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Articles Tagged "Editor's Choice"

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 »

Polymer Designed for Jet Bearings Used in Hip and Knee Replacement

by BONEZONE | 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 »

Forward Momentum Continues in Artificial Discs

by BONEZONE | Dec 2017

We highlight recent clinical trial results, a procedural milestone and a device launch.... Read more »

Study: Rotation Medical Bioinductive Implant Promotes Consistent Rotator Cuff Healing, Mitigates Tear Progression

by BONEZONE | Dec 2017

The study also shows the bioinductive implant increases tendon thickness for intermediate- to high-grade partial thickness tears.... Read more »

FDA Finalizes Additive Manufacturing Guidance

by BONEZONE | 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 »

Examining Methods to Determine Sample Sizes

by BONEZONE | Dec 2017

Consider use of the acceptance sampling approach or the six sigma acceptable error approach to determine a sample size using statistics.  ... 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 »

Learn to Incorporate Sensors Into Your Next Design Idea

by BONEZONE | Dec 2017

Micro Electro Mechanical Systems, referred to as MEMS devices or sensors, are being used for tasks that were previously only conceived of in science fiction.... Read more »

Sanford Health Stem Cell Therapy Trial First in U.S. for Shoulder Injuries

by BONEZONE | Dec 2017

The hospital system is attempting fat-based stem cell treatments on orthopaedic patients, using the cells to heal small/partial thickness rotator cuff tears. It's the first trial in the U.S. to gain FDA approval for the use of adipose stems cells to treat the injury.... Read more »

Medical Device Single Audit Program Attracts Growing Interest from U.S. Companies

by BONEZONE | Dec 2017

While device manufacturers were slow to adopt the program in its pilot days, the initiative has gained traction since FDA named it an official program earlier in 2017.   ... 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 »

DT MedTech Receives 510(k) Clearance for Hintermann Total Ankle

by BONEZONE | Nov 2017

The Hintermann Series H2 is a semi-constrained cemented prosthesis for primary or revision surgery, also indicated to treat failed total ankle replacement or non-union/mal-union of the ankle arthrodesis.... Read more »

Smith & Nephew's NAVIO Used in Bi-Cruciate Retaining Total Knee Replacement

by BONEZONE | Nov 2017

SNN completed the first robotics-assisted bi-cruciate retaining total knee replacement with its NAVIO® system and the JOURNEY™ II XR bi-cruciate retaining total knee.... Read more »

New Grant to Support Device Coating Research

by BONEZONE | 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 »

Smith & Nephew Adds to Sports Medicine Portfolio with Rotation Medical Acquisition

by BONEZONE | Nov 2017

Rotation Medical’s collagen-based bioinductive implant for rotator cuff repair boosts Smith & Nephew’s arthroscopy/soft tissue portfolio and focus on regenerative medicine.... Read more »

Spine Companies Target New Applications of PEEK and Metals for Implant Innovation

by BONEZONE | 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 BONEZONE | 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 »

Surgical Assistance: Milestones and Funding

by BONEZONE | Oct 2017

Within the second half of 2017, we’ve noticed a jump in announcements pertaining to what we call “surgical assistance” tools: platforms designed to improve ease of use, support a personalized implant fit for patients, etc. Here’s what’s been making the headlines.... Read more »

Smith & Nephew CEO Announces 2018 Retirement; Acquisition Buzz Returns

by BONEZONE | Oct 2017

Smith & Nephew's Chief Executive Officer, Olivier Bohuon, announced his intention to retire by the end of 2018 after seven years in the position. The Board is searching for his successor.... 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 »

Musculoskeletal Transplant Foundation Rebrands as MTF Biologics

by BONEZONE | Oct 2017

Today, the surgeon-founded entity offers R&D in pursuit of new biologics to support tissue regeneration. ... Read more »

Risk Assessments: How Often Should I Update Them?

by BONEZONE | Oct 2017

Denise Dion from EduQuest provides advice on when to update your risk documentation.... Read more »

DePuy Synthes Adds Hip Replacement Navigation through JointPoint Co-market Agreement

by BONEZONE | Sep 2017

DePuy Synthes entered into an exclusive U.S. agreement with JointPoint to co-market a surgical navigation platform for total hip replacement, beginning in 2H17.... 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 »

Improve Your Performance With These Tips

by BONEZONE | 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 »

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 »

