Thanks! You've successfully subscribed to the BONEZONE®/OMTEC® Monthly eNewsletter!

Please take a moment to tell us more about yourself and help us keep unwanted emails out of your inbox.

Choose one or more mailing lists:
BONEZONE/OMTEC Monthly eNewsletter
OMTEC Conference Updates
Advertising/Sponsorship Opportunities
Exhibiting Opportunities
* Indicates a required field.

Articles written by Julie Vetalice

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

by Julie Vetalice | Nov 2018

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

Smart Devices, Robotics, Sensors: Tools to Improve Patient Outcomes

by Julie Vetalice | Oct 2018

Dr. Martin Roche explains how these technologies are shaping the future of orthopaedic surgery: "A surgeon needs data to make objective decisions intra-operatively. The subjective Art of Surgery is poorly translatable ... Through all this rapid evolution, the clinician must take a leadership role." ... Read more »

NuVasive Announces Christopher Barry to Succeed Gregory Lucier as CEO

by Julie 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 »

Corin Increases Footprint with Acquisition of Global Orthopaedic Technology

by Julie 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 »

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

by Julie Vetalice | Oct 2018

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

11 Arthroscopy/Soft Tissue Repair Companies Worth Watching

by Julie Vetalice | Oct 2018

We looked at funding, patent and trial/study announcements from January 2017 to June 2018 to see whose initiatives are making waves; many of these companies offer technologies that could make them acquisition or collaboration targets for large OEMs. ... Read more »

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

by Julie Vetalice | Sep 2018

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

NASS Preview: 14 Spine Products That Caught Our Attention

by Julie 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 »

510(k) Recap: New Products from Companies You Know

by Julie Vetalice | Aug 2018

We provide a recap of how companies including Additive Orthopedics, Arthrex, Corin, DJO, Exactech, Orthofix, Wright Medical, Zimmer Biomet and more are supporting new product launches and maintaining their growth. ... Read more »

Trauma Surgeon: Value-Based Orthopaedic Care Can Positively Impact U.S. Healthcare

by Julie Vetalice | Jul 2018

"The majority of devices have become commodities," says Dr. Peter Althausen. "Devices coming to market have not demonstrated improved outcomes, yet carry hefty price tags and are not affordable. Clearly there’s no winning argument to pay more for devices that do not improve outcomes." ... Read more »

Final Patient Treated in NUsurface Artificial Meniscus Trials

by Julie Vetalice | Jul 2018

Active Implants is pursuing an FDA De Novo 510(k) clearance for the device. If cleared, NUsurface would be the first “artificial meniscus.”  ... Read more »

Zimmer Biomet Responds to FDA Form 483

by Julie Vetalice | Jun 2018

The company stated disagreement with certain aspects of some of the technical CAPA topics, based on perceived misunderstanding on behalf of the investigators, a lack of context and incomplete information reported by company representatives. ... Read more »

Spine, Joint Recon Product Launches Focus of Top Orthopaedic Companies

by Julie 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 »

FDA 510(k) Highlights: Five Companies Gain First Orthopaedic Clearances

by Julie Vetalice | Jun 2018

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

Why One Surgeon Entrepreneur is Focused on MIS, Orthobiologics and UDI

by Julie Vetalice | Apr 2018

Patrick Sweeney, M.D. is Founder of the Center for Minimally Invasive Surgery, an ambulatory surgery center in Illinois that addresses a range of orthopaedic and spinal conditions. He is also an inventor/entrepreneur, holing 30+ U.S. and European patents. ... Read more »

Smith & Nephew Names CEO with Acquisition, Turnaround Experience

by Julie 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 »

Supplier M&A on the Rise

by Julie 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 »

Three Companies Expand Patient Engagement Offerings and Digital Tools

by Julie Vetalice | Nov 2017

These tools are being launched by companies that seek to remain competitive in the market as they help hospitals and surgeons improve patient outcomes and control spend.  ... Read more »

New Grant to Support Device Coating Research

by Julie Vetalice | Nov 2017

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

Vivorte Launches New Bone Graft Products

by Julie Vetalice | Oct 2017

The new products round out Vivorte's offerings to provide a complete line of synthetic biomaterials. ... Read more »

Flower Orthopedics Expands Ready-For-Surgery Extremity Line

by Julie Vetalice | Oct 2017

Flower Orthopedics launched three new products: instruments in the Flower Efficiency (E-Kit™) Advanced system. ... Read more »

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

by Julie 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 »

