infrastructure.   ... Read more »

Anika Therapeutics to Acquire Parcus Medical and Arthrosurface

by Mike Evers | Jan 2020

The transactions diversify the company's revenue mix while expanding its product portfolio and pipeline.   ... Read more »

Johnson & Johnson Bolsters Digital Surgery Tools with Verb Surgical

by Julie A. Vetalice | Jan 2020

JNJ, parent to DePuy Synthes Companies, entered into an agreement to acquire the remaining ownership stake in Verb Surgical. The transaction is expected to close in 1H20.   ... Read more »

Conventus Orthopaedics Acquires Intramedullary Technology from IntraFuse

by Julie A. Vetalice | Jan 2020

Conventus Orthopaedics is expanding into lower extremity applications, adding to its self-expanding nitinol Conventus CAGE technology for novel 3-dimensional fracture management in the distal radius and proximal humerus.   ... Read more »

40+ Orthopedic Surgeons Form Network to Support New Companies and Innovation

by Natalie Shawver | Jan 2020

Orthopedic professionals seeking to collaborate on new technologies or to offer guidance may find Ortho Founders noteworthy. The organization seeks to be the go-to authority for surgeons with entrepreneurial interests. ... Read more »

10 Takeaways from Orthopedics in 2019

by Mike Evers | Dec 2019

Acquisitions, biologics, enabling technology and loss of market share by the big players all made our list. Read the specifics and access our projections for 2019 revenue by company and segment.... Read more »

3D Printing to Make Point-of-Care Manufacturing a Reality for Orthopedics

by Carolyn LaWell | Dec 2019

The ability to 3D-print orthopedic implants in a hospital setting continues to gain momentum with LimaCorporate and Hospital for Special Surgery building a new facility, as well as FDA engaging with stakeholders on guidance.  ... Read more »

Infographic: M&A Reshapes Contract Manufacturer Players

by Carolyn LaWell | Dec 2019

Our infographic illustrates how M&A activity has redefined the players in the orthopedic contract manufacturer market over the past 10 years.... Read more »

Globus Medical Leaders Discuss Joint Replacement and Robotics Expansion

by Mike Evers | Dec 2019

We sat down with leaders from Globus Medical to discuss their entrance into the joint replacement market, robotics’ role in orthopedic surgery and the company's future as a full-scale musculoskeletal player.... Read more »

Infographic: Top 10 Orthopedic Trauma Companies

by BONEZONE | Nov 2019

DePuy Synthes and Stryker combined hold more than 50% of the market share in the $7 billion+ trauma segment.... Read more »

Orthopedic Industry Investors Talk Funding Trends

by Heather Tunstall | Nov 2019

Smart tools and technologies that increase supply chain or operating room efficiencies are on investors’ shortlists for deploying capital in the musculoskeletal space.... Read more »

Stryker Boosts Extremities Portfolio with Wright Medical Acquisition

by Mike Evers | Nov 2019

Stryker entered a definitive agreement to purchase Wright Medical, speeding the company's path to leadership in extremities. ... Read more »

Smith+Nephew CEO Stepping Down

by Julie A. Vetalice | Oct 2019

Smith+Nephew CEO Namal Nawana will step down from his position on October 31, by mutual agreement, to pursue opportunities outside of the U.K. Incoming CEO, Roland Diggelmann, takes on the role in November.   ... Read more »

6 Companies Expand Robotic, Imaging, Navigation Tools via 2019 M&A

by Carolyn LaWell | Oct 2019

Acquisitions in the first nine months of the year afforded joint replacement and spine companies access to new enabling technologies to boost their robotic, navigation and imaging systems. We review the acquisitions and what they could mean each company's technology. ... Read more »

Keys to Understanding Your Chinese Colleagues

by Dale Tempco | Oct 2019

You must understand the complexities that define China in order to succeed in business. Dale Tempco, who led R&D for Medtronic Spine and Biologics in China, shares his observations on culture, communication and the orthopedic market. ... Read more »

Infographic: Top 10 Orthopedic Companies

by BONEZONE | Sep 2019

Billions of dollars separate the top 3 orthopedic device companies from the rest of the pack. Our infographic, built on proprietary knowledge of these companies, details the players and illustrates the gap between #1, DePuy Synthes and #10, Globus Medical.... Read more »

