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Articles written by Carolyn LaWell

Clinical Data and CE Mark: What are We Doing Wrong?

by Carolyn LaWell | Mar 2017

A reader called saying companies are failing the clinical evaluation portion of the initial CE Mark or audit process and asked what insights could we offer now and at OMTEC? Here's our response. ... 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 »

Scientists Engineer Stem Cells to Regrow Cartilage

by Carolyn LaWell | Dec 2016

Scientists have programmed stem cells to grow cartilage on a 3D woven scaffold shaped like a femoral head. The technology’s first focus is hip arthritis. ... 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 »

FDA Guidance Outlines How to Create a Unique Device Identifier

by Carolyn LaWell | Jul 2016

FDA recommends companies reexamine UDI basics with new draft guidance on how to form a proper identifier. ... Read more »

Instrument Testing: How to Capture the Best Data

by Carolyn LaWell | Jul 2016

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

Problem-Solving Lessons from HSS Chief of Knee

by Carolyn LaWell | Jul 2016

Orthopaedic professionals in every division of every company are being asked to do more with less. During his OMTEC 2016 Keynote, Steven Haas, M.D., offered lessons in how to work through any challenge.  ... 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 »

Building Evidence for Additive Manufacturing: What Questions Remain?

by Carolyn LaWell | Jun 2016

In order for additive manufacturing to move from tinkering technology to widely-used process, it’s imperative to prove its long-term benefits. In May, researchers, surgeons, device companies and additive manufacturing suppliers gathered to develop guidelines to build data and support reimbursement ... Read more »

FDA Issues Draft Guidance on Additive Manufactured Devices

by Carolyn LaWell | May 2016

FDA published draft guidance on technical considerations for additive manufactured devices in response to the technology’s advancements and investments. Among the top concerns of FDA and industry are post-processing, cleaning and sterilizing devices. ... 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 »

Stryker Announces Investments in 3D Printing

by Carolyn LaWell | Feb 2016

Stryker announced the construction of a state-of-the-art 3D printing manufacturing facility in order to produce new products across multiple divisions and set the company apart from its competitors. The announcement came during the company’s fourth quarter earnings call. ... Read more »

The Future of Nanotechnology in Orthopaedics

by Carolyn LaWell | Dec 2015

Major research is underway at the university and device company level, and new devices are expected to reach the market in the next five years. Can nanotechnology move from buzzword to industry-shaping technology? ... Read more »

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

by Carolyn LaWell | Nov 2015

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

Big Data Tops FDA’s 2016 Priorities

by Carolyn LaWell | Nov 2015

FDA’s Center for Devices and Radiological Health (CDRH) plans to embrace the use of big data and patient reported outcomes in regulatory decision making, according to its 2016 Regulatory Scientific Priorities. ... 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 »

Materials in Motion

by Carolyn LaWell | Oct 2015

Orthopaedic manufacturers and their supplier partners are adopting different strategies for how materials are surface treated and manufactured in order to enhance device performance. ... Read more »

Three Spine Companies Implement New Manufacturing Strategies

by Carolyn LaWell | Sep 2015

Alphatec Spine, Globus Medical and NuVasive, the three largest pure-play spine companies, announced revised manufacturing strategies during 2Q15 earnings calls. ... 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 »

How to Proceed When a Testing Standard Doesn’t Exist

by Carolyn LaWell | Jul 2015

Orthopaedic device innovation is evolving, and there will be gaps in device testing standards and guidance. Here are three proactive strategies to ensure that your customized test method assists in your device submission. ... 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 »

OEM Executives Offer Perspective on Robotics, Orthobiologics and Hospital Changes

by Carolyn LaWell | Jun 2015

In anticipation of OMTEC, we highlight discussion between the keynote speakers on the latest technologies and market players. After presenting at the ORTHOWORLD Symposium in June, the three will reconvene to provide OMTEC’s Wednesday keynote. ... Read more »

AAOS Recap: CAS and Robotic Technology Popular Product Launches

by Carolyn LaWell | Apr 2015

Robotics remain a polarizing topic in the orthopaedic industry, yet crowds on the exhibit hall floor and numerous product launches indicate persistent interest in the technology. ... Read more »

Standard, Sterile and Small: Packaging Trends Focus on Savings and Speed to Market

by Carolyn LaWell | Mar 2015

Complexities in orthopaedic device packaging have manufacturers seeking expertise from consultants and suppliers to discover process efficiencies and allow internal resources to focus on new product development and manufacturing support. ... Read more »

Materials a Major Driver in Implant Innovation

by Carolyn LaWell | Feb 2015

CEOs predict device innovation will come in the form of new materials. This recap of the panel discussion at The State and Future of the Orthopaedic Industry™ sympoisum offers detailed insight. ... Read more »

Tecomet CEO Expects Supplier M&A to Continue

by Carolyn LaWell | Jan 2015

Consolidation has picked up at the supplier level as manufacturers seek to meet the needs of OEM customers that are also expanding through consolidation. ... Read more »

Preparation for Spinal Reclassification Under Way, Despite Pending EU Regulations

by Carolyn LaWell | Nov 2014

While the EU has yet to set a completion or implementation date for spine implant reclassification, manufacturers shouldn’t wait to prepare. ... Read more »

Analyzing the Commercial Viability of Additive Manufacturing

by Carolyn LaWell | Sep 2014

As additive manufacturing gains traction in the orthopaedic industry, device companies must understand business, as well as mechanical, implications over traditional manufacturing. ... Read more »