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Articles written by Carolyn LaWell

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 »

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 »

Additive, AI, Digital Health Noted in FDA’s 2021 Science Report

by Carolyn LaWell | Jan 2021

FDA published its Focus Areas of Regulatory Science report, prioritizing research across the strategic initiatives of data, increasing choice and competition through innovation and empowering patients.    ... Read more »

FDA Adds Bone Screws and Spine Plates to Alternative 510(k) Pathway

by Carolyn LaWell | Jan 2021

The voluntary Safety and Performance Based Pathway allows manufacturers with moderate-risk devices to meet specific performance criteria instead of testing against a predicate device to demonstrate equivalence.    ... Read more »

Survey: Orthopedic Supply Chain Faces Familiar Challenges Amidst COVID Complexities

by Carolyn LaWell | Dec 2020

Orthopedic OEMs will continue to operate amidst uncertainty in 2021. In a recent survey, OEM decision makers highlighted the challenges they face and where they seek supplier support. ... Read more »

Anika CEO Shares Lessons in Leading through Change

by Carolyn LaWell | Dec 2020

A lesson that the pandemic has taught Cheryl Blanchard, Ph.D., Anika's CEO, is the need to stay aware of how quickly and dramatically the world can change. ... Read more »

3D Printing and Robotics Lead China’s Technology Opportunities

by Carolyn LaWell | Sep 2020

OEMs and consultants said the primary market opportunities in China will be tied to advanced technology, including systems that aid surgeries and implant surface structures.  ... 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 »

How COVID Has Impacted the Delivery of Spine Care

by Carolyn LaWell | Sep 2020

Dr. Eeric Truumees, a member of NASS's Board of Directores, shares COVID-19's impact on his practice and current and future trends in spine care.  ... Read more »

Video: Lincotek CEO Shares Preparations for COVID Recovery

by Carolyn LaWell | Sep 2020

Lincotek was integrating its acquisition of CoorsTek Medical and preparing for multiple facility expansions when COVID hit. Company CEO Winfried Schaller shares how the company prioritized its planned investments, what they're hearing from orthopedic device companies and lessons learned throughout t ... 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 »

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 »

FDA Repeats Call for Advanced Manufacturing Efforts

by Carolyn LaWell | Jul 2020

FDA's CDRH Director Dr. Jeffrey E. Shuren emphasized the need for a greater focus on Advanced Manufacturing during the MDIC 2020 Annual Public Forum. FDA leadership noted COVID-19 has furthered its Advanced Manufacturing efforts, which will be tied to the Case for Quality Initiative.  ... Read more »

Video: Orchid CEO Talks COVID-19’s Impact on Orthopedics

by Carolyn LaWell | Jul 2020

“We’ve found opportunities to support their growth playbook, and enable them to continue to play offense," says Orchid Orthopedic Solutions CEO Jerry Jurkiewicz about working with device company customers during COVID-19.    ... 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 »

Orthopedics Needs Minimally-Invasive, Streamlined Products More than Ever

by Carolyn LaWell | May 2020

Medacta CEO Francesco Siccardi talks orthopedic opportunities, headwinds and strategies in regards to COVID-19 and market fundamentals.  ... 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 »

Tiger Buford Makes COVID-19 Predictions for Technology and You

by Carolyn LaWell | Apr 2020

 COVID-19 has the potential to affect the work of orthopedic professionals profoundly—both how work is conducted and the end product that is created.  ... Read more »

EU MDR Postponement Clears Another Hurdle

by Carolyn LaWell | Apr 2020

The European Parliament voted to postpone MDR until 2021. The regulation's postponement now moves to its final steps.  ... Read more »

How To Build A More Resilient Supply Chain Post COVID-19

by Carolyn LaWell | Apr 2020

Our video interview with Vinod Dasa, M.D., highlights how automating the hospital-device company supply chain will eliminate waste, reduce redundancies and improve inventory management.  ... Read more »

