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Articles Tagged "Editor's Choice"

The Mill: What Design Engineers Need to Know about This Important Orthopedic Tool

by Deborah Munro, D.Eng | May 2019

The mill is a machine shop workhorse used for a wide array of machining tasks from simple facing to complex surface profiling. Almost every orthopedic implant and instrument is at least partially fabricated on a mill. Understanding its use is valuable to all design engineers.... 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 »

UDI Laser Marking Improved with Vision Technology

by BONEZONE | Apr 2019

Today’s laser marking technology has advantages and limitations depending upon your type of orthopedic part and your budget. A Unique Device Identification mark can be applied to a device using multiple methods, ranging from chemical etching to laser marking. Laser marking, particularly fiber... 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 »

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 »

Orthofix M6-C Disc Granted FDA Premarket Approval

by BONEZONE | Feb 2019

Clinical data on the disc demonstrated meaningful improvement in pain and lowered disability vs. anterior cervical discectomy and fusion in the treatment of cervical radiculopathy, with or without cord compression.... Read more »

Skills Gap Hampers Manufacturing Growth, Says Tooling U-SME Report

by BONEZONE | Jan 2019

Manufacturers recognize the challenge of the skills gap, but far too many fail to change their workforce development and training processes. The report details manufacturers’ trouble areas and identifies best practices for strengthening your team.... Read more »

NuVasive Announces New Organizational Structure, Streamlined Leadership Team

by BONEZONE | Jan 2019

CEO J. Christopher Barry, hired in November, implemented several changes to NuVasive's executive team to “lead the company’s next phase of growth and innovation.”... Read more »

Smith & Nephew Acquiring Ceterix, Meniscal Repair Technology

by BONEZONE | Dec 2018

Ceterix Orthopaedics is the developer of the NovoStitch® Pro Meniscal Repair System. SNN will pay up to $105MM, comprising an initial cash consideration of $50MM and $55MM over the next five years, contingent upon financial performance.... Read more »

Streamlined Inspections Imperative to Success of Micro-Machining Complex Components

by BONEZONE | Dec 2018

Maintaining the quality and repeatability that device companies require involves consistent, reliable and verifiable measurement and inspection of these small and complex parts, which in some cases is needed down to the micro and sub-micron levels.... Read more »

Precision OS: Using Virtual Reality for Surgeon Education, Pre-Operative Planning

by BONEZONE | Nov 2018

“VR’s ability to offer a safe environment to make mistakes is valuable in providing surgeons with building blocks on which to learn,” said Dr. Danny P. Goel, CEO. “Our technology goes beyond the technical steps of a procedure, through the enhancement of skills necessary to impact patien... Read more »

Professional, Personal Success Linked to Knowing Yourself and Achieving Your Goals

by BONEZONE | Nov 2018

Leveraging decades of training, managerial and life experience, orthopaedic industry veteran G. Bryan Cornwall, Ph.D., PEng, shares the insights that helped him hone his own professional and personal development skills.... Read more »

Orthopaedic Product Development: Forecasting Changes to Come

by BONEZONE | Nov 2018

Considering surgical techniques, regulations and technologies together as a whole, expect to see significant changes in orthopaedics over the next decade. Here we present seven shifts that OEMs should consider when choosing new product development initiatives.... Read more »

Orthopaedic Investors Prioritize Care Delivery, Post-Revenue Companies

by BONEZONE | 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 »

Synthetic Bioresorbables: Orthopaedics’ Evolution from PLLA to New Formulas

by BONEZONE | Nov 2018

These polymers have broad orthopaedic application. This article presents a focus on the transition away from Poly-L-lactic acid (PLLA)-type resorbable polymers to updated and novel resorbable biomaterials that are designed to perform better clinically.... Read more »

Smart Devices, Robotics, Sensors: Tools to Improve Patient Outcomes

by BONEZONE | Oct 2018

Dr. Martin Roche explains how these technologies are shaping the future of orthopaedic surgery: "A surgeon needs data to make objective decisions intra-operatively. The subjective Art of Surgery is poorly translatable ... Through all this rapid evolution, the clinician must take a leadership role."... Read more »

NuVasive Announces Christopher Barry to Succeed Gregory Lucier as CEO

by BONEZONE | Oct 2018

Christopher Barry joins NuVasive from Medtronic, where he has served as Senior Vice President and President, Surgical Innovations, since January 2015. Gregory Lucier will remain Chairman of the Board.... Read more »