MNVC to Highlight Musculoskeletal Startup and Investment Markets

by Carolyn LaWell | Sep 2019

MNVC will feature 22 private companies developing new and emerging technologies in the musculoskeletal hardware, biologics, software and diagnostics spaces.... Read more »

Stryker Enters Definitive Agreement to Acquire Mobius Imaging and Cardan Robotics

by Julie A. Vetalice | Sep 2019

To bolster its spine division, Stryker is acquiring Mobius Imaging and its sister company, Cardan Robotics for up to $500MM in cash. The acquisition provides Stryker with immediate entry into the intra-operative imaging segment to complement its implant and navigation offerings.   ... Read more »

DePuy Synthes Acquiring JointPoint Navigation Assets

by Julie A. Vetalice | Sep 2019

DePuy Synthes and JointPoint have held an exclusive agreement to market JointPoint in the U.S. since 2017. The platform will become a DePuy Synthes-owned component of the ANTERIOR ADVANTAGE system for hip replacement.   ... Read more »

Omar Ishrak to Retire as CEO of Medtronic

by Julie A. Vetalice | Sep 2019

Medtronic Chief Executive Officer Omar Ishrak announced his intention to retire in the beginning of 2Q20, following the end of the company’s fiscal year. At that time, he will become Executive Chairman of Medtronic. Geoff Martha will succeed Ishrak as CEO next year. ... Read more »

CoorsTek Acquisition Positions UnitedCoatings as a Top Supplier

by Heather Tunstall | Aug 2019

The purchase of CoorsTek Medical allowed UnitedCoatings Group to expand design and supply chain services and traditional manufacturing capabilities, establishing the company as a fully-integrated contract manufacturer.... Read more »

What You Need to Know about Emerging Opportunities in the Outpatient Surgery Market

by Patrick Vega | Aug 2019

Outpatient hip and knee replacements are expected to increase by 200% in the next five years, while spinal fusions are projected to increase by 56%. We highlight ambulatory strategies and suggest ways in which device companies can capitalize on the procedural shift from inpatient to outpatient setti... Read more »

Globus Medical Enters Hip, Knee Market with StelKast Acquisition

by Julie A. Vetalice | Aug 2019

Globus Medical also announced the launch of a robotic system for joint replacement in late 2020. The company seeks to leverage recent hardware and software investments in robotic technology.... Read more »

Medacta Enters U.S. and Australian Sports Medicine Markets

by Julie A. Vetalice | Aug 2019

Medacta is introducing the Mecta®Lock PEEK Suture Anchor and the Mecta®Screw PEEK Interference Screw in Australia and the U.S. following regulatory clearance of these products.   ... Read more »

Top 15 Spine Companies

by BONEZONE | Jul 2019

The 15 largest spine companies account for 86% of the market's revenue. Our infographic details the players and illustrates the gap between No. 1 Medtronic and everyone else. ... Read more »

NuVasive Launches Pulse Integrated Technology Platform for Spine Procedures

by Julie A. Vetalice | Jul 2019

Early clinical experience has demonstrated the Pulse system's utility to improve workflow, reduce surgical variability and increase reproducibility of surgical outcomes.   ... Read more »

DJO Launches AltiVate Reverse Short Stem Shoulder in the U.S.

by Julie A. Vetalice | Jul 2019

The bone-sparing short-stem with a 135° neck-shaft angle sits entirely within the humerus, supporting ease of conversion from anatomic to reverse shoulder arthroplasty.   ... Read more »

Celling Spine Acquires Assets of Link Spine

by Julie A. Vetalice | Jul 2019

Link had sought a company to further develop its system for facet fixation and minimally invasive surgery. Celling believes that this technology complements its current portfolio and supports the development of a biologically enhanced spinal fusion system.   ... Read more »

Fusion Robotics Gains Funding to Support Spinal Robotics System

by Julie A. Vetalice | Jul 2019

Fusion Robotics closed a financing round with lead investment by Alex Lukianov of Lukpartners, LLC and Kevin Foley, M.D. Proceeds will help ready the company's spinal robotics platform to obtain regulatory clearance and begin commercialization.   ... Read more »

MicroPort Orthopedics Launches Evolution NitrX Medial-Pivot Knee

by Julie A. Vetalice | Jul 2019

The implant features a titanium niobium nitride coating that has been shown in simulated clinical testing to reduce the release of certain metal ions.   ... Read more »