Infection Prevention Spurs New R&D Ideas

by BONEZONE | Jun 2017

Post-surgical infection control remains a topic of importance in orthopaedic product development, as surgeons, researchers and device companies continually seek to reduce complications, readmissions, revisions and cost. The sense of priority was validated at OMTEC® 2017, when these groups met to ad... Read more »

Pareto Analysis: Tools for New Product Testing

by BONEZONE | May 2017

Testing is, of course, a critical component to product development. To better understand how it can be proactively employed to help ensure product quality and longevity, we reached out to John McCloy, Founder & President of Engineered Assurance and author of the article on the industry’s 1% fa... Read more »

Elos Medtech’s Advantage Lies in Nimble Approach to Serve Orthopaedic Customers

by BONEZONE | May 2017

As part of its strategy to become a global solutions provider to the medical device industry, Elos Medtech acquired U.S. based Onyx Medical in 2015, effectively establishing a presence in the largest orthopaedic market.... Read more »

Orthopaedic Industry Revenue Reaches $48.1 Billion

by BONEZONE | 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 »

Leading Supply Chains Adopt These Principles

by BONEZONE | May 2017

As a purchasing or sourcing professional, you face pressures to understand and work with every facet of your own business while simultaneously working with supplier customers who face their own set of demands. At the end of the day, work needs to get done. These principles provide a reminder of rela... Read more »

Material Scientist Predicts Hip and Knee Advancements

by BONEZONE | May 2017

Surgical assistance technologies and services to track episodes of care have dominated joint reconstruction product development conversations in recent years, as players seek to innovate in a space that already claims highly successful procedures and implants.... Read more »

FDA 510(k) Insights: March Clearance Highlights

by BONEZONE | Apr 2017

Strategic FDA 510(k)s released in March 2017 include a cannula from AJU Pharm, Bodycad's uni knee, a new company from Surgical Frontiers' portfolio and a revision system from MicroPort Orthopedics.... 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 »

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 »

Resubmitting a 510(k) is More Than a Regulatory Decision

by John Gagliardi | Sep 2016

Do changes to your device warrant a 510(k) submission? There are several elements to consider: design controls compliance, risk analysis and postmarket surveillance data, among them.... 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 »

Making the Most of UDI

by Chris Mosby | Aug 2016

UDI regulations have altered your business. Gaining solid ROI from your compliance efforts comes down to internal efficiency, capturing your own master data and learning how to use that data for product development, marketing and logistics.... Read more »

Simplify to Succeed: Instrument Reduction in the OR

by Chris Mosby | Aug 2016

As the workload increases for orthopaedic surgeons, there is a greater need for effective surgery sets. Finding a way to reduce the burden that instrumentation can place on the system is a focus for much of the healthcare system.... Read more »

Instrument Testing: How to Capture the Best Data

by BONEZONE | 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 »

New Trauma Technologies Emerge to Treat Infections

by BONEZONE | Jul 2016

Infection control has been on the radar of various orthopaedic device companies, from start-up to top five. In the trauma market, technologies intended to minimize post-surgical infections are emerging as a potential solution to curb rising healthcare costs.... Read more »

How to Register Your Device in Australia

by Chris Mosby | Jul 2016

This article provides a high-level view of how a company can enter the Australian market and leverage their CE Marking in the process.... 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 »

OMTEC 2016: Download Presentations Critical to Your Success

by BONEZONE | Jun 2016

OMTEC 2016, with its critical education sessions and bustling exhibit floor, whirred by in a flash. If you weren't able to attend the event, missed a session you wanted to attend, or just needed to see your favorite speaker's presentation one more time, you're in luck. Download slideshow presentatio... 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 »

Invibio Settles FTC Antitrust Allegations Concerning PEEK Market

by BONEZONE | May 2016

Invibio, the first company to sell implant-grade polyetheretherketone or PEEK, agreed to settle Federal Trade Commission (FTC) charges that it violated antitrust law by using long-term, exclusive contracts to maintain a market monopoly.... Read more »

Midwest Orthopaedics at Rush Offers Flat Fee Payment Option, Shares Price Structure

by BONEZONE | May 2016

Midwest Orthopaedics at Rush (MOR), in Chicago, Illinois, is now offering patients package pricing—a flat fee payment option—for treating some of the most common orthopaedic conditions. MOR has listed the price structure on their website. At present, there are five surgical procedures that ... Read more »