6 Orthopedic Trends You Can’t Ignore

by Carolyn LaWell | Mar 2020

3D printing, robotics, regenerative medicine and minimally invasive surgery are among the trends that orthopedic veterans say you must consider to remain relevant in the next decade.    ... Read more »

MDR Deadline Still On—for Now

by Carolyn LaWell | Mar 2020

The European Commission will propose delaying the MDR deadline by one year. The announcement came after MedTech Europe and others called on the commission to pause the regulation, noting that device companies’ response to COVID-19 disrupts their ability to meet the transition timeline date.  ... Read more »

7 Digital Tools We Wanted to See at AAOS

by Carolyn LaWell | Mar 2020

The cancelation of AAOS' Annual Meeting isn't stopping us from sharing the technologies we were looking forward to learning more about. These digital technologies come from startup to mid-sized orthopedic companies. ... 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 »

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 »

Arthroscopy Pumps Targeted in New FDA Guidance

by Carolyn LaWell | Feb 2020

FDA released draft guidance for 510(k) submissions of arthroscopy pump tubing sets intended for multiple use after receiving reports of backflow of patient fluids. ... Read more »

Orthopedic Success Will Require Digitalization of Supply Chains and Products

by Carolyn LaWell | Dec 2019

3D printing, AI, augmented reality, robotics, sensors and virtual reality all hold promise to disrupt orthopedic manufacturing, supply chains and the delivery of patient care. Stefano Bini, M.D., Founder and Chair of DOCSF and OMTEC keynote speaker, shares his view on the integration of these tools. ... Read more »

Early Additive Manufacturing Adopters Share Lessons in Implementation

by Carolyn LaWell | Dec 2019

Early adopters and staunch supporters of additive manufacturing shed some of the hype and paint a picture of what it takes to experience success with the technology. In this recap of their OMTEC 2019 discussion, they talk market barriers, opportunities and considerations for materials and validation ... 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 »

Medin CEO Shares Lessons in Leading Change

by Carolyn LaWell | Nov 2019

Bill Donaldson, a former U.S. Marine who has spent his post-military career transforming large manufacturers into high-performing companies through lean improvement processes, talks about how he's implementing a new business system and culture at a mid-sized case and tray company. ... 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 »

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 »

PrinterPrezz Blends 3D Printing Open-Ecosystem and Clinical Expertise

by Carolyn LaWell | Sep 2019

PrinterPrezz utilizes an open-ecosystem business model and collaborates across the supply chain with companies like GE Additive, Materialise, nTopology and SI-BONE. Founder and Chief Medical Officer Dr. Alan BC Dang shares the startup's vision for 3D printing orthopedic devices. ... Read more »

Medtronic VP Says Instruments Integral to Robotic Advancements

by Carolyn LaWell | Aug 2019

Instrument design and manufacture play a critical role in robotic and navigation technology. Companies will look to develop smaller and lighter instruments in future system iterations.    ... 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 »

Additive Manufacturing: Tools for Finishing Your Orthopedic Device

by Carolyn LaWell | May 2019

Additive manufacturing (AM) requires that orthopedic device manufacturers choose from a host of technologies to post process and finish their parts to achieve the ideal surface. ... Read more »

Randy Theken’s Views on Contract Manufacturing, Additive Manufacturing and Much, Much More

by Carolyn LaWell | May 2019

Randy Theken of Theken Companies recently launched a contract manufacturing firm and has multiple business ideas in the works. We took the opportunity to ask him what excites him about orthopedics and what has led to his success during his 25+ year career. ... Read more »

9 Orthopedic Companies that Recently Received Funding

by Carolyn LaWell | May 2019

Funding 2019 has driven research & development and regulatory activity for companies working to get their first product on the market and those seeking to expand globally. Familiar names like Intrinsic Therapeutics and Graftys, as well as new companies like HAPPE Spine and Magnesium Develop ... Read more »

EU MDR: How to Respond to Today’s Knowns and Unknowns

by Carolyn LaWell | Apr 2019

Orthopedic device companies implementing EU MDR should consider these eight actions, while thinking strategically about the unknowns of the regulation.    ... Read more »