3 Additive Manufacturing Takeaways from OMTEC

by Carolyn LaWell | Jul 2019

Choosing technology, designing porous structures and validating processes drove additive manufacturing conversations at OMTEC 2019.... Read more »

Smith & Nephew Acquiring Optical Tracking Technology for CAS

by Julie A. Vetalice | Jun 2019

Atracsys’ fusionTrack 500 optical tracking camera will be a core enabling technology within Smith & Nephew's multi-asset digital surgery and robotic ecosystem.   ... Read more »

OrthoPediatrics Acquires Vilex, ExFix Technology

by Julie A. Vetalice | Jun 2019

The company gains access to the Orthex Hexapod, which offers easily calibrated struts and hydroxyapatite coated pins designed to reduce infection risk. It is accompanied by point and click software to simplify deformity correction planning.   ... Read more »

Hip Replacement Companies Expand Portfolios with New Product Launches

by Julie A. Vetalice | Jun 2019

A conversation with a surgeon pioneer of the anterior approach and a recap of 10 product launches provide a review of the hip replacement space.... Read more »

Orthopedic Industry Surpasses $50 Billion in Global Revenue

by Mike Evers | Jun 2019

Orthopedic industry revenue reached $51.2 billion in 2018, as the top players prioritized connected ecosystems of products, flagship technologies like robotics and outpatient procedures.... Read more »

Exactech Acquires EPIC Extremity, Trauma Device Company

by Julie A. Vetalice | May 2019

EPIC Extremity, an early-stage orthopedic device company, was founded to introduce a line of lowest total cost implants to the orthopedic extremity market.   ... Read more »

M&A Recap: Three 2Q Announcements in Spine

Of the 20 OEM-related M&A announcements we’ve covered in 2019 thus far, seven have related to the spine market. Of those, three were announced in rapid succession within this quarter. Let’s see who bought whom, and what they got: Medtronic/Titan Spine, Boston Scientific/Vertiflex and WishBon... Read more »

Xenco Medical Launches Interactive Vending Machines for Spinal Devices

by Julie A. Vetalice | May 2019

Implant maker Xenco Medical has announced the launch of the first interactive vending machines designed for spine surgery instruments and implants.  ... Read more »

HealthpointCapital Acquires Majority Stake in CrossRoads Extremity Systems

by Julie A. Vetalice | May 2019

The investment supports growth of CrossRoads' Active Stabilization portfolio of lower-extremity implant systems for orthopedic and podiatric surgeons.  ... Read more »

CoreLink Launches Lateral Access and Interbody Fusion Platform

by Julie A. Vetalice | May 2019

CoreLink has introduced a comprehensive platform for lateral MIS spine fusion including 3D printed titanium and PEEK-based implants, retractor and surgical instruments.   ... Read more »

Orthopedic Pediatric Companies Receive Funding from Pitch Competition

by Kim Snell | May 2019

Orthopedic pediatric care gained recognition with a funding pitch competition that granted five winners $50,000 to support commercialization.... Read more »

Maxx Orthopedics' First Successful Procedure with Libertas Hip Replacement

by Julie A. Vetalice | May 2019

The Libertas total hip replacement system comprises cemented and cementless femoral stems, cementless acetabular cups designed for use with highly crosslinked polyethylene modular liners and either Biolox delta or cobalt chrome head options in multiple head diameters and offset options. ... Read more »

In2Bones Launches TriWay TTC Nail Arthrodesis System and Soft Tissue Release System

by Julie A. Vetalice | May 2019

The new TriWay TibioTaloCalcaneal (TTC) Nail Arthrodesis System from In2Bones represents an alternative to traditional cannulated systems used by foot and ankle surgeons to enhance performance, stability and reliability during hindfoot and ankle fusions.   ... Read more »

AdvaMed Names Stryker CEO Kevin Lobo Chairman of the Board

by Kim Snell | Apr 2019

AdvaMed named Kevin Lobo, CEO of Stryker, Chairman of the association’s Board of Directors. Lobo's plans during his two-year chairmanship include: patient advocacy, developing pathways to approval and reimbursement for emerging medical technologies and promoting diversity in the industry.... Read more »

Exactech Announces First Surgeries Using InterSep Bone Void Filler

by BONEZONE | Apr 2019

Exactech's InterSep 100% synthetic calcium sulfate bone void filler provides surgeon flexibility with its bead and paste options. InterSep may be used in a variety of bone and joint replacement surgeries, including infected bone sites.   ... Read more »