OEMs Continue Focus on Reducing Instruments in Operating Rooms

by BONEZONE | Oct 2018

Several device companies within the last two years have capitalized on the shift toward simpler surgeries with fewer instruments in the forms of recent product launches or revisions, process initiatives and 510(k) clearances.... Read more »

Orthobiologics for Fracture Repair, Knee Cartilage Defects: 3Q18 Study Highlights

by BONEZONE | Oct 2018

Bone Therapeutics (ALLOB® allogeneic bone cell therapy) and Histogenics (NeoCart® tissue-engineered knee implant) are two of the five companies we tracked that announced completed studies in the last three months.... Read more »

Sterilization Expert Stresses Importance of Biocompatibility, Endotoxins, Planning

by BONEZONE | Oct 2018

Recent updates to standards and regulatory guidance have made these processes more complex: “When you look at [sterilization] as a process, rather than a step, you’re much more capable of avoiding problems rather than reacting to them when they happen."... Read more »

Surgeon Entrepreneurs Focus on Infection Prevention, Virtual Reality Training

by BONEZONE | 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 »

Stryker Moves to Strengthen Spine Business with $1.4 Billion Purchase of K2M

by BONEZONE | Sep 2018

K2M’s innovative technology platform will add a suite of complex spine solutions to Stryker’s core spine portfolio; K2M’s consistent support of additive manufacturing of devices could also benefit Stryker’s long-term growth.... Read more »

Ortho Development Announces First Surgery Using Balanced Knee System in China

by BONEZONE | Aug 2018

The company’s BKS features implants and instrumentation that address primary and revision procedures. A patented locking mechanism is designed to minimize micro-motion between the plastic tibial insert and titanium tibial baseplates.... Read more »

Spinal Cages Continue Trend Toward Metals, Expandable Designs

by BONEZONE | Aug 2018

"Cage design has been a game changer in spine surgery." Three veteran spine surgeons provide insight into the shift to titanium, a forecast for the next five years in cage technology and thoughts on device companies' priorities.... Read more »

Surgeons Establish Society to Advance Complex Additive Applications

by BONEZONE | Aug 2018

The American Orthopaedic Society of 3D Printing was formed to allow for orthopaedic surgeons to collaborate on the use of complex and customized clinical applications of additive manufacturing in revisions, limb salvage, and reconstructive surgeries.... Read more »

OEMs Share Perspectives on Additive Manufacturing Challenges

by BONEZONE | Aug 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 »

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 »

Tecomet Bolsters Instrument Manufacturing With Acquisition of HD Surgical

by BONEZONE | Jul 2018

As the number one-ranked contract manufacturer serving the orthopaedic market, based on 2017 ORTHOWORLD revenue estimates, the purchase aligns with Tecomet's recent M&A activity. HD Surgical manufactures high-precision instruments and possesses a wide array of machining capabilities.... Read more »

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

by BONEZONE | 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 BONEZONE | 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 »

Supply Chain Quality Panel, Part II: OEM and Supplier Perspectives

by BONEZONE | Jul 2018

In this installment, supply chain experts from Autocam Medical, MicroPort Orthopedics, Orchid Orthopedic Solutions and Zimmer Biomet discuss challenges associated with EU MDR, third-party audits and the need for more consistency across industry.... Read more »

Supply Chain Quality Panel, Part I: OEM and Supplier Perspectives

by BONEZONE | Jun 2018

In this installment, supply chain experts from Autocam Medical, MicroPort Orthopedics, Orchid Orthopedic Solutions and Zimmer Biomet discuss customer differentiation, building partnerships, regulatory challenges and continuous improvement efforts. ... 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 »

Spine, Joint Recon Product Launches Focus of Top Orthopaedic Companies

by Julie Vetalice | Jun 2018

The 1H18 product launches by the top orthopaedic companies were largely focused on the market segments of spine and joint reconstruction. We offer a list of new products and their descriptions. ... Read more »

Prototyping: OEM Survey Highlights Challenges

by BONEZONE | May 2018

We surveyed engineers and senior-level employees from orthopaedic device companies of all sizes, asking about prototyping, 3D printing, in-house vs. outsourcing, significant challenges and more.... Read more »

Study: Indentations on Artificial Femoral Heads Could Improve Implant Longevity

by BONEZONE | May 2018

By simulating the textured surface of cartilage, researchers from the University of Arkansas and the Czech Republic have found that using prostheses with square micro-dimples could extend the life of hip implants.... Read more »

Optimizing Your Supply Chain with Science, Data and People

by BONEZONE | May 2018

It is recommended to implement your optimal management of inventory, capacity and response time buffers to get the best possible solution for your unique challenges.... Read more »

