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Articles Tagged "Editor's Choice"

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 »

What Will Industry 4.0 Require of Supply Chain Leaders?

by Heather Tunstall | Mar 2020

Companies are prioritizing Industry 4.0 and its automated and data exchange manufacturing processes. This shift will require professionals to employ deep work and social and emotional learning.   ... 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 »

X-BOLT Introduces New Hip Fracture Concept

by BONEZONE | Sep 2019

X-BOLT Orthopaedics addresses the issue of screw cutout in hip fracture repair with technology that replaces the lag screw for femoral head fixation. Studies indicate that the system significantly reduces the reoperation rate.  ... Read more »

The Lathe: Engineers Take Note of Dimensions When Designing Components

by Deborah Munro, D.Eng | Jul 2019

Lathes operate differently than other machine tools; therefore, engineers must take note of design considerations for a lathe machined component.... Read more »

Zimmer Biomet Details the Ways They Manage Supplier Risk

by BONEZONE | Apr 2019

Zimmer Biomet’s supplier risk management program bolsters resiliency throughout their supply chain. More than two years into the initiative, Zimmer Biomet and their supplier, Precision Edge, share insight into how the program works and the lessons they’ve learned.   ... Read more »

The Orthopedic Business Model: Why it’s Different and How to Stay Competitive

by Dale Tempco | Mar 2019

Long lead times have summoned questions about why and how the industry faces months-long waits for products to be manufactured. We’ve been in this situation before, and need to look no further than our business model to know that we’ll be in this situation again.... 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 »

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

by BONEZONE | 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 »

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

by BONEZONE | 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 »

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

by BONEZONE | Oct 2018

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 »

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

by BONEZONE | Sep 2018

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 »

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

by BONEZONE | 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 »

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 »

Think Different About Management Reviews

by BONEZONE | Jun 2018

When done correctly—with preparation and an energized approach—these reviews can complement strategic planning and measure the effectiveness of your QMS in relation to your business model.... Read more »

Zimmer Biomet Responds to FDA Form 483

by BONEZONE | 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 »

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

by BONEZONE | 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 »

The Medical Device Labelling Process Needs to Start Early in Design Controls

by BONEZONE | Mar 2018

Mislabeled and misbranded medical devices are one of the top three causes for recalls in the United States. Companies can take several steps to minimize these mistakes — it comes down to being in control.... Read more »

Why You Should Stop Saying “Volume to Value” in Healthcare

by BONEZONE | Feb 2018

"Our goal should continue to be to improve outcomes and experience for the greatest number of patients possible by providing them with the types of care and experiences that they want and would pay for," says Mark Froimson, M.D., MBA.... Read more »

UDI: Is Your System Ready for Scale?

by BONEZONE | 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 »

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 »

Why a Well-Conceived Test Plan is Crucial to Efficient Product Development

by BONEZONE | Dec 2017

The elements are derived from the biological, mechanical or clinical performance requirements of the device and regulatory requirements for performance and safety.... Read more »

Understanding the Critical Differences Between Supplier Audit and Evaluations

by BONEZONE | Dec 2017

Martin Browning from EduQuest provides insight on evaluations and audits: "All of us who conduct audits recognize that most of them are nothing more than snapshots in time. In contrast, an evaluation gathers and analyzes data from all kinds of sources, without physical constraints associat... Read more »

UDI Direct Marking Guidance Finalized by FDA

by BONEZONE | Nov 2017

FDA did not offer device companies new direction on methods to direct mark, as it would be difficult to account for the wide variety of existing devices, use conditions and reprocessing methods.... Read more »

Your EU Medical Device Regulation Guide

by BONEZONE | Oct 2017

Big changes are underway for the European market and how it regulates medical devices with the recent unveiling of the Medical Device Regulation MDR 2017/745.... Read more »

Vivorte Launches New Bone Graft Products

by BONEZONE | Oct 2017

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

The Joint Surgeon's Wish List

by BONEZONE | 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 »

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 »

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 Should Your Supply Chain Look Like in Five Years?

by BONEZONE | Nov 2016

The supply chain has undergone greater scrutiny as stakeholders question how to find efficiency in process and spend. What changes will this spur to ensure success today—and five years from now? Supply chain experts weighed in at OMTEC 2016.... 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 »

When to Contract Your Device Testing

by Chris Mosby | Aug 2016

All medical devices must be tested. However, the varied aspects of device testing can be unfamiliar ground, and standards are often vague guidelines, open to interpretation.... 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 »

Third Party Reviews – Is This the Real Deal?

by BONEZONE | Jun 2016

Companies with simpler products like arthroscopes and surgical instruments could consider a regulatory route that doesn't start with FDA and instead utilize the Third Party Review program. The benefits to doing so include speeding time to market and saving time and resources for more complex 510(k) ... Read more »

Trade Secrets Go Federal

by BONEZONE | Jun 2016

Passage of the "Defend Trade Secrets Act" (DTSA) federalized the trade secret law. One of the key aspects of DTSA is that companies will now be allowed to file civil lawsuits in Federal court if their trade secrets have been stolen, possibly creating a new level of consistency in how trade secret la... Read more »

Trauma Surgeon Develops Fixation Platform, Looks to Future Innovations

by BONEZONE | May 2016

Thomas “Toney” Russell, M.D., an orthopaedic trauma surgeon and President and CEO of Innovision, developed the N-force fixation platform to meet his own clinical needs in optimal fixation of fractures in the extremities and pelvis. The N-force system was a massive regulatory endeavor for a surge... Read more »

Zoning In with Orthopaedic Surgeon Entrepreneurs

by BONEZONE | Dec 2015

BONEZONE looked back on some of the orthopaedic surgeon interviews conducted throughout the year to see what they had to say about the direction of the industry. Here, we recap four of those insights.... Read more »

Zoning In With Richard Randall

by BONEZONE | May 2015

ichard Randall, recently appointed CEO of OMNI, plans to drive growth by expanding the company’s robotics portfolio and targeting new partners to implement robotic devices for joint surgeries.... Read more »

Zoning In with Rod Mayer

by BONEZONE | Mar 2015

How can small companies thrive in the orthopaedic industry? Rod Mayer, President of Nextremity Solutions, shares solutions for success.... Read more »

Zoning In with Mark Augusti

by BONEZONE | Dec 2014

Mark Augusti of Integra LifeSciences discusses the company’s recent developments, including the creation of an independent spine company, SeaSpine.... 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 »

Unique Device Identification: From Compliance to Value

by BONEZONE | Oct 2012

It took five years, but the U.S. FDA has finally issued the proposed Unique Device Identification rule that will require manufacturers of medical devices to uniquely identify their products and populate FDA’s global UDI database. Orthopaedic manufacturers will be among the first impacted... Read more »