How to Boost Employee Engagement

by Heather Tunstall | Apr 2019

David Jensen, CEO of Strategic Business Systems and seasoned orthopedic executive, believes that a positive culture and employee engagement go hand-in-hand. One doesn’t necessarily lead to the other, but they are mutually dependent on one another. But, how do you get there?   ... Read more »

Acumed Acquires Elbow Arthroplasty Technology

by Julie A. Vetalice | Apr 2019

The move complements the company's robust portfolio of upper extremity plates and joint replacement devices.   ... Read more »

Burst of Orthopedic M&A at the Close of 1Q19

by Julie A. Vetalice | Mar 2019

Companies are taking strides to connect their devices with technologies that support improved patient outcomes. That connection can come in the form of M&A activity—which certainly applies to transactions announced over the month of March in joint replacement. In other segments, companies... Read more »

Brainlab Acquires Medineering, Robotics Platform

by Julie A. Vetalice | Mar 2019

Brainlab is creating the first openly scalable medical robotics platform paired with an efficient software ecosystem.  ... Read more »

Stryker Acquires OrthoSpace, Rotator Cuff Repair Device

by Julie A. Vetalice | Mar 2019

The InSpace device for treatment of massive irreparable rotator cuff tears is a biodegradable sub-acromial spacer, which is designed to realign the natural biomechanics of the shoulder.   ... Read more »

Smith & Nephew Acquires Brainlab Joint Replacement Business

by Julie A. Vetalice | Mar 2019

Brainlab provides pre-operative planning, intra-operative navigation and tools for post-op evaluation and information sharing. Smith & Nephew also gains access to cloud computing, tracking, augmented reality, robotics, artificial intelligence, machine learning, image fusion and anatomic segmenta... Read more »

3 Early-Stage Orthopedic Computer-Assisted Companies to Know

by Carolyn LaWell | Mar 2019

The proliferation of computer-assisted technology companies entering the joint replacement, spine and trauma markets indicates to us that industry believes that there's room for product introduction and adoption. Here we highlight three of those companies and their very different intraoperative... Read more »

Smith & Nephew to Acquire Osiris

by Julie A. Vetalice | Mar 2019

The transaction includes BIO4 viable bone matrix, an alternative to autograft, and Cartiform cryopreserved viable osteochondral allograft for articular cartilage repair.     ... Read more »

Exactech Acquires XpandOrtho

by Julie A. Vetalice | Mar 2019

The company's ligament balancing technology provides a framework for integration into ExactechGPS computer-assisted navigation to further advance the Truliant Total Knee.    ... Read more »

Here’s How Hospitals Want to Collaborate More with Orthopedic OEMs

by Patrick Vega | Mar 2019

As the hospital environment becomes more complex, traditional approaches to establishing relationships, selling products and servicing accounts have become less effective for orthopedic manufacturers. OEMs that understand the customer environment and invest in a partnership with them can be rewarded... Read more »

Corin Enters Orthopedic Robotics Market with OMNI Acquisition

by BONEZONE | Mar 2019

Corin entered into a binding agreement to purchase OMNI, maker of the OMNIBotics® robot-assisted total knee replacement system. The acquisition accelerates Corin’s joint replacement growth strategy and gives it a greater foothold in the U.S.... Read more »

Orthopedic Stakeholders Talk Coating Standards

by Carolyn LaWell | Mar 2019

Orthopedic and coating manufacturers are leading the discussions with ASTM, ISO and FDA to set standards and guidance for current and future coatings.... Read more »

Automation Implementation Comes with Benefits and Difficulties, Report Says

by BONEZONE | Mar 2019

Despite the benefits of automation, companies have not been quick to implement automation. Why?... Read more »

The Japanese Orthopedic Market: Considerations for Expanding Your Presence

by Carolyn LaWell | Feb 2019

The Japanese orthopedic market is attractive for multiple reasons, including its large size, attractive pricing and established regulatory pathways. As the U.S. adopts value-based care and the EU implements stricter regulations, the Japanese market may look even more attractive.... Read more »

Royal Philips Launches Zenition Mobile C-Arm

by Julie A. Vetalice | Feb 2019

Zenition addresses hospital challenges as image-guided MIS procedures increase. Philips' MetalSmart software automatically adjusts the contrast and brightness of images to improve image quality when metal objects such as implants are present, which is especially useful in orthopedic applications.... Read more »