FDA Clears First Implant with Molybdenum Rhenium Superalloy

by Carolyn LaWell | Apr 2019

MiRus received FDA 510(k) clearance for Europa, a pedicle screw made with MoRe®, a proprietary molybdenum rhenium superalloy expected to provide more strength, ductility and durability than titanium and cobalt.    ... 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 »

Numerate, Mayo Clinic Look to Drug and Device Combination to Coat Implants for Better Bone Integration

by Carolyn LaWell | Mar 2019

Orthopedic coating research focused on creating a drug and device combination is expected to support integration of existing bone with the implant—which in turn could reduce complications from implant loosening and potentially increase the lifetime of an implant.     ... 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 »

Process Automation: How Small Steps Lead to Large Productivity

by Carolyn LaWell | Mar 2019

How and why process automation will empower engineers and improve company culture, while increasing speed and quality. ... 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 »

Orthopaedic Companies Collaborate with NESTcc on Real-World Evidence Considerations

by Carolyn LaWell | Jan 2019

The National Evaluation System for health Technology Coordinating Center launched its first round of Real-World Evidence Test-Cases, which include a focus on postmarket surveillance in orthopaedics. NESTcc's Deputy Director discusses what manufacturers should know about Real-World Data and Real-Worl ... Read more »

Awake Spinal Fusion Surgeon Urges Industry to Consider Patient Experience

by Carolyn LaWell | Jan 2019

Alok D. Sharan, M.D., shares how he started performing one-level lumbar spine fusion while patients are awake and offers product development considerations to device companies. “We believe that we’ve completely transformed the experience of spinal fusion surgery,” Dr. Sharan says. ... 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 »

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 »

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 »

Surgeon Entrepreneurs Focus on Infection Prevention, Virtual Reality Training

by Carolyn LaWell | Oct 2018

Javad Parvizi, M.D. and Justin Barad, M.D. are leading critical conversations in orthopaedics and are thinking differently about product development—albeit in different ways—while maintaining a focus on better patient outcomes.  ... 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 »

How the European Union's MDR Will Impact Your Company's Supply Chain

by Carolyn LaWell | Aug 2018

OEMs must engage partners in conversations about the information needed from each party for Medical Device Regulation in order to meet regulatory requirements, timelines for CE Mark approval and make critical considerations for audits. ... Read more »

FDA Responds to Additive Questions on 510(k) Submissions, Reusing Powder, Testing

by Carolyn LaWell | Aug 2018

An agency representative, and experts from ASTM, DePuy Synthes, and SME, talked additive regulatory issues at OMTEC 2018. Among the insight provided: "Have a good process flow map of all of the steps involved. People tend to focus on the printing portion, but there are a number of steps upstream and ... 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 »

Success Story: Bruce Stroever on 30 Years of Leadership at MTF

by Carolyn LaWell | Jul 2018

Do what you say you’re going to do – pay attention – embrace change – have vision…recently retired MTF Biologics CEO Bruce Stroever shares practical advice for newcomers and veterans alike, as well as predictions for the orthobiologics market. ... Read more »

Surgeons Seek Innovation in Instruments, Delivery of Care

by Carolyn LaWell | Jul 2018

OMTEC’s Closing Panel brought together surgeon executives and entrepreneurs with diverse market backgrounds—joint reconstruction, spine and trauma—to provide perspective on patient-specific instruments, single-use devices, ASCs and more.  ... 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 »

Knee and Hip Manufacturers Focus on Additive, Materials, Robotics

by Carolyn LaWell | Mar 2018

Among our takeaways from the American Academy of Orthopaedic Surgeons Annual Meeting include the trend that products must correlate to better patient outcomes and more efficient (quicker, less expensive) procedures. ... Read more »