Orthopaedic Industry Reaches $49.3 Billion, Grows 3.7%

by BONEZONE | May 2018

Of note is the growth of the 20 largest orthopaedic device companies, which combined comprise 76% of the market.... Read more »

Protecting Your Design with Patents

by BONEZONE | May 2018

A smart legal strategy is to develop a comprehensive intellectual property portfolio of the various diverse—but related—IP rights associated with the inventive device.... Read more »

Successful Medical Device Design Transfers Hinge on Advance Planning

by BONEZONE | Apr 2018

Elements of a well-constructed plan include an understanding of regulatory requirements, a comprehensive review of all documentation and a thorough understanding of manufacturing methods and processes.... Read more »

Start Simple: Advice to Effectively Use Statistical Methods in Process Validation

by BONEZONE | Apr 2018

Thorough process development, optimization and control using appropriate statistical methods and tools is recommended to show that processes are stable and capable.... Read more »

Smith & Nephew Names CEO with Acquisition, Turnaround Experience

by BONEZONE | Apr 2018

Mr. Namal Nawana's experience includes 15+ years with Johnson & Johnson, primarily in the Medical Devices & Diagnostics segment and culminating in 2011 with his appointment as Worldwide President of DePuy Synthes Spine.... Read more »

Scientists Successfully Test New Titanium Plate for Bone Tissue Repair

by BONEZONE | Apr 2018

In animal testing, the patented titanium fiber plates did not demonstrate bone embrittlement after close contact for prolonged periods.... Read more »

Rapid + TCT Additive Conference Ramps up Medical Presence with MMI Series

by BONEZONE | Mar 2018

This year’s event, April 23-26 in Fort Worth, Texas, features several educational sessions and topics of interest for orthopaedic medical device professionals.... Read more »

Spine, Trauma Companies Continue a Focus on Sterile Packaging

by BONEZONE | Mar 2018

Increased infection rates at hospitals, regulatory implications on cleaning and the efforts of hospitals to cut costs have all driven sterilization changes in device packaging.... Read more »

The Contribution of Biomaterials to the Dawning of the Age of the Forgotten Hip

by BONEZONE | Mar 2018

Primary total hip arthroplasty (THA) has undergone 25 years of product development, thanks to contributions from a host of materials technologies. We look back at the history and also look forward to predict advancements.... 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 »

Surgeon Touts Benefits of Molybdenum-Rhenium in Spinal Applications

by BONEZONE | 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 »

Sensors: Conducting MEMS Research and Fabrication in Open-Use Facilities

by BONEZONE | Feb 2018

Microelectro mechanical systems (MEMS) are an exciting and innovative technology that can bring increased functionality and capability to medical device designs, thus providing more diagnostic information and hopefully improving patient outcomes.... Read more »

Supplier M&A on the Rise

by BONEZONE | Feb 2018

Over an eight-year span, the gap between the number of OEM transactions versus those in the supplier space was its narrowest in 2017.... Read more »

Smith & Nephew’s eCAP Shows 97% Decrease in Readmission Rates

by BONEZONE | Feb 2018

The initiative is designed to mitigate risk associated with readmissions in value-based healthcare reimbursement models.... 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 »

RTI Surgical Expanding Spine Fusion Portfolio, Acquires Zyga Technology

by BONEZONE | Jan 2018

Zyga Technology is the developer of the SImmetry® Sacroiliac Joint Fusion system.... Read more »

The Brazilian Market: A Regulatory Overview for Orthopaedic Products

by BONEZONE | Jan 2018

Most Brazilian surgeons use imported products, making the country attractive for international companies. Placing products on the market means creating relationships with Brazilian companies and understanding orthopaedic-specific regulations.... Read more »

Startup Aims to Monitor Joint Loosening and Infection with Implantable Sensors

by BONEZONE | 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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

The Fundamentals of a Human Factors Program

by Hannah Corcoran | Oct 2015

Prudent manufacturers already know that the deployment of human factors and usability engineering go beyond meeting regulatory requirements. Manufacturers can leverage their programs to cut costs, mitigate risks and understand how they stack up to competition in the market.... Read more »

Regulatory Expert Builds Web Tool to Assist Companies with 510(k)s

by Hannah Corcoran | Jul 2015

Frustrated with FDA’s 510(k) search function, Eric Eggers created kBLASTER to help companies simplify and speed their 510(k) submissions.... 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 2018 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 »

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 »

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 »