DFM: Partnerships, Considerations and Whom to Involve

by BONEZONE | May 2016

Design for manufacturability (DFM) is an essential element to the success of new devices from a standpoint of time and cost. Designs must be created with manufacturing in mind, before the design is locked down, to mitigate areas in production that would drive up costs and delay product launch. Howev... 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 »

Surgeons Seek Muscle-Sparing Techniques in Arthroscopy/Soft Tissue Repair Market

by BONEZONE | Apr 2016

Growth in the arthroscopy and soft tissue repair market is propelled by surgeon requests for devices that employ muscle- and tissue-sparing techniques to return patients to activity faster and with less pain. This is largely being driven by patients in this segment, particularly athletes and “week... Read more »

OEMs Achieve Sustainable Manufacturing Costs Through Supplier Relationships

by BONEZONE | Apr 2016

For cost reductions and supplier relationships to be sustainable, you must address more than just the quoted price. You must attack real supply chain improvement and cost drivers at both the supplier and the OEM with the intent to reduce cost while maintaining or improving margins. This article... Read more »

FDA Releases UDI Education as Deadline Approaches

by BONEZONE | Apr 2016

FDA released a series of resources to help companies understand GUDID submission, UDI labelling regulations and compliance schedules. The resources include slideshow presentations and video interviews with FDA.... Read more »

FDA Releases Final Guidance on Human Factors and Usability Engineering

by BONEZONE | Apr 2016

The Agency released the final guidance on considerations for human factors data in premarket submissions, as well as two draft guidances on the topic.... Read more »

Proving Medical Necessity: the Need for Evidence in Reimbursement

by BONEZONE | Mar 2016

Providers, OEMs and suppliers all say that they’ve been impacted by complexities in the reimbursement system. For example, bundled payments and an increased burden of evidence have changed the way that products are developed and launched. One theme has arisen from the many conversations—not a ne... Read more »

Sports Medicine Surgeon Embraces Push for Value in Industry

by BONEZONE | Mar 2016

Brett Sanders, M.D., created Tensor Surgical in 2012, a value-based sports medicine company. The focus of the company is to stay lean and increase revenue, while continuing to work on tunnel-specific devices for arthroscopic shoulder repair.... Read more »

Speed and Production-Equivalency Lead Prototyping Demands

by Hannah Corcoran | Mar 2016

Prototyping is a critical factor in the design stage. Competition in the industry, regulatory guidelines, speed to market, production-equivalency and additive manufacturing are influencing the prototyping conversation.... 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 »

Outsource Innovation by Tapping into Supplier Expertise

by David Finch | Nov 2015

When it comes to outsourcing, the traditional role of suppliers is based upon their core competencies in manufacturing or specialty services.... 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 »

International and Domestic Manufacturers Compete to Serve Growing Asian Population

by Ames Gross | Oct 2015

Orthopaedics remains an attractive and growing market, especially in Asia. Multiple factors contribute to the growth of the orthopaedic market in this region.... Read more »

Successful Purchasing Strategies Consider More than Price

by Jeoff Burris | Apr 2015

Proactive purchasing leaders understand the vision for the business, and manage supply chains to drive it to completion. Follow these steps to strategically manage your commodities.... 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 »

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 2015 and beyond. CEOs seeking to buy or sell should consider these best practices and expert tips.... Read more »

Surgeons Share Spine Device Trends and Challenges

by Hannah Corcoran | Oct 2014

Spine surgeons discuss trends that excite them, their biggest challenges when using devices and what they want you to know when working with them to collectively improve spinal care.... Read more »

The “Cost to Serve” Customer Fulfillment

by Doug Hicks | Aug 2014

Manufacturers can gain critical insight on customer and product profitability when “cost to serve” activities are measured and assigned.... Read more »

Five Steps to Regulatory Strategy Development

by Mark D. Kramer, RAC | Mar 2014

Regulatory requirements continue to evolve and become increasingly complex. A solid strategy and execution can maximize opportunity to achieve regulatory goals and provide competitive advantage.... Read more »

Synergetic Dissimilarity: Design Validation/Verification and Process Validation

by John Gagliardi | Mar 2014

Verification and validation are commonly confused. John Gagliardi defines the intertwined engineering tools and outlines how they are practiced.... Read more »

Mitigate Patent Infringement Risk with an FTO

by John W. Boger, Esq. | Oct 2013

Performing an FTO search is a critical tool when developing or getting ready to launch a new product. Here's how to execute the three-stage process.... 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 »