AAOS Preview: First-Time Exhibitors, New Offerings on the Exhibit Floor

by Julie A. Vetalice | Feb 2019

Each year, of the hundreds of exhibitors slated to be at the annual American Academy of Orthopaedic Surgeons meeting, I select a few you may not know. After you've gone to look at the robots, here are some other companies to meet.... Read more »

Trice Medical Acquires SegWAY Orthopaedics

by Julie A. Vetalice | Feb 2019

The transaction creates the first company to offer product lines for minimally invasive orthopedic diagnostics and surgical solutions.... Read more »

Kyocera Expands U.S. Business with Purchase of Renovis Surgical Technologies Assets

by BONEZONE | Jan 2019

Renovis Surgical Technologies is a developer of hip and knee joint reconstruction, spinal and trauma devices. The transaction complements U.S. sales of Kyocera’s own FDA-cleared total hip devices and grants the company access to spine products—a segment in which it formerly did not operate.... Read more »

HoloSurgical’s Augmented Reality, AI-Based System Used in Spinal Procedure

ARAI is an augmented reality and artificial intelligence-based surgical navigation system that provides real-time patient-specific 3D anatomical visualization for pre-op planning, real-time intra-op guidance and post-op data analytics.... Read more »

LimaCorporate, HSS Co-Found Hospital-Based 3D Printing Facility

This will reportedly be the first additive manufacturing 3D printing facility for custom complex orthopaedic implants in a hospital setting. The facility will be operated by Lima and reside on the HSS main campus; operations are expected to begin by early 2020.... Read more »

Most Popular Articles of 2018 Featured Robotics, Contract Manufacturer M&A

by Rob Meyer | Jan 2019

What else did you read about the most on our website last year? Arthroscopy/soft tissues companies to watch; products in spine, knee and hip; surgeon perspectives on implant material choice; supply chain quality; labelling mistakes, Brazil and more. ... Read more »

Skills Gap Hampers Manufacturing Growth, Says Tooling U-SME Report

by Rob Meyer | Jan 2019

Manufacturers recognize the challenge of the skills gap, but far too many fail to change their workforce development and training processes. The report details manufacturers’ trouble areas and identifies best practices for strengthening your team.... Read more »

NuVasive Announces New Organizational Structure, Streamlined Leadership Team

by Rob Meyer | Jan 2019

CEO J. Christopher Barry, hired in November, implemented several changes to NuVasive's executive team to “lead the company’s next phase of growth and innovation.”... Read more »

Histogenics to Explore Strategic Alternatives for NeoCart based on FDA Findings

Histogenics expects to suspend development of NeoCart, a tissue engineered implant, after FDA indicated that an additional clinical trial would be required to accept a Biologics License Application submission.... Read more »

Medtronic Completes US $1.7 BB Acquisition of Mazor Robotics

The previously announced purchase demonstrates Medtronic’s belief in the future of guided spinal procedures. Mazor joins Medtronic’s Neurosurgery business, part of the Restorative Therapies Group’s Brain Therapies division.... Read more »

Smith & Nephew Acquiring Ceterix, Meniscal Repair Technology

by BONEZONE | Dec 2018

Ceterix Orthopaedics is the developer of the NovoStitch® Pro Meniscal Repair System. SNN will pay up to $105MM, comprising an initial cash consideration of $50MM and $55MM over the next five years, contingent upon financial performance.... Read more »

Year in Review: Orthopaedic Companies New on Our Radar in 2018

by Julie A. Vetalice | Dec 2018

The companies highlighted here (either brand new or new to us) represent all five major market segments and comprise a broad geographical mix: Denmark, Finland, Israel, Italy, The Netherlands and the United States.... Read more »

Integra LifeSciences Announces First Procedures with XT Revision Total Ankle

by BONEZONE | Dec 2018

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

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

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

DePuy Synthes: A Look at PUREVUE and 2018 Product Launches

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

Cobalt Chrome Additive Total Knee Successfully Tested by Italian Startup

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

Contract Manufacturers Responding to Market Forces are Primed for Growth

by Carolyn LaWell | Dec 2018

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

Precision OS: Using Virtual Reality for Surgeon Education, Pre-Operative Planning

“VR’s ability to offer a safe environment to make mistakes is valuable in providing surgeons with building blocks on which to learn,” said Dr. Danny P. Goel, CEO. “Our technology goes beyond the technical steps of a procedure, through the enhancement of skills necessary to impact patien... Read more »