Medtronic Assumes Exclusive Commercial Rights for Mazor X

by Julie Vetalice | Sep 2017

Medtronic entered Phase II of its strategic partnership with Mazor Robotics, granting Medtronic exclusive global distribution of the Mazor X surgical robotic assistance platform. The partnership affords Medtronic the lead in robotics amongst the largest spine players. ... Read more »

The Fused and the Fractured: New Entrants to U.S. Spine and Trauma

by Julie Vetalice | Aug 2017

Globus Medical has received clearance for its first two trauma products. While they prepare to enter that space, numerous competitors are bringing out interbody fusion devices for introduction in U.S.    ... Read more »

Robotics, 3D Printing Gain Larger Adoption with Globus Medical, K2M Acquisitions

by Julie Vetalice | Aug 2017

In early August, both Globus Medical and K2M announced acquisitions that complement current products and position them for future growth. ... Read more »

The Joint Surgeon's Wish List

by Julie Vetalice | Aug 2017

In the Knowledge Pod at OMTEC 2017, Dr. Dietz, a joint surgeon, shared his take on challenges with patient care using present systems and devices, and offered thoughts on what he’d like to see in the future. This article includes three points from Dr. Dietz’s Wish List. ... Read more »

Hip and Spine: New Players Receive FDA 510(k)s

by Julie Vetalice | Jul 2017

Of the 56 orthopaedic-related 510(k)s that FDA released in June, we share observations and insights on two total hips, one interbody fusion system and a pedicle screw system. ... Read more »

Zimmer Biomet CEO Resigns

by Julie Vetalice | Jul 2017

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

Reimbursement Tips: Four Things Payors Want

by Julie Vetalice | Jul 2017

The complexity of reimbursement may be great, but the burden may be lessened if you begin with the end in mind—and know what you’re up against—and make good choices throughout the process. ... Read more »

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

by Julie Vetalice | Jul 2017

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

One Answer to Your Postmarket Challenge: Planning

by Julie Vetalice | Dec 2016

Planning goes a long way in moving from premarket to postmarket data collection. Vicki Anastasi, an OMTEC 2016 speaker, suggests the best way to start. ... Read more »

Spine Company 510(k)s from 1H16

by Julie Vetalice | Oct 2016

Not all spine companies attend NASS! Get to know ten recipients of their first FDA 510(k) clearances to see what technologies they’re offering. ... Read more »

Reimbursement in Spine: A NASS Priority

by Julie Vetalice | Sep 2016

In order for commercialization to succeed, everyone needs to be paid. Be proactive for you and your customers by making reimbursement a part of your development timeline. ... Read more »

Product Spotlight: Arthroscopy and Soft Tissue Repair

by Julie Vetalice | May 2015

Here, we present highlights from a variety of technologies cleared and launched during 2014 and 2015 across traditional and biologic approaches. ... Read more »

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Mar 2014

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

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Dec 2013

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

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Oct 2013

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

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Aug 2013

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

Company Financials: Orthopaedics and Spine

by Julie Vetalice | May 2013

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

Strategic Company Financials: Orthopaedics and Spine

by Julie Vetalice | Apr 2013

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

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Dec 2012

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

The Global Orthopaedic Supplier Market

by Julie Vetalice | Dec 2012

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

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Oct 2012

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

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Aug 2012

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

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Jun 2012

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

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Mar 2012

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

Company Financials: Orthopaedics and Spine

by Julie Vetalice | Dec 2011

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

Company Financials: Orthopaedic and Spine

by Julie Vetalice | Oct 2011

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

Blogs and Apps That Bring Solutions

by Julie Vetalice | Oct 2011

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

Blogs and Apps that Bring Solutions

by Julie Vetalice | Aug 2011

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

1Q11 Company Financials: Orthopaedic and Spine

by Julie Vetalice | Aug 2011

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

2010 Company Financials: Orthopaedic and Spine

by Julie Vetalice | Jun 2011

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

Blogs and Apps That Bring Solutions

by Julie Vetalice | Jun 2011

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

2010 Company Financials: Orthopaedic and Spine

by Julie Vetalice | Mar 2011

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

Blogs and Apps That Bring Solutions

by Julie Vetalice | Mar 2011

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

3Q10 Company Financials: Orthopaedic and Spine

by Julie Vetalice | Dec 2010

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

Review of Study Results: FDA Impact on U.S. Medical Technology Innovation

by Julie Vetalice | Dec 2010

FDA Impact on U.S. Medical Technology Innovation, a study released in November 2010, was undertaken to provide a view of medical technology (medtech) industry’s experiences with the current FDA environment. The study addressed the need for quantitative and qualitative data to help evaluate the imp ... Read more »