Surgeon Touts Benefits of Molybdenum-Rhenium in Spinal Applications

by Carolyn LaWell | Feb 2018

Dr. Kornelis Poelstra's researcn shows that molybdenum-rhenium (MoRe) offers greater strength in smaller implants compared to cobalt-chrome, titanium and stainless steel. ... Read more »

UDI: Is Your System Ready for Scale?

by Carolyn LaWell | Jan 2018

UDI requirements have led to layers of regulatory decoding, data collection and dissemination, additional costs and moments of confusion, annoyance and disapproval. ... Read more »

Startup Aims to Monitor Joint Loosening and Infection with Implantable Sensors

by Carolyn LaWell | Jan 2018

Synergistic Biosensors is working with RTI International and the North Carolina State University Department of Computer Sciences to develop a patent-pending system that detects micron shifts through an implanted sensor. ... Read more »

Consensus Orthopedics’ TracPatch Targets Efficiency in Post-Op Care

by Carolyn LaWell | Jan 2018

TracPatch data provides the healthcare provider with anytime, anywhere insight into a patient’s recovery, allowing for immediate care adjustments. ... Read more »

Polymer Designed for Jet Bearings Used in Hip and Knee Replacement

by Carolyn LaWell | Jan 2018

M.M.A. Tech’s MP-1, originally developed for NASA, was recently implanted during hip and knee replacement procedures in Israel. After finalizing its clinical trials and gaining market access, the company plans to become a supplier to device companies. ... Read more »

FDA Finalizes Additive Manufacturing Guidance

by Carolyn LaWell | Dec 2017

FDA published its guidance on additive manufacturing technical considerations, outlining the Agency’s long-awaited position on use of the technology for medical devices. ... 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 »

Examining Critical Trends in Trauma Surgery

by Carolyn LaWell | Nov 2017

Complex fractures and complications from fractures are challenging trauma surgeons’ views on periprosthetic fractures, infection prevention, weight-bearing recommendations and percutaneous pelvic fractures. ... Read more »

Coatings Support Early Integration, Infection Prevention

by Carolyn LaWell | Oct 2017

After reviewing company product launches, research and discussions, it's clear that implant coatings are of great interest to orthopaedic professionals. ... Read more »

NuVasive Founder Talks Minimally Invasive Surgery

by Carolyn LaWell | Oct 2017

Minimally invasive surgical (MIS) products are a staple of today’s spine company portfolios. In anticipation of new devices to be launched at the NASS Annual Meeting, we asked James F. Marino, M.D. about the technologies. ... Read more »

Centinel Spine to Acquire DePuy Synthes prodisc Assets

by Carolyn LaWell | Sep 2017

Centinel Spine has entered into an agreement to purchase DePuy Synthes’ worldwide prodisc assets. The acquisition is expected to close in mid-4Q17. Terms were not disclosed. ... Read more »

Additive Manufacturing Evidence: Industry Advances the Dialogue

by Carolyn LaWell | Sep 2017

A new white paper produced by the Society of Manufacturing Engineers’ (SME) Medical Additive Manufacturing/3D Printing Workgroup offers an evidence-building framework that may be used to conduct studies and set guidelines. ... Read more »

Value Analysis Committees: Develop Your Own

by Carolyn LaWell | Aug 2017

The influence of hospital VACs has created a market access risk that you must consider when assessing new technologies—before product development begins. How do you reduce that risk? One idea is to create your own panel of experts—or at the very least, interview experts—that extend beyond the ... 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 »

Yes, Your Work Influences Implant Purchasing

by Carolyn LaWell | Jun 2017

No matter your position within your company, it’s imperative that you consider how your work impacts the value created by your product. Committees have formed at hospitals and surgery centers across the U.S. with the mission to determine whether your product creates clinical and economic valu ... 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 »

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

by Carolyn LaWell | Mar 2017

A reader informed us that companies are failing the clinical evaluation portion of the initial CE Mark or audit process, and asked what insights we might 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. Orthopaedic device companies, large and small, have adopted additive manufacturing (AM) to varying degrees in implant ... Read more »