Medacta Invests in Personalized Medicine with Acquisition of Swiss Technology Company

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

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

by Rob Meyer | Nov 2018

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

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

by Rob Meyer | Nov 2018

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

Orthopaedic Investors Prioritize Care Delivery, Post-Revenue Companies

by Carolyn LaWell | Nov 2018

Investors who spoke during October's Musculoskeletal New Ventures Conference (MNVC) pointed to extremities, sports medicine, digital health and the hospital supply chain as areas that remain particularly attractive for innovation.... Read more »

American Academy of Orthopaedic Surgeons Launches Shoulder and Elbow Registry

At launch, this AAOS registry will collect total shoulder arthroplasty procedures data. Rotator cuff repair and total elbow arthroplasty will follow in 2019.... Read more »

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

by Rob Meyer | Nov 2018

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

Zimmer Biomet Completes First Procedures Using ROSA Knee Robot

by Rob Meyer | Nov 2018

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

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

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

NuVasive Announces Christopher Barry to Succeed Gregory Lucier as CEO

by Julie A. Vetalice | Oct 2018

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

Zimmer Biomet, Apple Collaboration Latest Example of Industry Focus on Digital Health

We believe this announcement, along with the products already on the market and FDA’s commitment to a streamlined regulatory pathway, is indicative of forthcoming multi-industry digital health collaborations and products that will impact orthopaedics.... Read more »

Corin Increases Footprint with Acquisition of Global Orthopaedic Technology

by Julie A. Vetalice | Oct 2018

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

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

by Carolyn LaWell | Oct 2018

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

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

Bone Therapeutics (ALLOB® allogeneic bone cell therapy) and Histogenics (NeoCart® tissue-engineered knee implant) are two of the five companies we tracked that announced completed studies in the last three months.... Read more »

Large Spine Players Focus Acquisitions on Robotics, Navigation, Additive

by BONEZONE | Sep 2018

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

NASS Preview: 14 Spine Products That Caught Our Attention

by Julie A. Vetalice | Sep 2018

Between now and NASS 2018, we expect to hear more about new spine products that use additive manufacturing, more variations on PEEK and titanium and more expandable interbody designs. The 14 companies highlighted are already on board.... Read more »

Musculoskeletal New Ventures Conference Offers Insights on Funding, Startups

by Carolyn LaWell | Sep 2018

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

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

Cartiva’s Synthetic Cartilage Implant is used to treat arthritis in the great toe. Wright’s $435MM purchase of the technology (expected to close in 4Q18) enhances its position in the space by providing access to what company leadership described as a ~$420MM addressable market.... Read more »

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

K2M’s innovative technology platform will add a suite of complex spine solutions to Stryker’s core spine portfolio; K2M’s consistent support of additive manufacturing of devices could also benefit Stryker’s long-term growth.... Read more »

HAPPE Spine Latest Company to Manufacture PEEK Devices in Novel Ways

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

Surgeons Establish Society to Advance Complex Additive Applications

by Rob Meyer | Aug 2018

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

OEMs Share Perspectives on Additive Manufacturing Challenges

by Carolyn LaWell | Jul 2018

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

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

by BONEZONE | Jul 2018

These funding announcements feature technologies related to each of the market segments: spine, trauma, arthroscopy/soft tissue, joint reconstruction and orthobiologics.... Read more »

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

by Edward S. Pound | Jul 2018

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

Spine, Joint Recon Product Launches Focus of Top Orthopaedic Companies

by Julie A. Vetalice | Jun 2018

The 1H18 product launches by the top orthopaedic companies were largely focused on the market segments of spine and joint reconstruction. We offer a list of new products and their descriptions. ... Read more »

Generic Device OEM Defines Value in Orthopaedic Care

by Steve Lichtenthal | Jun 2018

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

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

by Rob Meyer | May 2018

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

coflex Gains Disposable Instrument PMA, NASS Coverage Policy Recommendation

by BONEZONE | May 2018

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

Orthopaedic Industry Reaches $49.3 Billion, Grows 3.7%

by Carolyn LaWell | May 2018

Of note is the growth of the 20 largest orthopaedic device companies, which combined comprise 76% of the market.... Read more »

Eight Steps to Project Triage

by Deborah Munro | May 2018

Choosing which high-priority projects to work on first can be a challenging task; forming a strategy for triage is a highly recommended course of action for all professionals. ... Read more »

