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 »
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 »
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 »
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 »