Acquisitions Position NN, Inc. as Major Orthopaedic Supplier

by Rob Meyer | Apr 2018

The recent acquisition of Paragon Medical, coupled with purchases of several other household names during the past three years, means that NN has positioned itself as a top-10 contract manufacturing player. ... Read more »

Smith & Nephew Names CEO with Acquisition, Turnaround Experience

by Julie A. Vetalice | Apr 2018

Mr. Namal Nawana's experience includes 15+ years with Johnson & Johnson, primarily in the Medical Devices & Diagnostics segment and culminating in 2011 with his appointment as Worldwide President of DePuy Synthes Spine.... Read more »

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

by Rob Meyer | Mar 2018

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

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

by Rob Meyer | Mar 2018

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

Supplier M&A on the Rise

by Julie A. Vetalice | Feb 2018

Over an eight-year span, the gap between the number of OEM transactions versus those in the supplier space was its narrowest in 2017.... Read more »

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

by Rob Meyer | Feb 2018

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

RTI Surgical Expanding Spine Fusion Portfolio, Acquires Zyga Technology

by BONEZONE | Jan 2018

Zyga Technology is the developer of the SImmetry® Sacroiliac Joint Fusion system.... Read more »

Zimmer Biomet Appoints Bryan Hanson as President and CEO

by BONEZONE | Jan 2018

Hanson joins ZBH from Medtronic, where he served as Executive Vice President and President of the Minimally Invasive Therapies Group.... Read more »

CMS Finalizes Joint Bundled Payment, Outpatient Payment Changes

by Rob Meyer | Dec 2017

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

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

by Rob Meyer | Nov 2017

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

Spine Companies Target New Applications of PEEK and Metals for Implant Innovation

by Carolyn LaWell | Nov 2017

In response to spine surgeons’ shift away from traditional PEEK cages, materials were (again) one of the main themes discussed at the North American Spine Society Annual Meeting. At NASS, we sat down with representatives of companies promoting osteoconductive PEEK and molybdenum-rhenium.... Read more »

AAOS to Launch Orthopaedic Registries, Integrate With AJRR

by Rob Meyer | Nov 2017

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

3D Printing, Expandable Cages Popular Among Pre-NASS Product Launches

by BONEZONE | Oct 2017

Companies announced numerous spine product regulatory decisions and market launches well in advance of the 2017 NASS Annual Meeting. We've recapped product updates as a guide for what you can see and hear about on the exhibit floor.... Read more »

Smith & Nephew CEO Announces 2018 Retirement; Acquisition Buzz Returns

by BONEZONE | Oct 2017

Smith & Nephew's Chief Executive Officer, Olivier Bohuon, announced his intention to retire by the end of 2018 after seven years in the position. The Board is searching for his successor.... Read more »

Musculoskeletal Transplant Foundation Rebrands as MTF Biologics

by BONEZONE | Oct 2017

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

China: Do You Need to Revamp Your Customer Channel?

by Helen Chen | Oct 2017

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

Spine Companies $100MM to $2BB: Strategic Activity Update

by Julie A. Vetalice | Sep 2017

The majority of the spine market—just about 80%—is controlled by companies with annual spine revenue above $100 million. We highlight nine of these companies here.... Read more »

NASS: Supplier Company Exhibitors Grow 50% in 5 Years

by BONEZONE | Sep 2017

Nearly 100 suppliers are expected to exhibit at NASS 2017. As you decide whom to meet with on the exhibit floor, we thought you might have the same question we did for these companies: Why?... Read more »

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 A. 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 A. 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 2018 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 A. 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 A. 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 A. 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 A. 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 A. 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 A. 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 »

Follow These Six Steps to Execute a Strategic Planning Process

by Don Urbanowicz | Mar 2013

Following the SPP won’t guarantee correct decisions are made—but SPP does provide an opportunity for senior leaders to assist in formulating a company’s strategic plan, implementing the plan and connecting strategy and implementation to a rewards system.... 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 A. 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 A. 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 A. 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 A. 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 A. 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 A. 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 A. 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 A. 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 A. 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 A. 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 A. 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 A. 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 A. 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 A. 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 A. 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 A. 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

Nobody likes losing! Whether you missed a sale or got passed over for a promotion, it didn’t feel good. Nothing upsets progress like losing a key contributor within your own team. Yet it never fails that when you least expect it, it happens. One of your team walks into your office and closes the ... 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 »